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OECD Unique Identifier details

DP-356Ø43-5
Commodity: Soyabean / Soybeans
Traits: Acetolactate synthase (ALS) inhibitors tolerance,Glyphosate tolerance
European Union
Name of product applicant: Pioneer
Summary of application:

The genetically modified soybean DP-356Ø43-5, as described in the application, expresses the GAT protein which confers tolerance to glyphosate herbicides and GM-HRA protein which confers tolerance to ALS-inhibiting herbicides.

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Date of authorization: 10/02/2012
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):
Please see the EU relevant links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Event specific real-time quantitative PCR based method for genetically modified soybean DP-356Ø43-5. - Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for Detection
Reference Material
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Authorization expiration date (a blank field means there is no expiration date) 9/2/2022
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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Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Australia
Name of product applicant: Pioneer Hi-Bred International Inc.
Summary of application:
Dual herbicide tolerant soybean 356043 has been genetically modified for tolerance to the broad-spectrum herbicide glyphosate and acetolactate synthase (ALS)-inhibiting herbicides.
The intended product name for this soybean is Optimum GAT.
Soybean 356043 plants express two novel proteins, GAT4601 (glyphosate acetyltransferase) and GM-HRA (modified version of a soybean acetolactate synthase). The GAT4601 protein, encoded by the gat4601 gene, confers tolerance to glyphosate-containing herbicides by acetylating glyphosate and thereby rendering it non-phytotoxic. The GM-HRA protein, encoded by the gm-hra gene, contains two specific amino acid changes to the soybean GMALS enzyme, an essential enzyme in the biosynthesis of branched chain amino acids in plants. Expression of the GM-HRA enzyme confers tolerance to the ALS-inhibiting class of herbicides such as the sulfonylureas.
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Date of authorization: 18/02/2010
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): 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 A1006 - Food derived from Herbicide-tolerant Soybean Line DP-356043-5
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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)

Canada
Name of product applicant: Pioneer Hi-Bred Production Ltd.
Summary of application:
Soybean event 356043 (tradename Optimum GAT) was genetically modified using recombinant DNA techniques to introduce the coding sequences and associated regulatory sequences for a novel glyphosate acetyltransferase variant (gat4601) and an acetolactate synthase (ALS) from Glycine max (gm-hra). The gat4601 sequence codes for a novel glyphosate acetyltransferase, a variant of the native Bacillus licheniformis enzyme, which acetylates the herbicidal active ingredient glyphosate in the presence of acetyl-CoA. The gm-hra sequence codes for an acetolactate synthase, which catalyses the first step in the synthesis of the branched-chain amino acids (valine, leucine, and isoleucine). Expression of the GAT4601 and GM-HRA proteins confers tolerance to ALS-inhibiting herbicides and herbicides containing glyphosate in soybean event 356043.

The assessment conducted by Food Directorate evaluators determined: how soybean event 356043 was developed; how the composition and nutritional quality of soybean event 356043 compared to non-modified varieties; and what the potential is for event 356043 soybeans to be toxic or cause allergic reactions. Pioneer Hi-Bred Production has provided data which demonstrates that event 356043 soybeans are as safe and of the same nutritional quality as traditional soybean varieties used as food in Canada with the exception of a nominal increase in two fatty acids (heptadecanoic acid and heptadecenoic acid), and the presence of five acetylated amino acids (N-acetylaspartate, N-acetylglutamate, N-acetylserine, N-acetylthreonine, and N-acetylglycine). The two fatty acids do not pose a nutritional concern and are readily metabolized within the body. Acetylated amino acids are present in a wide variety of foods. Furthermore, the levels of acetylated threonine, serine, and glycine in soybean event 356043 are comparable to the conventional soybean cultivar Jack.

The Food Program has a legislated responsibility for the pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Division 28). Food use of soybean event 356043 is considered novel under the following part of the definition of novel foods:

"c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

(I) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism."
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Date of authorization: 23/09/2009
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): 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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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: Dupont Colombia S.A
Summary of application:

Authorization of the genetically modified soy 356043 tolerant to herbicide glyphosate

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Date of authorization: 24/06/2010
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (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: Du Pont K.K.
Summary of application:

DP-356043-5 is genetically modified soybean to be tolerant to herbicide glyphosate and acetolactate synthase inhibitors (gat4601, gm-hra, Glycine max (L.) Merr.).

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Date of authorization: 19/07/2007
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the links below (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), Food
Food safety assessment performed by Food Safety Commission of Japan (in Japanese), Feed
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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)

Mexico
Name of product applicant: Híbridos Pioneer de México, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 59


The genetically modified soybean DP-356Ø43-5, as described in the application, expresses the GAT protein which confers tolerance to glyphosate herbicides and GM-HRA protein which confers tolerance to ALS-inhibiting herbicides.

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Date of authorization: 21/08/2008
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: DP-356Ø43-5 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

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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: Pioneer Hi-Bred International Inc.
Summary of application:

Dual herbicide tolerant soybean 356043 has been genetically modified for tolerance to the broad-spectrum herbicide glyphosate and acetolactate synthase (ALS)-inhibiting herbicides.
The intended product name for this soybean is Optimum GAT.
Soybean 356043 plants express two novel proteins, GAT4601 (glyphosate acetyltransferase) and GM-HRA (modified version of a soybean acetolactate synthase). The GAT4601 protein, encoded by the gat4601 gene, confers tolerance to glyphosate-containing herbicides by acetylating glyphosate and thereby rendering it non-phytotoxic. The GM-HRA protein, encoded by the gm-hra gene, contains two specific amino acid changes to the soybean GMALS enzyme, an essential enzyme in the biosynthesis of branched chain amino acids in plants. Expression of the GM-HRA enzyme confers tolerance to the ALS-inhibiting class of herbicides such as the sulfonylureas.

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Date of authorization: 29/04/2010
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
FSANZ completed a comprehensive safety assessment of food derived from soybean line DP-356043-5, which was released in the First Assessment Report. This assessment included consideration of (i) the genetic modification to the plant; (ii) the potential toxicity and allergenicity of the novel proteins; (iii) the composition of soybean DP-356043-5 compared with that of conventional soybean varieties; and (iv) the nutritional adequacy of soybean DP-356043-5 when incorporated into the diet. No public health and safety concerns were identified in the pre-market safety assessment. On the basis of the available evidence, including detailed studies provided by the Applicant, food derived from dual-herbicide tolerant soybean line DP-356043-5 is considered as safe and wholesome as food derived from other commercial soybean 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: Application A1006 - Food derived from Herbicide-tolerant Soybean Line DP-356043-5
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

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

Useful links
Relevant documents
Stacked events:

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

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

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

Philippines
Name of product applicant: Pioneer Hi-Bred Philippines
Summary of application:
Pioneer Hi Bred has developed a transgenic soybean product via microprojectile bombardment of somatic embryos, to express the GAT460 I (glyphosate acetyltransferase) and GM-HRA (modified version of a soybean acetolactate synthase) proteins. The GAT460 I protein-confers tolerance to the active ingredient glyphosate by acetylating glyphosate and thereby rendering it non-phytotoxic. The GM-HRA protein confers insensitivity to the ALS-inhibiting class of herbicides. 356043 soybean, therefore, allows the use of glyphosate and ALS-inhibiting class of herbicides, making weed management in soybean production more efficient and effective.
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Date of authorization: 26/11/2009
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Pioneer Hi Bred submitted applications to the Bureau of Plant Industry (BPI), requesting for biosafety permits under Administrative Order (AO) No.8 for Soybean DP356043 for direct use as food, feed, or for processing. Soybean has been genetically modified for herbicide tolerance. Soybean DP356043 has been evaluated according to safety assessment by concerned agencies of the Department of Agriculture, such as the Bureau of Animal Industry (BAI) for feed safety, and Bureau of Fisheries and Product Standards (BAFPS) for food safety, and a Scientific Technical Review Panel (STRP) members. The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues which includes molecular characterization, protein characterization, toxicological, allergenicity and nutritional issues and food/feed comparison The petitioner/applicant published the Public Information Sheet (PIS) of the said application in two widely circulated newspapers to solicit comments from the public. BPI received no comment on the petition during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team, in consultation with DA Biotechnology Advisory Team (DA-BAT), completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Geronima P. Eusebio
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 203
Fax number:
Country introduction:

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

 

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Stacked events:

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

 

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

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

(a) genetic engineering, or

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

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

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

Notificatlon Requirement for Plant Products Carrying Stacked Genes

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

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

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

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

Republic of Korea
Name of product applicant: DuPont (Korea) Inc.
Summary of application:

Glyphosate herbicide tolerance, Sulfonylurea herbicide tolerance

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Date of authorization: 06/08/2010
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Singapore
Name of product applicant: Dupont
Summary of application:

Apply for use as food or feed or for processing 

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Date of authorization: 27/04/2011
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):
Soybean 356043 (DP-356043-5) is tolerant to herbicide glyphosate and to acetolactate synthase (ALS)-inhibiting herbicides. Protection is conferred by expression in the plant of two proteins: GAT4601 (glyphosate acetyltransferase) and GM-HRA (modified version of a soybean ALS). The GAT4601 protein, encoded by the gat4601 gene, confers tolerance to glyphosate-containing herbicides by acetylating glyphosate and thereby rendering it non-phytotoxic. The GM-HRA protein, encoded by the gm-hra gene, is able to function in the presence of the ALS inhibiting class of herbicides, thereby conferring tolerance to those herbicides. Molecular analyses showed that one copy of each novel gene has been inserted at a single site in the plant genome and the genes are stably inherited from one generation to the next. GAT4601 and GM-HRA are non-toxic and unlikely to be allergenic in humans. There are no compositional differences in forage or seed from transgenic soybean 356043, compared to non-GM counterpart. The metabolite residues (N-acetyl glyphosate and N-acetyl aminomethylphosphonic acid) generated by glyphosate-treated soybean 356043 plants are considered less toxic than glyphosate. Soybean line 356043 is considered as safe as food derived from other commercial soybean 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:
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Authorization expiration date (a blank field means there is no expiration date)
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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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Relevant documents
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: Du Pont Pioneer
Summary of application:

The GM soybean 356043 is produced by microparticle bombardment.. The soybean expresses gm-hra protein which confers tolerance to herbicide products containing sulfonylurea

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Date of authorization: 26/09/2011
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Biosafety Clearing House (BCH)
Summary of the safety assessment (food safety):
The GM soybean 356043 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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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 Agriculture Forestry and Fisheries
Contact person name:
Nompumelelo Mkhonza
Website:
Physical full address:
30 Hamilton street, Harvest House building, Arcadia, Pretoria, 0001
Phone number:
+2712 319 6382
Fax number:
+2712 319 6298
Country introduction:
Useful links
Relevant documents
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

Turkey
Name of product applicant: Special case: please show below
Summary of application:

Application for direct use as feed


Turkish Biosafety Law, entered in force in 2010, diverges from EU legislations in some points


 such as food and feed use require different separate applications, risk assessments and approvals.


 Addition, our Law forsees prision sentences in some circumtances of Law violation and joint


 reponsibilities for the violation. Therefore, GM product owners avoid to make application for approval and non product developer have made application till now. Instead, some Turkish assosiations  such as poultry producers assosiations, animal feed assosiations have applied to get approval for import of GM products for their members. Thus, name of product applicant is not product developers for our country.


 


Turkish Poultry Meat Producers and Breeders Association

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Date of authorization: 05/11/2015
Scope of authorization: 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):
After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee Biosafety Board has approved the use of genetically modified soybean 356043 and products thereof for animal feed.
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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):
DG of Agricultural Research and Policies (TAGEM)
Contact person name:
Ramazan BULBUL
Website:
Physical full address:
Universiteler Mah. Dumlupınar Bulvarı, Eskişehir Yolu 10. Km Çankaya/ANKARA/TURKEY
Phone number:
+90 312 307 60 48
Fax number:
+90 312 307 61 90
Country introduction:

Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010.

 Main objectives of the Biosafety Law are;

  • to prevent risks that may arise from GMO’s and products which are produced by using of modern biotechnology by taking into account scientific and technological developments;
  • to establish and implement biosafety system to ensure protection and sustainability of environment, biological diversity and health of human, animal and plant;
  • to inspect, regulate and monitor the activities in the scope of the law.

 The Law includes specific points regarding research, development, processing, releasing on the market, monitoring, using, import, export, handling, transportation, packaging, labelling, storage and similar operations in relation to GMO and GMOPs.

 Veterinarian medicinal products and medicinal products for human use and also cosmetic products which are permitted or certified by the Ministry of Health are out of this Law’s scope. 

 According to Biosafety Law following actions connected with GMO and GMOPs are prohibited:

  • Releasing  GMO and GMOPs on the market without approval of Ministry of Agriculture and Forestry.
  • Production of genetically modified plants and animals.
  • Using GMO and GMOPs in baby food and baby formulae, follow-on baby food and follow-on formulae, infant and kid’s nutritional supplements

 According to the Biosafety Law, which was enacted in 2010, the Biosafety Board, which was established within the scope of the Law, was responsible for evaluating the applications regarding GMO and its products.

 However, the duties and powers of the Biosafety Board were assigned to the Ministry of Agriculture and Forestry with the Presidential Circular No. 2018/3 published in the Official Gazette on the date of August 2, 2018.

 The task of evaluating the applications related to GMO and its products, performing the secretarial services of the Committees and other duties specified in the Biosafety Law and related regulations has been assigned to General Directorate of Agricultural Research and Policies (TAGEM) under the Ministry of Agriculture and Forestry pursuant to Ministerial Approval dated 05/12/2018.

 Ministry of Agriculture and Forestry makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account.

 For each application the Ministry of Agriculture and Forestry assigns a new committee and each committee makes different assessment for each application. It is important to note that in Turkey food and feed each have a different assessment application.

 Members of scientific committees are selected from the List of Experts.

 11 members are selected for each GMO application.

 List of Experts has been made up by the evaluation of Ministry of Agriculture and Forestry from the applicants who applied via using the Biosafety Clearing-House Mechanism of Turkey. Applicants were faculty members and experts of Universities and TÜBİTAK (The Scientific and Technological Research Council of Turkey).

 To date, 13 types of GM soybean and 23 types of GM maize were approved as feed for import.

Besides, by the use of aspergillus oryzae, developed through modern biotechnological methods, licences for industrial α-amylase, glucoamylase and hemicellulase enzyme production were granted.

 Threshold of labeling of GMO products that are approved by Ministry of Agriculture and Forestry is 0.9%.

There are not any applications for using GMO and products as food.

 After placing GMO and GMOPs on the market; the Ministry controls and inspects whether or not conditions designated by decision are met.

Activities of analysis are performed in laboratories designated by the Ministry.

In the case of any non-compliance detected with relation to the GMO Legislation (such as  a failure to specify the contained GMO on the label, identification of an unapproved gene, etc.) legal action is taken.

Application evaluation process is like below:

  • Evaluation of application by Ministry of Agriculture and Forestry      90 days
  • Feedback to the applicant                                                            15 days
  • Ministry of Agriculture and Forestry’s “Decision”                             270 days

(Starts from feedback to the applicant)

Establishing of Scientific Committees

Report preparation of Committees

Report’s public release

Evaluation of public opinions by Committees

Ministry of Agriculture and Forestry’s final decision after taking reports and public opinions into     

account

  • Publishing the Positive Decision                                                        30 days
  • Reclamation period to Negative Decision                                           60 days
  • Evaluation of reclamation by Ministry of Agriculture and Forestry        60 days
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Ministry of Agriculture and Forestry

General Directorate of Agricultural Research and Policies

Focal Point of the FAO GM Foods Platform

Ramazan BULBUL

Email: [email protected]

United States of America
Name of product applicant: Pioneer Hi-Bred
Summary of application:
Soybean
Trait 1 Added Protein: Glyphosate N-acetyltransferase (GAT)
Source: Bacillus licheniformis
Intended Effect: Tolerance to the herbicide glyphosate
Trait 2 Added Protein: Modified acetolactate synthase (GM-HRA)
Source: Soybean
Intended Effect: Tolerance to acetolactate synthase-inhibiting herbicides
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Date of authorization: 21/09/2007
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please consult the FDA website links below.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: FDA's webpage regarding this variety
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
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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Relevant documents
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