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OECD Unique Identifier details

MST-FGØ72-2
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance,Isoxaflutole tolerance
Australia
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:
A genetically modified (GM) soybean line, FG72, has been developed that provides tolerance to the herbicides glyphosate and isoxaflutole.

Tolerance to glyphosate is achieved through expression of a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoded by the 2mepsps gene derived from Zea mays (corn), a common crop plant. The epsps gene has been widely used in the genetic modification of a number of crop species. Tolerance to isoxaflutole is achieved through expression of a modified p-hydroxyphenylpyruvate dioxygenase (HPPD) encoded by the hppdPf W336 gene originally derived from the soil bacterium Pseudomonas fluorescens.

It is anticipated that soybean plants containing event FG72 may be grown in the United States of America (U.S)., Argentina, Brazil, China and India subject to approval. There is no plan to grow the line in Australia or New Zealand.
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Date of authorization: 09/02/2012
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):
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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 A1051 - Food derived from Herbicide-tolerant Soybean Event FG72
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
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 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)

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: Bayer S.A
Summary of application:

Commercial release of 


genetically modified
soybean tolerant to herbicides based on glyphosate and isoxaflutole, event FG72, for the
purpose of its release in the environment, marketing, consumption and any other activities
related to the GMO and progenies thereto. Tolerance to herbicides was reached by
introduction of two genes: one modified version of the maize (Zea mays) gene epsps that
grants tolerance to glyphosate; and one also modified version of bacterium Pseudomonas
fluorescens gene hppd isolate A32 that grants tolerance to herbicide isoxaflutole (IFT). The
coding sequence of maize epsps gene, coding for the native enzyme EPSPS (5-
enolpyruvylshikimate 3-phosphate synthase), was isolated from the maize genome and
changed in two positions through site directed mutation, originating mutated gene 2mepsps,
which codifies the double-mutant enzyme 2mEPSPS. The presence of enzyme 2mEPSPS grants
soybean FG72 tolerance to glyphosate herbicide. The coding sequence of gene hppd of
bacterium Pseudomonas fluorescens isolate A32, which codes for enzyme HPPD
(p-hydroxyphenylpyruvate dioxygenase), was also altered in one position through site directed
mutation, originating mutated gene hppd, coding for enzyme HPPD. The presence of enzyme
HPPD grants soybeans FG72 tolerance to herbicide isoxaflutole.

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Date of authorization: 08/10/2015
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
1) Soybean species Glycine max is in the food chain for over 4,000 years with no record of damage to humans, animals and the environment; 2) Over the relevant millennia, soybean failed to present characteristics of being a pest plant; 3) There is not in Brazil sylvan species with which soybeans may intercross; 4) Genes inserted in one single locus of the plant genome, the characteristics of such genes showed to be stable along generations and the segregation is mendelian; 5) Studies conducted in Brazil, Canada and United States of America showed that FG72 soybean is not different from the conventional variety in agronomic, morphologic, reproductive characteristics, in survival characteristics and the form of dissemination of plants, in the response to may pathogens and pests, except for the characteristics of tolerance to herbicides glyphosate and isoxaflutole, granted by the presence and expression of genes epsps of maize and hppd of bacterium Pseudomonas fluorescens, respectively; 6) Chemical composition analysis, conducted in planned releases conducted in different locations in Brazil and the United States of America, present similar results and show that FG72 is substantially equivalent to conventional soybean; 7) Studies of nutritional assessment and animal performance conducted in broiler chicken fail to reveal any change related to the consumption of FG72 soybean when compared to conventional soybean and any adverse effect to the birds; 8) Proteins 2mEPSPS and HPPD W336 produced by the genetically modified soybean failed to present any toxic or allergenic effect; 9) The change introduced failed to interfere in the ability to symbiotic association of genetically modified plants with Bradyrhizobium japonicum with no impact, therefore, in nitrogen fixation; 10) The event represents one additional available for farmers to manage populations of weed in soybean cultures; 11) Biosafety analyses of FG72 soybean already conducted by regulatory agencies of countries where the event had been analyzed and passed; 12) Information currently available in the scientific literature;
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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:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
gutemberg.sousa@mcti.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
Useful links
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: Bayer CropScience Inc.
Summary of application:

ayer CropScience Inc. has developed a herbicide tolerant soybean (Glycine max L.) event that is tolerant to the herbicide glyphosate and to 4-hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor herbicides. This soybean event was developed through biolistic-mediated transformation of soybean calli with a 7.3-kb DNA fragment (i.e.SalI fragment). This fragment contains the coding sequences (i.e.2mepsps and hppdPfW336) and required regulatory elements to express the 2mEPSPS and HPPD W336 proteins, respectively. The 2mepsps coding sequence was generated by introducing mutations into the native epsps gene from maize (Zea mays L.), leading to a double mutant EPSPS protein with two amino acid substitutions (i.e., 2mEPSPS). This modification confers glyphosate tolerance by decreasing the binding affinity of the 2mEPSPS protein for glyphosate, allowing the protein to maintain sufficient enzymatic activity in the presence of the herbicide. The native hppd gene was isolated from Pseudomonas fluorescens, a Gram-negative rod-shaped bacterium that is ubiquitous in nature and often found in water, soil, and the plant rhizosphere. The hppdPfW336 coding sequence differs from the native Pseudomonas gene by a single amino acid substitution (i.e., glycine substituted to tryptophan).

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Date of authorization: 20/06/2012
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.): 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:
Neil.Strand@hc-sc.gc.ca
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.

Useful links
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

Malaysia
Name of product applicant: Bayer Co. (Malaysia) Sdn. Bhd.
Summary of application:

Please refer to the uploaded document. 

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Date of authorization: 19/12/2014
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to uploaded document.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
biosafety@nre.gov.my
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Dept of Biosafety, Ministry of Natural Resources and Environment, Level 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Precinct 4, 62574 Putrajaya
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:

Malaysian Department of Biosafety 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: biosafety@nre.gov.my. Url: www. biosafety.nre.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: fsq-division@moh.gov.my
Mexico
Name of product applicant: Bayer de México, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 133


A genetically modified (GM) soybean line, FG72, has been developed that provides tolerance to the herbicides glyphosate and isoxaflutole.

Tolerance to glyphosate is achieved through expression of a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoded by the 2mepsps gene derived from Zea mays (corn), a common crop plant. The epsps gene has been widely used in the genetic modification of a number of crop species. Tolerance to isoxaflutole is achieved through expression of a modified p-hydroxyphenylpyruvate dioxygenase (HPPD) encoded by the hppdPf W336 gene originally derived from the soil bacterium Pseudomonas fluorescens.

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Date of authorization: 02/07/2014
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
UI OECD: MST-FGØ72-2 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:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

New Zealand
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:

A genetically modified (GM) soybean line, FG72, has been developed that provides tolerance to the herbicides glyphosate and isoxaflutole.

Tolerance to glyphosate is achieved through expression of a 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) encoded by the 2mepsps gene derived from Zea mays (corn), a common crop plant. The epsps gene has been widely used in the genetic modification of a number of crop species. Tolerance to isoxaflutole is achieved through expression of a modified p-hydroxyphenylpyruvate dioxygenase (HPPD) encoded by the hppdPf W336 gene originally derived from the soil bacterium Pseudomonas fluorescens. 

It is anticipated that soybean plants containing event FG72 may be grown in the United States of America (U.S)., Argentina, Brazil, China and India subject to approval. There is no plan to grow the line in Australia or New Zealand.

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Date of authorization: 05/04/2012
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):
In conducting a safety assessment of food derived from herbicide-tolerant soybean line FG72, a number of criteria have been addressed including: a characterisation of the transferred genes, their origin, function and stability in the soybean 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 proteins to be either allergenic or toxic in humans. No potential public health and safety concerns have been identified in the assessment of soybean line FG72. On the basis of the data provided in the present Application, and other available information, food derived from soybean line FG72 is considered to be as safe for human consumption as food derived from conventional soybean cultivars.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A1051 - Food derived from Herbicide-tolerant Soybean Event FG72
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
andrew.pearson@mpi.govt.nz
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Andrew Pearson
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448942535
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)

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

 


Glyphosate herbicide tolerance, Isoxaflutole herbicide tolerance

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Date of authorization: 09/01/2014
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the link below(in Korean).
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
mytrue85@korea.kr
Organization/agency name (Full name):
Ministry of Food and Drug Safety
Contact person name:
Website:
Physical full address:
Osong Health Technology Administration Complex, 187, Osongsaengmyeong 2-ro, Osong-eup, Cheongwon-gun, Chungcheonbuk-do, 363-700, Korea
Phone number:
82-43-719-2360
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
United States of America
Name of product applicant: Bayer CropScience USA LP
Summary of application:
Soybean
Trait 1 Added Protein: Modified 5-enolpyruvylshikimate-3-phosphate synthase (2mEPSPS)
Source: Zea mays
Intended Effect: Tolerance to the herbicide glyphosate
Trait 2 Added Protein: Modified p-hydroxyphenylpyruvate dioxygenase (HPPD W336)
Source: Pseudomonas fluorescens
Intended Effect: Tolerance to isoxaflutole-containing herbicides
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Date of authorization: 07/08/2012
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.):
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:
jason.dietz@fda.hhs.gov
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.

Useful links
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 (premarkt@fda.hhs.gov); Environmental Protection Agency