Food safety and quality
| share
 

OECD Unique Identifier details

BCS-GH811-4
Commodity: Cotton
Traits: Glyphosate tolerance,Isoxaflutole tolerance
Argentina
Name of product applicant: Bayer S.A.
Summary of application:

The GHB811 cotton event (HPPD) was developed to provide producers with a variety of cotton with tolerance to herbicides formulated based on glyphosate and inhibitory herbicides of HPPD, as is the case of isoxaflutole, in order to facilitate the management of weeds during the crop cycle. The GHB811 event was obtained by transformation by the Agrobacterium method of the Coker 312 variety of Gossypium hirsutum L. The only result of the genetic modification introduced is the expression of the 2mepsps and hppdPfW336-1Pa genes, which result in the expression of proteins 2mEPSPS and HPPD W336, respectively. The 2mEPSPS protein has two point mutations with respect to its natural variant of EPSPS maize, which gives it a lower sensitivity to the inhibition caused by glyphosate without modifying its enzymatic activity. While the HPPD W336 protein was modified through a substitution of the amino acid glycine 336 by tryptophan. This modification confers the enzyme insensitivity to HPPD inhibitors, conserving their original activity.
The combined 2mEPSPS and HPPD W336 proteins give the plants tolerance to the herbicide glyphosate and HPPD inhibitor herbicides, respectively, which offers options for weed control in cotton cultivation.

Upload:
Date of authorization: 20/10/2018
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
• Inheritance studies conducted indicated that Mendelian segregation exists. • New expression proteins are expressed in low levels. • It is compositionally equivalent to its non-transgenic counterpart. • No evidence of similarity or homology was found with known toxic proteins. • There is no evidence of expression of known allergenic substances for the proteins expressed in the event. It is concluded that the event is substantially equivalent to its conventional counterpart, therefore, it is as safe and no less nutritious than conventional commercial varieties.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: GMO approvals in Argentina
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministerio de Agroindustria
Contact person name:
Andrés Maggi
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 5222 5986
Fax number:
Country introduction:

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

Useful links
Relevant documents
Stacked events:

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

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

National Service for Agrifood Health and Quality (Senasa)

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

 

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

Australia
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:

FSANZ received an Application from Bayer CropScience Pty Ltd to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code). The variation is to add food derived from the genetically modified (GM) herbicide-tolerant cotton line GHB811 (hereafter referred to as GHB811), with the OECD Unique Identifier BCS-GH811-4. This line has dual-herbicide tolerance to glyphosate and isoxaflutole.


 


Tolerance to herbicides containing glyphosate is achieved with the introduction of a modified corn-derived gene 2mepsps, which encodes the 2mEPSPS enzyme. FSANZ has previously approved food from GM lines containing the 2mepsps gene in Applications: A362 – corn line GA21 (FSANZ 2000), A614 – cotton line GHB614 (FSANZ 2009), A1051 – soybean line FG72 (FSANZ 2011), A1073 – soybean line DAS-44406-6 (FSANZ, 2013) and A1112 – corn line MZHG0JG (FSANZ 2016). Tolerance to isoxaflutole is achieved by the expression of a modified p-hydroxyphenyl pyruvatedioxygenase (HPPD) enzyme, encoded by the hppdPf W336 gene derived from the soil bacterium Pseudomonas fluorescens. FSANZ has previously approved food from one GM line containing the modified hppdPf W336 gene in Application A1051 – soybean line FG72 (FSANZ 2011).


 


Cotton lines containing the GHB811 transformation event are intended initially for cultivation in the United States of America (USA) and Brazil. Food from GHB811 cotton will therefore enter the Australian and New Zealand food supply via imported products.

Upload:
Date of authorization: 24/05/2018
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):
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: A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811
Upload:
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.

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)

Canada
Name of product applicant: BASF Canada Inc.
Summary of application:

Health Canada has notified BASF Canada Inc. that it has no objection to the food use of herbicide tolerant cotton event GHB811 (GHB811). This event was initially submitted to the Department as an asset owned by Bayer CropScience Inc. During the assessment of this event, the ownership of this asset was transferred to BASF Canada Inc. The Department conducted a comprehensive assessment of this cotton variety according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.

Upload:
Date of authorization: 19/10/2018
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment (food safety):
See link to Decision Documents below.
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: Novel Foods Decision Document
Novel Feeds Decision Document
Upload:
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.

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

Japan
Name of product applicant: Bayer CropScience Ltd.
Summary of application:

GHB811 is a genetically modified cotton line, tolerant to herbicides against glufosinate and 4-hydroxyphenylpyruvate dioxygenase.

Upload:
Date of authorization: 07/09/2018
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please see the links below(in Japanese).
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: Safety Assessment Food
Safety Assessment Feed
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,
Contact person name:
Mariko Murakami
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Safety assessments of GM foods are mandatory under the Food Sanitation Law in Japan. The Ministry of Health, Labour, and Welfare (MHLW) legally imposes safety assessments of GM foods so that those that have not undergone safety assessments would not be distributed in the country. MHLW receives application and requests the Food Safety COmmission of Japan (FSCJ) to evaluate the safety of GM foods in terms of human health. Safety assessments are carried out by FSCJ.
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

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

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

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

Please refer to the NBB Decision Document

Upload:
Date of authorization: 10/11/2020
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Department of Biosafety Malaysia
CBD Biosafety Clearing House
Summary of the safety assessment (food safety):
Please refer to the Risk Assessment Report
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:
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Department of Biosafety Ministry of Environment and Water Level 4, Block F11, Complex F Lebuh Perdana Timur, Precinct 1 62000 Putrajaya, Malaysia
Phone number:
+60388861153
Fax number:
+60388904935
Country introduction:

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

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

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

 

Food Safety and Quality Division, Ministry of Health, Level 4, Menara Prisma, No. 26, Persiaran Perdana, Putrajaya, Malaysia, 62675. Phone: +603 88850797 Fax: +603 88850790 Email: [email protected]
New Zealand
Name of product applicant: Bayer CropScience Pty Ltd
Summary of application:

FSANZ received an Application from Bayer CropScience Pty Ltd to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code). The variation is to add food derived from the genetically modified (GM) herbicide-tolerant cotton line GHB811 (hereafter referred to as GHB811), with the OECD Unique Identifier BCS-GH811-4. This line has dual-herbicide tolerance to glyphosate and isoxaflutole.


Tolerance to herbicides containing glyphosate is achieved with the introduction of a modified corn-derived gene 2mepsps, which encodes the 2mEPSPS enzyme. FSANZ has previously approved food from GM lines containing the 2mepsps gene in Applications: A362 – corn line GA21 (FSANZ 2000), A614 – cotton line GHB614 (FSANZ 2009), A1051 – soybean line FG72 (FSANZ 2011), A1073 – soybean line DAS-44406-6 (FSANZ, 2013) and A1112 – corn line MZHG0JG (FSANZ 2016). Tolerance to isoxaflutole is achieved by the expression of a modified p-hydroxyphenyl pyruvatedioxygenase (HPPD) enzyme, encoded by the hppdPf W336 gene derived from the soil bacterium Pseudomonas fluorescens. FSANZ has previously approved food from one GM line containing the modified hppdPf W336 gene in Application A1051 – soybean line FG72 (FSANZ 2011).


Cotton lines containing the GHB811 transformation event are intended initially for cultivation in the United States of America (USA) and Brazil. Food from GHB811 cotton will therefore enter the Australian and New Zealand food supply via imported products.

Upload:
Date of authorization: 30/10/2018
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
No potential public health and safety concerns have been identified in the assessment of cotton line GHB811. On the basis of the data provided in the present Application, and other available information, food derived from GHB811 is considered to be as safe for human consumption as food derived from conventional cotton varieties.
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: A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811
Upload:
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)

Singapore
Name of product applicant: BASF
Summary of application:

Apply for use as food, feed and for processing 

Upload:
Date of authorization: 16/04/2021
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):
Cotton line GHB811 (BCS-GH811-4) has been developed to tolerate two herbicides: glyphosate and isoxaflutole. Tolerance to glyphosate is achieved through expression of the modified corn-derived gene 2mepsps, which encodes the 2mEPSPS enzyme. Tolerance to isoxaflutole is achieved by the expression of a modified phydroxyphenyl pyruvate-dioxygenase (HPPD) enzyme, encoded by the hppdPf W336 gene, derived from Pseudomonas fluorescens. Cotton line GHB811 contains two genes introduced on a single expression cassette via Agrobacterium-mediated transformation. The 2mepsps gene is a modified version of the epsps gene derived from Zea mays and encodes a modified version of 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS). The modified protein 2mEPSPS maintains enzyme function in the presence of glyphosate. The hppdPf W336 gene is a modified version of the hppd gene isolated from Pseudomonas fluorescens and encodes a modified p-hydroxyphenyl pyruvatedioxygenase (HPPD) enzyme, conferring tolerance to herbicides containing isoxaflutole. Molecular analyses of cotton line GHB811 indicate that one complete copy of the two-gene expression cassette is present at a single insertion site. The introduced genetic elements are stably inherited from one generation to the next generations. Cotton line GHB811 expresses two proteins – 2mEPSPS and HPPDPfW336 which are non-toxic and non-allergenic to humans. Composition analyses showed that the levels of key constituents in seed from cotton line GHB811 are equivalent to conventional cotton varieties. Food derived from GHB811 is as safe as food derived from conventional cotton varieties.
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:
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.

Useful links
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)

United States of America
Name of product applicant: Bayer CropScience
Summary of application:

Submission Date: Apr 26, 2017
Developer Name1: Submitted by Bayer CropScience LP, now BASF Agricultural Solutions Seeds US LLC
Developer Contact Information: 2 TW Alexander Drive
Research Triangle Park, NC 27709
Intended Use: Use in human and animal foods
Trait 1 Added Protein or DNA: Double mutant 5-enol pyruvylshikimate-3-phosphate synthase (2mEPSPS)
Source: Zea mays>/i> (corn, maize)
Intended Effect: Tolerance to the herbicide glyphosate
Trait 2 Added Protein or DNA: modified p-hydroxyphenylpyruvate dioxygenase (HPPD) W336
Source: Pseudomonas fluorescens
Intended Effect: Tolerance to HPPD inhibitors
Event Designation: GHB811

Upload:
Date of authorization: 19/11/2018
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Please consult the FDA website links below.
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: FDA's webpage regarding this variety
Upload:
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.

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 ([email protected]); Environmental Protection Agency