Bayer CropScience

Submission Date: Apr 26, 2017Developer Name1: Submitted by Bayer CropScience LP, now BASF Agricultural Solutions Seeds US LLCDeveloper Contact Information: 2 TW Alexander DriveResearch Triangle Park, NC 27709Intended Use: Use in human and animal foodsTrait 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 glyphosateTrait 2 Added Protein or DNA: modified p-hydroxyphenylpyruvate dioxygenase (HPPD) W336Source: Pseudomonas fluorescensIntended Effect: Tolerance to HPPD inhibitorsEvent Designation: GHB811

19/11/2018

Food and feed

Please consult the FDA website links below.

• FDA's webpage regarding this variety

Bayer S.A.

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.

20/10/2018

Food and feed

• 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.

• GMO approvals in Argentina

• documento-de-decision-algodon-bcs-gh811-4
• 15-gmo-food-feed-safety-assessment-res-412-2002-english

BASF Canada Inc.

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.

19/10/2018

Food and feed

See link to Decision Documents below.

• BioTrack Product Database
• Novel Foods Decision Document
• Novel Feeds Decision Document

BASF PARAGUAYA S.A.

Cotton (Gossypium hirsutum) modified with resistance genes for the herbicides isoxaflutole and glyphosate via Agrobacterium-mediated transformation using the vector pTSIH09 containing the hppdPfW336-1Pa and 2mepsps expression cassettes. Specifically, (i) The double mutant 5-enol pyruvylshikimate-3-phosphate synthase (2mepsps) gene that encodes for the 2mEPSPS protein. The 2mepsps coding sequence was developed by introducing two point mutations to the wild-type epsps gene cloned from maize (Zea mays). (ii) The hppdPf W336 gene encodes for the HPPD W336 protein. The hppdPf W336 coding sequence was developed by introducing a single point mutation to the wild type hppd gene derived from Pseudomonas fluorescens. Expression of the HPPD W336 protein confers tolerance to isoxaflutole herbicides.

08/11/2019

Food and feed

Differentiated approval procedure: Through MAG’s Resolutions 1030 and 1071 there was stated a differentiated treatment for the commercial release of novel GE crops and for GE crops that have been approved in third countries, whose scientific, technical and safety characteristics are well-founded. Paraguayan Ministry of Agriculture’s Resolutions authorize taking into consideration the decision documents from third countries with regard to both human and animal food safety in the cases where these evaluations have been based on Codex Alimentarius, such as the Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants and carried out in countries with time-tested regulatory systems and transparent procedures. Concerning environmental safety, assessments are accepted for GE crops that besides having been authorized for commercial planting in countries with sound regulatory systems, include in the decision documents considerations as follows: that the GE crop under review has been studied under different environmental conditions, behaving in the same way as the conventional non-GE counterpart; that it will be managed in an agronomic manner similar to any GE or conventional hybrid/variety of the species; another aspect is that Paraguay is not center of origin of that crop, and finally two relevant characteristics are that there are no related weeds in Paraguay with which the GE crop could cross-breed and that the main target pests and the main non-target arthropod species present in Paraguay have been taken into account in the GE risk assessment carried out in those countries. The Commercial Release Opinion of the National Commission for Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: 1) The commercial release of the event BCS-GH811-4 2) In case of detection of an unexpected effect, the company is obliged to inform CONBIO".

• BCS-GH811-4
• Paraguay’s Path Toward the Simplification of Procedures in the Approval of GE Crops

• 35-2019-resolucion-mag-n-278-lc-algodon-ghb11

Bayer CropScience Pty Ltd

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.

24/05/2018

Food

• OECD BioTrack Product Database
• A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811

• a1147-sd1-at-approval

Bayer CropScience Ltd.

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

07/09/2018

Food and feed

Please see the links below(in Japanese).

• Safety Assessment Food
• Safety Assessment Feed

BASF (Malaysia) SDN. BHD.

Please refer to the NBB Decision Document

10/11/2020

Food and feed

Please refer to the Risk Assessment Report

• Department of Biosafety Malaysia
• CBD Biosafety Clearing House

• nbb-decision-basf-ghb811-cotton-ffp
• gmac-malaysia-ra-report-ghb811-cotton

BASF

Apply for use as food, feed and for processing

16/04/2021

Food and feed

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.

BASF Paraguaya S.A.

Cotton (Gossypium hirsutum) modified to confer tolerance to herbicides and glyphosate via Agrobacterium-mediated transformation. To confer resistance to isoxaflutole, the cotton expresses Pseudomonas fluorescens 4-hydroxyphenylpyruvate dioxygenase (HPPD) W336, which contains a point mutation that confers reduced binding affinity to HPPD inhibitors. For tolerance to glyphosate, the cotton expresses the Zea mays double mutant 5-enol pyruvylshikimate-3-phosphate synthase, which has a reduced binding affinity to the herbicide.

08/11/2019

Food and feed

The Commercial Release Opinion of the National Commission of Agricultural and Forestry Biosafety (CONBIO), in its substantial part states: "...Recommends technically: (1) The commercial release of event BCS-GH811-4 (2) In case of detecting an unexpected effect, the company is under the obligation to communicate it to CONBIO". Please see decision document weblinks. For further information, please refer to the decision document link.

• OECD BioTrack Product Database

• 1-35-2019-resolucion-mag-n-278-lc-algodon-ghb11

Bayer CropScience Pty Ltd

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.

30/10/2018

Food

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.

• BioTrack Product Database
• A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811

• 1-a1147-application-redacted
• 1-a1147-sd1-at-approval