Dupont de Colombia S.A

GMO authorization for DP4114 maize as food for direct use or processing.

11/06/2021

Food

Based on the risk assessment, it can be concluded that the event shows the same risks as its conventional counterpart. Therefore, the National Technical Committee for GMO use exclusively in health and human consumption (CTNSalud) recommends its authorization.

• resolucion-2021023289-de-2021

Du Pont Production Agriscience (M) Sdn. Bhd.

Please refer to the decsion document of the National Biosafety Board

14/12/2018

Food and feed

Please refer to the Risk Assessment Report

• Department of Biosafety Malaysia
• CBD Biosafety Clearing House

• nbb-decision-statement-du-pont-dp4114-corn
• 4-nbb-decision-change-of-approved-person-du-pont
• gmac-malaysia-ra-report-dp4114-corn

Dupont Colombia S.A

Authorization of the genetically modified maize 4114 resistant to lepidoptera pest attack and tolerant to herbicides glyphosate and glufosinate

27/01/2016

Food

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.

Pioneer Overseas Corporation

The genetically modified maize 4114 expresses the Cry1F (truncated version), Cry34Ab1 and Cry35Ab1 proteins providing protection against specific lepidopteran and coleopteran pests, and the PAT protein conferring tolerance to glufosinate-ammonium based herbicides.

26/07/2019

Food and feed

Please see the EU relevant links below.

Method for detection: Event specific real-time quantitative PCR based method for detection of the genetically modified maize DP-ØØ4114-3. Reference material: ERM®-BF439 is accessible via the Joint Research Centre (JRC) of the European Commission. The relevant links are provided below.

• EU Register of authorised GMOs
• Method for detection
• Reference Material
• Opinion of the European Food Safety Authority

28/07/2029

DuPont (Korea) Inc.

Glufosinate herbicide tolerance , Coleopteran insect resistance , Lepidopteran insect resistance

10/10/2014

Food and feed

Please see the link below(in Korean).

• 17-report

Pioneer Hi-Bred Australia Ltd

Pioneer Hi-Bred Australia Ltd on behalf of Pioneer Hi-Bred International Inc has submitted, an application to FSANZ to vary Standard 1.5.2 – Food produced using Gene Technology – in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) corn line with OECD Unique Identifier DP-004114-3 (also referred to as line 4114). The corn has been modified to be tolerant to the herbicide glufosinate ammonium (glufosinate) and protected against lepidopteran insect pests, particularly European corn borer (Ostrinia nubilalis) and coleopteran insect pests, particularly western corn rootworm (Diabrotica virgifera virgifera). Tolerance to glufosinate is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from the common soil bacterium Streptomyces viridochromogenes. This protein has been considered in 19 previous FSANZ approvals and globally is represented in six major crop species and over 30 approved GM single plant events. Protection against lepidopteran insect pests is conferred by the cry1F gene, which is a synthetic version of a gene from Bacillus thuringiensis var. aizawai, and encodes a truncated version of an insecticidal protein, Cry1F. Protection against coleopteran insect pests is conferred by two genes, cry34Ab1 andcry35Ab1 both from B. thuringiensis strain PS149B1 and encoding the insecticidal proteins Cry34Ab1 and Cry35Ab1. These proteins have both been considered previously by FSANZ. Line 4114 is a molecular stack3 that, in terms of traits, is the equivalent of a breeding stack (known commercially as Herculex® XTRA) obtained by crossing two corn lines, DAS-01507-1 (line 1507) and DAS-59122-7 (line 59122). Food from both of these lines has been approved by FSANZ in applications A446 (FSANZ 2003) and A543 (FSANZ 2005) respectively and hence, food from the breeding stack is also approved to enter the Australian and New Zealand food supplies. The breeding stack was grown on approximately 10,000,000 ha in the U.S. in 2013. Food from line 4114 requires a separate approval since it represents a unique molecular event although the expressed traits are the same as those already assessed by FSANZ. The purpose in developing the line 4114 molecular stack was to have all of the inserted genes on a single transformation construct integrated at a single genetic locus in the corn genome. Line 4114 therefore has an advantage over the breeding stack because having three linked traits at a single locus will simplify future breeding efforts. The Applicant has stated that line 4114 is not intended to be a stand-alone product and will be crossed by conventional breeding with other approved GM corn lines as well as conventional lines. The Applicant indicates that any lines containing the DP-004114-3 event will be grown primarily in North America, and approval for cultivation in Australia or New Zealand is not currently being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.

14/01/2016

Food

In conducting a safety assessment of food derived from line 4114, a number of criteria have been addressed including: a characterisation of the transferred gene sequences, their origin, function and stability in the corn genome; the changes at the level of DNA, and protein in the whole food; compositional analyses; and evaluation of intended and unintended changes. No potential public health and safety concerns have been identified in the assessment of herbicide-tolerant and insect-protected corn line 4114. On the basis of the data provided in the present Application, and other available information, food derived from line 4114 is considered to be as safe for human consumption as food derived from conventional corn varieties.

• OECD BioTrack Product Database
• A1106 – Food derived from Herbicide-tolerant & Insect-protected Corn Line 4114

• a1106-appr-sd1

Corteva Agriscience do Brasil Ltda.

Commercial release of DP-ØØ4114-3 corn event and its derivatives for use in human and animal food.

10/06/2021

Food and feed

CTNBio, after analyzing the request for commercial release of genetically modified corn DP-ØØ4114-3 and its derivatives for use in human and animal food, including the purposes of handling, processing, commercialization, transport, import, export, storage, consumption and disposal, decided by the GRANTING according to this technical opinion. Corn DP-ØØ4114-3 (DP4114) confers resistance to insect pests and tolerance to herbicides containing the active ingredient glufosinate ammonium. This maize was obtained by Agrobacterium tumefasciens-mediated transformation using a single genetic construct for the introduction of cry1F, cry34Ab1, cry35Ab1 and pat genes. The cry1F gene, isolated from Bacillus thuringiensis var. aizawai, expresses the Cry1F protein that confers resistance to certain lepidopteran pests; genes cry34Ab1 and cry35Ab1, both isolated from Bacillus thuringiensis, express proteins Cry34Ab1 and Cry35Ab1 that promote resistance to certain pest insects of the order Coleoptera; and the pat gene, isolated from Streptomyces viridochromogenes, expresses the PAT protein, which confers tolerance to the herbicide glufosinate ammonium.

Molecular traddicional methods.

• commercal-release-7501-2021

Du Pont K.K.

4114 is genetically modified maize for insect-resistant and herbicide-tolerant, that insect resistance is conferred by the cry34Ab1, cry35Ab1 and cryIF genes from the common soil bacterium Bacillus thuringiensis, and glufosinate-ammonium herbicide tolerance through the pat gene from Streptomyces viridochromogenes.

15/01/2015

Food

Please see the link below.

• BCH Database
• Food safety assessment performed by Food Safety Commission of Japan

Pioneer Hi-Bred Australia Ltd

Pioneer Hi-Bred Australia Ltd on behalf of Pioneer Hi-Bred International Inc has submitted, an application to FSANZ to vary Standard 1.5.2 – Food produced using Gene Technology – in the Australia New Zealand Food Standards Code (the Code) to include food from a new genetically modified (GM) corn line with OECD Unique Identifier DP-004114-3 (also referred to as line 4114). The corn has been modified to be tolerant to the herbicide glufosinate ammonium (glufosinate) and protected against lepidopteran insect pests, particularly European corn borer (Ostrinia nubilalis) and coleopteran insect pests, particularly western corn rootworm (Diabrotica virgifera virgifera). Tolerance to glufosinate is achieved through expression of the enzyme phosphinothricin acetyltransferase (PAT) encoded by the pat gene derived from the common soil bacterium Streptomyces viridochromogenes. This protein has been considered in 19 previous FSANZ approvals and globally is represented in six major crop species and over 30 approved GM single plant events. Protection against lepidopteran insect pests is conferred by the cry1F gene, which is a synthetic version of a gene from Bacillus thuringiensis var. aizawai, and encodes a truncated version of an insecticidal protein, Cry1F. Protection against coleopteran insect pests is conferred by two genes, cry34Ab1 and cry35Ab1 both from B. thuringiensis strain PS149B1 and encoding the insecticidal proteins Cry34Ab1 and Cry35Ab1. These proteins have both been considered previously by FSANZ. Line 4114 is a molecular stack3 that, in terms of traits, is the equivalent of a breeding stack (known commercially as Herculex® XTRA) obtained by crossing two corn lines, DAS-01507-1 (line 1507) and DAS-59122-7 (line 59122). Food from both of these lines has been approved by FSANZ in applications A446 (FSANZ 2003) and A543 (FSANZ 2005) respectively and hence, food from the breeding stack is also approved to enter the Australian and New Zealand food supplies. The breeding stack was grown on approximately 10,000,000 ha in the U.S. in 2013. Food from line 4114 requires a separate approval since it represents a unique molecular event although the expressed traits are the same as those already assessed by FSANZ. The purpose in developing the line 4114 molecular stack was to have all of the inserted genes on a single transformation construct integrated at a single genetic locus in the corn genome. Line 4114 therefore has an advantage over the breeding stack because having three linked traits at a single locus will simplify future breeding efforts. The Applicant has stated that line 4114 is not intended to be a stand-alone product and will be crossed by conventional breeding with other approved GM corn lines as well as conventional lines. The Applicant indicates that any lines containing the DP-004114-3 event will be grown primarily in North America, and approval for cultivation in Australia or New Zealand is not currently being sought. Therefore, if approved, food derived from this line may enter the Australian and New Zealand food supply as imported food products.

07/12/2015

Food

• OECD BioTrack Product Database
• A1106 – Food derived from Herbicide-tolerant & Insect-protected Corn Line 4114

Pioneer Hi-Bred

CornTrait 1 Added Protein or DNA: Cry1FSource: Bacillus thuringiensis var aizawaiIntended Effect: Resistance to certain Lepidopteran and Coleopteran insectsTrait 2 Added Protein or DNA: Cry34Ab1 and Cry34Ab2 proteinsSource: Bacillus thuringiensis strain PS149B1Intended Effect: Resistance to certain Lepidopteran and Coleopteran insectsTrait 3 Added Protein or DNA: pat gene encoding the phosphinothricin acetyl transferase (PAT) proteinSource: Streptomyces viridochromogenesIntended Effect: Tolerance to glufosinate-ammonium herbicidesEvent Designation: Event 4114

07/06/2012

Food and feed

Please consult the website links below.

• FDA's webpage regarding this variety
• EPA Registered Plant Incorporated Protectants