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Notification report


General information

Notification Number
B/CZ/09/01

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
12/01/2009

Title of the Project
Field trials with Syngenta’s Bt11 x MIR162 x MIR604 x GA21 maize, Bt11 x MIR604 x GA21 maize, Bt11 x GA21 maize, MIR162 maize and MIR604 maize in the Czech Republic (2009-2012).

Proposed period of release:
01/04/2009 to 31/12/2012

Name of the Institute(s) or Company(ies)
Syngenta Czech, s.r.o., ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; Romania; Slovak Republic;

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/03/13; B/ES/08/32; B/ES/08/34; B/FR/03/03/03; B/RO/08/01; B/RO/08/04; B/RO/08/05;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Bt11: a truncated Cry1Ab protein for control of certain lepidopteran pests.
Bt11: a phosphinothricin acetyltransferase (PAT) protein that confers tolerance to herbicide products containing glufosinate ammonium.
MIR162: a Vip3Aa20 protein for control of certain lepidopteran pests.
MIR162: a phosphomannose isomerase (PMI) protein as a selectable marker. PMI allows transformed maize cells to utilize mannose as the only primary carbon source while maize cells lacking this protein fail to grow.
MIR604: a modified Cry3A (mCry3A) protein for control of certain coleopteran pests.
MIR604: a phosphomannose isomerase (MIR604 PMI) protein as a selectable marker. PMI is an enzyme that allows transformed corn cells to utilize mannose as the only primary carbon source while maize cells lacking this protein fail to grow.
GA21: a modified maize 5-enolpyruvylshikimate-3-phosphate synthase enzyme (mEPSPS) that confers tolerance to herbicide products containing glyphosate.


Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Bt11 maize:
Promoter sequences: Promoter and intron sequences derived from the Cauliflower Mosaic virus and maize. The function of these sequences is to control expression of the herbicide and insect tolerance genes.
Insect tolerance gene: cry1Ab gene, which encodes a Cry1Ab protein that confers resistance to certain lepidopteran insect pests. The cry1Ab gene was originally cloned from Bacillus thuringiensis var. kurstaki HD-1.
Herbicide tolerance gene: Streptomyces viridochromogenes gene encoding the selectable marker PAT. PAT confers resistance to herbicides containing glufosinate
NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the herbicide and insect tolerant gene expression.

MIR162 maize:
Promoter sequences: Promoter sequences from Zea mays. Provides root-preferential expression in Zea mays.
Insect tolerance gene: A modified version of the native vip3Aa1 gene from Bacillus thuringiensis that confers resistance to certain lepidopteran insect pests. After insertion in the plant, the vip3Aa19 gene was designated vip3Aa20; the encoded protein was designated Vip3Aa20.
Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of mannose-6-phosphate to fructose-6-phosphate.
NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the gene expression.

MIR604 maize:
Promoter sequences: Promoter sequences from Zea mays. Provides root-preferential expression in Zea mays.
Insect tolerance gene: encodes a modified cry3A gene from Bacillus thuringiensis subsp. kurstaki which confers tolerance to certain coleopteran insect pests.
Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of mannose-6-phosphate to fructose-6-phosphate.
NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the gene expression.

GA21 maize:
Promoter sequences: Promoter, intron and exon sequences derived from rice. The function of these sequences is to control expression of the herbicide tolerance gene.
Optimised transit peptide: N-terminal optimised transit peptide sequence constructed based on transit peptide sequences from maize and sunflower.
Herbicide tolerance gene: epsps (5-enolpyruvylshikimate-3-phosphate synthase) gene derived from maize. The function of the product of this gene is to confer tolerance to herbicide products containing glyphosate.
NOS terminator: Termination sequence of the nopaline synthase gene, isolated from Agrobacterium tumefaciens. The function of this sequence is to signal the termination of the herbicide tolerant gene expression.


6. Brief description of the method used for the genetic modification:
Events IR162 and MIR604 were produced using immature maize embryos derived from a proprietary Zea mays line, via Agrobacterium-mediated transformation. Modifications of Bt11 and GA21 were described in corresponding previous notifications.
Bt11 x MIR162 x MIR604 x GA21, Bt11 x MIR604 x GA21 and Bt11 x GA21 maize were produced by conventional breeding There was no further genetic modification to produce the stack.


7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable

Experimental Release

1. Purpose of the release:
The objective of the proposed field trial releases is to gain information relating to the performance of this stacked maize products under European conditions, to produce maize for comparative and expression analysis and to study potential effects on non-target organisms. They will also allow further assessment of the events in the environment.

2. Geographical location of the site:
4 locations are planned: Ivanovice na Hane, Popuvky, Pohorelice nad Jihlavou - Jihomoravsky region, Jarohnevice - Zlinsky region

3. Size of the site (m2):
A maximum of 4 locations will be sown every year. In 3 locations, the surface of the GM trials will not exceed 2 000 m² per location including all GM maize. In the 4th location, Pohorelice, the surface of the GM trial will not exceed 1 000 m² including all GM maize.

4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
Evidence from previous field trials in the USA suggests that the genetically modified lines do not differ from the recipient plant in mode or rate of reproduction, dissemination or survivability of the plant.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The Environmental Risk Assessment has been completed and submitted with the application. In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified maize with the environment when compared to non-modified maize have been identified.

Brief description of any measures taken for the management of risks:
The field trials will be no less than 200 m from other maize fields and will be surrounded by a border of conventional maize.
The products from the trials may be used for analysis and will not be used for human food or animal feed.
Plant material remaining after harvest will be ground and incorporated into the soil in the trial.
The sites will be monitored for at least one year after the release and any volunteer maize appearing will be eliminated before flowering. During this year, maize will not be grown on the trial sites.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The trials have not been designed to specifically gain new data on the environment and human health impact of the release. They will allow the further assessment of the event in the environment.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/05/2009 00:00:00
Remarks: