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Notification report


General information

Notification Number
B/ES/09/44

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
10/03/2009

Title of the Project
Application to perform field trials with Syngenta’s Bt11 x MIR162 x MIR604 x GA21 stacked maize product in Spain (2009).

Proposed period of release:
01/04/2009 to 30/11/2009

Name of the Institute(s) or Company(ies)
Syngenta Seeds, S.A., on behalf of Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies, ;


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

Has the same GMPt been notified elsewhere by the same notifier?
No

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 x MIR162 x MIR604xGA21 maize is a stacked genetically modified product that has been produced by a conventional breeding cross of Bt11 maize, MIR162, MIR604 maize and GA21 maize and expresses the following proteins:
- A truncated Cry1Ab protein for control of certain lepidopteran pests.
- A Vip3Aa20 protein for control of certain lepidopteran pests.
- A phosphomannose isomerase (PMI) protein, which acts as a selectable marker enabling transformed plant cells to utilize mannose as the only carbon source.
- A phosphinothricin acetyltransferase (PAT) protein that confers tolerance to herbicide products containing glufosinate ammonium.
- A modified Cry3A (mCry3A) protein for control of certain coleopteran pests.
- A phosphomannose isomerase (MIR604 PMI) protein, which acts as a selectable marker enabling transformed plant cells to utilize mannose as the only primary carbon source.
- 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:
Genetic material derived from Bt11 maize:
- Regulatory sequences: Promoter and intron sequences derived from the Cauliflower Mosaic virus and maize. The function of these sequences is to control expression of theherbicide 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.

Genetic material derived from 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 found in the Bacillus thuringiensis. It confers resistance to several lepidopteran insect pests.
- Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of manno se-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.

Genetic material derived from 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 species.
- Selectable marker: E. coli pmi gene encoding the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of manno se-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.

Genetic material derived from GA21 maize:
- Regulatory sequences: Promoter, int ron 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:
The Bt11xMIR162xMIR604xGA21 maize described in this application has been produced by crossing the genetically modified GA21 maize, MIR162, MIR604 and Bt11 maize through conventional breeding techniques. 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 as the recipient or parental plant is not a forest tree species.

Experimental Release

1. Purpose of the release:
The purpose of the field releases is to gain further information relating to the performance of the event under European conditions and to produce collect samples for compositional and expression analyses, and and to study the effect on target pests and potential effects on non-target organisms. They will also allow the further assessment of the event in the environment.

2. Geographical location of the site:
See question 3.

3. Size of the site (m2):
- Aragón:
Miralsot: 500 m2.

- Cataluña:
Lleida-1: 500 m2.
Lleida-2: 700 m2.
Lleida-4: 12500 m2.
Bellpuig-1: 500 m2.
Bellpuig-3: 500 m2.


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:
An 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:
All the fields will be sowed at a distance of at least 200 m from commercial maize fields.
A border of at least 8 rows of conventional maize will be planted surrounding the GM maize field.
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.
The sites will be monitored for one year after the release and any volunteer maize appearing will be eliminated before flowering. During the following planting season, commercial 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 been designed with the only purpose of collecting complementary data. However, if any unanticipated adverse effects on human health or the environment would be observed, it will be reported immediately to the Competent Authority.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known