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Notification report


General information

Notification Number
B/ES/10/29

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
05/01/2010

Title of the Project
Application to perform complementary field trials with Syngenta’s Bt11xMIR604 stacked maize product in Spain (2010).

Proposed period of release:
01/04/2010 to 30/11/2010

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


3. Is the same GMPt release planned elsewhere in the Community?
No

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

If yes, notification number(s):
B/ES/09/61;

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 MIR604 maize is a stacked genetically modified product that has been produced by a conventional breeding cross of Bt11 maize and MIR604 maize and expresses the following proteins:

- a truncated Cry1Ab protein for control of certain lepidopteran pests.

- 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.


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 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.


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 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.


6. Brief description of the method used for the genetic modification:
The Bt11xMIR604 maize described in this application has been produced by crossing the genetically modified MIR604 maize 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 and for nursery multiplication and observation of the event Bt11xMIR604.

2. Geographical location of the site:
Aragón:
- Alforque: 17500 m2.
- Sastago-1: 23000 m2.
- Sastago-2: 10000 m2.


3. Size of the site (m2):
Aragón:
- Alforque: 17500 m2.
- Sastago-1: 23000 m2.
- Sastago-2: 10000 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.

Seeds lots will be packed in sealed paper bags in facilities authorized to carry out confined release of GMOs; the bags will remain closed until planting. Each paper bag will be clearly labeled with a unique identifier code and an indication that it is containing GM seeds. The name of the event will be also mentioned. All the bags containing the seeds lots will be contained into a sealed and labeled box.

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 data and seed multiplication and observation. 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:
Yes
26/03/2010 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Aragón.