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Notification report


General information

Notification Number
B/ES/09/60

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
11/03/2009

Title of the Project
Application to perform complementary field trials with Syngenta’s Bt11xGA21 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 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?
Yes:
Romania;

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

If yes, notification number(s):
B/ES/08/32;

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 GA21 maize is a stacked genetically modified product that has been produced by a conventional breeding cross of Bt11 maize and GA21 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 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 are 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 GA21 maize:

- Regulatory 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:
The Bt11 x GA21 maize described in this application has been produced by crossing the genetically modified GA21 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 liberation is to do trials for the application of inscription of Bt11 x GA21 maize varieties in the Official Commercial Varieties Register, required by Law 3/2000, of January 7th.

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

3. Size of the site (m2):
- Aragón:
Miralsot (Huesca): 200 m2.
Fraga (Huesca): 200 m2.
Alforque: 200 m2.
Sastago-1: 200 m2.
Sastago-2: 200 m2.

- Cataluña:
Lleida-1 (Lleida): 200 m2.
Lleida-2 (Lleida): 200 m2.
Lleida-3 (Lleida): 200 m2.

- Andalucía:
Almodobar del Río (Córdoba): 1000 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. The Bt11 x GA21 stacked maize can be grown commercially in the USA and Canada and is currently cultivated with no adverse effects reported.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
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 only purpose of the liberation is to do preliminary trials for the application of inscription of Bt11 x GA21 maize varieties in the Official Commercial Varieties Register, required by Law 3/2000, of January 7th, the legal regime of the protection of the vegetal obtainings, and Law 11/1971, of seeds and plants of breeding ground. 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
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known