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Notification report


General information

Notification Number
B/ES/08/32

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
30/01/2008

Title of the Project
Application to perform complementary field trials with Syngenta’s Bt11 x GA21
stacked maize product in Spain (2008-2010).


Proposed period of release:
01/04/2008 to 30/11/2008

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):


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 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 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 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 field releases is to gain further information relating to the
performance of the event under European conditions and to produce maize for
comparative analysis. They will also allow the further assessment of the event
in the environment.


2. Geographical location of the site:
Castilla La Mancha:
- Villaseca de Henares -1 (Guadalajara): 5000 m²
- Villaseca de Henares -2 (Guadalajara): 150 m²

Cataluña:
- Bellpuig (Lleida): 150 m²
- Lleida-26 (Lleida): 150 m²
- Lleida-30 (Lleida): 150 m²


3. Size of the site (m2):
See previous question.

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:
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:
The field trials 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 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 also allow the
further assessment of the event in the environment.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known