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Notification report


General information

Notification Number
B/ES/08/34

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
MIR604 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, 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:
Romania;

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

If yes, notification number(s):


Other notifications
USA, Argentina

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 x GA21 maize was produced by combining Bt11, MIR604
and GA21 maize through conventional breeding. Therefore these maize plants
produce the five traits present in Bt11, MIR604 and GA21 maize plants
through the production of:
1. a truncated Cry1Ab protein for control of certain lepidopteran pests.
2. a phosphinothricin acetyltransferase (PAT) protein that confers tolerance to herbicide products containing glufosinate ammonium.
3. a modified Cry3A (mCry3A) protein for control of certain coleopteran
pests.
4. a phosphomannose isomerase (MIR604 PMI) protein as a selectable marker. PMI is an enzyme that allows transformed corn cells to utilize mannose as a sole carbon source while maize cells lacking this protein fail to grow.
5. 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:
- 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.

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.

Genetic material derived from 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:
Bt11 x MIR604 x GA21 maize was produced by combining Bt11, MIR604 and GA21 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 objective of the proposed field trial releases is to gain information relating
to the performance of this stacked maize product under European conditions,
to produce maize for comparative and expression analysis and to study
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:
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):
Please 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 MIR604 x GA21 stacked maize can be grown commercially in the USA and Canada.


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:
Yes
04/04/2008 00:00:00
Remarks: