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Notification report


General information

Notification Number
B/ES/03/12

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
14/02/2003

Title of the Project
Insect resistant maize, Spain 2003-2004
Field trials of maize resistant to insects. Event 3243M


Proposed period of release:
01/05/2003 to 01/11/2004

Name of the Institute(s) or Company(ies)
Syngenta Seeds SA, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
France;

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 maysmaysEvent 3243M and offspring

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
A gene encoding for a protein capable of conferring an insect resistance characteristic, and a gene, used as a marker gene for selection, which gives the plant the option to use mannose as a 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:
Regulatory sequences: Promoter sequences derived from maize. The function of these sequences is to control expression the insect resistance gene.
Insect resistance gene: cry1Ab gene derived from Bacillus thuringiensis. The function of the product of this gene is to confer resistance to certain lepidopteran pests.
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 insect resistance gene expression.
ZmUbiIntron: Promoter from a maize ubiquitin gene together with the first intron of the gene. The function of these sequences is to control and enhance expression of the Phosphomannose Isomerase (pmi) gene.
PMI: Coding sequence of the Phosphomannose Isomerase (pmi) gene isolated from Escherichia coli. The function of this gene product is as a selectable marker for the transformation, as it allows positive selection of transformed cells growing on mannose.
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 marker gene (pmi) expression.


6. Brief description of the method used for the genetic modification:
Transformation of immature maize embryos using Agrobacterium tumefaciens LBA4404 (Negrotto et al, 2000), was carried out at Syngenta Biotechnology Inc, Research Triangle Park, North Carolina, USA.

Experimental Release

1. Purpose of the release:
The purpose of the release is to compare the insect resistance of maize modified to express an enhanced resistance to certain lepidopteran species with existing non-modified varieties, grown under standard agronomic conditions and to produce plant material for compositional analysis.

2. Geographical location of the site:
Comunidad Autónoma de Aragón: La Cartuja Baja, Zaragoza (Zaragoza)
Comunidad Autónoma de Castilla-La Mancha: Barrax (Albacete)
Comunidad Autónoma de Castilla y León: Cubillas de los Oteros (León)
Comunidad Autónoma de Cataluña: Lleida (Lleida)
Torres de Segre (Lleida)


3. Size of the site (m2):
Each site is 750 m2 (including 8 border rows of non-GM maize).

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.
Field trials carried out previously in the USA have shown no adverse effects to humans or the environment.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Note especially if the introduced traits could directly or indirectly confer an increased selective advantage in natural environments; also explain any significant expected environmental benefits
An Environmental Risk Assessment has been completed and has been submitted in 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 fields will be 400m from other maize fields and each will be surrounded by a border of conventional maize.
The products from the trial will 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 site will be monitored for one year after the release. During this year, maize will not be grown on the trial site. Any volunteer maize appearing in the field will be eliminated before flowering.


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 gain new data on the environment and human health impact of the release.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
24/03/2003 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for the consent of field trials:
- Cataluña: 24/03/2003
- Aragón: 27/03/2003
- Castilla-La Mancha: 02/04/2003