Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Five year field trials programme (2004-2008) for development of genetically modified maize containing a Bacillus thuringiensis subsp. kurstaki gene that confers the resistance to the European Corn Borer (Ostrinia nubilalis) and the Roundup Ready® genes that confer tolerance to the herbicide glyphosate.

Proposed period of release:
01/04/2004 to 31/12/2008

Name of the Institute(s) or Company(ies)
Monsanto France, ;

3. Is the same GMPt release planned elsewhere in the Community?
Germany; Spain; Czech Republic; Hungary;

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

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:
The genes which have been introduced into the maize plant by traditional breeding (crossing of NK 603 and MON 810 parental lines) confer the following traits:
- tolerance to glyphosate, the active ingredient of the herbicide Roundup®.
- resistance to the European Corn Borer (Ostrinia nubilalis), by expression of a Bacillus thuringiensis subsp. kurstaki protein. This protein has been demonstrated to be specifically effective in controlling a number of lepidopterian (caterpillar) insects at the larval stage of growth.

Genetic modification

3. Type of genetic modification:

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
In the case of the Bt parental line (MON810), pUC-Kan plasmids from Escherichia Coli have been used as vectors. The vector backbones contain replication sequences, virulence genes, the nptII gene that confers neomycin phosphotransferase activity in bacteria under laboratory conditions, and a combination of the following genes:

1. A gene fusion between the chloroplaste transit peptide sequence from the Arabidopsis thaliana EPSPS gene and a sequence that encodes an EPSPS enzyme similar to that of Agrobacterium sp. Strain CP4. This enzyme confers Roundup tolerance in the plant.
2. A gene fusion between the chloroplast transit peptide sequence from the Arabidopsis thaliana SSU1a gene and a synthtetic sequence that encodes the glyphosate degradation thus conferring Roundup tolerance in the plant.
3. A synthetic gene encoding a Bacillus thuringiensis insect control protein.
The transformations contain and express only the Bacillus thuringiensis gene. The expression of Bt protein confers resistance to Lepidoptera larvae, including European Corn Borer.

In the case of the Roundup Ready parental line, the transformation event contains a protein gene from Agrobacterium species strain CP4 (e.g.CP4 EPSPS) which confers tolerance to glyphosate, the active ingredient in Roundup herbicide.

6. Brief description of the method used for the genetic modification:
Maize plants tissue have been transformed by particle acceleration method.

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

Experimental Release

1. Purpose of the release:
The proposed experiments are part of a programme based on progeny of maize plants containing, the Roundup Ready TM genes (tolerance to glyphosate). The aims of the programme are:
1 - to field test the performance of weed control programmes with different rates/stages of Roundup ;
2 - to evaluate the agronomic performance (yield) of maize containing the Roundup Ready TM genes when sprayed with rates/stages of application of Roundup ;
3 - to produce vegetative plant material and grain in order to assess quality parameters of the transformed maize ;
4 - to study the lepidopteran insect tolerance of maize plants ;
5 - to conduct small demonstrative platforms ;
6 - to conduct characterization trials to get the variety registration (CTPS) ;
7 - to follow seeds selection trials and seed production for research.

2. Geographical location of the site:
The releases are planned at several locations in 2004 within the following areas: Haute-Garonne, Landes, Loiret, Vienne.

3. Size of the site (m2):
Each site will have up to 5000 m2 sown with the GM plants concerned by this application, the total area covered by the trial will be higher.
There will be up to 9 field trials sown each year.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Several generations of the transgenic maize plants have been tested previously in different environments in Europe since 1994. These experiments have demonstrated that the plants resemble the recipient plant in all respect differing only in their ability to be tolerant to the European Corn Borer or to the herbicide glyphosate.
Measures will be taken to avoid seed dissemination at harvest and during transportation (see E.). Maize can hybridize with teosinte but these plants are not present in Europe. The possibility of hybridization with other maize plants will be minimised by a spatial isolation distance of 200 meters form other cultivated maize. Some trials (efficacy especially) could be carried out without isolation. In this case, the trials will be destroyed before the flowering stage of the crop. Four rows of non transgenic maize (commercial hybrid) will surround all the trials and act as pollen trap.

Brief description of any measures taken for the management of risks:
1. The spatial isolation distance (200 m) from other maize crops and/or the four rows of non transgenic maize surrounding the trials will prevent most of the possibility of hybridisation with other maize plants. Some trials (efficacy especially) could be carried out without isolation. In this case, the trials will be destroyed before the flowering stage of the crop.

2. The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.

3. After completion of harvest, the stalks will be chopped and then incorporated into the soil. Any shattered seed will be allowed to germinate. The resulting seedlings will be destroyed by soil incorporation.

4. Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown with a spring crop (different from corn). Volunteer plants will be controlled by the use of mechanical measures and applications of routinely used commercial antimonocotyledonous herbicides in this crop.

5. Seed will be transported in sealed and labelled bags placed in a rigid container.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
01/06/2004 00:00:00