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Notification report


General information

Notification Number
B/FR/05/03/01

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
08/02/2005

Title of the Project
Testing of genetically modified maize resistant to certain Coleopteran and Lepidopteran insects and tolerant to two herbicides (59122x1507xNK603 maize)

Proposed period of release:
01/04/2005 to 31/12/2008

Name of the Institute(s) or Company(ies)
Pioneer Genetique Sarl, Chemin de l'Enseigure
31840 Aussonne;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysexperimental varieties

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified 59122x1507xNK603 (DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ60Ø3-6) maize varieties that will be tested in these field trials are resistant to certain Coleopteran insects, such as Western corn rootworm (Diabrotica virgifera virgifera), and certain Lepidopteran insects, such as European corn borer (Ostrinia nubilalis), and can tolerate the use of glufosinate-ammonium and glyphosate herbicides for the weeding of maize field. This maize was derived through traditional breeding methods between progeny of the genetically modified 59122 maize, 1507 maize and NK603 maize (from Monsanto).

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:
59122x1507xNK603 maize contains the following genetic elements:
- the cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis strain PS149B1 that confer resistance to certain Coleopteran insects, such as Diabrotica virgifera virgifera, and the pat gene from Streptomyces viridochromogenes that confers tolerance to glufosinate-ammonium herbicide, from 59122 maize.
- the cry1F gene from Bacillus thuringiensis var. aizawai that confers resistance to certain Lepidopteran insects, such as Ostrinia nubilalis, and the pat gene from Streptomyces viridochromogenes that confers tolerance to glufosinate-ammonium herbicide, from 1507 maize.
- the cp4epsps genes from Agrobacterium sp. strain CP4 that confer tolerance to glyphosate herbicide, from NK603 maize.
All these genes have been introduced in the corresponding maize along with their regulatory components necessary for expression.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on the 59122x1507xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 59122, 1507 and NK603 maize.
59122 maize was genetically modified using Agrobacterium transformation method. 1507 maize was genetically modified using a particle acceleration method. NK603 maize was genetically modified by Monsanto using a 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:
Several types of trials will be carried out, to collect data on the agronomic value and insect resistance of 59122x1507xNK603 maize varieties, to observe the plant behavior, which could enable to collect morpho-physiological data, to control maize volunteers with different herbicides.

2. Geographical location of the site:
The releases are planned at several locations in France within the following areas: Aquitaine (Landes, Lot et Garonne), Centre (Eure et Loir, Loir et Cher, Indre, Indre et Loire, Loiret), Midi-Pyrénées (Haute-Garonne, Gers, Tarn, Tarn et Garonne), Languedoc-Roussillon (Aude).

3. Size of the site (m2):
Each year, there could be up to 10 sites, each sown with up to 5000 m² of genetically modified maize subject of this notification (59122x1507xNK603 maize), the total trial surface for each site (including all varieties and borders) being larger.
In the case of the trials that will be carried out to evaluate the control of transgenic maize with different herbicides, two plantings are planned each year, to simulate maize volunteers that may occur in spring and fall rotational crops.


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:
Many field trials have already been conducted at several locations across maize growing regions in North America, South America and Europe and no environmental problems were reported for these trials. The transgenic plants were indistinguishable from the non-genetically modified maize plants except for showing resistance to certain Coleopteran insects, such as Western corn rootworm, and certain Lepidopteran insects such as European corn borer and showing tolerance when glufosinate and glyphosate herbicides were applied, traits due to the genetic modifications.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No risks to human and animal health or the environment from the deliberate release of genetically modified maize resistant to certain Coleopteran and Lepidopteran insects and tolerant to glufosinate and glyphosate herbicides are expected, as per information contained in the environmental risk assessment included in the notification.

Brief description of any measures taken for the management of risks:
The shedding of pollen from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any other non-experimental maize crop. In addition, the trial site will be surrounded by four border rows of conventional maize of a similar relative maturity that will be also destroyed at the end of the release.
Seed dispersal of individual kernels does not generally occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. When a few seeds need to be collected for analysis; this will be done by sampling the whole ear and unused seeds will be destroyed.
In case of any emergency, the trial could be stopped by application of a non-selective herbicide, other than glufosinate and glyphosate, or by mechanical destruction and incorporation into the soil.
At the end of the release, all remaining plant matter that has not been harvested for analyses will be destroyed by chopping and incorporating into the soil.
Volunteer maize will be monitored during the following year in order to ensure their destruction, if needed.
No commercial maize will be cultivated in the trial site the following year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable to this release.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
27/04/2005 00:00:00
Remarks: