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
Testing of genetically modified maize resistant to Lepidopteran insects as well as herbicide tolerant.

Proposed period of release:
15/04/2004 to 15/12/2007

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?

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 maysmaysexperimental hybrids and inbred lines

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The introduced genes are the cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from Streptomyces viridochromogenes providing glufosinate-ammonium herbicide tolerance.

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:
The list of the genetic elements inserted is given in Annex 1 as this is to be considered as Confidential Business Information.

6. Brief description of the method used for the genetic modification:
The genetic modification has been done by the particle acceleration method using a "gene gun" to introduce, into maize cells, a linear DNA fragment containing the two genes along with their regulatory components necessary for expression.

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 goal of this release is on the one hand, to collect agronomic data and data on insect resistance, on the other hand to collect morpho-physiological data as well as data on proteins expression and chemical composition, of the genetically modified plants in comparison with the non-modified equivalent maize plants.

2. Geographical location of the site:
The releases are planned at several locations in France in 2004 within the following areas: Aude, Haute-Garonne, Gers, Lot et Garonne, Tarn et Garonne.

3. Size of the site (m2):
Each site will have up to 3000 m2 sown with the particular genetically modified plants concerned by this application, the total area covered by this trial (including all varieties and borders) will be higher. There will be up to 10 field trials sown each year.

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:
Since 1996, field trials have already been conducted in several locations with this genetically modified maize and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize. They were indistinguishable from the non-genetically modified maize plants except for being insect resistant and herbicide tolerant.
A marketing release application for cultivation has been filed under C/ES/01/01.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:

The e.r.a. has not identified any risks to human and animal health or the environment from the deliberate release of the genetically modified (GM) maize containing resistance to certain Lepidopteran insects and tolerance to glufosinate-ammonium. This is based on the information contained in the notification and the following concluding remarks:

- There is negligible likelihood for genetically modified maize to become environmentally persistent or invasive giving rise to any weediness;

- Expression of the insecticidal crystal protein and the herbicide tolerance protein does not confer any selective advantage outside the agricultural environment;

- There are no wild relatives of maize in the EU and the genetic modification in maize does not introduce any selective advantages to maize plants outside the heavily managed agricultural environments;

- The deliberate release of genetically modified maize will result in negligible immediate and/or delayed environmental impact resulting from direct and indirect interactions of genetically modified maize with non-target organisms;

- The genetic modification in maize does not introduce any new compounds known to cause, or expected to cause, any potential immediate and/or delayed effects on human health;

- The genetic modification in maize does not introduce any new compounds known to cause, or expected to cause, any possible immediate and/or delayed effects on animal health. Moreover, the genetically modified maize obtained from these field releases will not enter the feed/food chain.

- The genetic modification will not cause any possible immediate and/or delayed effects on biogeochemical processes.

- The specific cultivation, management and harvesting techniques used for the genetically modified maize are identical to those used for other non- genetically modified maize.

- The potential reduction of the control of certain lepidopteran insect pests if the target insect pests develop resistance to the protein as expressed in genetically modified maize has been identified as the only potential risk resulting from the interaction of genetically modified maize with target organisms. Given the size of this deliberate release, the probability of occurrence of such a phenomenon is negligible. However, an insect resistance management (IRM) strategy will be developed in the context of product stewardship when this genetically modified maize is placed on the European market.

Brief description of any measures taken for the management of risks:
The shedding of pollen from the genetically modified plants will be controlled either by maintaining a 200-meter isolation distance with any other commercial corn crop, or manually by removing the tassels or bagging them before any pollen shed can occur.
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 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. An herbicide treatment (other than glufosinate) will be used in order to ensure destruction if needed.

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

European Commission administrative information

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