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Notification report


General information

Notification Number
B/ES/05/20-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
18/02/2005

Title of the Project
Testing of maize tolerant to glyphosate herbicide.

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

Name of the Institute(s) or Company(ies)
PIONEER HI-BRED SPAIN S.L., Avenida Reino Unido s/n, Edificio ADYTEC-Euroficinas 2nda planta, ES-41012 Sevilla;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

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:
5394 maize has been genetically modified to tolerate application of glyphosate herbicide, which allows the farmers to use a broad-spectrum, non-selective, systemic herbicide for the weeding of the maize field.

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:
The gene introduced in 5394 maize is the gat gene from Bacillus sp, providing tolerance to glyphosate herbicide, along with the regulatory components necessary for expression.

6. Brief description of the method used for the genetic modification:
The genetic modification was done using Agrobacterium transformation method to introduce the DNA insert into the maize genome. The T-DNA on the Ti plasmid has been replaced by the construction containing the gat gene along with the regulatory components necessary for expression.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:
Several types of trials are planned, to evaluate the nutrient composition profile, protein expression, agronomic behavior and tolerance to glyphosate of the genetically modified maize in comparison with its non-genetically modified equivalent, to evaluate the residual behavior of glyphosate in the genetically modified maize plants, to collect data on the agronomic value of genetically modified maize varieties.

2. Geographical location of the site:
The release is planned at the following locations in Spain in 2005:
- Aragón: Pastriz (Zaragoza), Gurrea de Gállego (Huesca)
- Cataluña: Alpicat (Lérida), Alguaire (Lérida)
- Madrid: Estremera (Madrid)
- Navarra: Fustiñana(Navarra)
- Castilla-La Mancha: Membrilla (Ciudad Real)


3. Size of the site (m2):
Each site in 2005 could have up to 500 m2 sown with the genetically modified maize concerned by this application, the total area taken up by the release (all varieties and borders included) being higher.
In the following years, there could be up to 10 sites, each sown with up to 3000 m² of the genetically modified maize subject of this notification, the total trial surface (including all varieties and borders) being larger at each site.


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 2003, 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 tolerant to glyphosate herbicide, trait due to the genetic modification.

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 tolerant to glyphosate herbicide 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 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. An herbicide treatment (other than glyphosate) will be used in order to ensure 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:
Not known