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Notification report


General information

Notification Number
B/ES/05/05

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
23/02/2005

Title of the Project
Testing of maize varieties tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects.

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?
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 NK603xMON810 maize varieties that will be tested in these field trials can tolerate the use of glyphosate herbicide for the weeding of maize field and are resistant to certain Lepidopteran insect pests such as the European corn borer (Ostrinia nubilalis). This maize was derived through traditional breeding methods between progeny of the genetically modified NK603 maize (from Monsanto), which is tolerant to glyphosate herbicide, and MON810 maize(from Monsanto), which is resistant to certain lepidopteran insects.

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:
NK603xMON810 maize contains the following genetic elements :
-the cp4epsps genes from Agrobacterium sp. strain CP4 that confer tolerance to glyphosate herbicide.
- the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki that confers resistance to certain Lepidopteran insects, such as Ostrinia nubilalis.
These genes have been introduced with only their regulatory components necessary for expression in maize plant.


6. Brief description of the method used for the genetic modification:
No genetic modification was applied to obtain the NK603xMON810 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified NK603 maize and MON810 maize.
NK603 maize and MON810 were genetically modified by Monsanto using the 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 purpose of the release is the testing of genetically modified maize varieties in view of collecting regulatory data for registration on the National Catalogue of varieties.

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


3. Size of the site (m2):
The total trial surface will be 2500 m² approximately in each location (all the varieties and borders included). About 200 m² will be planted with genetically modified plant subject of this notification (1507 maize). La Rinconada site the total surface will be 3500m², about 350 m² will be planted with genetically modified plant subject of this notification.

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 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 showing tolerance to glyphosate herbicide and resistance to certain Lepidopteran insects such as the European Corn Borer, 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 tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects are expected, as per information contained in the Summary Notification Information Format of notification C/ES/04/01.

Brief description of any measures taken for the management of risks:
In order to limit any pollen flow from the genetically modified plants, a 200m-isolation distance will be maintained to any 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 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
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/05/2005 00:00:00
Remarks: