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Notification report


General information

Notification Number
B/ES/04/15-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
12/03/2004

Title of the Project
Testing of maize hybrids tolerant to an herbicide and resistant to Lepidopteran insects

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

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 hybrids

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified maize hybrids that will be tested in these field trials have been obtained by crossing two genetically modified inbred lines: one inbred line has received an insert providing tolerance to glyphosate herbicide and the other inbred line has received an insert providing resistance to certain Lepidopteran insects (confidential information is available in notification C/ES/04/01 submitted by 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:
The list of the genetic elements inserted in the parental lines are provided in Annex 1 as this is to be considered as Confidential Business Information.

6. Brief description of the method used for the genetic modification:
Genetic modification has been applied to the parental lines but the hybrid maize tested has been made by traditional crossing.

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 the release is to collect data on agronomic performances of genetically modified maize hybrids tolerant to glyphosate herbicide and resistant to certain lepidopteran insects, in comparison with check hybrids.

2. Geographical location of the site:
The release is planned at several locations in Spain in 2004:
- Andalucía: Los Palacios (Sevilla), Los Molares (Sevilla), Los Rosales (Sevilla).
- Aragón: Montañana (Zaragoza) (2 locations), San Juan de Mozarrifar (Zaragoza), Pastriz (Zaragoza), Barbastro (Huesca), Gurrea de Gállego (Huesca), Graus (Huesca).
- Castilla-La Mancha: Almoguera (Guadalajara)
- Castilla-León: Colinas de Trasmontes (Zamora), El Burgo Ranero (León) (2 locations)
- Cataluña: Vimbodí (Tarragona), Tremp (Lérida), Alguaire (Lérida).
- Madrid: Fuentidueña de Tajo (Madrid), Villamarique de Tajo (Madrid), Estremeda (Madrid).
- Navarra: Cortes (3 locations)


3. Size of the site (m2):
The trial at each site in 2004 will cover about 4000m² (all varieties and borders included) of which up to 2000m² will be planted with the transgenic plants concerned by this application.

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:
Field trials were conducted in 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 herbicide tolerance when glyphosate is applied and resistance against certain Lepidopteran insects.

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 and resistant to Lepidopteran insects have been reported. This is based on the information contained in the MONSANTO notification.

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 other commercial maize crop.
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. For this trial, a few seeds will 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.


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
30/03/2004 00:00:00
Remarks:
Consents given by the competent authorities of these Autonomous Commnuties:
- Cataluña: 30/03/2004.
- Aragón: 06/04/2004.
- Castilla- La Mancha: 10/04/2004.
- Navarra: 31/05/2004.