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Notification report


General information

Notification Number
B/ES/04/12

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
25/02/2004

Title of the Project
Testing of maize varieties tolerant to an herbicide

Proposed period of release:
01/04/2004 to 30/11/2004

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 and inbred lines

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
One transformation event, coded NK603, will be used for the proposed field programme. The maize plants express a CP4 EPSPS gene which confers tolerance to glyphosate, the active ingredient of Roundup herbicide. There have been no previous genetic modifications of the parental organism.

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 donor organism, Agrobacterium sp. strain CP4, was used to supply the CP4 EPSPS gene for glyphosate tolerance. Genetic analysis of line NK603 confirmed a single stable site of insertion of the sequences encoding CP4 EPSPS into the maize plant genome. The insertion resulted in the expression of the closely related proteins CP4 EPSPS and CP4 EPSPS L214P, which imparts tolerance to glyphosate.

6. Brief description of the method used for the genetic modification:
The transformation vector, containing the CP4 EPSPS gene and regulatory sequences, was introduced into the maize genome by a particle acceleration method to produce Roundup Ready maize line NK603.

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 the testing of genetically modified maize varieties in view of collecting regulatory data for registration on the National Catalogue.

2. Geographical location of the site:
The release is planned at one location in Spain in 2004:
- Andalucía: La Rinconada (Sevilla)


3. Size of the site (m2):
The trial at the site in 2004 will cover about 514 m² (all varieties and borders included) of which 90 m² 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.

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 have been reported.

Several generations of the transgenic maize plants have been tested previously in different environments in the US since 1997 and in Europe since 1999. These experiments have demonstrated that the trait is stably inherited and that the plants resemble the recipient plant in all respect differing only in their ability to be tolerant to glyphosate. Measures will be taken to avoid seed dissemination at harvest and during transportation (see E.).

Maize can hybridise with teosinte (Zea mays ssp. Mexicana) but these plants are not present in Europe. The possibility of hybridisation with other maize plants will be minimised by a spatial isolation distance of minimum 200 meters from other cultivated.


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
12/04/2004 00:00:00
Remarks: