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Notification report


General information

Notification Number
B/ES/06/23

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
28/12/2005

Title of the Project
Testing of genetically modified 59122 (DAS-59122-7) maize.

Proposed period of release:
01/04/2006 to 31/12/2009

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:
New genes were introduced into the genetically modified 59122 maize plants so that they can fight against the damages caused by certain Coleopteran insect pests, such as Western corn rootworm (Diabrotica virgifera virgifera). Tolerance to glufosinate-ammonium herbicide has been introduced as a selectable marker for the screening process.

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 genes introduced in 59122 maize are the cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis strain PS149B1, providing resistance to certain Coleopteran insects and the pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate herbicide, along with their regulatory components necessary for expression in maize plant:
- the cry34Ab1 gene, the UBIZM1(2) promoter, the PINII terminator.
- the cry35Ab1 gene, the Peroxidase promoter, the PINII terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.


6. Brief description of the method used for the genetic modification:
59122 maize was genetically modified using Agrobacterium transformation 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:
Several types of trials are planned, to collect various maize tissue samples for protein expression analysis in comparison with genetically modified maize combinations containing 59122 maize, and to evaluate the impact of the cultivation of transgenic maize varieties on key non-target arthropod populations.

2. Geographical location of the site:
The release is planned at the following locations in Spain in 2006:
- Aragón: Zuera (Zaragoza), Gurrea de Gállego (Huesca).
- Castilla-La Mancha: Tarazona de la Mancha (Albacete), Alpera (Albacete), Membrilla (Ciudad Real).
- Cataluña: Alpicat (Lleida), Alguaire (Lleida).
- Madrid: San Martín de la Vega (Madrid).
- Navarra: Cortes (Navarra).


3. Size of the site (m2):
In 2006, each site could have up to 100 m² sown with the genetically modified maize subject of this notification (59122 maize), the total trial surface (all varieties and borders included) being larger at each site. In 2006, the site in Alguaire (Cataluña) could have up to 4000m² sown with 59122 maize, as the trial to evaluate the impact on key non-target arthropod populations will be carried out in collaboration with the University of Lérida. The total trial surface (all varieties and borders included) will be larger.
In the following years, there could have up to ten sites and up to 5000 m² of 59112 maize sown per site, the total trial surface at each site (all varieties and borders included) being larger.


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 since 2001 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 resistance to certain Coleopteran insects, such as the Western corn rootworm, and showing tolerance when glufosinate has been applied, traits 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 resistant to certain Coleopteran insects and tolerant to glufosinate 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 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. No plant or plant product coming from the trials will enter the food or feed chains.
Volunteer maize will be monitored during the following year in order to ensure their 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
23/03/2006 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Castilla-La Mancha: 23/03/2006.
- Navarra: 04/04/2006.
- Aragón: 12/04/2006.
- Cataluña: 12/04/2006.
- Madrid: 25/05/2006.