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Notification report


General information

Notification Number
B/ES/06/21

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 1507 (DAS-Ø15Ø7-1) 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:
A new gene was introduced into the genetically modified 1507 maize plants so that they can fight against the damages caused by certain Lepidopteran insect pests, such as European Corn Borer (Ostrinia nubilalis). 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 1507 maize are the cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from Streptomyces viridochromogenes providing tolerance to glufosinate-ammonium herbicide, along with their regulatory components necessary for expression in maize plant:
- The cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA terminator.
- The pat gene, the CaMV35S promoter, the CaMV35S terminator.


6. Brief description of the method used for the genetic modification:
The genetic modification has been done by the particle acceleration method using a "gene gun" to introduce, into maize cells, a linear DNA fragment containing the two genes along with their 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:
The purpose of the release is to collect additional data on 1507 maize, such as the expression of the genes introduced in comparison with genetically modified maize combinations containing 1507 maize.

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 (1507 maize), the total trial surface (all varieties and borders included) being larger.
In the following years, there could have up to 10 sites, and up to 5000 m² of the genetically modified maize subject of this notification (1507 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:
Since 1996, 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 resistant to certain lepidopteran insects and tolerant to glufosinate-ammonium herbicide, traits due to the genetic modification.
A dossier for importing 1507 maize in Europe was submitted to the Competent Authority in the Netherlands in 2000 (Notification C/NL/00/10). In 2001, a novel food notification was also submitted to the Netherlands and the cultivation dossier of 1507 maize was submitted to Spain (Notification C/ES/01/01).
The placing on the market of 1507 maize for import and processing for feed use (Notification C/NL/00/10) has been authorized by the Commission of the European Communities (Commission decision of 3 November 2005).


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 1507 maize resistant to certain Lepidopteran 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 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. An herbicide treatment (other than glufosinate) 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
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.