Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Notification for the deliberate release of genetically modified DAS-Ø15Ø7-1 maize varieties in view of registration.

Proposed period of release:
01/04/2010 to 31/12/2010

Name of the Institute(s) or Company(ies)
Edificios ADYTEC – Euroficinas, 2nda planta
41012 Sevilla;

3. Is the same GMPt release planned elsewhere in the Community?

Has the same GMPt been notified elsewhere by the same notifier?

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmays

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 DAS-Ø15Ø7-1 maize (referred to as 1507 maize) so that it 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:

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 a plant-optimized cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and a plant-optimized pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, along with the regulatory components necessary to drive their expression:
- 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 the testing of genetically modified 1507 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 2010:

• Andalucía: Dos Hermanas (Sevilla), Los Palacios-Villafranca (Sevilla), Marchena (Sevilla), Alcalá del Río (Sevilla).
• Aragón: Tauste (Zaragoza), Villafranca de Ebro (Zaragoza)-(3 locations), Ejea de los Caballeros (Zaragoza), Nuez de Ebro (Zaragoza)-(2 locations).
• Castilla-La Mancha: La Gineta (Albacete).
• Castilla y León: Corbillos de los Oteros (León), Toral de los Guzmanes (León), Sahagún (León), Chozas de Abajo (León), Villarrabé (Palencia), Olmos de Ojeda (Palencia)-(2 locations), Nava de Roa (Burgos), Ribas de Campos (Palencia)-(3 locations).
• Extremadura: Villanueva de la Serena (Badajoz), Villar de Rena (Badajoz).
• Galicia: Mesía (La Coruña).

3. Size of the site (m2):
Each site could have up to 1000 m² sown with the genetically modified 1507 maize 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:
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, except for being resistant to certain lepidopteran insects and tolerant to glufosinate-ammonium herbicide, traits due to the genetic modification.
1507 maize has been approved for commercial cultivation in the USA in 2001, Canada and Japan in 2002, Argentina in 2005, Brazil in 2008. It is widely cultivated; no adverse effects have been reported.

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 former notifications in Spain.

Brief description of any measures taken for the management of risks:
The pollen shed from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any other commercial maize crop. As it is done for any trial with conventional maize, the trial site will be surrounded by agronomic border rows of conventional maize of a similar maturity. The agronomic border rows will be also destroyed at the end of the release.
Grains are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. Thus seed dispersal of individual kernels is not likely to occur. 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.
If needed, the trial could be stopped by mechanical destruction or application of a herbicide other than glufosinate-ammonium, and incorporation into the soil by a deep ploughing.
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 by a deep ploughing. No plant or plant product coming from the trials will enter the food or feed chains.
After the release, the plot will be visited regularly during the following year in order to ensure removal of maize volunteers, if any. Although volunteer maize cannot generally survive hard winter, maize volunteers, if any, will be monitored in order to ensure their destruction prior to flowering.
No commercial maize crop will be planted on the same plot 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:
09/03/2010 00:00:00