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Notification report


General information

Notification Number
B/ES/07/14

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
10/01/2007

Title of the Project
Application for the deliberate release of genetically modified DAS-Ø15Ø7-1xDAS-59122-7 maize varieties in view of registration.

Proposed period of release:
01/04/2007 to 31/12/2007

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 maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
DAS-Ø15Ø7-1xDAS-59122-7 maize, referred to as 1507x59122 maize hereafter, is resistant to certain Lepidopteran insects, such as the European corn borer (Ostrinia nubilalis) and to certain Coleopteran insects, such as the Western corn rootworm (Diabrotica virgifera virgifera), and tolerant to glufosinate-ammonium herbicide. This maize was derived through traditional breeding methods between progeny of genetically modified DAS-Ø15Ø7-1 maize (referred to as 1507 maize), which is resistant to certain lepidopteran insects and tolerant to glufosinate herbicide, and DAS-59122-7 maize (referred to as 59122 maize), which is resistant to certain coleopteran insects and tolerant to glufosinate herbicide. Tolerance to glufosinate has been introduced as a selectable marker in 1507 and 59122 maize.

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 1507x59122 maize are the cry1F gene from the soil bacterium Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, like in 1507 maize, the cry34Ab1 and cry35Ab1 genes from the soil bacterium Bacillus thuringiensis strain PS149B1, providing resistance to certain Coleopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate herbicide, like 59122 maize, 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.
- 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:
No genetic modification was made on the 1507x59122 maize directly: it was derived through traditional breeding methods between progeny of the genetically modified 1507 and 59122 maize.
1507 maize was genetically modified using a particle acceleration method, 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:
The purpose of the release is the testing of genetically modified 1507x59122 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 2007:

- Andalucía: La Rinconada (Sevilla), Los Palacios-Villafranca (Sevilla), Marchena (Sevilla).
- Aragón: Gurrea de Gállego (Huesca), Montañana (Zaragoza), Tauste (Zaragoza), Calatorao (Zaragoza), Mallén (Zaragoza), Zuera (Zaragoza).
- Castilla-La Mancha: Tarazona de la Mancha (Albacete), Alpera (Albacete), La Gineta (Albacete).
- Castilla y León: Rebollar de los Oteros (León), Llamas de la Ribera (León), Toral de los Guzmanes (León), San Vicente del Palacio (Valladolid), Pelabravo (Salamanca), Villarrabé (Palencia), Olmos de Ojeda (Palencia).
- Cataluña: Alcarrás (Lleida).
- Madrid: San Martín de la Vega (Madrid), Rivas-Vaciamadrid (Madrid).
- Galicia: Santa Uxía de Ribeira (La Coruña), Mesía (La Coruña), Villalba (Lugo).
- Navarra: Cortes (Navarra).


3. Size of the site (m2):
Each site could have up to 1000 m² sown with the genetically modified 1507x59122 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:
Field trials have already been conducted at different locations across maize growing regions in North America, South America and Europe, and no environmental problems were reported for these trials. The transgenic maize plants were indistinguishable from the non-genetically modified maize plants except for showing resistance to certain Lepidopteran insects, such as European corn borer, and to certain Coleopteran insects, such as Western corn rootworm, and showing tolerance when glufosinate herbicide was applied, traits due to the genetic modifications.
1507x59122 maize is no more regulated in the USA since 2005, in Japan since 2006, and is widely cultivated since that dates. 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 1507x59122 maize resistant to certain Lepidopteran and 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 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.
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 an emergency, 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 trial 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.
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:
Yes
14/02/2007 00:00:00
Remarks: