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Notification report


General information

Notification Number
B/ES/07/12

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
MON-ØØ6Ø3-6xMON-ØØ81Ø-6 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:
MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize, referred to as NK603xMON810 maize hereafter, can tolerate the use of glyphosate herbicide for the weeding of maize field and is resistant to certain Lepidopteran insect pests such as the European corn borer (Ostrinia nubilalis). This maize was derived through traditional breeding methods between progeny of the genetically modified MON-ØØ6Ø3-6 maize (referred to as NK603 maize), from Monsanto, which is tolerant to glyphosate herbicide, and MON-ØØ81Ø-6 maize (referred to as MON810 maize), from Monsanto, which is resistant to certain lepidopteran insects.

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 NK603xMON810 maize are the cp4epsps gene from Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 maize, and the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki that confers resistance to certain Lepidopteran insects such as Ostrinia nubilalis, like in MON810 maize, along with the regulatory components necessary for expression in maize plant:
- the cp4epsps gene, the P-ract1/ract1 intron + ctp2, the NOS 3’ terminator.
- the cp4epsps gene, the e35S promoter + Zmhsp70 + ctp2, the NOS 3’ terminator.
- the cry1Ab gene, the e35S promoter + Zmhsp70


6. Brief description of the method used for the genetic modification:
No genetic modification was applied to obtain the NK603xMON810 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified NK603 maize and MON810 maize.
NK603 maize and MON810 maize were genetically modified by Monsanto using the particle acceleration 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 NK603xMON810 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 NK603xMON810 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:
Many field trials have already been conducted at 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 tolerance to glyphosate herbicide and resistance to certain Lepidopteran insects such as the European Corn Borer, traits due to the genetic modifications.
NK603xMON810 maize is no more regulated in the USA since 2000 and 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 maize tolerant to glyphosate herbicide and resistant to certain Lepidopteran insects are expected, as per information contained in the Summary Notification Information Format of notification C/ES/04/01.

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 non-experimental 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 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 herbicide other than glyphosate or by mechanical destruction, 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. 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.
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: