Back

Notification report


General information

Notification Number
B/ES/06/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/01/2006

Title of the Project
Testing of 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) maize varieties in view of registration.

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

Name of the Institute(s) or Company(ies)
PIONEER HI-BRED AGRO SERVICIOS SPAIN, S.L., Ctra. Sevilla-Cazalla Km. 9,4
41309-La Rinconada
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:
The genetically modified 1507xNK603 maize varieties that will be tested in these field trials are resistant to certain Lepidopteran insects, such as the European corn borer (Ostrinia nubilalis) and tolerant to glufosinate-ammonium and glyphosate herbicides. This maize was derived through traditional breeding methods between progeny of the genetically modified 1507 maize, which is resistant to certain lepidopteran insects and tolerant to glufosinate herbicide, and NK603 maize (from Monsanto), which is tolerant to glyphosate herbicide.

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 1507xNK603 maize are the cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, like in 1507 maize, and the cp4epsps gene from Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 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 cp4epsps gene, the P-ract1/ract1 intron + ctp2, the NOS 3’ terminator.
- the cp4epsps gene, the CaMV e35S promoter + Zmhsp70 + ctp2, the NOS 3’ terminator.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on the 1507xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 1507 maize and NK603 maize.
1507 maize and NK603 maize (from Monsanto) were genetically modified 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 1507xNK603 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 2006:

- Andalucía: La Rinconada (Sevilla), Marchena (Sevilla).
- Aragón: Zuera (Zaragoza), Gelsa (Zaragoza), Gurrea de Gállego (Huesca).
- Castilla-León: Toro (Zamora), Llamas de la Ribera (Leon).
- Cataluña: Alguaire (Lérida).
- Castilla la Mancha: Membrilla (Ciudad Real), Tarazona de la Mancha (Albacete), Alpera (Albacete).
- Galícia: Santa Uxía de Ribeira (La Coruña).
- Madrid: San Martín de la Vega (Madrid).
- Navarra: Cortes (Navarra).


3. Size of the site (m2):
In 2006, each site could have up to 1000 m² sown with the genetically modified maize subject of this notification (1507xNK603 maize), the total trial surface (all varieties and borders included) being larger.
In the following years, there could have up to 1000 m² of genetically modified 1507xNK603 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:
Field trials have already been conducted at several locations across maize growing regions in North America, South America and Europe and no environmental problems were reported for these trials. The transgenic plants were indistinguishable from the non-genetically modified maize plants except for showing resistance to certain Lepidopteran insects such as Ostrinia nubilalis and showing tolerance when glufosinate and glyphosate herbicides have been applied, traits due to the genetic modifications.

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 Lepidopteran insects and tolerant to glufosinate and glyphosate herbicides are expected, as per information contained in the notification ESFA GMO Nr UK-2004-17.

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 and glyphosate, 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.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
06/03/2006 00:00:00
Remarks: