General informationNotification NumberB/ES/06/24Member State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority28/12/2005Title of the ProjectTesting of 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) maize.Proposed period of release:01/04/2006 to 31/12/2009Name 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?NoHas the same GMPt been notified elsewhere by the same notifier?NoGenetically modified plantComplete name of the recipient or parental plant(s)
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 modification3. 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:
|Common Name||Family Name||Genus||Species||Subspecies||Cultivar/breeding line|
|maize||poaceae||zea||zea mays||mays||Experimental varieties|
- 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 Release1. Purpose of the release:Several types of trials are planned, to collect various 1507xNK603 maize tissue samples for protein expression analysis, to evaluate the impact of the cultivation of transgenic maize varieties on key non-target arthropod populations, to control maize volunteers with different herbicides, to evaluate the glyphosate effects on transgenic maize varieties.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 500 m² sown with the genetically modified maize subject of this notification (1507xNK603 maize), the total trial surface (all varieties and borders included) being larger at each site. In 2006, the site in Alguaire (Cataluña) could have up to 8000m² sown with 1507xNK603 maize, as the trial to evaluate the impact on key non-target arthropod populations will be carried out in collaboration with the University of Lérida. The total trial surface (all varieties and borders included) will be larger.
In the following years, there could have up to ten sites and up to 10000 m² of 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 ManagementSummary 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 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 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 reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Yes23/03/2006 00:00:00Remarks: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.