General informationNotification NumberB/ES/04/01-CONMember State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority08/01/2004Title of the ProjectTesting of Coleopteran insect resistant as well as herbicide tolerant maize hybrids.Proposed period of release:01/04/2004 to 12/12/2004Name 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 plants that will be tested in these field trials have been modified for resistance to certain Coleopteran insects by the insertion of two genes from Bacillus thuringiensis and for glufosinate tolerance by the insertion of a gene from Streptomyces viridochromogenes.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 list of genetic elements inserted is given in Annex 1 as this is to be considered as Confidential Business Information.6. Brief description of the method used for the genetic modification:The genetic modification has been done using Agrobacterium tumefaciens, strain LBA4404 to introduce the DNA into the maize genome. The T-DNA on the Ti plasmid has been replaced by the construction containing the 3 genes along with the regulative components necessary for expression.7.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 Release1. Purpose of the release:The goal of this release is to collect data on the composition of different parts of the plant and on the expression of the produced proteins in comparison with the non-genetically modified equivalent hybrid, at different growth stages.
|Common Name||Family Name||Genus||Species||Subspecies||Cultivar/breeding line|
|maize||poaceae||zea||zea mays||mays||Experimental hybrids.|
This will be necessary to later apply for a marketing release of these genetically modified plants in the European Community.2. Geographical location of the site:The release is planned at several locations in Spain in 2004:
- Andalucía: Los Palacios (Sevilla), Los Molares (Sevilla), Los Rosales (Sevilla).
- Aragón: Montañana (Zaragoza) (2 locations), San Juan de Mozarrifar (Zaragoza), Pastriz (Zaragoza), Barbastro (Huesca), Gurrea de Gállego (Huesca), Graus (Huesca).
- Castilla-La Mancha: Almoguera (Guadalajara)
- Castilla-León:Colinas de Trasmontes (Zamora), El Burgo Ranero (León) (2 locations)
- Cataluña: Vimbodí (Tarragona), Tremp (Lérida), Alguaire (Lérida).
- Madrid: Fuentidueña de Tajo (Madrid), Villamarique de Tajo (Madrid), Estremeda (Madrid).
- Navarra: Cortes (3 locations)3. Size of the site (m2):The trial at each site in 2004 will cover about 1000m² (all varieties and borders included) of which 110m² will be planted with the transgenic plants concerned by this application.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:Pioneer began testing corn hybrids genetically modified with this transformation event in 2001. The genetically modified corn hybrids have been in continuous nurseries in Hawaii and Puerto Rico. Since 2002, several field trials have been conducted throughout the maize growing region of the United States of America and in Chile. Field trials were also conducted in Europe in 2003, in France and Bulgaria.
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 being insect resistant and herbicide tolerant.Environmental Impact and Risk ManagementSummary of the potential environmental impact from the release of the GMPts:The e.r.a. has not identified any risks to human and animal health or the environment from the deliberate release of GM maize containing resistance to certain Coleopteran insects and tolerance to glufosinate-ammonium. This is based on the information contained in this notification and the following concluding remarks:
- There is negligible likelihood for GM maize to become environmentally persistent or invasive giving rise to any weediness;
- Expression of the two insecticidal proteins and the herbicide tolerance protein does not confer any selective advantage outside the agricultural environment;
- There are no wild relatives of maize in the EU and the genetic modification in maize does not introduce any selective advantages to maize plants outside the heavily managed agricultural environments;
- The deliberate release of genetically modified maize will result in negligible immediate and/or delayed environmental impact resulting from direct and indirect interactions of genetically modified maize with non-target organisms;
- The genetic modification in maize does not introduce any new compounds known to cause, or expected to cause, any potential immediate and/or delayed effects on human health;
- The genetic modification in maize does not introduce any new compounds known to cause, or expected to cause, any possible immediate and/or delayed effects on animal health. Moreover, the genetically modified maize obtained from these field releases will not enter the feed/food chain.
- The genetic modification will not cause any possible immediate and/or delayed effects on biogeochemical processes.
- The specific cultivation, management and harvesting techniques used for the genetically modified maize are identical to those used for other non- genetically modified maize.
- The potential reduction of the control of certain coleopteran insect pests if the target insect pests develop resistance to the proteins as expressed in genetically modified maize has been identified as the only potential risk resulting from the interaction of genetically modified maize with target organisms. Given the size of this deliberate release, the probability of occurrence of such a phenomenon is negligible. However, if later a release for placing on the market is to be envisaged, a monitoring plan in order to minimize the development of insect resistance to these proteins will be submitted.Brief description of any measures taken for the management of risks:The shedding of pollen from the genetically modified plants will be controlled by bagging, before the pollen shedding, the tassels from the plants that will be self-pollinated and by detasselling the plants that will not be self-pollinated. Moreover, a 200m-isolation distance will be maintained to any other commercial corn crop.
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. For this trial, a few seeds will 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 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.
Volunteer maize will be monitored during the following year. An herbicide treatment (other than glufosinate) will be used in order to ensure destruction if needed.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 reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Yes10/03/2004 00:00:00Remarks:There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Aragón: 10/03/2004.
- Castilla-La Mancha: 10/03/2004.
- Navarra: 24/03/2004.
- Madrid: 24/03/2004.
- Cataluña: 30/03/2004.
- Castilla y León: 03/04/2004.