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Notification report


General information

Notification Number
B/ES/08/41-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
05/02/2008

Title of the Project
Field trials with hybrid insect resistance cotton transformation event for agronomic, nutritional and toxicological evaluation.

Proposed period of release:
21/03/2008 to 21/03/2009

Name of the Institute(s) or Company(ies)
Bayer BioScience N.V., Technologiepark 38
B-9052 Gent
Belgium;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Austria; Belgium; Germany; Denmark; Spain; Finland; France; United Kingdom; Greece; Ireland; Italy; Luxembourg; Netherlands; Portugal; Sweden; Iceland; Norway;

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
cottonmalvaceaegossypiumgossypium hirsutumCoker315, Coker 312

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Insect resistant and herbicide tolerance.

Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
Conventional crossing breeding between genetically modified parental lines. No additional genetic modifications.

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Genetic elements which confer the phenotype insect resistant and herbicide tolerance:
-cry2: Coding sequence of cry gene from Bacillus thuringiensis that confers the insect resistance trait.
-cry1Ab: Coding sequence of cry1Ab gene from Bacillus thuringiensis that confers the insect resistance trait.
- bar : Coding sequence of the phosphinothricin acetyltransferase gene (bar) from Streptomyces hygroscopicus that confers the herbicide resistance trait.
Refer to the Confidential Annex for further information.


6. Brief description of the method used for the genetic modification:
The transformation event is the result of the conventional breeding between the two genetically modified parental transformation events.
The transgenic cotton parental lines are generated using disarmed Agrobacterium-mediated transformation.


7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not relevant.

Experimental Release

1. Purpose of the release:
The purpose of this study is to evaluate agronomic, nutritional and toxicological aspects of the transformation event.It will be studied also the environmental behavior of the Genetically Modified Organism under the climatic conditions of the Spanish cotton cultivation zone. No crosses are planned.

2. Geographical location of the site:
2008:
Spain, Catalonia. 8 locations in the province of Tarragona:
- Municipio Vinyols i Les Arcs: 1 locations
- Municipio Cambrils: 2 locations
- Municipio Mont Roig del Camp: 1 location
- Municipio Santa Oliva: 1 location
- Municipio Ginestar: 1 location
- Municipio Camarles: 1 location
- Municipio Villa-Seca: 1 location


3. Size of the site (m2):
2008:
Field trials for agronomic, toxicological and nutritional evaluation with the transformation event will be included in field trials with other transformation events. The transformation event will cover a total surface of 360m2, in the field trial localization that will be of 2 ha.


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:
- The genetic change appears stable.
- The new insect resistant cotton varieties share the characteristics of cotton plants in agricultural production.
- There is no cause for concern to non-target organisms presented by the new plant varieties.
- The potential for gene flow, the transfer of insect resistance to conventional or wild cotton relatives, is low.
- The consequence of gene flow would not be detrimental to current agronomic systems and can be managed by current agricultural practices.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Genetically modified cotton has the same behavior as conventional cotton except for the characters encoded by the inserted genes.
Due to the measures taken in the trials and the lack of wild relatives of cotton in Europe, Bayer Bioscience N.V. consider that gene transfer is unlikely to happen, neither to other species nor to conventional cotton.


Brief description of any measures taken for the management of risks:
The trials will be conducted with an isolation distance of 200 m from any other cotton. The field trial sites will be surrounded with at least 4 rows of non-transgenic cotton (pollen trap) which will be destroyed after flowering.
The products harvested from the field trials will be used for experimental purposes or destroyed.
Each site will be visited on a regular basis during the trial period.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Evaluation of agronomic, toxicological and nutritional aspects and the environmental behavior of the Genetically Modified Organism under the climatic conditions of the Spanish cotton cultivation zone.
The planned field trials are not designed to address the impact of the release on human health.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/03/2008 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Cataluña.