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Notification report


General information

Notification Number
B/ES/13/13

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
29/01/2013

Title of the Project
Field trials of genetically modified cotton transformation event T304-40 for reference material production.

Proposed period of release:
21/03/2013 to 21/03/2014

Name of the Institute(s) or Company(ies)
Bayer CropScience SA-NV, Mommaertslaan 14
1831 Diegem
Brussels
Belgium;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/06/12-CON; B/ES/07/39-CON; B/ES/08/37-CON; B/ES/08/40-CON; B/ES/09/32-CON; B/ES/10/25-CON; B/ES/11/12-CON;

Other notifications
USA: APHIS 01-075-08n, 02-058-02n, 02-078-01n, 02-261-25n, 03-070-12n, 03-254-01n, 04-064-11n, 05-035-12n, 05-091-08n, 05-189-07n, 05-257-06n
USA: EPA: 264-EUP-RUN


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
cottonmalvaceaegossypiumgossypium hirsutum

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


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:
Genetic elements which confer the phenotype insect resistant and herbicide tolerance:
- 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.


6. Brief description of the method used for the genetic modification:
The transformation event has been 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:
Field Trials for reference material production.

2. Geographical location of the site:
Province of Seville: Alcalá de Guadaira (2 localidades), Dos Hermanas (2 localidades), Montellano.

Province of Tarragona: Cambrils, Mont-Roig del Camp (2 localidades), Vinyols i Els Arcs (2 localidades), Camarles.


3. Size of the site (m2):
Each location will have a maximum surface of 3000 m2.

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:
As summary of observations obtained from the previous releases:
- The genetic change appears stable.
- The new genetically modified cotton varieties share the characteristics of cotton plants in agricultural production and of cottonseed in commerce.
- 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 and herbicide tolerance to conventional or wild cotton relatives, is very 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 CropScience N.V. considers that gene transfer is unlikely to happen, neither to other species nor to conventional cotton.
The introduced traits do not confer any increased selective advantage in natural environments.
The introduced traits are expected to provide significant environmental benefits, such as the reduction of insecticide applications.


Brief description of any measures taken for the management of risks:
The trial will be conducted with an isolation distance of 800 m from any commercial cotton.
The products harvested from the field trials will be used for reference material purposes.
Each site will be visited on a regular basis during the trial period and during one year after the trial finalization.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The planned field trials are designed to produce reference material.
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
19/04/2013 00:00:00
Remarks:
Authorized by the Autonomous Community of Cataluña.