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Notification report


General information

Notification Number
B/ES/11/12-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
21/12/2010

Title of the Project
Field trials for Protein Expression Study of genetically modified cotton transformation event T304-40 and for agronomic and efficacy evaluation against Lepidoptera pest, grown in open field conditions in Andalucia.

Proposed period of release:
21/03/2011 to 31/03/2012

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?
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;

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-RU


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:
Insect resistant and herbicide tolerance.

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:
-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 transgenic cotton lines are generated using disarmed Agrobacteriummediated
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 protein expression studies in different parts of the genetically modified cotton plants and to evaluate agronomic aspect and efficacy against Lepidoptera pest, under the climatic conditions of the Spanish cotton cultivation zone.

2. Geographical location of the site:
Province of Seville
Villages:
- Dos Hermanas 1 location
- Brenes 1 location


3. Size of the site (m2):
Each location will have a maximum surface of 1 ha, including GM and no GM cotton. In each location other transformation events described in other notifications will be present.

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 variety 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 the inserted gens 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. considers that gene transfer is unlikely to happen, neither to other species nor to conventional cotton.
However if a weed or a volunteer would receive the transgene, this would not confer any selective advantage.
This transgenic cotton has been tested at various locations in the US and postharvest monitoring did not report any adverse effects on the environment.


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 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 in order to study the new expressed proteins and to evaluate the agronomic aspects and efficacy against Lepidoptera pest.
The planned field trial is 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
31/03/2011 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of AndalucĂ­a.