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Notification report


General information

Notification Number
B/ES/09/34

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
16/01/2009

Title of the Project
Field trials with glyphosate herbicide tolerant cotton transformation event GHB614 for agronomic, nutritional and toxicological evaluation.

Proposed period of release:
21/03/2009 to 21/03/2010

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:
Spain;

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

If yes, notification number(s):
B/ES/06/10-CON; B/ES/07/28-CON; B/ES/07/40-CON; B/ES/08/27; B/ES/08/38;

Other notifications
USA: (APHIS 01-282-03n; 02-072-04n; 02-296-01n; 03-064-14n; 03-255-03n; 04-
061-10n; 04-247-01n, 05-060-03n; 05-091-07n; 05-217-05n, 05-257-04n; 06-031-
01n; 06-054-02n; 06-054-03n; 06-089-03n; 06-223-106n; 07-065-110n; 07-082-
101n; 07-122-102n; 07-137-101n; 07-243-106n).
Argentina: N° 281.585/06.


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:
Glyphosate 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:
2mepsps: Coding sequence of 2mepsps from maize that confers the herbicide resistance trait.

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:
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:
Province of Tarragona:

Municipio Vinyols i Les Arcs: 1 locations
Municipio Cambrils: 2 locations
Municipio Mont Roig del Camp: 2 locations
Municipio Villa-Seca: 1 location


3. Size of the site (m2):
Each location will have a max. surface of 3 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 is stable and the introduced gene produces a protein which
has a proven safety profile.
- The new herbicide-tolerant cotton varieties share the characteristics of cotton plants in agricultural production and of cottonseed in commerce.
- In side-by-side comparisons with the non-transgenic parent variety of plant
morphological characters, no evidence of pleiotropic effects were detected.
- There is no cause for concern to non-target organisms presented by the new plant varieties or the new use of the herbicide.
- The potential for gene flow, the transfer of herbicide tolerance to conventional or wild cotton relatives, is low.
- The consequence of gene flow will not be detrimental to current agronomic systems and can be managed by current agricultural practices.
The agricultural requirements of cotton crops for irrigation and temperate climate prevent the herbicide-tolerant cotton from becoming invasive of new habitats as a result of cultivation.


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 gene.
Due to the measures taken in the trials and the lack of wild relatives of cotton in Europe, Bayer BioScience 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 in the absence of the herbicide tolerant treatment.
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.


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:
Evaluate 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
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European Commission administrative information

Consent given by the Member State Competent Authority:
No
28/04/2009 00:00:00
Remarks: