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Notification report


General information

Notification Number
B/ES/07/43-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
22/02/2007

Title of the Project
Field trials with glufosinate herbicide tolerant and insect resistance cotton transformation event GHB119 for agronomic, nutritional and toxicological evaluation and the production of reference material.

Proposed period of release:
21/03/2007 to 21/12/2009

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:


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

If yes, notification number(s):
B/ES/06/15-CON;

Other notifications
USA: (APHIS: 02-288-03n, 03-064-15n, 03-254-01n, 04-064-11n, 05-035-10n, 05-035-12n, 05-257-05n, 05-257-06n)
USA: (EPA: 264-EUP-RUR)


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
cottonmalvaceaegossypiumgossypium hirsutumCoker312, other breeding line

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Insect resistant and glufosinate ammonium 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:
Genetic elements which confer the phenotype insect resistant and glufosinate ammonium herbicide tolerance:

-cry2: Coding sequence of cry 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 1 for further information.


6. Brief description of the method used for the genetic modification:
The transgenic cotton 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 and to produce reference material. It will be studied also the environmental behavior (survivability, dormancy) 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:
2007:
Spain, Catalonia. 13 locations in the province of Tarragona:

- Municipio Vinyols i Les Arcs: 3 locations (one of them for reference material production).
- Municipio Cambrils: 2 locations.
- Municipio Mont Roig del Camp: 3 locations.
- Municipio Santa Oliva: 2 locations.
- Municipio Ginestar: 1 location.
- Municipio Camarles: 1 location.
- Municipio Villa-Seca: 1 location.


3. Size of the site (m2):
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 GHB119 will cover a total surface of 360m2, in the field trial localization that will be of 2 ha. An additional plot of 144 m2 will be present in 2 localizations for the gene flow studies.

The field trial for the reference material production will cover a surface of 2500 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:
The previous releases took place in the continental US or in Puerto Rico, from 2001 through 2005. A summary of observations to date include:

- The genetic change appears stable.
- The new insect resistant and glufosinate ammonium tolerant 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 or glufosinate ammonium herbicide tolerance 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, BCS consider 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 glufosinate treatment.
This transgenic cotton has been tested at various locations in the US and in Costa Rica and post-harvest 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 multiplication assay will be isolated by 1.5 km from any other cotton field.
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:
1- Evaluate agronomic, toxicological and nutritional aspects
2- Evaluate the environmental behavior (survivability, dormancy) of the Genetically Modified Organism under the climatic conditions of the Spanish cotton cultivation zone
3-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:
Not known