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Notification report


General information

Notification Number
B/ES/05/22

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
04/05/2005

Title of the Project
Field trials with herbicide tolerant cotton, following a two-year program frame (2004-2005).

Proposed period of release:
01/04/2005 to 30/11/2005

Name of the Institute(s) or Company(ies)
Bayer CropScience, S.L., Pol.Industrial el Plá, parcela 30
46290-Alcacer (Valencia) España;


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):


Other notifications
EFSA-GMO-NL-2005-13

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
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 of tolerance to the herbicide glufosinate ammonium:
- P35S3 : Promotor region of the 35S transcript from Cauliflower Mosaic Virus.
- bar : Coding sequence of the phosphinothricin acetyltransferase gene (bar) from Streptomyces hygroscopicus.
- 3’ nos : the 3’untranslated region of the nopaline synthase gene from the T-DNA of pTiT37 from Agrobacterium tumefaciens.


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 glufosinate tolerance under the climatic conditions of the Spanish cotton cultivation zone, and the efficacy on the problem weeds of cotton, as well as the environmental behaviour (survivability, dormancy) of the Genetically Modified Organism. No crosses are planned.

2. Geographical location of the site:
2005: 4 locations in Spain in the province of Catalonia.

3. Size of the site (m2):
Biosafety trial: each location will have a surface of approximately 500m² of transgenic plants.

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 US from 1999 to 2001, on a total of more than 40 locations. Trials are currently ongoing in Australia and Mexico. A summary of the findings include:
- The genetic change is stable and the introduced gene produces a protein which has a proven safety profile.
- The new glufosinate-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 and analysis of components of nutritional importance, 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, glufosinate.
- The potential for gene flow, the transfer of glufosinate herbicide tolerance to wild or weedy 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.
- There is no cause for concern for the human consumption and for animal feed use of the seed or plant products derived from the LibertyLink cotton varieties based upon transformation event LLCotton25.
- Liberty system complements current cotton field weed control practices.
- The agricultural requirements of cotton crops for irrigation and temperate climate prevent glufosinate-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 behaviour as conventional cotton except for the characters encoded by the inserted bar gene.
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 Australia and post-harvest monitoring did not report any adverse effects on the environment.
The bar gene has been approved in various crops since 1995, for environmental release, food and feed by different agencies in the world including Argentina, Australia, Canada, Europe, Japan and the US. Regarding cotton specifically, transgenic lines tolerant to herbicides are also developed and approved in various countries since 1994.


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. Confirm the efficacy of the Liberty system;
2. Evaluate any change in the capacity for survival or dormancy of the transgenic plant under typical Spanish conditions;

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:
Yes
13/05/2005 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Cataluña.