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Notification report


General information

Notification Number
B/FR/06/12/04-CON

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
10/11/2006

Title of the Project
Field trial of genetically modified wild tobacco (Nicotiana sylvestris) producing a taxane diterpenoid

Proposed period of release:
01/04/2007 to 31/10/2009

Name of the Institute(s) or Company(ies)
LIBROPHYT SAS, Centre de Cadarache, Bat. 185
13115 St-Paul-Lez-Durance
FRANCE;


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

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The GMPt contains three transgenes:
1) a tobacco gene fragment in both sense and antisense orientation under the control of its own promoter in order to silence the corresponding endogenous gene. Presence of this transgene results in a reduced content in cembranes (diterpenes) on the tobacco leaf surface.
2) The gene encoding taxadiene synthase from yew (Taxus brevifolia)
3) The gene encoding a taxadiene hydroxylase from yew (Taxus cuspidata)
The plants contain also a resistance gene marker that is expressed in the whole plant.
Supplemental confidential information is given in appendix I


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:
The genes of interest and their regulatory elements originate from plant species.
The marker gene is from bacterial origin but contains a functional intron. The presence of the intron prevents the marker gene to be expressed in procaryotic organisms. The expressed proteins are not pathogenic to humans nor deleterious to the environment.

Supplemental confidential information is given in appendix II


6. Brief description of the method used for the genetic modification:
The transgenes were introduced in Nicotiana sylvestris via Agrobacterium mediated transformation. Regeneration and selection of modified plants is performed on medium containing the selective agent, hygromycin. The copy number of transgenes insertion was determined by real-time quantitative PCR.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable

Experimental Release

1. Purpose of the release:
The field trial aims at:
· Testing the agronomic performance of the modified plants compared to control plants.
· Measuring the level of the taxoid produced in the GM Plant.
· Extracting purifying the taxoid molecule (approximately 50-100 g)


2. Geographical location of the site:
Allemanche, Marne, France

3. Size of the site (m2):
39 000 genetically modified plants and 1000 wild type plants of the same species will be grown in an area of 10 000 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:
No release of the same GM-plant was carried out previously.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Note especially if the introduced traits could directly or indirectly confer an increased selective advantage in natural environments; also explain any significant expected environmental benefits

Woodland Tobacco is not a wild plant in Europe. Woodland Tobacco plants cannot survive the winter in Europe and the germination of Woodland Tobacco seeds for cultivation is done in warm glass houses before transplanting in the field. The acquired trait in the modified plant does not affect resistance to cold or the ability to germinate in the field. Also, the genetically modified plants have an altered leaf surface composition with a novel diterpenoid of the taxane family. However this compound is non-volatile and present at such low concentrations on the leaf surface that no toxicity is expected for the fauna. Finally, the GM-plant is resistant to the antibiotic hygromycin. This trait does not confer any competitive advantage to the GM-plant under standard cultivation.
Consequently, there is no anticipated selective advantage of the GM-plant in a natural environment.


Brief description of any measures taken for the management of risks:
The GM-plant is a wild species which is not cultivated and does not grow wild in Europe. In addition, spontaneous crossing of woodland tobacco with cultivated tobacco (Nicotiana tabacum) is not significant in field conditions. Furthermore, interspecific hybrids, particularly between an amphidiploid and a diploid species, are generally sterile. Nonetheless, to completely prevent potential cross fertilization with cultivated tobacco, the plants will be harvested before flowering. Moreover, the fields will be located at least 500 m from the nearest cultivated tobacco field.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known