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Notification report


General information

Notification Number
B/FR/06/12/15

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
Notification for the release into the environment of genetically modified potatoes with improved resistance to Phytophthora infestans (2007 – 2011)

Proposed period of release:
01/04/2007 to 31/10/2011

Name of the Institute(s) or Company(ies)
BASF Plant Science GmbH, Carl-Bosch-Strasse 38, D-67056 Ludwigshaven GERMANY;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; United Kingdom; Netherlands; Sweden; Czech Republic;

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

If yes, notification number(s):
B/DE/05/174; B/GB/06/R42/01; B/IE/06/01; B/NL/05/03; B/SE/05/450; B/SE/05/8615;

Other notifications
B/DE/06/183

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
- improved resistance to Phytophthora infestans
- Ahas gene (tolerance to Imidazolinones) as selectable marker gene to identify transgenic cells in tissue culture


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:
- T-DNA borders, pTiT37, for incorporation into plant chromosome
- ahas gene, A. thaliana, imidazolinone tolerance in plant material
- Promoter and terminator from nopaline synthase gene, A. tumefaciens, gene regulation
- Resistance genes Rpi-blb1 and Rpi-blb2, Solanum bulbocastanum, with endogenous promoters and terminators for improved resistance to Phytophthora infestans


6. Brief description of the method used for the genetic modification:
Plasmid DNA was introduced into the potato lines by Agrobacterium-mediated gene transfer technology. This is standard technology for potato 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 applicable.

Experimental Release

1. Purpose of the release:
The purpose of the release is, within the frame of safety studies to compile data on agronomical performance and environmental effects, as well as to evaluate resistance against Phytophthora infestans, collect plant material for further analyses, as well as to generate seed tubers.

2. Geographical location of the site:
The release sites will be located in the regions Picardie and Nord-Pas-de-Calais.

3. Size of the site (m2):
The genetically modified plants will occupy no more than 1 ha (10,000m2) in an experimental plot of less than 2 ha.

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:
Releases of the same potato plants are ongoing in the Netherlands, Sweden and Germany, therefore relevant data related to the potential environmental and human health impacts from the release are not available yet. For other potato lines with ahas gene in previous field trials in Germany and other EU countries since 2002 or with an introduced Rpi-blb2 gene during 2005 in Sweden no adverse impacts on the environment or human health have been recorded.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified potato lines contain two NBS-LRR-genes, Rpi-blb1 and Rpi-blb2, from S. bulbocastanum for conferring improved resistance to P. infestans. Many conventional potato varieties also contain NBS-LRR-genes that have been introgressed from wild Solanum species. An intended effect of the introduced trait is an increased survivability in potato fields exposed to P. infestans. This possible selective advantage, however, is of importance only in the agricultural field, and will not improve the survivability in the surrounding environment. The reduced need for fungicides on these lines can easily be identified as an environmental benefit.
The ahas gene expressed in the potato plants imparts tolerance to the herbicidal active substance Imazamox to the shoots during the selection process in cell culture. This confers no selective advantage in the field since Imidazolinone herbicides are not approved for use on crops in France and since no field tolerance is expected in the potato plants. No difference with respect to persistence in agriculturally utilised habitats or invasiveness into natural habitats as compared to conventional potato varieties is expected. Through the measures that are taken during the release, distance from or absence of conventionally cultivated potatoes or wild species, the possibility of any gene transfer can be virtually ruled out. Even in the very improbable event that pollen were to be transferred to genetically unmodified potato plants, no consequences are to be expected, since potato propagation conventionally takes place via tubers and not via seeds. The interactions of the genetically modified potato line with non-target organisms and the effects resulting from this will be comparable to those with conventional potato varieties. Furthermore, no toxic or allergenic effects are expected on the basis of the improved resistance to Phytophthora infestans or the expressed AHAS protein. No effects on biogeochemical processes are expected, other than those that apply also to conventional potatoes.


Brief description of any measures taken for the management of risks:
An isolation distance of 10 m to other potato varieties will be observed. Planting and harvesting equipment will be cleaned on site to prevent the dispersal of GM tubers. There will be no potato cultivation on the release area the year following the release. Potential volunteers will be monitored and removed according to conventional agricultural practice. During the release the trial site will be monitored at defined intervals.

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