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Notification report


General information

Notification Number
B/DE/04/162

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
28/10/2004

Title of the Project
Application for the release into the environment of genetically modified potatoes with altered starch metabolism (2005 – 2009)

Proposed period of release:
01/04/2005 to 31/10/2009

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:
Sweden; Czech Republic;

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

If yes, notification number(s):
B/DE/03/154; B/NL/03/10; B/SE/00/1019; B/SE/02/1104-CON;

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:
A gene modifying the starch composition in potato tubers raising the level of amylopectin has been introduced into potato. An acetohydroxyacid synthase gene has been used as selectable marker gene.

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:
A gene containing the coding region of potato gbss in antisense orientation relative to the promoter, flanked by the the gbss promoter from Solanum tuberosum and the polyadenylation sequence from Agrobacterium tumefaciens nopaline synthase gene has been inserted into potato thus reducing the amount of amylose in the starch fraction. An ahas gene (acetohydroxyacid synthase) from Arabidopsis thaliana flanked by the nos gene promoter and the octopine synthase polyadenylation sequence from Agrobacterium tumefaciens serves as selectable marker gene conferring tolerance to Imazamox.

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 collect plant material for further analyses, as well as to generate seed tubers.

2. Geographical location of the site:
• Flurstücke 151/3, 352, 353, Flur 1, Gemarkung Gerdshagen, Gemeinde Lohmen, Landkreis Güstrow, Mecklenburg-Vorpommern;
• Flurstück 21, Flur 1, Gemarkung Klein Lüsewitz, Gemeinde Sanitz, Landkreis Bad Doberan, Mecklenburg-Vorpommern;
• Flurstück 11/0, Flur 11, Gemeinde Werpeloh, Landkreis Emsland, Niedersachsen.


3. Size of the site (m2):
Between 1 to 5 ha (between 10000 m2 to 50000 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 adverse impacts on the environment or human health have been recorded for the potato lines in previous field trials in Sweden, Germany and the Netherlands.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified potato lines show a shift of the tuber starch composition to amylopectin. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM lines via the introduced traits. Due to the measures to be taken during the release (distance to or absence of cultivated and wild relatives) will the potential for gene transfer virtually be excluded. Interactions of the GM potato lines with non-target species and resulting effects will be comparable to those of conventional potato varieties. No toxic or allergenic effects are expected from elevated levels of amylopectin, nor from the acetohydroxyacid synthase. Measures in place under current field trial practice will protect the trial from damage by animals as well as safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of to minimize or prevent contact to humans or animals. No effects are expected on biogeochemical processes. The GM potato lines will be cultivated under conventional agricultural practices.

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.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
15/04/2005 00:00:00
Remarks: