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Notification report


General information

Notification Number
B/DE/05/173

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
16/11/2005

Title of the Project
Application for the release into the environment of genetically modified potatoes with altered starch metabolism (II) (2006 – 2010)

Proposed period of release:
01/04/2006 to 31/10/2010

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:
Netherlands; Sweden; Czech Republic; Poland;

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

If yes, notification number(s):
B/CZ/05/642; B/DE/03/154; B/DE/04/162; B/NL/03/10; B/SE/02/1104-CON; B/SE/04/7943;

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:
- increased accumulation of amylopectin starch in tubers
- 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, terminator from octopine synthase gene, A. tumefaciens, gene regulation
- Promoter of gbss gene, S. tuberosum, gene regulation
- the antisense or inverted repeat fragment of the gbss gene leads to a reduction of the amylose fraction in the starch of the potato tuber resulting in a concomitant increase in the levels of amylopectin


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:
The release sites will be located in Mecklenburg-Vorpommern, Sachsen-Anhalt, Bayern and Niedersachsen.

3. Size of the site (m2):
Between approx. 1 to 50 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:
There have been previous releases of potato lines transformed with the same constructs in several countries, including Germany. No adverse impacts on the environment or human health have been recorded in any of the trials.

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.

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

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
08/06/2006 00:00:00
Remarks: