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Notification report


General information

Notification Number
B/DE/06/186

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
20/11/2006

Title of the Project
Application for the release into environment of genetically modified potatoes with altered starch metabolism (2007 - 2008)

Proposed period of release:
01/04/2007 to 31/10/2008

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;

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

If yes, notification number(s):
B/CZ/05/642; B/DE/03/153; B/NL/03/09; B/SE/04/7942;

Other notifications
Sweden: Dnr 22-4314/92, Dnr 22-4363/93, Dnr 22-28/95, Dnr 22 530/96, Dnr 22-1782/97, Dnr 22-2519/98, Dnr 22 1087/99, Dnr 22 1019/00

Genetically modified plant

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

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.

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
- promoter of gbss gene, Solanum tuberosum, gene regulation
- an antisense fragment of the gbss gene that 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
- nptII gene (neomycinphosphotransferase II), E. coli, for kanamycine tolerance in plant material
- nos (nopaline synthase) promoter, Agrobacterium tumefaciens
- nos (nopaline synthase) terminator, Agrobacterium tumefaciens


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 the production of amylopectin potatoes for use as seed potatoes in the following years either in field trials under part B 2001/18/EC or for cultivation and starch production under part C if a respective approval is issued.

2. Geographical location of the site:
The release sites will be located in Mecklenburg-Vorpommern and Brandenburg.

3. Size of the site (m2):
3 sites with an overall size of 154,7 ha (1,547,720 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:
There have been manifold previous releases of potato lines transformed with the same construct in Germany, Sweden, The Netherlands, and Czech Republic. 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. Conventional bred varieties with similar amylopectin/amylose ratio have never been reported to show a selective advantage. A difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is neither expected nor observed in any of the previous field trials. Nor is it expected or observed that a selective advantage or disadvantage is conferred to the GM lines via the introduced traits.
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 of the genetically modified potato are expected nor have been observed in the studies for application for commercialization under 2001/18/EC respective (EC) No 1829/2003.
Through the measures 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 case that pollen would 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. No significant differences have been observed in the application studies for commercialization under 2001/18/EC regarding abundance and occurrence of non-target organisms. 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


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/05/2007 00:00:00
Remarks: