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Notification report


General information

Notification Number
B/DE/09/205

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
24/09/2009

Title of the Project
Application for the release into environment of genetically modified potatoes with altered starch metabolism under simplified procedure (2010 - 2014)

Proposed period of release:
01/04/2010 to 31/10/2014

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:
Finland; Netherlands; Sweden; Czech Republic;

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

If yes, notification number(s):
B/CZ/06/02; B/DE/05/173; B/DE/06/183; B/DE/07/191; B/NL/05/05; B/NL/07/06; 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, Arabidopsis thaliana, imidazolinone tolerance in plant material
- Promoter and terminator from nopaline synthase gene, Agrobacterium tumefaciens, gene regulation
- Promoter of gbss gene, Solanum tuberosum, gene regulation
- the 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 amylopectine


6. Brief description of the method used for the genetic modification:
Plasmid-derived DNA was introduced into the potato line by Agrobacterium-mediated gene transfer technology using a binary vector system. 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 to conduct studies for product optimization and quality assurance as well as to generate seed tubers for further analyses and seed multiplications.

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

3. Size of the site (m2):
29.2 ha (292,000 m2), of which a maximum of 10 ha will be planted per year. Size of all release sites will not exceed 20 ha per year.

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 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 line 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 line via the introduced trait. Interactions of the GM potato line 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.
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 Germany and since no field tolerance is expected in the potato plants. No difference with respect to persistence in agriculturally utilized habitats or invasiveness into natural habitats as compared to conventional potato varieties is expected. No toxic or allergenic effects are expected from the expressed AHAS protein.
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 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 controlled according to conventional agricultural practice. During the release the trial site will be monitored at defined intervals.
Measures in place under current field trial practice will safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of. The GM potato line will be cultivated under conventional agricultural practices.


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
06/04/2010 00:00:00
Remarks: