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Notification report


General information

Notification Number
B/CZ/06/05

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
11/12/2006

Title of the Project
Release of genetically modified potatoes with an altered starch composition

Proposed period of release:
30/04/2007 to 30/09/2008

Name of the Institute(s) or Company(ies)
BASF CZ, ;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Sweden;

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;

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
- nptII gene (tolerance to kanamycin) 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
- nptII gene, E. coli, kanamycin tolerance in plant material
- Promoter and terminator from nopaline synthase gene, A. tumefaciens, gene regulation
- Promoter of gbss gene, S. tuberosum, gene regulation, and terminator from nopaline synthase gene, A. tumefaciens, gene regulation
- gbss gene, S. tuberosum, coding region fragment in antisense


6. Brief description of the method used for the genetic modification:
Plasmid DNA was introduced into the potato line 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, to generate seed tubers.

2. Geographical location of the site:
Three release sites in the region Vysocina: Velke Losenice, Nove Mesto na Morave and Radesinska Svratka.

3. Size of the site (m2):
Each site approx. 12 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 has been previous release of the same potato line in 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 shows 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 presence of neomycin phosphotransferase. No effects are expected on biogeochemical processes. The GM potato line 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 two years 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
22/05/2007 00:00:00
Remarks:
The scope of the trials was reduced to 1 location (Moravec, region Vysocina) and maximum 10 ha. Required isolation distance was extended to 20 m.