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Notification report


General information

Notification Number
B/NL/03/11

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
10/11/2003

Title of the Project
Application for the release into the environment of potato event AM99-2003.

Proposed period of release:
01/04/2004 to 31/12/2008

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:
Germany; Sweden;

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

If yes, notification number(s):


Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genes modifying the starch composition in potato tubers raising the level of amylose have been introduced into potato. The neomycin phosphotransferase II 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:
In potato line AM99-2003 a gene consisting pf gbss promoter from Solanum tuberosum, the coding region fragments of be1 and be2 (starch-branching enzyme) in tandem and antisense orientation relative to the promoter and the nos polyadenylation sequence from Agrobacterium tumefaciens have been inserted into potato variety Dinamo thus reducing the amount of amylopectin in the starch fraction of the tuber. In addition the neomycin phosphotransferase gene (nptII) connected to the Agrobacterium tumefaciens nopaline synthase promoter and g7 polyadenylation sequence from Agrobacterium tumefaciens nopaline as selectable marker gene conferring resistance to kanamycin.

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.

Experimental Release

1. Purpose of the release:
The purpose of the release is, within the frame of safety studies for event AM99-2003, to compile data on agronomical performance and environmental effects, as well as to collect plant material for further analyses (e.g. biochemistry, molecular biology). It is anticipated that in part the trial will be used as well to generate seed tubers.

2. Geographical location of the site:
The location of the release site will be at Borger-Odoorn, the Netherlands.

3. Size of the site (m2):
1 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:
No adverse impacts on the environment or human health have been recorded for the line AM99-2003 in previous field trials in Sweden.

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 amylose. 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 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 excluded. 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 amylose starch, nor from the neomycin phosphotransferase. 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 20 m to other potato varieties will be observed. Planting and harvesting equipment will be cleaned in site to prevent the dispersal of GM tubers. There will be no potato cultivation on the release area for the year following the release. Potential volunteers be monitored and removed according to conventional agricultural practice. During the release the trial site will be monitored at defined intervals.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
07/04/2004 00:00:00
Remarks: