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Notification report


General information

Notification Number
B/NL/03/10

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 events AM02-1003, AM02-1005, AM02-1012, AM02-1017 and AM99-1089.

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 tuberosumtuberosumSeresta, Kuras

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
A gene modifying the starch composition in potato tubers raising the level of amylopectin has been introduced into potato. The neomycin phosphotransferase II gene or an acetohydroxyacid synthase gene have been used as selectable marker genes.

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:
a) A gene containing the coding region of potato gbss in antisense orientation relative to promoter, flanked by the gbss promoter from Solanum tuberosum and the polyadenylation sequence from Agrobacterium tumefaciens nopaline synthase gene has been inserted into potato variety Seresta (lines AM02-1003, AM01-1005, AM02-1012) and Kuras (line AM02-1017) thus reducing the amount of amylose in the starch fraction. An ahas gene (acetohydroxyacid synthase) from Arabidopsis thaliana flanked by the Agrobacterium tumefaciens nos gene promoter and the octopine synthase polyadenylation sequence serves as selectable marker gene conferring tolerance to Imazamox.
b) AM99-1089 serves as a reference line. The inserted gene consists of the potato gbss (granule bound starch synthase) promoter, the coding region of potato gbss in antisense orientation and the polyadenylation sequence from Agrobacterium tumefaciens nopaline synthase gene thus reducing the amount of amylose in the starch fraction. In addition the neomycin phosphotransferase gene (nptII) connected to the Agrobacterium tumefaciens nopaline synthase promoter and g7 polyadenylation sequence from Agrobacterium tumefaciens has been inserted 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 lines 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 events AM02-1003, AM02-1005, AM02-1012, AM02-1017 and AM99-1089 (as a comparator high amylopectin event), 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 lines AM02-1003, AM02-1005, AM02-1012, AM02-1017 and AM99-1089 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 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 during the release 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 starch, nor from the neomycin phosphotransferase or 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 minimise or prevent contact to humans or animals. No effects are expected on biogoechemical processes. The GM 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 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.

Final report


European Commission administrative information

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