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Notification report


General information

Notification Number
B/NL/03/09

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 EH92-527-1

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 tuberosumtuberosumPrevalent

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 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 event EH92-527-1 a gene consisting of a potato gbss (granule bound starch synthase) promoter, a fragment of the coding region of potato gbss in antisense orientation relative to the promoter and the polyadenylation sequence from Agrobacterium tumefaciens nopaline synthase gene (gene construct pHoxwG) have been inserted into potato variety Prevalent 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 polyadenylation signal 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.

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 release is foreseen as part of the application process for variety registration and variety protection of potato event EH92-527-1.

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 in 2004.

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:
Comprehensive data from previous releases have shown that potato clone EH92-527-1 is compositionally - with the exception of the modified starch structure - as well agronomically equivalent to the parent variety Prevalent. There is no evidence that insects associated with the GM clone are more or less abundant compared with the non-GM parent. The GM clone is no more susceptible or resistant to aphids, leafhoppers, larvae, worms, snails or potato cyst nematodes than the parent variety. Similarly there is no evidence for modified susceptibility to Phytophthora, Erwinia, Alterniaria and the viruses PVP, PLRV, PMTV and TRV. No adverse impacts on the environment and human health were observed during any field trials carried out so far.

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. 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. 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:
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 for 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: