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Notification report


General information

Notification Number
B/DE/05/176

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
21/11/2005

Title of the Project
Assessment of technological properties, potential influence on the environment, ingredients and specific characteristic of different transgenic potatoes with pharmaceutical and technical traits.

Proposed period of release:
01/05/2006 to 31/10/2008

Name of the Institute(s) or Company(ies)
University of Rostock, ;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genes for either vp60 (viral protein 60 of rabbit haemorraghic disease virus, RHDV), ctxB (non-toxic B subunit cholera toxin of Vibrio cholerae), PsbY-cyel (cyanophycin synthetase) of Thermosynechococus elongates (with chloroplast transit peptide from A. thaliana) and/ or nptII (neomycin phosphotransferase II gene of E.coli) were introduced into potato under control of the constitutive 35S promoter from Cauliflower mosaic virus (CaMV).

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:
VP60: constitutive 35S promoter (of Cauliflower mosaic virus CaMV) driving expression of vp60 gene, vp60 gene (of RHDV) encoding the viral protein VP60 which is the predominant protein of the RHDV, t35S terminator (of CaMV)controlling transcription termination of the vp60 gene, constitutive 35S promoter (of CaMV) driving expression of nptII gene, nptII gene from E.coli which confers kanamycin resistance to transformed cells, t35S terminator (of CaMV)controlling transcription termination of the nptII gene.

CTB: constitutive 35S promoter (of CaMV) driving expression of ctxB gene, ctxB gene (of V. cholera) encoding the non-toxic B subunit of the cholera toxin, which can interact with the GM1-ganglioside receptor of mammalian cells and mediates transport of the protein complex into the cell, t35S terminator (of CaMV)controlling transcription termination of the ctxB gene, constitutive 35S promoter (of CaMV) driving expression of nptII gene, nptII gene which confers kanamycin resistance to transformed cells, t35S terminator (of CaMV) controlling transcription termination of the nptII gene.

Cyanophycin: constitutive 35S promoter (of CaMV) driving expression of PsbY-cyel gene, PsbY-cyel gene (of Thermosynecococcus elongatus with chloroplast transit peptide isolated from Arabidopsis thaliana) encoding the cyanophycin synthetase which is transported to the chloroplast to produce a copolymer of L-aspartic acid and L-arginine, t35S terminator (of CaMV) controlling transcription termination of the PsbY-cyel gene, constitutive 35S promoter (of CaMV) driving expression of nptII gene, nptII gene which confers kanamycin resistance to transformed cells, t35S terminator (of CaMV)controlling transcription termination of the nptII gene.

Neomycin Phosphotransferase II: constitutive 35S promoter (of CaMV) driving expression of nptII gene, nptII gene from Escherichia coli which confers kanamycin resistance to transformed cells, t35S terminator (of CaMV) controlling transcription termination of the nptII gene


6. Brief description of the method used for the genetic modification:
An Agrobacterium-mediated transformation and plant regeneration system slightly modified according to HORSCH et al. 1985 (Horsch, R., Fry, J., Hoffmann, N.L., Eichholtz, D., Rogers, S.G., Fraley, R.T. (1985) A simple and general method for transferring genes into plants. Science 227:1229-1231) was used for the transformation of potatoes cultivars Desiree and Albatros. Transformed tissue was selected using kanamycin.

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:
Evaluation of the new technological properties and ingredients of the genetically modified potatoes with focus of
- expression of the transgenes in field grown potatoes
- environmental impact of transgene expression
- nutritional requirement
- volunteerism
- interaction with aphids
- nutritional physiology .


2. Geographical location of the site:
Groß Lüsewitz, Schlag 3/07, 18190 Sanitz, District Bad Doberan (Mecklenburg/Vorpommern), Germany,

3. Size of the site (m2):
2006: 832 m2
2007: 2176 m2
2008: 1584 m2


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 previous release

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
There is no scientific reason to assume that the transgenic modifications resulting in a biosynthesis of the viral protein VP60, of the non-toxic B subunit of the cholera toxin or of cyanophycin may lead to changes in reproduction, dispersion, persistence or invasiveness of these plants compared to conventional potato plants. On the basis of current experience, the transgenic plants do not differ from non-transgenic plants in growth, size, phenology and seed formation. Under out-door conditions there is no selective pressure that might lead to a selective advantage of any of the transgenic lines. Due to current experience no effect of the proteins in the plants on pest or beneficial organisms or on health and environment is expected.

Brief description of any measures taken for the management of risks:
The measures for risk control are put down in a monitoring plan. In order to avoid cross-pollination, the distance of the nearest cultivation of potato plants will be at least 150 m. Seed containing berries will be collected, removed and autoclaved.
Sowing and harvesting machinery will be cleaned on site to prevent the dispersal of GM material. Harvested plant material will be transported from the site in closed and labelled containers to the laboratories for analyses. Before harvest, above ground parts will be inactivated chemically. Vegetative and non reproductive plant material will be chopped and dragged into the soil. The area will be controlled for volunteers during the vegetation period following the release. In case volunteers are identified, the monitoring will be extended for another year. During the release period the field manager and trained personnel will monitor the trial site at defined intervals.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The field trials are designed to investigate the environmental impacts:
- whether the cyanophycin production changes the nitrogen needs of the plants
- whether the new features change the volunteer characteristics of the plants
- whether there are any effects on the susceptibility for plant pathogens (viruses, aphids).


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
14/06/2006 00:00:00
Remarks: