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Notification report

General information

Notification Number
B/DE/09/204

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
31/08/2009

Title of the Project
Assessment of expression profile and substantial equivalence of different transgenic potatoes with pharmaceutical and technical traits

Proposed period of release:
01/04/2010 to 31/10/2012

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 Name	Family Name	Genus	Species	Subspecies	Cultivar/breeding line
potato	solanaceae	solanum	solanum tuberosum	tuberosum	Desiree

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genes for PsbY-cphATe (cyanophycin synthetase of Thermosynechococcus elongatus (T. elongatus) with chloroplast transit peptide from Arabidopsis thaliana (A. thaliana)) and nptII (neomycin phosphotransferase II gene of Escherichia coli (E.coli)) were introduced into potato under control of the constitutive 35S promoter.

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:
PsbY-cphATe – gene:
- constitutive 35S promoter (of Cauliflower mosaic virus (CaMV)) to drive expression of PsbY-cphATe gene
- cphATe gene (of T. elongatus)coding for a cyanophycin synthetase to produce a copolymer of L-aspartic acid and L-arginine
- PsbY: chloroplast transit peptide isolated from A. thaliana, linked to cyanophycin synthetase
- t35S terminator (of CaMV): transcription terminator of the PsbY-cphATe gene

Neomycin phosphotransferase II:
- constitutive 35S promoter (of CaMV) to drive expression of nptII gene
- nptII gene from E. coli confering kanamycin resistance to transformed cells
- t35S terminator (of CaMV): transcription terminator of the nptII gene.

6. Brief description of the method used for the genetic modification:
An Agrobacterium-mediated transformation and plant regeneration system according to HORSCH et al. 1985 was used with slight modifications for the transformation of the potato cultivar Desiree.

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

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 on
- field performance
- environmental influence on transgene expression
- evaluation of analytical methods using the produced plant material
- evaluation of substantial equivalence

2. Geographical location of the site:
Location 1: Thulendorf (Mecklenburg/Vorpommern)
Location 2: Üplingen (Sachsen-Anhalt)

3. Size of the site (m2):
Location 1: 2010 - 2012: 115 m2
Location 2: 2010 – 2012: 16 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:
Not applicable

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 genetic modification leading to the biosynthesis 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 state of scientific knowledge the transgenic plants do not differ from non-transgenic plants in growth, size, phenology and seed formation.

Brief description of any measures taken for the management of risks:
The measures for risk control are laid down in a monitoring plan. Sowing and harvesting machinery will be cleaned on site to prevent the dispersal of GM seed. Harvested plant material will be transported from the site in closed and labelled containers to the laboratories for analyses. Before harvest haulm will be inactivated chemically and ploughed in soil. The area will be controlled for volunteers for a period of one consecutive year. In case of occurrence of volunteers this period will be extended for an additional year. During the release period the Field Manager and trained personnel will monitor the trial site at defined intervals. The experimental site is surrounded by a fence.

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:
- variability of transgene expression
- substantial equivalence

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
06/04/2010 00:00:00
Remarks: