Back

Notification report


General information

Notification Number
B/DE/08/199

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
22/10/2008

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

Proposed period of release:
01/04/2009 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?
Not known

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

If yes, notification number(s):
B/DE/05/176;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
potatosolanaceaesolanumsolanum tuberosumtuberosumDesiree, Albatros and Fasan

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-cphATe (cyanophycin synthetase) of Thermosynechococcus 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.

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) to drive expression of vp60 gene, vp60 gene (of RHDV) codes for the viral protein VP60 which is the main protein of RHDV, t35S terminator (of CaMV) transcription terminator of the vp60 gene, constitutive 35S promoter (of CaMV) to drive expression of nptII gene, nptII gene from E. coli which confers kanamycin resistance to transformed cells, t35S terminator (of CaMV ) transcription terminator of the nptII gene

CTB: constitutive 35S promoter (of CaMV) to drive expression of ctxB gene, ctxB gene (of V. cholera) codes for the non-toxic B subunit of cholera toxin which can interact with the GM1-ganglioside receptor to support protein transport into intestinal epithelian cells, t35S terminator (of CaMV) transcription terminator of the ctxB gene, constitutive 35S promoter (of CaMV) to drive expression of nptII gene, nptII gene which confers Kanamycin resistance to transformed cells, t35S terminator (of CaMV) transcription terminator of the nptII gene

Cyanophycin: constitutive 35S promoter (of CaMV) to drive expression of PsbY-cphATe gene, PsbY-cphATe gene (of Thermosynecococcus elongates) linked to chloroplast transit peptide isolated from Arabidopsis thaliana) codes for the Cyanophycin Synthetase which is transported to the chloroplast and produce the copolymer of L-aspartic and L-arginine, t35S terminator (of CaMV) transcription terminator of the PsbY-cphATe gene, constitutive 35S promoter (of CaMV) to drive expression of nptII gene, nptII gene which confers kanamycin resistance to transformed cells, t35S terminator (of CaMV) transcription terminator of the nptII gene

Neomycin Phosphotransferase II: constitutive 35S promoter (of CaMV) to drive expression of nptII gene, nptII gene from Escherichia coli which confers 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 potato cultivars Desiree, Albatros and Fasan.

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 of
- 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: 2009: 485 m2
2010 - 2012: 547 m2
Location 2: 2009 – 2012: 190 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:
In B/DE/05/176, genetically modified potatoes showed no effects on environment and human health.

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 modifications leading to the biosynthesis of the viral protein VP60, the non-toxic B subunit of cholera toxin or cyanophycin may lead to changes in reproduction, dispersal, persistence or invasiveness of these plants compared to conventional potato plants. On basis of B/DE/05/176 and greenhouse experiments, the transgenic plants do not differ from non-transgenic plants in growth, size, phenology and seed formation under optimal growth conditions (except that cyanophycin-producing plants need more nitrogen). Under field conditions no selective advantages of any of the transgenic potato plants have been observed. No effects of the recombinant proteins on pest or beneficial organisms or on health and environment have been detected.

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 occurence 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 transgen expression
- substantial equivalence


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
08/05/2009 00:00:00
Remarks:
The consent does not include the potato lines containing the ctxB gene because the notifier decided not to release those lines in 2009.