General informationNotification NumberB/CZ/08/04Member State to which the notification was sentCzech RepublicDate of acknowledgement from the Member State Competent Authority23/12/2008Title of the ProjectRelease into the environment of genetically modified potatoes with altered starch composition EH92-527-1(2009 - 2010)Proposed period of release:01/04/2009 to 30/11/2010Name of the Institute(s) or Company(ies)BASF CZ, ;
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?YesIf yes, notification number(s): B/CZ/05/642; B/CZ/06/05; B/DE/03/153; B/DE/06/186; B/DE/08/197; B/NL/03/09; B/SE/04/7942; Genetically modified plantComplete name of the recipient or parental plant(s)
2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:- increased accumulation of amylopectin starch in tubers
|Common Name||Family Name||Genus||Species||Subspecies||Cultivar/breeding line|
- nptII gene (conferring tolerance to kanamycin) as selectable marker gene to identify transgenic cells in tissue cultureGenetic modification3. 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:- T-DNA borders, pTiT37, for incorporation into the plant chromosome
- nptII (neomycin phosphotransferase) gene from E. coli, for kanamycin tolerance in plant material
- Promoter and terminator from nos (nopaline synthase) gene from A. tumefaciens, for gene regulation
- Promoter of the gbss (granule bound starch synthase) gene from S. tuberosum, for gene regulation
- Fragment of gbss (granule bound starch synthase) gene from S. tuberosum, coding region fragment in antisense orientation6. Brief description of the method used for the genetic modification:Plasmid-derived DNA was introduced into the potato line by Agrobacterium-mediated gene transfer technology using a binary vector system. 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 applicableExperimental Release1. Purpose of the release:The purpose of the release is the production of amylopectin potatoes for use as seed potatoes in the following years and to analyze the starch content and composition after extraction in a starch factory under pilot scale and up-scaled conditions.2. Geographical location of the site:Moravec, Radesinska Svratka, region Vysocina3. Size of the site (m2):The release at all three fields will be maximum 50 ha (500,000 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:There have been previous releases of potato lines transformed with the same construct in Germany, Sweden, The Netherlands, and Czech Republic. No adverse impacts on the environment or human health have been recorded in any of the trials.Environmental Impact and Risk ManagementSummary 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. A difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is neither expected nor observed in any of the previous field trials. Conventional bred varieties with similar amylopectin/amylose ratio have never been reported to show any selective advantage. Likewise it is not expected or observed that a selective advantage or disadvantage is conferred to the GM line via the introduced traits.
No toxic or allergenic effects of the genetically modified potato are expected or have been observed in the studies for application for commercialization under Directive 2001/18/EC respective Regulation (EC) No 1829/2003.
Due to the measures to be taken during the release (distance to or absence of commercial potatoes) the potential for gene transfer will be virtually excluded. There are no wild plant species that are sexually compatible with potato in the EU.
The interactions of the genetically modified potato line with non-target organisms and the effects resulting from this will be comparable to those with conventional potato varieties. No significant differences have been observed in the application studies for commercialization under Directive 2001/18/EC regarding abundance and occurrence of non-target organisms. No effects on biogeochemical processes are expected, other than those that apply also to conventional potatoes. The GM potato line 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 three years following the release. Potential volunteers will be controlled according to conventional agricultural practice. During the release the trial site will be monitored at defined intervals.
Measures in place under current field trial practice will safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of.Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:Not applicableFinal reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Yes21/04/2009 00:00:00Remarks: