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Notification report


General information

Notification Number
B/FI/09/1MB

Member State to which the notification was sent
Finland

Date of acknowledgement from the Member State Competent Authority
30/11/2009

Title of the Project
Field testing of genetically modified potatoes
with an altered starch composition


Proposed period of release:
01/04/2010 to 31/10/2014

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; Netherlands; Sweden; Czech Republic;

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

If yes, notification number(s):
B/CZ/05/642; B/CZ/06/02; B/CZ/06/05; B/DE/03/153; B/DE/05/173; B/DE/06/183; B/DE/06/186; B/DE/07/191; B/DE/08/197; B/NL/03/09; B/NL/05/05; B/NL/07/06; B/SE/04/7942; B/SE/04/7943;

Other notifications
Line EH92-527-1:
B/CZ/05/642, B/CZ/06/05, B/DE/03/153; B/DE/06/186, B/DE/06/197, B/NL/03/09, B/SE/04/7942
Other notifications Sweden: Dnr 22-4314/92, Dnr 22-4363/93, Dnr 22-28/95, Dnr 22 530/96, Dnr 22 1782/97, Dnr 22-2519/98, Dnr 22 1087/99, Dnr 22 1019/00

Line AM04-1020:
B/SE/04/7943, B/DE/05/173, B/DE/06/183, B/DE/07/191, B/NL/05/05, B/NL/07/06 and B/CZ/06/02


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
potatosolanaceaesolanumsolanum tuberosumtuberosumPrevalent, line EH92-527-1

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
- line EH92-527-1: nptII gene (conferring tolerance to kanamycin) as selectable marker gene to identify transgenic cells in tissue culture
- line AM04-1020: ahas gene (tolerance to Imidazolinones) as selectable marker gene to identify transgenic cells in tissue culture


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:
- T-DNA borders, pTiT37, for incorporation into the plant chromosome
- Promoter and terminator from nos (nopaline synthase) gene from Agrobacterium tumefaciens, for gene regulation
- Promoter of the gbss (granule bound starch synthase) gene from Solanum tuberosum, for gene regulation
- Line EH-92-527-1: nptII (neomycin phosphotransferase) gene from E. coli coding for enzyme APH(3’)II, for kanamycin tolerance in plant material
- Line EH-92-527-1: Fragment of gbss (granule bound starch synthase) gene from Solanum tuberosum, coding region fragment in antisense orientation leading to a reduction of the amylose fraction in the starch of the potato tuber resulting in a concomitant increase in the levels of amylopectin
- Line AM04-1020: ahas gene, from Arabidopsis thaliana, imidazolinone tolerance in plant tissue material
- Line AM04-1020: inverted repeat fragment of the gbss (granule bound starch synthase) gene from Solanum tuberosum leading to a reduction of the amylose fraction in the starch of the potato tuber resulting in a concomitant increase in the levels of amylopectin


6. 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 applicable.

Experimental Release

1. Purpose of the release:
The purpose of the release is to assess agronomic performance and to produce seed potatoes.

2. Geographical location of the site:
The release sites will be located in the areas of Hämmenlinna city (community of Lammi) and Seinäjoki city (community of Ylistaro).

3. Size of the site (m2):
The field size will be less than 1 ha (10000 m2) per location per year.

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 constructs in Germany, Sweden, Czech Republic and the Netherlands (only line AM04-1020). No adverse impacts on the environment or human health have been recorded in any of the trials.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified potato lines show 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 has been observed in previous field trials that a selective advantage or disadvantage is conferred to the GM lines via the introduced traits.
The ahas gene in potato line AM04-1020 imparts tolerance to the herbicidal active substance Imazamox to the shoots during the selection process in cell culture. This confers no selective advantage in the field since no field tolerance is expected in the potato plants. No difference with respect to persistence in agriculturally utilized habitats or invasiveness into natural habitats as compared to conventional potato varieties is expected. No toxic or allergenic effects are expected from the expressed AHAS protein.
In potato line EH92-527-1, the gene product of the introduced selection marker is the enzyme APH(3’)II, which originates from the bacterium E. coli. The protein has no toxicological of allergenic features. The nptII gene is readily available in natural microbial populations. The safety of APH(3')II with regard to human health was examined and published in a set of publications and in different statements of the EFSA and competent authorities and other bodies.
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 lines with non-target organisms and the resulting effects will be comparable to those with conventional potato varieties. No effects on biogeochemical processes are expected, other than those that apply also to conventional potatoes. The GM potato lines will be cultivated under conventional agricultural practices.


Brief description of any measures taken for the management of risks:
An isolation distance of 5 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 the year 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. The GM potato line will be cultivated under conventional agricultural practices.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known