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Notification report


General information

Notification Number
B/DE/07/191

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
07/09/2007

Title of the Project
Application for the release into environment of genetically modified potatoes
with altered starch metabolism or with improved resistance to
Phytophthora infestans under simplified procedure (2008 - 2012)


Proposed period of release:
01/04/2008 to 31/10/2012

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:
France; United Kingdom; 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/07/01; B/DE/04/162; B/DE/05/173; B/DE/05/174; B/DE/06/183; B/FR/06/12/15; B/GB/06/R42/01; B/GB/07/R42/01; B/IE/06/01; B/NL/03/10; B/NL/05/03; B/NL/05/05; B/SE/00/1019; B/SE/02/1104-CON; B/SE/04/7943; B/SE/05/450; B/SE/05/8615;

Other notifications
Potato lines with increased amylopectin content:
- B/SE/02/1104, B/SE/04/7943 (by Plant Science Sweden AB)
- B/DE/04/162, B/DE/05/173, B/DE/06/183
- B/NL/03/10, B/NL/05/05
- B/CZ/05/642, B/CZ/06/02
Potato lines comparable (i.e. transformed with a very similar construct) to the lines that are subjects of this application have been previously released in Sweden, the Netherlands and the Czech Republic. Reference is made to the following further notifications: B/SE/00/1019, B/NL/03/10 and B/CZ/05/642.
Potato lines with improved resistance to Phytophthora infestans based on constructs VCPMA16 und VCPMA19 (except of B/SE/05/450 with only Rpi-blb2):
- B/SE/05/450, B/SE/05/8615 (by Plant Science Sweden AB)
- B/DE/05/174, B/DE/06/183
- B/NL/05/03
- B/CZ/07/01
- B/IE/06/01
- B/FR/06/12/15
- B/GB/06/R42/01
- B/GB/07/R42/01


Genetically modified plant

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

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
- increased resistance against Phytophthora infestans
- 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 plant chromosome
- ahas gene, A. thaliana, imidazolinone tolerance in plant material
- Promoter and terminator from nopaline synthase gene, A. tumefaciens, gene
regulation
- Promoter of gbss gene, Solanum tuberosum, gene regulation
- the inverted repeat fragment of the gbss gene leads to a reduction of the amylose fraction in the starch of the potato tuber resulting in a concomitant increase in the levels of amylopectine
- Resistance genes Rpi-blb1 and Rpi-blb2, Solanum bulbocastanum, with
endogenous promoters and terminators for improved resistance to Phytophthora
infestans


6. Brief description of the method used for the genetic modification:
Plasmid DNA was introduced into the potato lines by Agrobacterium-mediated gene
transfer technology. 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, within the frame of safety studies to compile data on agronomical performance and environmental effects, as well as to collect plant material for further analyses, as well as to generate seed tubers.

2. Geographical location of the site:
The release sites will be located in Brandenburg, Sachsen-Anhalt, and Mecklenburg-Vorpommern.

3. Size of the site (m2):
Four sites with an overall size of approx. 76 ha (758,900 m2). The size of the
individual sites ranges from approx. 4 to 46 ha (48,600 m2 to 458,800 m2). The
actual area that will be planted per location per annum will not exceed 1 ha
(10,000 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
constructs in Germany, Sweden, The Netherlands, United Kingdom, and Czech
Republic. 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. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional potato varieties is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM lines via the introduced trait. Interactions of the GM potato lines with nontarget species and resulting effects will be comparable to those of conventional potato varieties. No toxic or allergenic effects are expected from elevated levels of amylopectin.
The genetically modified potato lines with improved resistance to Phytophthora
infestans contain two NBS-LRR-genes, Rpi-blb1 and Rpi-blb2, from Solanum
bulbocastanum. Many conventional potato varieties also contain NBS-LRR-genes
that have introgressed from wild Solanum species. An intended effect of the
introduced trait is an increased survivability in potato fields exposed to P. infestans.
This possible selective advantage, however, is of importance only in the agricultural field, and will not improve the survivability in the surrounding environment. The reduced need for fungicides on these lines can easily be identified as an environmental benefit. Furthermore, no toxic or allergenic effects are expected on the basis of the improved resistance to P. infestans.
The ahas gene expressed in the potato plants 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 Imidazolinone herbicides are not approved for use on crops in Germany and 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.
The interactions of the genetically modified potato lines with non-target organisms and the effects resulting from this 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.


Brief description of any measures taken for the management of risks:
An isolation distance of 10 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 monitored and removed according to conventional
agricultural practice. During the release the trial site will be monitored at defined intervals.
Through the measures taken during the release, distance from or absence of
conventionally cultivated potatoes, the possibility of any gene transfer can be
virtually ruled out. Even in the very improbable event that pollen were to be
transferred to genetically unmodified potato plants, no consequences are to be
expected, since potato propagation conventionally takes place via tubers and not via seeds.
Measures in place under current field trial practice will protect the trial from damage by animals as well as safeguard that all seed and plant material is properly managed, harvested, stored, transported or disposed of to minimize or prevent contact to humans or animals. The GM potato lines 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:
Yes
31/03/2008 00:00:00
Remarks: