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Notification report


General information

Notification Number
B/SE/03/6347

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
17/12/2003

Title of the Project
Application for the deliberate release of oilseed rape lines genetically modified for altered oil content in seed.

Proposed period of release:
01/04/2004 to 31/10/2008

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?
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 NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
spring oilseed rapebrassicaceaebrassicabrassica napusnapus (syn. oleifera)Westar

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genes involved in regulating the accumulation of seed storage compounds have been introduced into oilseed rape in order to alter the level of total oil in the seed. The neomycin phosphotransferase II gene is used as selectable marker gene.

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:
(a)
A gene encoding an Arabidopsis thaliana transcription factor involved in the response to the endogenous plant hormone abscisic acid has been cloned into the pPZP based binary plant expression vector containing the usp (unknown seed protein) promoter from Vicia faba and the ocs (octopin synthase) terminator from Agrobacterium tumefaciens as well as the selectable marker gene neomycin phosphotransferase II flanked by the nopaline synthase promoter from Agrobacterium tumefaciens and the polyadenylation region of the 35S gene from Cauliflower mosaic virus. The respective gene construct is Lo224. The gene plays a role in regulating the accumulation of the seed storage compounds oil and protein.

(b)
Binary vector pBPS-LM047 contains a kinase gene from the moss Physcomitrella patens under the control of the seed-specific promoter usp from Vicia faba and the ocs polyadenylation signal from Agrobacterium tumefaciens affecting the partitioning of carbon between oil and protein biosynthesis. The selectable marker gene neomycin phosphotransferase II is flanked by the nopaline synthase promoter and the g7 polyadenylation fragment from Agrobacterium tumefaciens.


6. Brief description of the method used for the genetic modification:
A standard Agrobacterium tumefaciens based transformation system was used for transformation of spring oilseed rape cv. Westar according to Molony et al. (1989) and Hoekema (1983).

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 trait performance under field conditions and selection of lines for further testing and analysis of the trait.

2. Geographical location of the site:
Municipalities of Vara and Klippan.

3. Size of the site (m2):
1 ha at each site.

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:
No previous releases have been carried out.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified oilseed rape lines show a modified level of the inherent seed component oil. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats compared to conventional oilseed rape is expected. Nor is it expected that a selective advantage or disadvantage is conferred to the GM lines via the introduced trait. Due to the measures to be taken during the release (distance to or absence of cultivated and wild relatives) the potential for gene transfer will be virtually excluded. Interactions of the GM oilseed rape lines with non-target species and resulting effects will be comparable to those of conventional oilseed rape varieties. The potential of elevated levels of the seed component oil resulting in any effects on human and animal health from contact or consumption is considered negligible. 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 and animals. No effects are expected on biogeochemical processes. The GM oilseed rape lines will be cultivated under conventional agricultural practices.

Brief description of any measures taken for the management of risks:
The distance from the nearest cultivation of oilseed rape plants will be at least 400 m. A 6m-wide protective border containing unmodified male-sterile rape will surround both experiments in order to decrease dissemination of the pollen. Sowing and harvesting machinery will be cleaned on site to prevent the dispersal of GM seed. Harvested material and seed will be transported from the site in closed and labelled containers to the laboratories for analyses. Remaining seed will be inactivated. Vegetative plant material will be chopped and worked into the soil. The area will be controlled for volunteers for a period of 2 consecutive years. During this time there will be no conventional oilseed rape cultivation, which equals conventional crop rotation practice. Volunteers will be treated using conventional agricultural practices. During the release the project leader and trained personnel will monitor the trial site at defined intervals.

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
20/04/2004 00:00:00
Remarks: