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Notification report


General information

Notification Number
B/SE/07/10746

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
26/10/2007

Title of the Project
Notification “A” for the field testing of spring oilseed rape (Brassica napus) genetically modified for increased oil content in the seed

Proposed period of release:
01/03/2008 to 31/12/2012

Name of the Institute(s) or Company(ies)
Plant Science Sweden AB, Herman Ehles väg 2-4
SE-268 31 Svalöv
Sweden;


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 and Stratos

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 spring oilseed rape in order to increase the level of total oil in the seed.
- nptII gene (neomycin phosphotransferase II) 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:
Origin of trait genes: Arabidopsis thaliana, 3 genes
Brassica napus, 4 genes
Saccharomyces cerevisiae, 1 gene

The application comprises transformation events from 7 different gene constructs.

Trait genes used:
- Carbohydrate metabolic protein 1
- Cellular redox protein 1
- DNA binding protein regulating primary carbon metabolism in plants 1
- DNA binding protein 2
- Lipid metabolic enzyme 4
- Lipid metabolic enzyme 5
- Primary carbon metabolism enzyme 1
- Protein modifying enzyme 1

The trait genes are combined with three different promoters:
- the promoter of a seed protein gene from Vicia faba (p-USP)
- the promoter of the legumin B4 gene from Vicia faba (p-2.7LeB4)
- the Peroxiredoxin-promoter of Linum usitatissimum (p-PXR)
- the napin promoter from Brassica napus (p-Napin)

Following terminators were used for termination of the trait genes:
- the terminator of the legumin B3 gene from Vicia faba (t-Leb3_3’UTR)
- the terminator of the peroxiredoxin gene PER1 Arabidopsis thaliana (t-AtPer)
- the terminator of the 35S gene from the Cauliflower mosaic virus (t-CaMV35S)
- the terminator of the octopine synthase gene from Agrobacterium tumefaciens (t-OCS)

The selection cassette contains following elements:
- nos (nopaline synthase) promoter from Agrobacterium tumefaciens
- nptII gene (neomycin phosphotransferase II) from Escherichia coli
- nos (nopaline synthase) terminator from Agrobacterium tumefaciens
- the mf-SceI1 sense and antisense excision recognition sides


6. Brief description of the method used for the genetic modification:
An Agrobacterium based transformation system was used for transformation of spring oilseed rape cv. Westar and Stratos.

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 specific purpose of the release is the evaluation of the performance of the added trait and the plants general performance under field conditions for research purposes.

2. Geographical location of the site:
Municipalities of Eslöv, Klippan, Kristianstad, Svalöv and Vara.

3. Size of the site (m2):
Total area will not exceed 15 ha (150 000m2) 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:
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 an increase in oil content in the seeds. The plant material also shows tolerance to the aminoglycoside type antibiotics kanamycin and neomycin in tissue culture.

The added traits are not likely to have a critical influence under field conditions on any important competitive factors such as pollen production/dispersal, fertility or compatibility, nectar production, seed dispersal or general fitness. Based on observations in the greenhouse the genetically modified oilseed rape lines do not differ from the parental control lines in their morphology, flowering time, germination rate or kernel weight. No difference regarding persistence in agricultural habitats or invasiveness in natural habitats or persistence in agricultural habitats compared to conventional oilseed rape is expected.

Considering the very low likelihood of the introduced traits to confer increased fitness or the GM oilseed rape lines in any other way to become more persistent than the parental Brassica napus plant materials in agricultural habitats or more invasive in natural habitats, the overall impact is expected to be negligible.

Any effects from the nptII gene on non-target organisms are not expected and have not been reported from other field trials harbouring this gene. The nptII gene is already present in the environment, since it is derived from soil organisms. The overall impact is expected to be negligible.


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 800 m. A 6 m wide border containing unmodified male-sterile rape will surround experimental areas. Sowing and harvesting machinery will be cleaned on site to prevent the dispersal of GM seed. Harvested seed material will be transported from the site in closed and labeled 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 4 consecutive years and there will be no oilseed rape or any other crossable crop cultivation at the trial site. Occurrence of volunteers will be registered and the plants will be removed by conventional agriculture methods. During the release period the Field Manager 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
20/03/2009 00:00:00
Remarks: