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Notification report


General information

Notification Number
B/FI/08/1MB

Member State to which the notification was sent
Finland

Date of acknowledgement from the Member State Competent Authority
16/09/2008

Title of the Project
Environmental risks of birch genetically modified to be sterile

Proposed period of release:
01/01/2009 to 31/12/2012

Name of the Institute(s) or Company(ies)
University of Joensuu, ;


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
silver birchbetulaceaebetulabetula pendula

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The flowering is prevented by introducing a barnase gene regulated by an inflorescence specific birch promoter (BpFULL1). Resistance to kanamycin (marker gene npt II).

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:
* RB (right border), insertion boundary (Agrobacterium tumefaciens).
* the promoter sequence (Nos-pro) from the T-DNA nopaline synthase (nos) gene (Agrobacterium tumefaciens).
* the bacterial nptII gene (Escherichia coli). It codes for the enzyme neomycin phosphotransferase II (NPTII), which gives resistance to the antibiotic kanamycin.
* the 3’ untranslated region of the nopaline synthase gene (nos-term) from Agrobacterium tumefaciens, containing plant polyadenylation signals
* the promoter of BpFULL1 gene from birch (Betula pendula), regulates the expression of the barnase gene.
* the coding region of the barnase gene (without signal sequence) from Bacillus amyloliquefaciens. The expression of the gene in inflorescence-forming cells leads to the death of the cells through the action of the RNase-enzyme coded by the gene.
* barstar gene from Bacillus amyloliquefaciens. Not expressed in plant cells.
* the 3’ untranslated region of the nopaline synthase gene (nos-term) from Agrobacterium tumefaciens, containing plant polyadenylation signals
* LB (left border), insertion boundary (Agrobacterium tumefaciens).


6. Brief description of the method used for the genetic modification:
The plants are modified by using Agrobacterium-mediated gene transfer.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
The GM-plants are non-flowering.

Experimental Release

1. Purpose of the release:
The purpose of the release is to study environmental risks associated with the prevention of flowering by genetic modification

2. Geographical location of the site:
Joensuu, Finland

3. Size of the site (m2):
1000 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:
The release is a continuation of an already established field study on environmental risks of genetically modified non-flowering birch. The results so far show, that the non-flowering phenotype is stable: none of the individual plants of the transgenic lines have formed inflorescences during the study (2005-2008), although the early flowering non-transgenic control line has flowered every season. Secondly, compared to the wild type, the only common features of the transgenic lines have been slightly slower height growth, increased branching, and smaller leaf size. The increased branchiness was positively correlated with abundance of spiders on saplings, which may affect the number of herbivorous insects. However, there were no statistically significant differences in visual damage estimates of the lines. The transgenic lines did not differ from the wild type either in chemical composition or in insect feeding assays, but rather, the results varied depending on the transgenic line and insect species.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The introduced traits (prevention of flowering, kanamycin resistance) have no direct consequences for other organisms in the environment.

The likelihood of transfer of the transgenes into the populations of the wild birch species due to the instability of the expression of the transgenes, and the consequential reversal of the phenotype (i.e., flowering) is very small. The consequences of the potential spread of the transgene are likely to be negligible or very small, because the introduced traits confer no selection advantage in a natural environment. Therefore the overall risk of the potential spread of the transgenes is very small.

The risk associated with the potential horizontal transfer of the transgenes barnase, barstar, and npt II (all of bacterial origin) from the GM plants into bacteria is remote, and the hazard arising from such gene transfer is very small.


Brief description of any measures taken for the management of risks:
The GM-plants are modified to be non-flowering. The release site is fenced and guarded. During growing season, possible formation of inflorescences is monitored. Possible single inflorescences are removed, when formed. Flowering individuals are removed from the field. After the field study, the field site is treated with a herbicide (glyphosate), and above-ground transgenic plant parts exterminated by burning on release site. The release site is treated with herbicide during the next two growing seasons.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The release is a continuation of an already established field study on environmental risks of genetically modified non-flowering birch. The main aim of the release is to gain new information on the environmental consequences of prevention of flowering by genetic modification. The field performance of the plants, resistance to herbivores and other stresses, possible changes in chemical composition and global gene expression of the GM plants is monitored.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
28/11/2008 00:00:00
Remarks: