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Notification report


General information

Notification Number
B/FI/05/1MB

Member State to which the notification was sent
Finland

Date of acknowledgement from the Member State Competent Authority
15/02/2005

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

Proposed period of release:
12/06/2005 to 31/10/2008

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

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 likelyhood 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 consequental 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 asscociated 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 in two-week intervals. Possible single inflorescences are removed, when formed. Flowering individuals are removed from the field. After the field study, all plants are treated with a herbicide, and exterminated by burning or in autoclave. 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:
One of the main aims 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 or global gene expression of the GM plants is monitored, as well as consequences for the soil consumer community.

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
10/05/2005 00:00:00
Remarks:

BOARD FOR GENE TECHNOLOGY, FINLAND Unofficial translation
Helsinki 10 May 2005




DECISION


OPERATOR: Institute of Biology
University of Joensuu
P.O.B. 111
80101 JOENSUU
FINLAND

APPLICATION I/MB/05 Date of arrival 15 February 2005



PARTICULARS

Content of application
Application according to section 17 of the Gene Technology Act for the deliberate release into the en-vironment of genetically modified organisms for any other purpose than for placing on the market.

Genetically modified plant
The application concerns birch (Betula pendula) that has been genetically modified to be sterile. The flowering is prevented by introducing a barnase gene regulated by the promoter (BpMADS5pro) of the inflorescence-specific gene (BpFULL1) from silver birch. The marker gene is neomycin phosphotrans-ferase gene (nptII). Agrobacterium-mediated transformation has been used in gene transfer. The ex-periment will use four genetically modified lines of birch clone BPM5.

Experiment site and period
The experiment site is situated in Joensuu within the area of the botanical garden Botania. The total area of the experiment with the protection area is 1000 m2. The experiment will last from 2005 to 2008.

Purpose and implementation of the experiment
The purpose is to study the potential environmental effects of GM-birches. Information will be got e.g. of the stability and ecological interactions of preventing flowering. Potential unforeseen adverse ef-fects are a special object of interest in the experiment, and they are studied by examining e.g. changes in gene expression, chemical composition of plants, plant resistance to herbivores and pathogens, and in functions of the soil organism community.

Altogether 450 genetically modified birches are to be planted in the experiment site that will be fenced.

Risk assessment
It is stated in the conclusions of the risk assessment drawn up by the operator that there is no reason to assume that the experiment will pose a risk to human or animal health or to the environment. There is very little possibility that the modified gene will spread, since the sterility prevents transfer of genes to natural populations. It is not assumed that the transferred genes will affect directly other organisms. Neither are any effects on the biogeochemical processes of the soil expected to emerge.


Expert opinions
Opinions on the application were asked from the Finnish Environment Institute and the Finnish Forest Research Institute. Based on them the Board for Gene Technology decided at its meeting on 19 April 2005 to request further information from the operator.

Consulting the public
The public has been consulted in accordance with section 36 b of the Gene Technology Act. During the consulting the Board for Gene Technology received comments from three bodies: the Finnish As-sociation for Nature Conservation (Suomen Luonnonsuojeluliitto), Friends of the Earth Finland (Maan Ystävät) and the People’s Biosafety Association in Finland (Kansalaisten Bioturvayhdistys ).


DECISION

The Board for Gene Technology grants the Institute of Biology at the University of Joensuu consent for the deliberate release into the environment of genetically modified birch for any other purpose than for placing on the market for the years 2005-2008, as applied and on the following additional condi-tions:

1. The operator shall submit to the Board for Gene Technology at the latest two weeks prior to the establishment of the experiment a detailed experiment plan indicating the location of birches in the experiment site, including the common birches planted in the protection area.
2. If a GM-birch will unexpectedly develop inflorescences the GM birches of the same line shall be taken under special control, and the development of inflorescences shall be checked on a weekly basis.
3. If at least 20 % of the individuals of the same line start to develop inflorescences, all the GM birches of the line concerned shall be removed with their stumps by the end of the growing sea-son. The removed birches shall be disposed of by autoclaving or burning.
4. The post-monitoring period of the experiment is three years from the end of the experiment. During the post-monitoring period the experiment site and the protection area shall be treated with a herbicide. During the post-monitoring period the operator shall check the experiment site at least three times per growing season and submit to the Board for Gene Technology an-nually an interim report on the monitoring carried out after the release.

The liaison authority for the inspections of the experiment is the Finnish Environment Institute.

Statement of reasons
In the risk assessment under section 8 of the Gene Technology Act and Chapter 6 of the relevant De-cree of the Ministry of Social Affairs and Health (110/2005) no risk has been detected for human or animal health or the environment, and the experiment arrangements are sufficient to prevent unfore-seen environmental effects. The technical dossiers for the application have been drawn up as laid down in section 17 of the Gene Technology Act and in Chapter 4 of the relevant Decree of the Ministry of Social Affairs and Health (110/2005), and the operator has supplied the further information requested by the Board for Gene Technology.

Under the consulting of the public no such circumstances related to risk assessment have appeared from the comments received that would be essential for the evaluation of the application or that would not have been taken into account in the risk assessment included in the application or in the conditions for the consent included in the proposal for decision.

Based on what has been stated above the conditions under section 18 of the Gene Technology Act for granting consent are met.

Provisions applied
Gene Technology Act of Finland (377/1995), section 18
Decree of the Ministry of Social Affairs and Health on Deliberate Release of Genetically Modified Organisms (110/2005), Chapters 4 and 6
Administrative Procedure Act (434/2003), sections 31 and 45


Instructions for appeal are attached to this decision.





Pirjo H. Mäkelä Irma Salovuori
Chairperson Presenting Official



Appendix to decision of the Board for Gene Technology


APPEAL INSTRUCTIONS

A decision of the Board for Gene Technology can be appealed to the Supreme Administrative Court (Gene Technology Act, section 44)

A decision can be appealed by any person to whom the decision is addressed or whose right, obligation or interest is directly affected by the decision appealed against. (Administrative Judicial Procedure Act, section 6)

The appeal document shall be submitted directly to the Supreme Administrative Court. Its contact in-formation is as follows:

THE SUPREME ADMINISTRATIVE COURT
Postal address P.O.B. 180, 00131 Helsinki
Visiting address Unioninkatu 16, Helsinki
Fax (09) 1853 382
E-mail Korkein.hallinto-oikeus@om.fi

Telephone, exchange (09) 18531
Client service (09) 1853 233

Appeal period
An appeal shall be lodged within 30 days of notice of the decision. When calculating the appeal period the day of notice is not included (Administrative Judicial Procedure Act, section 23). If the final deci-sion document has been sent to the operator by mail in an unregistered letter, the notice is considered to have been served on the seventh day from the date of posting the document. (Act on Service of No-tice in Administrative Affairs, section 22).

Form and content of appeal
An appeal shall be made in writing. The appeal document shall specify:
1) the decision which is appealed against;
2) in which part the decision is appealed against and what amendments are demanded to be done; and
3) the grounds on which the amendment is demanded, the appellant’s name and municipality of resi-dence, and the name and municipality of residence of the legal representative or attorney, or if the ap-peal has been made by some other person, that person’s name and municipality of residence;
4) the postal address and telephone number where notices relating to the matter can be served on the appellant.
5) In addition, the appellant, his/her legal representative or attorney shall sign the appeal document (Administrative Judicial Procedure Act, sections 23 and 24).

Appendices to the appeal document
The appeal document shall be appended with:
1) the decision which is appealed against, in original or as a copy;
2) a certificate indicating the day of notice of the decision or some other specification about the date when the appeal period begins; and
3) the documents which the appellant appeals to in support of his/her claim, unless they have been submitted to the authority before.
The attorney shall append to the appeal document his power of attorney as laid down section 21 of the Administrative Judicial Procedure Act (Administrative Judicial Procedure Act, section 25).