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Notification report


General information

Notification Number
B/FI/04/1MB

Member State to which the notification was sent
Finland

Date of acknowledgement from the Member State Competent Authority
30/01/2004

Title of the Project
Improved starch content of potato

Proposed period of release:
15/05/2004 to 15/09/2008

Name of the Institute(s) or Company(ies)
Boreal Plant Breeding Ltd, ;


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
potatosolanaceaesolanumsolanum tuberosumtuberosum

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Increased starch content in potato tubers.
The marker gene used for transformation are neomycin phosphotransferase II (nptII) and hygromycin phosphotransferase (hyg).


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:
Confidential information, appendix 1.

6. Brief description of the method used for the genetic modification:
Genetic modification was achieved using Agrobacterium-mediated transformation of stem/shoot explants from dihaploid potato lines.

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:
To assess the starch content other industrial traits and agronomic characteristics of the transformed potatoes under field conditions.

2. Geographical location of the site:
Jokioinen Community, Jokioinen, Finland. Jokioinen is located in South Finland county, 120 km from Helsinki to the north.

3. Size of the site (m2):
Total trial area is 20 m x 30 m = 600 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:
No previous releases.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Transgenic potato lines grown in green house trials do not differ developmentally from normal potato and from mother lines. It is therefore anticipated that transgenic potato lines will not exhibit any increased selective advantage under field release conditions compared with the mother line.

Brief description of any measures taken for the management of risks:
Transgenic potato line will be grown in species isolation I.e. potatoes and transgenic potatoes will not be cultivated in the same area. Volunteer potatoes will be avoided by planting/harvesting by hand. All potato haulms, roots and stolons will be collected, bagged then burned. Potatoes will be transported to/from the trial area in sealed boxes. No potatoes will be cultivated in the same trial field for two years from the end of the trial.

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
24/04/2004 00:00:00
Remarks:

BOARD FOR GENE TECHNOLOGY, FINLAND Unofficial translation
Helsinki 21.4.2004



DECISION


OPERATOR Boreal Kasvinjalostus Oy /Boreal Plant Breeding Ltd
Myllytie 10
31600 JOKIOINEN
FINLAND

NOTIFICATION Notification of research and development experiment 1/MB/04


CONTENT OF NOTIFICATION

Notification according to Article 6 of Directive 2001/18/EC on deliberate release into the environment for any other purpose than for placing on the market.

Genetically modified plant
The notification concerns genetically modified potato (Solanum tuberosum L.) and its several breeding lines. The aim of the modification is to increase the starch content of tubers. The marker genes are neomycin phosphotransferase gene (nptII) and hygromycin phosphotransferase (hyg). Agrobacterium-mediated transformation has been used in gene transfer.

Experiment site and period
The experiment site is situated in the municipality of Jokioinen. The total area of the experiment with protection area is 600 m2. The experiment is proposed to last from 15 May 2004 to 15 September 2008.

Purpose and implementation of the experiment
The purpose is to study the starch content, other industrial quality and agronomic properties of GM- potato lines under field conditions.

Environmental risk assessment
The GM-potato material to be tested under field conditions was tested in greenhouse experiments in 2002-2003. The lines do not differ in respect of growth properties from the normal potato genotypes used as recipient cultivars /lines. The starch content of GM-potato lines has been analysed and their starch content has differed essentially from the recipient cultivars /lines used as controls. GM-potato lines are sterile, they flower and produce berries but in crossing experiments their pollen has been found to be sterile and the lines do not produce seeds.

The starch produced as a result of genetic modification is only formed in the tubers of potatoes. GM- lines are not toxic or harmful to people or the environment.

DECISION
The Board for Gene Technology grants Boreal Kasvinjalostus Oy/Boreal Plant Breeding Ltd. consent for the deliberate release into the environment of genetically modified potato for any other purpose than for placing on the market in 2004 - 2008 on the following conditions.

1. The operator shall check the GM-potato growth regularly during the growing season, and the berries that are formed must be removed. The berries and other genetically modified plant ma-terial must be carefully collected from the experiment site and disposed of in a way that the spread of GM material is prevented.
2. The operator shall take care of the control of water voles.
3. Each experiment site must be fallowed after use for two years. The monitoring shall continue thereafter one year at a time until no volunteers are found in the area, and potatoes may not be grown in the experiment site during that time.
4. It has to be ensured during the analysis and handling of genetically modified potatoes that the GM material is not mixed with non-modified potatoes so that they would end up to be used as nutrition or in cultivation.

STATEMENT OF REASONS
The additional information supplied by the operator has been sufficient. The experiment is not consid-ered to cause risk to human health and to the environment.

Provisions applied
Directive 2001/18/EC, Article 6
Gene Technology Act of Finland (377/1995), section 18


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).