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Notification report


General information

Notification Number
B/CZ/16/01

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
08/04/2016

Title of the Project
Notification for the release into the environment of genetically modified soya with gene LTB (2016-2021)

Proposed period of release:
30/06/2016 to 31/10/2021

Name of the Institute(s) or Company(ies)
Institute of Experimental Botany AS CR, ;


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
soyafabaceaeglycineglycine max

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
- production of the beta subunit pentamers in plant seeds
- hpt gene (conferring tolerance to hygromycin) 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:
- glycinine promoter and terminator for the LTB gene regulation
- fragment of LTB coding for the E.coli protein (monomer of beta- subunit)
- ubiquitin promoter and terminator from potato for the resistance gene regulation
- fragment of htp coding for the plant resistance to hygromycin


6. Brief description of the method used for the genetic modification:
Plasmid derived DNA fragment was introduced into plant embryo using biolistics.

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 purpose of the release is the production of the seeds for the next plant generations and for the analyses concerning the stability of the LTB protein production under variable environmental conditions.

2. Geographical location of the site:
Prague 6, the residential area of the Institute of Experimental Botany

3. Size of the site (m2):
10 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:
This genetically modified transgenic line is tested for the first time in field trials. No adverse impacts on the environment or human health are expected.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
It is not expected that a selective advantage or disadvantage is conferred to the GM line via the introduced traits. No selection will be applied to plants resistant to hygromycin. The beta-subunit pentamers have no function in plant and are formend only in seeds.

Brief description of any measures taken for the management of risks:
Soya plants are unable to grow outside the cultivated area and to form weedy plants. Only limited number of the transgenic plants will be planted. All manipulations will be done by hand and each plant will be harvested separately. The distance for transportation of plants or seeds is only a few meters to the laboratory facilities. The cultivation area will be surrounded by manicured lawn.
Measures in place under current field trial practice will safeguard that all plant material is properly managed, harvested, stored, transported or disposed of.


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
21/06/2016 00:00:00
Remarks: