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Notification report


General information

Notification Number
B/CZ/10/3

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
07/12/2010

Title of the Project
Field trials with Rhizomania resistant SBVR111 sugar beet, glyphosate tolerant H7-1 sugar beet and stacked SBVR111 x H7-1 sugar beet to be carried out between 2011 and 2014 in the Czech Republic

Proposed period of release:
01/03/2011 to 31/12/2014

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


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain; Sweden;

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
sugar beetchenopodiaceaebetabeta vulgarisvulgaris var. saccharifera

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
SBVR111 and H7-1 sugar beet confer resistance to Rhizomania and tolerance to herbicide products containing glyphosate, respectively.

Rhizomania is a disease in sugar beet that is spreading rapidly and is induced by the Beet Necrotic Yellow Vein Virus (BNYVV). SBVR111 sugar beet expresses a gene (RZM) which confers resistance to the disease through interaction with the reproductive system of the virus that will lead to a reduction of the development of the virus in the plant. SBVR111 sugar beet also expresses a Phosphomannose Isomerase (PMI) protein, which acts as a selectable marker enabling transformed plant cells to utilize mannose as a primary carbon source.

H7-1 sugar beet expresses the CP4 EPSPS enzyme which confers the tolerance to glyphosate herbicide.


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:
SBVR111 x H7-1 sugar beet is produced by conventional breeding crosses of SBVR111 and H7-1 sugar beet.

SBVR111 sugar beet was transformed with a plasmid carrying two genes:
- a gene that confers resistance to Rhizomania
- a gene that allows selection on media containing mannose.
Source of the donor organisms and function of the inserted fragment:
Ubiquitin 3 - Promoter - from Arabidopsis thaliana
RZM - Resistance to BNYVV
Nos - Terminator - from Agrobacterium tumefaciens
Hsp80 - Promoter - from Brassica sp.
PMI - Selectable marker - from E. coli
35S - Terminator - from Cauliflower Mosaic Virus


Vector components and function of the inserted fragment in H7-1 sugar beet:

Right Border: nucleotide sequence that acts as the initial point of DNA transfer into plant cells originally isolated from A. tumefaciens pTiT37
P-FMV : 35S promoter from a modified figwort mosaic virus (FMV) used to drive expression of cp4 epsps gene
ctp2 : N-terminal chloroplast transit peptide sequence from the Arabidopsis thaliana epsps gene
cp4 epsps : 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps) synthetic gene based on the sequence from Agrobacterium sp. strain CP4
E9 3’: 3’ end of the Pisum sativum rbcS E9 gene which provides the polyadenylation sites for the cp4 epsps gene
Left Border : nucleotide sequence that delimits the T-DNA transfer into plant cells. It was originally isolated from A. tumefaciens pTiA6


6. Brief description of the method used for the genetic modification:
The single sugar beet events were generated by standard transformation techniques.

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 objective of the field releases is to gain further information relating to the performance of SBVR111 x H7-1, SBVR111 and H7-1 sugar beet under European conditions, to produce material for analysis, to study the agronomic performance, to gain further information relating to the performance against the target pest under European conditions and to evaluate the level of weed control in glyphosate tolerant beets. The trials will also allow further assessment of the events in the environment.

2. Geographical location of the site:
3 release sites: Troubelice (Olomoucky region), Nosislav and Unkovice (both Jihomoravsky region)

3. Size of the site (m2):
maximum 3 600 m2 per site

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:
Evidence from previous field trials in the USA and EU suggests that the genetically modified lines do not differ from the recipient plant in mode or rate of reproduction, dissemination or survivability of the plant. No environmental or human health negative impact has been reported from these trials.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An environmental risk assessment has been conducted for these small-scale field trials. Sugar beet is non-invasive of natural habitats in Europe. Cross-pollination between SBVR111 x H7-1, SBVR111 and H7-1 sugar beet and sexually compatible wild relatives or other sugar beet crops is unlikely to occur given the layout and the design of these small-scale field trials and because plants will not be allowed to flower and set seed. At the end of the trial any remaining plant materials will be destroyed so no GM sugar beet will be used for human food or animal feed.
The following year any volunteer plants will be removed. No adverse effects of SBVR111 x H7-1, SBVR111 and H7-1 sugar beet on human health or the environment are therefore anticipated.
In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified sugar beet with the environment when compared to non-modified sugar beet have been identified.


Brief description of any measures taken for the management of risks:
The GM sugar beet will not be allowed to flower and set seed. The trial will be visited regularly, and bolting plants will be mechanically removed, before any flower is developed. This will prevent any spread of pollen.

The products from the trials may be used for analysis. Plant material remaining after harvest will be destroyed and will not be used for human food or animal feed.

The sites will be monitored for one year after the release and any volunteer sugar beet appearing will be eliminated before flowering. During this year, sugar beet will not be grown on the trial sites.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The trials have not been designed to specifically gain new data on the environment and human health impact of the release.
They will however allow the further assessment of the events in the environment.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
07/04/2011 00:00:00
Remarks: