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Notification report


General information

Notification Number
B/ES/09/46

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
29/01/2009

Title of the Project
Sugar beet tolerant to glyphosate and resistant to Rhizomania, Spain, 2009-2012.

Proposed period of release:
01/03/2009 to 30/11/2009

Name of the Institute(s) or Company(ies)
Syngenta Seeds SA, Travessera de Gracia, 73; 7ª planta
08006 Barcelona
On behalf of: Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies;


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

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/SE/07/12880;

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:
The trait that is introduced provides tolerance to the herbicide glyphosate and resistance to Rhizomania.

Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
The stacked events will contain 3 genes, i.e. epsps, RZM and PMI. Epsps provides tolerance to glyphosate, RZM provides resistance to Rhizomania and PMI was used a selectable marker.

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Summary of the genetic elements in plasmid PV-BVGT08:
- Right Border: A 25 bp nucleotide sequence that acts as the initial point of DNA transfer into plant cells originally isolated from A. tumefaciens pTiT37 (Depicker et al., 1982).
- P-FMV: The 35 S promoter from a modified figwort mosaic virus (FMV) used to drive expression of cp4 epsps gene (Shepherd et al., 1987; Richins et al., 1987; Gowda et al., 1989; Sanger et al., 1990).
- ctp2: The N-terminal chloroplast transit peptide sequence from the Arabidopsis thaliana epsps gene (Timko et al., 1988).
- cp4 syn: The 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps) synthetic gene based on the sequence from Agrobacterium sp. strain CP4 (Padgette et al., 1993).
- E9 3’: The 3’ end of the Pisum sativum rbcS E9 gene which provides the polyadenylation sites for the cp4 epsps gene (Coruzzi et al., 1984; Morelli et al., 1985).
- Left Border A 25 bp nucleotide sequence that delimits the T-DNA transfer into plant cells. It was originally isolated from A. tumefaciens pTiA6 (Barker et al., 1983).

Summary of the genetic elements in plasmid PHINK188:
- Promoter Arabidopsis thaliana promoter used to drive constitutive expression.
- RZM From BNYVV. Resistance to BNYVV.
- Terminator Agrobacterium tumefaciens polyadenylation sites used to terminate transcription.
- Hsp80 Hsp promotor from Brassica sp. used to drive constitutive expression of the PMI gene (Brunke and Wilson, 1993).
- PMI Phosphomannose isomerase gene derived from E. coli (Joersbo et al., 1998) used as selectable marker.
- 35S 35S Terminator from Cauliflower Mosaic Virus (Odell et al., 1985).


6. Brief description of the method used for the genetic modification:
The single sugar beet events were transformed using standard Agrobacterium mediated 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 purpose of the release is to evaluate the phenotypic stability of the stacked events, i.e. the level of weed control provided by the glyphosate tolerant trait and the level of resistance to Rhizomania.

2. Geographical location of the site:
The release will take place in:
- Magaz de Pisuerga (Palencia).
- Bercero (Valladolid).
- Pampliega (Burgos).
- Laguna de Negrillos (León).
- Pajares de los Oteros (León).


3. Size of the site (m2):
The sites of releases will be not more than 3000 m2. This area includes the GM plants, the non-GM control plants, and the surrounding area that is not cultivated.

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 negative impact on the environment or human and animal health was recorded during these releases.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The intended effect of the modification is increased resistance to Rhizomania and tolerance to a specific herbicide. This may confer a selective advantage to the plant during the growth cycle but it is not anticipated to affect the agronomic characteristics that lead to selective advantage in natural environments. Management measures (see Section E) are taken to reduce the potential release in the environment. Therefore, even though the introduced traits could confer a selective advantage to the sugar beet stacks, the risk for the GM sugar beet stacks to escape outside the release site or persist in the field is considered negligible. No significant environmental benefits are expected from these field trials.

Brief description of any measures taken for the management of risks:
A number of measures will be taken to minimise any potential risk with this field release:
- a tight control will be enforced during drilling, to ensure that no plant escapes outside the release site,
- the drilling machine will go through a careful cleaning procedure after the drilling is finished,
- drilling will be performed by dedicated Syngenta personnel that has gone through a special training for the handling of GM material,
- the GM sugar beet will not be allowed to bolt and shed pollen. Any bolting plants will be removed before pollen is released.
- at the end of the trial, the plants will be ploughed into the soil. This will destroy the plants and minimise the potential for regeneration of a sugar beet plant in the following spring,
- monitoring will be done during one year after the trial. A monocot crop will be grown on the release site during this year. The monocot crop will be sprayed with a herbicide that controls dicots (including sugar beet). Thus, any sugar beet that were not destroyed by the ploughing, and survived the below-zero temperatures of the winter, will be controlled by the herbicide used in the monocot crop. The site will be visited regularly during this year to check for and eliminate if necessary, any surviving sugar beet.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The purpose of this release is to evaluate weed control efficacy, disease resistance and phenotypic stability in different plant breeding material, not to gain new data on the environmental and human health impact of the release.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/06/2009 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Castilla y León.