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Notification report


General information

Notification Number
B/ES/08/35

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
30/01/2008

Title of the Project
Registration Field Trials of Sugar beet tolerant to glyphosate.

Proposed period of release:
21/03/2008 to 21/09/2008

Name of the Institute(s) or Company(ies)
Syngenta Seeds, S.A., 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/03/6371-CON; B/SE/04/7951;

Other notifications
H7-1 is deregulated for cultivation in USA and Canada.

B/SE/03/6371-CON (GM RZ 13 2004-2008: Dnr 22-6371/03 (Syngenta Seeds))
B/SE/04/7951 (RR H7-1 2005-2009: Dnr 22-7951/04 (Syngenta Seeds))


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
sugar beetchenopodiaceaebetabeta vulgarisvulgaris var. sacchariferaR01/H7-1

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.

Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
Only the DNA required to confer the glyphosate tolerance phenotype was
transferred and inserted at a single locus.


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).


6. Brief description of the method used for the genetic modification:
The sugar beet was 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 level of weed control in different
breeding material.


2. Geographical location of the site:
The release will take place in the region of Castilla y León:
- Laguna de Negrillos (León) 1000 m2
- Magaz de Pisuerga (Palencia) 1000 m2
- Palazuelos de Muño (Burgos) 1000 m2


3. Size of the site (m2):
The sites of releases will be not more than 1000m2. 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:
The same event have been grown in deliberate releases in EU since 1995. No
negative impact on the environment or human an animal health were recorded during
these releases.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The glyphosate tolerance trait would confer a selective advantage to the beet plant if the GM sugar beet would 1) escape outside the release site and this area would be sprayed with glyphosate, or 2) would survive in the soil after the monitoring period and the field would be sprayed with glyphosate.
Management measures (see Section E) are taken to reduce the potential release in
the environment. Therefore, even though the glyphosate trait could confer a selective advantage to the sugar beet, the risk for the GM sugar beet 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 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
04/04/2008 00:00:00
Remarks: