Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Field trials of genetically modified H7-1xSBVR111 sugar beet to be carried out in 2010.

Proposed period of release:
01/03/2010 to 30/11/2010

Name of the Institute(s) or Company(ies)
Syngenta Seeds SAS, Syngenta Seeds SAS on behalf of Syngenta Crop Protection AG, Basel Switzerland and all affiliated companies;

3. Is the same GMPt release planned elsewhere in the Community?

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

If yes, notification number(s):
B/ES/09/46; 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 purpose of the genetic modification is resistance to Rhizomania and tolerance herbicide products containing glyphosate. 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. H7-1 sugar beet expresses the CP4 EPSPS enzyme which confers the tolerance glyphosate herbicide.

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.

Genetic modification

3. Type of genetic modification:

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
Vector component and function of the inserted fragment H7-1 sugar beet:

Vector component: Size (Kb). Function.

- Right Border: 0.025 kb. A nucleotide sequence that acts as the initial point of DNA transfer into plant cells originally isolated from A. tumefaciens pTiT37.

- P-FMV: 0.672 kb. The 35S promoter from a modified figwort mosaic virus (FMV) used to drive expression of cp4 epsps gene.

- ctp2: 0.31 kb. The N-terminal chloroplast transit peptide sequence from the Arabidopsis thaliana epsps gene.

- cp4 epsps: 1.363 kb. The 5-enolpyruvylshikimate-3-phosphate synthase (cp4 epsps) synthetic gene based on the sequence from Agrobacterium sp. strain CP4.

- E9 3’: 0.63 kb. The 3’ end of the Pisum sativum rbcS E9 gene which provides the polyadenylation sites for the cp4 epsps gene.

- Left Border: 0.025 kb. A nucleotide sequence that delimits the T-DNA transfer into plant cells. It was originally isolated from A. tumefaciens pTiA6.

Source of the donor organisms and function of the inserted fragment SBVR111 sugar beet:
DNA sequence. Intended function. Source and reference.

- Constitutive Promoter Sequence*: Promoter *.

- RZM: Resistance to BNYVV *.

- Termination Sequence*: Terminator *.

- Hsp80: Promoter. Brassica sp.

- PMI: Selectable marker. E. coli.

- 35S: Terminator. Cauliflower Mosaic Virus.

* Information treated as Confidential Business Information.

6. Brief description of the method used for the genetic modification:
The single sugar beet events were generated by standard Agrobacterium 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 as the recipient or parental plant is not a forest tree species.

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 locations of the releases in Castilla y Léon are:

- Laguna de Negrillos (León).
- Magaz de Pisuerga (Palencia).
- Bobadilla del Campo (Valladolid).
- Villalazán (Zamora).

3. Size of the site (m2):
The site of release will not be bigger 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:
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. Expression of the cp4 epsps in H7-1xSBVR111 sugar beet is very unlikely to result in any selective advantage or disadvantage when compared to conventional sugar beet, especially under the uses proposed in this application. These conclusions were based on the fact that (i) sugar beet is a highly domesticated plant and is unlikely to survive without human intervention and (ii) expression of the cp4 epsps protein could confer advantage to sugar beet plants when herbicide products containing glyphosate are applied; however this rarely happens outside agricultural environments. Therefore, expression of cp4 epsps is highly unlikely to confer selective advantage to sugar beet plants.

In addition, cross-pollination between H7-1xSBVR111 sugar beet and sexually compatible wild relatives or other sugar beet crops is unlikely to occur given the layout and the design of this 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.

Field trials with H7-1xSBVR111 sugar beet have been conducted to date and no adverse effects on human or animal health effects have ever been reported.

No adverse effects of H7-1xSBVR111 sugar beet on human health or the environment as a results of these trials 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 event in the environment.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
15/04/2010 00:00:00
The competent authority for give the consent of these field trials is the Autonomous Community of Castilla y León.