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Notification report


General information

Notification Number
B/SE/09/12598

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
14/12/2009

Title of the Project
SBVR111. Rhizomania resistant sugar beets, Sweden, 2010-2014

Proposed period of release:
15/04/2010 to 31/12/2014

Name of the Institute(s) or Company(ies)
Syngenta Seeds AB, Säbyholmsvägen 24Box 302S-261 23 Landskrona Sweden
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:
Spain;

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

If yes, notification number(s):
B/FR/03/01/03; B/SE/03/6371-CON;

Other notifications
SBVR111 sugar beet (previously designated GM RZ 13) has been notified for release in: Sweden: B/SE/03/6371-CON
France: B/FR/03/01/03
Note: SBVR111 sugar beet has been notified in the USA since 2002.


Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
beetchenopodiaceaebetabeta vulgarisvulgaris

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. 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.

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:
DNA sequence, Intended function, Source Constitutive Promoter Sequence, Promoter, A. thaliana RZM, Resistance to BNYVV, virus Termination Sequence, Terminator, A. tumefaciens Hsp80, Promoter, Brassica sp.
PMI, Selectable marker, E. coli
35S, Terminator, CaMV


6. Brief description of the method used for the genetic modification:
SBVR111 sugar beet was generated by standard Agrobacterium tumefaciens 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 objective of the field releases is to gain further information relating to the agronomic performance of SBVR111 sugar beet and to its performance against the target pest under European conditions. They will also allow the further assessment of the event in the environment.

2. Geographical location of the site:
The releases will take place in Landskrona, Helsingborg, Svalöv, Simrishamn, Kävlinge, Lomma, Ystad, Eslöv, Lund and Kristianstad.

3. Size of the site (m2):
The total size per year will be maximum 30.000m2. This area includes the GM plants, the non-GM control plants and the surrounding border 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 Sweden 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 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 trait expressed in SBVR111 sugar beet is resistance to Rhizomania. SBVR111 also expresses PMI, an enzyme which acts as a selectable marker enabling transformed plant cells to utilize mannose as a primary carbon source. The persistence and invasive potential of this event is expected to be the same as conventional sugar beet. Field studies with SBVR111 sugar beet have been previously conducted to compare its agronomic performance with its near-isogenic non-GM sugar beet counterpart. The data obtained confirmed that the performance of SBVR111 sugar beet is similar, and for most parameters, equivalent to its near-isogenic control sugar beet counterpart. The following year after the field release, any volunteer plants will be removed. No adverse effects of SBVR111 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 event in the environment

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
13/04/2010 00:00:00
Remarks: