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Notification report


General information

Notification Number
B/SE/07/12880

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
17/12/2007

Title of the Project
Sugar beet tolerant to glyphosate and resistant to virus disease Rhizomania, Sweden, 2008-2012

Proposed period of release:
01/04/2008 to 31/12/2012

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


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

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

If yes, notification number(s):


Other notifications
B/SE/03/6371Both traits has been tested individually on several locations in EU and USA. RR H7-1 is deregulated for cultivation in USA and Canada. Also for food and feed, this line has been deregulated in several countries.
Permissions for field trials for the traits in SE with notification numbers:
B/SE/03/6371 (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. sacchariferaDifferent conventional breeding lines

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The traits that are introduced provides;
Tolerance to the herbicide glyphosate, known under the trademark Roundup®. The tolerance is mediated by the introduced epsps gene.
Resistance to virus disease Rhizomania. The gene comes from Beet Necrotic Yellow Vein virus, which in the plant reduces the formation of the virus
The genes have been introduced individually and have then been crossed together sexually.
The selectable marker phosphomannose isomerase (PMI) has been used in the GM RZ 13 line. PMI results in a positive selection of cells with the PMI-gene.


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:
Each genetic element was transferred and inserted at a single locus.
The stacked event 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.

Summary of the genetic elements in plasmid PV-BVGT08 (RR H7-1)

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 (GM RZ 13)

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:
Disarmed Agrobacterium tumefaciens plant transformation system was used to produce events RR H7-1 and GM RZ 13. This delivery system is well documented to transfer and stably integrate transferred DNA (T-DNA) into a plant nuclear chromosome (White, 1989; Howard et al., 1990). The transformation was conducted using conventional diploid fertile sugar beet ines.
The sugar beet lines, with the different traits, were crossed together sexually.


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, virus control and agronomical performance in different breeding materials.

2. Geographical location of the site:
The release will take place in Landskrona, Helsingborg, Svalöv, Simrishamn, Kävlinge and Kristianstad

3. Size of the site (m2):
The sites of releases will be not more than 20 000m2. 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:
RR H7-1. The same event has been tested in field trials in EU since 1995 (by another applicant) and by Syngenta since 2005. No negative effects on human health or on the environment have been recorded. The event is also deregulated for cultivation in USA and Canada. Also for food and feed the event is deregulated in several countries. The event has received a positive EFSA opinion (EFSA, 2006) and is fully approved for food and feed in the EU (Commission Decision 2007/692/EC).
GM RZ 13 has been tested in Sweden since 2004 and in USA since 2002. No negative effects on the environment or on human health have been recorded.
When crossed together, no negative effects are anticipated.


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 and harvest, 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 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.
- selected roots will be transported to Syngenta site for sugar and quality analyses.
- all transport will be performed by dedicated personnel that has gone through a special training for the handling of GM material
- Transport of seeds and roots will take place in closed containers or boxes.
- 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 minimum 2 times 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, Rhizomania control and agronomical performance in different plant breeding material, not to gain new data on the environmental and human health impact of the release.

Brunke KJ and SL Wilson. 1993. Patent application EPA 559 603: Brassica hsp80 promoter.

Barker, R.F., K.C. Idler, D.V. Thompson and J.D. Kemp. 1983. Nucleotide Sequence of the T-DNA Region from the Agrobacterium tumefaciens octapine Ti Plasmid pTi 15955. Plant Mol. Biol. 2: 335-350.

Coruzzi, G., C. Broglie, C. Edwards and N. Chua. 1984. Tissue specific and Light regulated Expression of a Pea Nuclear Gene Encoding the Small Subunit of Ribulose 1,5 bisphosphate Carboxylase. EMBO J. 3: 1671 1679.

Depicker, A., S. Stachel, P. Dhaese, P. Zambryski and H. Goodman. 1982. Nopaline Synthase: Transcript Mapping System and DNA Sequence. J. Molec. Appl. Genet. 1: 561 573.

Gowda, S., F.C. Wu and R.J. Sheperd. 1989. Identification of Promoter Sequences for the Major RNA Transcripts of Figwort Mosaic and Peanut Chlorotic Streak Viruses (Caulimovirus Group). J. Cell. Biochem. 13D (supplement): 301.

Howard, E., V. Citovsky and P. Zambryski. 1990. Transformation: The T Complex of Agrobacterium tumefaciens. In Plant Gene Transfer. C. J. Lamb and R. N. Beachy, editors. Alan R. Liss, Inc., New York, New York. 1 12.

Joersbo, M., Donaldson, I., Kreiberg, J., Petersen, S.G., Brundstedt, J. and Okkels,
F.T. 1998. Analysis of mannose selection used for transformation of sugar beet. Mol. Breeding 4: 111-117.

Morrelli, G., F. Nagy, R.T. Fraley, S.G. Rogers and N. Chua. 1985. A Short Conserved Sequence is Involved in the Light inducibility of a Gene Encoding Ribulose 1,5 bisphosphate Carboxylase Small Subunit of Pea. Nature 315: 200 204.

Odell, J. T., Mag, F., Chua, N-H. 1985. Identification of DNA sequences required for
activity for the Cauliflower Mosaic Virus 35S promoter. Nature 313: 810-812.

Padgette, S.R., Barry, G.F., Re, D.B., Weldon, M., Eicholtz, D.A., Kolacz, K.H. and Kishore, G.M. 1993. Purification, cloning and characterisation of a highly glyphosate tolerant EPSPS synthase from Agrobacterium sp. Strain CP4. Monsanto Technical Report, MSL - 12738, St Louis.

Richins, R.D., H.B. Scholthof and R.J. Sheperd. 1987. Sequence of Figwort Mosaic Virus DNA (Caulimovirus Group). Nucl. Acids Res. 15: 8451 8466.

Sanger, M., S. Daubert and R.M. Goodman. 1990. Characteristics of a Strong Promoter from Figwort Mosaic Virus : Comparison with the Analogous 35S Promoter from Cauliflower Mosaic Virus and the Regulated Mannopine Synthase Promoter. Plant Mol. Biol. 14:433 443.

Shepherd, R.J., J.F. Richins, J.F. Duffus and M.K. Handley. 1987. Figwort Mosaic Virus : Properties of the Virus and its Adaptation to a New Host. Phytopathology 77: 1668 1673.

Timko, M.P., L. Herdies, E. de Alameida, A.R. Cashmore, J. Leemans and E. Krebbers. 1988. Genetic Engineering of Nuclear encoded Components of the Photosynthetic Apparatus of Arabidopsis. In The Impact of Chemistry on Biotechnology A Multidisciplinary Discussion. M. Phillips, S.P. Shoemaker, R.D. Middlekauff, and R.M. Ottenbrite, editors. ACS Books, Washington, DC. 279 295.

White, F.F. 1989. Vectors for Gene Transfer in Higher Plants. In Plant Biotechnology. S. Kung and C. J. Arntzen, editors. Butterworths, Boston. 3 34.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/04/2008 00:00:00
Remarks: