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Notification report


General information

Notification Number
B/SK/10/01

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
11/12/2009

Title of the Project
Field evaluation of sugar beet (Beta vulgaris) lines and hybrids derived from transformation event H7-1 tolerant to the herbicide glyphosate.

Proposed period of release:
01/03/2010 to 31/12/2012

Name of the Institute(s) or Company(ies)
Plant Production Research Center Piestany. The trial is set up on behalf of SESVanderHave nv., Bratislavska cesta, 122, 921 68 Piestany, Slovak Republic.;


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

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

If yes, notification number(s):
B/ES/09/28;

Other notifications
B/ES/10/02

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
sugar beetchenopodiaceaebetabeta vulgarisvulgaris var. saccharifera3S0057

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
H7-1 expresses the CP4 EPSPS protein, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate.

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:
H7-1 contains the cp4 epsps gene which codes for the CP4 EPSPS protein derived from Agrobacterium sp. strain CP4. This protein confers tolerance to glyphosate. A full description of the genetic elements in H7-1, including the approximate size, source and function is provided in Table 1.

Table 1. Summary of genetic elements in the plasmid PV-BVGT08
Genetic elements Size (kb) Function
Right border 0.025 A 21-25 bp nucleotide sequence that acts as the initial point of DNA transfer into plant cells originally isolated from A. tumefaciens pTiT37
P-FMV 0.672 The 35S promoter from a modified Figwort Mosaic Virus (FMV)
ctp2 0.31 Sequences encoding the chloroplast transit peptide from the ShkG gene of Arabidopsis thaliana encoding EPSPS
cp4 epsps 1.363 The 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) coding sequence from Agrobacterium sp. strain CP4
E9 3’ 0.63 3' nontranslated sequence from the ribulose-1,5-bisphosphate carboxylase small subunit (rbcs2) E9 gene of pea (Pisum sativum)
Left border 0.025 A 21-25 bp nucleotide sequence that delimits the T-DNA transfer into plant cells, originally isolated from A. tumefaciens plasmid pTi15955, a derivative of the octopine type plasmid pTiA6
ori-V 0.393 Origin of replication from the broad host range plasmid RK2 for plasmid maintenance in Agrobacterium
ori-322 0.629 Origin of replication from pBR322 for plasmid maintenance in E. coli
rop 0.191 A segment of plasmid pBR322 that represses the formation of RNA primer critical to maintenance of the plasmid in bacterial hosts such as E. coli
aadA 0.789 Bacterial gene encoding an aminoglycoside-modifying enzyme, 3' (9)-O-nucleotidyl-transferase from the transposon Tn7


6. Brief description of the method used for the genetic modification:
H7-1 was produced by Agrobacterium-mediated transformation of cotyledons of sterile sugar beet seedlings.

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:
This type of yield and observation trial is part of a normal breeding program where lines and hybrid are extensively tested to develop the optimal varieties to address the needs of the grower for high performing varieties such as high yield, high white sugar extractability, low soil tare, tolerance to fungal and viral diseases in Slovakia.

2. Geographical location of the site:
The selected site is located in Borovce, Slovak republic.

3. Size of the site (m2):
The actual surface of the trial will be around maximum 2000 m2.

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:
H7-1 sugar beet has been notified in Belgium, United Kingdom, Italy, the Netherlands, France, Germany and Spain under Part B of Directive 90/220/EEC and 2001/18/EC (see Table 2). Furthermore, H7-1 has been released for field-testing at several locations in the U.S.A., Canada, Russia, Chile, Czech Republic and Poland since 1998. These field trials were conducted to produce material for the regulatory studies and to assess agronomic performance (efficacy, selectivity, yield assessment).
Following rigorous regulatory assessment, environmental authorizations have been received in the U.S.A. (2005), Canada (2005), and Japan (2007) for H7-1 sugar beet.
The results of the described field-testings and post-marketing experience in these countries showed no evidence that H7-1 is likely to cause any adverse effects to human or animal health and the environment. Except for its tolerance to glyphosate, H7-1 could not be distinguished from conventional sugar beet.

Table 2. List of previous notifications under Part B of Directive 90/220/EEC and 2001/18/EC
Year Country Notification Number
1995 Belgium B/BE/95/WSP4 (Monsanto)
1996 Belgium B/BE/95/WSP4 (Monsanto)
United Kingdom B/GB/96/R22/7 (96/R 22/7) (Monsanto)
1997 Belgium B/BE/95/WSP4 (Monsanto)
Italy B/IT/97/18 (Monsanto)
The Netherlands B/NL/96/22 (BGGO 96/22) (Monsanto)
1998 Belgium B/BE/95/WSP4 (Monsanto)
Italy B/IT/97/18 (Monsanto)
France B/FR/97/10/11 (Monsanto)
The Netherlands B/NL/96/22 (BGGO 96/22) (Monsanto)
United Kingdom B/GB/98/R22/11 (B/UK/98/R22/11) (Monsanto)
1999 Belgium B/BE/95/WSP4 (Monsanto)
France B/FR/99/01/07 (Monsanto/KWS)
France B/FR/99/11/02 (KWS)
Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)
Italy B/IT/97/18 (Monsanto)
Italy B/IT/99/03 (KWS)
Italy B/IT/99/27 (KWS)
Italy B/IT/99/36 (KWS)
Spain B/ES/99/03 (Monsanto)
The Netherlands B/NL/96/22-EXT1 (BGGO 96/22-01) (Monsanto)
United Kingdom B/GB/98/R22/11 (B/UK/98/R22/11) (Monsanto)
2000 Belgium B/BE/95/WSP4 (Monsanto)
Belgium B/BE/00/VSP2 (KWS)
France B/FR/99/01/07 (Monsanto/KWS)
France B/FR/00/07/01 (KWS)
Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)
Spain B/ES/00/08 (Monsanto)
The Netherlands B/NL/96/22-EXT1 (BGGO 96/22-01) (Monsanto)
2001 Belgium B/BE/95/WSP4 (Monsanto)
France B/FR/99/01/07 (Monsanto/KWS)
Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)
The Netherlands B/NL/96/22-EXT1 (BGGO 96/22-01) (Monsanto)
2002 Germany B/DE/99/94 (ZG2 6786-01-0094) (Monsanto)
2005 Sweden B/SE/04/7951 (Syngenta Seeds)
2006 Spain B/ES/06/01 (Monsanto)
2008 Germany B/DE/07/192 (Planta KWS)
Spain B/ES/08/01 (Monsanto)
Spain B/ES/08/28 (SESVanderHave)
Spain B/ES/08/35 (Syngenta Seeds)


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of H7-1 has shown that the risk of potential adverse effects on human health or the environment, resulting from the deliberate release of this sugar beet for field testing, is negligible:
 The risk of the introduced trait in H7-1 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. The likelihood of unintended spreading of H7-1 in the non-agricultural environments is negligible, as sugar beet is neither persistent nor invasive and these parameters are unaltered when compared to conventional sugar beet.
 Outcrossing will be negligible since this application is for consent to cultivate H7-1 sugar beet for trial purposes, implying that sugar beet is grown for its vegetative root and the lifecycle is limited to the vegetative stage in agricultural production. Nevertheless, measures will be taken to avoid hybridization with other sugar beet plants and to prevent seed dissemination at harvest and during transportation (see Point E).
 As H7-1 sugar beet is herbicide tolerant it has no target organisms with which to interact, either directly or indirectly. Therefore, no characteristics that may cause any adverse environmental effects could be identified.
 Based on the well-characterised mode of action of the EPSPS enzymes and the confirmation through studies of no adverse effects found, it is highly unlikely that H7-1 sugar beet would be hazardous to nontarget organisms. The ecological interactions with non-target organisms or the biochemical processes in soil are considered similar to the ones caused by conventional sugar beet.
 Any occupational health aspects of handling H7-1 are not different from conventional sugar beet. Additionally this sugar beet was shown not to cause any toxic or allergenic effects in humans or animals and to be as safe and nutritious as any other sugar beet without any consequences for the feed/food chain.
 The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the cultivation of any other sugar beet.
Since no characteristics of H7-1 could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.


Brief description of any measures taken for the management of risks:
The environmental risk assessment has indicated that the environmental risks posed by this sugar beet are negligible. Therefore, strategies for risk management for H7-1 sugar beet would be the same as for traditional sugar beet.
However, the trial site will be checked regularly by trained staff during the period of the deliberate release to destroy sugar beet plants showing signs of bolting before flowering and pollen emission, making unnecessary any need for isolation distances.
In case any adverse environmental effects, linked to the deliberate release of H7-1 sugar beet, are observed during the period of release, these will be reported immediately to the Competent Authorities.
At the end of the field-testing season, a report will be made available by the notifier to the Competent Authorities. This report will detail any unexpected adverse environmental effects that were observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.
A field logbook will record all actions and observations made in the trial with respect the management and stewardship in the trial.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable. The trials have not been designed to specifically gain new data on the environment and human health impact of the release.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/03/2010 00:00:00
Remarks: