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Notification report


General information

Notification Number
B/ES/13/01

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/09/2012

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of glyphosate tolerant H7-1 sugarbeet for the use in field trials in Castilla y León (Spain).

Proposed period of release:
01/03/2013 to 31/10/2013

Name of the Institute(s) or Company(ies)
KWS SAAT AG, Represented by KWS Semillas Iberica.;


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


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

If yes, notification number(s):
B/BE/00/VSP2; B/DE/07/192; B/ES/10/01; B/ES/11/02; B/ES/12/01; B/ES/12/02; B/FR/00/07/01; B/FR/99/11/02; B/IT/99/03; B/IT/99/27; B/IT/99/36;

Other notifications
B/DE/12/215

Many field trials have already been conducted across sugar beet growing regions in Europe, Russia, and North and South America.
Further notifications: The notification UK-2004-08, for import and use according to Regulation (EC) 1829/2003, has received a positive EFSA report and has been approved by the European Commission.
Furthermore, an application for authorisation of H7-1 sugar beet for cultivation in the European Union according to Regulation (EC) 1829/2003 was submitted (Application number EFSAGMO-DE-2008-63).


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:
RR sugar beet event H7-1 contains a fully functional and intact gene encoding the CP4 EPSPS protein, which confers tolerance to Roundup herbicide.

The nature of the product and the objective of the genetic modification are to improve weed management practices in sugar beet. Weed management is an expensive, labour intensive, and in some cases complicated operation necessary for optimal production efficiency of sugar beet.
No single currently-registered herbicide offers the broad spectrum weed control afforded by Roundup. Instead, farmers today must resort to using several applications of multiple herbicides with high input of the respective chemicals.

The use of RR sugar beet for sugar beet production would enable farmers to use Roundup herbicide for effective and sustainable control of weeds while making use of the benefits of Roundup's environmental safety characteristics. This new RR sugar beet could positively impact current agronomic practices, reducing energy consumption and soil erosion.


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:
The genetic elements intended for insertion in H7-1 sugarbeet were as follows:

Genetic Elements - Size (Kb)- Function:

- Right Border: 0.025 Kb. A 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 Kb. The 35 S 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 syn.: 1.363 Kb. The 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) gene 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 25 bp nucleotide sequence that delimits the T-DNA transfer into plant cells. It was originally isolated from A. tumefaciens pTiA6.


6. Brief description of the method used for the genetic modification:
A disarmed Agrobacterium tumefaciens plant transformation system was used to produce event H7-1. This delivery system is well documented to transfer and stably integrate transferred DNA (T-DNA) into the plant nuclear chromosome. The vector used is PVBVGT08. The original transformation was conducting using a diploid fertile sugar beet line.

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 release has the purpose to generate data for the official registration of commercial varieties.

2. Geographical location of the site:
Castilla y León:
- Valladolid: Valladolid, Cigales, Tordesillas y Ventosa de la Cuesta.
- Burgos: Pampliega y Palazuelos de Muno.
- Palencia: Magaz de Pisuerga.
- Leon: Laguna de Negrillos.


3. Size of the site (m2):
The maximum surface occupied in each site by H7-1 sugarbeet will be: 1.000 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:
No change in dormancy or characteristics other than glyphosate tolerance could be observed in the used seed lots comparing H7-1 and common used, diploid, multicarp and monocarp sugar beet breeding lines.

It can be concluded that there are no meaningful differences between H7-1 and the nontransgenic counterparts in regards to survivability.


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 H7-1sugar 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.

- 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 non-target 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 food/feed chain. Although H7-1 sugar beet has already received food/feed approval in the EU, crop material and plant residues from H7-1 sugar beet produced during the field trials applied for with this application will not enter the food/feed chain.

- The environmental impact of planting, 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 risk of this sugarbeet is negligible. Therefore, strategies for risk management for H7-1 sugarbeet would be the same as for conventional sugar beet.

However, the trial site will be checked regularly during the period of the deliberate release to destroy bolting sugarbeet plants before pollen emission, making unnecessary any need of isolation distances.

In case any adverse environmental effects, linked to the deliberate release of H7-1 sugarbeet, are observed during the period of release, these will be reported immediately to the Competent Authorities.

At the end of the field-testing campaign, a report of 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.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
08/02/2013 00:00:00
Remarks: