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Notification report


General information

Notification Number
B/DE/10/215

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
19/08/2011

Title of the Project
Notification according to Directive 2001/18/EC, Part B, and to decision 94/730/EC for the deliberate release of glyphosate-tolerant sugar beet (H7-1) for field trials in Germany

Proposed period of release:
01/03/2012 to 30/11/2018

Name of the Institute(s) or Company(ies)
KWS SAAT AG, Grimsehlstr. 31
D-37574 Einbeck
Germany;


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/BE/00/VSP2; B/DE/07/192; B/ES/10/01; B/ES/11/02; B/FR/00/07/01; B/FR/99/11/02; B/IT/99/03; B/IT/99/27; B/IT/99/36;

Other notifications
Many field trials have already been conducted across sugar beet growing regions in Europe, Russia, and North and South America.

Furthermore, the application EFSA-GMO-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.
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 EFSA-GMO-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:
H7-1 sugar beet expresses the CP4 EPSPS protein, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate. Glyphosate is the active ingredient of the herbicide Roundup.
The nature of the product and the objective of the genetic modification is 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 H7-1 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 glyphosate-tolerant 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:
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: The genetic elements inserted in H7-1 sugar beet

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 The N-terminal chloroplast transit peptide sequence
from the Arabidopsis thaliana EPSPS gene
cp4 epsps 1.363 The 5-enolpyruvylshikimate-3-phosphate synthase
(CP4 EPSPS) gene from Agrobacterium sp. strain CP4
E9 3’ 0.63 The 3’ end of the Pisum sativum rbcS E9 gene,
containing polyadenylation sites that direct mRNA
processing and polyadenylation
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


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 PV-BVGT08. The original transformation was conducted by 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:
Within the framework of field trials, the data basis for H7 1 sugar beet cultivated under European field conditions will be extended.
Main purpose of the releases is the acquisition and evaluation of agronomic properties and phenotypic characteristics during the vegetation period as well as the yield performance, processing quality and composition of the genetically modified beets.


2. Geographical location of the site:
The selected sites are located in the following localities:
D-37154 Northeim / Stöckheim (Lower Saxony)
D-39393 Ausleben / Üplingen (Saxony-Anhalt)
It is planned to notify further locations according to Decision 94/730/EC in the following years.


3. Size of the site (m2):
The size of the area planted with H7-1 sugar beet per site and year will be 10.000 m2 (1 ha) at maximum.

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, the Czech Republic, Slovakia, Poland and Spain under Part B of Directive 90/220/EEC and 2001/18/EC. Furthermore, H7-1 has been released for field-testing at several locations in the U.S.A., Canada, Russia and Chile since 1995. These field trials were conducted to perform 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.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
• 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.
• 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 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 experimental site will be controlled regularly during the release.
Possibly appearing bolters in the trial plots will be removed before flowering so that no pollen will be produced by transgenic plants. For this purpose the experimental sites will be controlled with regard to the appearance of bolters at least every two weeks during the flowering period. For this reason an isolation distance is not required as the risk of hybridization with other beets and herbaceous plants is not relevant.
The sowing depth for the transgenic beet seed is 2-3 cm, as it is usual for conventional sugar beet. Accordingly the seed material will be as far as possible prevented from carryover by wildlife. Mechanical carryover during sowing is inhibited by control and cleaning of the sowing machine on the experimental site.
Plant material taken for analysis will be transported to the lab in closed and labelled containers. Left over will be destroyed at the site of the lab. Non-required plant material and vegetative plant residues are left on the experimental site. The plants are destroyed by appropriate measures as chopping or chemical measures and will be incorporated shallow into the soil. Topped and non-reproductive sugar beets may alternatively be carried to compost preparation or biogas facilities. In no case crop material and plant residues from sugar beet will enter the food/feed chain.
The experimental site will be controlled a further year after the release. During the growing season after the release, no sugar beets are cultivated on the experimental site. Accordingly possibly emerging beets can be identified and removed by mechanical, manual or chemical measures.
Due to the information given in the previous section and the described measures (e.g. prevention of flowering), a risk for human and the environment is negligible.
No further measures as described above or emergency plans are required because no risks for human health and the environment are anticipated by the released sugar beets.


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

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/03/2012 00:00:00
Remarks: