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Notification report


General information

Notification Number
B/DE/10/211

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
19/10/2011

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of H7-1 sugar beet for the use in field trials in Germany.

Proposed period of release:
01/01/2011 to 31/12/2013

Name of the Institute(s) or Company(ies)
Monsanto Company, Represented by Monsanto Agrar Deutschland GmbH;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Denmark; Spain; Romania;

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

If yes, notification number(s):
B/BE/00/VSP2; B/BE/95/WSP4; B/DE/07/192; B/DE/99/94; B/ES/00/08; B/ES/06/01; B/ES/08/01; B/ES/10/01 ; B/ES/99/03; B/FR/00/07/01; B/FR/97/10/11; B/FR/99/01/07; B/FR/99/11/02; B/GB/96/R22/7; B/GB/98/R22/11; B/IT/97/18; B/IT/99/03; B/IT/99/27; B/IT/99/36; B/NL/96/22; B/NL/96/22-EXT1;

Other notifications
Many field trials have already been conducted across sugar beet growing regions in Europe, Russia, and North and South America, as described in Section C.4. No environmental problems were reported for these trials.

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 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.

Experimental Release

1. Purpose of the release:
Generation of data of the GMPt with respect to agronomic, phenotypic characteristics, expression of the introduced CP4 EPSPS protein in different tissues, on non-target organisms in the agricultural environment and regulatory data and recommendations on the weed management during the growing season in comparison with conventional sugar beet systems.

2. Geographical location of the site:
D-06429 Nienburg/Saale (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):
5000 m2 per year and site

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.


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 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 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:
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 in relevant spaces of time, at least every two weeks. For this reason sowing of a cover crop 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.
The experimental site will be controlled a further year after the release. Possibly emerging beet plants are removed by mechanical, manual or chemical measures. The plant material remains on the site or may be carried to compost preparation or biogas facilities.
During the growing season after the release, no sugar beets are cultivated on the experimental site. Accordingly possibly emerging beets can be identified and eliminated.
Plant material taken for analysis will be transported to the lab in sealed containers. Left over will be destroyed at the site of the lab. For further analysis non-required plant material and vegetative plant residues are left on the experimental site or will be carried to another release site for deactivation. 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 facilities. In no case crop material and plant residues from sugar beet will enter the food/feed chain.
The experimental site will be controlled regularly during the release and additionally one year after finalization of the release.
Due to the information given in the previous section and the described measures (e.g. prevention of pollen formation and flowering), a risk for human and the environment is negligible.
Emergency plans are not required because the risk of the released GM sugar beets and the seeds on human health and the environment is negligible.
No further measures as described above 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:
Field trials with H7-1 sugar beet will be carried out to generate data of the GMPt with respect to agronomic, phenotypic questions in the agricultural environment as well as regulatory data and recommendations on the weed management during the growing season in comparison with conventional sugar beet systems.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
20/04/2011 00:00:00
Remarks: