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Notification report


General information

Notification Number
B/DK/11/01

Member State to which the notification was sent
Denmark

Date of acknowledgement from the Member State Competent Authority
01/02/2011

Title of the Project
Comparision of the herebicide effect and the selectivity of different Glyphosate formulation in the Glyphosate tolerant H7-1 sugar beet.

Proposed period of release:
01/05/2011 to 01/12/2015

Name of the Institute(s) or Company(ies)
Monsanto Company, Represented by Monsanto Crop Sciences Danmark A/S;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Denmark; Spain; United Kingdom; Czech Republic; Romania;

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

If yes, notification number(s):
B/DE/10/211; B/ES/11/04; B/RO/11/02;

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 inserted in H7-1

Genetic elements Size (kb) Function

Right border 0.025 A 21-25 bp nucleotide
sequencethat 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 from
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


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:
To compare the herbicide effect and the selectivity of different Glyphosate formulations in the Glyphosate tolerant sugar beets.

2. Geographical location of the site:
The release site is located in West Zealand

3. Size of the site (m2):
Up to 2 ha (20.000 m²) per year

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. 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:
The environmental risk assessment has indicated that the environmental risks of these sugar beets are negligible. Therefore, strategies for risk management for H7-1 sugar beets would be the same as for traditional sugar beets. However, special attention will be paid to following to points: 1) all sugar beet bolters have to be pulled up before flowering and left on the ground at the site, and 2) in order to avoid re-germination from the crowns (the top part of the tubes), it is important that the plant material is left on the soil surface for decomposition; the tubes and the crowns will not survive the winter. In the highly unlikely case of volunteer sugar beet plants surviving the winter, a suitable mechanical or selective herbicide treatment will be applied in the following crop for controlling eventual volunteers. In addition to the scheduled observations of agronomic parameters that form the basis of the planned research, the trial site will be checked regularly during the period of the deliberate release for potentially occurring, direct or indirect, adverse effects. This will be done by visual inspection of the status of the H7-1 sugar beet crop and that of its receiving environment. In case any adverse environmental effects, linked to the deliberate release of H7-1 sugar beets, are observed during the period of release, these will be reported immediately to the competent authorithy. At the end of the field-testing campaign, a report of will be made available by the notifier to the competent authority. 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. However, any unanticipated adverse effects on human health or the environment would be reported immediately to the competent authority.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known