Date of publication: January 10,
2006
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification number:
B/ES/06//01
Member State: Spain
Date of Acknowledgement :28/11/2005
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).
This application under Directive 2001/18/EC, Part B is for
deliberate release of sugarbeet plants, derived from
transformation event H7-1 (which is tolerant to treatment with
glyphosate), to complete residue data after application over the
crop of glyphosate herbicide.
Proposed period of release From:01/01/2006
To:31/12/2006
Name of the Institute(s) or Company(ies): Monsanto
Europe, S.A., represented by Monsanto Agricultura España, S.L.;
3. Is the same GMPt release planned elsewhere in the
Community?
Yes: Germany; Spain; France; United Kingdom; Italy
4 - Has the same GMPt been notified elsewhere by the same
notifier?
Yes
If yes, notification number(s):
-
Other notifications
C/DE/00/08, according to EC Directive 2001/18 and UK-2004-08
according to EEC Regulation 1829/2003.
Genetically
modified plant
1. Complete name of the
recipient or parental plant(s)
|
Common Name
|
Family Name
|
Genus |
Species
|
Subspecies
|
Cultivar/breeding line
|
| beet
|
chenopodiaceae |
beta
|
beta
vulgaris |
vulgaris |
H7-1
|
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 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 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;
4. 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:
- 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: 0.672Kb. The 35 S promoter from a modified figwort
mosaic virus (FMV) used to drive expression of cp4 epsps gene.
- CTP2: 0.31Kb. The N-terminal chloroplast transit peptide
sequence from the Arabidopsis thaliana EPSPS gene.
- CP4 syn.: 1.363Kb. The 5-enolpyruvylshikimate-3-phosphate
synthase (CP4 EPSPS) gene from Agrobacterium sp. strain CP4.
- E9 3’: 0.63Kb. The 3’ end of the Pisum sativum rbcS E9 gene
which provides the polyadenylation sites for the CP4 EPSPS gene.
- Left Border: 0.025Kb. 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
PV-BVGT08 (also coded pMON17227). 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 of sugarbeet varieties derived from
transformation event H7-1 (which is tolerant to treatment with
Roundup herbicide containing glyphosate), has the aim to
complete the residue data to allow the registration of a new
glyphosate formulation.
2. Geographical location of the site:
The selected sites are located in the following localities:
- Villavendimio (Zamora).
- Tordesillas (Valladolid).
- Tercero (Valladolid).
- Villabarba (Valladolid).
- Villafranca de Duero (Valladolid).
3. Size of the site (m2):
The total surface will be lower than 500 m2 (0,05 ha) and the
potential surface occupied in every site by H7-1 sugarbeet will
be:
- Villavendimio (Zamora): 100 m2.
- Tordesillas (Valladolid): 100 m2.
- Tercero (Valladolid): 100 m2.
- Villabarba (Valladolid): 100 m2.
- Villafranca de Duero (Valladolid): 100 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 non-transgenic 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 sugar beet event H7-1 have
shown that the likelihood of potential adverse effects on human
health and the environment in the European Union, resulting from
its cultivation and use as any other sugar beet is negligible.
Therefore, the overall environmental risk posed by the proposed
field trials with event H7-1 is also negligible, and strategies
for risk management would be the same as for conventional sugar
beet.
Brief description of any measures taken for the management of
risks:
The environmental risk assessment has indicated that the
environmental risks of this sugarbeet is negligible. Therefore,
strategies for risk management for H7-1 sugarbeet would be the
same as for traditional maize.
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 Competent
Authority: Not Known |
