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Notification report


General information

Notification Number
B/ES/08/01

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
18/02/2008

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, including measurement of residues following glyphosate application, agronomic characterization and study of effects on non target organisms.


Proposed period of release:
01/02/2008 to 31/12/2008

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?
Not known

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
sugar beetchenopodiaceaebetabeta vulgarisvulgaris var. sacchariferaH7-1

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;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
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 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 has the purpose to complete the residue data to support approval of a glyphosate formulation, protein expression / agronomic characterization of H7-1 varieties and study of potential effects on non target organisms.

2. Geographical location of the site:
The selected sites are located in the following localities:
• Valdefuentes del Páramo (León).
• Tordesillas (Valladolid
• Pampliega (Burgos)
• Villaquirán (Burgos).
• Melgar de Fernamental (Burgos).
• San Cristóbal de la Polantera (León)
• Miranda de Ebro (Burgos).


3. Size of the site (m2):
The maximum surface occupied in each site by H7-1 sugarbeet will be:
• Valdefuentes del Páramo (León): 3.000 m2.
• Tordesillas (Valladolid): 18.000 m2.
• Pampliega (Burgos): 3.000 m2.
• Villaquirán (Burgos): 3.000 m2.
• Melgar de Fernamental (Burgos): 3.000 m2.
• San Cristóbal de la Polantera (León): 3.000 m2.
• Miranda de Ebro (Burgos) : 3.000 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 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 Member State Competent Authority:
Yes
28/03/2008 00:00:00
Remarks:
The competent authority for give the consent of these field trials is the Autonomous Community of Castilla y León.