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Notification report


General information

Notification Number
B/ES/12/03

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
26/10/2011

Title of the Project
“Field evaluation of sugar beet (Beta vulgaris) hybrids derived from transformation event H7-1 tolerant to the herbicide glyphosate.”

This application under Directive 2001/18/EC, Part B is for the deliberate release of sugar beet plants derived from the sugar beet transformation event H7-1, for trials in Spain.


Proposed period of release:
01/03/2012 to 15/12/2012

Name of the Institute(s) or Company(ies)
SESVANDERHAVE N.V., Represented by S.A.MARISA;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Czech Republic; Slovak Republic;

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

If yes, notification number(s):
B/CZ/10/2; B/ES/09/28; B/ES/10/02; B/ES/11/15; B/SK/10/01;

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 Roundup Ready 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 Roundup Ready® 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:
The genetic elements intended for insertion in H7-1 sugarbeet were as follows:

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 conducted 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:
These release trials aim at generating yield and observation data on H7-1 derived hybrids of sugar beets for the official registration of commercial varieties; needed by the law 3/2000, of January 7 , of the juridical regime for the protection of the vegetable obtaining, and the law 11/1971, of seeds and plants.

2. Geographical location of the site:
- Dueñas (Palencia).
- Bercero (Valladolid).
- Tordesillas (Valladolid).
- Villalazán (Zamora).
- Laguna de Negrillos (León).


3. Size of the site (m2):
The maximum surface occupied in each site by the H7-1 sugar beet plots and the control plots will be in total: 1000 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:
SESVANDRHAVE as other companies involved in the the sector, has carried out in the previous years, releases with the same genetically modified plant.
Both the field data and the analysis of the characteristics of the sugar beet event H7-1 in many trials in many regions 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 with 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 will be the same as for any conventional sugar beet.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No change in dormancy or any other characteristics other than glyphosate tolerance trait could be observed in the used seed lots when comparing H7-1 and commonly used, diploid, multigerm or monogerm sugar beet breeding lines.

It can be concluded that there are no meaningful differences between H7-1 derived sugar beet and their non-transgenic counterparts in regards to survivability or any other trait that is observed in sugar beet breeding.


Brief description of any measures taken for the management of risks:
“SESVANDERHAVE Work instructions”. Ensure an appropriate labeling transport and packing of the genetically modified material.

“SESVANDERHAVE Stewardship Plan” of this release, it describes how the essays will be managed, with the maximum safety.

“SESVANDERHAVE Incident Management Plan”, describes how will be handled any involuntary event.

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 for isolation distances.

In case any adverse environmental effects, linked to the deliberate release of H7-1 sugarbeet, would be 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 the trial monitoring will be made by the notifier to the Competent Authorities. This report will detail any particular observation or unexpected adverse environmental effects that would have been observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.

A post-harvest monitoring will be done, during two year after.


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
23/12/2011 00:00:00
Remarks: