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Notification report


General information

Notification Number
B/CZ/11/3

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
30/11/2011

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

Proposed period of release:
10/03/2012 to 31/10/2012

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., Represented by MONSANTO CR, s.r.o.;


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

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;

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:


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 from Agrobacterium sp. strain CP4, which provides tolerance to ghyphosate herbicide. This gene has been introduced with regulatory components necessary for expression in plant cells.
Full description of the genetic elements in H7-1:
Right Border: 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: 35 S promoter from a modified Figwort Mosaic Virus (FMV)
ctp2: N-terminal chloroplast transit peptide sequence from the Arabidopsis thaliana EPSPS gene
cp4 epsps: 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) gene from Agrobacterium sp. strain CP4
E9 3’:The 3’ end of the Pisum sativum rbcS E9 gene, containing polyadenylation sites that direct mRNA processing and polyadenylation
Left Border: 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:
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 PVBVGT08. 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:
H7-1 sugar beet will be planted in field trials with the aim of assessing the selectivity and efficacy of glyphosate herbicide.

2. Geographical location of the site:
Probluz (Region Kralovehradecky)
Nechanice (Region Kralovehradecky)


3. Size of the site (m2):
Maximum of 2.000 m2 per site will be planted with H7-1 sugar beet.

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 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 trial site will be checked regularly during the period of the deliberate release to remove bolting sugar beet plants before pollen emission.
Plant material remaining after the harvest will be destroyed and will not be used for human food or animal feed. The sites will be monitored for one year after the release and any volunteer sugar beet appearing will be eliminated before flowering. During this year, sugar beet will not be grown on the former trial sites.
In case any adverse environmental effects, linked to the deliberate release of H7-1 sugar beet, 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
03/04/2012 00:00:00
Remarks: