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Notification report


General information

Notification Number
B/RO/11/02


This notification has been withdrawn by the notifier
26/04/2012


Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
19/01/2011

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

Proposed period of release:
01/04/2011 to 31/12/2015

Name of the Institute(s) or Company(ies)
Monsanto Europe, S.A., Represented by Monsanto Romania SRL, address: Bucharest North-street, no 10, Global City Business Park, Building O21, Floor 5, Voluntari, Ilfov County, Zip code 77190; Phone: 004 021 305 71 40; Fax: 004 021 305 71 65.;


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

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

If yes, notification number(s):
B/BE/00/VSP2; B/BE/95/WSP4; B/DE/07/192; B/DE/99/94; B/ES/00/08; B/ES/06/01; B/ES/08/01; B/ES/10/01; B/ES/99/03; B/FR/00/07/01; B/FR/97/10/11; B/FR/99/01/07; B/FR/99/11/02; B/GB/96/R22/7; B/GB/98/R22/11; B/IT/97/18; B/IT/99/03; B/IT/99/27; B/IT/99/36; B/NL/96/22; B/NL/96/22-EXT1;

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Sugar beet event 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:
Genetic Elements. Size (Kb).Function.

- Right Border: 0.025 Kb.A 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: 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. Sequences encoding the chloroplast transit peptide from the ShkG gene of Arabidopsis thaliana encoding EPSPS

- cp4 epsps 1.363 Kb. The 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) gene from Agrobacterium sp. strain CP4.

- E9 3’: 0.63 Kb. The 3' nontranslated sequence from the ribulose-1,5-bisphosphate carboxylase small subunit (rbcs2) E9 gene of pea (Pisum sativum) .

- Left Border: 0.025 Kb. 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.

-ori-V: 0.393 Kb.Origin of replication from the broad host range plasmid RK2 for plasmid maintenance in Agrobacterium.

-ori-322 :0.629Kb. Origin of replication from pBR322 for plasmid maintenance in E. coli

- rop :0.191Kb. A segment of plasmid pBR322 that represses the formation of RNA primer critical to maintenance of the plasmid in bacterial hosts such as E. coli

- aadA : Kb. Bacterial gene encoding an aminoglycoside-modifying enzyme, 3' (9)-O-nucleotidyl-transferase from the transposon Tn7


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:
The purpose of the release is to evaluate the efficacy and selectivity , including prelevation of samples, of different formulations based on glyphosate in order to register their use in Roundup Ready sugar beet crops.

2. Geographical location of the site:
The selected sites are located in the following localities:
Mărculeşti - Călăraşi County
Hărman - Brasov County


3. Size of the site (m2):
Mărculeşti - Călăraşi County, 3500 m2
Hărman - Brasov County, 3500 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:
The 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-testing 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.
• Out crossing 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 in Annex II indicates that the environmental risks of this sugar beet are negligible. Therefore, strategies for risk management for H7-1 would be the same as for conventional sugar beet.
However, in addition to the scheduled observations of agronomic parameters that form the basis of the planned research, the trial site will be monitored during the period of the deliberate release and one year after for any direct or indirect potential damaging effect on the environment. This will be done by visual inspection of the status of the H7-1 crop and that of its receiving environment.
In case any adverse environmental effects, resulting from the deliberate release of H7-1 are observed during the period of release, these will be reported immediately to the Competent Authority.
At the end of the field-testing campaign, a report 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.
The trials will be located at minimum 1000 m from conventional sugar beet crops and they will be surrounded by a buffer area by 4 -6 rows of conventional sugar beet.
All sugar beet related plant material harvested from the trials which are not required for further analysis will be left and destroyed on the experimental site. Samples taken from the trials and shipped to labs for analysis will be destroyed in the lab after analysis
One year monitoring program to prevent Occurrence of volunteer sugar beets will be implemented. Observation frequency: at least once every two months in the vegetation period of the year following the trial implementation in order to track and destroy and volunteer sugar beet.
In any case, no sugar beet will be grown on the trial sites the year after field trial implementation.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Does not apply for this deliberate release. 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