Notification report

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Field trials with genetically modified sugarbeet plants (Beta vulgaris) derived from transformation event H7-1 with tolerance to glyphosate.

Proposed period of release:
01/03/2011 to 31/12/2011

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?
Belgium; Germany; Denmark; Czech Republic; Romania;

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

If yes, notification number(s):
B/ES/00/08; B/ES/06/01; B/ES/08/01; B/ES/08/35; B/ES/09/28; B/ES/09/45; B/ES/10/01; B/ES/10/02; B/ES/10/20; B/ES/99/03;

Other notifications
H7-1 has already been notified for release in different sugar-beet cultivating areas of Europe, Russia and several growing regions of North and South America. The field trials performed in the EU, including those performed in Spain under the provided notification numbers, showed that, except for from its glyphosate-tolerance trait, H7-1 sugar beet is not different from conventional sugar beet.

H7-1 sugar beet has already been approved in the EU for import, processing and food/feed use since 2007 (Commission Decision 2007/692/EC). The authorization for cultivation of H7-1 sugar beet varieties has been requested in November 2008 under Regulation (EC) No 1829/2003 (EFSA-GMO-DE-2008-63).

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:
RR sugar beet event H7-1 contains a fully functional and intact gene encoding the CP4 EPSPS protein, which confers tolerance to glyphosate herbicide.

Genetic modification

3. Type of genetic modification:

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 sugar beet contains the gen cp4 epsps encoding the CP4 EPSPS protein, which derives from Agrobacterium sp. strain CP4. The CP4 EPSPS protein imparts sugar beet tolerance to glyphosate herbicide. Molecular analyses were performed to characterize the DNA inserted into the H7-1 sugar beet genome. These analyses demonstrated that H7-1 contains one single copy of the cp4 epsps cassette. A full description of the genetic elements used for insertion in H7-1, including the approximate size, source and function is provided as follows:

- B-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.

- TS-ctp2: 0.31Kb. The N-terminal chloroplast transit peptide sequence from the Arabidopsis thaliana EPSPS gene.

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

- T-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 sugarbeet 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, selectivity and efficacy data to support approval of a glyphosate formulation over the top of sugarbeet varieties derived from H7-1.

2. Geographical location of the site:
The selected sites are located in the following localities:
- Valdefuentes del Páramo (León)
- Laguna Dalga (Leon)
- Urdiales del Paramo (Leon)
- Tordesillas (Valladolid)
- Cabezon de Pisuerga (Valladolid)

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
- Laguna Dalga (Leon): 3.000 m2
- Urdiales del Paramo (Leon): 3.000 m2
- Tordesillas (Valladolid): 3.000 m2
- Cabezon de Pisuerga (Valladolid): 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:
H7-1 sugarbeet has been released for field-testing at several locations in the EU (Belgium, the United Kingdom, The Netherlands, France, Germany and Spain) under Directive 90/220/EEC and 2001/18/EC. Moreover, H7-1 has been assessed in field trials in other geographies and it is authorized for cultivation in the US and Canada since 2005, as well as in Japan since 2007.

The results of the release in these countries and the long experience of cultivation and commercialization in these countries showed that H7 1 sugar beet is substantially equivalent to conventional sugarbeet, except for its tolerance to glyphosate herbicide. There are no evidences that H7 1 sugar beet is likely to cause any adverse effects to human or animal health and the environment.

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, resulting from its cultivation and use as any other sugar beet is negligible, given that:

- 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.

- Outcrossing 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 seed dissemination during transportation to the release sites and to avoid hybridization with bolting sugar beet plants (see Point E).

- Based on the well-characterized mode of action of the EPSPS enzymes and the safety history against non target organism, which have co-evolved in a close interaction with a wide spectrum of green plants and microorganisms, 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 has indicated that the environmental risk of this sugarbeet is negligible. Therefore, strategies for risk management for H7-1 sugarbeet would be the same as for conventional sugarbeet.

Seeds will be transported in sealed and labeled bags. Any material manipulation necessary to perform the trial will be done by trained and qualified personnel who will be informed of any precautionary measure to be considered to avoid material dissemination. The equipments will be cleaned on the experimental site, thus preventing seed dissemination.

It is not necessary to set any spatial isolation distance from conventional sugarbeet crops since the scheduled observations and/or assessments will be done during the first year of the release and on the vegetative parts of the sugarbeet plant. However, the trial site will be checked regularly during the period of the deliberate release, to destroy bolting sugarbeet plants before pollen emission, if any.

The vegetable material coming from the trial site will be employed exclusively for the uses of the planned research specified in this notification and will be destroyed afterwards in the same site, into non-viable fractions. If samples have to be taken for extra analyses, this will be done by qualified personnel, following traceability and a under a complete custody chain, to avoid any portion of H7-1 sugar beets to reach the food/feed chain.

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:
17/03/2011 00:00:00
The competent authority for give the consent of these field trials is the Autonomous Community of Castilla y León.