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Notification report


General information

Notification Number
B/ES/04/08-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
09/01/2004

Title of the Project
Evaluation in field conditions of Fungal resistant wheat.

Proposed period of release:
01/03/2004 to 30/11/2004

Name of the Institute(s) or Company(ies)
Instituto de Agricoltura Sostenibile
Consejo Superior de Investigaciones Cientificas, ;


3. Is the same GMPt release planned elsewhere in the Community?
No

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
wheatpoaceaetriticumtriticum aestivum

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Two individual transformation events will be used in this trial: FR3173 and FR3177. They were transformed with :

- An frg gene coding for a protein capable of conferring a Fusarium fungal resistance characteristic (See Appendix 1 Confidential Business Information).

- A pmi gene, used as a marker gene for selection during the plant transformation process, which gives the plant the option to use mannose as a carbon source.

FR3173 event has only one intact copy of the frg gene.
FR3177 event has only one intact copy of the frg and pmi genes.


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:
- A frg gene coding for a protein capable of conferring a Fusarium fungal resistance characteristic (See Appendix 1 Confidential Business Information).

- A pmi gene, used as a marker gene for selection during the plant transformation process, which gives the plant the option to use mannose as a carbon source.

Mannose tolerance is conferred by the pmi gene, isolated from Escherichia coli. In plants and other organisms, mannose intervenes in the intermediary metabolism of the glycolytic pathway; it is phosphorylated into mannose-6-phosphate by a hexokinase. Naturally, the plants are not capable of using mannose-6-phosphate as a carbon source; the pmi gene codes for a protein, Phosphomannose Isomerase, which converts mannose-6-phosphate into fructose-6-phosphate, a metabolisable sugar, which enters glycolysis directly. Plants containing the PMI gene are capable of transforming mannose into fructose-6-phosphate.


6. Brief description of the method used for the genetic modification:
The transformation method applied is microprojectile-mediated direct gene transfer using a microprojectile gun for cell cultures produced from the culture of immature embryos published according to Chang et al., 1999 (Patent US 5,955,362).

After gene delivery, the cells are transferred onto the selection medium containing mannose. The presence of the fungal resistance gene (frg) is screened for in the cell clusters that develop on this medium, using PCR.


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 objective of the field release is to evaluate the performance of these plants in Spain by assessing the damage to wheat ears due to infection by Fusarium and to study the levels of the main mycotoxins in the GM wheat compared to conventional wheat.

2. Geographical location of the site:
Finca experimental "Alameda del Obispo".
Término municipal de Córdoba
Instituto de Agricultura Sostenible
Alameda del Obispo, s/n - 14004 CORDOBA


3. Size of the site (m2):
The area comprising the released GM wheat plus the non-GM wheat border rows (no less than 5 m) will be approximately 325 m2.

The GM plants will occupy 55 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:
Similar field trials have been conducted in the USA and Canada and no adverse effects to humans and the environment were observed. Also, over 20GM wheat field trials have already been conducted in Europe with no adverse effects reported.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The trial has been carefully designed to isolate the GM plants and the risk assessment conducted prior to the release indicates that the potential effects on humans and the environment will be minimal.
The likelihood of the wheat plants becoming more invasive or persistent in the environment as a result of this release can be considered negligible.
The self pollinating nature of wheat, the short pollen life, the absence of species with which hybridisation is possible at the site, the border of non modified wheat and the distance the trial will be located from other wheat and barley crops, indicates that there is very little potential for gene transfer either to the same or sexually compatible species, or from the same or other sexually compatible species to the trial plot, under the conditions of the trial. The likelihood of any selective advantage or disadvantage being conferred to these species can be considered negligible. No direct, indirect, immediate or delayed effects on non-target organisms are expected as a result of this field trial. No immediate or delayed effects on biogeochemical processes arising out of direct or indirect interactions between the modified wheat and the target Fusarium fungal pathogens are anticipated

If there were any unanticipated effects, these would be likely to be short-lived due to the small scale and transient nature of the trial. No reports of any adverse effects were received from similar field trials in the USA and Canada, where wheat plants with the same genetic modification have been released.


Brief description of any measures taken for the management of risks:
- The nearest cultivated durum wheat, rye or triticale will be no less than 10m from the proposed trial site.
- In order to minimise the limited pollen pressure exerted by the genetically modified wheat plants, a border 5m wide with conventional wheat will surround the test site. This border will be treated as if it were transgenic at the end of the trial.
- A net will cover this area to prevent birds coming into the field straight after sowing and at early ear emergence.
- The ears from genetically modified plants, as well as the ears from the conventional control plants for analysis, will be harvested manually before they reach full maturity, to avoid spontaneous hulling.
- The wheat ears remaining in the plots and the wheat grain from the conventional 5m border will be bagged and incinerated. A total vegetative control herbicide will then be applied to the trial area. Herbicide treated plant material remaining after harvest will be pulverised and incorporated into the soil.
- The following year, a crop other than a cereal, that will allow the clear identification of volunteers, will be grown and any wheat volunteers emerging will be removed and incinerated or destroyed by treatment with an appropriate herbicide.
- The trial site will be carefully monitored regularly throughout the release and for one year after trial termination. Any wheat seedlings that appear as volunteers will be easily identified and will be removed and incinerated or destroyed by treatment with an appropriate herbicide.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The trials have been designed to gain new data on the environment and human health impact of the release.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
05/03/2004 00:00:00
Remarks: