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Notification report


General information

Notification Number
B/IT/04/02

Member State to which the notification was sent
Italy

Date of acknowledgement from the Member State Competent Authority
03/05/2004

Title of the Project
Study of the stability of the transgene and his hereditability of genetically modified wheat under of open field conditions.

Proposed period of release:
01/11/2004 to 31/07/2005

Name of the Institute(s) or Company(ies)
Metapontum Agrobios s.c.a r.l., S.S. Jonica 106 Km. 448,2
75010 Metaponto (MT)
Italy;


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
spring wheatpoaceaetriticumtriticum aestivumBob white

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
From a genetic point of view, modifications brought to GMPt consist in the insertion within the genomic DNA of the following transgenes:
- Gene for the sub-unit Dx5B: fragment EcoRI of 8.7 Kb that contain the gene Glu-D1-1b under transcriptional control of the endogenous promoter for tissue-specific expression in wheat endosperm;
- Gene for the sub-unity Dy10A: EcoRI fragment of 6.4 Kb that contain the gene Glu-D1-2b under transcriptional control of the endogenous promoter for tissue-specific expression in wheat endosperm;
- Gene for the sub-unity Ax2: contain the gene Glu-A1-1c under transcriptional control of the endogenous promoter for tissue-specific expression in wheat endosperm


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:
Organism donor: Triticum aestivum var Bob white
The sub-unity Dx5B, Dy10A e Ax2* have been inserted at the aim to obtain an increasing level of gluteninic complex in wheat endosperm.
The ubiquitin-BAR cassette has been inserted to allow the selection of transformation events.


6. Brief description of the method used for the genetic modification:
Transformants were obtained by bombardment using particle gun

Experimental Release

1. Purpose of the release:
- Studies of stability of the transgenes;
- heredity in conditions of open field;
- evaluation of the agronomic performances of genetically transformed wheat


2. Geographical location of the site:
The trial will be located in a field property of Metapontum Agrobios s.c.a r.l, S.S. Jonica 106, Km 448.2, Metaponto (MT), ITALY

3. Size of the site (m2):
5000 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:
No previous release were carried out with this GM-plant.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No unique factor to this field test has been identified that would have an effect on any plant or animal species. In these plants, there were no intentional changes influencing their susceptibility to disease-causing organisms. Moreover there are no reasons to believe that the GMPt peculiarity affects the dissemination and the palatability of seeds to insects. Cross-pollination with wild species is not possible since, up to date, no interspecific crosses have been reported. Crosses of the transgenic pollen with wheat commercial varieties is highly unlikely since wheat show an high percentage of self-pollination (95%). Moreover transgenic plot will be surrounded by wheat and canola barriers and is fairly distant from other wheat fields.

Brief description of any measures taken for the management of risks:
The field trial will take place on one small plot on agricultural land in the Basilicata (ITALY). The site will provide adequate physical security. Site monitoring of the field trial and agronomic management practices creating controlled environment are expected to provide the necessary degree of both biological and physical containment. Pollen dispersal will be avoided by canola and wheat barriers, which surround the entire field. After sample collection and seed harvesting, the remaining plants will be removed, autoclaved and/or burned and finally disposed off. Possible plant residues left on the field will be harvested and burned on site. The test area will be marked to monitor re?emergence of volunteer wheat plants during the following seasons. The plots will not be planted the following season but will be checked several times to destroy any plant material.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The GMPt under discussion does not possess any form of resistance or tolerance to pathogens or insects, so it does not have any selective advantage respect to the control plant.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known