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Notification report


General information

Notification Number
B/IT/04/01

Member State to which the notification was sent
Italy

Date of acknowledgement from the Member State Competent Authority
08/03/2004

Title of the Project
"Safety Assessment in Food and Environment - S:A:F:E"
"Studio delle interazioni tra piante di melanzana (Solanum melongena L.) transgenica esprimente la tossina Cry3B e l'artropodofauna presente nell'agroecosistema"


Proposed period of release:
31/05/2004 to 30/10/2004

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
eggplantsolanaceaesolanumsolanum melongenalinea DH-LVBt H # 7

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Genetically modified eggplants bring the following genes into the genomic DNA which encode for proteins with different function: a Bacillus thuringensis Cry3B gene expressing a d-endotoxin, active against coleopteran; the enzyme neomycin acetyl-phosphotransferase II which confers resistance to the antibiotics neomycin and kanamycin.
Thus the GMPs display the following traits: kanamycin resistance, determined either as the ability of plants to grow on kanamycin containing medium or to detoxify the antibiotic after spraying it on leaves of young plant which do not show any chlorotic symptom; resistance to coleopteran tested through insect bioassays and field trials, due to the presence of the d-endotoxin within the tissue of the GMPs (identified by Elisa and Western blot).
GMPs do not show any other phenotypical difference compared to untransformed wild type eggplant.


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:
The inserted DNA region corresponds to the Agrobacterium plasmid pLVBtHBin T-DNA which includes two physically linked expression cassettes:
- a 3,5 Kb chimeric cassette, conferring the insect resistance phenotype, obtained by a transcriptional fusion of the 35S promoter of cauliflower mosaic virus (CaMV) which allows constitutive expression in transgenic tissues, the tobacco mosaic virus (TMV) W leader sequence, the CryH genes which codifies for a coleoptera-specific d-endotoxin from B. thuringiensis and the OCS terminator of the octopine synthetase gene of A. tumefaciens, as transcription termination signal. The CryH gene represent a synthetic gene codifying a Cry3B protein which confers resistance to Colorado Potato Beetle.
- a 1.4 Kb chimeric cassette, conferring kanamycin resistance phenotype, obtained by the insertion of the neomycin phosphotransferase (NPTII) gene, obtained from Escherichia coli. which codifies for the detoxifying enzyme, between the NOS promoter and the NOS terminator from the nopaline synthase gene of A. tumefaciens.


6. Brief description of the method used for the genetic modification:
Genetic transformation was achieved by in vitro infection of leaf, cotyledon and hypocotyl explants (Rotino & Gleddie, 1990 Plant Cell Rep 9: 26-29; Rotino et al., 1992 VIII Eucarpia Meet. "Genetics and Breeding on Capsicum and Eggplant" Roma 7-10/9/1992: 295-300) with the disarmed strain LBA4404 of Agrobacterium tumefaciens carrying the binary plasmid pLVBtHBin which harbors the chimeric T-DNA. Transgenic plants were selected on kanamycin containing medium and were analysed by molecular techniques for exogenous DNA integration.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
The GMPt of this release is not a forest tree.

Experimental Release

1. Purpose of the release:
The main objectives of this field experiment are:
- To determine the biodiversity of pollinator guilds in transgenic fields using specific sampling procedures.
- To assess the effects of the transgenic Bt-crop plants on biodiversity of non-target insects, in the field.


2. Geographical location of the site:
Farm, which belongs to Basilicata Region Local Government (Regione Basilicata) 100 meters far the "Metapontum Agrobios" Research Centre (S.S. Jonica 106, Km 448.2, Metaponto (MT), ITALY.

3. Size of the site (m2):
2200 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:
In the release area eggplant can only cross-pollinate plants of the same species. The assessment of possible effect by Cry toxins expressed in transgenic plants on non target organisms is the main objective of the present study. Cross pollination with wild species is not possible because in this environment no wild type species compatible with eggplant are present. Crosses of the transgenic pollen with eggplant commercial field will be avoided since the plot will be surrounded by maize and the experimental field is fairly distant from other eggplant fields.

Brief description of any measures taken for the management of risks:
Due to the safety measures taken, no uncontrollable spreading of GMP genetic material is expected.
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 maize, which will surround the entire field. After sample collection and fruit harvesting, the remaining plants or parts 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 eggplant 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 aim of the current notification is to study of relationships between transgenic eggplants and non-target insects in the agroecosystems.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
30/06/2004 00:00:00
Remarks:
Metapontum Agrobios LTD has been requested to develop a marker system alternative to those using resistance to antibiotics.