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Notification report


General information

Notification Number
B/RO/08/01

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
12/02/2008

Title of the Project
Field trials with genetically modified insect resistant maize
MIR604 Maize


Proposed period of release:
01/04/2008 to 01/12/2011

Name of the Institute(s) or Company(ies)
Syngenta Agro SRL, Victoria Park
73-81 Bucureşti-Ploieşti Str.
Floor. 4, 013685
Bucharest, România
Tel: + 40 21 5281200
Fax: + 40 21 5281299;


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Spain;

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

If yes, notification number(s):
B/ES/07/33;

Other notifications
Event MIR604 has been evaluated by Syngenta in field trials in multiple locations in the North and South America and in Spain. No adverse effects on human health or the environment were reported.

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysVarious

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Event MIR604 is a genetically modified (GM) maize expressing a modified Cry3A (mCry3A) protein that confers protection against the Western Corn rootworm (WCR) (Diabrotica virgifera virgifer, LeConte), the Northern Corn rootworm (NCR) (Diabrotica longicornis barberi, Smith and Lawrence) and related Diabrotica species. It also expresses a marker gene, pmi, that encodes the enzyme phosphomannose isomerase (PMI) allowing the plants to utilise mannose as a carbon source, untransformed maize plants cannot use mannose, therefore PMI protein acts as a selectable marker when plants are grown on media containing mannose as the sole source of carbon.

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:
Event MIR604 is a genetically modified (GM) maize expressing two transgenes:

1. A modified cry3A (mcry3A) gene encoding the mCry3A protein that confers resistance to the Western Corn rootworm (CRW) (Diabrotica virgifera virgifera) and other related coleopteran pests of maize like the Northern Corn rootworm (CRW) (Diabrotica longicornis barberi, Smith and Lawrence)
2. the pmi (manA) gene from Escherichia coli, which encodes the enzyme PMI as a selectable marker. PMI allows transformed corn cells to utilize mannose as a sole carbon source, while maize cells lacking the pmi gene fail to grow.


6. Brief description of the method used for the genetic modification:
Event MIR604 was produced using immature maize embryos derived from a proprietary Zea mays line, via Agrobacterium-mediated transformation.

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 as the recipient or parental plant is not a forest tree species.

Experimental Release

1. Purpose of the release:
Field trial release of MIR604 insect resistant maize within the Romanian State Institutue for Variety Testing and Registration (ISTIS) and Agricultural Research and Development Station Lovrin (SCDA Lovrin) with the objectives of registrating MIR604 maize varieties in the Official Catalogue of agricultural plant varieties and, gathering of necessary information regarding the agronomical performances, environmental compatibility of MIR604 maize varieties under geo-climatic conditions of Romania during 2008-2011. The final objective of the field release in Romania is to assess the potential effects of event MIR604 on key non-target arthropods when cultivated under European field conditions.

Testing within the ISTIS network and SCDA Lovrin of MIR604 insect resistant maize varieties during 2008-2011 is also carried out for comparative analysis (sampling of silage, grain, fresh vegetable material and pollen) and for the study of gene expression of GM and non-GM, conventional hybrids.


2. Geographical location of the site:
In Romania, the field trial studies will be conducted at seven (7) different location sites (2008-2011).

a) within the ISTIS network of 5 (five) centres for variety testing named hereafter CTS (Official registration trials and Testing under production conditions)

b) within the Lovrin Agronomical Research and Development Station named hereafter SCDA Lovrin – Lovrin, Timis county (200 Principala Str., Lovrin) – two experimental field trial locations (Lovrin, Timis county and Petresti, Satu Mare county) – Testing under production conditions


3. Size of the site (m2):
The field trials will be carried out in Romania in seven (7) different locations between 2008-2010. The surface area planted with MIR604 genetically modified maize plants will be maximum 300 sqm/location (4 experimental field trials – 2 in ISTIS and 2 in SCDA Lovrin) for comparative analysis and gathering of agronomical data (Testing under production conditions). The field trial for assessing the potential effects of event MIR604 on key non-target arthropods when cultivated under European field conditions will not exceed 7500 sqm/location (one location – SCDA Lovrin) planted with GM plants. The field trial releases for registration of MIR604 maize varieties in the Official Catalogue of agricultural plant varieties will not exceed 100sqm/location/hybrid (5 ISTIS locations). In 2008, Syngenta will carry out field trials with only one MIR604 maize variety (NX44267DW).

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:
Event MIR604 has been evaluated by Syngenta in field trials in multiple locations in the North and South America and in Spain. No adverse effects on human health or the environment were reported.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
An Environmental Risk Assessment study has been completed and submitted with the application. In summary, no immediate or delayed adverse effects as a result of the direct and indirect interaction of the genetically modified maize with the environment when compared to the non-modified maize have been identified.

Brief description of any measures taken for the management of risks:
• The experimental field trails will be conducted in areas where maize is not cultivated for the production of seeds;
• The isolation distance to other maize fields will be no less than 200 m;
• A minimum of 4 non-GM maize (conventional) rows will surround the field trials (buffer rows) to minimize pollen dispersal and act as a pollen trap;
• The plants growing in the buffer zone will not be used for human food or animal feed;
• Sowing and harvesting will be conducted under the supervision of Syngenta personnel trained on precaution measures;
• Carrying out regular visits to inspect field trails sites, making observations and verifying that adequate measures are applied for preventing pests and diseases;
• Harvesting and destroying of plant material remaining after sampling is complete;
• No seed products resulting from the field trails will be used as food or feed;
• After harvest Syngenta personnel will supervise the incorporation of any plant remains into the soil;
• The sites will be monitored for one year after the harvest and any volunteer maize appearing will be eliminated and destroyed using conventional herbicides or by mechanical mean before flowering. During this year, maize will not be grown on the trial sites.
• The following year no commercial maize cultivation will take place on the field trail location site.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Field trial release of MIR604 insect resistant maize within the Romanian State Institutue for Variety Testing and Registration (ISTIS) and Lovrin Agricultural Research and Development Station (SCDA Lovrin) with the objectives of registering MIR604 maize varieties in the Official Catalogue of agricultural plant varieties and, gathering of necessary information regarding the agronomical performances, environmental compatibility of MIR604 maize varieties under geo-climatic conditions of Romania. The trials are also carried out for comparative analysis (sampling of silage, grain, fresh vegetable material and pollen) and for the study of gene expression of GM and non-GM, conventional hybrids. The final objective of the field release in Romania is to assess the potential effects of event MIR604 on key non-target arthropods when cultivated under European field conditions.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known