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 trial of maize Bt11 x MIR604 x GA21 under AMIGA Project: Assessing and Monitoring Impacts of Genetically modified plants on Agro-ecosystems (AMIGA 289706 SPI cooperation).

Proposed period of release:
01/04/2013 to 30/11/2014

Name of the Institute(s) or Company(ies)
Instituto Nacional de Investigación y Tecnología Agraria y Alimentaria (INIA), ;

3. Is the same GMPt release planned elsewhere in the Community?

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

Genetically modified plant

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

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Maize Bt11 x MIR604 x GA21 was generated by crossing the maize lines MIR604 and Bt11, resistant to insects, and the line GA21 tolerant to glyphosate.

The Bt11 line carries the gene cry1A (b) from Bacillus thuringiensis kurstaki and protects the plant against Ostrinia nubilalis. It also carries the gene pat which encodes for the PAT protein (Phosphinothricin-acetyl transferase) that confers tolerance to glufosinate used only as a marker.

The MIR604 line carries the gene cry3A from Bacillus thuringiensis ssp. kumamotoensis and protects the plant against Diabrotica virgifera virgifera and Diabrotica longicornis barberi well as against other coleopteran species.

The GA21 line carries the gene mepsps from Zea mays encoding for a modified EPSPS (5- enolpyruvylshikimate-3-phosphate synthase) protein which is not inhibited by the herbicide glyphosate.

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:
The Bt11 x MIR604 x GA21 maize described in this application was generated by crossing the lines MIR604 and Bt11 resistant to insects, and line GA21 tolerant to herbicides by conventional breeding techniques. In the production of the resulting line not genetic modification was performed. The size, source and functions of elements inserted in the Bt11, MIR604 and GA21 events are described below:

The origin, function and size expected for each of the elements chosen for Bt11 insertion are:
- 35S1 promoter of the 35S gene of the cauliflower mosaic virus for high constitutive expression in plant tissues.
- IVS6 intron of the alcohol dehydrogenase 1S maize gene. Regulatory sequence that increases expression of the gene cryIAb in plants.
- Btk gene from Bacillus thuringiensis subsp. kurstaki HD-1 line. Encodes a truncated version of the cryIAb gene that confers tolerance certain species of Lepidoptera.
- NOS Terminator 3'nopaline synthase gene of Agrobacterium tumefaciens. Contains the termination signal of transcription and directs polyadenylation.

The origin, function and size expected for each of the elements chosen for insertion in maize MIR604 are:
- MTL promoter derived from the metallothionein-like gene of Zea mays, confers preferential expression in Zea mays root.
- mcry3A encodes a modified cry3A gene of Bacillus thuringiensis subsp. kurstaki conferring tolerance to some species of coleoptera.
- NOS terminator sequence of the nopaline synthase gene of A. tumefaciens. Its function is to provide the termination site.
- ZmUbiInt. Region of the Zea polyubiquitin gene promoter containing the first intron. Provides constitutive expression in monocots.
- pmi E. coli pmi gene which encodes the enzyme phosphomannose isomerase (PMI). Catalyzes the isomerization of mannose-6-phosphate to fructose-6-phosphate.
- NOS terminator sequence of the nopaline synthase gene of A. tumefaciens. Its function is to provide the termination site.

The origin and function expected for each of the elements chosen for GA21 insertion are:
- Promoter and intron of the rice actin provides constitutive gene expression of mepsps maize.
- Optimized transit peptide of sunflower and corn. Directs the modified protein 5-enolpyruvylshikimate-3-phosphatase synthase (mEPSPS) in the chloroplast.
- Mutant epsps maize gene. Sequence encoding modified EPSPS protein (mEPSPS) of Zea mays, which confers glyphosate tolerance.
- nos 3 ' Agrobacterium tumefaciens. Terminates transcription and directs polyadenylation of mRNA.

6. Brief description of the method used for the genetic modification:
The maize Bt11 x MIR604 x GA21 described in this application is generated by conventional breeding of MIR604 and Bt11 maize lines resistant to insects and line GA21 herbicide tolerant. In the resulting line there is no additional genetic modification.

Experimental Release

1. Purpose of the release:
This trial aims to study the agricultural and environmental effects of Bt and glyphosate-tolerant maize and the effect that may have on the agroecosystem, especially on weeds and arthropods, related to different management control done for weed control. It will evaluate the effect of different managements on the abundance and diversity of weeds and arthropods in a context of integrated control. This trial for which permission is requested for the release into the environment of Bt11 x MIR604 x GA21 maize is part of the research project "Assessing and Monitoring Impacts of Genetically modified plants on Agro-ecosystems" (289706 AMIGA cooperation SPI).

2. Geographical location of the site:
Municipality of Alcala de Henares. Madrid

3. Size of the site (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:
The letter of access provided by the producer will allow the National Biosafety Commission access this information.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The maize used is resistant to insects and tolerant to glyphosate. It is difficult for maize to survive, reproduce and maintain out of agricultural areas. In addition, in our growing area, maize has not species close enough to produce hybrids.

Brief description of any measures taken for the management of risks:
The trial will be sown in an experimental farm, fenced and not freely accessed. Trial will be located at a distance of at least 200 m from any other maize field and will be surrounded by 4 to 8 no genetically modified maize. There will be regular monitoring inspections. If any anomalies were detected they will be communicated to the competent authorities and according to them the measures deemed necessary will be taken. The plant material will not enter the food chain in any case. All plant material will be destroyed by shredding and buried at the site of release. After the end of the trial, no maize will be sow in the following season and whole plot will be monitored monthly to detect potential volunteers. Volunteers will be hand pulled and destroyed.

The measures to be taken during the transport of maize will be: the material shall be properly labeled as GMO and with the name of the variety. Each different seeds will and separated from any other materials. A double packaging in two resistant containers both fully closed will be used for transport.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
17/05/2013 00:00:00