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 genetically modified to resist lepidopters and coleopters larvae and tolerate glyphosate.

Proposed period of release:
01/04/2011 to 30/11/2011

Name of the Institute(s) or Company(ies)

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:
Introduction of resistance to lepidopters and coleopters by expression of four Bacillus thuringiensis and one Chromobacterium sp. genes specifically active against the larvae of several species. Introduction of tolerance to the glyphosate herbicide by expression of a bacterial EPSPS protein insensitive to the herbicide. This herbicide acts as an inhibitor of this protein in plants. The enzyme 5-enolpyruvyl-shikimate-3-phosphate synthetase (or EPSPS) is involved in the biosynthetic pathway of the aromatic amino-acids (tryptophan, tyrosine and phenylalanine).

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:
Ubiquitin promoter: Saccharum officinarum (non coding regulatory sequence).
Cry9E: Bacillus thuringiensis (coding sequence).
Vip3 homologous: Bacillus thuringiensis (coding sequence).
Cry1Ac: Bacillus thuringiensis (coding sequence).
Cry3Aa homologue: Bacillus thuringiensis (coding sequence).
Toxin active against coleopters: Chromobacterium sp. (coding sequence).
transit peptide: Chlamydomonas reinhardtii (coding sequence).
epsps: Arthtrobacter globiformis (coding sequence).
CaMV terminator: Cauliflower mosaic virus (non coding regulatory sequence).
RB / LB: Agrobacterium tumefaciens (non-coding sequence)

6. Brief description of the method used for the genetic modification:
Agrobacterium tumefaciens 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.

Experimental Release

1. Purpose of the release:
Evaluate the agronomic behavior (lepidopter resistance) of different transformation events expressing five bacterial insecticidal proteins active against lepidopters and coleopters and a bacterial gene conferring to maize plants a tolerance to the herbicide glyphosate. These events have been back-crossed into different experimental hybrids. The agronomic evaluation will be used to make a choice between the different events.
Collection of samples (leaves, grain) for laboratory analyses.

2. Geographical location of the site:
- Murillo el Cuende, Navarra.
- Ejea de los Caballeros, Zaragoza.

3. Size of the site (m2):
The maximum surface occupied by GM plants on each site is:
- Murillo el Cuende, Navarra 1100 m2.
- Ejea de los Caballeros, Zaragoza 1100 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 observation or data have been collected up to now leading to suppose any potential environmental and human health adverse effects. General observations were made during previous releases of the same transformation events in the USA during the years 2009 and 2010.
These plants are unlikely to pose any risk to environment and human health.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The introduced trait has no potential effects to modify the plant persistency in the environment. There are no wild relatives of corn in Europe and out-crossing is not possible. One of the introduced traits is intended to make the plants tolerant to insect larvae of lepidopters. The genes used, from B. thuringiensis are specific to different lepidopters, which are target organisms (Ostrinia and Sesamia). Two genes are specific to coleopters: one from B. thuringiensis and the second from Chromobacterium sp. Possible interactions with non-target organisms are supposed to be very limited as a result of the specificity of the proteins, the small size of the experiment and limited to insects feeding on the plant. There is no expected effect on human health and on animal health. Plants will not be used as food or feed. At the end of the experiment, plants will be destroyed by chopping and then the wastes will be buried by ploughing. Post-harvest monitoring of the field will be conducted during one year, during which possible volunteers will be destroyed before flowering.
There is no short-term possible effect on specific cultivation management and harvesting techniques.
Potential environmental impact considered minimal, given the conditions of the field trial (location, field isolation, small size of the trial, minimal contacts with fauna and flora, absence of wild relatives of maize species in the release areas...).

Brief description of any measures taken for the management of risks:
Release sites are located in intensive agriculture areas, spatially isolated from commercial maize crops.
Seeds bags, prepared in the laboratory will be opened only on the site; the surplus of seeds in the planter after sowing will be collected and destroyed. The experiment will be inspected frequently during the release period; any environmental effect will be reported. After the harvest, plants will be chopped on the field and incorporated into the soil. Ears and seeds eventually collected will be transported in sealed and labeled bags. During the following year, no commercial culture of corn will be grown on the field. Possible volunteers will be monitored and destroyed during one year following the end of experiment.

Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable. However, any unanticipated adverse effect (environment and human health) observed on the site will be reported without delay to the authorities.

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
15/04/2011 00:00:00
There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Aragón: 15/04/2011.
- Navarra: 24/06/2011.