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Notification report


General information

Notification Number
B/ES/09/55-CON

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
16/02/2009

Title of the Project
Notification for the deliberate release of genetically modified DP-Ø9814Ø-6xDAS-59122-7 maize (4-year program: 2009 to 2012).

Proposed period of release:
01/04/2009 to 31/12/2009

Name of the Institute(s) or Company(ies)
PIONEER HI-BRED AGRO SERVICIOS SPAIN S.L., Avenida Reino Unido, s/n
Edificios ADYTEC – Euroficinas, 2nda planta
41012 Sevilla;


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
maizepoaceaezeazea maysmays

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
DP-Ø9814Ø-6xDAS-59122-7 maize, referred to as 98140x59122 maize hereafter, is tolerant to herbicides containing glyphosate and a range of acetolactate synthase (ALS)-inhibiting herbicides such as sulfonylureas, resistant against certain coleopteran insect pests, such as Western corn rootworm (Diabrotica virgifera virgifera), and tolerant to glufosinate-ammonium (trait introduced as a selectable marker).
98140x59122 maize has been obtained from traditional breeding methods between progeny of genetically modified 98140 maize and 59122 maize. No genetic modification other than those of these maize has been introduced in 98140x59122 maize.


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 98140x59122 maize, obtained from traditional breeding methods between progeny of genetically modified 98140 and 59122 maize, contains the genetic elements introduced in 98140 maize and 59122 maize:
- the gat4621 gene derived from the soil bacterium Bacillus licheniformis, which confers tolerance to herbicides containing glyphosate, and the zm-hra gene, a modified maize acetolactate synthase gene which confers tolerance to a range of acetolactate synthase inhibiting herbicides, from 98140 maize,
- the cry34Ab1 and cry35Ab1 genes from the soil bacterium Bacillus thuringiensis strain PS149B1, providing resistance against certain Coleopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium, from 59122 maize;
along with the necessary regulatory elements for gene expression in the maize plant. Thus:
- the gat4621 gene [control sequences are provided in Annex 1 as confidential]
- the zm-hra gene [control sequences are provided in Annex 1 as confidential]
- the cry34Ab1 gene, the UBIZM1(2) promoter, the PINII terminator.
- the cry35Ab1 gene, the Peroxidase promoter, the PINII terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on 98140x59122 maize directly: it was obtained from traditional breeding methods between progeny of the genetically modified 98140 and 59122 maize.
98140 maize and 59122 maize were genetically modified using Agrobacterium-mediated transformation method.


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:
The purpose of the trialing program is to evaluate 98140x59122 maize with and without applications of herbicides (glyphosate, ALS-inhibiting herbicides such as sulfonylureas, glufosinate).

2. Geographical location of the site:
The release is planned at the following locations in Spain in 2009:
- Aragón: Gurrea de Gállego (Huesca), Sariñena (Huesca), Tauste (Zaragoza), Villafranca de Ebro (Zaragoza), Castiliscar (Zaragoza), Nuez de Ebro (Zaragoza) (2 sites), Ejea de los Caballeros (Zaragoza).
- Castilla-La Mancha: La Gineta (Albacete), Alpera (Albacete) (2 sites), Tarazona de la Mancha (2 sites).
- Cataluña: Juneda (Lleida), Alcarrás (Lleida).
- Madrid: San Martín de la Vega (Madrid).
- Navarra: Mélida (Navarra).
- La Rioja: Calahorra (La Rioja).


3. Size of the site (m2):
Each site could have up to 1000 m² sown with the genetically modified 98140x59122 maize subject of this notification.

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:
Field trials have already been conducted at several locations across maize growing regions in North America and South America, and no environmental problems were reported for these trials. The transgenic plants appeared normal in all respects. They were indistinguishable from the non-genetically modified maize plants except for being tolerant to herbicides containing glyphosate, ALS-inhibiting herbicides such as sulfonylureas, and glufosinate, and resistant against target coleopteran insect pests, traits due to the genetic modifications.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
No risks to human and animal health or the environment from the deliberate release of 98140x59122 maize, tolerant to glyphosate, a range of ALS-inhibiting herbicides such as sulfonylureas, and glufosinate, and resistant against certain coleopteran insect pests are expected, as per information contained in the environmental risk assessment included in the notification.

Brief description of any measures taken for the management of risks:
The pollen shed from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any other commercial maize crop. As it is done for any trial with conventional maize, the trial site will be surrounded by agronomic border rows of conventional maize of a similar maturity. The agronomic border rows will be also destroyed at the end of the release.
Grains are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. Thus seed dispersal of individual kernels is not likely to occur. When a few seeds need to be collected for analysis, it will be done by sampling the whole ear and unused seeds will be destroyed.
If needed, the trial could be destructively stopped by mechanical destruction or application of a herbicide other than glyphosate, ALS-inhibiting herbicides and glufosinate-ammonium, and incorporation into the soil by a deep ploughing.
At the end of the release, all remaining plant matter that has not been harvested for analyses will be destroyed by chopping and incorporating into the soil by a deep ploughing. No plant or plant product coming from the trials will enter the food or feed chains.
After the release, the plot will be visited regularly during the following year in order to ensure removal of maize volunteers, if any. Although volunteer maize cannot generally survive hard winter, maize volunteers, if any, will be monitored in order to ensure their destruction.
No commercial maize crop will be planted on the same plot the following year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The purpose of the planned field trials is to collect specific data on the genetically modified maize in the environment; the field trials are not designed to collect specific data linked with environmental impact studies.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/03/2009 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:

- Castilla- La Mancha: 25/03/2009.
- Aragón: 31/03/2009.
- La Rioja: 20/04/2009.
- Cataluña: 29/05/2009.
- Navarra: 11/06/2009.
- Madrid: Withdrawn by the notifier.