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Notification report


General information

Notification Number
B/ES/10/39

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/01/2010

Title of the Project
Notification for the deliberate release of genetically modified DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize (4-year program 2010 to 2013).

Proposed period of release:
01/04/2010 to 31/12/2010

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:
DAS-Ø15Ø7-1xMON-ØØ6Ø3 maize, referred to as 1507xNK603 maize hereafter, is resistant to certain Lepidopteran insects, such as the European corn borer (Ostrinia nubilalis) and tolerant to glufosinate-ammonium and glyphosate herbicides. This maize was derived through traditional breeding methods between progeny of the genetically modified DAS-Ø15Ø7-1 maize (referred to as 1507 maize), which is resistant to certain lepidopteran insects and tolerant to glufosinate herbicide (trait introduced as a selectable marker), and MON-ØØ6Ø3 maize (referred to as NK603 maize), which is tolerant to glyphosate herbicide.

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 genes introduced in 1507xNK603 maize are a plant-optimized cry1F gene from the soil bacterium Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and a plant-optimized pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, like in 1507 maize, and the cp4epsps gene from the soil bacterium Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 maize, along with the regulatory components necessary to drive their expression:
- the cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.
- the cp4epsps gene, the P-ract1/ract1 intron + ctp2, the NOS 3’ terminator.
- the cp4epsps gene, the CaMV e35S promoter + Zmhsp70 + ctp2, the NOS 3’ terminator.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on the 1507xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 1507 maize and NK603 maize.
1507 maize was genetically modified using the particle acceleration method. NK603 maize was genetically modified by Monsanto Company using particle acceleration method; the genetic modification was licensed to Pioneer for use in its own germplasm.


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 release is to refine knowledge concerning the behavior in the environment and the agronomic performances of 1507xNK603 maize varieties, with and without applications of herbicides.

2. Geographical location of the site:
The release is planned at the following locations in Spain in 2010:
• Aragón: Tauste (Zaragoza), Villafranca de Ebro (Zaragoza)-(3 locations), Ejea de los Caballeros (Zaragoza), Nuez de Ebro (Zaragoza)-(2 locations).
• Cataluña: Alcarrás (Lérida).


3. Size of the site (m2):
Each site could have up to 5000 m² sown with the genetically modified 1507xNK603 maize subject of this notification, except the site in Cataluña which could have up to 9000 m² sown with the genetically modified 1507xNK603 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, South America and Europe and no environmental problems were reported for these trials. The transgenic plants behaved as non-genetically modified maize plants except for showing resistance to certain Lepidopteran insects such as Ostrinia nubilalis and showing tolerance when glufosinate and glyphosate herbicides have been applied, traits due to the genetic modifications.
1507xNK603 maize is no more regulated in the USA since 2001, in Canada since 2003, in Japan since 2002. It is widely cultivated and no adverse effects have been reported to our knowledge.


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 genetically modified 1507xNK603 maize resistant to certain Lepidopteran insects and tolerant to glufosinate and glyphosate herbicides 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, this will be done by sampling the whole ear and unused seeds will be destroyed.
If needed, the trial could be stopped by mechanical destruction or application of a herbicide other than glyphosate 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 trial 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 prior to flowering.
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:
A trial is planed to refine knowledge on the impact of the cultivation of this maize on key non-target arthropod populations.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/03/2010 00:00:00
Remarks:
There are several Autonomous Communities as competent authorities for give the consent of these field trials:
- Cataluña: 23/03/2010.
- Aragón: 26/03/2010.