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Notification report


General information

Notification Number
B/ES/06/20

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/01/2006

Title of the Project
Testing of genetically modified 59122xNK603 (DAS-59122-7xMON-ØØ6Ø3-6) maize varieties in view of registration.

Proposed period of release:
01/04/2006 to 31/12/2009

Name of the Institute(s) or Company(ies)
PIONEER HI-BRED AGRO SERVICIOS SPAIN, S.L., Ctra. Sevilla-Cazalla Km. 9,4
41309-La Rinconada
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 maysmaysExperimental varieties

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified 59122xNK603 maize varieties that will be tested in these field trials are resistant to certain Coleopteran insects, such as the Western corn rootworm (Diabrotica virgifera virgifera) and tolerant to glufosinate-ammonium and glyphosate herbicides. This maize was derived through traditional breeding methods between progeny of genetically modified 59122 maize, which is resistant to certain coleopteran insects and tolerant to glufosinate herbicide, and NK603 maize (from Monsanto), 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 59122xNK603 maize are the cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis strain PS149B1, providing resistance to certain coleopteran insects and the pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate herbicide, like in 59122 maize, and the cp4epsps gene from Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 maize, along with their regulatory components necessary for expression in maize plant:
- 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.
- 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 59122xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 59122 maize and NK603 maize.
59122 maize was genetically modified using Agrobacterium transformation method. NK603 maize was genetically modified by Monsanto using the particle acceleration 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 release is the testing of genetically modified 59122xNK603 maize varieties in view of collecting regulatory data for registration on the National Catalogue of varieties.

2. Geographical location of the site:
The release is planned at the following locations in Spain in 2006:

- Andalucía: La Rinconada (Sevilla), Marchena (Sevilla).
- Aragón: Zuera (Zaragoza), Gelsa (Zaragoza), Gurrea de Gállego (Huesca).
- Castilla-León: Toro (Zamora), Llamas de la Ribera (Leon).
- Cataluña: Alguaire (Lérida).
- Castilla la Mancha: Membrilla (Ciudad Real), Tarazona de la Mancha (Albacete), Alpera (Albacete).
- Galícia: Santa Uxía de Ribeira (La Coruña).
- Madrid: San Martín de la Vega (Madrid).
- Navarra: Cortes (Navarra)


3. Size of the site (m2):
Each site in 2006 could have up to 1000m2 sown with genetically modified 59122xNK603 maize, the total area taken up by the release (all varieties and borders included) being higher.
In the following years, there could have up to 1000m² of genetically modified 59122xNK603 maize sown per site, the total trial surface at each site (all varieties and borders included) being larger.


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 were indistinguishable from the non-genetically modified maize plants except for showing resistance to certain Coleopteran insects such as the Western corn rootworm and showing tolerance when glufosinate and glyphosate herbicides have been applied, 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 genetically modified maize resistant to certain Coleopteran insects and tolerant to glufosinate and glyphosate herbicides are expected, as per information contained in the environmental risk assessment and the following concluding remarks:

- There is negligible likelihood for 59122xNK603 maize to become environmentally persistent or invasive giving rise to any weediness;
- Expression of Cry34Ab1, Cry35Ab1, PAT and CP4 EPSPS proteins in 59122xNK603 maize does not confer any selective advantage outside the agricultural environment;
- There are no wild relatives of maize in the EU and the traditional breeding that led to 59122xNK603 maize does not introduce any selective advantages to maize plants outside heavily managed agricultural environments;
- The deliberate release of 59122xNK603 maize will result in negligible immediate and/or delayed environmental impact resulting from direct and indirect interactions of 59122xNK603 maize with non-target organisms;
- The genetic modifications in 59122xNK603 maize do not introduce any new compounds known to cause, or expected to cause, any potential immediate and/or delayed effects on human health. Moreover, 59122xNK603 maize subject of the release will not enter the food chain;
- The genetic modifications in 59122xNK603 maize do not introduce any new compounds known to cause, or expected to cause, any possible immediate and/or delayed effects on animal health. Moreover, 59122xNK603 maize subject of the release will not enter the feed chain;
- The 59122xNK603 maize will not cause any possible immediate and/or delayed effects on biogeochemical processes;
-The specific cultivation, management and harvesting techniques used for the 59122xNK603 maize are identical to those used for non-genetically modified maize, with the exception of the herbicide regime and monitoring plan to be proposed for commercial cultivation of 59122xNK603 maize;
- The potential reduction of the control of certain coleopteran insect pests if the target insect pests develop resistance to the Cry34Ab1 or Cry35Ab1 proteins as expressed in 59122xNK603 maize has been identified as the only potential risk resulting from the interaction of 59122xNK603 maize with target organisms. In the case of the trials, the likelihood of the occurrence of this potential identified adverse effect is negligible. The risk posed by the target-insect resistance development is thus negligible. However, an IRM strategy will be developed in the context of product stewardship for the placing on the market of 59122xNK603 maize.


Brief description of any measures taken for the management of risks:
The shedding of pollen from the genetically modified plants will be controlled by maintaining a 200-meter isolation distance with any other non-experimental maize crop. In addition, the trial site will be surrounded by four border rows of conventional maize of a similar relative maturity that will be also destroyed at the end of the release.
Seed dispersal of individual kernels does not generally occur. They are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. 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.
In case of any emergency, the trial could be stopped by application of a non-selective herbicide, other than glufosinate and glyphosate, or by mechanical destruction, and incorporation into the soil.
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. No plant or plant product coming from the trials will enter the food or feed chains.
Volunteer maize will be monitored during the following year. An herbicide treatment (other than glufosinate and glyphosate) will be used in order to ensure destruction if needed.
There will be no commercial maize grown on the same field the following year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable to this release.

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Not known