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Notification report


General information

Notification Number
B/SK/08/04

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
13/02/2008

Title of the Project
Evaluation of economic parameters of biotech maize DAS-59122-7 (referred as 59122) and MON-ØØ6Ø3-6 (NK603)

Proposed period of release:
15/04/2008 to 31/12/2010

Name of the Institute(s) or Company(ies)
Slovak Center of Agricultural Research, Research Institute of Plant Production;


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 maysmays59122 and NK603

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
New genes were introduced into the genetically modified 59122 maize so that it can fight against the damages caused by certain Coleopteran insect pests, such as Western corn rootworm (Diabrotica virgifera virgifera). Tolerance to glufosinate-ammonium herbicide has been introduced as a selectable marker for the screening process.
Maize NK603 has been genetically modified to tolerate application of glyphosate herbicide, which allows the farmers to use a broad-spectrum, non-selective, systemic herbicide for the weeding of the maize fields.


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 59122 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, 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.
NK603 maize, from Monsanto, has been genetically modified by the introduction of cp4epsps genes, from Agrobacterium sp. strain CP4, that confer tolerance to glyphosate herbicide, along with their regulatory components necessary for expression in maize plant:
- 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:
The genetically modified 59122 maize was obtained through Agrobacterium-mediated transformation method.
The genetic modification of NK603 was done using particle acceleration method by Monsanto. Subsequently, maize plants tested in the trials have been obtained by traditional breeding.


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 collect agronomic data on 59122 and NK603 maize varieties.

2. Geographical location of the site:
Locations Borovce, Špačince, Milhostov, and Sokolce (Slovak Republic).

3. Size of the site (m2):
Field trial site will have in summary up to 20000 m2 (maximum), i.e. up to 5000 m2 (Borovce) + up to 5000 m2 (Špačince) + up to 5000 m2 (Milhostov) + up to 5000 m2 (Sokolce), including borders.

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:
59122 maize has been approved for commercial cultivation in the USA and Canada in 2005, Japan in 2006 and is widely cultivated since that dates. No adverse effects have been reported. Many field trials have already been conducted at several locations since 2001 and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize. They 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 was applied, traits due to the genetic modification.
NK603 maize is no more regulated in the USA since 2000, in Canada and Japan since 2001, in South Africa and Bulgaria since 2002, in Argentina since 2004, in the Philippines since 2005 and is widely cultivated since that dates. No adverse effects have been reported. They were indistinguishable from the non-genetically modified maize plants, except for showing herbicide tolerance when glyphosate was applied, trait due to the genetic modification.


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 herbicide are expected, as per information contained in the environmental risk assessment included in the notification.
No risks to human and animal health or to the environment from the deliberate release of genetically modified maize tolerant to glyphosate are expected, as per information contained in the summary of the application EFSA-GMO-NL-2005-22.


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. In addition, the trial site will be surrounded by four border rows of conventional maize of a similar maturity that 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. If a few seeds need to be collected, 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 glufosinate-ammonium (59122) and glyphosate (NK603), and incorporation into the soil by a deep ploughing.
At the end of the release, all remaining plant matter 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
30/04/2008 00:00:00
Remarks:
Geographical location of the release site
Locations Borovce, Milhostov, and Sokolce (Slovak Republic).

Size of the site (m2)
Field trial site will have up to 1200 m2 (Borovce) + up to 1200 m2 (Milhostov) + up to 1200m2 (Sokolce