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Notification report


General information

Notification Number
B/PT/06/03

Member State to which the notification was sent
Portugal

Date of acknowledgement from the Member State Competent Authority
24/02/2006

Title of the Project
Field trials program for the testing of genetically modified DAS-59122-7xMON-ØØ6Ø3-6 (59122xNK603) maize.

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

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Sementes de Portugal, ;


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:
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 to verify the behavior of 59122xNK603 maize under glyphosate applications.

2. Geographical location of the site:
The release is planned at the following locations in Portugal in 2006:
Freguesia de Vila Nova de Muia, Concelho de Ponte da Barca e Freguesia do Paço, Concelho de Arcos de Valdevez.


3. Size of the site (m2):
In 2006, each site could have up to 500 m² sown with the genetically modified maize subject of this notification (59122xNK603 maize). The total surface of the release (all varieties and borders included) could reach 5000 m² per site in 2006.
In the following years, there could have up to three sites of release per year, each sown with up to 500 m² of 59122xNK603 maize, 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 included in the notification.

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 400-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:
The shedding of pollen from the genetically modified plants will be controlled by maintaining a 400-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.


Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known