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Notification report


General information

Notification Number
B/PT/05/02

Member State to which the notification was sent
Portugal

Date of acknowledgement from the Member State Competent Authority
17/03/2005

Title of the Project
Testing of genetically modified maize resistant to certain Lepidopteran insects and tolerant to two herbicides.

Proposed period of release:
01/04/2005 to 31/12/2008

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 maysmaysexperimental varieties

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
The genetically modified 1507xNK603 maize varieties that will be tested in these field trials are resistant to certain Lepidopteran insects, such as the European corn borer (Ostrinia nubilalis) and can tolerate the use of glufosinate-ammonium and glyphosate herbicides for the weeding of maize field. This maize was derived through traditional breeding methods between progeny of the genetically modified 1507 maize, which is resistant to certain lepidopteran 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:
1507xNK603 maize contains the following genetic elements :
- the cry1F gene from Bacillus thuringiensis var. aizawai that confers resistance to certain Lepidopteran insects, such as Ostrinia nubilalis,
- the pat gene from Streptomyces viridochromogenes that confers tolerance to glufosinate-ammonium herbicide
- the cp4epsps genes from Agrobacterium sp. strain CP4 that confer tolerance to glyphosate herbicide.
All these genes have been introduced with only their regulatory components necessary for expression.


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 and NK603 maize (from Monsanto) were genetically modified 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 evaluate the residual behavior of glufosinate and glyphosate in the genetically modified maize and collect data on agronomic transgenic maize.

2. Geographical location of the site:
In 2005, two locations of the release sites will be in Ribatejo, Vila Nova, Vilar, Cadaval (Vale Poços, Sociedade Agrícola, Lda) and Entre Douro e Minho, Vila Nova de Muia, Ponte da Barca(Campo de Padrenda).

3. Size of the site (m2):
The trial site in 2005 will have up to 300 m2 sown with the particular genetically modified plants concerned by this application, the total surface area taken up by the release (all varieties and borders included) being higher.
In the following years, up to 4 – 10 field trial sites could be sown, each with up to 2000 m² of the particular genetically modified plants concerned by this application, the total surface area taken up by the release( all varieties and borders included) being higher .


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 Lepidopteran insects such as Ostrinia nubilalis 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 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 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.
Volunteer maize will be monitored during the following year in order to ensure their destruction, if needed.
There will be no commercial maize grown in the trial site 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.

Final report
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European Commission administrative information

Consent given by the Member State Competent Authority:
Not known