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Notification report


General information

Notification Number
B/RO/07/12

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
08/03/2007

Title of the Project
Testing of 1507xNK603 (DAS-Ø15Ø7-1xMON-ØØ6Ø3-6) maize. Request of the revision of the consent for deliberate releasing into environment for testing of genetically modified plant of corn (Zea mays -1507xNK603), nr 11 din 26 April 2006 – by the Romanian Ministry of Environment and Water Management

Proposed period of release:
15/04/2007 to 01/12/2009

Name of the Institute(s) or Company(ies)
Pioneer Hi-Bred Seeds Agro SRL, Departamentul de cercetare
DN 2, km. 19,7
OP Afumaţi
Cod 077010
Jud. Ilfov
România;


3. Is the same GMPt release planned elsewhere in the Community?
Not known

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 hybrids

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 tolerant to glufosinate-ammonium and glyphosate herbicides. 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:
The genes introduced in 1507xNK603 maize are the cry1F gene from Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, like in 1507 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 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 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 this release is to collect data necessary for the registration of new 1507xNK603 maize hybrids on the National list of Romania.

2. Geographical location of the site:
Delibetrate release into the environment is planned for 2007 in the following locations:
•The official network of State Institute for Variety Testing and Registaration (ISTIS) where 1507xNK603 hybrids will be tested for collecting the necessary data for registration:
CTS Tecuci, Galaţi county, Lat.= 45.80993, Long.=27.40142
CTS Mircea Vodă, Brăila county, Lat.=45.10785, Long.=24.40990
CTS Dâlga, Dor Mărunt, Călăraşi county, Lat.=44.42489, Long.=27.03711
CTS Râmnicu Sărat, Buzău county, Lat.=45.39225, Long.=27.06995
CTS Troianu, Teleorman county, Lat.=44.00437, Long.=25.02520


3. Size of the site (m2):
In 2007, the hybrids of genetically modified corn1507xNK603 will be tested in each of the five testing locations in plots of 4 rows, 70 cm apart, containing maximum 100 plants (plot area 18-20 m2 accordingly to the plant populations) in 5 replications, summing an area of maximum 100 m2/hybrid/location. It is very probable that in the next years, genetically modified corn, subject of this application, would be planted in the same locations and on the same areas like in 2007.

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 notification ESFA GMO Nr UK-2004-17.

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 in order to ensure their destruction, if needed.
No commercial maize will be cultivated 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


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
23/04/2007 00:00:00
Remarks:
It also includes the import permit no. 12/23.04.2007