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Notification report


General information

Notification Number
B/RO/07/10

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
01/03/2007

Title of the Project
Application for the deliberate release of genetically modified DP-Ø9814Ø-6xDAS-Ø15Ø7-1xDAS-59122-7 maize

Proposed period of release:
14/04/2007 to 01/12/2010

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?
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:
DP-Ø9814Ø-6xDAS-Ø15Ø7-1xDAS-59122-7 maize, referred to as 98140x1507x59122 maize hereafter is tolerant to herbicides containing glyphosate and a range of acetolactate synthase (ALS)-inhibiting herbicides such as sulfonylureas, resistant against certain lepidopteran insect pests, such as European corn borer (Ostrinia nubilalis), and certain coleopteran insect pests, such as Western corn rootworm (Diabrotica virgifera virgifera), and tolerant to glufosinate-ammonium (trait introduced as a selectable marker).
98140x1507x59122 maize has been obtained from traditional breeding methods between progeny of genetically modified 98140 maize, 1507 maize and 59122 maize. No new genetic modification has been introduced in 98140x1507x59122 maize.


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 98140x1507x59122 maize, obtained from traditional breeding methods between progeny of genetically modified maize 98140, 1507 and 59122 maize, contains the genetic elements introduced in 98140 maize, 1507 maize and 59122 maize:
- the gat4621 gene derived from the soil bacterium Bacillus licheniformis, which confers tolerance to herbicides containing glyphosate, and the zm-hra gene, a modified maize acetolactate synthase gene which confers tolerance to a range of acetolactate synthase inhibiting herbicides, from 98140 maize,
- the cry1F gene from the soil bacterium Bacillus thuringiensis var. aizawai, providing resistance against certain Lepidopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium, from 1507 maize,
- the cry34Ab1 and cry35Ab1 genes from the soil bacterium Bacillus thuringiensis strain PS149B1, providing resistance against certain Coleopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium, from 59122 maize;
along with the necessary regulatory elements for gene expression in the maize plant. Thus:
- the gat4621 gene
- the zm-hra gene
- the cry1F gene, the UBIZM1(2) promoter, the ORF25PolyA terminator.
- the pat gene, the CaMV35S promoter, the CaMV35S terminator.
- 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.


6. Brief description of the method used for the genetic modification:
No genetic modification was made on 98140x1507x59122 maize directly: it was obtained from traditional breeding methods between progeny of the genetically modified 98140, 1507 and 59122 maize.
98140 maize and 59122 maize were genetically modified using Agrobacterium-mediated transformation method. 1507 maize was genetically modified using a 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 trialing program is to evaluate 98140x1507x59122 maize, with or without applications of glyphosate and ALS-inhibiting herbicides such as sulfonylureas.

2. Geographical location of the site:
•Testing for collecting scientific data regarding 98140x1507x59122 corn, such as, synthesis of the proteins coded by transgenes in different plant tissues (regulatory trials) is planned for 2007 in the following locations:
Universitatea de Ştiinţe Agricole şi Medicină Veterinară a Banatului Timişoara, Timişoara, jud Timiş, Lat.=48.35637N,Long.= 20.52294E
Staţiunea de cercetare şi dezvoltare Agrigolă Caracal, Caracal, Jud. Olt, Lat.=44.11755, Long.= 24.39523


3. Size of the site (m2):
Each trial site in 2007 will have up to 1000 m2 sown with 98140x1507x59122 maize 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 trial locations could be sown, each with up to 5000 m² of 98140x1507x59122 maize concerned by this application.


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:
In previous field trials, carried out at different locations across maize growing regions in North America, the transgenic plants appeared normal in all respects. They were indistinguishable from the non-genetically modified maize plants except for being tolerant to herbicides containing glyphosate, ALS-inhibiting herbicides such as sulfonylureas and glufosinate and resistant against target Lepidopteran and Coleopteran insect pests, 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 98140x1507x59122 maize, tolerant to glyphosate, a range of ALS-inhibiting herbicides such as sulfonylureas and glufosinate, and resistant against certain Lepidopteran and Coleopteran insect pests 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 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 an emergency, the trial could be destructively stopped by mechanical destruction or application of a herbicide other than glyphosate, ALS-inhibiting herbicides and glufosinate-ammonium, and incorporation into the soil by a deep ploughing.
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 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:
Not applicable to this release.

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. 10/23.04.2007