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Notification report


General information

Notification Number
B/RO/07/06

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 DAS-59122-7 maize

Proposed period of release:
01/04/1900 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 hybrids

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 DAS-59122-7 maize (referred to as 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.

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.


6. Brief description of the method used for the genetic modification:
59122 maize was genetically modified using Agrobacterium transformation 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 collect additional data on 59122 maize, such as the protein expression in various maize tissues, as well as data necessary for the registration of 59122 maize varieties 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 59122 hybrids will be tested for collecting the necessary data for registration of 59122 corn hybrids:
CTS Tecuci,Tecuci, Jud. Galaţi, Lat.= 45.80993, Long.=27.40142
CTS Mircea Vodă Com. Mircea Vodă, Jud. Brăila,Lat.=45.10785, Long.=24.40990
CTS Dâlga,Comuna Dor Mărunt, Jud. Călăraşi, Lat.=44.42489, Long.=27.03711
CTS Râmnicu Sărat, Jud. Buzău, Lat.=45.39225, Long.=27.06995
CTS Troianu, Com. Troianu, Jud. Teleorman, Lat.=44.00437,Long.=25.02520
• Testing for collecting scientific data regarding 59122 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):
• Official network of State Institute for Variety Testing and Registaration (ISTIS) where 59122 hybrids will be tested for collecting the necessary data for registration of 59122 corn hybrids in National Catalog - In 2007, the hybrid of genetically modified corn 59122, 38B83 (sinonime PR38B83, X5P385Z) 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.
• Testing for collecting scientific data regarding 59122 corn, such as, synthesis of the proteins coded by transgenes in different plant tissues (regulatory trials) is planned for 2007 - In 2007 genetically modified corn 59122 will be tested in plots of 2 center rows (sided by 2 lateral rows with non-modified, conventional corn), 0.7 m apart, containing maximum 60 plants (plot area maximum 12 m2) in 1-4 repplications, summing an area of maximum 48 m2/hybrid/location. It is very probable that in the next years, genetically modified corn, subject of this application, would be planted in other locations and on larger plots accordingly to the type of data planned to be collected.


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:
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.
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.


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.

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.
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, it will be done by sampling the whole ear and unused seeds will be destroyed.
In case of an emergency, the trial could be stopped by mechanical destruction or application of a herbicide other than 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. 6/23.04.2007