General informationNotification NumberB/RO/07/07Member State to which the notification was sentRomaniaDate of acknowledgement from the Member State Competent Authority01/03/2007Title of the ProjectApplication for the deliberate release of genetically modified DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maizeProposed period of release:10/04/2007 to 01/12/2010Name of the Institute(s) or Company(ies)Pioneer Hi-Bred Seeds Agro SRL, Departamentul de cercetare
DN 2, km. 19,7
3. Is the same GMPt release planned elsewhere in the Community?NoHas the same GMPt been notified elsewhere by the same notifier?NoGenetically modified plantComplete name of the recipient or parental plant(s)
2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:DAS-59122-7xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize, referred to as 59122x1507xNK603 maize hereafter, is resistant to certain Coleopteran insects, such as Western corn rootworm (Diabrotica virgifera virgifera), and certain Lepidopteran insects, such as 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 DAS-59122-7 maize (referred to as 59122 maize), DAS-Ø15Ø7-1 maize (referred to as 1507 maize) and MON-ØØ6Ø3-6 maize (referred to as NK603 maize) (from Monsanto).Genetic modification3. 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 59122x1507xNK603 maize are the cry34Ab1 and cry35Ab1 genes from the soil bacterium Bacillus thuringiensis strain PS149B1, providing resistance to certain Coleopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate herbicide, like in 59122 maize, the cry1F gene from the soil bacterium Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate-ammonium herbicide, like in 1507 maize, and the cp4epsps gene from the soil bacterium 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:
|Common Name||Family Name||Genus||Species||Subspecies||Cultivar/breeding line|
|maize||poaceae||zea||zea mays||mays||experimental varieties|
- 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 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 59122x1507xNK603 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified 59122, 1507 and NK603 maize.
59122 maize was genetically modified using Agrobacterium transformation method. 1507 maize was genetically modified using a particle acceleration method. NK603 maize was genetically modified by Monsanto 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 Release1. Purpose of the release:The purpose of the release is to collect data necessary for the registration of 59122x1507xNK603 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 59122x1507xNK603 hybrids will be tested for collecting the necessary data for registration of 59122x1507xNK603 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.=25.025203. Size of the site (m2):In 2007, the hybrids of genetically modified corn 59122x1507xNK603: 37F76 (sinonims PR37F76, X6N612TZ), 37Y14 (sinonimsPR3Y14, X6P820TZ) şi 38B87 (sinonims PR38B87, X6P817TZ), 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 Coleopteran insects, such as Western corn rootworm, and certain Lepidopteran insects such as European corn borer and showing tolerance when glufosinate and glyphosate herbicides were applied, traits due to the genetic modifications.
59122x1507xNK603 maize is no more regulated in the USA since 2005, in Japan since 2006, and is widely cultivated since that dates. No adverse effects have been reported.Environmental Impact and Risk ManagementSummary 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 59122x1507xNK603 maize resistant to certain Coleopteran and 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 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, this 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 glyphosate 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 trial 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 reportEuropean Commission administrative informationConsent given by the Member State Competent Authority:Yes23/04/2007 00:00:00Remarks:It also includes the import permit no. 7/23.04.2007