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Notification report


General information

Notification Number
B/RO/11/05

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
06/05/2011

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of of genetically modified DAS-59122-7x DAS-Ø15Ø7-1xMON-ØØ6Ø3-6 maize for the use in field trials in Romania.

Proposed period of release:
01/04/2011 to 31/12/2015

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


3. Is the same GMPt release planned elsewhere in the Community?
Yes:
Germany; Spain;

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/DE/06/179; B/DE/06/180; B/DE/06/181; B/DE/10/207; B/ES/04/05-CON; B/ES/05/17; B/ES/06/27; B/ES/06/32; B/ES/07/15; B/ES/08/20; B/ES/09/22; B/ES/10/34; B/ES/10/41; B/NL/06/05; B/NL/06/06; B/NL/06/07; B/RO/07/07;

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmays

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 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 glyphosate and glufosinate-ammonium herbicide. Tolerance to glufosinate in the European Union is only used as a selectable marker. 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).

Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
59122x1507xNK603 maize has been obtained from traditional breeding methods between progeny of genetically modified 59122, 1507 and NK603 maize. No genetic modification other than those of these maize has been introduced in 59122x1507xNK603 maize.

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 maize-optimized versions of cry34Ab1 and cry35Ab1 genes from the soil bacterium Bacillus thuringiensis strain PS149B1, providing resistance to certain Coleopteran insects and a plant-optimized version of the pat gene from the soil bacterium Streptomyces viridochromogenes, introduced as a selectable marker, providing tolerance to glufosinate herbicide, like in 59122 maize; a plant-optimized version of cry1F gene from the soil bacterium Bacillus thuringiensis var. aizawai, providing resistance to certain Lepidopteran insects and a plant-optimized version of 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 the regulatory components necessary to drive their expression:
- 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 Company 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 release is to refine knowledge concerning the behavior in the environment and the agronomic performances of 59122x1507xNK603 maize varieties (inbreds and/or hybrids), with or without applications of herbicides, including collection of data necessary for the registration of 59122x1507xNK603 maize varieties on the Official Catalogue of Varieties and Hybrids Crop Plants in Romania.

2. Geographical location of the site:
The release is planned at the following location:
CTS Dalga – Calarasi county;
CTS Mircea Voda – Braila county;
CTS Ramnicu Sarat – Buzau county;
CTS Tecuci – Galati county;
CTS Troianu –Teleorman county;
CTS-Inand- Bihor County


3. Size of the site (m2):
CTS Dalga – Calarasi county-5000 sq.m;
CTS Mircea Voda – Braila county-5000 sq.m;
CTS Ramnicu Sarat – Buzau county-5000 sq.m;
CTS Tecuci – Galati county-5000 sq.m;
CTS Troianu –Teleorman county-5000 sq.m;
CTS-Inand- Bihor County-5000 sq.m


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 behaved as non-genetically modified maize plants except for showing resistance to certain Coleopteran insects, such as Western corn rootworm, and certain Lepidopteran insects such as Ostrinia nubilalis and showing tolerance when glufosinate and glyphosate herbicides have been applied, traits due to the genetic modifications.
59122x1507xNK603 maize is no more regulated in the USA and Canada since 2005, in Japan since 2006. It is widely cultivated and no adverse effects have been reported.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The Environmental Risk Assessment has not identified any risks to human and animal health or the environment from the deliberate release of 59122x1507xNK603 maize. This is based on the information contained in the notification and the following concluding remarks:

- There is negligible likelihood for 59122x1507xNK603 maize to become environmentally persistent or invasive giving rise to any weediness;
- Expression of Cry34Ab1, Cry35Ab1, Cry1F, PAT and CP4 EPSPS proteins in 59122x1507xNK603 maize does not confer any selective advantage outside the agricultural environment;
- There are no wild relatives of maize spontaneously in the European Union and the traditional breeding that led to 59122x1507xNK603 maize does not introduce any selective advantages to maize plants outside heavily managed agricultural environments;
- The deliberate release of 59122x1507xNK603 maize will result in negligible immediate and/or delayed environmental impact resulting from direct and indirect interactions of 59122x1507xNK603 maize with non-target organisms;
- The genetic modifications in 59122x1507xNK603 maize do not introduce any new compounds known to cause or expected to cause any potential immediate and/or delayed effects on human health. Moreover, 59122x1507xNK603 maize subject of the release will not enter the food chain;
- The genetic modifications in 59122x1507xNK603 maize do not introduce any new compounds known to cause, or expected to cause, any possible immediate and/or delayed effects on animal health. Moreover, 59122x1507xNK603 maize subject of the release will not enter the feed chain;
- There is negligible likelihood that the 59122x1507xNK603 maize cause any possible immediate and/or delayed effects on biogeochemical processes;
- The specific cultivation, management and harvesting techniques used for 59122x1507xNK603 maize in the proposed release are identical to those used for non-genetically modified maize, with the exception of the herbicide regime (as glyphosate can be used for the weeding of the maize crop), containment measures (isolation distance and border rows) and destruction of the plant material (not used for food or feed);
- The potential reduction of the control of certain coleopteran and lepidopteran insect pests if the target insect pests develop resistance to the Cry34Ab1, Cry35Ab1 or Cry1F proteins as expressed in 59122x1507xNK603 maize has been identified as the only potential risk resulting from the interaction of 59122x1507xNK603 maize with target organisms. In the case of the proposed trials, the likelihood of the occurrence of this potential identified adverse effect is negligible. The risk posed by the target-insect resistance development is thus negligible. However, for commercial cultivation of this maize, a detailed proposal for insect resistance management (IRM) has been developed in the context of product stewardship and will be applied when 59122x1507xNK603 is placed on the market.


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 to any commercial maize crop. In addition, the trial sites will be surrounded by four agronomic border rows of conventional maize of a similar maturity that will be also destroyed at the end of the release.
Grains are fixed on a cob and enclosed in many husks that protect the seeds from outside contact. Thus dispersal of individual kernels is not likely to occur. 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.
If needed, the trial could be stopped by mechanical destruction or by 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. The border rows planted with conventional maize surrounding the trial site will be also destroyed at the end of the release by chopping and incorporating into the soil. 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 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 prior to flowering.
No commercial maize crop will be grown on the same plot area the following year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
The purpose of the planned field trials is to collect specific data on the genetically modified maize varieties in the environment; the field trials are not designed to collect specific data linked with environmental impact studies.
However, if any unanticipated adverse effects on the environment or human health were observed, they would be immediately reported to the Competent Authority.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/05/2012 00:00:00
Remarks: