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Notification report


General information

Notification Number
B/RO/10/06

Member State to which the notification was sent
Romania

Date of acknowledgement from the Member State Competent Authority
19/04/2010

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of of genetically modified MON ØØ6Ø3 × MON ØØ8Ø1-6 maize for the use in field trials in Romania.

Proposed period of release:
01/04/2010 to 31/12/2014

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?
Yes:
Spain;

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

If yes, notification number(s):
B/ES/07/12; B/ES/08/17; B/ES/09/24; B/ES/10/36; B/FR/06/03/01; B/FR/06/12/03; B/RO/07/13;

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:
MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize, referred to as NK603xMON810 maize hereafter, can tolerate the use of glyphosate herbicide for the weeding of maize field and is resistant to certain Lepidopteran insect pests such as the European corn borer (Ostrinia nubilalis). This maize was derived through traditional breeding methods between progeny of the genetically modified MON-ØØ6Ø3-6 maize (referred to as NK603 maize), which is tolerant to glyphosate herbicide, and MON-ØØ81Ø-6 maize (referred to as MON810 maize), which is resistant to certain lepidopteran insects.

Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
Combination obtained by conventional crossing between genetically modified MON 810 maize and genetically modified NK603 maize. . No additional genetic modification is involved

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 NK603xMON810 maize are the cp4epsps gene from Agrobacterium sp. strain CP4 that confers tolerance to glyphosate herbicide, like in NK603 maize, and the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki that confers resistance to certain Lepidopteran insects such as Ostrinia nubilalis, like in MON810 maize, along with the regulatory components necessary for expression in maize plant:
Summary of the inserted DNA fragment inherited from NK603:

Genetic Element: Size (kb). Function.

- P-Ract1/ I-Ract1: 1.4kb. 5’ region of the rice actin gene containing the promoter, transcription start site and first intron.
- TS-CTP2: 0.2kb. DNA sequence coding for the N-teminal chloroplast transit peptide.
- CS-cp4 epsps: 1.4kb. DNA sequence coding for the native CP4 EPSPS protein.
- T-nos: 0.3kb. 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation.
- P-e35S: 0.6kb. Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA (Odell et al., 1985) containing the duplicated enhancer region.
- I-Hsp70: 0.8kb. Intron from the maize heat-shock protein 70 gene.
- TS-CTP2: 0.2kb. DNA sequence coding for the N-teminal chloroplast transit peptide.
- CS-cp4 epsps l214p: 1.4kb. DNA sequence coding for the CP4 EPSPS L214P protein.
- T-nos: 0.3kb. 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation.
cp4 epsps gene cassette (1)
- P-ract1/ract1 intron
Source: Oryza sativa Intended function: 5’ region of the rice actin 1 gene containing the promoter, transcription start site and first intron. (1.4 kb)

- ctp 2
Source: Arabidopsis thaliana Intended function: DNA sequence for chloroplast transit peptide, isolated from Arabidopsis thaliana EPSPS, present to direct the CP4 EPSPS protein to the chloroplast, the site of aromatic amino acid synthesis. (0.2 kb)

- cp4 epsps
Source: Agrobacterium sp. strain CP4 Intended function: The DNA sequence for CP4 EPSPS, isolated from Agrobacterium sp. strain CP4, which imparts tolerance to glyphosate. (1.4 kb)

- NOS 3’
Source: Agrobacterium tumefaciens Intended function: A 3’ nontranslated region of the nopaline synthase gene from Agrobacterium tumefaciens T-DNA which ends transcription and directs polyadenylation of the mRNA. (0.3 kb) cp4 epsps gene

second cassette

- e35S
Source: Cauliflower mosaic virus Intended function: The cauliflower mosaic virus (CaMV) promoter with the duplicated enhancer region. (0.6 kb)

- Zmhsp70
Source: Zea mays L. Intended function: Intron from the corn hsp70 gene (heat-shock protein) present to stabilize the level of gene transcription. (0.8 kb)

- ctp 2
Source: Arabidopsis thaliana Intended function: DNA sequence for chloroplast transit peptide, isolated from Arabidopsis thaliana EPSPS, present to direct the CP4 EPSPS protein to the chloroplast, the site of aromatic amino acid synthesis. (0.2 kb)

- cp4 epsps
Source: Agrobacterium sp. strain CP4 Intended function: The DNA sequence for CP4 EPSPS, isolated from Agrobacterium sp. strain CP4, which imparts tolerance to glyphosate. (1.4 kb)

- NOS 3’
Source: Agrobacterium tumefaciensIntended function: A 3’ nontranslated region of the nopaline synthase gene from Agrobacterium tumefaciens T-DNA which ends transcription and directs polyadenylation of the mRNA. (0.3 kb)
Summary of the inserted DNA fragment inherited from MON 810:

Genetic Element - Size (~kb) - Function (Reference)

-e35S - 0.32 - DNA sequence derived from cauliflower mosaic virus (CaMV) containing a portion of the CaMV promoter with the duplicated enhancer region and 5’ untranslated region
-Zmhsp70 - 0.81 - DNA sequence derived from maize containing the intron sequence from the maize hsp 70 gene (heat-shock protein) present to stabilize the level of gene transcription.
-CS-Cry1Ab - 2.45 - DNA sequence containing synthetic linker and a portion of the synthetic coding sequence for a variant of Cry1Ab1 protein from Bacillus thuringiensis subsp. kurstaki


6. Brief description of the method used for the genetic modification:
No genetic modification was applied to obtain the NK603xMON810 maize varieties directly: they were derived through traditional breeding methods between progeny of the genetically modified NK603 maize and MON810 maize.
NK603 maize and MON810 maize were genetically modified by Monsanto Company using the particle acceleration method. The genetic modifications were licensed to Pioneer for use in its own germplasm.


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 the behavior in the environement and agronomic performances of NK603xMON810 maize varieties (inbreds and/or hybrids), including collection of data necessary for the registration of NK603xMON810 maize varieties on the National list of Romania.

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


3. Size of the site (m2):
Dalga – Calarasi county-10000 sq.m
Mircea Voda – Braila county-10000 sq.m
Ramnicu Sarat – Buzau county -10000 sq.m
Tecuci – Galati county-10000 sq.m
Troianu –Teleorman county -10000 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:
Many field trials have already been conducted at several locations and no environmental problems were reported for these trials. The transgenic plants behaved as conventional maize, except for showing tolerance to glyphosate herbicide and resistance to certain Lepidopteran insects such as the European Corn Borer, traits due to the genetic modifications.
NK603xMON810 maize is no more regulated in the USA since 2000, in Canada since 2001, in the Philippines since 2005, in Argentina and South Africa since 2007, in Brazil since 2009. It is widely cultivated and no adverse effects have been reported to our knowledge.


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 NK603xMON810 maize tolerant to glyphosate herbicides and resistant to certain Lepidopteran insects are expected, as per information contained in the environmental risk assessment included in the notification.
Characteristics of NK603xMON810 maize, reveals that are no risks to human and animal health or the environment from the deliberate release.
• The traits introduced in NK603xMON810 maize does not confer any significant advanteage or disadvantage in the environment. Persistence in agricultural habitans and invading ability of the natural habitats are unchanged at NK603xMON810 maize as compared to conventional maize and consequently the invading ability in non-agricultural environments has a negligible propability. Also, gene transfer from NK603xMON810 to other wild species plants in Europe is not possible.
• Potential of gene transfer from NK603xMON810 maize to wild species plant in Europe is null. Genes transfer from other varieties of corn has a low probability. Even if the introduced genes would be transferred to other plants of maize, environmental consequences would be negligible. Therefore, is considered that the adoption of management strategies is not necessary. Even if the risks are minimal, measures will be taken to avoid hybridization with other corn plants as well as seeds dissemination at harvest and during transport.
• Risk of adverse environmental effects as a result of interaction of NK603xMON810 with non-target organisms is negligible. Interaction of NK603xMON810 maize with non-target organisms or with soil processes are not different from interactions of conventional maize.
Highly selective activity of Cry1A(b) protein to larve of certain insects specifically targeted causes that risks for non-target organisms to be negligible. Non-target organisms may cannot be affected by exposure to CP4EPSPS protein, because of its properties.
• NK603xMON810 is as safe and nutritious like as any other maize. Any professional harmfull effects due to handling of NK603xMON810 maize do not differ from the effects issued by conventional maize.
• Environmenta impact due to cropping technologies, specific for field tests, do not differ from normal practices impact of cropping used with conventional maize.
• Moreover, NK603xMON810 usage brings more benefits for growers and for environment. Application of herbicide based on glifosate in corn, offers to farmers advantage given by favorable properties and environmental safety. Glifosate -tolerant corn offers to the growers the following advantages :1) an effective herbicides with broad action ; 2)possibility to apply a total herbicide post-emergent; 3) large flexibility in timing of treatment ; 4) superior economic efficiency of the herbicide and ; 5) opportunity to use technology of soil cultivation with minimum tillage which is essential to control the effects of drought. Additionaly, this technology has some clear benefic influences for the environment: improvement of the soil quality and soil moisture conservation, reduces erosion, reduces surface water contamination with pesticides and chemical fertilizers, improvement of th wildlife habitats, reduces fossil fuel consumption, increases retention rate of carbon in the soil, reduces fuel consumption and contribute to a better tranzition to a sustainable agriculture.
• Genetic protection against some harmful lepidopteran insect attack results in a number of important benefits: 1)a safe method of control for lepidopteran harmful; 2)this type of control of target insect species does not affect useful species; 3)reduces the consumption of harmful chemical insecticides and exposure of the people applying the treatments to these products; 4)ideal for sustainable agriculture systems ; 5)the significant reduction of levels of contamination of maize grains with mycotoxins produced by Fusarium sp. ;6)maximize the efficiency of agricultural technologies by maximizing yield.


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. As it is done for any trial with conventional maize, the trial site will be surrounded by 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 seed 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 application of a herbicide other than glyphosate, 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 two years 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 planted on the same plot the following two year.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable.
However, any unanticipated adverse effects on human health or the environment would be reported immediately to the Competent Authority.


Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
03/06/2010 00:00:00
Remarks: