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Notification report


General information

Notification Number
B/RO/10/07

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 NK603 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, 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/06/181; B/DE/10/207; B/ES/07/10; B/ES/08/15; B/ES/09/23; B/ES/10/35; B/FR/06/12/03; B/NL/06/05; B/PT/06/01; B/RO/07/14; B/RO/09/01;

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-ØØ6Ø3-6 maize (referred to as NK603 maize) has been genetically modified to tolerate application of glyphosate herbicide, which allows the farmers to use a broad-spectrum, non-selective, systemic herbicide for the weeding of the maize fields.

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:

NK603 maize has been genetically modified by the introduction of cp4epsps genes, from Agrobacterium sp. strain CP4, that confer tolerance to glyphosate herbicide, along with their regulatory components necessary for expression in maize plant:
- 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.

Summary of DNA components of the vector PV-ZMGT32L, used for transformation

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)


6. Brief description of the method used for the genetic modification:
NK603 maize was modified by insertion of a DNA fragment into the maize genome using a particle acceleration method.
The genetic modification was done by Monsanto Company. Subsequently, maize plants tested in the trials have been obtained by traditional breeding.


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 deliberate introduction in the environment of NK603 is to perform comparative studies with samplings of NK603 versus the conventional maize in experimental fields for bioefficacy and selectivity assessments.

2. Geographical location of the site:
The release is planned in the same location, each year:
Brăila County


3. Size of the site (m2):
Every season, NK603 maize will be grown on a area up to 5.000 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 in several locations with this genetically modified maize and no environmental problems were reported for these trials. The transgenic plants have appeared normal in all respects. They were indistinguishable from the non-genetically modified maize plants, except for showing herbicide tolerance when glyphosate was applied, trait due to the genetic modification.
NK603 maize is no more regulated in the USA since 2000, in Canada and Japan since 2001, in South Africa since 2002, in Argentina since 2004, in the Philippines since 2005 and is widely cultivated since that dates. No adverse effects have been reported.
The results of the monitoring during introduction as well as and post-introduction were done in accordance with legislation in force and submitted to competent authorities during the whole duration of the authorizations. No adverse effects for the human health and environment have been noticed and reported during the whole duration of the authorizations.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
NK603 maize was approved on 19 July 2004 for import, feed use and processing in the EU under Directive 2001/18/EC (Commission Decision 2004/643/EC). Food and food ingredients derived from NK603 were approved under Regulation (EC) No. 258/97 (Commission Decision 2005/448/EC) and existing feed materials, feed additives and food additives produced from NK603 were listed in the Community Register, according to Regulation (EC) No. 1829/2003 . An application for cultivation of varieties of NK603 in the European Union was submitted under Regulation (EC) No. 1829/2003 and EFSA adopted a favorable scientific opinion (published on 11 June 2009) concluding that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human and animal health and the environment.
Analysis of the characteristics of NK603 has shown that the risk of potential adverse effects on human and animal health and the receiving environment, resulting from the deliberate release of this maize for field testing, is consistently negligible.


Brief description of any measures taken for the management of risks:
The environmental risk assessment has indicated that the environmental risks of this maize are negligible and the favourable scientific opinion adopted by EFSA concluded that NK603 is as safe as its conventional counterpart with respect to potential direct effects on human or animal health and the environment. Therefore, strategies for risk management for NK603 would be the same as for traditional maize.
In order to limit any pollen flow from the genetically modified plants, a 200m-isolation distance will be maintained to any other non-experimental maize crop. As it is done for any trial with conventional maize, the trial site will be surrounded by minim 4 rows agronomic border rows of conventional maize of a similar maturity. The agronomic border rows 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 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 application of a herbicide other than glyphosate or by mechanical destruction, 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 prior to flowering.
Two years following harvest of GM maize trial, maize will not be grown on the trial sites.


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: