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Notification report


General information

Notification Number
B/PL/09/02-05

Member State to which the notification was sent
Poland

Date of acknowledgement from the Member State Competent Authority
12/03/2009

Title of the Project
Comparison of the different cultivation systems in corn: conventional /with standard chemical treatment/, GMO and ecological /without any chemical treatment/

Proposed period of release:
15/04/2009 to 30/11/2012

Name of the Institute(s) or Company(ies)
Monsanto Polska Sp. z o.o., ul. Domaniewska 41
tel 022/5704350, fax: 0 22 570 43 51
02-672 Warsaw
Poland;


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

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

If yes, notification number(s):
B/AT/96/02; B/CZ/09/03; B/DE/06/185; B/DE/08/201; B/ES/08/12; B/ES/09/08; B/FR/06/12/08; B/SK/09/03;

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 89034 x NK 603 maize consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and NK 603.

Like MON 89034, MON 89034 x NK 603 maize produces the Cry 1A.105 and Cry 2Ab2 insecticidal proteins, which impart protection against feeding damage caused by the European corn borer /ECB, Ostrinia nubilalis/ and other lepidopteran insect pests.

Like NK 603, MON 89034 x NK 603 maize expresses the CP4 EPSPS proteins, derived from Agrobacterium sp. Strain CP4, which provides tolerance to glyphosate


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 x NK 603 maize consist in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and NK 603 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:
Figure 1. Genetic Element Size (~kb) Function (Reference)

B1-Left Border 0.24 239 bp DNA region from the B Left Border region remaining after integration
Pp2-e35S 0.30 Modified promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA (Odell et al., 1985) containing the duplicated enhancer region (Kay et al., 1987)

L3-Cab 0.06 5' untranslated leader of the wheat chlorophyll a/b binding protein (Lamppa et al., 1985)
I4-Ract1 0.48 Intron from the rice actin gene (McElroy et al., 1991)
CS5-cry1A.105 3.53 Coding sequence for the Bacillus thuringiensis (Bt) Cry1A.105 protein (Monsanto unpublished data)
T6-Hsp17 0.21 3' transcript termination sequence for wheat heat shock protein 17.3, which ends transcription and directs polyadenylation (McElwain and Spiker, 1989)
P-FMV 0.56 Figwort Mosaic Virus 35S promoter (Rogers, 2000)
I-Hsp70 0.80 First intron from the maize heat shock protein 70 gene (Brown and Santino, 1995)
TS7-SSU-CTP 0.40 DNA region containing the targeting sequence for the transit peptide region of maize ribulose 1,5 bisphosphate carboxylase small subunit and the first intron (Matsuoka et al., 1987)
CS-cry2Ab28 1.91 Coding sequence for a Cry2Ab2 protein from Bacillus thuringiensis (Donovan, 1991; Widner and Whiteley, 1989). This coding sequence uses a modified codon usage
T-nos 0.25 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation (Bevan et al., 1983)
B-Left Border 0.23 230 bp DNA region from the B Left Border region remaining after integration

Figure 2. Genetic Element Size (kb) Function (Reference)
P1-Ract1/ I2-Ract1 1.4 5’ region of the rice actin gene containing the promoter, transcription start site and first intron (McElroy et al., 1990).
TS3-CTP2 0.2 DNA sequence coding for the N-teminal chloroplast transit peptide (Klee et al., 1987).
CS4-cp4 epsps 1.4 DNA sequence coding for the native CP4 EPSPS protein (Padgette et al., 1996).
T5-nos 0.3 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation (Fraley et al., 1983).
P-e35S 0.6 Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA (Odell et al., 1985) containing the duplicated enhancer region (Kay et al., 1987).
I-Hsp70 0.8 Intron from the maize heat-shock protein 70 gene (Rochester et al., 1986).
TS-CTP2 0.2 DNA sequence coding for the N-teminal chloroplast transit peptide (Klee et al., 1987).
CS-cp4 epsps l214p 1.4 DNA sequence coding for the CP4 EPSPS L214P protein (Padgette et al., 1996).
T-nos 0.3 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation (Fraley et al., 1983).
1. P – promoter
2. I – intron
3. TS – targeting sequence
4. CS – coding sequence
5. T – transcript termination sequence


6. Brief description of the method used for the genetic modification:
NK603 Roundup Ready maize was modified by incorporation of a restriction fragment of plasmid DNA, designated as PV-ZMGT32L into the maize genome using a particle acceleration method
NK603 Roundup Ready maize was generated using a particle acceleration transformation system and a gel-isolated MluI fragment, PV ZMGT32L (Figure 1), containing a 5-enolpyruvyl¬shikimate-3-phosphate synthase (EPSPS) gene from Agro¬bacterium sp. strain CP4 (CP4 EPSPS). The cp4 epsps gene encodes a tolerant form of EPSPS, which confers glyphosate (Roundup) tolerance to the plant.

MON 89034 was developed through Agrobacterium-mediated transformation of immature embryos of maize tissue. Agrobacterium-mediated transformation is a well-documented process for the transfer and integration of exogenous DNA into a plant’s nuclear genome. Agrobacterium tumefaciens strain ABI, containing plasmid PV ZMIR245 was used to transform the embryonic maize cells. The bacterium contains a disarmed Ti plasmid without borders and genes encoding phytohormone biosynthesis but allows for the transfer of the T-DNA from PV-ZMIR245.
PV ZMIR245 is a 2T DNA vector (Matthews et al., 2001) which contains two independent transfer-DNA (T DNA) regions. Each T DNA is surrounded by a left and a right border region (B Left Border and B Right Border, respectively) containing the left and a right border sequences, which allow the transformation. The first T DNA region (T DNA I) contains the cry1A.105 and the cry2Ab2 expression cassettes and the second T DNA region (T DNA II) contains the selectable marker nptII. T DNA II was used for the selection of the transformed cells, thanks to the presence of nptII. Once the transgenic cells were identified, in order to produce marker-free, lepidopteran-protected maize, the nptII cassette was segregated away from the cry1A.105 and the cry2Ab2 expression cassettes, by means of traditional breeding. This process is well documented and it was most recently successfully used in transformation of corn (Miller et al., 2002).


7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
N/A

Experimental Release

1. Purpose of the release:
The aim of this experimental release is to gather the data to the PhD project “Comparison of the different cultivation systems in corn: conventional /with standard chemical treatment/, GMO and ecological /without any chemical treatment/.

2. Geographical location of the site:
Krościna Mała, dolnośląskie voivodship, Poland

3. Size of the site (m2):
Area of releasing will be precisely define in the methodology of trials.

Area of releasing will cover 1000 sqm and 900 sqm of buffer zone for one localization


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:
MON 89034  NK603 was first field tested for efficacy in Puerto Rico during the 2004/2005 winter season. Field trials were also conducted in U.S.A. and Argentina, where agronomic performance was assessed.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of MON 89034 ´ NK603 maize has shown that the risk of potential adverse effects on human and animal health or the environment, resulting from the planned deliberate release of this maize for field testing, is negligible:

• The risk of the introduced traits in MON 89034 × NK603 maize to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. As for any other maize, the likelihood of this maize to spread into non-agricultural environments is negligible, as its persistence in agricultural habitats and its invasiveness into non-agricultural habitats are unaltered compared to conventional maize.
• There is no potential for gene transfer from MON 89034  NK603 maize to wild plant species in Europe and low to negligible likelihood for gene transfer to other maize crops. In the event that the introduced genes would outcross to another maize plant, its transfer would, in any case, have negligible consequences for the environment. Therefore, no risk management strategies are considered necessary. Nevertheless, measures will be taken to avoid hybridization with other maize plants and seed dissemination at harvest and during transportation (see Point E).
• As for parental lines MON 89034 and NK603, MON 89034  NK603 maize poses negligible risk for adverse environmental effects through its interaction with target organisms. By definition, the glyphosate tolerance trait has no direct or indirect interaction with any target organism. The insect-protection trait has activity only toward the larvae of particular target lepidopterans. Therefore, the effect of MON 89034  NK603 on target organisms is limited to specific conditions in the field, spatially limited and short in duration.
• Based on the selectivity of the Cry1A.105 and Cry2Ab2 toxins for certain lepidopteran pests, their well-characterised mode of action and the confirmation through studies of no adverse effects found, the risk of an adverse effect on non-target organisms is considered negligible. The ecological interactions with non-target organisms or the biochemical processes in soil are considered similar to the respective caused by conventional maize.
• Any occupational health aspects of handling MON 89034  NK603 maize are not different from conventional maize, and this maize was shown not to cause any toxic or allergenic effects in man or animal health and to be as safe and nutritious as any other maize without any consequences for the feed/food chain.
• The environmental impact of the cultivation, management and harvesting techniques applied in the planned trials is considered no different from the farming practices for conventional maize.

It is actually expected that the production of MON 89034  NK603 maize will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The benefits of planting this maize result, in one hand, from its lepidopteran-protection trait and include: 1) a reliable means to control the target lepidopteran maize pests; 2) control of target insects while maintaining beneficial species; 3) potential for reduced use of hazardous chemical insecticides and reduced applicator exposure to these products; 4) fit with integrated pest management (IPM) and sustainable agricultural systems; 5) potential for reduced mycotoxin levels in maize kernels; 6) reduced likelihood for lepidopteran insects to develop resistance to Bt proteins and 7) no additional labour or machinery requirements, allowing both large and small growers to maximize hybrid yields. Likewise, the use of glyphosate-tolerant maize enables the farmer to take advantage of the herbicides favourable environmental and safety properties (see Annex I listing of glyphosate under Council Directive 91/414/EEC). Glyphosate-tolerant maize benefits the farmer by providing (1) an additional broad-spectrum weed control option in maize, (2) a new herbicidal mode of action for in-season maize weed control, (3) increased flexibility to treat weeds on an “as needed” basis, (4) cost-effective weed control and (5) an excellent fit with reduced-tillage systems. In turn, a number of environmental benefits arise from the use of conservation tillage including improved soil quality, improved water infiltration, reductions in erosion and sedimentation of water resources, reduced runoff of nutrients and pesticides to surface water, improved wildlife habitat, increased carbon retention in the soil, reduced fuel use and encouragement of sustainable agricultural practices.

Since no characteristics of MON 89034 × NK603 maize could be identified that may cause adverse effects on human health or the environment, no risk management strategies are considered necessary.


Brief description of any measures taken for the management of risks:
No adverse effects of the GMHP have been identified. This indicates that a requirement for case-specific post-release monitoring is not appropriate, which is consistent with approvals granted in other world areas
In order to ensure the implementation of good agricultural practice in the cultivation of MON 89034 x NK 603 and to ensure a channel of communication in the unlikely event that unanticipated adverse effects might occur applicant will implement:
- strict control of use of seed for the foeld trials
- isolation distances
- possibility of trials cancellation in any moment


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
N/A

Final report
-

European Commission administrative information

Consent given by the Member State Competent Authority:
No
27/10/2009 00:00:00
Remarks:
The negative decision, raised during procedure pursuant to the national law, was made because of public opinion objections.