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Notification report


General information

Notification Number
B/SK/08/02

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
21/01/2008

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034, MON 88017 and MON 89034 × MON 88017 maize, for the use in field trials in Slovakia.

Proposed period of release:
10/04/2008 to 30/11/2010

Name of the Institute(s) or Company(ies)
Slovak Center of Agricultural Research, Research Institute of Plant Production;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
maizepoaceaezeazea maysmaysMON 89034, MON 88017, MON 89034 × MON 88017

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 produces the Cry1A.105 and Cry2Ab2 insecticidal proteins, which impart protection against feeding damage caused by the European corn borer (ECB, Ostrinia nubilalis) and other lepidopteran insect pests.

MON 88017 expresses the modified Cry3Bb1 protein, derived from Bacillus thuringiensis subsp. kumamotoensis. Expression of this protein provides protection against certain coleopteran insect pests including members of the corn rootworm (CRW) complex (Diabrotica spp.). In addition, MON 88017 expresses the CP4 EPSPS protein, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate.

MON 89034 × MON 88017 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and MON 88017. Therefore, MON 89034 × MON 88017 is protected against certain lepidopteran and coleopteran insect pests, and is tolerant to glyphosate herbicide.


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 × MON 88017 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and MON 88017. 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:
MON 89034 x MON 88017 results form traditional breeding of MON 89034 and MON 88017. The inserted DNA fragments from both inbred parental lines are inherited in MON 89034  MON 88017. The individual components and the size, source and function of these inherited DNA sequences are given in Tables 1 and 2.

Table 1. Summary of the inserted DNA fragment inherited from MON 89034

Genetic element ; Size (~kb); Function
; ;
B-Left Border; 0.24; 239 bp DNA region from the B Left Border region remaining after integration
Pp-e35S; 0.30; Modified promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region
; ;
L-Cab; 0.06; 5' untranslated leader of the wheat chlorophyll a/b binding protein
I-Ract1; 0.48; Intron from the rice actin gene
CS-cry1A.105; 3.53; Coding sequence for the Bacillus thuringiensis Cry1A.105 protein
T-Hsp17; 0.21; 3' transcript termination sequence for wheat heat shock protein 17.3, which ends transcription and directs polyadenylation
P-FMV; 0.56; Figwort Mosaic Virus 35S promoter
I-Hsp70; 0.80; First intron from the maize heat shock protein 70 gene
TS-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
CS-cry2Ab2; 1.91; Coding sequence for a Cry2Ab2 protein from Bacillus thuringiensis. 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
B-Left Border; 0.23; 230 bp DNA region from the B Left Border region remaining after integration

Table 2. Summary of the inserted DNA fragment inherited from MON 88017

Genetic element ; Size (~kb); Function
B-Left Border; 0.02; Portion of the left border sequence from Agrobacterium tumefaciens involved in transfer of T-DNA
P-Ract1; 0.93; Promoter from the rice actin gene
I-Ract1; 0.48; Intron from the rice actin gene
TS-CTP2; 0.23; DNA sequence coding for the N teminal chloroplast transit peptide
CS-cp4 epsps; 1.37; DNA sequence coding for the native CP4 EPSPS protein
T-nos; 0.25; 3' nontranslated region of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation
P-e35S; 0.61; Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region
L-Cab; 0.06; 5’ untranslated leader of the wheat chlorophyll a/b binding protein
I-Ract1; 0.48; Intron from the rice actin gene
CS-cry3Bb1; 1.96; DNA sequence coding for a synthetic variant of Cry3Bb1 protein from Bacillus thuringiensis
T-Hsp17; 0.21; 3’ nontranslated region of the coding sequence for wheat heat-shock protein 17.3, which ends transcription and directs polyadenylation




B – border region
CS coding sequence
I intron
L leader
P – promoter
Pp –modified promoter
T – transcript termination sequence
TS – targeting sequence
Cry2Ab2 refers to the protein expressed by MON 89034 ´ MON 88017 and MON 89034, unless otherwise stated
Cry3Bb1 refers to the protein expressed by MON 89034 ´ MON 88017 and MON 88017, unless otherwise stated


6. Brief description of the method used for the genetic modification:
While MON 89034 ´ MON 88017 results from traditional breeding, genetic modification was used in the development of the parental lines MON 89034 and MON 88017. These parental maize lines were produced by Agrobacterium-mediated transformation of maize cells.

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:
MON 89034 × MON 88017 and the parental lines MON 89034 and MON 88017 will be planted in field trials for assessment of the following criteria: biological efficacy, comparison with chemical insecticide strategies, evaluation of possible effects on non target organisms, breeding activities - testing of local germplasm with above mentioned characteristics of genetically modified maize, variety registration trials and assessment of weed treatment strategies in maize under Slovak conditions.

2. Geographical location of the site:
Borovce, Špačince, Milhostov, Sokolce, Gabčíkovo, Tekovské Lužany, Ša?a

3. Size of the site (m2):
169.500 m2 is the max. size of all locations for 2008.

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
MON 89034 has been released for field-testing at several locations in the U.S.A. and Argentina since 2002. These field trials were conducted to produce material for the regulatory studies and to assess agronomic performance (efficacy, selectivity, yield assessment). It has also been tested in Canada in 2005 for agronomic characterization and evaluations. It is also been tested in France, Germany and Spain for regulatory purposes (protein expression, composition and agronomic characteristics).
The results of the release in these countries showed no evidence that MON 89034 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran insects, MON 89034 could not be distinguished from conventional maize.
MON 88017
Many field trials have already been conducted for performance assessments (efficacy, yield, breeding, etc.) at several locations across maize growing regions in the U.S.A since 2000 and Argentina in 2003-2004. Environmental assessments have been performed in Japan in 2002 and agronomic evaluations in Canada in 2003. It is also been tested in Germany, France and Spain for the regulatory studies (protein expression, composition and agronomic characteristics).
The results of the release in these countries showed no evidence that MON 88017 is likely to cause any adverse effects to human or animal health and the environment. Except for its tolerance to glyphosate and its protection against certain coleopteran insects, MON 88017 could not be distinguished from conventional maize. Additionally, coleopteran-protection and glyphosate-tolerance traits present in MON 88017 are already present in two commercial products MON 863, and NK603, respectively, from which no adverse effect have been reported.
MON 89034  MON 88017
MON 89034  MON 88017 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. It is also been tested in France, Germany and Spain for regulatory purposes (protein expression, composition and agronomic characteristics).
The results of the releases in these countries showed no evidence that MON 89034  MON 88017 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran and coleopteran insects and its tolerance to glyphosate, MON 89034  MON 88017 could not be distinguished from conventional maize.


Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
Analysis of the characteristics of MON 89034, MON 88017 and MON 89034  MON 88017 has shown that the risk for potential adverse effects on human and animal health or the environment, resulting from the deliberate release of this maize for field testing, is negligible:

• The risk of the introduced traits in MON 89034, MON 88017 and MON 89034  MON 88017 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. The likelihood of unintended spreading of MON 89034, MON 88017 or MON 89034  MON 88017 in the non-agricultural environments is negligible, as maize is neither persistent nor invasive and these parameters are unaltered when compared to conventional maize.
• There is no potential for gene transfer from MON 89034, MON 88017 or MON 89034  MON 88017 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 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).
• MON 89034, MON 88017 and MON 89034  MON 88017 pose 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 (MON 89034 and MON 89034  MON 88017) and coleopterans (MON 88017 and MON 89034  MON 88017), therefore the effect of these maize plants 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 proteins (expressed in MON 89034 and MON 89034  MON 88017) and the Cry3Bb1 protein (expressed in MON 88017 and MON 89034  MON 88017) for certain lepidopteran and coleopteran pests, respectively, 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. Potential exposure of non-target organisms to the CP4 EPSPS protein (expressed in MON 88017 and MON 89034  MON 88017) presents no conceivable mechanism to cause adverse effects because of its properties. Therefore, the ecological interactions of MON 89034, MON 88017 and MON 89034  MON 88017 with non-target organisms or the biochemical processes in soil, poses negligible risk for adverse environmental effects and are considered similar to the respective interactions caused by conventional maize.
• Any occupational health aspects of handling MON 89034, MON 88017 and MON 89034  MON 88017 are not different from conventional maize. Additionally 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 cultivation of any other maize.

It is actually expected that the production of MON 89034, MON 88017 and MON 89034  MON 88017 will positively impact current agronomic practices in maize and provide benefits to farmers and the environment. The benefits of planting these maize result, in one hand, from their respective insect-protection traits and include: 1) a reliable means to control the target lepidopteran and/or coleopteran 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 (for MON 89034 and MON 89034  MON 88017) and 7) no additional labour or machinery requirements, allowing both large and small growers to maximize hybrid yields. Likewise, the glyphosate-tolerance trait (in MON 88017 and MON 89034  MON 88017) 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, MON 88017 and MON 89034 × MON 88017 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:
In addition to the scheduled observations of phenotypic and agronomic parameters that form the basis of the planned research, the trial site will be checked regularly during the period of the deliberate release for potentially occurring, direct or indirect, adverse environmental effects. This will be done by visual inspection of the status of MON 89034, MON 88017 and MON 89034 × MON 88017 crops and that of their receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 89034, MON 88017 or MON 89034 × MON 88017 are observed during the period of release, these will be reported immediately to the Competent Authority.
The minimal isolation distance (200 m) from other maize crops, together with the eight rows of non transgenic maize surrounding the trials will prevent most of the possibility of hybridization with other maize plants.
The equipment, especially the experimental drill and combine, will be cleaned on the experimental site, thus preventing seed dissemination.
Although regrowth in the rotation crops is unlikely because of poor winter survival, the site will be sown with a crop different from maize the year following the planned trial.
Volunteer plants will be controlled by mechanical destruction or non-selective herbicides.
Seeds will be transported in sealed and labelled bags.
At the end of the field-testing campaign, a report will be made available by the notifier to the Competent Authority. This report will detail any unexpected adverse environmental effects observed during the general surveillance, if any, and further actions elicited as an effect of these findings, if applicable.


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
30/04/2008 00:00:00
Remarks: