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Notification report


General information

Notification Number
B/SK/09/03

Member State to which the notification was sent
Slovakia

Date of acknowledgement from the Member State Competent Authority
22/01/2009

Title of the Project
Notification according to Directive 2001/18/EC, Part B, for the deliberate release of MON 89034 × NK603 and NK603 × MON 810 for the use in field trials in Slovakia.

Proposed period of release:
10/04/2009 to 30/11/2011

Name of the Institute(s) or Company(ies)
Slovak Agricultural Research Centre, Research Institute of Plant Production;
Piešťany, Bratislavská 122, 921 68 Pieštany, Slovak Republic;


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 × NK603 and NK603 × MON 810

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
MON 89034 × NK603 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and NK603.
 Like MON 89034, MON 89034 × NK603 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.
 Like NK603, MON 89034 × NK603 expresses the CP4 EPSPS proteins, derived from Agrobacterium sp. strain CP4, which provides tolerance to glyphosate (N-phosphonomethyl-glycine), the active ingredient in the non-selective herbicide Roundup®1.

NK603 × MON 810 hybrid maize consists in the combination, by traditional breeding, of two genetically modified parental inbred lines, derived from maize transformation events NK603 and MON 810.
 Like NK603, NK603 × MON 810 expresses the CP4 EPSPS proteins, derived from Agrobacterium sp. strain CP4, which imparts tolerance to glyphosate (N-phosphonomethyl-glycine), the active ingredient in the non-selective herbicide Roundup®.
 Like MON810, NK603 × MON 810 expresses the Cry1Ab protein, which provides the maize plant protection from certain lepidopteran insect pests, including European Corn Borer (Ostrinia nubilalis).


Genetic modification

3. Type of genetic modification:
Insertion; Other;
Other
MON 89034 × NK603 consists in the combination, by traditional breeding, of two genetically modified parental inbred lines derived from MON 89034 and NK603. 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:
Limited to the development of the individual hybrids MON 89034 and NK603

MON 89034 × NK603 results form traditional breeding of MON 89034 and NK603. The inserted DNA fragments from both inbred parental lines are inherited in MON 89034 × NK603. 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 (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 containing the duplicated enhancer region
L3-Cab - 0.06 - 5' untranslated leader of the wheat chlorophyll a/b-binding protein
I4-Ract1 - 0.48 - Intron from the rice actin gene
CS5-cry1A.105 - 3.53 - Coding sequence for the Bacillus thuringiensis Cry1A.105 protein
T6-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
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
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

1. B – border region 6. T – transcript termination sequence
2. Pp –modified promoter 7. P – promoter
3. L – leader 8. TS – targeting sequence
4. I – intron 9. Cry2Ab2 refers to the protein expressed by MON 5. CS - coding sequence 89034, unless otherwise stated


Table 2. Summary of the inserted DNA fragment inherited from NK603

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
TS3-CTP2 - 0.2 - DNA sequence coding for the N-teminal chloroplast transit peptide
CS4-cp4 epsps - 1.4 - DNA sequence coding for the native CP4 EPSPS protein
T5-nos - 0.3 - 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation
P-e35S - 0.6 - Promoter and leader for the cauliflower mosaic virus (CaMV) 35S RNA containing the duplicated enhancer region
I-Hsp70 - 0.8 - Intron from the maize heat-shock protein 70 gene
TS-CTP2 - 0.2 - DNA sequence coding for the N-teminal chloroplast transit peptide
CS-cp4 epsps l214p - 1.4 - DNA sequence coding for the CP4 EPSPS L214P protein
T-nos - 0.3 - 3' transcript termination sequence of the nopaline synthase (nos) coding sequence from Agrobacterium tumefaciens which terminates transcription and directs polyadenylation

1. P – promoter
2. I – intron
3. TS – targeting sequence
4. CS – coding sequence
5. T – transcript termination sequence

NK603 × MON 810 results form traditional breeding of NK603 and MON 810. The inserted DNA fragments from both inbred parental lines are inherited in NK603 × MON 810. The individual components and the size, source and function of the inherited DNA sequences from NK603 are given previously in Table 2, and from MON 810 are given below in Table 3.

Table 3. Summary of the inserted DNA fragment inherited from MON 810

Genetic Element - Size (~kb) - Function (Reference)
P-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
I-Zmhsp70 - 0.81 - Intron from the maize heat-shock protein 70 gene
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:
While MON 89034 × NK603 results from traditional breeding, genetic modification was used in the development of the parental MON 89034 and NK603. These parental maize lines were produced by Agrobacterium mediated transformation of maize cells and particle acceleration transformation, respectively.
While NK603 × MON 810 results from traditional breeding, genetic modification was used in the development of the parental NK603 and MON 810. These parental maize lines were produced by particle acceleration transformation


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 × NK603 and NK603 × MON 810 will be planted in field trials for assessment of the following criteria: biological efficacy, characterization of introduced traits, compositional analysis, 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:
Gabčíkovo, Sokolce, Tekovské Lužany, Borovce, Špačince, Viglaš-Pstruša and Milhostov

Remark - without prolongation of validity, the authorization was amended in this way:
one geographical location of the release site were added – Milhostov (Slovak Republic).
the size of the sites was changed – the total surface of site on the location Borovce will not exceed 10 000 m², including the borders.


3. Size of the site (m2):
179.500 m2 is the max. size of all locations in 2009

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. In the E.U., MON 89034 × NK603 was field tested in Spain and France during 2007/2008. The results of the releases in these countries showed no evidence that MON 89034 × NK603 is likely to cause any adverse effects to human or animal health and the environment. Except for its protection against certain lepidopteran insects and its tolerance to glyphosate, MON 89034 × NK603 could not be distinguished from conventional maize.
Field trials with NK603 × MON 810 have been notified in the E.U. since the year 2000 in several countries such as Spain, France, Czech Republic and Germany. No adverse effects to human or animal health and the environment have been observed from the results of the release of NK603 × MON 810 in those countries. Additionally, post-release general surveillance from environments inside and outside the E.U. has shown that NK603 × MON 810 and its single trait parental lines, NK603 and MON 810, are unlikely to pose any risk of adverse effects to human or animal health or to the environment.


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 and NK603 × MON 810 have shown that the risk of potential adverse effects on human and animal health or the environment, resulting from the planned deliberate release of these maize plants for field testing, is negligible:
 The risk of the introduced traits in MON 89034 × NK603 and in NK603 × MON 810 to be the cause of any meaningful competitive advantage or disadvantage in natural environments is negligible. As for any other maize, the likelihood of MON 89034 × NK603 and NK603 × MON 810 to spread into non-agricultural environments is negligible, as their persistence in agricultural habitats and their invasiveness into non-agricultural habitats are unaltered compared to conventional maize.
 There is no potential for gene transfer from MON 89034 × NK603 and from NK603 × MON 810 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 the respective parental lines MON 89034, NK603 and MON 810, MON 89034 × NK603 and NK603 × MON 810 pose negligible risk for adverse environmental effects through their 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 lepidopteran pests. Therefore, the effect of MON 89034 × NK603 and NK603 × MON 810 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 (expressed in MON 89034 × NK603) and of the Cry1Ab toxin (expressed in NK603 × MON 810) for certain lepidopteran pests, the well-characterised mode of action of the cry proteins and the confirmation through studies of no adverse effects found, the risk of an adverse effect on non-target organisms is considered negligible. Further, the potential exposure of non-target organisms to CP4 EPSPS protein expressed in NK603 × MON 810 presents no conceivable mechanism to cause adverse effects because of its properties. 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 and NK603 × MON 810 are not different from conventional maize, and these maize plants were 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 and NK603 × MON 810 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) no additional labour or machinery requirements, allowing both large and small growers to maximize hybrid yields and 7) reduced likelihood for lepidopteran insects to develop resistance to Bt proteins in the case of MON 89034 × NK603, since the combination of the Cry1A.105 and Cry2Ab2 insecticidal proteins in a single plant provides better insect control and offers an additional insect-resistance management tool.
Likewise, the glyphosate-tolerant trait in MON 89034 × NK603 and NK603 × MON 810 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 reducedtillage 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 and NK603 × MON 810 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, 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 × NK603 and NK603 × MON 810 crops and that of their receiving environment. In case any adverse environmental effects, linked to the deliberate release of MON 89034 × NK603 and NK603 × MON 810 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 nonselective 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
22/04/2009 00:00:00
Remarks:

ODBOR BIOLOGICKEJ BEZPEČNOSTI

Bratislava dňa 22. 04. 2009
Číslo: 17784/2009-2.3.-9-ZZP14


R O Z H O D N U T I E

Ministerstvo životného prostredia Slovenskej republiky (ďalej len „ministerstvo“) odbor biologickej bezpečnosti ako príslušný orgán štátnej správy podľa § 2 zákona č. 525/2003 Z. z o štátnej správe starostlivosti o životné prostredie a o zmene a doplnení niektorých zákonov v znení neskorších predpisov podľa § 24 ods. 1 písm. b/ zákona č. 151/2002 Z. z. o používaní genetických technológií a geneticky modifikovaných organizmov v znení neskorších predpisov (ďalej len „zákon“), vo veci ohlasovateľa Centrum výskumu rastlinnej výroby Piešťany, Bratislavská cesta 122, 921 68 Piešťany rozhodlo

t a k t o :

Ohlasovateľovi na základe § 17 ods. 1 písm. a/ a § 17 ods. 2 zákona udelilo súhlas na prvé a každé ďalšie zavedenie geneticky modifikovaných hybridov kukuríc MON 89034 × NK603 (MON-89Ø34-3 × MON ØØ6Ø3-6) a NK603 × MON 810 (MON ØØ6Ø3-6 × MON-ØØ81Ø-6) do životného prostredia v lokalitách Centra výskumu rastlinnej výroby Piešťany: Borovce, Špačince, Gabčíkovo, Sokolce, Tekovské Lužany a Vígľaš - Pstruša s rozlohou pokusných pozemkov max. 70 880 m2 na jednu lokalitu.

Súhlas sa vydáva na obdobie odo dňa nadobudnutia právoplatnosti rozhodnutia do 31. 12. 2011.

Súčasne sa ukladá povinnosť:
- osivo geneticky modifikovaných hybridov kukuríc MON 89034 × NK603 a NK603 × MON 810 uskladniť v takých uzavretých priestoroch Centra výskumu rastlinnej výroby Piešťany, na ktorých prvé použitie uzavretých priestorov na genetické technológie bol vydaný súhlas MŽP SR podľa § 13 zákona č. 151/2002 v znení neskorších predpisov,
- prepravu osiva, vzoriek zrna a častí rastlín k analýzam vykonávať podľa podmienok uvedených vo vyhláške ministra zahraničných vecí č. 64/1987 Zb. o Európskej dohode o medzinárodnej cestnej preprave (ADR),
- osivo prepraviť z uzavretých priestorov podľa bodu 1 priamo na pole k sejbe bez medziskladovania,
- dodržať izolačnú vzdialenosť najmenej 200 m od porastov kukuríc pestovaných konvenčným spôsobom, 300 m od porastov kukuríc pestovaných ekologickým pestovaním a okolo parciel s geneticky modifikovanou kukuricou vykonať obsev konvenčnou kukuricou v šírke min. 8 riadkov,
- pozberanú geneticky modifikovanú kukuricu (zrno, obsev, vzorky analyzované na poli a zvyšky rastlín) zlikvidovať rozdrvením resp. rozsekaním a zaoraním na pozemku. Po ukončení výsevu v r. 2011 nepoužité osivo rozdrviť a inaktivovať, alebo odovzdať spoločnosti MONSANTO SLOVAKIA, s. r. o., Kukuričná 1, 831 03 Bratislava, ktorá zabezpečí prevoz nepoužitého osiva na svoje pracoviská v zahraničí.,
- vyčistiť sejací stroj po ukončení sejby, zberový kombajn po ukončení zberu a sekací stroj po jeho použití,
- z úrody každého geneticky modifikovaného hybridu kukuríc MON 89034 × NK603 a NK603 × MON 810 odobrať na analýzy maximálne 150 kg vzorky (zrna, častí rastlín),
- v prípade analýzy vzoriek GM kukurice v laboratóriu podať Ohlásenie na začatie činnosti podľa §12 zákona č. 151/2002 v znení neskorších predpisov na MŽP SR,
- monitorovať výskyt výdrolu kukuričných zŕn počas nasledujúceho roku po ukončení vegetačného obdobia a predložiť na ministerstvo záznam o výsledku monitorovania. Počas tohto roku platí zákaz pestovania kukurice ako následnej plodiny na tej istej ploche.,
- miesto zavádzania, spôsob zavádzania, plány kontroly zavádzania, monitorovacie plány, monitorovacie techniky, spracovanie odpadu a iné spôsoby nakladania s geneticky modifikovanými kukuricami MON 89034 × NK603 a NK603 × MON 810 dodržiavať tak ako sú uvedené v žiadosti, evidovanej na MŽP SR pod číslom: 2587/2009-2.3-1-ZZP14, doručenej dňa 22. 01. 2009,
- spolupracovať so spoločnosťou MONSANTO SLOVAKIA, s. r. o., Bratislava pri zisťovaní zmien v zavádzaní geneticky modifikovaných hybridov kukuríc MON 89034 × NK603 (MON-89Ø34-3 × MON ØØ6Ø3-6) a NK603 × MON 810 (MON ØØ6Ø3-6 × MON-ØØ81Ø-6) do životného prostredia alebo zmien od jeho predpokladaného priebehu a pri preverovaní dostatočnosti a úplnosti bezpečnostných opatrení v skúšobných lokalitách počas celého zavádzania a po ukončení pokusov v priebehu celého vegetačného obdobia nasledujúceho roku,
- informovať zamestnancov narábajúcich s geneticky modifikovanými kukuricami a ich osivami o povinnostiach uvedených v tomto rozhodnutí.

Toto rozhodnutie nenahrádza ďalšie súhlasy a konania potrebné podľa zákona.


O d ô v o d n e n i e:

Dňa 22. 01. 2009 podal ohlasovateľ Centrum výskumu rastlinnej výroby Piešťany, Bratislavská cesta 122, 921 68 Piešťany návrh na súhlas na prvé a každé ďalšie zavedenie geneticky modifikovaných hybridov kukuríc MON 89034 × NK603 (MON-89Ø34-3 × MON ØØ6Ø3-6) a NK603 × MON 810 (MON ØØ6Ø3-6 × MON-ØØ81Ø-6) do životného prostredia v zmysle § 34 ods. 1 zákona. Svoj návrh opieral o ustanovenie § 17 ods. 1 písm. a/ zákona.
Ministerstvo preskúmalo žiadosť používateľa na zavedenie geneticky modifikovaných hybridov kukuríc MON 89034 × NK603 (MON-89Ø34-3 × MON ØØ6Ø3-6) a NK603 × MON 810 (MON ØØ6Ø3-6 × MON-ØØ81Ø-6) do životného prostredia a doklady, ktoré ohlasovateľ predložil a to najmä údaje o geneticky modifikovanej rastline, o vyšších rastlinách darcu a príjemcu, o genetickej zmene rastliny, o možnom dopade na životné prostredie, ľudské zdravie a zdravie zvierat, o mieste zavádzania a o zavádzaní, o plánoch kontroly zavádzania, monitorovacích plánoch a technikách, stave po zavedení, o spracovaní odpadu, o výsledkoch z predchádzajúcich ohlásení, súhrnný ohlasovací informačný formát, havarijný plán, posudok z posudzovania rizika, plán katastrálneho územia s vyznačením miesta zavádzania v Borovciach, Špačinciach, Gabčíkove, Sokolciach, Tekovských Lužanoch a Vígľaši - Pstruši.
Na základe uvedených skutočností a kladného stanoviska Komisie pre biologickú bezpečnosť zo dňa 2. 4. 2009, ministerstvo vyhodnotilo podmienky na vydanie súhlasu na prvé a každé ďalšie zavedenie geneticky modifikovaných hybridov kukuríc MON 89034 × NK603 (MON-89Ø34-3 × MON ØØ6Ø3-6) a NK603 × MON 810 (MON ØØ6Ø3-6 × MON-ØØ81Ø-6) ako splnené.

Poučenie: Proti tomuto rozhodnutiu možno podľa § 61 zákona č. 71/1967 Zb. o správnom konaní v znení neskorších predpisov podať do 15 dní odo dňa jeho doručenia rozklad na Ministerstvo životného prostredia Slovenskej republiky, Námestie Ľudovíta Štúra 1, 812 35 Bratislava. Rozhodnutie je súdne preskúmateľné.




Ing. Igor Ferenčík
riaditeľ odboru
biologickej bezpečnosti



Doručí sa:
Centrum výskumu rastlinnej výroby Piešťany, Bratislavská cesta 122, 921 68 Piešťany

Na vedomie:
1. SIŽP, Ústrediu inšpekcie biologickej bezpečnosti, Karloveská 2, Bratislava
2. MONSANTO SLOVAKIA, s. r. o., Kukuričná 1, 831 03 Bratislava