Mr Stavros Dimas Commissioner Directorate-General Environment European Commission




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Mr Stavros Dimas

Commissioner

Directorate-General Environment

European Commission

Budapest, 11 September 2006

Subject: Commission decision concerning the provisional prohibition of the use and sale in
Hungary of genetically modified maize (Zea mays L.line MON810)

Dear Commissioner,


I am writing you in relation to the meeting of the Committee on the Release of Genetically Modified Organisms into the Environment that is to be held on 18 September 2006. At the upcoming meeting voting is scheduled on a proposed Commission Decision concerning the provisional prohibition of the use and sale in Hungary of genetically modified maize (Zea mays L.line MON810) expressing the Bt cryIA(b) gene, pursuant to Directive 2001/18/EC of the European Parliament and of the Council.
The Hungarian Government considers that voting on such a proposal would be premature as new scientific information has been gathered in Hungary in relation to the product at issue. New evidence suggests that environmental impacts different from those submitted in the original notification by Monsanto (hereinafter: the notifier) may indeed emerge in the Pannonian biogeographical region as a result of the release into the environment of the seeds of and hybrids derived from the maize line MON810. Consequently, the Hungarian Government invites the European Food Safety Authority (hereinafter: EFSA) to reassess its opinion of 8 June 2005 in the light of the findings presented below, as envisaged by point B (fourth indent) of Annex II to Directive 2001/18/EC1 (hereinafter: the Directive).
This letter provides detailed legal and scientific arguments why the provisional prohibition should be maintained.
1. Introduction and scope of the provisional prohibition
In accordance with Article 23, paragraph (1) of the Directive the Hungarian competent authority provisionally prohibited the production, the use and the placing on the market in the territory of Hungary and import to the territory of Hungary of the seeds of inbred lines and hybrids derived from maize line MON810 (hereinafter: MON810), with effect from 20 January 2005.
The prohibition also extends to progeny originating from crossing with maize bred with the use of traditional plant breeding methods. The prohibition however does not apply to the use of maize containing the gene construction MON810 in the food- and feed industry, neither to transit without repacking and further handling in the territory of Hungary, provided that any accidental or deliberate release into the environment is prevented.
2. The Hungarian submission of 2005
The Hungarian Government immediately informed the Commission of the provisional prohibition and the underlying reasons of its decision. The reasoning of the decision is based on legal and scientific arguments. These arguments have to be seen in the specific historic context of Hungary’s accession to the European Union, in particular that Hungary did not participate in the notification procedure of MON810.
a) Legal arguments
From the legal point of view Hungary noted that the environmental risk assessment undertaken by the notifier did not cover the specific biogeographical conditions prevailing in Hungary. The distinct features of the so-called Pannonian biogeographical region, in which lies the entire territory of Hungary, are recognised by Community legislation (see below). Consequently, the lack of specific testing under the regional conditions falls short of the requirement set forth in the Directive that environmental risk assessments should be carried out on a case-by-case basis, in view of inter alia the specific features of the receiving environment (Annex II, Point B, third indent).
This situation is further aggravated by the fact that at the time of the notification procedure of MON810 Hungary was not a member of the European Union. As a result, it was unable to exercise the participative and control rights under Directive or its predecessor (receipt of documentation, consultations, raising of objections, etc.) which are designed to channel Member States’ potential concerns into the decision-making process. Therefore, in the absence of other avenues, in view of the preliminary scientific concerns outlined below and in order to meet the fundamental obligation of Article 4, paragraph (1) of the Directive, the Hungarian competent authority chose to undertake the provisional prohibition.
b) Scientific arguments
The Hungarian Government submitted scientific arguments in support of the provisional prohibition concerning the extreme production by MON810 of a particular toxin and the accumulation thereof in the soil and the high mortality rate of a protected butterfly as a result of exposure to the pollen of MON810 (see in detail below). It must be pointed out that some of these findings were at a preliminary stage at the time (presented at the International Plant Protection Symposium in Budapest, February 2003), while some of the underlying experimental reports were not yet published at the time of the introduction of the prohibition. Nevertheless, the Hungarian competent authority considered that sufficient evidence had been gathered to reasonably suggest the emergence of a risk to the environment.
3. Consideration of the Hungarian submission by EFSA
Upon the investigation of the documentation included in the Hungarian submission EFSA’s Scientific Panel (hereinafter: the GMO Panel) concluded that there were no new information affecting the available scientific evidence in terms of risk to human health and to the environment that would, on the one hand, invalidate the risk assessment of the genetically modified maize line MON810 conducted under Directive 90/220/EEC and, on the other hand, that would justify a prohibition to cultivation of these genetically modified crops in Hungary. In addition, EFSA claimed that the summaries presented by Hungary were insufficient to draw definitive conclusions on the compliance by Hungarian scientists with accepted international scientific standards. EFSA published its opinion to that effect on 8 June 2005 (EFSA Journal (2005) 228, 1-14.).
It must be pointed out that a large part of the criticism of EFSA relates to the alleged lack of examinations or data that the notifier failed to undertake or submit in the context of its original notification, neither has EFSA requested it to do so!
Even though the Hungarian Government has not been invited to reflect on the conclusions of the GMO Panel, scientists of the Plant Protection Institute of the Hungarian Academy of Sciences, the major contributor to the scientific evidence used in support of the prohibition, forwarded their detailed comments to the EFSA in two separate occasions in 2006.
4. Reasons for a continued prohibition
As in the case of the 2005 submission, the Hungarian Government bases its plea for a continued prohibition of MON810 on legal and scientific arguments. The legal arguments are based on the construction of the Directive in view of the precautionary principle and of the Community’s nature conservation legislation. The scientific arguments are based on new findings arrived at as a result of continued testing that has been commissioned by the Hungarian Government.
a) Legal arguments
The underlying principle of the Community regime relating to the release into the environment of genetically modified organisms is the precautionary principle and the principle that preventive action should be taken. Recital (8) of the preamble to the Directive states that “[t]he precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it”. Application of this principle is a fundamental objective of the Directive (Article 1) and a general obligation of the Member States (Article 3 (1)). Derived from this principle is the basic duty that “Member States shall […] ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs.” (Article 3 (1)).
Implementation of the precautionary principle presupposes the conduct of adequate environmental risk assessments. Recital (19) calls for a case-by-case environmental risk assessment prior to release while recital (25) specifies that such assessment should include a “[…] satisfactory field testing at the research and development stage in ecosystems which could be affected […]”. Article 4, paragraph (3) of and Annexes to the Directive make it clear that a “case-by-case” environmental risk assessment implies that risks have to be assessed according to the nature of the receiving environment and that, as a result, “the required information may vary […] depending on the potential receiving environment” (Annex II, Point B).
It follows from the foregoing that a “competent authority should give its consent only after it has been satisfied that the release will be safe for human health and the environment” (recital 47).
In Hungary’s view the wider receiving environment of any genetically modified organisms is main classification unit of the Community’s nature conservation legislation, that is the biogeographical regions. Consequently, so long as no adequate environmental risk assessment takes place for a specific biogeographical region, any release of the particular GMO in that region would run counter the spirit and letter of the Directive, and the obligations laid down in Article 4, paragraphs (1) and (3) in particular (it must be underlined that the latter obliges not only the Member States but also the Commission to see to it that adequate testing does take place). Insufficient testing in the particular biogeographical region may also lead to a breach by Member States of their obligations under Directive 92/43/EEC2 (hereinafter: the Habitats Directive) or Directive 79/409/EEC3 (hereinafter: the Birds Directive) to maintain and protect animal and plants species as well as habitats enjoying Community protection.
In the context of the present case it should be noted that the environmental risk assessment used as the basis for notification has not been carried out for Hungary and the Pannonian biogeographical region.
b) Scientific arguments
The scientific arguments submitted by the Hungarian Government in support of the continuation of the provisional prohibition are twofold. First, the Hungarian Government maintains that the Pannonian biogeographical region is characterised by such ecological and geographical features that render it different from any other biogeographical region for the testing of GMOs. Second, in 2005 the Hungarian Government commissioned independent scientific research institutions to carry out a comprehensive testing of MON810 in the Pannonian biogeographical region. Results available after one year of testing suggest the emergence of adverse environmental effects that justify further research and, consequently, the maintenance of the provisional prohibition.
The Pannonian biogeographical region
Biogeograpical regions are the fundamental categories of the Community’s nature conservation nomenclature, delimiting geographical areas of distinct ecological, climatic, etc. features. Following amendments by the Accession Treaty a total of 7 regions are distinguished in the biogeographical map of Europe under the Habitats Directive (Article 1 (1) (c)) of which the Pannonian biogeographical region comprises primarily the territory of Hungary, together with surrounding areas of similar biogeographic characteristics.
Ecological sciences apply the technical term “Pannonian biogeographical region” to designate a set of clearly distinguishable habitat types and ecosystems having special individual features (see point 1 of the Annex to this letter). They also have been recognised by the Community by way of its inclusion in the Habitats Directive as an independent region as well as the listing in the relevant annexes to the Birds and the Habitats Directive of a large number of new species and habitat types that are endemic in this biogeographical region.
It also must be pointed out that the presence of the specific features of the Pannonian biogeographical region is not limited to areas submitted by Hungary for inclusion in the Natura 2000 network and/or subject to national conservation measures (some 21% of the territory of Hungary). Experience shows that populations of species that are characteristic of the traditional agricultural landscape as well as the genetic stock of such species are also becoming increasingly endangered. Since the population genetic uniqueness of these indigenous species cannot be ignored relevant testing should be carried out only on the domestic populations, in the domestic ecological environment.
Testing of MON810 in the Pannonian biogeographical region
In May 2005 the Hungarian Ministry of Environment and Water commissioned the Plant Protection Institute of the Hungarian Academy of Sciences to undertake additional research on the environmental impacts of MON810 in the Pannonian biogeographical region. This research draws upon the findings of previous research activities undertaken by the Institute at its own account (findings cited under section 2 b) above).
The environmental risk assessment has been in progress for over a year. Nevertheless, substantive results can only be expected after several years, taking into account of the adaptation to biological cycles. Even though the research activities have not yet been finalised but in four areas problems have been identified. Several studies are expected to be completed and closed in 2006.
Below is a summary of the findings as available in mid 2006. Details of the research methods and findings concerning the Bt-maize originating from the DK-440-BTY MON810 event are provided in point 2 of the Annex to this letter. The Annex also addresses, as appropriate, the critical remarks of the 2005 EFSA opinion.
I./ Extremely high production of ~Cry1A-toxin per hectare
Measurements have revealed that the DK-440-BTY Bt-maize produces, through its organic matter production per hectare, about 1500-2000 times more (!) ~Cry1A-toxin, than is permitted in Hungary to be used for the treatment of a hectare of crop in the form of DIPEL4.

II./ Very slow decomposition of ~Cry1A-toxin in stubble residues
8% of the ~Cry1A-toxin measured in the stubble residues of the DK-440-BTY Bt-maize was still a detectable quantity after the passage of 11 months.
III./ Decreased activity of organisms living in soil containing Bt-stubble residues
During two years scientists carried out testing directly after harvest (September 2001 and August 2002) and then more than half a year after harvest (April 2003). On each occasion significantly lower activity levels in the soil under maize producing Cry1A-toxin was found than in the soil under the isogenic maize.
IV./ High mortality of hatching caterpillars of protected butterflies exposed to MON810 pollen
Some 16% of the 186 protected butterfly species in Hungary live in ruderal areas and during the period of pollen shedding they may come into contact with Bt-containing pollen. This includes in particular the first stage larvae of the protected butterflies feeding on nettle species such as Inachis io (European peacock) and Vanessa atalanta (Red Admiral) along with the also rare species Polygonia c-album (Comma).
Scientists have discovered that on nettle plants within 5 metres of the MON810 event maize field a critical quantity of ~Cry1A-toxin can occur which may kill some 20 % of the Inachis io population hatching there.

5. Conclusions
The Community’s legal regime concerning genetically modified organisms is based on the strict application of the precautionary principle. In view of this principle the Directive does not only allow but also requires Member States to ensure that no GMOs are released so long as their potential impacts on the receiving environment have been adequately tested.
The Directive foresees a case-by-case environmental risk assessment that takes account of the variety of the different environments where GMOs are intended to be released. This requirement, together with the Community’s nature conservation legislation, leads to a conclusion that as a precondition of authorisation adequate environmental risk assessment should take place at least at every distinct ecological unit of the European Union, i.e. every biogeographical region where the GMO at issue is to be used.
It is clear from the notification of MON810 that no such risk assessment has been undertaken with regard to the Pannonian biogeographical region. Therefore, the Hungarian Government has commissioned independent research concerning the potential environmental impacts of MON810. The findings of these research activities reveal that serious environmental consequences are likely to emerge in relation to the soil and certain protected butterfly species. In line with the spirit and the letter of the Directive such findings necessitate further in-depth research as well as justify the continuation of the provisional prohibition. Lifting the prohibition would result in Hungary’s breaching its obligations under Article 4, paragraph (1) of the Directive to avoid adverse effects on the environment which might arise from the deliberate release of GMOs, as well as its obligations to maintain the favourable conservation status of wild flora and fauna under the Community’s nature conservation legislation.
Given the lack of sufficient testing of MON810 with regard to the Pannonian biogeographical region, in view of the scientific evidence already gathered on the environmental consequences of this product, as well as the unique historic situation, namely that Hungary did not take part in the original authorisation procedure, the Hungarian Government requests the Commission to reconsider its position concerning the provisional prohibition introduced by the competent authority in 2005.

Sincerely yours,

Dr. Miklós Persányi

Minister of Environment and Water



Annex
Detailed scientific arguments
1. Distinct features of the Pannonian biogeographical region

The Pannonian Basin is regarded both by ecology and nature conservation – as well as two EU directives: Birds Directive and the Habitats Directive – to be a separate and special ecological region. Proofs of the distinctive nature of the region include the phytogeographic and zoogeographic features (Varga, 1995; 2003; Komlódi, 2003) and habitat type characteristics of the Pannonian Basin (Fekete and Varga, 2003); with its practical consequence in the form of the Hungarian laws on nature conservation specifying species and habitat types under protection (Anonymus 1996; 2001). The “habitat types of community interest” listed in Annex I to the Habitats Directive includes a number of habitats (including “priority habitat types”) that are specific (i.e. exclusive) to the Pannonian biogeographical region with a number of habitats of Illyrian nature, meaning that they are only to be found in Hungary and Slovenia. Annex II to the Habitats Directive lists 12 Pannonian species as special endemism, 21 Pannonian and/or Carpathian (Dacian) endemisms, 41 species significant for the Pannonian region as typical species of Pannonian habitat types. 32 species were suggested by the Accession Countries and accepted in the course of the accession negotiation, out of which 29 were submitted by Hungary (Varga, 2005). 


2. Detailed comments concerning the Bt maize originating from the DK-440-BTY MON810 event
I./ ~Cry1A-toxin production per hectare
According to the measurements taken by Székács et al., (2005) (also in Németh, 2005): the DK-440-BTY Bt-maize produces, through its organic matter production per hectare, about 1500-2000 times more ~Cry1A-toxin, than is permitted in Hungary to be used for the treatment of a hectare of crop in the form of DIPEL.
The concentration of the ~Cry1A toxin protein was measured in the DK-440-BTY Bt-maize by applying an immune-analytical method. The analytical quantity measurement was carried out using the enzyme linked immunoassay (ELISA) system of EnviroLogix Inc. (Portland, ME, USA). The ELISA method detects Cry1Ab and Cry1Ac proteins, its detection limit is 0.14 ng/ml (ppb) for the Cry1Ab toxin protein in the extract (for Cry1Ac toxin protein it is 1.2 ng/ml). The so-called sandwich ELISA method can detect the Cry1Ab lectin protein in a concentration range of 0.14-10 ng/ml within which in the concentration range 0-5 ng/ml it provides a colour intensity signal that is linear with the lectin protein concentration. Accordingly, in the tests the scientists applied four calibrating concentrations (0, 0,5, 2.5 and 5 ng/ml), where the correlation coefficient (r2) of the linear correlation between lectin protein concentration and the signal level was found to be between 0.989 and 0.998.
By applying the ELISA method the scientists also established the distribution of the ~Cry1A-toxin protein within the DK-440-BTY Bt-maize along with the seasonal changes in the concentration to the toxin in the various plant organs. In respect of the concentrations measured in the plant organs we found the following order leaf > anther > root > stem > fruit > pollen, while – in view of the weights of the various plant organs – in respect of the absolute quantities of toxin produced, the following order was found leaf > stem > fruit > root > anther > pollen. To enable interpretation of the measured toxin protein concentrations, with the aid of the above ELISA method the scientists established the ~Cry1A-toxin content of the biological crop protection chemical DIPEL (Valent Biosciences), and found that the per-hectare toxin quantity calculated from the toxin concentrations measured in the plant organs and multiplied by their weight factors exceeded the one-off dosage of the DIPEL product by some 1500-2000 times. The scientists are currently working on an extended version of these measurements.
II./ Decomposition of stubble residues
According to the measurements taken by Székács et al., (2005): the 8 % proportion of the ~Cry1A-toxin measured in the stubble residues of the DK-440-BTY Bt-maize was still a detectable quantity after the passage of 11 months.
The 8 % toxin content was not measured in the soil, it was measured in the stubble residue found in the soil, in which the concentration of the ~Cry1A-toxin protein was, after the passage of 11 months, still 8 % of the level measured in October in the preceding year. The findings of the scientists concerning decomposition of the maize residues containing Bt-toxin (DK-440-BTY) and the near isogenic (DK-440) maize residue based on animals and micro-organisms living in the soil are identical with those laid out in the documents produced by the EFSA GMO Panel.
III./ Decreased activity of organisms living in soil containing Bt-stubble residues
A variety of techniques are available for estimating the biological activity of soil. One such method is von Törne’s ‘bait lamina’ test. The method and its applicability is discussed by Kratz (1998). The EU Committee on Toxicity, Ecotoxicity and the Environment found the technique suitable for measuring the feeding activity of the invertebrate fauna of the soil. (CSTEE, 2000). Accordingly, the choice of method must be regarded to be adequate. Irrespective of whether the method is used for measuring total biological activity or feeding activity, from the aspect of the research of the scientists the only relevant factor is whether or not there is a difference between the control group and the GMO group.
In two years the scientists carried out the ‘bait lamina’ test directly after harvest (September 2001 and August 2002) and then more than half a year after harvest (April 2003). On each occasion the scientists found significantly lower activity levels in the soil under maize producing Cry1A-toxin than in the soil under the isogenic maize. The EFSA GMO Panel has discussed biological activity in general – primarily with respect to micro-organisms –but they have not delivered an opinion on biological activity measured on soil fauna with the ‘bait lamina’ method applied by the Hungarian researchers.
According to Biró et al., (2002; 2005) the number of microbe groups (heterotrophic, oligotrophic organisms, sporogenous organisms and microscopic fungi, including the Trichoderma sp. controlled for species composition as well) cultured in the rhysosphere of the Bt-maize and the isogenic maize also showed seasonal changes depending on the method applied and the features of the group studied. The increased activity of the total microbe mass identified by hydrolysis of fluorescein-diacetate was explained by the authors based on the different biological and eco-physiological characteristics of the Bt-maize. For lack of continued funding the effect has not been clarified to date despite the fact that the difference of the plant material’s composition had also been indicated by the preliminary tests of the C:N ratio (Villányi et al., 2002). Owing to the initial colonisation disadvantage of endo-symbiotic (arbuscular mycorrhiza) and the slower rate of decomposition of Bt-maize residues the authors proposed continued testing in long term experiments with respect to micro-organisms as well.
IV./ The effect of MON810 pollen on hatching caterpillars of protected butterflies
Some 16 % of the 186 protected butterfly species live in Hungary in ruderal areas and during the period of pollen shedding they may come into contact with Bt-containing pollen (Darvas et al., 2004a). This includes particularly the first stage larvae of the protected butterflies feeding on nettle species such as Inachis io (European peacock) and Vanessa atalanta (Red Admiral) along with the also rare species Polygonia c-album (Comma). These butterflies feed on nettle plants, the third most common species on the edges of maize fields in Hungary.
According to the EFSA GMO Panel this issue is relevant in the present case but it is not sufficient for a complete risk analysis, for the following reasons:
i./ no testing of acute impact was carried out;

ii./ the pollen density was tested using sticky sheets, without taking leaf surface ratios and orientations into account;



iii./ effects of other environmental factors (e.g. rain, wind, application of pesticides, edge row effect) were not tested.
By contrast, the opinion of Darvas et al., based on five years of experiments, is as follows:
- ad point i./: on nettle plants within 5 metres of the MON810 event maize field where the pollen contains low levels of toxin (Darvas et al., 2004a Figure 4) a critical quantity of ~Cry1A-toxin can occur which may kill some 20 % of the L1 stage Inachis io population hatching there (Darvas et al., 2003a; 2004b). This has been confirmed by control tests carried out since using the DIPEL product which have proven that protected caterpillars living on nettle species are more sensitive - by several orders of magnitude - to the Cry1-toxin than the concentrations applied against pest species (Lauber et al., 2006a). Accordingly, in comparison to the assertion the scientists have data on acute effect;
- ad point ii./: pollen density was counted not only on black sheets covered with silicon oil but also on the maize leaves as well as on silicon oil sheets fixed on leaves in parallel with the leaf blades (Darvas et al., 2004a, Figure 2). The scientists did measure the leaf surface and compared it to the leaf weight (Darvas et al., 2004a, Figure 6). Comparable data concerning the leaf surface orientations are also demonstrated in Figure 2 presented by Darvas et al. (2004a). The silicon oil sheets fixed on the leaves followed their natural position of the leaves. Accordingly, the methods applied by the authors took account of the orientations of the leaf surfaces as well as other relevant versions;
- ad point iii./: the scientists carried out the experiments under field conditions. In 2001 and 2004 there was no rainfall during the two weeks of the typical period of pollen shedding of the species while in 2005 rain fell during this period. This question can, however, be answered by a meteorologist by analysing the time series of the month and a half that is characteristic of the varieties produced in Hungary, to a certain degree of probability. In contrast to the GMO Panel’s argument the scientists followed circular pollen distribution in the nearby field and measured a pollen density in the dominant wind direction six times high as in other directions (Darvas et al., 2004a). The GMO Panel is not familiar with the crop protection practices applied in Hungary: no chemical is applied to maize fields, and this applies especially to the pollen shedding period. Some attempts have been made during recent years to spray fields by aircraft to protect the crop against corn rootworm (Diabrotica spp.) but the high price and the low effectiveness of the chemical caused by the poor penetration of the solution (maize is about 2 metres tall at this time), this attempt has been abandoned.
The effects of the three outside rows were also tested and it provided an adequate safety level for the caterpillars of the protected butterflies in the case of the MON810 event variety group and from the aspect of non-intraspecific hybridisation (Darvas et al., 2004a, Figures 3-4). It must not be assumed however that the application of three rows of non-modified parent plants would not have serious deficiencies – as a consequence of its difficulty to accomplish and the impossibility of controlling – anywhere in practice. Indeed in spots of irregular shapes in fields under water pressure, where the crop is mixed with weeds, this solution is simply not one of the possible alternatives.
The GMO Panel considers the collection of the following data to be necessary for a sound risk analysis:

A./ proof of coincidence of pollen shedding in maize and the larval activity of protected caterpillar species;

B./ sizes of populations of protected caterpillars on weeds thriving along maize fields;

C./ assessment of the modes of cultivation planned to be applied in Hungary;

D./ total size of fields under maize varieties of the MON810 genetic event.
The answers of the authors are the following:

- ad point A./: relevant data accumulated to date in Hungary, from the Lepidoptera Collection of the Hungarian Natural History Museum, definitely confirmed the coincidence, see again Darvas et al., (2004a) Figure 8., which is the most important message of the scientists’ paper and which was not taken on by the GMO Panel;

- ad point B./: identifying or giving a good estimate of the part of the affected population is highly labour intensive. However, the National Nature Conservation Master Plan produced on the basis of Act LIII of 1996, prescribes the following: „TEV-5. Protection of natural habitats, particularly those of endangered plant and animal species, shall be ensured.” Accordingly, populations of protected species must not be thinned or destroyed by any means; indeed, unchanged quality of their habitats must be preserved. Therefore, the level of tolerance of deviation from the natural state is zero (see also, the proposal for tests on positions of nettle leaves, possible rains, wind directions and strengths etc.). On the other hand, the pollens of plant species producing the insect-pathogen Cry-toxin definitely violates the unchanged status that is prescribed by law concerning the type of habitat in question, where the caterpillars of protected butterflies hatch;

- ad points C./ and D./: estimation is not a task for environmental science. The Hungarian submission is based on environment scientific research – tests and experiments – therefore these points are irrelevant.


V./ Conclusions
In the course of the experiments and tests carried out in Hungary on DK-440-BTY Bt-maize it was found that the concentration of the ~Cry1A-toxin protein in the parts of Bt-maize plants could be identified using the ELISA method. The Toxin protein is produced in the largest concentrations and absolute quantities in the leaves and the per-hectare quantity of the toxin protein produced by the DK-440-BTY Bt-maize in the maize fields exceeds the permitted dosage of the biological plant protection product called DIPEL by some 1500-2000 times. Some 8% of the ~Cry1A-toxin contained in plant parts remaining in the fields in the form of stubble residue can still be identified and measured during the next year.
For lack of an adequate quantity and quality of tests it cannot be stated that the production of MON810 genetically modified plants in Hungary is safe from the aspect of the soil fauna and the functions they affect. The above findings are indicative of possible risks.
Based on traditional – not adequately representative – population growing methods the scientists checked the total microbial activity and the operability of the plant-microbe relationships from the aspect of one characteristic. The findings were indicative mostly of indirect impacts whose clarification requires additional extended tests.
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1 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

2 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild flora and fauna

3 Council Directive 97/409/EEC of 2 April 1979 on the conservation of wild birds

4 DIPEL is an insecticide produced by Bacillus thuringiensis



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