The History and Background of the Hungarian MoratoriumVeronika Mra

The evolution of the Hungarian GMO regulation

Main regulatory issuesALL activities related to gene technologies (establishment of laboratories, filed trials, marketing, transport) require approval, except for contained experiments of a purely scientific nature (but these should also be announced).

Permission request (dossier)

Pre-evaluationExpert opinion and recommendation

Votes by simple majority, except for marketing decisions, when a qualified majority is needed. The negative opinion of the Committee cannot be overturned by the authority.

Authorities at relevant ministries depending on the type of use (agriculture, medicine etc.)

Gene Tecnology Advisory Committee

Ministry of Environment and Waters binding opinionComposition:6 representatives of the Academy of Sciences (different fields of expertise)5 representatives of various ministries (Agriculture, Environment, Health, Education, Economy) NOT civil servants!1 representative of health protection NGOs1 representative of consumer NGOs4 representatives environmental NGOs

Experience since 1999

1+3 years of field trials required before seed registration.

App. 55 field trials (varieties):species: corn, sugar beet, rape seed, tobacco, potato, (experiments discontinued in 2001), wheat, poplar trees (latter ones dont aim at direct commercialisation); traits: glyphosate tolerance (RR), gluphosinate tolerance, pest resistance (Bt), virus resistance (against Y virus); area never exceeded 12 ha altogether all around the country;First request for marketing approval was filed and deferred in 2004.

Implementation and administrative oversight:field trials: regular control during the vegetation period of the isolation distances, protection against theft and animals, eventual destruction of the harvest (burning);seeds: control for the adventitious presence of GMOs in imported seed stocks. Many elevators also require certification!food: agency to randomly control imports necessary laboratory background only built up last year MAIN SHORTCOMING, labelling is thus not really implemented yet.

The moratoriumAnnounced by the Minister for Agriculture and Rural Development on 20 January 2005, using the safeguard clause (Art 23.) of the 2001/18/EC Directive- such a measure must be based on new scientific information on health or the environment!

Main arguments:1.) Preliminary results of the independent risk assessment research carried out by the Plant Protection Institute of the Hungarian Academy of Sciences and the St. Istvn University2.) Lack of testing under the circumstances of the Pannonian biogeographic region

Scientific arguments I.Research started in 2001 and was officially commissioned by the Ministry of Environment and Waters is 2005 results:

I./ Extremely high production of ~Cry1A-toxin per hectareMeasurements 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 DIPEL[1]. II./ Very slow decomposition of ~Cry1A-toxin in stubble residues8% 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 residuesDuring 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.Rearrangement of the soil nematode community (change in the composition of species).Some springtail species (Folsomia candida) differentiate between conventional and Bt corn, and avoid the consumption of the latter of offered the choice.

[1] DIPEL is an insecticide produced by Bacillus thuringiensis

Scientific arguments II.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.

V./ Resistance of pests evolves relatively fastLepidopteran pests fed with ~Cry1A-toxin containing corn develop resistance in 10 generations.

The Pannonian biogeographic region

Legal argumentsWhen the MON810 was tested and approved in the EU (1998), Hungary hasnt yet been a member MON810 wasnt tested under the ecological conditions of the Pannonian region as prescribed by the Directive.The application of the precautionary principle: EFSA consistently refuses findings and arguments challenging authorisation vs.competent authorities have an obligation to halt the proceedings and investigate the matter in depth until they can fully make sure that negative impacts on the environment and human health can be excluded.

Political argumentsHungary is a significant Euro-pean exporter of corn, including seeds! 1,5 million ha areaEuropean public opinion refuses GMOs (Eurobarometer: 58%) Hungary is among the top five countries Buyers request GMO free certificates this status provides Hungary a competitive advantageCorn borer is not a significant pest in Hungary MON810 does not offer any advantage to farmersThe 10-year authorisation of MON810 is currently being re-evaluatedWith the new, stricter environmental risk assessment criteria, it is questionable whether it can remain on the market

Parliamentary DecisionAdopted with consensus of all of the five parties of the Parliament (rare case in Hungary) on 27 November 2006, same day when the amendment of the GMO Act.

The Decision declares thatthere is a need for further research regarding environmental impacts on the Pannonian biogeographical region of genetically modified plant species which already have a consent within the EC scientific research on environmental impacts of the maize line MON810 has to be continued in the future as wellthe coexistence of genetically modified crops with conventional and organic farming must be strictly regulated in a way which ensures that the crop production can be supervised and traced effectivelyHungary has to use every effort in order to achieve that the European regulation on gene technological activities reflects the interests of the European citizens and local communities in a better way; minimizes the environmental and social risks of GMOs; and creates conditions for covering the extra costs of the society connected with the application of the gene technology by those who are responsible for creating such expenses. strong mandatethe Hungarian Government has to carry out an effective and well balanced mass communication campaign on the impacts of growing genetically modified seedsthe Hungarian Government has to increase the severity of the national supervision system, has to ensure the effective operation of the monitoring system as well as to strenghten its institutional backgroundthe Hungarian Parliament calls upon the civil society, parties and media in order to help that the Hungarian society become acquainted with the above mentioned questions.

The process of Hungarian co-existence approvalProducerLicencePreliminary approvalAuthorityFinal approvalSeed purchasePlantingNeighbours agreeRecordPublic registerSeed distributors keep recordControlPractical application isquestionable!

The history of the moratorium since 2005EFSA opinion issued in summer 2006 but not distributed it among member statesCommission proposal to lift the moratoriumVoting in the Regulatory Committee 18 September 2006: no qualified majorityVoting in the Environmental Council 20 February 2007: qualified majority rejected the Commission proposal to lift the moratorium (FIN, NL, SE & UK in favour of the proposal, RO abstained) An issue of national sovereignity

Meeting between the EFSA and the Hungarian authority and experts 11 June 2008 no questions were raised regarding the Hungarian arguments presented thereEFSA opinion issued 2 July 2008 no new scientific data had been presented, lack of dialogue with Hungarian scientistsRenewed Commission proposal upcoming voting the the Environmental Council scheduled for the 2nd of March 2009

Thank you for you attention!

Veronika Mramove@okotars.hu