The History and Background of the Hungarian Moratorium

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The History and Background of the Hungarian
Moratorium

• Veronika Móra

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The evolution of the Hungarian GMO regulation
1996/LIII Framework Act on Nature Conservation call for relevant regulation
1998/XXVII Act on Gene technologies amended in 2002 (transposing EU 2001/18) - amended in 2006 (including a new chapter on co-existence regulations)
82, 128/2003 Implementation decrees by the Ministry of Agriculture and Rural Development
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Main regulatory issues ALL 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-evaluation Expert 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
Composition 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 NGOs 1 representative of
consumer NGOs 4 representatives environmental NGOs
Ministry of Environment and Waters binding
opinion
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Experience since 1999

• 13 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.

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The moratorium

• Announced 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. István University
• 2.) Lack of testing under the circumstances of
  the Pannonian biogeographic region

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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
  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 DIPEL1.
• 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.
• 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

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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 fast Lepidopteran pests fed with
Cry1A-toxin containing corn develop resistance
in 10 generations.
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The Pannonian biogeographic region
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Legal arguments

• When 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.

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

• Adopted 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 that
• there 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 well
• the 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
  effectively
• Hungary 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 mandate
• the Hungarian Government has to carry out an
  effective and well balanced mass communication
  campaign on the impacts of growing genetically
  modified seeds
• the 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 background
• the 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.

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The process of Hungarian co-existence approval
Producer
Licence
Public register
Preliminary approval
Authority
Final approval
Record
Seed purchase
Neighbours agree
Planting
Seed distributors keep record
Practical application is questionable!
Control
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The history of the moratorium since 2005

• EFSA opinion issued in summer 2006 but not
  distributed it among member states
• Commission proposal to lift the moratorium
• Voting in the Regulatory Committee 18 September
  2006 no qualified majority
• Voting 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 there
• EFSA opinion issued 2 July 2008 no new
  scientific data had been presented, lack of
  dialogue with Hungarian scientists
• Renewed Commission proposal upcoming voting the
  the Environmental Council scheduled for the 2nd
  of March 2009

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• Thank you for you attention!
• Veronika Móra
• move_at_okotars.hu