Parliamentary Commissioner
for Future generations

CONTRIBUTION OF THE PARLIAMENTARY COMMISSIONER FOR FUTURE GENERATIONS OF THE REPUBLIC OF HUNGARY
TO THE PUBLIC CONSULTATION ON THE CULTIVATION OF GENETICALLY MODIFIED ORGANISMS ORGANISED BY THE EUROPEAN COMMISSION

The content of this questionnaire is identical to the one submitted to the survey conducted by GHK Consulting Ltd. entitled “Evaluation of the EU legislative Framework in the Field of Cultivation of GMOs under Directive 2001/18/EC and Regulation(EC) No 1829/2003 and marketing of their other uses under Directive 2001/18/EC – Stakeholder Consultation: E-survey for Other Stakeholders”. The survey forms part of the review procedure initiated by the European Commission concerning the authorisation of genetically modified organisms for cultivation.

September 2009

1 - The objectives of the legislation

The stated objectives of Directive 2001/18/EC and Regulation 1829/2003 are, broadly, to protect human and animal health, the environment and consumer interest, while ensuring the effective functioning of the internal market.

Q1To what extent do you agree that the current objectives of the EU legislation as it relates to cultivation of GMOs are in line with the needs of society?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

Neither the legislative framework, nor its current application can ensure the realisation of the above objectives.

The legislative framework suffers from a fundamental systemic deficiency that necessarily leads to a conflictual and dysfunctional implementation. Notably, the release into the environment of GMOs for cultivation is predominantly considered as an internal market (trade) issue and, consequently, is subjected to a “free movement of goods”-type of legislation (use of Art. 37 and 95 as a legal basis). This approach completely overlooks the following important facts that render GMO cultivation substantially different from all other products uses. (i) First, cultivation of GM crops is not just an ordinary use of a product, but also constitutes an irreversible intervention into nature with potentially hazardous consequences. Once released, GMOs cannot be withdrawn from the environment. No need to demonstrate that it is not comparable to the ordinary use of e.g. consumer goods (such as driving a car). (ii) Second, not only is cultivation more than an ordinary use of a product, but the impacts of such a use differ greatly according to the actual receiving environment. Consequently, the cultivation of GMOs is always a local, regional phenomenon. Given that the legislative framework does not adequately address the irreversible nature and local character of the cultivation, it will continue to fail to afford appropriate protection to human and animal health, to the environment and to consumer interests.

The above factors necessarily result in a controversial application of the legislative framework. The authorisation system as it stands today is criticised by industry for its unpredictable operation while it is constantly attacked for its biased pro-cultivation application by almost all other stakeholders. The political circumstances surrounding authorisation (i.e. the mainly opposing stance of the majority of Member States to cultivation, the Commission’s indiscriminate support to EFSA’s opinions and the inherent inability of the committee procedure to manage this conflict in a balanced manner) have completely undermined public trust in the existing framework. So long as the current authorisation system remains in place and the political circumstances, in particular the Commission’s uncritical attitude to EFSA’s opinions remain unchanged the system will continue to result in highly contested and politically motivated authorisations.

The needs of society are completely overlooked in the current legislative framework. The underlying internal market orthodoxy of the authorisation system considers the question of the needs of society (i.e. whether the cultivation of GMOs brings along any social benefit) irrelevant. So long as a GM crop passes the technical tests it is automatically considered as a product that is subject to the principle of free movement of goods.

How should they be changed?

The existing legislative framework should be comprehensively revised with a view to redressing the balance between social, environmental needs and market considerations. This requires the overhauling of the underlying internal market philosophy of the legislation along the following lines. (i) First, cultivation of GMOs should be considered as a local matter in accordance with the “prevention” and the “source” principles laid down in Article 174.2 of the Treaty. (ii) Consequently, Member States should be able to decide whether they expose their soil, flora and fauna to the potential or proven hazards of GMO cultivation, especially where there is no social or economic need for such cultivation (or these needs militate against) or where it is probable that the environmental and public health concerns outweigh the potential benefits. (iii) Third, in view of the “precautionary principle” (Art 174.2) the environmental and health risk assessment of any GMO crop, food and feed should be considerably strengthened and opened up for independent peer review. Today, authorisation is granted not in view of conclusive scientific evidence but as a result of EFSA’s (self-declared) monopoly to decide over which information is scientific and relevant. Member States and independent researchers are barred by procedural obstacles and intellectual property constraints from testing the environmental and public health effects of GMOs in a rigorous and transparent manner.

2 - The scope of the legislation

Background briefing:

The current EU legislation defines a GMO as "an organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination". It covers organisms derived from:

- Recombinant nucleic acid techniques;
- Techniques involving injecting heritable material into an organism, prepared outside this organism;
- Cell fusion or hybridisation techniques where live cells with new combinations of heritable or hybridisation genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

But the science continues to develop. In its report "New Techniques in Plant Biotechnology", The Netherlands’ Commission on Genetic Modification (COGEM) has argued that it is unclear whether the prevailing GMO legislation covers:

- reverse breeding;
- agroinoculation;
- gene silencing (by DNA methylation or RNA degradation;
- grafting on GM rootstock;
- site-directed mutation using oligonucleotides;
- site-directed insertion using homologous recombination.

Q2 Would inclusion of the new techniques that we have listed above raise new issues in terms of the socio-economic impacts, environmental impacts or health impacts (please provide examples and evidence where possible)?

No information.

Q3 What would be the socio-economic, environmental or health impacts of excluding any of the above new techniques (please provide examples and evidence where possible)?

No information.

Q4 What changes are required for the legislation to accommodate new techniques in the future?

No information.

3 - Risk assessment

3.1 Issues with the legislation governing authorisation for cultivation of GMOs

Background briefing:

Under the legislation, all applications for GMOs must undergo a risk assessment. For those submitted under the Directive 2001/18/EC, and those submitted under the Regulation 1829/2003 whose scope includes cultivation, an environmental risk assessment must also be completed. It is the responsibility of applicants to complete the risk assessment, and provide the evidence on which their conclusions are based. Member States and EFSA are then responsible for assessing the quality of this risk assessment. If either feels that the information submitted is inadequate, additional information can be requested.

For applications whose scope includes cultivation, an applicant has a choice:

- the application in its entirety is subject to Regulation (EC) No 1829/2003 under the "one door, one key" principle with authorisation for the deliberate release of the GMO into the environment in accordance with the criteria laid down by Directive 2001/18/EC, and the authorisation to use the GMO in food or feed managed in accordance with the criteria laid down by Regulation (EC) No 1829/2003; or
- the application - or part of the application - is submitted both under Directive 2001/18/EC and Regulation (EC) No 1829/200.

3.1.1 General questions

Q5 To what extent are the current procedures for risk assessment...

a) ...Transparent (i.e. the process, and the basis of the decision, are clear to those outside it)?     Not at all - Somewhat - A great deal
b) ... Efficient?        Not at all - Somewhat - A great deal

Please justify your response:

Any risk or impact assessment procedure has at least two mandatory elements: (i) a technical assessment phase and (ii) a (political/institutional) decision-making phase. In order to ensure a transparent and efficient assessment of risks, the underlying legislative and institutional framework as well as its implementation must meet certain fundamental criteria such as the uniformity of the assessment procedure (both (i) and (ii)), strong institutional guarantees against conflicts of interest, the availability of a review procedure of the technical results and the decision. The existing system fails to meet these requirements for at least the following reasons:
-    Lack of procedural consistency: at present a notifier of GM food, feed and cultivation may leapfrog the (otherwise much criticised) institutional guarantees of the Directive simply applying the less cumbersome Regulation. Such a choice provides the notifier with an unjustified benefit and deprives Member States from certain important guarantees (such as the national safeguard measures). Such unjustified and market-distorting forum-shopping a priori undermines the transparency and the fairness of the assessment procedure, regardless of the actual quality of the technical assessment.
-    Conflicts of interest: while certain guarantees exist so as to ward off certain inappropriate personal links between the notifier and the decision-makers (notably EFSA) these are insufficient to prevent a series of more fundamental conflicts of interest. These include:
   o    the notifier carries out the risk assessment with no mandatory external supervision (in-built bias);
   o    much of the data of the technical risk assessment phase are subject to commercial secrecy and thus remain inaccessible even to Member State authorities.
-    Lack of review procedure: the existing legislative framework does not provide for an institutional review procedure of the technical assessment phase. Member State authorities cannot require the notifier or any independent body to repeat or carry out additional risk assessment even if serious questions arise as to the validity of the tests performed. Moreover, given the strict intellectual property protection of any data relating to a GM crops, Member States or any independent body may only carry out such tests if the notifier supplies certified GM seeds and isogenes. Notifiers have a tendency not to supply such seeds or only to certain laboratories and on their own terms. Consequently, the existing legislative framework effectively bars the independent peer review of the submitted test results or the performance of fresh or additional tests by a body other than the notifier.

In summary: the existing risk assessment procedure laid down by the two legislative acts is neiher transparent, nor efficient. Developers of GM crops carry out risk assessments that cannot be made subject to independent review. They may even chose among various procedures that further reduce Member States’ voice in the decision-making and the transparency of the assessment procedure.

How could the procedures be made more efficient and transparent?

The above barriers to the transparency and efficiency of the risk assessment procedure should be eliminated as follows:
-    the technical assessment should be conducted or supervised by a body other than the notifier. Such a body should be independent in status, funding, professional links etc. from the notifier and should operate under the oversight of Member State authorities;
-    independent risk assessments should be institutionalised. To that effect intellectual property rights relating to novel and existing GM products must as a priority be revised in such a way that the supply of testing material can be made mandatory by Member State authorities;
-    the choice of authorisation channel (i.e. Directive or Regulation) should be eliminated.

Q6 In what other ways could the current procedural aspects for risk assessment (as detailed above) be improved?

See above.

Q7 Does the “one door one key” option available under Regulation 1829/2003 ...

a) ... improve on the process available under Directive 2001/18EC?

         Yes – no – no impact

b) ... impact on the quality or the outcome of the ERA assessment?

         Yes – no – no impact

Please justify your response:

Under the Regulation Member States have a(n even) reduced voice in the evaluation of the ERAs. As mentioned in relation to Q5 such a differentiation is not justifiable for reasons of environmental policy and fairness of trade. The reduced transparency of the procedure under the Regulation also reduces the legitimacy and public acceptance of the final decisions.

3.1.2 General conduct and assessment of the Environmental Risk Assessment (ERA) in applications for GMO cultivation

Background briefing:

All applications for cultivation whose scope includes cultivation, including those submitted under Regulation 1829/2003, must meet the criteria for an ERA that are specified in Annex II of Directive 2001/18/EC and Decision 2002/623/EC.

Q8 In general, how satisfied are you with the ERA requirements as specified in the legislative framework?

Not at all satisfied, somewhat dissatisfied, no opinion, somewhat satifsied, very satisfied

Please justify your response:

It is not the technical requirements of the ERA, but the surrounding broader institutional and legal framework that is seen problematic. As described above, even where a Member State authority seeks additional information, solely EFSA can decice over the issue. Member States on their own are unable to obtain such additional information unless the notifier provides them at will.

Q8b What could be improved?

As noted above, the institutional voice of Member States should be strengthened and independent control mechanisms should be established.

Q9 On a scale of 1 to 5 (where one is poor and five is excellent), to what extent do you think the way ERAs are currently conducted and assessed are achieving the following objectives of an ERA:

a) on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of GMOs may have?

   Rating: 2

   Please justify your response:

As ERAs do not cover long term environmental and health impacts, nor do they address the specific features of the local receiving environment.

b) to identify if there is a need for risk management and if so, the most appropriate methods to be used?

   Rating: 2

   Please justify your response:

As a Member State authority cannot have access to the raw data used for the ERAs and cannot demand further tests, it is difficult to say wether all the risks are indeed identified, thus if risk management proposed is thorough enough.

Q10 On a scale of 1 to 5 (where one is poor and five is excellent), how well is the preparation and assessment of ERAs following the principles of Annex II of the Directive 2001/18/EC (as supplemented by Decision 2002/623/EC):

a) Identified characteristics which have the potential to cause adverse effects should be compared to those of the non-modified organism and its use

   Rating: 1

   Please justify your response:

As the assessments follow the principle of „substantial equivalence” that automatically excludes the evaluation of a series of impacts.

b) To be carried out in a scientifically sound and transparent manner based on available and scientific data

   Rating: 1

   Please justify your response:

As the raw data of the assessments are not accessible and no independent control tests can be conducted for a series of reasons. A particular obstacle is the lack of available GM seeds for tests because they are held back by notifiers.

c) To be carried out on a case-by-case basis

   Rating: 1

   Please justify your response:

The case-by-case requirement would mean that, as a minimum, risk assessments are conducted for every planned new receiving environment. Not only are such regional, local assessments completely omitted, very often tests that serve as a basis of the risk assessments of the notifications are conducted outside Europe.

Q11 On a scale of 1 to 5 (where one is poor and five is excellent), to what extent do you think the way in which ERAs are being conducted by notifiers are sufficiently rigorous, comprehensive, and in line with the legislative requirements?

Rating: 1

Please justify your response:

So long as ERAs cannot be made subject to independent peer review and raw data are not accessible the quality of the assessments undertaken by notifiers cannot be evaluated objectively. Part of this problem is rooted in the lax nature of the legislative requirements concerning the contents and the process of ERAs (broad framework categories instead of detailed mandatory testing protocols).

Q12 Once the ERA has been conducted, how satisfied are you with the way in which ERAs are being assessed by Member States and by EFSA?

Not at all satisfied, somewhat dissatisfied, no opinion, somewhat satifsied, very satisfied

Please justify your response:

The assessment by EFSA of ERAs has been much criticised by Member State authorities. EFSA’s evaluation cannot be challenged, made subject to independent review. Effectively, all national opinions pointing to the hazardous or uncertain impacts of GM crops are classified by EFSA as insignificant or un-scientific. EFSA fails to meet the requirements of its own statute that provides that in the case of substaintial differences between its own and Member States’ opinions, those have to be clarified through negotiations. It fails to meet these requirements despite the fresh call to that effect by the Council’s conlcusions adopted on the issue in December 2009. Consequently, EFSA’s practice is neither transparent, nor consistent, nor cooperative when it comes to the assessment of ERAs.

Q13 How consistent are Member States in assessing ERAs for applications whose scope includes cultivation?

Not at all consistent, somewhat consistent, very consistent

Please justify your response:

Some Member States, such as Austria and Hungary, undertake a rigorous case-by-case critical evaluation of each application. Some Member States consider the issue to be of a lesser importance or – at a political level – are more relaxed in their approach to GMOs. While there always appear to be a significant divergence among Member States’ views some countries consistently take the assessment of notifications for cultivations very seriously.

Q13b What impact do you think this variability has?

The rather divergent approach of Member States leads to „forum shopping”: notifiers submit applications to more lax authorities (UK, NL) hoping for a more „favourable” attitude from authorities. This completely undermines public trust in the authorisation system and creates a general suspicion that uniform or similar standards are applied in a completely different fashion in different countries.

Q13c What would improve the consistency of Member States’ requirements for ERAs and the consistency with which ERAs are assessed?

As mentioned in relation to Q1, as a priority, the sovereignty deficit of the issue should be properly addressed. Member States should retain the right to independently decide whether or not to expose their ecosystems to the potential hazards of GM crops. This would alleviate the problem of inconsistency.

At a more technical level:

-    rigorous mandatory testing protocols;
-    full access to the basic data of the original ERAs;
-    legally and institutionally defined system of independent control tests;
-    strengthened procedural guarantees for the cooperation between EFSA and Member States;
-    mandatory review procedures of all EFSA and Member State opinions on ERAs.

Q14 What do you believe determines the country that notifiers make their submission in for placing a GMO on the market? (e.g. most often it has been the UK, Netherlands, Germany, France, Spain, Czech Republic)

The “positive” political and administrative attitude of the given Member States towards GMOs. The above list coincides with a historic (not recent) pro-GMO voting list in Council.

Background briefing:

Regulation 1829/2003 (Articles 6(5)e and 18(5)e) and Directive 2001/18/EC (Article 19(3)c) allows EFSA opinions and the consents given to notifiers to include specific conditions for the protection of particular ecosystems/environments and/or geographical areas. So far, neither Member States nor EFSA have given much consideration to the effects of different agricultural structures and regional ecological characteristics in their assessments of the ERAs.

Q15 Should scientific opinions and conditions of consents take more account of regional variability?

Yes, no, no opinion

This practice is already in violation of the existing legislation that is based on the source principle, the prevention and the preacutionary principle as well as on the full consideration of the receiving environment. Defying the basic logic of EU environmental policy, GMO authorisations to date consider the territory of the Community as a uniform bio-geographical bloc (which it is not) where the impacts of GMOs can be expected to be the same without variation. This may lead to such extreme results that GMOs designed to resist certain insects are authorised for cultivation in regions where such insects do not even appear. For example MON 810 generates toxins for Ostrinia Nubilalis that appears in Hungary only at a 10-12 years interval. If MON 810 was cultivated in Hungary it would unnecessarily contaminate the soil to ward off a problem that does not even exist.

Q16 Unlike authorisation procedures for GMOs in other parts of the world, the EU requires that stacked events also require authorisation, even when single events have already been authorised. Do you think this should continue to be the case?

Yes, no, no opinion

Please justify your response:

Unless we prove that a stacked event has no other negative impact than the two parental single events, the precautionary principle must be followed and separate tests must be conducted to assess the potential risks of the stacked events.

3.2 Questions on the Implementation of Part B Directive 2001/18/EC governing Field Trials of GMOS

Q17 To what extent is the process for applying and conducting a field trial sufficiently transparent?

Not at all transparent, somewhat transparent, very transparent

Please justify your response:

As there is no possibility to conduct independent control tests, the problem of transparency is present in relation to field trials also.

Q18 Do you agree that there is a need to further harmonise the way in which field trials are designed, conducted and analysed across Member States?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

The issue of field trials is critical in the authorisation process. Full harmonisation of the design, conduct and analysis of the process is of urgent necessity in order to strengthen the factual scientific basis of authorisation. However, such harmonisation must not equal to the monopolisation of supervision and opinion by any authority (e.g. EFSA) but should go hand in hand with the strengthening of the role of national authorities and independent research centres.

Q18c What aspects need to be harmonised, and how could harmonisation be achieved?

Both the procedural (see Q18) and the technical aspects should be revised. From the technical point of view of the testing and assessment methodologies, periods and geographical areas should as a minimum be defined in a more rigorous manner. Long term impacts should be investigated through multi-seasonal field trials and monitoring.

Q19 Should differentiated procedures for field trials be introduced as familiarity increases?

Yes, no, no opinion

Q19a What would be the disadvantages and advantages?

There would be only disadvantages as the risk to human health and the environment would increase. There should be a separate risk assessment for every new type of GM plant, as the negative effects can be different.

Q20 Could you suggest any improvements to the process by which a field trial is authorised, or the way in which a field trial is conducted?

Field trials should not or not only be conducted by the notifier. The transparency and the verifiable nature of the field trials should be maintained in the whole process. Raw data should be made accessible to authorities. The examination of long term effects should be rendered mandatory.

3.2.1 Links between field trials and authorisation for cultivation

Q21 Since 1998, no other GMO has been authorised for cultivation in the EU. What effect do you think this is having on field trial applications?

No information.

Q22 Do you agree that the current operation of Part B of Directive 2001/18 is affecting the number of applications submitted for placing a GMO on the market (given possible difficulties in obtaining approval, or obstacles to successfully completing a field trail?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

Q23 Does the design, conduct and analysis of Part B field trials provide adequate evidence (in terms of quality and quantity) for subsequent authorisations for cultivation?

Never, rarely, sometimes, very often

Please justify your response:

Part B field trials are vaguely defined in the legislation as well as in EFSA’s guidance documents. It provides notifiers with ample opportunity to design field trials in such a way that no or no significat impact is ever discovered. As many of the fundamental data are not available for review, nor can alternative field trials be implemented by Member States without the sympathetic attitude of the notifier, Part B field trials do not provide sufficient data for a scientfically sound authorisation.

3.2.2 The use of Antibiotic Resistance Markers (ARMs)

Background briefing:

EFSA recently (2009) issued a statement on the use of ARMs in GM plants that replaced both a previous opinion (2004) and a statement (2007) on the matter. The 2004 opinion suggested classifying ARMs into different categories of use (unrestricted; not to be used in commercial GM plants; prohibited). The 2009 statement, however, indicated that bacterial resistance to any antibiotic cannot be discounted and the antibiotic resistance traits as present in whole GM plants are to be evaluated on a case-by-case basis for their safety to humans, animals and to the environment.

Q24 To what extent do you agree with EFSA’s current position on ARMs?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

3.3 Questions on the interplay between Directive 2001/18/EC and Directive 91/414/EEC

Background briefing:

Currently, a herbicide used on a herbicide-tolerant GM (GMHT) plant is assessed differently from the same herbicide used on a non-GMHT plant. Under Directive 91/414/EEC, the ERA of herbicides includes an assessment of impacts on certain non-target organisms and studies of residual activities in soil and water, but does not include assessment of impacts on biodiversity within crops and changes in agro-ecosystems, which are required in relation to GM plants. As such, a herbicide used on a GMHT plant requires a different assessment compared to the same herbicide used on non-GMHT plants and conventional plants.

To date, no agreement has been found regarding a common approach for the risk assessment of GMHT plants.

Q25 What loopholes, overlaps or problems are there between the assessment of herbicide tolerant GMOs (under Directive 2001/18/EC) and the risk assessment of the associated herbicides (under Directive 91/414/EEC)?

No information.

Q26 How do you think the interplay should be addressed between Directive 91/414/EEC and Directive 2001/18/EC on the assessment of the environmental impacts of herbicides associated with herbicide-tolerant GM plants?

No information.

Q27 How satisfied are you with the way that herbicide tolerance, and its impact on the environment was treated in the ERA for the applications including cultivation, such as the application for NK603, Bt11 and 1507 maize, as well as soybean 40-3-2?

Not at all satisfied, somewhat dissatisfied, no opinion, somewhat satifsied, very satisfied

Please justify your response:

4- Risk Management

Background briefing:

Risk management involves the consideration of policy alternatives and the selection of appropriate prevention and control options. GMO risk assessment has been separated from GMO risk management In the EU regulatory framework. EFSA provides independent scientific advice and communication on existing and emerging risks while undertaking risk assessment. Risk management measures are not within EFSA’s remit and remain the responsibility of the European Commission and Member States. As a consequence, risk assessment can be performed on a purely scientific basis, whereas risk management can take additional aspects into consideration, such as socio-economic or ethical questions.

4.1 General Questions

Q28 Do you agree that the risk management requirements introduced in Directive 2001/18/EC and Regulation 1829/2003 provided a more transparent and predictable EU regime compared to that under the Directive 90/220/EEC and the Novel Foods Regulation (258/97/EC)?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

In Directive 90/220/EEC and the Novel Food Regulation, provisions for post market monitoring were lacking.

Q29 Do you agree that the provisions in Directive 2001/18/EC and Regulation 1829/2003 for inspections, controls, monitoring and special protection of eco-systems, environments and geographical areas, are fit for purpose?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

The system of the two pieces of legislation pays very limited attention to the diversity of the ecosystems and geographical conditions in the EU.

In our view, there are many problems with monitoring. More detailed requirements and clear guidance are needed (what should be monitored by which studies, during how much time, etc.).

Special protection of ecosystems, environments and geographical areas cannot be effectively ensured under the existing legislation. It is individual Member States that know about specific features of their particular ecosystems, nonetheless risk assessments are carried out in a centralised manner.

If a Member State would like to protect some of its ecosystems and define special management measures for their protection in the final consent, it has to persuade EFSA and 26 other Member States. In our opinion, the current ERA and decision-making system cannot ensure an effective protection of special eco-systems, environments and geographical areas.

Background briefing:

The Regulatory Committee of Directive 2001/18/EC and the Council of Ministers have yet to reach a qualified majority for the approval of a new GMO for cultivation under the new legislation. Consequently, the European Commission’s draft decisions on whether to approve the new GMO have been accepted by default.

On the 25th of June, 2009, Austria submitted a paper to the Environmental Council concerning the right of Member States to opt-out of growing GMOs on their territory which have already been approved by the EU. The proposal was supported by Bulgaria, Ireland, Greece, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland Slovenia. Previously, the Netherlands submitted a similar declaration to the Environmental Council on 2 March 2009 and to the Agricultural Council on 23 March 2009.

Q30 To what extent do you think this is an appropriate solution to the problems represented by Member States’ inability to achieve a qualified majority?

Not at all appropriate, somewhat appropriate, very appropriate

Please justify your response:

Until a comprehensive revision of the entire regulatory system on a non-internal market basis, the national opt-out solution would provide an adequate response to the „perverse” operation of the committee procedure as described above. However, creating national enclaves through an opt-out mechanism (a political response) does not solve the technical and procedural deficiencies of the authorisation procedure discussed in relation to the previous questions.

Q31 Do you agree that socio-economic concerns should be taken into account when making decisions on the authorisation of GMOs for cultivation?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

The complete ignorance of socio-economic factors in the authorisation process (“free market orthodoxy”) is one of the reasons of its cumbersome and dysfunctional operation. At least the following factors should be taken into consideration:
-    lack of agricultural advantages: as described in Q15, many of the GMOs address problems that do not even exist in certain areas of the EU. In this case the cultivation would only serve the interests of the patent-holder at the expense of the local population and environment that continue to suffer from the long-term impacts of the unnecessary toxin-production. Hence, where a GMO crop is designed to cater for a problem that is insignificant in a particular region of the EU, that particular region should automatically be entitled to ban cultivation without any further argument for lack of agricultural advantages;
-    lack of economic advantages: the controversies surrounding GMOs as well as a series of food crises over the past decades have given rise to a strong demand for organic or at least GM-free food. To meet such market demand is a vital and legitimate economic interest of thousands of farmers in many regions of the EU. However, safe supply of non-GM food can only be provided if no GM crop production interferes with organic production. Therefore, such legitimate interests of non-GM producers to exclude GM cultivation should be supported through the recognition of a ban on cultivation with reference to economic interests;
-    freedom of choice: even if significant agricultural or economic advantages can be shown to exist in relation to a particular GMO, regions should still be free to decide not to permit cultivation with reference to freedom of choice. The freedom of choice of food production should be regarded as a fundamental right of every region of the EU. Imposed cultivation authorisations (as it is the case under Directive 2001/18/EC) completely undermine the legitimacy of EU decision-making further aggravating the democratic deficit of the European Union.

4.2 Risk Management measures following authorisation and/or the risk evaluation of field trials

Q32 Has standard practice or best practice been defined for management of cultivated GMOs in your Member State? (e.g. isolation distances or “buffer zones” , or use of border rows of non-transgenic plants to catch pollen).

Yes, no, no information

Further comment:

A specific act of Parliament addresses the question of co-existence.

Q33 To what extent do risk management measures as defined in your Member State take into consideration the variability in ecosystems/environments and/or geographic areas?

Not at all, somewhat, a great deal, no information

Please justify your response:

Risk management measures are defined according to the specificities of the actual receiving environment.

The nature conservation authority may impose special cultivation conditions in order to ensure compliance with EC legislation on the conservation of natural habitats, of wild fauna and flora, of wild birds and also with the rules included in national legislation on designation of protected areas and on environmentally sensitive areas.

4.3 Post market environmental monitoring

Background briefing:

Post-market environmental monitoring (PMEM) is an integral part of the regulatory system for placing GMOs on the EU market. It is intended to identify unanticipated adverse effects on human health or the environment which could arise. Under Directive 2001/18 a PMEM plan must be submitted with an application for authorisation to cultivate GMOs and for authorisation under Part B.

Q34 Given the guidance that has been developed by the Commission, do you believe that the types of post-release monitoring that will be required will be consistent in terms of design, scope and application across all Member States?

Not at all consistent, somewhat consistent, very consistent, no information

If not, why? What differences in requirements currently occur or are expected to occur?

The standard reporting format proposed by the Commission is a big step towards a more comprehensive monitoring system.

Nevertheless, current guidelines are too general and there is still a need for a more detailed guidance on the scientific methods that must be used in the monitoring process.

Of course, as eco-geographic features of the various Member States are different, monitoring will not exactly be the same everywhere (as different effects have to be examined), nonetheless standard scientific methods are needed.

4.3.1 Case Specific and General Surveillance

Background briefing:

The environmental monitoring programmes for genetically modified plants are based on two approaches: Where there is scientific evidence of a potential adverse effect linked to the genetic modification, then case-specific monitoring should be carried out after placing on the market. For unanticipated adverse effects general surveillance is mandatory for GMOs for cultivation.

Q35 Are there any issues concerning the boundary between case-specific monitoring and general surveillance monitoring which you would like to see addressed?

Yes, no, no opinion

What are they?

Given that EFSA ususally does not find any significant risk in its opinions, it never calls for case-specific monitoring. Hence, only general surveillance is necessary that does not include scientific assessment. It is highly questionable whether general surveillance is able to detect any significant and unforeseen long term impact at all. The lack of negative impacts that results from inadequate monitoring is also used to demonstrate the lack of any adverse effect and to refrain from case-specific monitoring in future cases. In general, both types of monitoring should be made subject to mandatory uniform protocols.

Q36 Is there a need for further action on case-specific post-release monitoring?

Yes, no, no opinion

What action is needed?

There are no uniform methods for case-specific monitoring and it is not clear what minimum requirements are connected to it. This must be changed.

Q37 Is there a need for further action on general surveillance?

Yes, no, no opinion

What action is needed?

In our opinion, the methods used for general surveillance that are not using scientific tests are not fit for the purpose of identifying adverse effects that may arise.

Q38 In your view are monitoring activities in PMEP plans referenced to a clear agronomic/environmental baseline (e.g. current conventional cropping, historic agricultural or environmental data)?

Yes, no, no opinion

Please justify your response:

Q39 Have the provisions in Directive 2001/18/EC and Regulation 1829/2003 for monitoring and special protection of eco-systems, environments and geographical areas, encouraged relevant authorities in Member States to establish links with applicants in order to coordinate data collection and analysis from different monitoring programmes?

Yes, no, don’t know

4.3.2 Recommendations and guidance

Q40 Do you agree that EFSA GMO Panel’s recommendations for the management and conduct of PMEM by both applicants and risk managers is:

a) ... Clear and practical?

b) ...Cost-effective and comprehensive?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

More guidance is needed on how to conduct PMEMs.

As an example, the EFSA guideline states: “Where there is scientific evidence of a potential adverse effect linked to the genetic modification, case-specific monitoring should be carried out. The objective of a general surveillance is to identify the occurrence of unanticipated adverse effects.” It is unclear for us, how to handle uncertainty in the ERA. In some cases, unexpected adverse effects will not be discovered through general surveillance. We believe that in the case of uncertainty in the ERA or in the case of new research (post-ERA) that shows risks case-specific monitoring is needed. Moreover, more guidance is needed on the scientific methods of the monitoring (e.g. how trials should be designed, by which statistical methods data should be analysed, which are the most appropriate methods for case-specific monitoring and for general surveillance) – especially in the case of general surveillance where – in most cases – no scientific research is carried out and mainly farmer questionnaires are used. In the framework of the general surveillance guidance is needed on how to collect scientifically sound long term data.

Q41 Do you have any comments to make about the Recommendation 2004/787/EC on technical guidance for sampling and detection of GMOs and material produced from GMOs?

No information.

4.4 Impact of zero tolerance policy on imports and seed prices

Q42 Do you agree that the ‘zero-tolerance’ policy for unauthorised GM material in seeds is having a negative impact on trade (e.g. on imports of seeds and related seed prices)?

Strongly agree, agree, disagree, strongly disagree, no opinion

Please justify your response:

The zero-tolerance policy helps maintaining a high level of confidence in the seeds market. If buyers (consumers) cannot be sure that they are buying GM-free seeds (and the subsequently processed products) it would cause a serious disturbance on the market and would significantly increase transaction costs (additional checks, certifications etc.). Removal of the zero-tolerance policy would only be beneficial for the hidden proliferation of GM seeds which would comprehensively undermine public confidence in the operation of the market.

Q42b Is it having any cost implications?

As any administrative requirement, it also has cost implications. However, as mentioned in relation to Q42, elimination of the zero-tolerance policy is likely to raise transaction costs far in excess of today’s cost range.

Q43 To what extent is the ‘zero tolerance policy’, having any environmental and social impacts, across Member States?

Not at all, somewhat, a great deal

Please briefly describe the impact:

It has an enourmosly positive environmental and social impact. In case of a higher tolerance threshold the level of GM residues would be higher in end products. It would, as mentioned above (Q42b), also trigger a hidden proliferation of GM crops on the seeds market that would undermine public confidence and the business opportunities of non-GM producers.

Q44 What changes could improve the current situation?

The existing threshold should remain in place (0.1%).

Q45 What would be the impact if a tolerance threshold were to be introduced?

See Q42b and 43 above.

4.5 National Safeguard and Emergency Issues

Q46 Some Member States have not repealed bans on cultivation of specified GMOs in spite of EFSA completing its examination of the scientific evidence for the ban and producing an opinion ‘of no adverse effects’. In your view, what would increase the confidence in the rigour and reliability of EFSA’s opinion?

To date EFSA has rejected any argument by any Member State authority or independent researcher supporting the existence of significant environmental impacts of GMOs. EFSA’s conclusions have not been preceded by any meaningful and substantial consultations with Member State experts or independent researchers (apart from – in the case of Hungary – a 2 hour long questions and answers session). EFSA’s decision-making procedure is completely intransparent and free of any review mechanisms (see Q1). Moreover, Member States do not have any institutionalised possibility to undertake control tests and feed their results into the authorisation procedure for mandatory consideration.

Q47 In addition to the bans introduced by a number of countries are there any other national restrictions impacting on farmers' ability to cultivate authorised GMO?

In addition to a national safeguard measure Hungary maintains a set of rules on co-existence.

Q48 Do you believe that national concerns regarding GMOs should be managed under a different legislation?

Yes, no, no information

Please justify your response:

The choice of legal instrument (existing or new legislation) is completely irrelevant so long as it provides Member States with the necessary tools to adequately address their national concerns (see Q31).

5- Risk Communication

Q49 What do you think are the objectives of risk communication activities carried out under the Directive and the Regulation?

The fundamental objective of risk communication should be informing decision-makers and the general public (including individual consumers) of the real health and environmental implications of the cultivation of GMOs as well as their use in products, especially in food and feed.

Q50 How has consultation and engagement with stakeholders on applications for release of GMOs, under the Directive and the Regulation, changed over the last 5 years?

No information.

Q51 How satisfied are you with :

a).... the current arrangements for public consultation and engagement regarding authorised GMO releases under the Directive (Parts B and C) and the Regulation satisfactory?

Not at all satisfied, somewhat dissatisfied, no opinion, somewhat satifsied, very satisfied

b)... the clarity and substance of the information provided to the public in the context of consultation under the Directive (Parts B and C) and the Regulation?

Not at all satisfied, somewhat dissatisfied, no opinion, somewhat satifsied, very satisfied

Please justify your response:

a) Documents concerning Part B are in Hungarian, so a large public has real access to them. This is not the case for notifications under Part C of the Directive and the Regulation, which represents an important barrier to the Hungarian public.

Another problem is that public comments of non-scientific nature, for example the unanimous rejection by a country's population of GMOs, cannot be taken into consideration.

b) The substance of the information is satisfactory, but the clarity could be improved. We must not forget that most of the public consulting the relevant documents does not have a scientific background, so information should be explained in a more user-friendly fashion.

Q52 How significant are the differences across Member States in the provision of information to the public?

Not at all significant, somewhat significant, very significant

What impact do you think this variability has?

No information.

Q53 Are there any examples of public consultation that have had a direct impact on outcomes (e.g., risk assessment opinions and authorisation decisions)?

Yes, no, no information

Q54 To what extent do the results of public consultation feed into risk assessment opinions and authorisation decisions on GMO releases?

Not at all, somewhat, a great deal, no opinion

At EU level the public opinion has no impact whatsoever on the actual authorisations. For a number of years the European public has been sceptical (or hostile) to the cultivation of GM crops and the marketing of GM products. This negative attitude has been consistently represented by the majority of governments in the committee procedure and in Council deliberations. Yet, the Commission in its appraisal of EFSA opinions has never taken into consideration the concerns of Member States and the voice of the public.

Q55 To what extent are public views, expressed in the context of consultation, on the following issues taken into account...

a)Socio-economic considerations?

b)Concerns about uncertainty, knowledge gaps and ambiguity?

c) Ethical issues?

Not at all, somewhat, a great deal, no opinion

Please justify your response:

So long as cultivation is considered a trade (internal market) issue, these concerns fall outside the scope of considerations by the EFSA and the Commission. The internal market logic of the authorisation system only accepts scientific exceptions from free circulation. Hence, when socio-economic or ethical issues arise they tend to be labelled as “unscientific” and “market-distorting”.

Q56 On a scale of 1 to 5 (where one is poor and five is excellent), how well do you think risk is communicated through the following websites of relevant stakeholders...

a) the relevant authority in your country? 4
b) DG Environment? 2
c) DG SANCO? 1
d) EFSA? 1
e) GMO Compass? 3

f)    the main biotechnology companies? 1

Q57 How satisfied are you with the quality of the information on risk communication provided through these stakeholders' websites in terms of...

a) Availability?
b) Coverage?
c) Timeliness
d) Accuracy/ reliability?
Not at all satisfied, somewhat dissatisfied, no opinion, somewhat satifsied, very satisfied

Q58 How could the current arrangements for risk communication be improved?

The fundamental issue is the availablity of raw data, testing minutes and findings. So long as most of these data are considered confidential and no access is permitted even to Member State authorities, any information provided on the relevant websites remain non-verifiable PR tools. The fact that most risk communication documents are only produced in English creates a significant language barrier.

6- Confidentiality

Q59 How satisfied are you with the provisions for confidentiality within the EU’s GMO legislative framework (the Directive and the Regulation)?

Not at all satisfied, somewhat dissatisfied, somewhat satisfied, very satisfied, no opinion

Please justify your response:

The GMO authorisation process is completely paralysed by excessive trade secrecy. Where fundamental data are not available for inspection, re-evaluation, neither can Member State authorities obtain independent data as notifiers decline to provide seeds for testing, the whole authorisation process remains a delaying exercise in which the scientific validity of the decision cannot be verified as a result of confidentiality. In summary, under the existing legislation the commercial interests of the notifiers are not balanced with Member States’ and the public’s right to know.

Q60 How should the need for transparent and open processes and decisions, be reconciled with the need to protect commercial confidentiality?

Following the issue of authorisation for field trials notifiers should be obliged to deposit a sufficient amount of the trial specimen as well as the relevant isogenes with the authorities. The authorities of any Member States should, with full respect to the intellectual property of the notifier, be able to use the deposited genetic material for additional or control trials. Unused specimen would be returned.

Q61 Under Part B of the Directive what sorts of documents, or aspects of information, should be considered confidential and on what basis?

Q62 Under Part C of the Directive which documents, or aspects of information, should be considered confidential and on what basis?

Q63 Member States vary in the way they have implemented the provisions of confidentiality under the Directive. To what extent does this impact on your organization?

Not at all, somewhat, a great deal

Please justify your response:

Q64 In your opinion, are the confidentiality provisions of the Directive and the Regulation consistent?

Yes, no, no information

Q64a Is one more clear and rigorous than the other?

Yes, no, no information

Please justify your response:

Q65 Are there any tensions between the requirements of the EU’s GMO legislative framework (the Directive and the Regulation) and the requirements of Regulation 1049/2001 regarding confidentiality/disclosure of information?

Yes, no, no information

Please justify your response:

Q66a What do you think the impacts would be, of making it easier to keep information confidential?

This would further erode the existing low level of public confidence in the authorisation system.

Q66b What do you think the impacts would be, of making it more difficult to keep information confidential?

Increased transparency, better informed authorities and public.

Q67How could the current provisions for confidentiality be improved?

See Q60.