Regional Aspects in Precautionary GMO Decision Making

Transcription

1 Regional Aspects in Precautionary GMO Decision Making Conference in Vienna, March 2009

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3 Regional Aspects in Precautionary GMO Decision Making EU Conference in Vienna, March 2009

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5 Table of Contents Introduction... 7 Conference Programme... 9 Opening Address by the Federal Minister of Health Alois Stöger Opening Address on behalf of the Federal Minister of Agriculture, Forestry, Environment and Water Management Monika Stangl Freedom of choice and regional self determination Felix Löwenstein The Role of Precaution and Regional Aspects in the Authorization of GMOs: A Legal Perspective Gábor Baranyai Nature Conservation in the EU: Seeking a Balance between EU wide and Regional Approaches Petr Roth Socio Economic Aspects Nina Vik Discussion Following the First Session Considering Regional Characteristics in the GMO Decision Making Paula Rey Garcia Approaches to an Ecological Coexistence Nature Protection Areas and GMO Cultivation Beatrix Tappeser Authorisation of Plant Protection Products in the EU Robert Womastek Experiences with GMO Authorisations in the Netherlands Ruben Dekker Plenary Discussion Following the Second Session EU Council Conclusions on GMO Risk Assessment Marc Strauss

6 Update of Guidance on Environmental Risk Assessment of GM Plants Goals and Working Strategy Elisabeth Waigmann Cooperation between the EU Member States Andreas Heissenberger Concepts of Environmental Risk Assessment Angelika Hilbeck Panel Discussion Following the Third Session Summary and Conclusions Helmut Gaugitsch About the Speakers List of Participants

7 Introduction The European Conference on Regional Aspects in Precautionary GMO Decision Making took place in Vienna on the 26 th and 27 th of March It was jointly organized by the Umweltbundesamt (Environment Agency Austria) and the AGES (Austrian Agency for Health and Food Safety) on behalf of the Austrian Ministry of Health, the Competent Authority for Directive 2001/18/EC and Regulation (EC) No 1829/2003, together with the Austrian Ministry of Agriculture, Forestry, Environment and Water Management. The consideration of regional aspects such as sensitive and/or protected areas is a key element of a precautionary environmental risk assessment based on the case by case principle. The latter is often addressed as the region by region principle when dealing with regionally different conditions that need to be taken into account in the environmental risk assessment of GMOs (e.g. climate, protected species and habitats, agricultural practices). Its implementation however is still under discussion. The importance of considering different environmental characteristics of the individual Member States has been recognized by the Environment Ministers in the Council conclusions adopted on December 4 th Different stakeholders were invited to present their concepts and approaches for an improved consideration of regional aspects in the risk assessment of GMOs. The presentations ranged from socio economic to environmental aspects and included experiences from other fields where regional aspects play an important role (e.g. nature conservation, plant protection products). This broad conceptual approach inspired a lively debate about possible options for improvement not only at the scientific and technical level, but also with respect to socioeconomic considerations and legal procedures. This publication comprises the presentations of the speakers and summarizes the discussions that took place in the course of the conference. This documentation thus provides information for future discussions on the consideration of regional aspects in precautionary GMO Decision Making.

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9 Conference Programme Thursday 26 March :00 Opening Mr. A. Stöger, Ministry of Health Mr. N. Berlakovich, Ministry of Agriculture, Forestry, Environment and Water Management Session 1: Regional Aspects A Challenge for GMO Decision Making Chairperson: Mr. L. Girsch, Austrian Agency for Health and Food Safety (AGES) 09:30 Freedom of choice and regional self determination Mr. F. Löwenstein, President of the German Association of Organic Farmers, Food Producers and Traders, Germany 10:10 The role of precaution and regional aspects in the authorization of GMOs: a legal perspective Mr. G. Baranyai, Office of Parliamentary Commissioner for Future Generations, Hungary 10:50 Coffee break 11:15 Nature conservation in EU: seeking balance between EU wide and regional approaches Mr. P. Roth, Director, Dept. of International Conservation of Biodiversity, Ministry of Environment, Czech Republic 11:55 Socio economic aspects Ms. N. Vik, Directorate for Nature Management, Norway 12:35 Lunch break Session 2: Accounting for Regional Aspects Experience in Europe Chairperson: Mr. T. Jakl, Ministry of Agriculture, Forestry, Environment and Water Management, Austria 14:10 Considering regional characteristics in the GMO Decision Making Ms P. Rey Garcia, DG Environment, European Commission 14:40 Approaches to an ecological coexistence Nature Protection Areas and GMO cultivation Ms. B. Tappeser, Federal Agency for Nature Conservation, Germany 15:10 Coffee break

10 15:30 Authorisation of Plant Protection Products in the EC Mr. R. Womastek, AGES (Austrian Agency for Health and Food Safety, Dept. for Plant Protection), Austria 16:00 Experience with GMO Authorizations in the Netherlands Mr. R. Dekker, Dutch Ministry of Housing, Spatial Planning and the Environment, the Netherlands 16:30 Panel Discussion End Friday 27 March 2009 Session 3: The way forward Considering Regional Aspects in the Future Chairperson: Ms. E. C. Lang, Ministry of Health, Austria 09:10 EU Council Conclusions on GMO Risk assessment Mr. M. Strauss, Permanent Representation of France 09:40 Update of guidance of Environmental Risk Assessment of GM plants goals and working strategy Ms. E. Waigmann, EFSA (European Food Safety Authority) 10:10 Coffee break 10:30 Cooperation between the EU Member States Mr. A. Heissenberger, Environment Agency Austria 11:00 Concepts of Environmental Risk Assessment Ms. A. Hilbeck, EcoStrat, Switzerland 11:30 Panel Discussion 12:30 Conclusions of the Organiser Mr. H. Gaugitsch, Environment Agency Austria End

11 Opening Address by the Federal Minister of Health Alois Stöger Ladies and Gentlemen! It is a great pleasure for me to welcome you at this Conference in the Austrian Agency for Health and Food Security (AGES). I like to express my thanks to the AGES and to the Umweltbundesamt, the Austrian Environment Agency, for the organization of this conference. The issue of precautionary decision making in the GMO approval process has been of high priority for the Austrian Ministers of Health already for a long time. This of course regarding the safety of food and feed, but also in the context of the protection of protected natural areas, biodiversity and sustainable ways of farming in Austria. Austria has ever since been very cautious with approvals of GMOs as in our opinion several questions concerning the risk assessment of GMOs still have to be clarified. We do not stand alone with this view. In the Council Conclusions of 4 th December 2008 all member states of the European Union have clearly expressed, that the European risk assessment procedures need further improvements, in particular when it comes to long term effects of GMOs on the environment including health aspects. EFSA has been asked to elaborate specific guidelines on the assessment of environmental effects including in particular long term effects. In addition, EFSA is undertaking a review of its guidelines on the risk assessment of food and feed derived from genetically modified plants. We consider this ongoing work as extremely important, as in our opinion the current ways of risk assessment cannot be considered as sufficient. The focuses of this conference are regional aspects in GMO Decision making. These aspects are directly linked to Directive 2001/18/EC, as the criteria for risk assessment for the release of GMOs therein clearly state that the effects of a GMO on the receiving environment must be taken into account. In consequence before cultivating a GMO the baseline of the receiving environment and the possible risks posed by the GMO to this environment have to be explored. This can certainly be done much better at regional or local level than at supranational level. This leads us to the aspect of subsidiarity: In the mentioned Council Conclusions the Member States also asked for better options to establish national restrictions when it comes to cultivation of GMOs. The same was expressed on the issue of GMO free areas.

12 These views have been affirmed by the decision of the Environment Council on 2 nd March 2009 when the proposals of the European Commission to repeal the safeguard Clauses of Austria and Hungary were rejected by qualified majority. Dear Ladies and Gentlemen! You are going to work in the course of this conference on ways and possibilities, how regional aspects and local experiences can be better taken into account when GMOs are to be allowed for cultivation. I trust in your excellence and expertise and by concentrated efforts you can make this conference a further mile stone to get to reasonable solutions for the problems that many Member States, including Austria, are facing at present. In this sense I am confident that this conference turns out with the greatest possible success.

13 Opening Address on behalf of the Federal Minister of Agriculture, Forestry, Environment and Water Management Monika Stangl Ladies and Gentlemen, I have the honour of representing Federal Minister Berlakovich here on the occasion of this internationally important conference. Unfortunately, due to prior commitments he is unable to attend the opening of this event. Please permit me to say a few words on his behalf: The present conference comes at just the right time. The current events of recent weeks have made the subjects of this conference once again the centre of attention. The conclusions adopted by the Environment Council on genetically modified organisms focus on the regional aspects of approval and on socio economic criteria. These issues are also scheduled for today and will thus be widely discussed. I would like to take this opportunity to emphasise that Federal Minister Berlakovich again succeeded in enforcing the Austrian cultivation bans. He will now focus his attention on safeguarding GMO free cultivation in Austria for the long term. All possibilities are being considered to voice a strong call in particular for the right of self determination of Member States and European regions. At the recent meeting of the Agriculture Ministers, which took place on Monday this week, Federal Minister Berlakovich discussed this issue on EU level. He is planning further steps to achieve legal establishment and will take all efforts to win the support of other Member States for his project. Ladies and Gentlemen, to continue the way which Austria has started in the field of genetic engineering it is important that expert level events like the present one take place. Today and tomorrow this conference will offer participants an opportunity to contribute significantly to this issue. We are therefore awaiting with great interest the speakers experiential reports and the resulting discussions. We wish the organisers every success and all participants two days of fruitful discussions and a pleasant stay in Vienna.

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15 Freedom of choice and regional selfdetermination Felix Löwenstein Mr. Chairman, dear Ministers Stöger and Berlakovich, Ladies and Gentlemen! You might be wondering why it is an organic farmer and representative of a national organic sector giving the key note speech to a conference about Regional Aspects in Precautionary GMO Decision Making giving a special focus on environmental and ecological issues. But obviously or unfortunately organic farmers and food producers are faced very directly with GMO s and have to take part in the discussion about how to handle the problems linked to that technology. This is not only due to the European legislation that binds organic farming not to use genetically engineered organisms but also to the way organic farming sees itself working with nature: not forcing it into the frames of our technical needs but using its own possibilities and mechanisms the best we can. So normally we don t have to do with GMO s and we would be very happy, if we could just stay out of all this, if we could just not mind the business of those who have a different understanding of farming and food producing and just continue to do our own job. It would save us a lot of time and money. But this is not possible, when we talk of what we call in German Grüne Gentechnik which means green genetic engineering and stands for the part of biotechnology dealing with living and propagating organisms in the open and not contained system of nature. It is the major characteristic of this kind of genetic engineering that it leads to contamination of not engineered plants in both other fields and farms and in wild plantpopulations. So we have to take part in discussions about the legal regulation of a technology we don t want to use, give our opinion in hearings and congresses and feed information into the public discussion that those who promote GE would not mention by themselves. It is for that reason, why the organic sector is definitely interested in all the questions raised during this conference. To start with I should like to distinguish two issues which are both discussed intensely but have to be distinguished carefully. One is about risks and chances of GMO and deals both with questions of health and of environment. The second concerns the first and basic consumer right: freedom of choice. It has nothing to do with the risk discussion, because as a consumer I do not feel obliged to give a scientific reason why I want to buy or to refuse a certain consumer good. Let me start with Consumers freedom of choice and give you an example, where the whole of Europe unanimously and obviously without any discussion consents to refuse something

16 others I am talking about the United States seem to offer their consumers without any concern: BST the bovine somatotrophe hormone, a genetically engineered hormone used to increase the amount of milk given by a cow and the speed of growth in beef production. The Americans get not tired to stress, that this hormone, applied by injection, is practically identical to the one produced by the animals themselves and that there is no proof whatever that it should be harmful to human health. But all the Europeans and, by the way, an increasing number of American citizens insist on beef and milk produced with nothing but natural feed that passed the mouth of the beast. The question whether plants for food production should be genetically engineered or not is not at all seen unanimously. But still, depending how you ask the question, between 50 and 80% of Europeans vote for food made by nature and not by laboratories and this level of disapproval is constant since many years. This is why the food producers all over the continent and not only those producing organic products insist on getting GMO free raw material. Obviously there is no interest in producing one part of a product line with and the other without GMO, just because you have a certain percentage of consumers who wouldn t care about a GMO label, if there is not a single one who would really ask for a GMO product. So by risking high costs of separation no producer would gain anything. As a result European farmers have an intense interest in being able to produce GMO free rawmaterial and in being able to do so without additional costs and efforts. But that s where the real problem is: in spite of the fact that in Europe there is practically no agricultural GMO production yet farmers, trade and industry are already faced with considerable costs. Friday last week in Berlin we presented a study to the public. It evaluated many studies and reports worldwide in order to find out the costs and benefits of today s GMO in agriculture and food industry. The result was so unequivocal, that we decided to call it Gentechnik Schadensbericht, GMO damage report. The report makes clear, that an economical benefit of GMO can only be pretended, if you agree to skip all the costs left to the public and to those who do not want to use the technology. A lot of the costs are contributed by scandalous incidents like the presence of a not approved GMO trait produced by the Bayer company in American long grain rice in The damage for the American rice industry exceeded 1 billion US Dollars needless to stress that Bayer didn t pay a penny up to now, even though it was one of their experimental fields from which the event had escaped. But there are day to day costs of individual companies that amount to considerable sums too. I would like to mention, as an example, the biggest German cornmill. They estimate their GMO safety costs to as much as 3% of the end product s price. And I would like to mention a recent study of the governmental research institute of Saxony, published last year. Over two years they calculated costs and benefits of Bt corn production at different places in the area where GMO corn is produced and compared them to conventional corn planted in the same place. In the average of the two years and the different fields the costs were not surpassed by the returns from better yields in the Bt corn fields, which means that planting Bt corn showed to be rather an expensive insurance than an economical progress.

17 Considering all this, regional self determination on allowing or banning GMO turns into a quality assurance measure for a GMO free production and protects the economical interests of those producing in this region. Two years ago the leading German baby food producer announced that he would transfer his production to Austria in case Germany would seriously start planting GMO. What made our Austrian friends look very happy was a real concern to the many German farmers producing for this company. The reason, its owner planned these consequences is very simple and practical: first he feared the costs he inevitably would have and then of course he preferred the security of a large GMO free area, where contaminations would stay very unlikely. Please let me be clear about one thing: If I am talking in favour of regional self determination in the context of quality assurance it is only, because I see it as a measure of self defence. What we really would need on European level is more than the right to organize GMO free areas. We would need a system of consequent contribution of costs following the polluter pays principle. And we need regulations for GMO Production, that do not accept constant minimum levels of contamination (like: let s stay under 0,9%) but that aim to avoid any contamination as it is said in the regulation 2001 / 18 EU 26: Member States may take appropriate measures to avoid the unintended presence of GMOs in other products The second issue concerns risks and chances of GMO As this conference is about Regional Aspects this is not the moment to go into questions concerning health risks of GMO. Just let me mention that it is not correct when advocates of GMO in agriculture pretend, there is no indication of such dangers. I just point to the study of Velimirov, Binter and Zentek, published by the Bundesministerium für Gesundheit (Federal Ministry of Health) in Vienna in October 2008 and the study of Finamore et al., published in the journal of Agricultural and Food Chemistry in November Both indicate to be very conservative that there is urgent need of looking closer before approving a GMO for Production. Needless to say, that the fact that there is more than a million hectares of GMO worldwide but no reported case of instant health damage doesn t say anything about healthrisks as long as no epidemiologic study exists. This is even more the case with regard to the fact that almost all the GMOs produced do not go into direct human consumption but are either fed to animals with a rather short life expectancy or turned into textiles. The two traits used actually in practically 100% of the world wide cultivated GMO do raise concerns not only with regards to human health but also regarding environmental effects. These concerns are not confined to the direct effect the GMO could have on other organisms but have also to do with the agricultural systems going along with their use. The increase of Corn Monocultures made possible with Bt corn or the use of formerly wooded land in Argentina for the expansion of soybean production in no tillage system are not due to the genetic modification itself, but their influence on ecosystems is important nevertheless. The fact that 14 Million hectares out of 34 million hectares of arable land in Argentina is cultivated with Round Up Ready Soybean means, that after application of this complete spectrum herbicide there is no other green plant living. This also is seen on the face of it no direct effect of the genetic modification itself. But it is not hard to see, that this system has

18 tremendous effects on biodiversity and maybe also on resources like drinking water. The farm scale evaluation, published in Britain in 2003 shows these effects in plain terms. Up to now these indirect effects of GMO are not satisfyingly considered in the risk assessments that precede the approval of a GMO. I am anxious to hear, what Ms. Waigmann from the EFSA will tell us tomorrow on the plans to reform the approval process for GMO. When it comes to more direct effects of GMO on the environment and subsequently to the issue if GMOs are a risk to Nature Protection Areas the most important question will be: why is it more of a risk, when a genetically modified plant grows in or in the vicinity of such an area than if any other cultivated plant does the same? Therefore it is crucial to know: is a GMO plant is fundamentally different from another? Or, as the GMO producers would put it: is genetic engineering just a continuation of the many thousand year old cultural technique of plant breeding, which only differs by being more precise then before? A first answer is written down in Article 3 of the German law on Genetic Engineering. It says: a GMO is an organism whose genetic material is altered in a way that does not happen through crossbreeding or natural recombination under natural conditions. If this is correct, Genetic Engineering is not a smooth transition from traditional breeding techniques to a more modern one, but is an act of creation of something entirely new. In that context it is interesting to have a look on an experiment you might have heard about. It was made in Australia and the findings where published in the Journal of Agricultural Chemistry in The Scientists took a gene from a bean, which enables the plant to resist to a pest insect by producing an alpha amylase inhibitor which hampers the insect to digest the starch it eats when it gnaws at the leafs. After having inserted the gene into a pea which is a quite closely related species this plant was able to produce also the same protective protein. When feeding mice with both the bean and the new pea it was found, that the pea caused inflammation. I am not telling this story because of the obviously critical result even if it is worth mentioning, that the inflammation result may have not been detected using traditional feedings studies, as used in the EU assessment procedure. I rather want to draw your attention on the conclusion the Australians drew from the experiment: transgenic expression of nonnative proteins in plants may lead to the synthesis of structural variants possessing altered immunogenicity. In other words: It is the way genetic information is transferred from one organism to another that can cause unforeseen risks. So it might be wise to presume that a GMO is something else then an organism improved by man just using the tools offered by evolution. But it is not only fundamental considerations that urge us to be very careful. All of you might have heard about the experiment Dr. Kaatz undertook at the University in Jena from 2001 to 2004 with bees. When he compared Bees fed with GMO corn pollen to those who got pollen from conventional corn he didn t find any difference. It was only, when microsporidia attacked the swarms that he found a scientifically higher mortality with the GMO bees than with the others.

19 To have better results the bees all got prophylactic antibiotics before the experiment was continued. Now the initial findings where confirmed. So the result published said: Bees in good health are not influenced by Bt corn pollen. This result was underlined by the comment, that both the amount of Bt pollen and the length of period they were fed with it exceeded by far what could be found under natural circumstances. Is it really justified to give an all clear signal based on these results? I should like to invoke another experiment, which has nothing to do with GMO, to explain why I don t think the Jena findings can be neglected. The study was realized at the Department of Biological Sciences at the University of Pittsburgh. They wanted to find out, if concentrations of the pesticide carbaryl found not harmful to tadpoles in the standard evaluation experiments could have an effect when the tadpoles where exposed to the pesticide not in isolated basins but in natural ponds. The results where rather surprising: the mortality of the tadpoles was dramatically higher in the pond compared to the basin as well as compared to a not contaminated pond. The reason was found in a chemical substance produced by predatory salamanders also living in the same pond. It was the combination of the predator cue and the pesticide which caused the tadpoles to die. This shows that concentrations seeming innocent in experiments can have completely different effects in the complicated and complex situation in open nature. Coming back to the bees I would dare to claim, that the findings of Bt toxin being more harmful when combined with microsporidia are indeed significant. I certainly will not pretend that the world wide bee disease is caused by GMO. But to insist that Bt corn pollen or other influences of GMO plants would not be one of the stressors contributing to the disease seems to be a bit bold, doesn t it? So considering that bees are not just one of the thousands of species living in an area but crucial entities for the fruitfulness both of cultivated and of wild plants it could be reasonable to be rather cautious than rash. The German philosopher Hans Jonas put these reflections into clear words in his book The Imperative of Responsibility in He demands of man to protect the integrity of his world from assaults of his own technological power. The danger of biotechnology he sees in the fact, that it proceeds neither patiently nor slowly but condenses the many tiny steps of natural evolution into a few colossal moves. Thus, he says, man abandons the live saving advantage of a tentative nature. He therefore stresses the necessity to apply the principle of precaution rather than to rely upon the hope that cognition of science keeps up with progress of technology. In view of the irreversible character of genetically engineered plants an ethics of responsibility, of conservation and of preservation should lead to abstaining from the use of this technology in open nature. But if Europe cannot find an agreement to do so, it should at least be left to regions to take their own decision. And there should be one convincing argument for those who take GMO as indispensable for agricultural progress: it is never bad to have a fall back position, if something goes wrong. which is one more argument for regional self determination.

20 I do hope that this conference will help to pave the way to political decisions in this direction. And I am convinced that this would be the only way of guaranteeing freedom of choice to farmers and consumers not only of our time but also of future generations.

21 Session 1 Regional Aspects A Challenge for GMO Decision Making

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23 The Role of Precaution and Regional Aspects in the Authorization of GMOs: A Legal Perspective Gábor Baranyai Office of Parliamentary Commissioner for Future Generations Hungary

24 I. The GMO deadlock Precaution and regionalism: how to break the GMO deadlock? a legal perspective Mr Gábor Baranyai Office of the Parliamentary Commissioner for Future Generations Hungary The visible conflict Public opinion strongly opposed to the cultivation of GM crops Vast majority of Member States in favour of national moratoriums (subsidiarity) Perverse authorisation system: Commission strongly biased on behalf of authorisation EFSA operates without external control: decides over what is science and what is new 2 The hidden conflict Great cultural divide among regions, countries within the EU Strong economic interests on both sides (developers, organic farmers) Result: deadlock Full politicisation of the issue Recurring voting at Committee and Council level: circulus vitiosus II. How to break the deadlock? Political level: Reform of the operation of EFSA Push for a comprehensive reform of the current authorisation system (mainly Directive 2001/18/EC) Legal perspective: To make full use of Directive 2001/18/EC (the Directive ) Comprehensive application of the precautionary principle (authorisation everywhere) Enhanced reference to regional aspects (authorisation here) 3 4 III. The precautionary principle What is the precautionary principle? The precautionary principle is a fundamental tool for decision makers: the missing link between science and decision making The main elements: Scientific uncertainty Decision (+/ ) Guidance for decision: reversal of the burden of proof 5 What is the legal effect of the precautionary principle in EC law? Article 174 (2) of the EC Treaty: a guiding principle of Community environment policy Its scope has been progressively extended by the European Court of Justice and the Court of First Instance to become a general principle of Community law applicable to the entirety of the operation of Community decision making (Artedogan v. Commission, T 74 & 76/00) Not a stand alone principle: to be applied together with the prevention principle and the requirement to ensure high level of (environmental, health, etc.) protection. 6

25 No legislative formulation, but extensive jurisprudence by the ECJ/CFI (food additives, hazardous substances, environment): [t]he precautionary principle [ ] require[s] the competent authorities to take appropriate measures to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests (idem, para 184) Sweden v. Commission (T 229/04) Removal of a particular substance from the list of banned substances by the Commission The issue was solely decided with regard to the precautionary principle The Commission was condemned for the breach of the precautionary principle for the disregard of a number of probable harmful effects presented by Sweden The CFI reinforces existing case law that [T]he existence of solid evidence which, while not resolving scientific uncertainty, may reasonably raise doubts as to the safety of a substance, justifies, in principle, the refusal (para 161) 7 8 The role of the precautionary principle of GMO authorisations GMO authorisation is a par excellence field for the application of the precautionary principle Directive 2001/18/EC is unequivocal concerning the role of the principle in the context of authorisations: [t]he precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it. (recital (8)) The role of the precautionary principle of GMO authorisations GMO authorisation is a par excellence field for the application of the precautionary principle Directive 2001/18/EC is unequivocal concerning the role of the principle in the context of authorisations: [t]he precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it. (recital (8)) 9 9 One of the fundamental obligations of Member States is to [ ] in accordance with the precautionary principle, 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. (Art. 4(1)) Therefore, the 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)) Application of the precautionary principle in GMO authorisations What should be Commission Communication on the precautionary principle (2000) Proportionate Non discriminatory Transparent Coherent 10 11

26 The trigger factor: Even if scientific advice is supported only by a minority fraction of the scientific community, due account should be taken of their views, provided that the credibility and reputation of this fraction are recognised (p. 17) WTO Appellate Body: In some cases, the very existence of divergent views presented by qualified scientists who have investigated the particular issue at hand, may indicate the state of scientific uncertainty What is Unsatisfactory and non transparent risk assessments Consistent refusal by EFSA of any scientific arguments presented by external experts or Member States questioning the safety of the release Complete reversal of the burden of proof No legal challenge of the procedure IV. Regional aspects Article 173(3) of the EC Treaty: [i]n preparing its policy on the environment, the Community shall take account of [ ] environmental conditions in the various regions of the Community [ ] Directive 2001/18/EC is also based the obligation to take make case by case assessments with due account of regional differences The assessment must include [ ] satisfactory field testing at the research and development stage in ecosystems which could be affected [ ] (recital (25)) take into account the receiving environment (Article 4(3)) and the fact that the required information may vary [ ] depending on the potential receiving environment (Annex II, Point B) What is the receiving environment? Not defined, but in view of the precautionary principle at least the specific features of the Community s nature conservation units, the biogeographical regions must be taken into account Smaller units should be assessed if the conditions of the receiving environment so requires V. Conclusions The authorisation process is helplessly struggling with the questions what is uncertain? what is scientific? what is new information? The precautionary principle is to provide guidance in such dilemmas: stop and investigate further This guidance has been disregarded in defiance of the basic nature of the evolution of science: uncertainty is not an anomaly but an inherent element (the non existence of counter argument does not amount to verification!) Complete erosion of the public confidence in the assessment procedure that has to be redressed. 16

27 Nature Conservation in the EU: Seeking a Balance between EU wide and Regional Approaches Petr Roth Ministry of Environment Czech Republic

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35 Socio Economic Aspects Nina Vik Directorate for Nature Management Norway

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43 Discussion Following the First Session Following the keynote presentation the GMO authorization system was highlighted from a legal perspective. Then the balance between EU wide and regional approaches was presented on the basis of examples from nature protection followed by the Norwegian example of considering socio economic aspects in GMO decision making. Especially the presentations on legal issues and socio economic factors resulted in many questions from the audience which are subsequently summarized. A question was raised referring to the fact that Directive 2001/18/EC is based on Article 95 of the EC Treaty harmonizing the internal market of the EU and the practical implications of the fact that GMOs are thus considered a trade issue. Here a legal expert asked to recall the intention of the legislator when drafting the Directive, which obviously was the acknowledgment of the fact that GMOs as living organisms interacting with their environment are inherently different from other technical products. It was argued that if this fact does not gain recognition in the practical implementation of the Directive, the deadlock cannot be broken and the current unsatisfying situation will continue. Another question concerned the use of the term solid scientific evidence in the course of the authorization procedure of GMOs. In the opinion of an expert the precautionary principle provides the necessary flexibility to deal with complex discussions on what is biologically significant or which scientific evidence is solid enough. Moreover he clarified that the precautionary principle is not just an environmental principle but that the European Court has extended the scope of its application and thus it is now a general principle in EU law and thus applies to decision making at large. It constitutes a powerful tool to handle scientific uncertainties, which is of high relevance in the GMO issue in risk management as well as in risk assessment. A participant raised the issue of the current practice of GMO authorization in the EU which has in a way lead to a reversal of the burden of proof and where the Member States are forced to present scientific evidence on the impact of GMOs in support of their precautionary measures (e.g. safeguard clauses). It was pointed out that as there will always be different scientific views there is a need for procedures to assess risks apart from the scientific side. In the light of the Council Conclusions and their reference to socio economic risks and benefits the Norwegian approach of considering socio economic aspects raised interest. In Norway procedures are implemented to weigh potential risks of GMOs against the benefit of GMO applications for society and their contribution to sustainable development. Questions concerning the expertise of the Norwegian Scientific Committees and Advisory Boards, the aggregation of contributions from various sources (e.g. public hearings, advisory boards and scientific committees) and the experience with this system were discussed. The Norwegian expert reported that according to their concept concerns raised by the public should be dealt with by the Scientific Committees and Advisory Boards, which are composed of experts from different fields. In the respective Advisory Boards a broader range of disciplines is represented than in the Scientific Committees. For the implementation of this approach in Norway which takes into account benefits for society and contributions to sustainable development in addition to potential risk of GMOs it was necessary to develop criteria and checklists.

44 There was a common understanding that in order to seriously take into account scientific uncertainties and socio economic aspects the development of procedures as well as criteria is indispensible not only national and EU wide but also at the international level. However these will constantly require further development and continuing adjustment.

45 Session 2 Accounting for Regional Aspects Experience in Europe

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47 Considering Regional Characteristics in the GMO Decision Making Paula Rey Garcia DG Environment European Commission

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51 Approaches to an Ecological Coexistence Nature Protection Areas and GMO Cultivation Beatrix Tappeser Federal Agency for Nature Protection Germany

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63 Authorisation of Plant Protection Products in the EU Robert Womastek Agency for Health and Food Safety (AGES) Austria

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71 Experience with GMO Authorisations in the Netherlands Ruben Dekker Ministry of Housing, Spatial Planning and the Environment The Netherlands

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75 Plenary Discussion Following the Second Session The main topics of this discussion were the Dutch proposal at the Agricultural Council in March 2009 and possibilities for its implementation as well as the importance of a standardized baseline and the need for increased common understanding in value judgements among Member States. At the Council of Ministers for Agriculture the Netherlands have suggested that in conformity with present legislation internal market rule shall apply to the import of GM and GM products, but when it comes to cultivation of GMPs the choice should be left to individual Member States. With this suggestion the Netherlands wanted to initiate a discussion among Member States and to actively contribute to an improvement in the decision making process of GMO approval in particular for cultivation. Linked to this proposal is the request to find ways to include the socio economic dimension of the use of GMOs in the decision making process in a transparent manner. Asked about the reactions of Member States to this proposal the Dutch expert reported that in a first reaction many MS welcomed this suggestion as an acceptable way forward as it could solve a lot of the current problems. However, others remarked that some Member States oppose such a solution as they see GMOs as products and thus consider their approval an internal market issue only. Many participants were of the opinion that long discussions about a general revision of Directive 2001/18/EC and Regulation (EC) No 1829/2003 should be avoided but that small and specific amendments on this single point need to be debated. In particular two options how the Dutch proposal could be implemented were discussed. The first possibility is an opt out clause, allowing Member States to prohibit cultivation but not the marketing of a certain GMO on their territory. In the Dutch perception this would only be possible for other reasons than issues already dealt with in the risk assessment (e.g. socioeconomic considerations). It was noted that this would facilitate an authorization on scientific grounds, but that possible implications at the WTO level need to be taken into account. For some it was unclear how a Member State could vote in favour of a decision and at the same time aim at making use of the opt out clause. Someone else raised the question whether opting out could mean having to abstain from the vote. The Dutch announcement to continue work on the issue of socio economic aspects and to provide the Member States with a substantial input by January 2010 was highly appreciated. In this respect the European Commission based on the Council Conclusions from December 2008 called to exchange all relevant information on socio economic implications and welcomed all Member States to contribute to the report the Commission will draft in June The second possibility that was discussed was the opt in solution: an additional authorisation at the national level after the EU wide authorisation. This approach would be similar to the two step authorization procedure for pesticides in the EU. Here reactions in the audience were quite cautious. One remarked that in contrast to plant protection products there is no common ground in the EU for the need of GMOs. So beside the question of safety

76 of a certain GMO the question of its benefit for society needs to be dealt with leading to the issue of socio economic aspects. Another topic that was discussed was which form of agriculture should be used as a basis for comparison in the environmental risk assessment of GMOs. Often it is referred to conventional agriculture in this respect, but someone remarked that conventional agriculture is not a standard to be used as baseline, because there are many different practices generally applied in conventional agriculture. A participant noted that some of these practices have significant effects on biodiversity and if these are chosen as baseline the loss of biodiversity will be continued instead of halted. Someone claimed that the environmental impact of the use of GMOs in agriculture should at least be less than the environmental impact of conventional agriculture. In this respect it was acknowledged that for such an evaluation criteria would need to be developed and that at any rate the baseline needs to be specified in more detail. Someone remarked that nevertheless each decision will per se be accompanied by a certain amount of uncertainty. This participant stated that acknowledging and specifying uncertainty is a prerequisite in order to be able to achieve consensus on how much uncertainty a society is willing to accept. Additionally the point was raised that even if socio economic aspects are considered they will most likely be weighed differently by Member States as in Europe there are not only different ecosystems, but also different cultures and different risk perceptions, which makes it difficult to agree on the use of a certain GMO. Here again options for the specification of decisions on cultivation were put forward in order to be able to take into account not only different environments and different forms of nature protection but also socio economic and cultural differences among Member States: for instance the possibility to give Member States the right to take specific measures (e.g. GMO free areas) following an EU wide authorization of GMOs or to restrict cultivation to those regions, in which the safe use of a certain GMO has been demonstrated. A participant remarked that Regulation (EC) No 1829/2003 allows for less flexibility of the Member States for individual measures (e.g. safeguard clauses) than Directive 2001/18/EC. Against this background another participant highlighted the importance of the independence of the experts of the EFSA GMO panel. It was acknowledged that the scientific evaluation forms the basis of the authorization and that it is important to keep scientific discussions apart from political arguments. However the point was raised that the evaluation of potential impacts of GMOs involves value judgments and as such is a political and cultural decision, which cannot be left to science alone. In this respect the question was raised which tools would facilitate a distinction between risk assessment and risk management and thus provide for a transparent decision making process. The examples of regulation of plant protection products and nature protection have shown that increased exchange of views and intensive collaboration among Member States about regional differences, for instance in the form of bio geographical seminars, can enhance the development of a common understanding on value judgements. For GMOs a participant made clear that common grounds are needed in the understanding of risk and uncertainty. Again the need to develop criteria to be able to take into account socio economic aspects and to appraise the sustainability of applications of GMOs was emphasized.

77 Session 3 The way forward Considering Regional Aspects in the Future

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79 EU Council Conclusions on GMO Risk Assessment Marc Strauss Permanent Representation of France France

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83 Update of Guidance on Environmental Risk Assessment of GM Plants Goals and Working Strategy Elisabeth Waigmann European Food Safety Authority (EFSA)

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89 Cooperation between the EU Member States Andreas Heissenberger Environment Agency Austria

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93 Concepts of Environmental Risk Assessment Angelika Hilbeck EcoStrat GmbH Switzerland

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103 Panel Discussion Following the Third Session In the final round of discussion the EFSA general mandate by the DG Environment, the discrepancy between the legal requirements and their implementation, the improvement of risk assessment standards, and the cooperation between EU Member States were debated. The implementation of the mandate EFSA has received from DG Environment to update the EFSA Guidance Document for the environmental risk assessment of GMOs was discussed at the beginning. Questions were raised concerning the legal status and the comprehensiveness of the Guidance as well as the approach and activities of EFSA in this respect. The EC announced that this Guidance will most likely get the status of a commission decision. As far as the specificity of the recommendations in the Guidance is concerned EFSA made clear that they will apply on a case by case basis. Additionally EFSA called upon all Member States and stakeholders to participate in the consultation with EFSA and to provide input to the draft document thus strengthening the scientific risk assessment and contributing to a strong guidance document. It was acknowledged that there is a discrepancy between the legal requirements and their practical implementation, which has implications for both: risk assessment and risk management. Some experts claimed that at the moment in risk assessment regional aspects are not sufficiently taken into consideration in order to fulfill the requirements of the legislation. Therefore the scientific standards currently used need to be improved. They admitted that regional aspects do constitute a challenge, but possible effects of the whole GM plant and its interaction with the receiving environment could certainly be accounted for, if fundamental conceptual changes in the environmental risk assessment were applied. This resulted in the discussion of another important issue: the availability of test material for independent research. Some participants reported that scientists had difficulties in getting access to GM material needed for their experiments. One participant mentioned cases in which the experimental setup was not only determined by the scientists conducting the study, but in which the design of the experiments had to be negotiated with the consent holder. Another informed the audience that in the US scientists have recently sent an (anonymous) letter to the US Environmental Protection Agency (EPA) complaining about their constraints in conducting independent research on GMOs. The EFSA representative acknowledged this situation as problematic and agreed to the demand for an improvement of this situation. On the other hand a discrepancy between the legal requirements and their practical implementation becomes apparent in risk management, in particular in decision making. Here beside the lack of transparency differences in the evaluation of scientific facts, uncertainties and socio economic aspects were discussed. In this respect someone also mentioned the difficulty to adequately account for national responsibilities in nature protection and international obligations (e.g. WTO). It was noted that there is room for progress in the existing legislative framework to alleviate the problems resulting from the centralized authorization procedure for cultivation. Some participants claimed the need for a bottom up approach to tackle the problem of regional and socio economic aspects. A first step to start this process would be to intensify the exchange of views, the communication of scientific arguments and the cooperation in particular among Member States but also with EU