Precautionary Expertise for GM Crops

National Report – Germany

Precaution for Choice and Alternatives

Quality of Life and Management of Living Resources Key Action 111-13: socio-economic studies of life sciences Project n° QLRT-2001-00034

Karin Boschert and Bernhard Gill Institute of Sociology

Ludwig-Maximilians-Universität (LMU) Konradstrasse 6

D-80801 München Germany

Karin.Boschert@soziologie.uni-muenchen.de Bernhard.Gill@soziologie.uni-muenchen.de

May 2004

Contents LIST OF ABBREVIATIONS 1 ABSTRACT 3 MAIN FINDINGS 4

QUESTIONS FOR THE STUDY 4 SUMMARY OF MAIN FINDINGS FOR THE GERMAN CASE STUDY 4 DIFFERENCES IN ACCOUNTS OF PRECAUTION 5 1997-2003: THE CHANGE IN BIOTECHNOLOGY DISCOURSE – FROM RISK TO COEXISTENCE 8 TOWARDS MORE PRECAUTIONARY PRACTICES? 9 CONCLUSIONS FOR POLICY LEARNING? 12

1 INTRODUCTION 14 1.1 THE 1990S: DEREGULATION, PUSH IN INNOVATION, AND STRONG OPPOSITION 14 1.2 FROM 2001: AGRARWENDE AND PRECAUTIONARY CONSUMER PROTECTION 15

2 SCOPE OF PRECAUTION 17 2.1 THE PRECAUTIONARY PRINCIPLE IN GERMAN ENVIRONMENTAL LAW 17 2.3 CONTESTED VIEWS ON PRECAUTION 20

3 THREE INSTITUTIONAL PRACTICES 25 3.1 REGULATORY MEASURES 25 3.2 EXPERT BODIES AND JUDGEMENT 57 3.3 STAKEHOLDER ROLES 59 3.4 TRANSPOSITION OF EU DIRECTIVE 2001/18 INTO NATIONAL LAW 67

REFERENCES 71 ANNEXES 77

ANNEX I: INTERVIEWS 77 ANNEX II: KEY POLICY EVENTS 1997-2003 78

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List of abbreviations AGÖL Arbeitsgemeinschaft ökologischer Landbau

Association of Organic farming

BBA Biologische Bundesanstalt für Land- und Forstwirtschaft Federal Biological Research Centre for Agriculture and Forestry

BfN Bundesamt für Naturschutz Federal Agency for Nature Conservation

BfR Bundesinstitut für Risikobewertung Federal Institute for Risk Assessment

BgVV Bundesinstitut für Gesundheitlichen Verbraucherschutz und Veterinärmedizin Food Safety Agency

BLL Bund für Lebensmittelrech und Lebensmittelkunde German Federation Food Law and Food Science

BMBF Bundesministerium für Bildung und Forschung Federal Ministry for Education and Research

BMGS Bundesgesundheitsministerium Ministry of Health and Social Affairs

BMU Bundesumweltministerium Federal Ministry for the Environment, Nature Conservation and Nuclear Safety

BMVEL Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft Federal Ministry for Consumer Protection, Food and Agriculture

BMWi Bundesministerium für Wirtschaft und Technology Federal Ministry of Economics and Technology

BÖLW Bundesverband ökologischer Lebensmittelwirtschaft Organic Farming and Processing Association

BUND Bund für Umwelt- und Naturschutz Friends of the Earth, Germany

BE Bundesverband der deutschen Ernährungsindustrie National Association for the German Food Industry

BVL Bundesinstitut für Verbraucherschutz und Lebensmittelsicherheit Federal Agency for Consumer Protection and Food Safety

BVL Bundesverband des deutschen Lebensmittelhandels National Association of the German Retail Industry

DAF Dachverband wissenschaftlicher Gesellschaften der Agrar-, Forst-, Ernährungs- und Umweltforschung Umbrella organisation for the science associations in agricultural, forest, food and environmental research

DBV Deutscher Bauernverband National farmers’ organization

DFG Deutsche Forschungsgemeinschaft German Research Society

DIB Deutsche Vereinigung Biotechnologie German Biotechnology Association

FiBL Forschungsinstitut für biologischen Landbau Research Institute for Organic Farming

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GenTG Genetic Engineering Act

GEN Gen-ethisches Netzwerk GMO-critical NGO

GM Genetically modified

NABU Naturschutzbund Deutschland German Nature Conservation Association

NGG Gewerkschaft Nahrung-Gaststätten-Genuss Union for Food Industry

PP Precautionary principle

RKI Robert-Koch Institute, Centre for Genetic Engineering

SRU Sachverständigenrat für Umweltfragen German Council of Environmental Advisors

UBA Umweltbundesamt Federal Environmental Agency

RA Risk assessment

RM Risk management

Vzbv Verbraucherzentrale Bundesverband Federal Consumer Protection Agency

ZKBS Zentrale Kontrollstelle für biologische Sicherheit Scientific Advisory Committee on Biological Safety

ZsL Zukunftstiftung Landwirtschaft Foundation on Future Farming

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Abstract In Germany, the precautionary principle (PP) is a well-established legal principle in environmental law. Biotechnology legislation is one of many pieces of legislation that are based on, or incorporate elements of, the PP. Although the precautionary principle is widely accepted in Germany as a basis for decision-making with respect to GM crops, there are many differing perspectives on its interpretation and implementation. We use the concept of framing as an ordering device to cluster these different perspectives. The three frames we use are: ‘innovation’, ‘risk’ and ‘alternatives’ and each frame has its own account of precaution. We can then show which of these accounts inform regulatory practice in Germany. Our study covers the period from1997 to 2003, during which there were a number of important developments in risk regulation and agricultural policy, which impacted on biotechnology regulation and the use of the precautionary principle. The parliamentary elections in 1998 brought the Green Party into the government as a coalition partner of the Social Democrats. In 2000, the PP was invoked as grounds for suspending market approval of GM maize 176. New groups, such as the nature conservationists, were entering the field of discourse. Problems such as out-crossing of genes became legal and economic issues. However, more important for the regulation of agro-biotechnology and institutional change was the BSE crisis in 2000, as it triggered the revision of agricultural policies and led to the Agrarwende [turning agricultural policy towards consumer interests and choices]. In the wake of that crisis, a planned large-scale field test of GM crops was cancelled and replaced by a public debate. Consumer choice and coexistence became the leading principles in agro-biotechnology regulation. In 2002, political responsibility for GM crops was shifted from the Ministry of Health to the Ministry of Consumer Protection, Agriculture and Food. Newly proposed biotechnology regulation is aimed at safeguarding agricultural choices, and creating new types of expertise. We demonstrate that in many of these developments and decisions the PP plays an explicit or implicit role. As a further result we show that the PP, usually associated with environmental risks, takes on a broader meaning now that agro-biotechnology has become caught up in a more complex debate on consumer choice and coexistence.

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Main findings Questions for the study Although the precautionary principle has been widely accepted in Europe as a basis for decision making about GM crops, there are many perspectives on its interpretation and how it should be implemented. This study was based on the following questions:

For GM crops and their food uses, how do current European practices – regulatory measures, expert judgement and stakeholder roles – compare with different accounts of the precautionary principle (PP)? How do these accounts inform policies and practices regarding GM crops? How do these facilitate (or impede) efforts to mediate conflicts and gain legitimacy for decisions?

This report1 elaborates on the interpretation and use of precautionary approaches in Germany during the study period 1997-2003.2

Summary of main findings for the German case study • Various accounts of precaution and precautionary practices can be found in the

German case study3. These varying understandings of precaution are informed by differences in judgements about scientific uncertainty, the normative baseline for risk comparison, the role of scientific expertise, and models of agriculture and food production. Overall, our analysis shows that the employment of the PP is dependent not only on the value commitments and perspectives of those involved in the policy discourse, but also on institutional arrangements, and on the balance of power between political forces.

• In Germany, the different implicit and explicit understandings of precaution can be grouped according to three different issue framings. These understandings broadly correspond with the main stakeholder positions on the PP. Within a framing we call ‘innovation’, a rather narrow understanding of precaution can be found in, for instance, industry circles or the former competent authority (RKI). A broader understanding of the PP, within a framing we call ‘risks’, can be assigned to the Federal Environmental Agency (UBA) and other groups critical of, but not fundamentally antagonistic to, biotechnology. The environmental NGOs and other more fiercely critical opponents of biotechnology can be clustered into an ‘alternatives’ framing, which is linked to a very broad account of precaution.

• The regulatory measures we researched – risk research, risk assessment and risk management – and the different precautionary practices, actual or proposed, within these fields can be understood as being largely informed by these different understandings of precaution. In fact, the boundaries and definition of the categories themselves can hinge upon a specific interpretation of the PP.

1 In January 2002 there was a German workshop held on the subject of precaution in GMO regulation; for the results see Boschert, K.; Gill, B. (2002) German Workshop Report. (http://technology.open.ac.uk/cts/peg/index.htm) 2 The PEG project has research partners in Austria, Denmark, France, the United Kingdom, Spain, and the Netherlands. The project is co-ordinated by the UK team. 3 Preliminary analysis indicated that the terms ‘precaution’, ‘precautionary approach’ and ‘precautionary principle’ were being used somewhat interchangeably to denote similar meanings, while the same term was given different meanings. So the research encompasses all such terms.

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• The public controversy over agro-biotechnology has always gone beyond the scientific dimensions of environmental and health risks to include models of alternative forms of agriculture and technological decision-making. In fact, as the findings show, different understandings of precaution open up space for the consideration of such issues, often dismissed as ‘non-scientific’.

• Specific accounts of the PP inform the GM crop approval procedure. Within the official regulatory sphere there is a clash in understanding particularly between the Environmental Agency (UBA) and the former competent authority (RKI) and its scientific advisory committee (ZKBS). Fundamental concerns, as exemplified by the third framing, that go beyond the legal confines of the Genetic Engineering Act (GenTG) are wholly excluded from the regulatory procedure. Hegemonic accounts of narrow precaution have thus rendered a mediation of conflicts between the regulators themselves and between regulatory and public concerns difficult, if not impossible.

• The regulatory sphere has in the past been relatively closed to broader accounts of precaution. Challenges to these conventional practices have thus basically come from outside the system: the change in government in 1998, the new European Directive, several food crises especially BSE, the resulting policy of Agrarwende [turning agricultural policy towards consumer interests and choices], and the subsequent change in the competent authority for GM regulation. Together these developments have shaken the regulatory system and have challenged the dominant scientific-technological framing of agro-biotechnology in Germany. This has opened up space for new themes and groups and has given greater legitimacy to broader accounts of the PP in the regulatory sphere from 2000 onwards.

• Debates over the issues of choice and coexistence, which became central in 2001, have reframed the former agronomic-environmental focused debates. Moreover, the change in subject and discourse has brought in new actors, such as the organic and conventional farmers, and created new dynamics. Risk and safety issues remain important, but disputed, themes of precaution. However, precaution takes on a new and broader meaning now that these issues are part of a more complex debate on consumer and producer choice and coexistence. A novel aspect of proposed new biotechnology legislation is that the PP is invoked in order to safeguard agricultural and consumer choices.

• The debate about the precautionary principle is caught up in the continuous political-scientific controversy about biotechnology. This can lead to contradictory interpretations. For some, recourse to the PP entails both a demand for more science, and the addressing of scientific uncertainties, while for others the invocation of the PP is decried as ‘unscientific’ or ‘political’. The different conceptualisations of the PP can thus give interesting insights into the question of the separation of science and politics.

Differences in accounts of precaution In Germany, we identified various different accounts of precaution in (policy) statements, documents and the analysis of specific practices. In order to make sense of these varied explicit and implicit accounts of precaution we applied the idea of framing (Snow & Benford 1992) as an ordering device. As applied to precaution, the idea of framing is as follows. Although there exist abstract concepts of precaution and the precautionary principle, in ‘real’ life accounts of precaution do not stand alone but are constructed and articulated within specific views on the subject, and within specific contexts. These views or interpretative schemes in turn are informed by the

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value commitments and perspectives of those involved in the policy discourse on GM crops. On the basis of these ideas, we propose the three framing categories presented below as a way of clustering the different accounts we identified. The way in which these framings link to accounts of precaution are summarised in Table 1.

‘Innovation’ frame – making agbiotechnology possible Within this frame, biotechnology is considered to be an innovative problem-solving tool, which could allow more sustainable practices and should therefore be promoted. This view of biotechnology can be linked to the following account of precaution: within this frame, the PP is viewed at the level of a political idea (politische Leitidee), which is considered prior to a specific legislative action. It is thus associated with the general requirement for pre-market risk assessment and authorisation. Risk management is justified on the basis of evidence of risk, in which case precaution becomes prevention. Assumptions about uncertainty are often dismissed as being speculative. The state of knowledge about the technology is generally assumed to be high and sufficient. It is assumed that there are no specific risks from biotechnology beyond conventional ones; however, this needs to be assessed on a case-by-case basis. Science is understood as the appropriate tool for objective decision-making and no factors other than scientific ones are considered. The level of protection, that is, the type or extent of unacceptable damage, is based on conventional standards in agriculture.

‘Risk’ frame – making agbiotechnology safe Within this frame, risk and safety considerations are pivotal. In this sense biotechnology is viewed as a risk-creating, but possibly problem-solving, technology. In either case, alternative solutions posing lower risks to the environment should be considered. The actors in this category differ from those in the ‘innovation’ frame category especially with respect to their judgement on scientific uncertainty and the use of normative criteria. The PP is understood as a legal principle, which needs to be considered at all stages of approval. Precaution in risk assessment or risk management is justified on the grounds that uncertainty and gaps in knowledge about biotechnological effects on the environment cannot be fully assessed. The PP is thus also regarded as a decision-making tool triggered in cases of uncertainty. It is furthermore claimed that decisions cannot be based only on science as there needs to be societal consensus with respect to protection levels and acceptable risks. In a similar vein, it is argued that biotechnological applications should be judged against higher sustainability standards.

‘Alternatives’ frame – preventing agbiotechnology Within this frame, the prevention of the introduction of biotechnology is pivotal. Biotechnology is perceived as a problem-perpetuating and problem-causing technology, and hence its use should be banned or at least heavily restricted. For the views in this category, the PP is more than just a legal principle, it is a framework or mindset for being precautionary. On the basis of precaution GMOs should not be released into the environment. This kind of strong precaution is justified on the grounds of systemic uncertainties and unpredictable and uncontrollable effects, even beyond environmental risks. On the basis of precaution, new technologies should only be considered on the basis of problem analysis and need. Moreover, new technologies should be chosen in an open and transparent fashion and should constitute an absolute improvement over conventional practices. The PP is thus also used as a principle for introducing quality standards in environmental decision-making. In any case, these decisions cannot be left to scientists alone because the question of GMOs is perceived as being first and foremost political.

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Table 1 Framings and contested views on precaution Issue

framing ‘Innovation’

– making agbiotech possible –

‘Risks’

– making agbiotech safe –

‘Alternatives’

– preventing agbiotech –

PP in general

Political idea and general legal principle for pre-market approval

Legal principle and specific decision-making tool

Mind set, legal principle, and quality tool

Trigger for PP

Positive scientific evidence of risk

Uncertainty and knowledge gaps

Systemic uncertainty

Uncertainty No basis for preventative action, risks will be handled by risk management practices. Uncertainty often dismissed as speculative concept

Basis for preventative action (ban only as a last resort). Uncertainty changes risk research, risk assessment and risk management practices. Uncertainty can be reduced through research (‘need to know more’) and risk-reducing measures

Basis for preventative action including banning, since uncertainty cannot be reduced

State of knowledge

‘There is considerable knowledge about GM crops’

‘We do not know enough about the effects’

‘We don’t know what we don’t know’

Evidence of damage/ Baseline

Conventional standards in agriculture applied (‘as safe as conventional products’)

Preferably higher sustainability and nature conservation standards applied (improving the status quo)

New technologies should only be considered on basis of absolute improvement of practices, beyond the status quo. That is, problems need to be solved by conventional technologies first

Cost-effective measures

Intervention needs to be cost-effective and ‘practical’

Intervention focuses most of all on risk avoidance, yet (cost) limits accepted

Possible costs should not hinder intervention on the grounds of safety

Cost–benefit analysis

In general cost-benefit analysis rejected as these decisions should be left to the market: ‘acceptable social demand no legal criterion’

Cost-benefit analysis as basis for decision-making on risks. However, assessment confined to direct and indirect environmental effects. Alternative solutions posing lower risk to the environment should be considered

Cost-benefit analysis rejected because (1) risk avoidance is highest priority, (2) society should not be forced to bear the costs of expensive technology assessments. Problem analysis first Cost-benefit analysis demanded (4th hurdle): full test for socio-economic need

Burden of proof

Proof of risk lies with regulators. However ‘reasonable’ public safety demands on technology introducer accepted

Principally lies with the regulator. However, uncertainty and knowledge gaps may require reversal of burden of proof

Proof of safety/need lies with risk creator

Science Science as tool for objective decision-making. ‘Politicization of science’ should be prevented

Science alone does not provide adequate basis for risk decisions because (1) scientific evidence may not be available (2) risk assessment and risk management is influenced by society’s moral concepts about protection levels

Science alone (but what science?) does not provide basis for risk decisions. Question of GMOs is beyond science and is foremost political. ‘Scientification’ hides political character of decision

Other legitimate factors

Not relevant in risk assessment procedure. Individual preferences and societal concerns mainly delegated to market sphere

Values necessarily come into research and risk assessment and risk management (‘what effects are considered to be damage and acceptable?’).

See above

Risk philosophy

Close to additive concept Synergistic concept Synergistic concept

Participation Decisions should be left to Experts’ judgement should Decisions should be taken

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experts (scientists); ‘de-scientification’ should be prevented

represent scientific controversies. Decisions need to be transparent and open to lay people’s concerns

‘democratically’, usually translated into demand for new decision-making procedures that are more transparent and participatory

Sustainable agriculture

Biotech allows more sustainable agricultural practices

Biotech might provide a tool for sustainable agriculture

Biotech contradicts sustainable agriculture

Biotech in general

Problem-solving technology Risk-creating but possibly problem-solving technology, alternatives need to be considered

Problem-perpetuating and new problem-causing technology

Biotech risk in general

No specific risk beyond conventional ones. ‘No more or less effects than any other things we do’

Basic risks and uncertainties acknowledged

Stress on ‘new quality’ of biotechnological interventions. Potentially fatal consequences anticipated

Co-existence

Not part of precautionary rationale. Coexistence is economic concept and not safety related

Part of precautionary rationale for coexistence allows keeping natural spaces free of GMOs and coexistence allows individual safety judgement

In the event of cultivation, coexistence is imperative! Part of precautionary rationale for coexistence allows for both keeping natural spaces free of GMOs and individual safety judgements. However, economic damage, in terms of ‘safeguarding alternatives’, is also part of the precautionary rationale

1997-2003: The change in biotechnology discourse – from risk to coexistence In Germany, the public controversy over agricultural biotechnology has been ongoing for a number of years and seems set to continue. Since the 1990s the claimed benefits of the technology have been strongly promoted by some and equally strongly contested by others. Since the beginning of the 1990s biotechnology proponents have supported the framing of biotechnology as a central tool for innovation, technological progress and international competitiveness. Opponents, on the other hand, have stressed the lack of need, and the risks, and have used the precautionary principle as means to resist the introduction of the technology. Throughout the 1990s biotechnology policy in Germany was characterized by strong political support for research and capacity building in the R&D sector. Politically the decision-making elites followed a ‘duck and cover strategy’ (Hampel et al. 2001), keeping the volume of public debate to a minimum. Hegemonic ‘innovative’ precautionary rationales favoured equally technology-friendly approval practices. The narrow scientific-technical frameworks chosen did not take account of public concerns. The official debate was confined to sound scientific arguments alone, while other precautionary accounts were dismissed or termed irrelevant.

This general hegemonic line of biotechnology framing was maintained even after the political changes in 1998, when 16 years of conservative/liberal rule were replaced by a coalition between the Social Democrats and the Green Party. However, green pressures eventually had an impact on the biotechnology policies of the country. In 2000, the PP was invoked in order to suspend market approval of Bt maize 176 on grounds of safety concerns. The role of the environmental agency, UBA, was strengthened and put on an equal footing with the competent authority RKI. New groups, such as nature conservationists, were entering the field of discourse. Moreover, problems, such as out-crossing of genes into neighbouring fields started to become legal and economic problems. Market-based resistance strategies of biotechnology’s critics, i.e. blacklisting of products and firms, were finally taking effect, as were labelling initiatives. At the European level the deregulatory phase of the 1990s has gone into reverse, towards stricter regulation.

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Agrarwende and consumer choice In the mid-1990s, EU-wide discussion on biotechnology had already focused on topics such as agriculture, food, and the environment. However, in Germany the big changes in discourse and practices in the regulatory arena came only with the food and agricultural crisis at the end of 2000. The advent of BSE sent the agricultural and food related system into turmoil. The crisis was of such an extent that it led to the resignation of both the health and the agricultural ministers and a change in the agricultural ministry’s focus from agriculture to consumer protection. But more importantly, the crisis caused the restructuring of the German risk regulation system and triggered a fundamental turnaround in agricultural policies. With a focus on Agrarwende and ‘precautionary consumer protection’, agricultural policy should in future be based on sustainable production, consumer concerns and food safety. As a consequence of the new discourse on consumer-oriented agricultural policies, a large-scale GM cultivation programme initiative, agreed between the red-green government and industry, was stopped. The initiative was eventually replaced by a public debate, the Diskurs grüne Gentechnik, this time under the political lead of the new Consumer Protection Minister, Renate Künast, a Green party member. After re-election of the government in 2002, political responsibility for agro-biotechnology shifted from the Ministry of Health to the new Ministry for Consumer Protection, Food and Agriculture (BMVEL).

The new GM policy line as advanced by Agricultural Minister Künast was framed around Agrarwende and consumer choice. In this way, for the first time, a senior government official promoted a new way of conceiving of agro-biotechnology applications by linking them to the broader problématique of agriculture and food production. For the sake of agricultural change, Künast promoted organic agriculture as a model for more sustainable forms of farming, and aimed to increase its share to 20% within ten years. New technologies needed to prove their contribution towards the goal of sustainable agricultural change. More importantly though, new technological applications needed to withstand the test of consumers and producers and their food/feed/seed choices. In any case, the introduction of new technologies should not compromise the freedom of choice of the consumer or the farmer. Künast framed the question of agro-biotechnology as one of social preferences about what we eat, how we live and what structures (i.e. of farming) we support. This framing of the issue was, unsurprisingly, highly contested as it openly politicized the question of technology introduction and opened up the field to broader, more fundamental discussions and accounts of precaution. Rather than focusing on risk, the new Künast discourse stressed options and solutions for agriculture and food systems. The choice/coexistence and Agrarwende debate thus challenged the established understanding of GM policy making and threatened entrenched institutional perceptions, arrangements and power relations. Following the recommendations of the Diskurs grüne Gentechnik, in 2002 coexistence and consumer choice were identified as the new policy goals of the re-elected red-green coalition government.

Towards more precautionary practices?

Institutional innovations and new practices The events following BSE and the subsequent change in framing and perception of agro-biotechnology, together with the difficulties arising in the area itself, i.e. outcrossing, have brought about institutional innovations and new practices. The change in political responsibility implied that the subordinate agencies involved in GM crop regulation had to be changed accordingly (see Figure 1). The competent authority (CA) was thus changed from the Robert-Koch Institute to the Federal Agency for Consumer Protection and Food Safety (BVL), a newly created subordinate agency of the BMVEL. UBA’s role in the approval procedure will be taken over by the Federal Agency for Nature Conservation (BfN), an institution known for its critical stance on GMOs. In June 2001 another approval decision, on GM maize Artius (T25), was postponed by an intervention from Künast on the grounds of

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precautionary consumer protection. In October 2003 a GM apple field trial was halted, as alternative non-GM research was perceived as being more promising.

Coexistence and precaution More importantly though, the framing of coexistence and consumer choice has broadened the boundaries of politically accepted uncertainties and has fostered the use of the precautionary principle and broader forms of expertise. Even though the themes dominating coexistence are not (officially) part of risk regulation, precaution has been linked to the choice and coexistence discourse in various ways. According to consumer and environmental NGOs, farmers and the BMVEL, precautionary measures need to be taken from the outset to safeguard freedom of choice. Precautionary measures are furthermore regarded as a way of dealing with ecological, health and economic risks when it comes to large-scale introduction of GMOs. Choice is thus, in turn, serving precaution because it allows the limiting, and to a certain degree the containing, of the extent of spread of GMOs in the food chain and the environment. Equally importantly, freedom of choice allows individual choice in terms of what the individual regards as better for the environment (e.g. GM or organic agriculture) and human safety. These views, however, are not shared by proponents of agro-biotechnology, who hold that the question of coexistence is a purely economic one.

In the new draft bill for the transposition of EU Directive 2001/18 into national law, coexistence and consumer choice are being made central by the BMVEL. The PP is explicitly mentioned in the risk assessment and with respect to the minimization of out-crossing. Moreover, the PP is invoked in order to safeguard agricultural and consumer choices and to manage the ‘peaceful coexistence’ of different forms of agriculture and consumption. Environmental parameters, such as outcrossing, now serve a double purpose, as indicators for environmental and economic damage. Biodiversity considerations are given more attention with the involvement of the Nature Conservation Agency in risk regulation. In addition, a change in the composition of the scientific advisory body, the ZKBS, is foreseen, thus broadening the range of expertise involved in risk assessment. Biosafety research is being broadened and research into alternatives is being promoted politically. The clientele and expertise base of the BMVEL is gradually changing.

Ambiguous developments The subsytem of agro-biotechnology in Germany has thus undergone considerable change over the last three years. These changes together could be seen as an indication of a broadening of precautionary expertise and as a way of incorporating the different interests with respect to agro-biotechnology. However, to date there can be no overall judgement on this process and its possible outcome. There are institutional and thematic innovations, the draft bill of the Genetic Engineering Act (GenTG) endorses a strong precautionary rationale and (critical) stakeholder input has been increasing. However, these changes are strongly disputed and opposed by entrenched political forces. Thus contradictory developments can be observed. Though it seems that ‘risks’ and even ‘alternative’ accounts of precaution inform supplementary activities beyond product approval, regulatory practice itself continues largely as before. The assessment of new product files does not indicate a move away from the conventional risk assessment rationale of the RKI, at least until recently. At the European level, Künast has pushed for more strict demands with regards to EU-wide coexistence regulation or a change in the decision-making procedure in the case of seed thresholds. However, with respect to approval decisions in EU committees, the new German policy line means merely a shift from approval to abstention (as in the case of the Bt 11 maize decision). Therefore, even after all these changes (but with most of the same administrative officers still in charge), institutional practices – regulatory measures, and the role of expertise and stakeholders – remain subject to interpretations of the PP and the distribution of power between political forces.

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Figure 1 Institutional innovation: the change in the competent authority

BBA: Federal Biological Research Centre for Agriculture and Forestry BfN: Federal Agency for Nature Conservation BfR: Federal Institute for Risk Assessment BgVV: Food Safety Agency BMGS: Ministry of Health BML: Ministry of Agriculture BMU: Ministry of Environment BVL: Federal Agency for Consumer Protection and Food Safety RKI: Robert-Koch Institute, Centre for Genetic Engineering UBA: Federal Environmental Agency ZKBS: Scientific Advisory Committee on Biological Safety

BMLMinistry of Health

RKIBBA

BgVV (novel food)

Länder

ZKBS

Old:

Political responsibility (Fachaufsicht) Competent Authority

Consultative body (opinion or consent – decision-dependent)

BMU

Ministry of Consumer Protection,

Agriculture and Food

BVL

BBA

BFN

RKI

Länder

ZKBS

New: BMGS

BfR

BMU

UBA

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Conclusions for policy learning? The developments described in the German food and agricultural system over the last three years have put great pressure on policy makers to regain credibility and public confidence in regulatory measures. This has led to institutional and policy changes, with repercussions for biotechnology regulation. In addition, in the face of the anticipated ending of the de facto moratorium, and given the new emphasis on sustainable, less intensive farming and consumer choice, these developments have further contributed to a demand for new regulation and corresponding institutional changes. The dynamic of these developments in Germany has required a learning process on the part of policy makers and stakeholders alike, concerning how to change institutions in order to make them more trustworthy, how to redesign procedures in order to reconcile different interests, how to involve policy actors and expert advice in order to solve the scientific-public controversy, and how to talk about biotechnology in the first place in order to gain public legitimacy and support. Some aspects of policy learning are briefly discussed below.

(i) References to the PP are politically contingent and are used by all kinds of actors to support their stance on the GMO issue or to mediate between (new) conflicts in the policy arena:

The precautionary principle is caught up in the continuous political-scientific controversy about agro-biotechnology. The new debate on Agrarwende, coexistence and the safeguarding of non-intensive agricultural alternatives has added new dimensions to what is meant by precaution for decision-making processes on agro-biotechnological applications. Further proof of the relational nature of the concept is that in the most extreme polarization of the case, the PP is used in both the support of and the opposition to agro-biotechnology. For instance, for opponents agro-biotechnology means a continuation of intensive agricultural methods, thus contributing to environmental damage and a loss in biodiversity. In contrast, for the proponents it is precisely the use of biotechnology that will help to overcome the problems of industrialized agriculture. Consequently, for the first stance a stop to development would be required by the PP, while for the second one a stop to development would be ‘unprecautionary’. This suggests that in the policy process meanings and standards for precaution need to be clarified and agreed.

(ii) Actors have repositioned themselves and learned new discursive strategies. Some examples:

The prominent rise of consumer issues and the reframing of the GMO debate under the label of Agrarwende and consumer choice have given rise to new openings for some actors while forcing others to reposition themselves. NGOs and organic farming organizations have picked up on the Agrarwende discourse and linked industrial agriculture and food production with biotechnology. However, the demand for a change in agricultural practices is not only used as another means to oppose the introduction of agro-biotechnology. Instead NGOs have recently turned to economic arguments, stressing the opportunities of a GM-free Europe as a quality food market.

Likewise, given the strong public support for agricultural change, biotechnology proponents have taken up the Agrarwende rhetoric and have felt under pressure (or seen the opportunity) to speak in such terms when talking about agro-biotechnology. In this way, the Agrarwende rhetoric is used to promote agro-biotechnological applications.

The BMVEL is not primarily concerned about possible environmental safety aspects with respect to coexistence regulation. Yet interestingly enough, nature protection is also framed as a coexistence issue, in terms of safeguarding not only GM-free agricultural and food choices but also ‘GM-free nature’.

(iii) Actors and policies have challenged the assumption that normative issues can be separated from scientific issues:

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The talk of Agrarwende and coexistence has broadened the scope of biotechnology regulation to include the socio-political demands of coexistence and consumer choice. Biotechnolgy regulation should henceforth not only protect health and the environment but also safeguard consumer choices and agricultural options. In the wake of the debate, the distinction between environmental and other risks, i.e. economic ones, has become increasingly blurred. As a result some actors have increasingly felt the need to stress the division between the scientific and the non-scientific aspects in risk regulation. Biotechnology proponents fear a ‘politicisation’ or ‘de-scientification’ of risk assessment, thus implying that risk assessment could be value-free (Weingart 1999). Biotechnology opponents, in turn, accuse the proponents of ‘scientification’, that is, of using science or neutral expertise as a mask for political and cultural choices. Notwithstanding this name game in the political debate, regulators have recognized, both implicitly and explicitly, the value basis of risk assessment decisions. For instance, risk assessment files of the RKI (and now those of the BVL) mention that GM crops constitute an ecological solution to certain problems, and the UBA claims that judgements about damage criteria or the extent of uncertainties depend on a societal consensus. This suggests an opening up of the politically relevant value assumptions involved in risk regulation, making them more transparent and available for public deliberation. The outcome could be decisions that are science-based and publicly acceptable. This could make risk decision-making more ‘socially robust’ and less vulnerable to suspicions of ‘interest capture’.

From 2000 onwards the BSE crisis has undermined the risk and expertise arrangements in the German risk regulation system. In response, the ‘red-green’ government has undertaken measures to change institutional structures and political responsibilities, with the establishment of a new ministry and the creation of new risk regulating agencies. Furthermore, with the Agrarwende new additional types of expertise and networks (organic farming organizations, nature conservationists) have entered the political arena and are being given expert status in policy deliberations. This trend has only been strengthened by the recent changes from risk to coexistence regulation. Taken together these developments mean there is now a greater opportunity for divergent views to inform expert advice and regulatory practices. It could also mean greater scope for mediation between socio-political and techno-scientific interests. However, these developments also increase the likelihood of expert conflicts as contradictory value judgements and interests enter the regulatory arena. The development of the risk regulation system, with an increased emphasis on the separation between scientific expertise and decision-making, is thus countered by a tendency to re-open these contingent boundaries of science and politics, or experts and stakeholders. The new developments are thus challenging this scientific-technocratic model of decision-making and may force actors to clarify disagreements over (value) judgements.

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1 Introduction 1.1 The 1990s: deregulation, push in innovation, and strong opposition The debate in Germany about the regulation of biotechnology in the 1990s is characterized by conflicting developments and yet, the decade started with a regulatory breakthrough. After long and intensive conflict over genetic engineering in the 1980s and the disputed need for a specifically designated law, the Genetic Engineering Act was agreed upon in 1990. However, instead of putting an end to political controversy the act perpetuated it (Gill 1995). The mere existence of the act acknowledged the fact that biotechnological developments were such that they needed special provisions and yet the act equally declared that research and development should be fostered. It is biotechnology promotion and push in innovation, alongside continued opposition, which defines these principal conflicting developments in the 1990s.

In 1993, as a result of increasing importance given to economic competitiveness after German reunification and by stressing the potential economic role of the technology the law was ‘deregulated’, that is some regulatory provisions were relaxed. The ongoing economic recession and the marginalization of critical groups and themes made such a move possible. A means of accommodating the public protest and channeling the hostile debate was seen in the establishment of a ‘Technology assessment procedure on herbicide-resistant crops’ organized by the Wissenschaftszentrum Berlin, a public research centre.4 However, in practice the concept failed as a means of appeasement because the narrow scientific-technical framework chosen did not acknowledge the issues that the protesters were mainly interested in – the question of alternatives in agriculture and models of modernization.

So the conflict dragged on, and in principle the German government kept the volume of political debate to a minimum. Meanwhile Germany increased its efforts to push deregulation at the European level. Moreover, the government realized that Germany was lagging behind other countries in developing applications for biotechnology. As a result major efforts were undertaken to support the development of a strong German biotech-Industry. Under the lead of the Ministry for Research and Technology and funded with considerable amounts of public money, in 1995 Germany initiated a promotion programme called the ‘BioRegio Competition’ to improve the commercial activities in the sector and to foster co-operation between science and industry. Furthermore it started, amongst other initiatives, a Plant Genomic Project (GABI) to promote research into knowledge on plant genomics for practical applications. The BioRegio programme sparked intense activities and proved highly successful. In 1999 the number of start-up companies in Germany was higher than in any other European country (Hampel et al. 2001).5

However, the biotechnology boom of the 1990s was mainly in the area of medical applications, a field that became increasingly acceptable amongst the public (Gaskell/Bauer 2001). Apart from ethical debates, i.e. on cloning or reproductive medicine, public protest in Germany was generally shifting towards agricultural biotechnology and its food uses. The year 1996 marked the watershed of the debate when the first GM soja-beans reached Hamburg harbor and transgenic crops finally 4 At the Länder level two other extensive public discourse initiatives on GMOs should be mentioned: The Academy for Technology Assessment in Baden Württemberg, commissioned by the Government of Baden Württemberg conducted a combined procedure of expert discourses and public forum between 1993 and 1995. The Protestant Academy Loccum conducted a discourse scheme between 1995 and 1996 commissioned by the Government of Niedersachen. Between 1994 -1996 there was another private dialogue between Unilever and BUND. 5 For an overview on the initiatives see: (BMBF 2000).

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hit the German market. The commercialization of GM crops thus increased the awareness of genetic engineering in everyday life (Hampel et al. 2000). Due to a lack of effort on the part of the authorities to accommodate public suspicion and protest, the focus of opposition shifted to the market (Dreyer/Gill 1999). Larger environmental NGOs such as Greenpeace Germany started to pursue market and consumer oriented strategies designed to undermine successful market introduction. Moreover, labeling initiatives and the provision of consumer information on GM company policies have drawn powerful economic actors of the food chain into the conflict, especially the retailers that are closer to the consumer and vulnerable to consumer boycotts.

While in other European countries the conflict was beginning to have an impact at the regulatory level and former initiatives to deregulate the EU Directive 90/220 were gradually turning around, leading to even stricter regulation, German Government policies and regulatory practices seemed on the whole unaffected. Even though the German competent authority has expressed some reservations about product files it had never rejected any of them on grounds of safety concerns (Vogel/Tappeser 2000). Instead, the two leading political parties, the Conservatives and the Social Democrats, have continued to express their support for the technology on the grounds of its allegedly high economic potential and in the face of global competitive pressures and growing unemployment. This general line of biotechnology framing was kept even after the great political changes in 1998 when 16 years of conservative/liberal ruling were replaced by a coalition between the Social Democratic and the Green Party. However, green pressures have eventually had an impact in the biotechnology policies of the country as will be shown later.

1.2 From 2001: Agrarwende and precautionary consumer protection

1.2.1 Food safety scares and reorganization of administration The first mad-cow disease case in Germany in November 2000 and the following Food-and-Mouth-Disease crisis across the EU has had a radical impact on the debate concerning agricultural practices and food production. After years of denial that BSE could also be a German problem, the discovery of the first BSE infected cow and the subsequent constant rise in the number of BSE cases led to a massive loss in consumer confidence and sent the German agricultural and food industry into turmoil. The crisis reverberated throughout the political system leading to the replacement of two ministers (Minister of Health and Minister of Agriculture) in the Social Democratic/Green Party coalition government. Furthermore, consumer issues where placed high on the agenda causing the reorganization of the Ministry of Agriculture into the Ministry of Consumer Protection, Agriculture and Food under a new Minister, the Green party member Renate Künast.

Agrarwende – turnaround in agricultural and consumer protection policies

Through the reorganization of the administration, agricultural production, food safety and consumer issues were now brought together in one institution. Intensive agricultural methods, mass production in food, damage to the environment and the maltreatment of farm animals, all together identified as the negative outcome of a narrow-minded productivist philosophy (‘Agrarfabriken’), were promised to be taken up on the political agenda by the coalition government and brought about to change by the new Minister Künast. A turnaround in agricultural policy under the slogan Agrarwende and ‘Precautionary Consumer Protection’ (Vorsorgender Verbraucherschutz) was supposed to address these issues and restore consumer confidence. The explicit reform goal was, inter alia, the increase of the organic farming sector to 20 per cent by 2010. Additionally, the risk regulation system was changed and two new agencies were created: the Federal Institute on Risk Assessment (BfR) and the Federal Agency on Consumer Protection and Food Safety (BVL). Both institutions will be involved in the authorization of GM crops and food.

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1.1.2 Cultivation programme halted; instead new rounds of talks: Diskurs grüne Gentechnik GM politics – an issue, which has been highly politicized for years and hits the mark of consumer worries regarding food and environmental safety – has not been left untouched by the crisis. An initiative on an extensive experimental three-year GM cultivation programme – negotiated between the biotech-industry and the government – was brought to a standstill when in January 2001, at the height of the BSE-crisis, Chancellor Schröder cancelled his support for the activities. It was found that this was not the time to further discuss an already highly controversial food issue like GMOs. Since the breakdown of the GM cultivation initiative the task of politically handling GM food was passed on from the Chancellor’s Office to the Ministry of Consumer Protection. The new Minister Künast was now in charge and promised to take up the issues. However, instead of cultivation Künast initiated the Diskurs grüne Gentechnik (public debate on agro/food biotechnology)6 in December 2001. The Diskurs, the first federal forum on agro-biotechnology of its kind in Germany, brought together over 53 experts and the whole range of stakeholders involved in GM crop politics. The aim of the Diskurs was mainly to inform about and assess the status quo of research, developments and applications of agro-biotechnology, and to elaborate on the action corridor for new GM policies (Hammerbacher 2003).

1.1.3 ‘Consumer choice’ and ‘coexistence’ as new German biotech policy To guarantee consumer and producer choice has been identified as the main common concern in the Diskurs grüne Gentechnik in Germany (BMVEL 2002a). The coalition government has henceforth taken on choice and coexistence as the new German policy goals to be realized. This way the market could decide whether there was a future for GM crops and food. The consumer choice strategy allows the ministry to support mechanisms that empower the consumer, so that his or her purchasing choices translate into the according market situation for GMO products. The complementary strategy is to support more pluralistic ways of farming and food production, some of which are GM-free. This is the consumer choice direction Künast pushes for, both nationally and Europe wide. That is, for restrictive labeling practices, coexistence rules and an increase in organic farming. In Germany, debates over the issues of choice and co-existence have reframed the former agronomic-environmental focused debates. Moreover the change in subject and discourse has brought in new actors and new dynamics. Risk and safety issues and the role of precaution and precautionary practices remain important and disputed. However, these issues are now implicated in a more complex debate on consumer and producer choice and coexistence.

6 In German ‘green biotechnology’ refers to GM technology in the area of plants and food. It does not refer to any kinds of more sustainable or environmentally friendly applications of biotechnology.

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2 Scope of precaution 2.1 The precautionary principle in German environmental law The ‘Vorsorgeprinzip’ (precautionary principle) developed in the early 1970s into a leading principle in German environmental policy. It constitutes, next to the polluter-pays- and the cooperation principle, one of the three fundamental legal principles in German environmental law.7 The content of the PP can be interpreted as a ‘minimum consensus’ toward a development and understanding of environmental policy as being based on preventive/precautionary rather than reactive state action. The PP means preventing risk and damage as far as possible or preventing risk and harm from arising in the first place (emission prevention before emission minimization). The principle can further be used to reduce and minimize risks before damage is established (Rehbinder 1997). In German there is no distinction made between the terms prevention and precaution since both are translated as ‘Vorsorge’ (Gill 1995). However, traditionally German environmental law differentiates two forms of prevention. First, Gefahrenabwehr, meaning prevention of immediate hazard, and second Gefahrenvorsorge as the prevention of future harm or danger. How definite and concrete these dangers have to be (plausible, hypothetical) in order to trigger precautionary action remains controversial.

In 1986 the German Government defined the PP in its guiding principles of environmental protection as follows: A precautionary approach requires anticipation of even possibilities of harm which cannot be ruled out just because conclusive cause-and-effect relationships are not fully established at the present level of scientific knowledge. These guiding principles, following the wording of a court decision in 1985 (Whyl-verdict) concerning atomic energy law, suggest that precaution legitimizes state action – or may even require it – on the basis of hypothetical harm or in the case of a ‘potential for concern’ (Rehbinder 1997). Yet, this state action needs to be balanced against constitutional rights, the principle of proportionality and economic viability.

In the national report to the Rio Conference (UNCED) in 19928, the German Government further specified the PP as including sustainability considerations. In the report the PP was laid down so as to incorporate three components: defence against danger and threats (Gefahrenabwehr), risk prevention/precaution (Risikovorsorge) and securing of the future (Zukunftssicherung). In this way the PP is not just regarded as a guiding principle for the regulation of danger and risks but as a ‘multifunctional principle’ (Rehbinder 1997: 04/019) which also addresses resource use and the maintenance and creation of future living spaces. Thus some would argue that the PP can be used in order to develop qualitative goals in environmental regulation.9 This interpretation of the PP is, however, far from being a consensus within the German legal community.

The precautionary principle is used in many important environmental laws in Germany, for instance in Federal Emission Law, Chemical Law, Water Law, and Soil Protection Law and in the area of Genetic Engineering. However since there is no legal specification of its use the PP appears in varying forms in these different legal acts. That is, even though the PP is widely recognized as a guiding legal and political

7 This so-called trias of environmental principles was stated in the German Reunification Treaty in 1990 and was this way given proper legal status (Storm 2002). 8 In the National Report to the Johannesburg Conference ‘Rio + 10’ in 2002, the PP is not mentioned as a general legal principle. Instead, the report is based around the concept of sustainability. According to legal experts, the relationship between the PP and the principle of sustainability remains unclear and contested (Rehbinder 1997). 9 So, for instance, argues the SRU, see (Storm 2002).

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principle in environmental law, its concrete legal meaning, breath and limits are highly contested. Hence, the concrete application of the PP – the trigger criteria for its use, the criteria for the evaluation of risk, and finally the instruments to be used – remain subject to the matter in question, the political process and the value judgments of the respective authorities (Rehbinder 1997).

Apart from highly specific expert discourses in environmental law, in the recent past the PP has been most prominently invoked in areas relevant to consumer and food safety.10 In response to the BSE and the food-and-mouth-disease crisis in Germany, precautionary measures concerning, for instance, the banning of animal feed, the ban on use of BSE risk material, or restrictive regulation of animal transports have been taken by the new Ministry of Consumer Protection. As a consequence of the crises, ‘precautionary consumer protection’ has become the new policy goal of the Ministry.

2.2 Precaution – in-between innovation, protection and the common market: the legal framework(s) for GMOs

The German Genetic Engineering Act (GenTG) was passed in May 1990 at the time when the Deliberate Release Directive 90/220 came into force. Alongside rules concerning contained use of GMOs it sets the legal framework for field trials and market approval. The GenTG was amended four times (1990, 1993, 1997, and 2002). At the time of this study, a new amendment is in progress.

The aim of the GenTG is twofold: • To protect life and health of humans, animals, plants as well as to protect the

environment in its complex setting (Wirkungsgefüge).

• To create a legal framework for the research, development, use and promotion of the scientific, technological and economic potentials of biotechnology.

That the act combines both promotion purposes and protection concerns in one legal setting has, from the very beginning, been identified by critics as a problem. It suggests that safety and risk concerns have always to be considered against the background of the stated aim of biotechnology development and promotion. This legal construct is often held up against proposed precautionary measures that are deemed to be too restrictive. As one official in the Ministry of Health stated: ‘The aim of the act is making GM technology safe and not rendering it impossible (through over-regulation) or prohibiting it.’

In this way, the act embodies the political divide in biotech policies that finds it’s equivalent in the ministerial structure in Germany. There are on the one hand the Ministry of Economics (BMWi), the Ministry of Education and Research (BMBF) and the Ministry of Health (BMGS) that support biotechnology applications, and on the other hand the Ministry of Environment (BMU) and the newly created Ministry of Consumer Protection, Food and Agriculture (BMVEL) that are more critical as to what concerns health and environmental risks in GM technology. This division was furthermore visible in the administrative units that are responsible for the legal enforcement of the act. Until 2002 the Centre for Genetic Engineering at the Robert-Koch Institute (RKI) was assigned the role of the national competent authority in GMO release and market approval. In case of GMO field trial approvals, two other units, the Federal Environmental Agency (UBA) and the Federal Biological Research 10 In German Food Safety Law (Lebensmittel und Bedarfsgegenständegesetz LMBG), action is only possible on the basis of a „concrete health risk’. A mere suspicion of a violation against food safety requirements is thus not enough to justify precautionary action. As a consequence of the famous ‘Birkel-case’ in 1991, the authorities have become very hesitant in issuing health warnings with respect to suspicious food products. In the ‘Birkel-case’ the state of Baden-Württemberg had to pay over 6 Mio EUR in compensation to the noodle firm Birkel because of a precautionary, but in the end falsely issued consumer warning. This state of affairs has, however, come under increasing critique. A new consumer information law (Verbraucherinformationsgesetz), pushed by the BMVEL and various supporting institutions is aimed at improving the information rights of the consumer and the intervention rights of the authorities.

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Centre for Agriculture and Forestry (BBA) need to consent; in the case of market approval these units only need to be consulted. With regards to GM food approval, responsibility is shared between the RKI and the food safety agency (BgVV) of the Ministry of Health. Due to the conflicting aims of the GenTG, the decision-making structure – RKI on the one hand and UBA and BBA on the other – and the legal weight assigned to them, there is political and scientific dissent incorporated into the legal framework.

As will be shown, this political divide plays a role in the interpretation of the legal provisions for approval decisions stated in the act – the core questions to be answered in the risk assessment. These read as follows: In principle approval for release into the environment must be granted if, next to reliability and sufficient knowledge of the subject on the operator’s behalf: • All required safety provisions are met according to the present state of the art in

scientific knowledge and technology.

• According to the state of the art in scientific knowledge and proportional to the purpose of release unacceptable harmful effects to the goods stated in Art.1 are not to be expected. (For market approval only the last condition must be fulfilled.)

1 ‘state of the art in scientific knowledge and technology’

means that the application can be approved only if no scientific evidence of a risk exists or if the risk can be prevented by an available technique. This, however, depends upon the selection and interpretation of scientific knowledge and goes to the heart of the question of ‘sound science’ and the handling of uncertainty.

2 ‘proportional to the purpose of release’

this provision suggests a weighing of purpose and possible damage as a criteria for approval. However, in the practice of risk assessment this clause has not been applied in any of the approval cases. So far regulators have always found a way to reduce the risk by imposing specific safety measures, that is, there was no need for a risk-benefit analysis. However, according to officials, in case such a risk-benefit clause was to be used there would be no concept let alone consent on what criteria (possibly socio-economic or ethical) to use.

3 ‘unacceptable harmful effects’

what is considered to be harm and damage to the environment and more importantly what extent of damage would be acceptable is most of all a question of normative judgement (environmental norms etc.)

The Genetic Engineering Act – as well as the Deliberate Release Directive – leave crucial questions open to interpretation and hence open up the terrain to normative and political judgements. The act neither defines a level of protection or set priorities nor does it give information on an ‘appropriate’ risk philosophy to use. It thus puts these decisions in the hands of scientific experts and administrators who then, by exercising their specific precautionary rationale, decide upon a more innovation-friendly or protection-based interpretation of the law.11

The European Deliberate Release Directive, or respectively the German GenTG, form the basis of the approval procedure for GM crops. However, for specific approval, i.e. as food, as seed, or in terms of use of complementary herbicides, other bodies of law and different institutions/procedures were frequently involved. This concerned the Seed Directive, the Novel Food Directive and pesticide/herbicide

11 Legal experts have noted that due the prominent use of indefinite law terms in environmental legislation, decision-making about environmental quality is increasingly done by the executive, in association with specific client- and lobby groups, and the administrative judiciary rather than the parliament (Rehbinder 1997).

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regulation. In the past these boundary issues, for instance, allowed for singling out certain effects or applications of GM crops and considering them under different regulation. This was, for instance, done when secondary herbicide environmental implications were turned into an issue of pesticide rather than GMO regulation (Dreyer/Gill 1999).

More recent developments in German GMO regulation show a continuation of this trend of boundary crossing into neighbouring legal fields. This concerns considering GMO approval procedures with a view to nature conservation law or the EU organic regulation. This time the parallel, systematic and consistent reading of different but issue-related legal areas is intended to provide the legal grounds for the prevention and defense against hazards for humans and the environment and the prevention of property infringement to organic and non-GM farmers. These protective measures – and some would argue precautionary measures possibly justified by Art. 174 EU Treaty12 (UBA 2003a) – are intended to place restrictions on the GMO which is placed on the market and are thus questioning the ‘trade harmonization’ rationale of Art. 95 EU Treaty13, on which the Deliberate Release Directive is based.

2.3 Contested views on precaution There are no formal policy statements as to what constitutes a precautionary approach in relation to agricultural biotechnology. In general there is a wide scope in interpretation as to what constitutes precaution in the context of GMOs and how this is, should or can be applied in the Genetic Engineering Act. Following will be first introductory statements and positions made by different groups which give an idea about the variety of opinions on the relevance and scope of the PP, as viewed by the German scene. On the basis of these opinions (and taking into account later findings) a summary table is presented which heuristically clusters the findings according to three different framings of precaution (see Table 2, at the end of this section).

2.3.1 Government agencies and the PP As was mentioned above, the German regulators do not speak with one voice with respect to agricultural biotechnology. To note, the agencies implicated in GM regulation differ with respect to their institutional mandate (i.e. UBA: Environment, BBA: Agriculture) and are embedded in different policy discourses and client bases. A considerable difference on their understanding and concerns with respect to the PP can be found:

A legal representative of the German Ministry of Health (BMGS) (which hosts the RKI) differentiates between the PP as a general political approach towards GMO, which is considered prior to definite legislative action and the PP which is applied in case-by-case approval. In his reasoning, the EU Directive and hence the GenTG are nothing but a concrete manifestation of the PP in juridicial form, since technology approval hinges upon a prior risk assessment. However, the recourse to precaution in the actual case-by-case assessment procedure he perceives as very critical: ‘The PP does not exist at this level within the EU for there is no standardization of its application.’ And if it did ‘how could you possibly operationalise the PP for the administrator and make sure that decisions stand up in court?’ (interview BMGS,

12 Art. 174, para 2 EU Treaty: ‘Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay.’ 13 Art. 95 para 1 EU Treaty: ‘By way of derogation from Article 94 and save where otherwise provided in this Treaty, the following provisions shall apply for the achievement of the objectives set out in Article 14. (Art. 14: The Community shall adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992, in accordance with the provisions of this Article and of Articles 15, 26, 47(2), 49, 80, 93 and 95 and without prejudice to the other provisions of this Treaty.

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06/02). Asked about the PP both RKI and BBA officials argue along similar lines stressing the fact that precaution has been exercised in GMO approval all along and that the new Directive will not have an impact on the risk assessment procedure.

For the Federal Environmental Agency (UBA), precaution constitutes part of the case-by-case assessment procedure and needs to be considered at all stages of approval. Thereby uncertainties and insufficient knowledge about environmental effects are invoked to justify the recourse to the PP. UBA stresses that decisions should not only be based on science because action may be required before science-based proof is given. It further stresses the need for a societal consensus with respect to protection levels and acceptable risks. Beyond this the environmental agency points to the close link between the PP and the model of sustainability. This opinion suggests that a proper consideration of a precautionary practice in GMO release requires a reconsideration of hitherto applied normative guidelines (Nöh, 2001a). The new EU Directive is very much welcomed by the agency, as it strengthens the PP and thus ‘gives more legitimate grounds for interventions’ (interview UBA, 06/02).

2.3.2 Biotech industry and the PP The Chemical Industry Association (VCI) and its sub-organization the German Biotechnology Association (BDI) have both issued statements with respect to the Commission Communication on the PP (Europäische Kommission 2000). For both organizations limiting the PP is the principle focus of attention.

According to the VCI the PP ranges on the level of a ‘political idea’ which is not concrete enough to justify interventions on the grounds of civil rights and liberties. Restrictions on civil liberties and risk minimization measures have to be carefully balanced. The VCI criticizes in this respect that the state’s responsibility for the promotion and use of technologies does not find enough attention in the Commission Communication. The association further criticizes the Commission’s stance on scientific minority opinions. According to the VCI minority opinions should only be considered in case of a positive vote of the scientific (that is, mainstream) community. Long-term risks with unclear causal relationships should rather require moderate measures. Furthermore the organization is of the opinion that health protection does not have absolute priority (VCI 2000).

The BDI on the whole follows these ideas. The BDI further stresses that the risk assessment should be based solely on objective scientific criteria, and that only the risk of considerable harm with a high likelihood of occurrence justifies an intervention (Gent 2001). In case the scientific assessment leads to the result that a product might cause such adverse effects it is justified that approval is denied. An interview with an association representative confirms the critical stance of the above statements. For the representative the stress on the PP in the new EU Directive leads to arbitrariness in law application. This way the PP necessarily translates into a ‘principle of biotechnology prevention’ (interview BDI, 07/02).

2.3.3 Farming organizations and PP There are various farmer’s organizations in Germany. Most important and visible in the political arena are the national farmer’s organization (DBV) covering most of conventional farming and the umbrella organization of organic farmers (AGÖL later BÖLW). The farmer’s organizations share common precautionary concerns with respect to certain effects but differ on the breath of the PP.

For the national farmer’s organization (DBV) to act on the basis of precaution requires a) a detailed and comprehensive assessment of all possible effects of a certain technology and b) the introduction of measures to prevent unwanted effects (interview DBV, 11/03). In this respect the DBV demands large-scale field-testing in order to find out about these effects and the measures to be taken. DBV stresses that economic effects (coexistence and liability issues) need to be taken into account. For the DBV only adequate precaution can guarantee consumer and producer choice.

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For a representative of the organic farmers association (interview AGÖL, 07/02) the PP means introducing a technology in such a way that it does not cause irreversible effects: ‘How big the danger to humans and the environment is I do not know. But one of the real dangers lies in the fact that shortly there could be no more GMO-free products. To take precautionary measures to prevent this from happening, that is guaranteeing choice, needs to be part of the PP’. He further criticizes a purely scientific, experimental approach towards the PP and claims instead the right to understand the PP from a lay-knowledge point of view: ‘We as farmers were told that it did not matter what kind of protein we feed to our cows (…). I would have solely argued that God did not foresee cows to eat carnivore products. That’s completely unscientific but led by a sense of humility for we do not know nature in all its variations.’

2.3.4 NGOs and PP The most radical interpretation of precaution in the context of GMOs is held by the Environmental NGOs. ‘Better safe than sorry’ suggests that out of precaution GMOs should not be released into the environment. Insufficient knowledge (‘what can we know, are we asking the right questions?’) about the possible consequences and the difficulties, if not impossibilities to react in case of damage are seen as the crucial problems. Environmental NGOs stress the systemic uncertainty in which knowledge about the properties of specific gene sequences does not suffice to fully understand biological relationships and interactions (Then 2001). In general GM products are perceived as potentially dangerous products (‘Gefahrengüter’) in which case risk-benefit considerations would only undermine a strict application of the PP (interview BUND, 12/02). However, apart from fundamental rejections, NGOs refer to approval practices in agricultural biotechnology as being more or less precautionary. Hence their comment: ‘It is easier to define what is not a precautionary practice as to say what could be one’ (interview Greenpeace, 07/02).

A consumer NGO representative argues for the PP as being justified on grounds of legitimate wider social interests and values. In his understanding the PP is a means for legitimate state intervention in the course of a critically perceived technological development. Rational or irrational consumer concerns need to be taken into account. Most important for the vzbv is the principle of consumer protection, which the market as such cannot guarantee. ‘Market related mechanisms, such as ‘consumer choice’ cannot be a precautionary instrument. If that were to count as precaution the consumer would need to be fully informed. But the reality is different’ (interview vzbv, 06/02).

2.3.5 The German Parliament and the PP In a resolution from the German Bundestag (lower house) in the year 2002 it is stated that: „To support the responsible use of genetic engineering, the German Bundestag demands the introduction and consistent implementation of the precautionary principle at all levels (Bundestag 2002). In a Bundesrat (upper house) resolution concerning the Commission’s Communication on the „Strategic Vision of Life Sciences and Biotechnology’ the parliament criticizes the lack of recourse to the precautionary principle. In view to precaution and global responsibility the Bundesrat does not tolerate the commission’s opinion that regulation should not jeopardize trade and life science developments in developing countries (Bundesrat 2002).

Table 2 Framings and contested views on precaution Issue

framing ‘Innovation’

– making agbiotech possible –

‘Risks’

– making agbiotech safe –

‘Alternatives’

– preventing agbiotech –

PP in general

Political idea and general legal principle for pre-market approval

Legal principle and specific decision-making tool

Mind set, legal principle, and quality tool

Trigger for Positive scientific Uncertainty and knowledge Systemic uncertainty

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PP evidence of risk gaps

Uncertainty No basis for preventative action, risks will be handled by risk management practices. Uncertainty often dismissed as speculative concept

Basis for preventative action (ban only as a last resort). Uncertainty changes risk research, risk assessment and risk management practices. Uncertainty can be reduced through research (‘need to know more’) and risk-reducing measures

Basis for preventative action including banning, since uncertainty cannot be reduced

State of knowledge

‘There is considerable knowledge about GM crops’

‘We do not know enough about the effects’

‘We don’t know what we don’t know’

Evidence of damage/ Baseline

Conventional standards in agriculture applied (‘as safe as conventional products’)

Preferably higher sustainability and nature conservation standards applied (improving the status quo)

New technologies should only be considered on basis of absolute improvement of practices, beyond the status quo. That is, problems need to be solved by conventional technologies first

Cost-effective measures

Intervention needs to be cost-effective and ‘practical’

Intervention focuses most of all on risk avoidance, yet (cost) limits accepted

Possible costs should not hinder intervention on the grounds of safety

Cost–benefit analysis

In general cost-benefit analysis rejected as these decisions should be left to the market: ‘acceptable social demand no legal criterion’

Cost-benefit analysis as basis for decision-making on risks. However, assessment confined to direct and indirect environmental effects. Alternative solutions posing lower risk to the environment should be considered

Cost-benefit analysis rejected because (1) risk avoidance is highest priority, (2) society should not be forced to bear the costs of expensive technology assessments. Problem analysis first Cost-benefit analysis demanded (4th hurdle): full test for socio-economic need

Burden of proof

Proof of risk lies with regulators. However ‘reasonable’ public safety demands on technology introducer accepted

Principally lies with the regulator. However, uncertainty and knowledge gaps may require reversal of burden of proof

Proof of safety/need lies with risk creator

Science Science as tool for objective decision-making. ‘Politicization of science’ should be prevented

Science alone does not provide adequate basis for risk decisions because (1) scientific evidence may not be available (2) risk assessment and risk management is influenced by society’s moral concepts about protection levels

Science alone (but what science?) does not provide basis for risk decisions. Question of GMO is beyond science and is foremost political. ‘Scientification’ hides political character of decision

Other legitimate factors

Not relevant in risk assessment procedure. Individual preferences and societal concerns mainly delegated to market sphere

Values necessarily come into research and risk assessment and risk management (‘what effects are considered to be damage and acceptable?’).

See above

Risk philosophy

Close to additive concept Synergistic concept Synergistic concept

Participation Decisions should be left to experts (scientists); ‘de-scientification’ should be prevented

Experts’ judgement should represent scientific controversies. Decisions need to be transparent and open to lay people’s concerns

Decisions should be taken ‘democratically’, usually translated into demand for new decision-making procedures that are more transparent and participatory

Sustainable agriculture

Biotech allows more sustainable agricultural practices

Biotech might provide a tool for sustainable agriculture

Biotech contradicts sustainable agriculture

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Biotech in general

Problem-solving technology

Risk-creating but possibly problem-solving technology, alternatives need to be considered

Problem-perpetuating and new problem-causing technology

Biotech risk in general

No specific risk beyond conventional ones. ‘No more or less effects than any other things we do’

Basic risks and uncertainties acknowledged

Stress on ‘new quality’ of biotechnological interventions. Potentially fatal consequences anticipated

Co-existence Not part of precautionary rationale. Coexistence is economic concept and not safety related

Part of precautionary rationale for coexistence allows keeping natural spaces free of GMO and coexistence allows individual safety judgement

In the event of cultivation, coexistence is imperative! Part of precautionary rationale for coexistence allows for both keeping natural spaces free of GMOs and individual safety judgements. However, economic damage, in terms of ‘safeguarding alternatives’, is also part of the precautionary rationale

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3 Three institutional practices 3.1 Regulatory measures The following section will look at the areas of risk research, risk assessment (RA) and risk management (RM) and will analyze how these are linked, and which accounts of precaution can be found in the respective areas. As can be gathered from Table 2 above, the PP spans these three risk regulating areas, however it can be applied to a much wider range of issues than this categorization suggests. Risk research, risk assessment and risk management are usually portrayed in a sequential manner, one logically following the other. This way risk research informs scientific assessment and on the basis of this assessment a risk management judgment, including normative values, is made. This logic informs the step-by-step procedure of the Directive, on the basis of which a step-wise gathering of risk knowledge will lead to a step-wise relaxing of controls.

However, as will be shown in the following analysis, the links between these areas are more manifold and complex than this model suggests. For instance, risk assessment and risk management, which according to the model are separating science from value judgment, are not so neatly separated in the real world. Value judgments do frequently enter RA, even though not explicitly termed as such. Risk assessment not only uses risk research information but may also create a demand for more research to be done in order to answer questions of safety. Risk management, and especially the new post-monitoring measures, are ways of dealing with remaining risks and uncertainty, yet with respect to a general assessment of unknown effects, risk management crosses the boundary and becomes risk research.

The precautionary principle is intermingled with these questions of definition and boundary crossing of the respective field. For instance, usually the question of the normative acceptance of damage is a part of risk management. Yet depending on the account of precaution, questions of alternatives in agriculture can become part of risk assessment (in the question of the comparator) in GM regulatory practices or else can be used to go entirely beyond the question of GM safety. A judgment on where the question of comparators belongs (i.e. RA or RM) can be decisive for whether some will judge the process to be ‘unscientific’ or ‘unprecautionary’ or vice versa. Coexistence and economic liability, as another example, are not part of risk regulation as understood by the Deliberate Release Directive for these are not considered to be managing environmental or health risks. And yet again, it will be shown that this is subject to precautionary judgments.

3.1.1 Risk research German science and technology policy considers biotechnology as an area of the highest priority both on the Federal and on States (Länder) level (BMBF 2001b, BMWi/BMBF 2000). The Federal Government spends roughly 750 Mio EUR annually on research and technology promotion in the life sciences (BMBF 2000a).14 The German public biotechnology research institutional framework is very complex. The most important funding organization is the Federal Ministry of Education and Research (BMBF). It is responsible for about 60 per cent of total R&D expenditures of the federal government. These expenditures include the biotechnology research budgets of such institutions as the German Research Society (DFG), the Max-Planck Society (MPG) and the Frauenhofer Society (FhG). Next to the BMBF, the Ministry of the Environment (BMU) and Ministry of Consumer Protection, Agriculture and Food (BMVEL) are important funding sources. Besides federal or state ministries a variety of other funding associations and donors exist. Also relevant are the general budgets of various research institutions, including universities.

14 An overview on public biotechnology R&D programmes in Germany and the complex institutional setting is given in: European Commission (1999)

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General policy goals of German biotech programmes are to secure broad basic research and to promote high-level research. Apart from promoting research infrastructure another explicit funding goal is to strengthen technology transfer and commercialization.15 For the BMBF promotion of biotechnology, the ‘using and shaping of its opportunities’ is the clearly stated goal of its funding policies. This is done in order to support ‘Germany’s consistent development into an established biotechnology location’. In terms of agricultural biotech research the ministry holds that ‘the prerequisites for sustainable development are to be created through (…) the use of innovative technologies’ thus making agriculture more environmentally sound, efficient and sustainable by using biotechnological applications (BMBF 2002). Most of the BMBF project money is put into structural measures to strengthen research infrastructure, basic innovations research, such as genome analysis and molecular biology, and research for application. Preventive research in the area of biological safety, biodiversity and animal protection amounts to roughly 10 per cent of BMBF projects funds.16 From this source 8 Mio EUR per year are spent on specifically dedicated biosafety research programmes in plant biotechnology.17

Research programmes on biological safety are mainly implemented under the auspices of the BMBF. The Ministry of Environment (BMU) is further involved, however on the basis of a budget that comprises one-tenth of BMBF’s research funds. Since 1987 the BMBF has been involved in biosafety research18 and has sponsored 70 different projects between 1987 and 2001.19 Within the promotion-framework ‘Biotechnology 2000’ of the federal red-green government a new research programme had been launched by the BMBF, which forms the basis of the most recent biosafety efforts. The aim of the programme ‘Safety research and Monitoring’ is to support release-related safety research and the development of monitoring methods. In addition, the ministry supports two new research projects on communication management. In spring 2001 40 research projects have been included in the new funding scheme. These projects conduct research in the following research areas:

New strategies for optimizing gene transfer

Project aim: Research into limiting transgenic gene sequences to the functional minimum to reduce, for instance, the use of problematic marker genes and to limit and direct gene expression. (11 projects)

Potential effects of GM rape cultivation

Project aim: Research into volunteers, cross pollination and the principle introgression behaviour of GM rape. (4 projects)

GenEERA – Modeling of geneflow from GM rape cultivation in large areas

Project aim: Research into volunteers and cross-pollination both between different cultivation areas and between wild relatives. Extrapolation methods are used in order to allow conclusions for large-scale cultivation areas. (3 projects)

15 An overview of the various project funds is given in (BMBF 2002) 16 For instance, BMBF project funds (in Mio EUR) for 2001: 145,7, for 2002: 154 and for 2003:166 (BMBF 2002: 42). 17 Since 1998 biosafety and risk research funding was raised by 65 per cent (from 4.8 Mio EUR to 7.9 Mio EUR) due to the pressure of the Green Party within the coalition agreement. The need for safety research is explicitly stated in the 2002 coalition agreement. 18 The question of what constitutes risk, respectively biosafety research as such is disputed. The programme under BMBF is explicitly termed biosafety research and justified as measure of precaution. Its aim is to clarify open questions in relation to GMO applications. Field tests as such do not count as being biosafety related research. Only in cases of scientific investigations into ecological effects (in Germany being done in 15 per cent of the test cases) one can speak of release-related biosafety research (Steinhäuser/Miehe 2001: 66) 19 www.biosicherheit.de

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Carbohydrate metabolism of GM potatoes

Project aim: Research into fitness behaviour of GM potatoes and the effects on non-target organisms. (5 projects)

Biosafety research and monitoring of Bt maize

Project aim: Research into toxic effects on non-target organisms, the effect of Bt protein on the soil and when used as feed. (9 projects)

Environmental effects of GM trees

Project aim: Research into methods to prevent vertical and horizontal gene transfer and potential environmental effects of GM trees. (5 projects)

Methods for cultivation related monitoring in the agro-ecosystem

Project aim: Research into the development of post-release monitoring networks with special attention given to the use of existing surveillance programmes. (3 projects)

Communication management in biosafety research

Project aim: To make biosafety research more transparent and to communicate national and international biosafety research findings to the wider public. This information is published on a webside (www.biosicherheit.de). Other activities planned are workshops and expert meetings.

According to the funding guidelines, the aim of the above mentioned research programmes is to broaden the knowledge on GM crops under conditions of release for this is required by a ‘responsible and precautionary use of the technology’. It is claimed that ‘when selecting research projects, scientifically sound objections and concerns voiced in the public debate should be taken into account’ (BMBF 2000b: 1). Interesting in terms of the ministry’s precautionary rationale are the conditions for funding: So according to the guidelines:

‘Hypothesis about reasonable cause-effect relationships should constitute the basis of research projects. Non-hypothesis led research approaches concerning possible effects of transgenic plants on the food chain, biodiversity and habitat structures, as well as general environmental monitoring into unknown and unexpected effects do not constitute part of the support concept’ (BMBF 2000b: 2).

With its specific allocation of funds and its funding guidelines the Education and Research Ministry thus sets the standards for most of the biosafety research agendas in Germany. Those who challenge these agendas, for instance UBA (which does safety research under the BMU)20, are poorly funded and are most of all not well – if at all – represented in the specific decision-making circles (Dolata 2003). Unsurprisingly, the BMBF’s funding policy has met great opposition from biotech critics and opponents. For from an institutional point of view, biosafety research is incorporated into a technology promotion scheme and does not form part of environmental research. Overall the criticism is made that there is a dominance in molecular biology and that ecological expertise is greatly lacking. Hence direct and indirect long-term effects of mass release on fauna and flora are given too little attention. According to an UBA official, a different institutional incorporance would allow setting research agendas differently, such as putting more emphasis on ecological impact research of transgenic plants or stimulating a more open, critical and interdisciplinary research environment (UBA interview, 06/02).

For another set of critics biosafety research under the auspices of the BMBF is seen as being too intimately connected to the development and application of the technology. In a number of cases in the recent programme, biosafety research projects are conducted by or in collaboration with private companies, in which case 20 UBA safety research has in the past mainly dealt with concepts related to post-release GMO monitoring (see later passages). In addition, UBA has worked on topics such as nature conservation, field trail regulation and coexistence.

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conflicts of interest are likely to occur. Critics point to research projects whose safety-related rationale is questionable and which hence give rise to suspicion of publicly financed product development. For example in the case of the project ‘New strategies for optimizing gene transfer’ which labels under biosafety research, and receives the biggest part of the programme’s funding (interview GEN, 10/03).21

The ministry’s narrow science and evidence based approach towards risks further forecloses research into socio-economic and ethical questions since only ‘scientifically sound objections’ (BMBF 2000b: 1) are taken as valid, research-worthwhile concerns. Contrary to raising public concerns, sustainability considerations in GM farming practices are not explicitly considered (apart from the fact that agro-biotechnology is heralded as a potentially more sustainable way of doing agriculture) and the reference base for judgements are ‘traditional methods’ (ibid.).22 Finally, effects on land cultivation in general or on other forms of agriculture (i.e. organic) do not form part of BMBF’s research foci. GM food safety related research is practically non-existent in the funding catalogue.

To sum up the common criticism: the kind of one-sided promotion of biotechnology as a future problem-solving technique, the distribution of funds and competency, and the ignorance towards uncertainty-related questions and ‘non-scientific’ concerns are seen as strongly shaping the future direction of research and developments while undermining alternative solutions. In general, research policies should be more problem-solving oriented than technology oriented, according to critics. Biosafety research budgets should be extended and research questions changed for it is suspected that ‘the lack of negative ecological effects is rather an indication of a lack of research than a lack of risk’ (Vogel/Tappeser 2000: 2). Biotech proponents do not support these claims. As they vehemently stressed in the Diskurs Grüne Gentechnik many years of risk research have shown that there are no negative effects.23

Nevertheless, things slowly started to change when a red-green government came into power in 1998. The biosafety budget was increased by 65 per cent, communication and transparency was given more attention and research groups, formally marginalized, have been given access to research budgets (i.e. in the GenEERA project) and decision-making structures. In addition, in 2000 the Government proposed a three-year large scale, multi-stakeholder cultivation and monitoring programme of GM crops, as part of a voluntary delay in commercialization. This programme was to originally include research on gene flow from herbicide tolerant oilseed rape, as a precautionary measure to improve risk assessment. This initiative, however, eventually fell prey to the BSE crisis in 2001, as mentioned previously.

More recently, against the background of new agricultural policies and the promotion of organic farming, the funding policies of the Ministry of consumer protection, agriculture and food came under pressure.24 According to the Öko-Institut the BMVEL invests about 25 percent of its agricultural R&D into biotechnological applications while a research specialization in the area of organic farming is hardly established (Öko-Institut 2002). If the issue of tackling agricultural problems is taken seriously, and if organic farming is to be recognized as a more sustainable form of farming then

21 To note, the RKI has in the past classified ‘Limitation to genes of interests’ as a precautionary measure. See footnote 20. 22 There is some indication of possible change. The BMBF initiated a rather well funded programme on socio-ecological research (10 years, 8 Mio EUR per year) and is currently planning a research project on biological diversity – however, to what extent there are links to biotech is unclear. 23 Biotech proponents, however, stated that there is too little research into questions of coexistence (interview BBA, 06/03) 24 Sustainability research or the demand that ‘new agricultural policies require new research foci’ has become one of the focal points for critical groups, see (BfN 2003).

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– so the critics say – research priorities should be shifted accordingly.25 Alternatives to biotechnology could this way be promoted as more precautionary practices of land cultivation.

A possible indication of a shift in research priorities of the BMVEL and its subordinate agricultural research institutions may be seen in the decision on an insect-resistant GM apple tree trial in October 2003. After a favourable decision of the scientific advisory body (ZKBS) on the case, in the beginning of October the BMVEL eventually stopped the trial from going ahead. There was no official justification for this decision, however, green parliamentary members have argued that ‘the development of alternative measures was more promising’ (Hermenau/Hettlich 2003). Biotech proponents have strongly condemned this decision of the BMVEL. For them this was only one more indication of the ‘ideological and technology-hostile’ attitude of Minister Künast.

3.1.2 Risk assessment In Germany, unlike in many other European countries, the role of the competent authority is not assigned to the environmental department. Instead until October 2002 the Ministry of Health (BMGS) had the political responsibility and the Centre for Genetic Engineering at the Robert-Koch Institute (RKI) was assigned the role of the national competent authority in GMO release and market approval. This competency was supplemented by the expertise of the Environmental Agency (UBA) and the Federal Biological Research Centre for Agriculture and Forestry (BBA). A scientific expert circle, the Central Commission for Biological Safety (ZKBS), advises the RKI. (Before GM crops are granted market approval BBA and UBA need to be consulted, though there is not a requirement for consent.) Assigning the Ministry of Health political responsibility in an area which is considered strongly involved in questions concerning the environment has been a constant source of friction. UBA, which denotes more attention to ecological issues and puts more emphasis on precaution, has for years criticized this matter. As a consequence, there exists a scientific dispute amongst these regulating agencies and external expertise as to what constitutes a proper, respectively precautionary, risk assessment.

Following are key themes that emerged in the past few years concerning the problem of uncertainty, the question of the normative baseline, the broadening of damage criteria and the contested nature of science. As will be shown, different understandings of the subject matter are informed by varying, disputed and sometimes even contradictory, understandings of the PP. New product files, based on Directive 2001/18 and (re)submitted to the German CA in 2002, will be furthermore described at the end of this section. The issue of new risk assessment files will be used to introduce the institutional changes that followed the change in competency from the Ministry of Health to the Ministry of Consumer Protection, Agriculture and Food in the year 2002.

The question of uncertainty

The Genetic Engineering Act (GenTG) stipulates that before a GMO may be introduced to the field or placed on the market, its characteristics have to be assessed and its behaviour in the environment to be estimated and evaluated. As opposed to risk assessment schemes in which damage and probabilities are known, the risk assessment situation in biotechnological applications is characterized by uncertainties (WGBU 1998). On the question of what these uncertainties are, what possible consequences should be drawn and what this has to do with the PP the regulators in Germany differ quite widely.

25According to the new research plan of the BMVEL from 2002, the Ministry states that because of the new policies the research foci of its subordinate research institutes will shift to subjects, such as consumer relevant research, food safety, product and process quality and healthy diets (BMVEL 2002b). In the field of organic farming, the BMVEL has launched a new federal programme on organic farming (35 Mio EUR in 2002 to be continued) and a programme on regional agricultural development.

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The problem of how to deal with uncertainty has been laid out in a judicial explanation to the GenTG. There it states that even those possibilities of harm have to be taken into account which cannot, at this point of scientific knowledge, be finally demonstrated. In practice, however, a situation of uncertainty is not admitted (Schütte et al. 2001). An assessment of the RKI approval practice shows that theoretical concerns, including knowledge gaps, have not been taken into account (Kleinhauer 1998). The assessment furthermore shows that probabilities are only considered once harm is established (Winter et al. 1998). Harm, in turn, depends on the normative standards applied and hence informs the perceptions of uncertainties (Vogel/Tappeser 2000). Since RKI works with a narrow frame of reference, the effects considered are limited. The practice of the RKI thus seems more informed by a classical understanding of risk prevention, which means taking action only on the basis of evidence of risk. According to an RKI official ‘precaution means that we act on the basis of justified doubts’ (interview RKI, 06/03). However, this understanding of what justified doubts mean, with respect to what effects and the consequences to be taken, differs from what critics, including UBA, define to be a precautionary approach.

UBA is the first and hitherto only authority involved in the implementation of the GenTG to have presented a risk assessment concept. This is done in order to ensure that decisions taken are comprehensible and comparable (Nöh, 2001a). The environmental agency stresses the scope of interpretation in the GenTG that allows for different judgements on the matter: ‘Usually UBA wants to know more than BBA and RKI. These regulators consider this nice to know but not need to know’ (interview UBA, 06/02). In this respect, for instance, UBA supports the making of so-called ‘uncertainty profiles’, meaning listings of possible uncertainties and hypothetical assumptions with minor likelihood of occurrence. It urges taking into consideration the fact that scientific knowledge about the extent of a possible risk might not be available and that in order to take a qualified decision new scientific knowledge needs to be waited for.26 Hence UBA wants to take approval restrictive action on grounds of ‘sufficiently justified indications for adverse effects’ or existing knowledge gaps whereas RKI asks for more scientific proof before any restriction or safety measure can be applied. Moreover, UBA contends that approval decisions are not solely based on an objective, scientific treatment of the problem, but are also influenced by a society’s moral concepts with regard to protection levels and risk acceptance, while RKI – and in particular its scientific advisory body ZKBS – stresses the scientific nature of its decisions.

With regard to refining the assessment concepts in approval decisions UBA highlights the future challenges as lying in concepts that are integrating nature conservation principles, which, up to this point, had been given insufficient attention. UBA considers its approach to risk assessment confirmed and supported by the new European Directive, the Convention on biological safety, and the resolution from the German Parliament, which altogether demand to take precaution in the field of GMOs more seriously. It sees therein a chance to be given more legitimate grounds on intervention in the name of precaution, to widen the range of possible effects that are taken into account and to demand more attention to remaining knowledge gaps.

From the above it can be concluded that in UBA’s precautionary understanding risk avoidance is pivotal, and hence the consideration of uncertainties crucial. It contends that from a precautionary point of view possibly every adverse unintended effect should be avoided through appropriate measures (following the principle of emission prevention before emission minimization). Again in comparison, RKI argues that from the beginning of the GenTG the RKI has followed a precautionary approach. It acknowledges the different perceptions of the agencies involved, however, given its view on uncertainty, it questions the practicability, appropriateness and cost-effectiveness of some of the suggested measures. According to an agency official:

26 In this context a statement from Ulrike Riedel, former State Secretary at the Ministry of Health, is important. She says that „The application of the PP does not mean that we can make our judgements detached from a scientific basis. Instead it means that we relativize the degree of certainty with respect to scientific knowledge’ (Riedel 2001).

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‘We approve in order to learn…We cannot let precaution strangle our ability to act’. The question needs to be asked ‘what is society willing to pay for the last bit of safety?’ And further: ‘Once we know the dynamics we can act accordingly…not every unintended effect poses a risk. I just have a different judgment on that matter.’ And else: ‘ Experiences with GM crops so far cannot be used to built up a scenario of unknown risks.’27

In its 1998 report the German Council of Environmental Advisors (SRU) took up on the issue of uncertainty. Therein the council specifies that precautionary measures to reduce risks to the environment are only justified in case there are indications for a possibility of harm. The council admits that there is considerable dispute about how real these indications have to be. As a point of reference it considers empirically available risk knowledge and theoretical considerations and estimations as appropriate, whereas purely speculative risks are rejected. In this respect SRU criticizes the practice of UBA, which in cases has undertaken measures to minimize effects of transgenic plants without having previously determined their actual harmfulness. It approves, however, an approval practice, which negates the probability of harmful effects when no serious indications for these effects are given beforehand (SRU 1998).28

A fundamental critique of the German assessment procedure with respect to uncertainty is given by the Öko-Institut. In a comparative GM-approval assessment paper, written for the Technology assessment office at the German Parliament (TAB), it is stated that risks have not been taken into account in case: a) no data was available to verify or refute a specific risk scenario, b) risk scenarios have not been or hardly been proven experimentally, c) risk scenarios have very long and complex reaction chains and are thus hard to prove, d) no methods are available to prove specific scenarios, i.e. for allergies (Vogel/Tappeser 2000). On top of this lack of knowledge it identified a lack of effort to improve the data information. The German approval practice was identified as showing these characteristics. Given RKI’s narrow frame of reference uncertainties are thus basically argued away.29

Unsurprisingly the environmental NGOs share this kind of criticism. They too criticize the narrow interpretation of what constitutes a risk. However, they also recognize a difference in approach between UBA and RKI – UBA in this case is regarded as acting more precautionary than RKI. According to Greenpeace, for instance, the RKI denies the fact that there are additional risks involved. They act as if the properties and risks of a GMO could be fully assessed by summing up the properties of the

27 It is important to point out that in the past the RKI advocated precaution related measures beyond the Directive in the form of general, but optional advice. This concerns, first, the establishment of a gene-register in order to keep track of the multiple, internationally released organisms into the gene pool. Second, the advising of applicants to restrict gene inserts to ‘genes of interest’ and third, the introduction of post-release monitoring, to facilitate learning. For these measures do not relate to primary demands of critics and opponents, Dreyer and Gill have termed them ‘Elite precaution’ (Dreyer/Gill 1999). 28 Another report written in 1998 by the German Advisory Council on Global Change (WGBU) has dealt with the conceptualization of models for risk classification and risk management strategies (WGBU 1998). The WGBU states that the risks involved in genetic engineering cannot be calculated by the classic risk formula. In case of genetic engineering, probability and extent of damage are not known, hence a situation of uncertainties prevails. The risks in biotechnology are therefore subsumed under the typology of „Phytia.’ (Phytia was one of the oracles of Delphi who foresaw that major danger might be impending, however, its severity, distribution and the probability remained unknowns.) The WGBU states that the principles of precaution should be applied in such cases of uncertainty. Concerning precaution, the Council recommends pursuing a strategy that employs tools such as the ALARA (As Low As Reasonably Achievable) principle or the ‘best available scientific knowledge and technology’ test. The second strategy is to improve knowledge in order that future risk analyses can deliver more reliable appraisals. 29 This is not to say that the RKI has never asked for any more information from applicants, see (Vogel/Tappeser 2000).

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changed elements (additive risk model).30 Moreover, they criticize the fact that the RKI only looks at the trait as such and disregards the practical context of the application (interview Greenpeace, 07/02). Overall the critical groups contend that because of the way uncertainty is treated in approval practice the RKI supports an innovation and company friendly interpretation of the GenTG (‘innovation bias’).

Hence, the powerful role of the RKI and ZKBS, its assessment policy and the political weight assigned to these bodies is considered to be one of the major obstacles to more precautionary practices. In 1998, with the change in coalition government from liberal-conservative (CDU/FDP) to social democratic-green (SPD/Grüne) this situation was bound for gradual change. A member of the green party became the Minister of Health and, interestingly, uncertainties and the PP were given more weight – as can be seen in the decision on Bt maize in 2000 (see below). Furthermore the role of UBA was enforced by a ministerial enactment requiring its consent and not just opinion on market approval, hence providing it with effective veto power. In 2002 at the Diskurs grüne Gentechnik the questions on environmental risks and uncertainties sparked one of the major controversial discussions. However, the principal division in accounts given above was generally confirmed.

The problem of outcrossing and gene flow

Intimately connected to the question of uncertainty and its consequences is the question of outcrossing of genes into conventionally bred plants of the same species or to its close wild relatives. Over the course of the years the topic has, for various reasons, become increasingly important in the German GM controversy. In a rising number of cases GM contaminated seed has been detected by the German Länder authorities. These authorities have, due to a lack of legal requirements and a common Länder strategy, reacted differently to the issue. Some have ordered the destruction of GM contaminated fields or seed31 or have demanded labeling while other authorities did not consider this to be a problem – of whatever kind – and did not interfere. This arbitrariness in handling has caused major problems between the seed/biotech companies, the farmers and the authorities.

Although the source of contamination could (in some cases) not be established, field tests have come under increasing scrutiny, and also because of a gradual reduction of confinement measures in field trials within the last few years (UBA 2000). A highly disputed verdict by a court in Nordrhein Westfalen has brought the issues to the fore. The case of the so-called ‘Münster verdict’ is as follows: The neighbouring farmer of a GM rape-seed field test site has been ordered by the Ministry of Environment to refrain from selling his harvest due to outcrossing which occurred between the test field and his agricultural land. As was argued by the ministry the product was a genetically modified organism and selling it illegal because it lacked an approval under part C of the Directive. The farmer went to court arguing that he did not deliberately use GMOs. This, however, was not the issue for the court. For them the real issue was whether the field test approval included the consequences of outcrossing, or whether these contaminated plants should be classed as an illegal bringing to the market (as the GMO in question lacked market approval). The court decided in favour of the latter stating the public interest and the precautionary nature of the Genetic Engineering Act.32

30 Beusman/Stirn (2001) state that there is no longer a fundamental dissent about synergistic effects. Instead the main dispute lies now in the question of the appropriate reactions to be taken. 31 So, for instance, it happened in the case of the state Schleswig Holstein. The government had ordered the plowing in of contaminated seeds, which triggered a lawsuit against it. In 2003 the courts confirmed the action taken by the Länder government as legal. 32 OVG Münster NRW, 31.8.2000, NVwZ01,110. Another German court, however, decided differently in a similar case. The legal committee on environment for the German Länder (LAG) is sharing the position of the Münster court. See www.hamburg.de/behoerden/umweltbehoerden/gen/oeffentlich/index.htm

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The RKI criticized the verdict on the grounds that outcrossing was an accepted consequence of field trial approval and did as a result not require market approval. It is argued that since outcrossing will be prevented in case a specific effect cannot be adequately assessed, it can be followed that outcrossing does not pose a safety issue. In fact, for the RKI outcrossing as such is only harmful in cases when it causes an advantage in selection due to an increased fitness of the plant. Gene flow is considered a ‘biological principle’, which in itself has nothing to do with genetic modification. Critics have frequently condemned this position arguing that this was an unjustifiable ‘normalization of risks’ downplaying the potential uncertainties involved in an uncontrollable spread of GMOs (Brauner 2002). Out of precaution UBA has followed the line of minimization of gene flow even when harm as such was not established. This practice, however, has been criticized for it hinders the collection of ‘risk knowledge’ and as such the facilitation of learning (Schütte et al. 2001). In terms of isolation distances, Länder authorities have frequently criticized the federal CA for not adequately taking into account their opinion.

This situation of gene flow and contamination of seed, in the absence of clear regulation, or worse, a common understanding of its legal status and a lack of thresholds for adventitious presence in seed has lead to legal quarrels and insecurities. This situation has been made responsible for the continuous decline in field trial proposals since the year 2000. This situation was furthermore decisive for the fact that in the framework of the once planned three-year large-scale cultivation programme of GMOs seed companies have been reluctant to provide the seeds out of fear of possible liability claims (interview BMVEL, 06/03). In terms of consequences for risk management measures the CA (at the time under new leadership of the green-led Ministry of Health) has been ordered to reintroduce isolation distances. Under the new red-green government it is argued that field trials should be contained as much as possible (Bundestag 2001). In the new discussion on coexistence, of course, these issues have become key.

The normative standards for damage and risk-benefit considerations

The key question to be answered in the risk assessment is the question of ‘acceptable damage’. In a report commissioned by the German Federal Parliament about ‘Risk assessment and post-market monitoring’ in the year 2000, it was stated that the choice of normative standards was pivotal in the assessment procedure for it defines the damage and its acceptability. These differences in normative standards, the report suggests, were one of the main reasons for the different assessment results of the competent authorities in the past (Sauter/Meyer 2000).

By assessing the different practices of EU member states, the report identifies the following practice in the German case: Hitherto the RKI regarded conventional agricultural practices as a normative baseline for evaluating the effects of transgenic crops. That is, as long as GM crops did not pose any higher or additional risks compared to conventional ones, its effects were deemed to be acceptable. As a result, the RKI judged it to be acceptable if Bt became ineffective for controlling pests since the development of resistance is considered to be a classic agronomic problem, not specific to GM plants. Or it disregarded indirect or long-term effects that potentially come along with the widespread application of herbicide tolerant crops. In the past, in the case of a development of multiple herbicide resistance has the RKI shown concern, but again, this has not been identified as an ecological but as an agronomic problem.

UBA does not share this position. It is criticizing this rather narrow interpretation of the relevant regulation, which excludes broader environmental concerns and sustainability considerations. It opposes an approval practice that contradicts policies that it – as an environmental agency – otherwise follows, for instance, herbicide reduction or the promotion of more environmentally friendly pesticides. UBA therefore sees a definite need in deciding upon the ‘overarching goals’, that is, the form of agriculture and land cultivation practices that are desirable (interview UBA, 06/02). Moreover, it is claimed that taking into account sustainability standards is suggested by a proper consideration of the PP. This line of reasoning is strongly taken up by the NGOs, which have long demanded that new crops should be measured against

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higher environmental standards. However, their claims go even further in demanding that crops should only be considered for approval if they contribute to a more sustainable agriculture. Industry, in stark contrast, considers the demand for higher standards for GMOs as discriminatory and the demand as such to be methodologically flawed, since one practice of land cultivation (i.e. conventional) cannot be judged according to standards demanded in another practice (i.e. organic farming). Hence, products only need to be ‘as safe as their conventional counterparts’ (interview BDI, 07/02).

This question on baseline and alternatives is not new to the German GM-controversy. Already in 1993, in the framework of the ‘WZB technology assessment procedure on herbicide-resistant crops’, the dispute over which form of agriculture should be developed was identified as ‘the real core of political disagreement over transgenic herbicide-resistant crops’ (van Daele et al. 1997: 80). However, at the time the demand for broadening the frame of reference was dismissed on the grounds of, first, a lack of a legal basis and second, the claim that decisions on innovation should not be in the domain of politics.33 To underscore its’ claims the WZB report further concluded that ‘there is no established rule under the precautionary principle that alternatives must be taken into account in order to minimize risks’ (van den Daele et al. 1997: 84).

This line of weak precautionary reasoning can be taken as the hegemonic one for approval decisions up until the year 2000. It was only with the advent of various food scandals and finally the BSE-crisis that new light has been thrown on the question of agricultural/food practices and that the benchmark for discussion has finally been shifted. The talk of precautionary consumer protection and the demands formulated in the concept of Agrarwende have not gone unnoticed in the GM controversy. The new Künast line has supported long-standing critic’s claims that new regulation needs to incorporate agronomic aims and that regulatory practices need to change accordingly. This could put pressure on the conventional risk assessment rationale. When asking the proponents of this rationale about the new demands formulated in Agrarwende, respondents stressed that ‘under current regulation the environment is not only protected if criteria for organic farming are applied’ (interview BMGS, 06/02). Instead, it is argued that this kind of decision needs to be decided politically and cannot be left to the administrators. In a similar vein the following argument: ‘As long as we have not decided upon the issue politically, we will decide on a scientific basis’ (interview RKI, 06/03).

Another line of reasoning concerning agro-biotechnology and sustainability considerations is based on an argument of ‘biotechnology as a problem-solving tool.’ In this way it is assumed that improvements in agriculture, i.e. in terms of use of chemicals or toxin developments, can be achieved by using biotechnology, for instance, in the Diskurs grüne Gentechnik when one of the experts claimed that the PP demanded the use of biotechnological applications (Maxeiner 2003). It is claimed that a false distinction has been built up between biotechnology and sustainable farming practices, and that there is no scientific reason to exclude GM from organic agriculture (interview RKI 06/03, BBA 06/03). Even the biotech industry has taken up the talk of Agrarwende and has, at least rhetorically, accepted the broadening of the referential frame. However, industry strongly contests the view that organic farming represents the superior model in terms of environmental impacts and sustainability and hence claims that agro-biotechnology represents an equally viable alternative.34

33 The line in the report is worth quoting:’ Most of the participants in our technology assessment defended the established institutional balance between markets and political decision-making. They pointed out that the decline of the socialist countries had demonstrated that no model for an efficient economy exists in which decisions on innovation and investment are the domain of politics’ (van Daele et al. 1997: 86). A rather interesting statement given the public biotech funding schemes. 34 A common reference to illuminate this point is made with respect to the use of copper spraying in organic farming. It is argued that this fungal disease problem with potatoes could be

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Summing up, from the proponents side the case is made that agro-biotechnology is not only safe but also useful and that potential benefits outweigh small risks. This shows how the question of damage is not only determined by the comparator but also intimately tied up with risk-benefit considerations. In Germany, different camps of critics openly demand relative or absolute improvements in agricultural practices, basing their demands on the PP. This means in the relative case taking into account direct and indirect environmental effects and considering the choice of alternatives with lower risks for the environment. In the more extreme case this means either full ban of the technology, due to zero risk policy, or a full-fledged risk-benefit analysis, including screening for need. Proponents have hitherto insisted on approving in isolation, that is keeping the referential frame narrow, meaning ‘scientific’. Yet at the same time they pose supposed positive effects of GM crops against potential risks (these arguments have in fact been mentioned in risk assessment files (Vogel/Tappeser 2000)). This way implicit – but not scientifically proven – cost-benefit considerations are entering risk assessment schemes and hence question the pretention of a strict science-based approach.

The consideration of nature conservation and biodiversity

In July 2002 the German CA approved a field trial with herbicide resistant oilseed rape submitted by Bayer CropScience. The decision caused a major uproar in the environmental community for the proposed trial site in Swisttal-Morenhoven, Nordrhein-Westfalen was next to a nature conservation area. Approval was given on the basis of a simplified approval procedure (vereinfachtes Verfahren) that is, since the plant has been on trial before the selection of a new test site requires only a notification procedure. This procedure foresees a time-restrictive participation of the competent Länder authorities and does not cater for public consultation. Critics, including the BfN, have tried to stop approval on the grounds of the ‘specific sensitive living space’ (BUND 2002a) that a nature conservation area tries to protect and which they see jeopardized by genetic influx. Members of the Green Party, Friends of the Earth (BUND) and the Nature Conservation Association (NABU) criticized the authorities for not having properly taken into account these specific local site conditions and having instead pushed through a quick, non-public ‘secretive procedure’. Even the Länder Ministry of environment, which needs to be officially consulted, was expressing doubts about the approval, albeit conceding that the CA was indeed acting within the law.

Nature conservation law allows for the most intensive protection of fauna and flora in specifically dedicated areas. These localities are supposed to be maintaining biodiversity the way it ‘historically developed’ thus making interference and alteration (Verfälschung) either subject to approval (i.e. agriculture or road building) or strict prohibition.35 The hot issue in the Swisttal case was hence whether the influx of GMOs into these areas would pose a threat to biodiversity and would thus qualify as a ‘harmful effect’. Environmental NGOs consider any gene-transfer as harm because of irreversibility. BfN argues along similar lines – stressing uncertainties – and emphasizing the precautionary principle as a decisive factor to keep at least nature conservation areas free of GMOs. As opposed to this the CA had in the Swissthal case – as it has argued all along – decided that outcrossing as such was acceptable as long as there was no advantage in selection.36 Thus the CA saw no reason to apply different standards for nature conservation areas.

solved in a more environmentally friendly way if genetically modified varieties were available, so the argument in (Warenkette 2003). 35 See nature conservation law, BNatSchG 36 UBA was also giving green light for approval, which brought it into conflict with the BfN. UBA argued that there was, at the present legal practice, no basis of hindering approval because the existing law does not foresee any special treatment for nature conservation areas. UBA, however, supported an initiative to at least screen for nature conservation requirements. Yet the Nature Conservation Agency had no legal competency in this matter for RKI was the competent authority and RKI did not see why it would make a difference in approval (interview UBA, 06/02).

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The incident above was not for the first time pointing towards the problematique of nature conservation in relation to agricultural biotechnology. In 1998 the German Council of Environmental Advisors (SRU) had proposed to include nature conservation principles in the approval procedure in case of large-scale introductions of GM crops. In 2000 at a national expert conference dedicated to the subject and organized by both UBA and BfN, demands were formulated to consider nature conservation related requirements in the context of the risk assessment for GMO release (Lemke/Winter 2001). Later in the year in the course of the transposition of the European Habitat Directive into the Nature Conservation Act (Bundesnaturschutzgesetz) environmental NGOs, together with other GM critical institutions, had forcefully – but without any success – tried to lobby for the creation of a legal basis to exclude GMOs from nature conservation areas.

All these attempts suggest integrating nature conservation principles in the risk assessment practice of GMO release. The specific objective of biotope and species protection would thus broaden the scope of interpretation concerning ‘protection of the environment in its complex setting’ of the Genetic Engineering Act. As is argued in the UBA survey (ibid.), the conventional criteria for risk assessment, such as advantage in selection and modification of biodiversity, are based on causality thinking and do not properly take into account any time dimensions. SRU adds the point that there is a qualitative break between field trial release and potential large-scale release in mass cultivation and that this quantitative aspect needs to be considered and assessed in its effects on the household of nature (Naturhaushalt) (SRU 1998).

In order to address these shortcomings the UBA survey suggests the risk assessment to be enlarged to include the concepts of hemeroby37, and range of fluctuation and evolutionary integrity, all concepts that try to come to terms with the level of alteration (Grad der Verfälschung) of fauna and flora.38 Especially the concept of ‘evolutionary integrity’ has caused heated debates, as it suggests to differentiate in terms of human induced genetic modification and ‘naturally’ developed modification. In this respect it seems to justify critics of the concept who fear that by using such benchmarks a scientific basis of risk assessment was left behind because ‘there is a fundamental rejection of agricultural biotechnology at play’ (Bartsch: 264 in Lemke/Winter 2001). But even those who are sympathetic to these concepts criticize the lack of specification and operationality since, amongst many other problems, in order to judge, a ‘fictitious’ natural state (Naturzustand) needs to be determined.

The debate on nature conservation principles, and especially with evolutionary integrity, shows the fundamental cleavage between those that base their precautionary argument on the uncertainties involved in genetic modification per se and those that insist on focusing solely on the specific induced properties (assuming that these are known). In the later more extreme version of the perspective genetic modification can even be an instrument to maintain and improve nature conservation (Bartsch: 264 in Lemke/Winter, 2001). While on the other side of the extreme the idea of ‘gene garbage’ (Moch/Modelhauer 2003) meaning free floating GMOs happily reproducing and combining in an unrestricted way invokes discomfort and fear.

37 The increase of human influence on the urban areas is presented by using the so-called hemerobic index (scale) which is the degree of anthropological influence on the environment. 38 The German Council of Environmental Advisors (SRU) has developed the following definition of ecological damage in its 1987 Annual Report. The SRU defines ecological damage as changes exceeding the normal range of variation in the affected population or eco-systems and often only manifesting themselves over prolonged periods of time. In addition changes should be classified as „ecological damage’ which are irreversible or can only be reversed decades after the anthropogenic impact has taken place and at considerable cost.

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Notwithstanding the difficult scientific, legal39 and normative issues at hand the demand for GM free areas has been a constant and increasingly persistent topic in the German debate about GMOs. Nature conservation arguments in relation with the PP are invoked to justify spaces that stay GM free for the protection of specific sensitive natural spaces and species but also for the protection of organic agriculture – considered to be the most sustainable use of natural goods – and finally for the creation of referential sites for monitoring purposes.

Beyond these concrete demands, however, the debate points towards more fundamental issues at stake with the regulation of GMOs. As pointed out in the UBA survey, the debate can be interpreted as a way of bringing back in locally specific issues as well as local decision-making structures. In this sense, the practice of GMO release can be described as a process of ‘eclipse of space’ (Winter 2001). Although cultivation itself is a locally specific process, approval is increasingly, so to speak step-by step, removed from local specific conditions. While in the case of field trials the release area is regionally-spacially well defined and authorization can be granted by imposing by-regulation, this regional spatial relation is lost in the approval for EU-wide commercialization. But since harmful effects depend considerably on the regionally varying specific characteristics of the environment, it is deduced that an approval cannot claim to have possibly assessed all the risks. From these considerations it is finally concluded that approval, for instance, in the case of Bt maize 176, where no conditions are attached, would violate the precautionary principle as stated in Art. 174 EU treaty. In this way the PP is invoked to justify local objections and by doing so puts into question the trade harmonization rationale on which EU GM crop regulation, Art. 95 EU treaty, is based (ibid.).

Due to the new political constellation after 1998 nature conservation and biodiversity considerations have been gradually given a chance to enter the discourse on environmental risks and biodiversity considerations (Grewer 1999).40 Later, in 2002 the Diskurs grüne Gentechnik has made the issue of biodiversity protection central and has incorporated the expertise of nature conservationists. But the nature conservation discourse has not only entered the discussion on the national level. The new EU Directive 2001/18 does in Art. 19 para. 3 refer to ‘the protection of special eco-systems’ on the basis of which the use of GM crops could be locally limited.

Public participation and transparency

In Germany, the opponents of biotechnology are not integrated into the political system. The participation provided for by the Genetic Engineering Act neither serves to influence the decision-making procedure nor to render decision-making more acceptable (Gill 1995). The GenTG, formulated in 1990, provided for public hearings in case of field trials. This legal provision was dismantled in 1993 during the course of a deregulation of the act, and was substituted by a written petition system. According to a BMGS official the subjects that were brought up by the hearing participants – ranging from concerned neighbours, to scientists and anti-GMO activists – had very often little to do with the concrete case in question but were more of a general, ethical and political nature and hence not relevant (interview BMGS, 06/02). The narrow regulatory ‘scientific’ procedure thus excluded broader political and ethical issues, which, however, lie at the centre of the pubic debate.

For field trials, the GenTG allows for a written petition system. Yet in case of simplified procedures (vereinfachte Verfahren) public participation is not foreseen. For market approval applications no opportunity for participation is provided for anyhow. Hence, in writing objections to field trials there is very little official means left

39 For instance, another point an UBA official has pointed out in the difficulty in applying nature conservation principles lies in the relatively high damage threshold demanded in the Nature Conservation Act. According to the act, it is only „considerable damage’ that justifies intervention whereas the damage threshold in the GenTG is much lower. 40 For instance, in 1996 the Technology assessment office of the German Parliament (TAB) had been commissioned to work on the question of biotechnology and biodiversity and published its report in 1998 (Meyer et al. 1998).

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for critical knowledge to enter the regulatory procedure. The closed, intransparent and secretive mode of the administrative style is further hindering dialogues and complicating access to information, i.e. the advice from the Scientific Advisory Committee ZKBS and other public bodies involved are not publicly available. NGOs thus revert to strategies of information provision, the staging of public events, lobbying or the use of market-based strategies, such as labeling or consumer information on company’s GM policies, in order to hinder the introduction and spread of the technology.

A recent case on a field trial on GM wheat exemplifies the dilemma. In April 2003 the RKI approved a field test with fungicide resistant wheat from Syngenta. The information on the trial provided to the public did not include – for the first time – data on the gene construct inserted into the plant. In order to formulate scientific objections this is, however, pivotal, so the NGOs claimed. Greenpeace hindered the start of the trial by sowing out conventional wheat on the designated test field. As a result Syngenta has stopped the trial. The scientists and the regulators have strongly condemned the action accusing Greenpeace and other GMO critical groups of hindering the gathering of risk knowledge and thus obstructing the safety of the technology.

The issue of transparency, access to material and decision statements and the opening up of procedures has been a long-standing demand of the GMO critical community (Vogel/Tappeser 2000) and an issue at the Diskurs grüne Gentechnik. Critical groups thus welcome the new provisions in the EU Directive on cultivation registers and public participation. New risk communication programmes on the national level, for example the biosafety website, have improved the situation of transparency. There are signs of a modest shift in accessibility and readiness for dialogue, for instance shown in the Internet Forum on Monitoring organized by the RKI. The new draft bill foresees a broadening of public participation in approval procedures, however what the provisions are is not yet public.

Specific cases for the invocation of the precautionary principle

The case of Bt maize 176

Another decision regarding GMO regulatory measures has caused major disputes in Germany’s GMO-related political and scientific community. This decision concerns the invocation by Germany of Article 16 of Council Directive 90/220 EEC regarding Bt maize 176 by Ciba-Geigy (Novartis) in April 2000. In the beginning of 2000 Bt maize was in the process of getting commercial scale cultivation approval as the first GMO seed trait in Germany. However, before authorization was granted by the Federal Seed Agency the German government used the precautionary principle as a rationale for suspending market approval. The application for commercial scale cultivation was subsequently put on hold. The German Government justified its claims on the grounds of new scientific evidence, which cast reasonable doubts upon the long-term safety of the GMO plant.41 The following four points were put forward: Effects on non-target organisms, development of resistance to Bt, toxin releases to soil and antibiotic resistance (horizontal gene transfer).

In this case, the competent authority RKI was asked by the Ministry of Health to disregard the recommendations of the scientific advisory body ZKBS, which confirmed the safety of Bt maize in 1999. Additionally, there was no counseling before the ban, even though this constitutes a usual practice in authority decision-making. This caused major trouble between the regulators and the scientists. The

41 Ulrike Riedel, BMGS State Secretary at the time, explains the decision as follows: The approval decision for Bt maize was given under the old directive without imposing additional safety measures or post-release monitoring. Once the EU wide approval procedure is closed it is no longer possible to impose national safety measures. With the possibility of large-scale cultivation – which a seed approval would have authorized – Bt maize could thus spread in an uncontrollable way. Since private consultations with Novartis to take deliberate action of self-limitations in commercialization did not succeed, there was no way of preventing this from happening other than through Art. 16. This measure was thus justified by the PP (Riedel 2001).

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ZKBS claimed that the information did not show any new evidence and that some of the scientific studies provided were methodologically flawed (ZKBS 2000). This led the advisory body to the conclusion that the decision was political rather than scientifically sound. This suspicion was nurtured by the fact that the new Minister of Health, Andrea Fischer, was an outspoken GM critical Green Party member. Hence allowing the seed approval to proceed would have meant that GMOs would finally have been given a go-ahead under a green ministry.

One of the subjects of dispute was a study on antibiotic resistance submitted by the Öko-Institut Freiburg at the request of the Ministry. The Öko-Institut is known for its critical stance on agro-biotechnology and its close links to the German Green Party. One of the main arguments between the opponents was therefore – what constitutes legitimate and scientifically sound evidence? The following extract of an interview with Ulrike Riedel, State Secretary under Andrea Fischer, Ministry of Health (BMGS) and Gerd Hobom, Chairperson of the ZKBS, printed in the weekly paper DIE ZEIT in 2000 gives insights into the arguments:

DIE ZEIT: ‘Professor Hobom, why do you plead for the approval of GM maize?’

Hobom, ZKBS: ‘For me GM maize constitutes an ideal ecological solution.’ (…)

Riedel, MoH: ‘Whether Bt maize constitutes such an ideal solution needs to proven first. (…) Whenever the ZKBS points towards the reduction of chemical pesticides it does not base its decision on scientific facts but takes into consideration economic factors, which is, however, not up to the ZKBS to decide.’

(…)

Riedel: ‘We have looked at the scientific data and found that these provide reasonable grounds for the assumption that Bt maize could cause environmental damage. (…)’

Hobom: ‘(…) But the votes of the experts do not verify such an assumption. As you said before: ‘All decisions on GMO releases have to be based on the current state of scientific knowledge, which cannot be politically decided.’ This principle does not seem to apply in this case?

DIE ZEIT: ‘Who defines the current state of scientific knowledge? The ZKBS alone?’

Hobom: There is no such thing as definition power in science. However the selection process for members of the ZKBS, which is usually done by the Scientific Council, brings together the reputable expertise in the field in Germany.’ (…)

Riedel: ‘(…)’As a basis of our decision-making we consider the whole spectrum of scientific opinion. (…) In asking the Öko-Institut for advice we wanted to broaden the pluralistic basis of decision-making.’42

(…)

Hobom: ‘(…) When unproportional weight is given to scientific minority opinions then this is a political decision.

(…)

Riedel: ‘Of course we trust our experts. The ZKBS does an important job, but it is an advising committee. (…) In assessing the consequences of highly complex technologies there cannot be one true scientific opinion. These days, one researcher criticizes the other, especially in the field of biotechnology. There are

42 One of the main subjects of dispute was a study on antibiotic resistance submitted on demand of the Ministry by the Öko-Institut Freiburg – an institution well-known for its critical stance on agro-biotechnology and its close links to the German Green Party.

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cases where the authority has to disregard the vote of its experts. It is the state, which is held responsible in the end, not the ZKBS.

An UBA official commented the decision as follows: ‘The decision was a product of the red-green coalition government. It was not an idea born by the RKI. It is a science-based politically pushed decision. However, justified by precaution’ (interview UBA, 06/02). Greenpeace stresses the point of selectivity of scientific evidence: ‘The question is, on what kind of study does an authority base its decision? This strongly relativises the concept of science-based decision-making. What matters most is which questions are perceived as relevant and what data is used to underscore this. Hence there are different opinions. This explains why the German Government decided the way it did’ (interview Greenpeace, 07/02).

In September 2000 the Scientific Committee on Plants (SCP) of the EU basically confirmed the reasoning of the ZKBS by stating in its opinion that ‘The SCP has examined the scientific information by the German Competent Authority and does not consider that this alters the original risk assessment carried out on the Bt-maize 176 line (…)’ (SCP 2000). However, the German CA has not pulled back its decision and Novartis did not file a lawsuit against the German CA.

The case of GM maize ‘Artuis’ (T25)

Another time the German CA intervened in an approval procedure on commercial scale cultivation was in the case of GM maize ‘Artuis’ (T25) in June 2001. This time the expected approval decision was postponed by an intervention of the new Consumer Protection Minister Renate Künast (in case of Seed the Competent Authority lies with the Ministry of Consumer Protection, Agriculture and Food). As a result of the intervention the approval decision was postponed. Although there were no concrete health dangers brought forth, the ministry stated that ‘out of precautionary consumer protection approval should not be precipitated’ (quoted in TransGen 2001). GM maize ‘Artius’ was granted full market approval as a GM plant in 1998 shortly before the Moratorium. Austria, Italy and the UK stopped market approval subsequently partly due to safety concerns. Artius maize is mainly used as feed maize and is not approved for food uses (only notified under Novel Food legislation in processed form). According to press sources (TransGen 2001) the ministry intervened because it wanted to base approval on a novel food authorization in order to take into account unintended uses of the product. This action, albeit criticized, was widely considered to take account of heightened consumer awareness in food safety questions resulting from the BSE and foot-and-mouth-disease phase in Germany. In order to prevent long-term scientific re-evaluations or respectively legal quarrels with the German CA, the Seed company eventually withdrew its application. Greenpeace had for a long time lobbied against the approval decision, citing feeding studies that indicated risks for humans.

The reorganization of the Competent Authority

With the Chancellor’s organization directive from October 2002, following the coalition agreement of the re-elected social democratic/green government, the political responsibility for GM crops was shifted from the Ministry of Health (BMGS) to the Ministry of Consumer protection, Agriculture and Food (BMVEL). This decision implied that the respective competence of subordinate agencies involved in GM crop regulation had to be changed accordingly. The Competent Authority (CA) is thus changing from the Robert-Koch Institute to the Federal Agency for Consumer Protection and Food Safety (BVL), a newly created subordinate agency of the BMVEL (Bundestag 2003). The draft version of the new Genetic Engineering Act further foresees that UBA’s role in the approval procedure will be taken over by the Federal Agency for Nature Conservation (BfN). GM crop approval for release and commercialization will be given by consultation with the newly created Federal

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Institute for Risk Assessment (BfR), BfN and RKI. Furthermore, BBA and respective Länder agencies will be asked for their opinions in the process (see Figure 2).43

New CA = old CA?

The decision to move the competency coincides with the remodeling of risk management strategies as a consequence of the BSE crisis. In the aftermath of BSE, a report commissioned from the government identified a weakness in risk management strategies in the German consumer protection and food safety related system. As a consequence of the so-called ‘von Wedel Report’, the former Food safety agency (BgVV) of the Ministry of Health was dissolved and replaced by two new agencies, the Federal Institute for Risk Assessment (BfR) and the Federal Agency on Consumer Protection and Food Safety (BVL) (Böschen et al. 2002). This reorganization is supposed to take account of a functional separation between risk assessment and risk management institutions.44 Regulator’s responses to these organizational changes are mostly negative. People hold that a separation of risk assessment from risk management is impossible and counterproductive. ‘A risk manager needs to have some idea about the risk assessment and vice versa’(RKI 06/03, UBA, 06/02).

As already mentioned, both institutions will be engaged in the authorization of GM crops and food/feed. BVL will play the role of the risk management agency whereas BfR will be playing the role of the risk assessor. In practical terms, this means that parts of the former Centre for Genetic engineering of the RKI will be placed in these two new agencies. With respect to the personnel, it looks as if the same people will basically take care of the approval procedure.

The decision to shift the overall competency in GMO crop regulation away from the Ministry of Health has been a long-standing demand. For its predominantly environmental relevance it was found that the environmental Ministry had to be more credibly entrusted with this role. However, political shifts triggered by the BSE-crisis made a move to the Consumer, Agriculture and Food Ministry (BMVEL) opportune. Although a green party member, Renate Künast, heads the new ministry, GMO critical groups did not overly welcome this decision, fearing that it favoured a trend away from environmental questions towards economic/agronomic considerations.

The changes in the competent authority are critically perceived on both sides of the specter, albeit for different reasons. Common is the critique that too much power is allocated to the new agency and too few checks and balances are left to counterweight its decision-making power. The GMO critics side fears that the kind of arrangement is too short-sightedly knitted in favour of the current political constellation and could hence fly back in their faces as soon as the government changes and the agriculture ministry falls back into more GMO-friendly hands.

Shift from UBA to BfN

This shift in environmental competency from UBA to BfN has been explained by the BMVEL as being required by the changing subject matters. The competency for the assessment of environmental effects is seen to lie better with an institution that focuses on living organisms in their interaction with nature – which BfN does, rather than with UBA that focuses on harmful products (Bundestag 2003).45 With the BfN a

43 This information is based on interviews, press releases and the website: www.transgen.de 44 The propositions in the von Wedel report are tied back to and justified by EU policy (von Wedel 2001). Böschen et al. (2002) criticize the German propositions for institutional change in the following: They argue that these are based on a classic understanding of a separation between science and politics and that these do not elaborate on how these different functions can (need to) be brought together. Furthermore the propositions stress the criteria of efficiency at the expense of transparency. This is insofar problematic, according to the authors, as the BSE crisis was a political legitimacy crisis. 45 Much countering this official version is the following narrative. UBA had frequently been criticized for giving consent to approval decisions that had been widely opposed by the environmental community and the BfN, for example in the case of GM crop trials next to

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more outspokenly GMO critical institution will take part in the official approval procedure. The decision is therefore not very well perceived on the biotech proponent’s side. However, against a superficial reading of competence enhancement on the environmental side of regulation there is concern that environmental aspects could be further sidelined; BfN is perceived as being too critical in approach46 and the agency is not as well positioned in the reign of competent institutions in GM crop regulation as UBA used to be. Furthermore, BfN might lack a great deal of competency in matters of GMOs as a number of UBA officials will not move to the Bonn agency. In addition, the way the bill is drafted at the moment, BfN will not have a veto power in market approval decisions but will only be asked for its opinion (Benehmen).47 Overall from the environmental critic’s side there is the concern that this move from UBA to BfN and the likely consequences of great quarrels between the agencies over specific decisions could have a negative impact on the quality and weight of the environmental risk assessment.48

Critique of ‘Politicization of approval decisions’

A different kind of critique considering the political shifts in regulation is coming from GMO proponents. Industry, for instance, also makes the point of high concentration of decision-making power. However they also criticize the ‘multiplication of agencies’ involved in approval decision. Most importantly though, their critique focuses on the structural set up of the approval procedure. Due to the proclaimed institutional separation of risk assessors from risk managers it is feared that there will be a ‘politicization of approval decisions’. So far the RKI was giving approvals on a ‘relatively autonomous basis’ and decisions were taken on a ‘strict science base’ (interview industry, 06/03). Now it is feared that the regulators, the politicians, will ultimately take decisions possibly irrespective of risk assessment considerations.

Up to this point these mentioned statements concerning the institutional changes and its effects are mostly based on speculation. To what extent the worries and hopes of either side will prove to be right in the end can only be validated in the future practices exercised by the new competent authority. The respective institutional changes in competency were decided upon in December 2003 within the framework of a specific bill (Vorschaltgesetz), which will later become part of the new Genetic Engineering Act. Altogether the decision took over six months, as the respective majorities to clear the bill could not be found.

New product files

Among the new products requested for approval in the European Union, four were submitted to the German CA (as at December 2003). Three of these products are requested for cultivation, hence full environmental risk assessment and monitoring requirements apply under the new Directive. Difficulties arise in the German context in the situation of current restructuring of competency. At the moment it seems that the former institutional set-up and personnel are taking care of the risk assessment and management, however, new institutions are already involved.

specifically dedicated nature conservation areas. In the wake of institutional brokering between the Environmental and the Consumer Protection Ministry over regulatory competency, and with the decision in favour of the later, the environmental Minister Trittin decided to entrust the BfN with the environmental competency, effectively disempowering UBA. 46 Its president, Hardy Vogtman, has been known to support a total ban on GMOs. 47 This is one point of great contention between the parties of the coalition government. 48 As one commentator contented, this may even have a negative impact on the development of organic agriculture in Germany for the President of the agency, Hardy Vogtman – an outspoken critic of GMOs and a well established figure in the field of organic farming – could be squeezed between the two fronts. This could lead to a situation in which a negative light could be thrown on the organic movement in general (interview ZsL, 06/03). (Hardy Vogtman holds the first professorship in organic farming at Göttingen University, Germany.)

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Glufosinate tolerant oilseed rape C/DE/98/6 & C/DE/96/5, Bayer CropScience (SNIFs only)49

Bayer submitted two products for cultivation purposes to the German CA in February 2003. In both cases it concerns two types of Glufosinate tolerant oilseed rape. Both

49 SNIFs available on EU Joint Research Centre webside.

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Figure 2 Institutional innovation: the change in Competent Authority

BBA: Federal Biological Research Centre for Agriculture and Forestry BfN: Federal Agency for Nature Conservation BfR: Federal Institute for Risk Assessment BgVV: Food Safety Agency BMGS: Ministry of Health BML: Ministry of Agriculture BMU: Ministry of Environment BVL: Federal Agency for Consumer Protection and Food Safety RKI: Robert-Koch Institute, Centre for Genetic Engineering UBA: Federal Environmental Agency ZKBS: Scientific Advisory Committee on Biological Safety

BMLMinistry of Health

RKIBBA

BgVV (novel food)

Länder

ZKBS

Old:

Political responsibility (Fachaufsicht) Competent Authority

Consultative body (opinion or consent – decision-dependent)

BMU

Ministry of Consumer Protection,

Agriculture and Food

BVL

BBA

BFN

RKI

Länder

ZKBS

New: BMGS

BfR

BMU

UBA

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products had been submitted under the old Directive and have been brought up to date to conform to the new requirements of Directive 2001/18. Bayer understands this up dating as first of all consisting of the submittance of a post-release monitoring plan, i.e. that is there is no fundamental change in the risk assessment (interview industry, 06/03). In its risk assessment Bayer identified two potential adverse effects – glufosinate volunteers and weeds from outcrossing. However, ‘taking into account risk management strategies’ overall risk is claimed as being ‘nil’ (SNIF C/DE/98/6: 15 & SNIF C/DE/96/5: 17). On that basis, the company proposes case specific monitoring to confirm its assumptions.

Bayer aims to demonstrate that the risks are fully manageable in a practical way in the farmer’s field. To support this the company submits ‘Good Agricultural Practice’ plans that give advice to farmers on how to handle the product best. The case specific monitoring will then confirm the effectiveness of these management strategies. Bayer underscores its claims by referring to experiences in the field with good agricultural practices, for instance Stewardship programmes already in use in Canada50. Even though Bayer develops a management concept that strongly focuses on the farmer, the company suggests that other actors or institutions, ‘the ones that are already on the fields’, i.e. agricultural advisory bodies, could also reasonably be involved. Bayer thus puts a lot of emphasis on the use of existing networks in the implementation of the monitoring plan. The food health and safety of the processed oil has been confirmed by the food safety agency (BgVV). Up to this point only the Summery Notification Information Format (SNIF) is available. The CA does not give out any information on ongoing procedures.

Insect-protected maize line MON 863 and maize hybrid MON 863xMON 810, Monsanto C/DE/02/9 (SNIF and RA available)

Monsanto submitted the request in December 2002. RKI, however, asked for further information so that the document was completed and as such approved in February 2003. The product in request is for import only and the maize kernels will be used as animal feed and for further processing. Monsanto has submitted an application for food/feed use in 2002 but no decision on safety has been reached yet. The company holds that there is effectively overall zero risk relating to environmental effects arising from the placing on the market, as it is to be import only. Furthermore, the company holds that the product presents effectively zero risk to human and animal health. According to the SNIF, the ‘conclusions have been reached on the basis of scientific data and analysis, rather than on the basis of assumptions, case specific monitoring of the product is not relevant’ (p. 25). With respect to general surveillance the company suggests making product information available to traders and the processing industry, to directly inform the European animal feed industry and to request parties in the food chain to report on any adverse effects.

The RKI’s risk assessment on maize MON863 and hybrid MON863xMON 810 (06.05.2003). With respect to feed use the RKI concludes that there was no reason to anticipate that harmful effects would arise from feeding animals these proteins. The RKI further concludes and thus confirms Monsanto’s assessment that kernels of both the maize MON863 and its hybrid were ‘substantially equivalent’ to conventional maize, except for the newly expressed proteins. It furthermore concludes on the basis of the data that there were no indications of unintentional effects on the plant metabolism. The RKI does, however, stress the possible positive effect of reduction in fusarium infestation through the use of the product. Horizontal gene transfer cannot be excluded but the RKI classifies it as improbable. The product contains antibiotic marker genes, however, the RKI concludes, on the basis of a ZKBS recommendation from 1999, that no adverse effects on human health or environment are to be expected. Yet it will limit registration until a common EU position on the phasing out of antibiotic marker genes has been reached. With respect to risks to the environment the RKI concludes that since cultivation is not foreseen there is no threat to the

50 Aventis: Stewardship and plant biotechnology. Responsible Commercial Production in InVigor, LibertyLink and Navigator Canola

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environment to be expected. With respect to the monitoring plans the RKI suggest that the national veterinary services of each country should be informed of the introduction.

Comments from the Dutch and the British scientific committees concerning the application. Advice from the Dutch scientific committee COGEM51 • Request for additional data to evaluate feed safety concerning the hybrid,

detailed analysis of F2 hybrid is lacking

• Additional data on molecular characterization not supplied

• File contains contradictory information

• Antibiotic resistance marker genes should not be allowed

• Additional measures to prevent spill to environment should be undertaken, because maize could become feral in Southern Europe

Final conclusion is negative because of lacking data

Advice from the British scientific committee ACRE52

‘ACRE has considered the information provided in this dossier and the Committee is satisfied, at this stage, that there is no evidence to suggest that the marketing of this product for importation and processing in the UK poses a risk to human health and the environment. However in order to make a full assessment of this GM product and before an opinion as to whether this product should be marketed in the EU is made ACRE requests further information as detailed below. In coming to this conclusion ACRE have taken account of the advice of the Advisory Committee on Animal Feedstuffs (ACAF).’

1 A consideration of the molecular characterization of parental line MON 810, and in particular an assessment of risks associated with the possible presence of multiple inserts and vector backbone sequence.

2 Full data concerning the broiler-chick feeding study with MON 863 maize kernels.

3 A risk assessment for the MON 863 x MON 810 hybrid taking into account the fact that it will be the F2 generation which will be imported and that there may be a very small opportunity for recombination. Any uncertainties should consequently be taken into account in the post-market monitoring plan.

Roundup Ready Sugar Beet, Monsanto/KWS C/DE/00/8 (SNIF only)

Monsanto/KWS submitted the application file in 2000. The date of publication on the Joint Research Centre website was the 24.02.2003. The product in request is a herbicide tolerant sugar beet submitted for cultivation approval. The beet is to be used in the same manner as any other sugar beet and substantially equivalent to other sugar beet. In the environmental risk assessment it is claimed that gene flow may result in glyphosate-tolerant weedbeet, but since these would not gain any selective advantage they would not cause any environmental harm. Volunteers could be readily controlled and the strategies of risk management would be the same as for conventional sugarbeet. The companies argue that RR sugar beet would improve weed management and can positively impact current agronomic practices and that there would be no greater risk to biodiversity, instead even permitting higher in-field biodiversity. On the basis of the data the companies reach the conclusion that overall risk to the environment and human and animal health is negligible. Since no adverse effects are identified in the company’s risk assessment (according to the SNIF) case specific monitoring is not relevant. The company stresses that these ‘conclusions have been reached on the basis of scientific data, rather than on major assumptions’ (p. 21). As to that time no institutional risk assessment is available. 51 Advice available at: www.cogem.net 52 Advice available at: http://www.defra.gov.uk/environment/gm/index.htm

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Insect resistant Bt11 maize, Syngenta Seeds C/FR/96/05/10

RKI opinion on Bt11 from 21.03.1997 on C/UK/96/M4/1 (import)53

RKI could not approve unlimited market release because of methodological shortcomings. The RKI doubted that the isolated microbe-derived Bt from which conclusion were drawn with respect to non-target organisms and human health was equivalent with the Bt proteins that are actually built in the plant. The data that showed this proposed equivalence was lacking.

RKI opinion on Bt11 C/FR/96/05/10 (cultivation) not officially available

According to press sources, Germany abstained in the respective EU decision on Bt11 in November 2003 because there was no common Government position on the issue.54

A change in risk assessment and management practices?

There is an ongoing argument amongst German regulators as to what constitutes a proper risk assessment and respectively adverse effects. If UBA/BfN and RKI/BVL are asked about the risk assessment requirements of the new EU Directive the answers reflect the different issue framings of the involved authorities. UBA/BfN contend that there will be substantial changes (direct and indirect, short and long-term effects) in the new risk assessment whereas RKI (BVL) and BBA do not see a major difference in comparison to the former requirements, apart from monitoring or the limiting of approval in RM. On the question of whether the new political responsibilities would make a difference with respect to risk judgements an official from the BMVEL states the following:

‘In the GenTG it is stated that the risk assessment is carried out on a scientific basis. There may be no major changes in the scientific risk assessment. But how the results of the assessment will be used afterwards will be the decisive question. (…) Since we do not know about long-term uncertainties, we might have to implement specific measures in consideration of the PP. That’s why I think the assessment might stay the same while the risk management considerations could be changed’ (interview BMVEL, 06/03)’.

With respect to the new approval procedures it needs to be noted that due to the change in political responsibility from the BMGS to the BMVEL the ministerial enactment from 1999, which enforced the role of UBA in market approval procedures providing it with an effective veto power, is no longer valid. That is, the above (market) approval procedures will be done on the basis of consultation with the environmental agency only. Given that the same people (and conventional framings) are basically in charge it is thus questionable if a different, or more precautionary, risk assessment practice will prevail in the future.

3.1.3 Risk management Post-release monitoring

Many of the efforts regarding new approval provisions are concentrating on the development of the required monitoring concept for GMOs. There are numerous and varied monitoring activities in Germany. Different institutions as well as various interest groups have presented their own specific concepts as to how a monitoring could or should be done. These accounts vary as to the reason of monitoring, the objects and actors of monitoring, the priorities, and the methods/parameters to be used. The precautionary principle does play an explicit role in some actors monitoring rationale.

53 Extracts from the RKI assessment in: (Vogel/Tappeser 2000) 54 www.transGen.de

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Since 1995 the environmental agency UBA has been dealing with the subject of monitoring of GMOs and has since that time conducted numerous studies.55 In its 1998 Annual Environmental Report, the German Council of Environmental Advisors (SRU) stated that it saw a considerable need for further research on ecological effects of GMOs and recommended a long-term environmental observation after approval. In 1999, on the basis of the coalition agreement of the new red-green government, great importance was attached to scientifically accompanying the cultivation of GMOs. Upon the decision of the Conference of Federal Environmental Ministers the Environmental Agency (UBA) had finally been entrusted with heading a Governmental/Länder working group to prepare a concept for the monitoring of GMOs as envisaged by the directive.56 In 1999 a second working group was established under the leadership of the Federal Biological Research Centre for Agriculture and Forestry (BBA).57 In 1999 the relevant German Industry Associations also developed ideas for a practical cultivation-related monitoring.58

For the Environmental Agency (UBA) monitoring is an instrument of a precautionary environmental policy. The agency considers monitoring of GMOs as an appropriate means to check the impact hypothesis in the sense of precaution. The monitoring is supposed to be used to discover potential, and in particular unforeseen impacts of the cultivation of GMOs on the environment. UBA considers monitoring as an early warning system which helps to improve the risk assessment, thus contributing to consolidating the step-by-step concept as it is practiced at present (Troge 2001). It is considered a suitable instrument to verify the assumptions and decisions made in risk assessment in light of the real situation and for detecting long-term, not to be predicted effects.59 In a more recent draft concept of the Joint Working Group the monitoring is even considered ‘to yield clear and targeted results and decision-making aids as an orientation tool for future agricultural policies’ (Joint Working Group 2002: 5).

In comparison to the UBA group’s focus on ‘Monitoring of environmental effects’ the BBA working group puts its stress on ‘Cultivation-related monitoring’. Their work focuses on direct and indirect effects of GMOs on the agricultural-ecosystem taking into account cultivation sites and field margins. Monitoring for this group is thus mainly an instrument to detect potential negative and positive changes60 in the agricultural-ecosystem relationship, i.e. with respect to pests or resistances, always in comparison to conventional systems of agriculture (BBA 2000).

55 For more information on the various UBA reports, see: www.uba.de 56 Members of the working group are: representatives from the Ministry of Environment (BMU) and the Federal Agency for Nature Conservation (BfN), Federal Environmental Agency (UBA), Federal Biological Research Centre for Agriculture and Forestry (BBA), Robert-Koch Institute and experts from the 12 out of the 16 Länder authorities. 57 Members of the working group are: representatives from the Federal Ministry of Consumer Protection, Agriculture and Food (BMVEL), from various BBA institutions, several plant health centres, RKI, UBA, the Federal Plant Variety Office (BSA), the Plant Variety Control and Advice Office of the Länder Authorities, The Association of German Plant Breeders (BDP), Institute for Sugar Beet Research, (IFZ), from Universities, and from the European Academy for Environment and Economy 58 Other actors worth mentioning are: The Society for Ecology (GFO) which has organized a workshop on Monitoring and made statements with regards to ecological parameters, see (UBA 2002) 59 In this respect it is, however, argued that although monitoring rests foremost on observation and is thus part of risk management, in case of unanticipated, new effects it is necessarily risk research. 60 This seems to be another contentious point between the parties. According to the revised EU Directive, the risk assessment must include any effects of changes to the management practices, i.e. in herbicide use. When asked about this point, the company officer responded the following: ‘It would be good if we monitored the changes in herbicide use. However, I had to learn from UBA that the aim of the monitoring was to identify potential adverse effects only (that is no positive effects)’ (interview industry, 06/03).

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According to UBA the monitoring includes three modules that complement each other: Environmental effects, Health Effects/Consumer Protection and Agricultural Effects. Following will be outlines on environmental and agricultural effects.61 Comparing the two monitoring concepts most developed at the time from both the UBA and BBA working groups, one can detect major differences in approach:

The breadth and width of monitoring

The general difference lies in the breadth and width of possible effects that are supposed to be observed. BBA reduces its general surveillance to the agrarian ecosystem and agronomic effects. UBA, in contrast, has a much broader definition as to what counts as the environment and what effects to monitor. It strongly emphasizes the need to monitor proven, suspected and plausible ecosystem relationships (including non-target biotopes) and to take into account biodiversity and nature conservation questions beyond the agricultural land. In general, the questions about which knowledge gaps and uncertainties have to be cleared within risk research and risk assessment and which gaps can be left to post-marketing monitoring are under dispute. Also arguments continue over the environmental norms (i.e. what is the natural ecosystem), which provide a comparative baseline as well as damage thresholds and discontinuation criteria.

The case of outcrossing

For the BBA working group outcrossing, persistence and dispersal of GMOs as such is not considered to be an adverse effect and hence does not need to be monitored, at least not within case-specific monitoring. The UBA group, in contrast, argues for the inclusion of out-crossing, both within the framework of case-specific monitoring as well as general surveillance (Joint Working Group 2002). They argue that although outcrossing may not pose immediate risks, it may carry a potential for possible adverse effects and thus – from a precautionary point of view – needs to be monitored (interview BfN, 10/03).

The use of existing networks and monitoring programmes

The BBA working group puts a lot of emphasis on the use of existing networks and monitoring devices in the implementation of the monitoring plan. To work out such possible cooperation networks BBA has cooperated with seed companies and various agricultural institutions, i.e. plant/seed protection agencies, within the framework of a BMBF- sponsored programme on ‘Biosafety Research and Monitoring’.62 For instance, in 2001 and 2002 the so-called maize platform – a network of maize breeders with scientific support from the BBA – developed a questionnaire as a monitoring device in which each farmer was asked to give specific information about the crops and possible changes that cultivation implied.63 The UBA group welcomes such activities, however, they stress that, for instance farmer’s observations could only be supplementary but could not deliver any scientific results. Furthermore they argue that none of the existing environmental surveillance and monitoring programmes will be able to cover the monitoring of GMOs completely or at least in most parts, i.e. there is no standardized biodiversity-monitoring programme. Hence, UBA argues that existing networks and programmes should be used but that there is additional need for the development of new or complementary surveillance programmes.

61 The UBA draft concept highlights the fact that so far no concept for monitoring health effects exists. Current food monitoring includes only GMO labeling and according to the Federal Institute for the Protection of Consumers and Veterinary Medicine (BgVV), it is at present not feasible to monitor anything beyond that (Joint Working Group 2002: 12). 62 The BMBF programme has as one of its aims the development of parameters and methods for a monitoring plan. This new programme was initiated despite the fact that UBA had already worked on these questions for years. This is, however, according to insiders, constantly ignored. It seems that UBA is in constant having to defend its status and expertise against BBA and its associated networks. 63 For more information, see www.bba.de

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A national centre for coordination

The monitoring activities need to be coordinated and the data from various data collectors assembled and assessed. Thus there is a general agreement on the need for national coordination. However, the question of where such a national focal point should be set up is still under dispute. The UBA group argues that this clearing-house task should be established within the environmental sector. The BBA group, in contrast, argues a case for the authorizing authorities.

Organizational and financial responsibilities

Even though the monitoring plan lies in the sole responsibility of the companies, public institutions in Germany are intensely involved in its conceptualization. However, to what extent Länder and Federal authorities are to be eventually implicated in the monitoring activities is not yet clear. The division of tasks between the Federal State, the Länder authorities and the applicant is thus a heavily disputed aspect of monitoring conceptualization. The UBA group stresses the monitoring responsibility of the operator in providing both for case-specific monitoring as well as general surveillance. However, due to the use of existing or to-be-built-up surveillance programmes and the necessity of regulatory functions of the authorities the involvement of public institutions is indispensable. UBA thus argues that it appears appropriate to make the applicant contribute to the costs of general surveillance via fees and contributions or the establishment of a fund. This, however, is a controversial point for a general obligation of the notifier to bear the costs for monitoring and surveillance is considered to be unproportional and apt to distort competition.

As can be seen from the comparison there are substantial differences in opinion between the principal players in the monitoring arena.64 UBA focuses on ecological effects and the broader environment whereas BBA looks at mainly agricultural effects on the cultivated areas. UBA stresses the importance of non-hypothesis led precautionary monitoring whereas BBA puts practicability and cost-effectiveness in the foreground. A common national approach to monitoring thus needs to integrate these different interests and opinions in an overall monitoring strategy. In 2002 a common position between UBA and BBA had been elaborated, which has, however, never been published. Another difficulty in the harmonization process was added with the shift in competency from the Environmental Agency (UBA) to the Federal Nature Conservation Agency (BfN) in 2003. The BfN will now be responsible for the coordination of the former UBA monitoring group – a decision that has not been friction-free.

However, most of the monitoring parameters and methods for four representative cases, herbicide resistant rape, pest resistant maize, virus-resistant sugar beets and potatoes with modified starch have been developed already and are now under discussion between the competent authorities (UBA 2003b). In the meantime new applications (i.e. Bayer’s Glusifonate tolerant oilseed rape) are used to elaborate the monitoring plan on a case-by-case basis. Major efforts are being made in order to come to a final agreement between the opposing parties and to finalize the Monitoring regulation (Verordnung), which will supplement the new Genetic Engineering Act. In general though, the agencies agree on the point that the EU guidelines are far from being sufficient to get the monitoring on EU wide standards and are criticizing the EU-wide negligence of the subject area.

Critique of post-release monitoring

The critics of monitoring plans argue as follows: Friends of the Earth Germany (BUND) and Greenpeace strongly reject the claim that post-release monitoring could be a precautionary measure. Instead they consider it to be risk research at the stage

64 The wording in the coalition agreement between the Social Democratic Party and Bündnis 90/Die Grünen concerning the monitoring reflects this controversy. One side demanded an „efficient monitoring’ the other side opted for a „comprehensive monitoring.’ The former version was eventually used in the agreement.

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of market release, where GMO affected fields turn into huge experimental test sites (Moldenhauer 2002). More importantly – a point stressed by the Öko-Institut – they fear that these measures make approval and cultivation more acceptable because it seems that extra safety measures are taken. Or the experience of long-time monitoring makes approval even necessary since remaining insecurities and potential risks can be reduced and tested. Principally, risk assessment and management is blurred, which means for the application of the precautionary principle that the risk debate will necessarily shift towards testable insecurities and hypotheses (Vogel/Tappeser 2000). It is furthermore criticized that consumer groups, organic farmers and environmental NGOs are not incorporated in the monitoring activities (Rudolf 2001).65

Coexistence and consumer choice

To guarantee consumer and producer choice has been identified as one of the main common concerns in agro-biotechnology during Diskurs grüne Gentechnik in Germany (BMVEL 2002a). These central demands concerning coexistence were also taken up in the coalition agreement between the Social Democratic and the Green Party (SPD/Bündnis90/Die Grünen 2002). Hence, the talk of consumer choice and coexistence of different production systems dominates the current discourse on the German GMO debate. Debates about choice and coexistence are thus reframing the former agronomic-environmental focused debates. This does not mean, however, that issues surrounding precaution, risk and safety have been put aside. They merely surface within a different framework.

The discourse on choice presupposes two production systems that can be run independently and simultaneously. However, since genetic contamination in the field and in the market has been proven to be a real scenario, the widespread release of GMOs not only poses an economic threat to organic and non-GM farming but also potentially jeopardizes consumer choice. This likely scenario is especially precarious against the background of a newly propagated agricultural policy, which aims at increasing the percentage of organic farmers to 20 percent. One of the salient issues with GM crop release lies, therefore, in the protection of non-GMO and organic farming and products from GMO contamination in the field and the market.

Arguments arise as to the basis on which such a compromise could be reached. Managing coexistence under circumstances of gene transfer is most of all disputed in the question of thresholds and responsibilities. GMO proponents define coexistence on the basis of practical, meaning high, contamination thresholds whereas the opponents understand coexistence and choice as clear-cut alternatives, that is, GMO-free meaning 100% free. However, as the Diskurs clarified, coexistence on the basis of zero tolerance was impossible to reach in the fields, or too expensive to be realized in the market. The preservation of an entirely GMO free agricultural and food production was therefore dropped. Hence, for the NGOs the argument of consumer choice and coexistence does not really solve any of the fundamental oppositions (Moldenhauer 2003). For them coexistence means ‘contamination’ while for other concerned critical groups coexistence means at least ‘pseudo-choice’ as the least bad solution to the dilemma (interview vzbv, 06/02). 66 The coexistence line (on the basis of thresholds) was posed as being without any alternative along the lines of ‘Agro-biotechnology is a reality – we need to deal with it’ (BMVEL). However, despite these judgements most of the societal groups have engaged in the course of

65 RKI established an Internet forum on the subject of monitoring with the aim to provide a platform for discussion and exchange of opinions (www.rki.de). How this information is being incorporated into the discussion process is not clear. 66During the Diskurs, there was disagreement on thresholds within the critic’s camp. i.e. consumer NGOs and organic farmers were leaning towards higher thresholds out of fear that otherwise there would be practically nothing left labeled GMO-free. They urged the environmental NGOs to drop their reluctance and start negotiating about separation distances, costs and other practical steps to be taken to make coexistence and „pseudo-choice’ possible (interview vzvb, 06/02).

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discussion and have given input to the debate on how to understand and organize coexistence.67

Even though the themes dominating coexistence do not primarily relate to environmental safety arguments precaution has been linked to the choice and coexistence discourse in multiple ways. According to consumer and environmental NGO’s, the farmers and the BMVEL it is argued that precautionary measures need to be taken to safeguard the freedom of choice in the first place. These measures are furthermore regarded as ways of dealing with ecological, health and economic risks when it comes to a large-scale introduction of GMOs. Choice is thus in turn serving precaution because it allows limiting, and to a certain degree containing, the extent of spreading of GMOs in the food chain and the environment. Equally importantly, the freedom of choice allows for an individual choice in terms of what is regarded as being better for the environment (i.e. organic agriculture) and human safety.

Thus as can be expected from the range of interests involved, coexistence and its political, legal and scientific issues are framed and solved differently by the various parties involved:

Biotech-industry : ‘What’s the problem anyway?’

Industry considers coexistence as a mere economic issue and nothing new in the farming business. For them coexistence is a question of thresholds which need to be plausible and workable. Industry finds the discussion about coexistence highly overrated and mainly pushed by ideological interests. After all, ‘admixtures’ (i.e. in case of herbicide residues) are a reality and accepted even in organic agriculture – up to a certain threshold. Accordingly, industry supports the Fischler line in terms of subsidiarity and responsibility ‘The state should be rolled back, the concerned parties are able to organize themselves’ (interview industry, 06/03). Another rhetorical strategy seems to be to blur the line between the different production systems: Agricultural biotechnology is being propagated as a form of sustainable farming which benefits could also accrue to organic production if only producers were ever to drop their resistance (Warenkette 2003)68.

Food processors and retailers: ‘Consumers should be given a choice’

In a policy statement concerning agro-biotechnology members of the food supply chain declared that, „consumer acceptance can be increased by ensuring freedom of choice and the coexistence of different agricultural practices’ (Warenkette 2003: 8). This goal to ensure ‘effective coexistence’, however, can only be achieved on the basis of comprehensive and practical regulation. The food industry clearly wants the innovation potentials in biotechnology to be realized (BVE 2002; Warenkette 2003). Consumers should be given a choice, also with respect to genetically modified products. The retail sector is more cautious in terms of ‘biotech promotion’ and argues neither in favour nor against it. The sector stresses that it offers a platform for every safe product. The retail sector wants coexistence to be regulated on a

67 Meanwhile, a range of reports had been published: In December 2000 UBA held a stakeholder conference on the subject of ‘Green genetic engineering and organic farming’. During this conference, possible approaches towards protecting organic production were discussed between the different groups. These talks resulted in a report, which was prepared by the two Research Centres for organic farming in Berlin and Frick (CH) together with the Öko-Institut. It was released in February 2003 (UBA 2003). In December 2002 another report was released from the Öko-Institut ‘Gene flow: so what?’ addressing the subject of gene flow and its likely economic and ecological consequences (Brauner 2002). In 2002 another report was worked out by the Öko-Institut and the Centre for organic farming in Berlin (Fibl) on the issue of Coexistence. The report was commissioned by Friends of the Earth Germany (BUND) (BUND 2002b). It focused on the question of contamination sources within the food chain and worked out different future scenarios on the basis of varying political and regulatory frameworks. 68 The Warenkette is a common initiative of industry, the national farmer’s organization and the Unions which was formed during the course of the „Diskurs grüne Gentechnik’. Together they developed a common stance on the issue, published in (Warenkette 2003).

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European level, for different understandings and regulations of coexistence would not bring closure to the debate which they think is, however, pivotal for finally achieving consumer confidence (interview BVL, 10/03).

National Farmers Organization: ‘Keep consumer’s (and farmer’s) trust.’

As a principle the Farmers Organization (DBV) does not want to rule out any type of farming. Hence there is no fundamental opposition to agricultural biotechnology. However, the DBV identifies strict coexistence regulation as the key issue for guaranteeing choice and for providing a reliable legal framework for farmers. The DBV insists on clear EU wide responsibility and liability regulation before the ending of the Moratorium. In this respect DBV criticizes the Fischler line because it does not live up to this task; ‘subsidiarity is wrong’. In addition the DBV supports a lower than 0.9 percent threshold in seed and the idea of voluntary GM-free areas (DBV 2003a). The DBV is mainly driven by fear of economic damage and the loss of trust in farming and its products. As one farmer put it: ‘The BSE fiasco has shown that no facts are necessary in order to cause damaging consumer boycotts.’69

Organic farmers and organic food industry: ‘Nothing but survival.’

The organic farming and processing community (BÖLW) is principally against and by law prohibited from the use of agricultural biotechnology. For them the coexistence question is a question of survival. They demand protection against ‘contamination’ whereby all the costs need to be borne by the introducer of the GMOs (strict application of polluter-pays principle). In addition they demand clear liability regulation (i.e. Biotech industry fund), strict regulation of good agricultural practices, a 0.1 percent threshold in seeds and a cultivation register (BÖLW 2003).70 Organic farmers claim not to be speaking just for themselves but for the majority of farmers since, according to a poll conducted by Greenpeace in 2002, 70 percent of German farmers reject agricultural biotechnology. Most of all BÖLW demands regulation to be in place before the lifting of the moratorium.71

Environmental NGOs: ‘Avoid creeping contamination.’

‘Coexistence may be impossible in many cases, but if we need to deal with GM cultivation in Europe than we need to tackle the problem of contamination’ (interview ZsL, 06/03). In this respect the Fischler proposal is absolutely unacceptable for these groups. Even though the environmental NGOs strongly side with the organic farmers they stress that the question of coexistence is not just an economic but also an environmental and ethical issue. Outcrossing or unwanted spread of reproductive material is posing an environmental risk, as this spread would be irreversible. For reasons of precaution introgression of GM material, especially in seed, should be avoided, not just minimized. Strict coexistence rules are thus regarded as a basic precautionary measure, as they alone provide the necessary conditions that would allow a withdrawal in case of damage (Haerlin 2003). In addition, ‘coexistence is (…) an issue of long term guarantee of the freedom to choose what to consume and how to produce.’ In this respect they argue that the freedom of choice is primarily a defensive right to avoid a certain technology for precautionary or ethical reasons (ibid: 2). The concept of thresholds is basically looked at as a concession to industry and a

69 This quote is taken from a panel discussion on agro-biotechnology organized by the Government of Baden-Württemberg in September 2003. The comment was made by Gerhard Glaser, the Vice President of the Baden Württemberg section of the DBV. 70 Problem adventitious presence: Officially organic farmer’s organizations support the „as low as possible line’. However, they fear in case of very low thresholds that there would be nothing left to be declared GM-free. Organic farmers are thus caught in a dilemma. As a baseline they demand that „those who consciously reject the use of GMOs should be allowed to call their products GM free’ (Löwenstein 2003). 71 Within the Diskurs no consensus could be found on this question. Farmers demanded that regulation needed to be in place before the lifting of the moratorium, whiles other’s hold that regulation could be introduced gradually.

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‘deception of consumers’ (Nagy 2002).72 For NGOs the coexistence problematique means capitulation and challenge at the same time. For on the one hand discussing coexistence could be interpreted as a sign of accepting GMOs. On the other hand the coexistence theme has provided critical groups with new and hitherto neglected but highly plausible political arguments of why GM technology – in case it is introduced – would have to be highly regulated and contained.

BMVEL: Safeguarding choice and preventing the ‘war in the villages’

With the new Künast line the GM controversy has been embedded in a more fundamental discussion on food production and a restructuring of farming. Künast makes no secret of her idea that GM cultivation does not fit into this scenario of a more sustainable form of future food production (Künast 2002). Seen from this perspective the demand for coexistence means something more fundamental, beyond the direct impact on farmers and their economic interests. According to Künast coexistence means being able to choose how we cultivate our land, how we produce our food and what we eat. In that vein, the questions regarding the regulation of biotechnology in agriculture and food imply concerns beyond health and the environment – it also affects social and ethical concerns. However, thresholds alone do not guarantee this freedom of choice if there is no protection of organic and conventional farmers and others being affected by the introduction of GMOs into the food chain. That is why Künast demands strict coexistence rules. She contends that the introduction of provisions on coexistence is required since this is the only way to achieve a balance between the interests of non-GMO and GMO cultivators and their clients. It is regarded that the Deliberate Release Directive could be used as a statutory basis for such measures. In Art. 26a (new) it states that member states can specify protective measures in order to avoid adventitious presence of GMOs in non-GMO products.

‘Coexistence is not primarily a matter of safety considerations but there are connections to the safety question, i.e. with respect to monitoring and tracebility. Coexistence allows an individual safety decision according to individual preferences. That’s the basic principle’ (interview BMVEL, 06/03). The Ministry is thus not primarily concerned about possible environmental safety aspects with respect to coexistence regulation. Interestingly enough though, nature protection is also framed as a coexistence issue in terms of safeguarding not only GM-free agricultural and food choices but also ‘GM-free nature’, in particular with regard to protected areas (interview BMVEL, 06/03)’.

With this policy line, Künast is receiving much support from the organic and environmental community for they claim that the Directive’s provisions are not taking enough account of the changing realities and altered background conditions concerning quality food production and sustainable agriculture. As is argued in the UBA coexistence report: ‘The European lawmaker has recognized the growing significance for the consumer of foods produced through organic farming and is giving organic farming a role in the reorientation of the joint agricultural policy’ (UBA 2003a: 35). Current GMO regulation would thus dwarf these aspirations. The report therefore suggests that the necessary protective measures for this non-GMO sector could be based on a ‘well founded protective and precautionary concept by the member state.’73

72 However, Greenpeace almost euphorically celebrated the new labeling and tracebility requirements from July 2003 as progress for consumers. 73 Notwithstanding of the critique on the EU Directive the report claimed that the Directive could be used as legal basis to introduce measures for the prevention of non-GM agriculture and food production through the „specific conditions of use and handling’ (UBA 2003a: 36).

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Although the Künast Ministry has used a great deal of expertise from the Öko-Institut74 and the organic community in conceptualizing its coexistence strategy, the Ministry stresses that it does not speak for the organic community alone, but for the majority of farmers and consumers. Coexistence provisions are considered as so pivotal to safeguard choice and for keeping peace between the different forms of agriculture that the BMVEL calls upon a ‘duty to precautionary practices’ (Vorsorgepflicht) in order to strengthen damage prevention (Wollersheim 2003).

Liability

One key issue in the coexistence debate is the question of damage and liability. 75 Gene transfer will occur and can surely be economically damaging for the organic or non-GMO producer. This, however, has so far not been legally defined as such, neither in European nor in German Law.76 As the UBA report (2003a) specified, up to this point the issue of economic damage could be settled under the so-called ‘neighborhood paragraph’ 906 of the German Civil Code (BGB). It suggests that a concerned party can claim compensation in case of harm inflicted by a neighbour. This conflict solution, which principally pits farmer against farmer, is, however, strongly opposed by the farming community. In privatizing the cultivation risks, farmers fear becoming once again victimized in a battle that is not their own (i.e. BSE) (Sonnleitner 2002). Especially organic farmers stress their vulnerability with respect to contamination. The real problem is not so much individual material damage, as the loss of credibility of the whole sector is put at stake (interview FiBL, 10/03).

The question of how to prevent damage is therefore considered to be the more pressing problem and to be solved before GMO seeds are brought to the fields and liability claims need to be made. However, since liability regulation does have both a preventive and compensatory function it plays a pivotal role in coexistence regulation. Farmers, the NGO community and the BMVEL argue for the application of the polluter-pays principle meaning those who bring GMOs to the field/market should be held liable in case of damage. However, applying this conflict resolution principle is less straightforward than it sounds as many problems still remain to be solved: For instance, what is considered damage? The breaching of the 0.9 percent threshold of contamination as applied to conventional products or of an even more sensitive threshold for organic products? How far does liability go? Can one be held liable even when undertaking preventative measures? How to establish causality when the source of contamination could be multiple? Notwithstanding the problems, critics pressed that this issue should be dealt with within a revised GenTG since there is no other legal institution that regulates the coexistence of different production systems (as will be shown later the draft bill does take up many of the issues). Industry, however, does not even accept being held accountable/liable in case of contamination and does not see why contamination as such constitutes a problem. With respect to organic or ‘Non GM’-labeled products they argue that ‘those who hope to benefit [from special production] should be paying for it’ (interview industry, 06/03).77

74 In fact, according to insiders, Künast is to a great extent taking on external forms of expertise mainly for the reason of a lack of cooperation within her own Ministry 75 This section only covers the question on economic liability since this issue seems to be the more pressing one in the current discussion. However, in the Diskurs grüne Gentechnik the question of environmental liability was asked with respect to damage to biodiversity. As can be imagined, the opinions where greatly polarized. As opposed to economic liability, however, it seems that the question of damage definition and the extent of damage compensation in case of ecological damage will be even harder to answer. 76 i.e. as in the case of the Stuttgart verdict (Abel-Lorenz 2000). 77 The question of liability has increasingly become a challenge for the German insurance industry, for instance, see Munich Re Group: www.munichre.com

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BMVEL thesis paper on coexistence of conventional and organic agriculture from 09.05.2003

After month of discussion on the subject, in May 2003 the Ministry had finally put forward the following proposed principles for GMO handling: • Polluter-pays principle

• Coexistence requires specific measures to be put in place throughout the food chain

• Coexistence requires thresholds (seed: as low as possible)

• Even though specific measures need to be put in place throughout the food chain, most important will be to safeguard seed and agricultural production

• To guarantee effective property protection of GMO-free cultures and to secure a ‘peaceful coexistence’ of different production systems, a minimum of public regulation is needed. i.e. conditions at deliberate release (coexistence as clear object of protection next to health and environment), definition of good production practices in the handling of GMOs, general requirements with respect to qualification of farmers and information dispersal (maybe next to voluntary agreements)

• Liability for GMO producer and cultivator

• Obligation to register GMO application in a public register (cultivation objective and production site)

• Establishment of GM-free zones

• Civil laws in case of property infringement of non-GMO products

In this proposal (BMVEL 2003a) it is stated that national measures are necessary, but for purposes of market harmonization a European regulatory framework is needed. The Künast Ministry criticizes Fischler’s advance in coexistence since the Ministry formulates a clear demand for European and national regulation beyond voluntary agreements. However, the German government does not make coexistence regulation a condition for the lifting of the moratorium. Instead, according to government sources, they favor a two-track approach, that is, to first put in place national regulation, which will then be followed up by European regulation. With this, however, Künast finds herself in opposition to the demands of the farmers who require full regulation before a lifting of the moratorium.

Tracebility and labeling, the question of seed thresholds

The position of the Künast Ministry concerning thresholds for adventitious presence of GM was ‘below 1 per cent’. But Künast welcomed the 0.9 per cent in the respective Council meeting, which brought her into conflict with biotech critics. The Ministry, however, supported a 0.1 per cent level of detectability in the case of non-EU approved GM material.

The commission’s seed threshold proposal was rejected by many critical groups, including the Agency for Nature Conservation (BfN). BfN suggests a threshold of 0.1 percent – the threshold for detectability. Künast demanded that the seed threshold should be politically decided upon in the European council (the eventual change in legal basis was thus partly attributed to her political pressure). Her stance on the issue is ‘thresholds should be as low as possible’, meaning lower than the Commission proposal, as an explicit precautionary measure. Yet there is no specification of numbers in this case, possibly because in the Diskurs grüne Gentechnik Künast has supported the demand from small and medium German seed suppliers to push for reliable and feasible thresholds. However, the ‘as low as possible’ line is not a government stance. Künast’s colleague Clement, the Minister of Economics, supports the Commission proposal of a 0.3-0.7 percent threshold of contamination in seed.

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3.2 Expert bodies and judgement From 2000 onwards the BSE crisis has undermined the risks and expertise arrangements in the German risk regulation system. In response, the red-green government has undertaken measures to change institutional structures and political responsibilities through the establishment of a new ministry and the creation of new agencies. Furthermore, with the Agrarwende new additional expertise and networks have entered the political arena and are given expert status in policy deliberations. This trend has only been strengthened by the recent changes from risk to coexistence regulation. These developments altogether mean greater prospect for divergent views informing expert advice and regulatory practices. It could also mean a greater scope for mediation between socio-political and techno-scientific interests. However, these developments also increase the likelihood of expert conflicts and contradictory value judgements entering the regulatory arena. The development of the risk regulation system with an increased emphasis on the separation between scientific expertise and decision-making is thus countered by a tendency to reopen these contingent boundaries of science and politics, or experts and stakeholders. For instance, in the past the German Competent Authority (CA) has not seen itself as a mediator between conflicting interests but as a politically independent institution which takes decisions on the basis of the law and sound scientific expertise (Dreyer/Gill 1999). The new developments are challenging this scientific-technocratic model of decision-making and may force actors to clarify disagreement over (value) judgements.

3.2.1 The Central Advisory Committee for Biological Safety (ZKBS) The Central Advisory Committee for Biological Safety (ZKBS) is the scientific body in Germany responsible for advising government on the risks of genetic engineering. It was founded in 1978 and has implemented the initial self-regulatory guidelines for genetic engineering experiments. Since 1990 the ZKBS has reviewed and set standards for contained use as well as deliberate release of GMOs within the framework of the Genetic Engineering Act. The ZKBS consists of a panel of 15 members and 15 deputy members, who are recommended by the Ministry entrusted with the responsibility for GM crops regulation (BMGS until October 2002). According to the Genetic Engineering Act the commission is comprised of 10 scientists, ranging from microbiology, tissue biology, virology, genetics, hygiene, ecology and safety techniques and five nominated experts: one union representative, one person for workplace safety, one representative from industry and a research supporting institution and finally one person concerned with environmental questions.

The ZKBS is situated at the Centre for genetic engineering at the Robert-Koch Institute. As the central scientific body it takes on a powerful position within the administrative and Länder units involved in approval decisions. Its recommendations need to be taken into account and deviations from their advice require an explicit justification. However, even though the ZKBS’s recommendations are not binding by law, it is understood that the competent authority follows its advice (see Bt 176 case). The ZKBS has thus substantial influence over the relevant risk-related decisions taken within the regulatory system.

The ZKBS is perceived as a highly reputable scientific body, which is based on a broad spectrum of expertise. Nevertheless, its recommendation practices have continuously faced a great deal of criticism. The main criticism is based on the approach taken towards risks, having, inter alia, to do with the specific composition of the body, the closed and secretive manner of its operation and the honorary basis of its work. With respect to deliberate release, biotech critics have frequently made the criticism that the majority of committee members had an interest in biotechnology and were hence biased towards its application. It is furthermore argued that ecological expertise was highly underrepresented and that broader societal interests were not adequately taken into account. With respect to its risk approach it is argued that the committee, dominated by molecular biologists, favoured an approach towards risks in biotechnology, which was strongly influenced by the ideas of scientific knowledge and

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certainty. As opposed to this ‘additive model’78 of risk assessment, ecological expertise was much more skeptical in terms of the knowledge of certain effects and hence the safety claims of the GM plants in question (interview BUND, 12/02).

However, with the procedural rules designed to favour dominant persons and majority rule, more critical voices have little impact on the final decisions.79 In addition, the secretive and closed manner of the committee’s procedures – the sessions are closed and no minutes are publicly available – prevents bringing these questions into the public domain or getting external support for minority positions. Finally, the unpaid basis of the committees work creates a bias towards scientists in established institutions by making membership difficult for NGOs with comparatively few resources. These combined circumstances led in 1993 to the resignation of the two members of environmental NGOs as they perceived their contribution as having a pure cosmetic function.80

These above mentioned points brought forth by biotech opponents question the adequacy, neutrality and for that matter legitimacy of the committee. More moderate critical voices argue that a ‘representation of the scientific controversies in the ZKBS’ could possibly solve the conflictive approval situation (Lemke/Winter 1998: 10). Although being well aware of this long standing criticism, the established forces have continuously opposed any change on the grounds of this being unnecessary ‘the expertise has been constantly adapted’ and unsubstantiated ‘the critique of one-sidedness is based on a lack of knowledge’ (interview RKI, 06/03). For a long time, the criticism did not result in any changes. Unsurprisingly, since there was little conflict apparent among the bureaucrats, scientific and political forces in the regulatory system until the year 2000. Then open conflict broke out between the new, more GMO critical red-green government and its scientific advisory body over the invocation of Art. 16 concerning Bt maize 176. With respect to the composition of the advisory body, an additional position was granted to a representative of consumer organizations in June 2002, in the wake of the transposition of the new contained use Directive. This change, however, marked only the beginning of the new consumer- and Agrarwende-oriented GM politics under the Künast competency. More recently another more fundamental change in expertise is foreseen in the new draft bill of the Genetic Engineering Act. It suggests splitting the committee into one section responsible for deliberate release and one for medical applications and to include additional expertise in the area of farming and nature conservation.

3.2.2 Other relevant expert bodies German Council of Environmental Advisors (SRU)

The SRU is an independent environmental advisory body which is located at the Ministry of Environment (BMU) and whose task it is to advise government on current German environmental questions and possible policy solutions.81 The body is staffed

78 In the German debate the additive concept means that the properties and risks of biotechnology could be fully assessed by summing up the properties of the changed or introduced elements. In contrast the synergistic model asserts that due to complexity of eco-systems there can be no certainty in judgments about biotechnological effects, see (Weber 2000). 79 Minority votes could be stated but were usually denied any ‘substantiation’ (interview BUND, 12/02). 80 Since none of the criticisms have been addressed, these positions have since not been occupied by the environmental NGOs. Instead they were filled by independent environmental experts. 81 More recently, under the red-green government a range of new governing advising councils have been founded. Amongst them is the German National Ethics Council, which was established in June 2001. It is a government and parliament advisory body for the ethical issues raised in the field of bioscience. So far it has only dealt with medical questions, such as stem cell research and genetic diagnostics. The German Risk Council was founded by the Ministry for Environment and the Ministry of Health in October 2000 as an ad-hoc committee.

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with interdisciplinary expertise. The SRU publishes annual reports in which it picks up on certain subjects, which are then researched and reviewed by experts in the field. As could be seen above, the SRU has constantly taken issue with the subject of agro-biotechnology and has given expert advice on the handling of uncertainty, monitoring or nature conservation issues. Its advice is frequently cited and it has a high reputation within the policy community.

Öko-Institut

The Öko-Institut is an independent expert institution founded in the 1970s. The Institute started off as a product of a resistance movement against nuclear energy, which formulated the need for independent counter-expertise on questions of nuclear safety. Meanwhile the institution has developed expertise in various environmental areas and has gained a reputation as a leading German environmental research institution. Since its inception, the institute has dealt with the questions of biotechnology. However, its expertise on the issue is regarded by the mainstream scientific community (i. e. ZKBS), as political (‘ideological’) and hence biased. However, against the backdrop of sustainability in agriculture and a broadening of expertise the Öko-Institut has gained acceptance under the new political leadership. It has cooperated with UBA and other environmental and organic research institutions on the question of coexistence and environmental safety issues.

3.3 Stakeholder roles In Germany stakeholders have continuously played an important role in the emergence and development of the GM controversy. Apart from the fact that stakeholders have introduced or pushed certain framings of the debate, in the corporatist model of the German state stakeholders, respectively lobbyists, have always been incorporated into public policy making activities of the government. However, some stakeholders are more equal than others and in the past it was more protagonists in science and industry that have been able to successfully influence the political decision-making process in science and technology (Dolata 2003). Critical groups, such as environmental or consumer organizations which have tried to broaden the terms of the debate have been heard in public deliberation exercises (i.e. the WZB TA procedure), yet these demands and critical comments were hardly ever taken up in the regulatory arena. Instead NGOs have reverted to actions in the market place, in this way trying to interfere in the marketing process of GM crops. Against the background of the BSE crisis and the Agrarwende GMO critical stakeholder input has gained momentum. The Ministry of consumer protection launched a broad stakeholder debate and new networks and alliances have been formed. The Agrarwende discourse in relation to the question of coexistence changed the terms of reference in the debate and provided critical groups with a new understanding of the problem and a common basis for coalition building. The new politics of the BMVEL has slighly opened up regulatory procedures to these new groups.

3.3.1 Stakeholder dialogue: The Diskurs grüne Gentechnik The Diskurs grüne Gentechnik can be looked at as a specific product of the post-BSE phase in Germany and the international/European biotech developments and subsequent changing regulatory demands. A change of direction in agricultural policies and a change in the political approach towards GM crop regulation characterize the post-BSE phase in Germany. Instead of the proposed three-year cultivation programme, Minister Künast initiated the Diskurs grüne Gentechnik in December 2001. The aim of the Diskurs was to bring together national and international expertise in order to assess the developments in research and application in the field of agro-biotechnology and to lay the groundwork for pressing

Its task is to develop suggestions on how to improve the organization and coordination of risk regulation in Germany. The Risk council has published its recommendations recently (Risikokommission 2003).

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decisions in the transposition of new EU legislature into national law. As opposed to the previous Schröder-initiative, the new Green minister decided to widen the participation to include basically all members of the food chain and various NGOs. Against the background of new agricultural policies it was the political intention of the BMVEL to strengthen the areas of consumer protection and organic agriculture in biotech regulation, which, according to the Moderation report, resulted in a slight over-representation of these groups (Hammerbacher 2003). To take account of the great concern among the public the debate was widely documented on the Internet.82

The Diskurs was the first federal forum on agrobiotechnology of its kind in Germany, which brought together over 53 experts and the whole range of stakeholders (over 30 groups) involved in GM crop politics. As can be expected, in the extremely polarized political landscape of the German biotech scene the various stakeholders perceived the initiative of the Diskurs quite differently. A representative range of participants held the opinion that the government was using the Diskurs to put off decisions before federal elections in September 2002. However, a more general divide between the participants was reflected in the hopes and expectations concerning the Diskurs’ rationale and results.

The new agricultural Minister Künast, a green party member and definite advocate of green issues, sent out ambivalent signals regarding her stance on the issues: • On the one hand Künast openly considered GMOs as a ‘fait accompli’ meaning

something that had to be dealt with and possibly contained but which could no longer be ignored. The brokering around the issues of separating distances, thresholds, labeling and post-release monitoring suggested that she had basically accepted the status quo of post-Moratorium releases. Industry, although disappointed about the stop of the cultivation programme and suspicious of the new political leadership, took the initiative as a sign of opening and acceptance of realities and hoped for a ‘fact-based consensus’ towards biotechnology development. The environmental NGOs saw exactly therein a possible risk of the debate in that it contributed to an acceptance of GMOs.

• On the other hand Künast initiated a debate dealing with issues that were so fundamental, i.e. the safety question, the question of benefit and agricultural options that it conveyed the impression that ‘opting out’ might still be an issue. This way the green Minister nurtured the hopes in the critique’s camp for a definite ban or an at least precaution-and consumer based restrictive practice of GMOs while this scenario was putting off industry.

Hence the discourse seemed fundamentally divided between the ones that discussed the question of whether GM crops technology should be allowed to proceed while for others this was no longer a question. They were more interested in the question of how and under what circumstances. Yet the fact that the Diskurs was organized by the new BMVEL, rather than an independent institution, and was thus closely connected to the pivotal decision-makers made the event strategically important and interesting to participate for both sides of the political specter (ibid.).

The selection of expertise – in between scientific knowledge and stakeholder interests

Even though the BMVEL set the principle framework for the Diskurs, it was the groups themselves that decided on the relevant questions concerning the procedure and the selection of expertise (the fine tuning and organizational work was given to an external Moderation Team). This was done in a Steering Committee, which was staffed by proportional representation of the participating groups. Amongst numerous conflictive decisions, it was the topic of expert selection that proved to be one of the most controversial ones (ibid.). The opponents demanded that all expert positions

82 www.transgen.de/diskurs

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should be staffed by pro-contra proportional representation. The biotech proponents, however, were against this proposition on the grounds that they practically no longer accepted a fundamental questioning of the technology’s safety for they held these aspects to be sufficiently researched and finally proven. However, in order to prevent a stalemate there was an eventual agreement on the pro-contra proportional approach towards selecting expertise. This, unsurprisingly, led to a polarization of the Diskurs, also because experts not neatly falling into one of the two extreme positions would not be selected. According to the Moderation Team report, this ‘expertise in proportional representation’ did have an impact on the debate’s content for it allowed GM opposing groups to launch their line of reasoning in multiple ways: „Questions on legal arrangements between GM-farming and non-GM farming, respectively organic farming would not have been as intensely discussed without proportional expert representation.’ (ibid.,p.18)

As a result of the thematic bargaining the following five Diskurs rounds were set up. The rounds started in May 2002 and final results were presented in September 2002. • First Round: The Preservation of Biodiversity. Agro-biotechnology and its effects

on biodiversity.

• Second Round: Innovation Potentials and future perspectives of agro-biotechnology. Varying opinions.

• Third Round: Benefits and risks for consumers and producers. Health, safety and food security –with or without agro-biotechnology?

• Fourth Round: Preconditions, chances and consequences in opting out of agro-biotechnology. Is opting-out a possibility?

• Fifth Round: Information, public participation and consumer choice. Creating transparency and public participation.

Against the background of mistrust and diverging interests between the opposing stakeholders the process proved to be difficult and highly conflict-laden.83 As a consequence, the debate did not reach the goal of bridging the principle divide between these groups: With respect to the application and the use potential of the technology the respective groups remained strongly divided. Principle non-agreement was also stated with respect to the appropriate use of scientific methods for the assessment of risks. The final report on the Diskurs done by the Moderation Team interpreted this cleavage as follows: „Different judgments on knowledge and uncertainty as well as the meaning of the precautionary principle were the reason for the fundamentally different views and argumentative strategies of the participants’ (Hammerbacher 2003: 30). However, there was an agreement reached on the goal of safeguarding biodiversity in risk assessment and management and on the necessity of developing regulation to safeguard consumer and producer choice (BMVEL 2002a).

Even though there was no final agreement on how to eventually develop regulation the Diskurs was generally welcomed as an instrument that allowed the clear spelling out of the differences and positionings set the scene for follow-up discussions and decisions. In fact, the Diskurs was widely used to foster old and to form new alliances between the groups. The proponent’s side formed a coalition between members of the supply chain and some Unions and put forth a common statement regarding innovation potentials and technological diversity (Warenkette 2003). The environmental NGOs cooperated strongly with the organic community in focusing on the question of plural and practical approaches towards agriculture and the

83 In order to prevent a domination of discourses during the respective debates, the environmental NGOs managed to push through proportional presentation in the specific contributions made during the discourse rounds. Both the opponent’s side as well as the proponents side threatened to leave the debate at one stage when they felt that the procedure was unfair and one-sided (Hammerbacher 2003).

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safeguarding of alternatives. Various critical actors from the Diskurs finally formed a Round Table thus offering a critical platform for the elaboration of political strategies and for contact with the authorities, especially the BMVEL.

3.3.2 Stakeholder groups and alliances Consumer organizations

In the wake of BSE and various other food safety scandals, the spectrum of stakeholder and interest groups involved in GMO policies has been slightly altered. The prominent rise of consumer issues and the reframing of the GMO debate under the label of consumer choice and Agrarwende opened up new entry points for opposition in the political and administrative realm. Along with a restructuring of the Ministry of Agriculture, numerous previously scattered consumer lobby groups within Germany were bundled in one organization: the Federal Consumer Association (vzvb). With a prominent president84 and propped up with considerable funding and personnel, this organization quickly became a critical political voice in Germany and more broadly involved in food and agricultural policies. In the year 2001 a new consumer watchdog organization ‘Foodwatch’, was founded by the former head of Greenpeace International, Thilo Bode. Even though this organization has so far not been very visible in GM crops and food issues, its rise clearly indicates a growing awareness of food safety issues and related consumer advocacy work.

Farmers’ organizations

Due to the ‘reality shock’ of a falling Moratorium, a continued consumer rejection of GMOs and yet a possible soon-to-be-started large-scale cultivation of GM crops in Germany, farmers’ organizations have become increasingly aware of the possible economic risks and consequences of GM crop cultivation. As the issue of agro-biotechnology has ‘finally made it to the fields’, farmers have thus become increasingly involved in the debate. Spearheading the demand for coexistence are the organic farmer’s associations, holding that their fate as producers hinges upon a strict and working separation of the two production systems. ‘Safeguarding the alternatives in agriculture and food production’ is hence made more central in their campaigns than speaking out against biotechnology (interview FiBL, 10/03). Due to the new agrarian policies the organic and family (small-scale) farming movements have received powerful support from the highest political level, the BMVEL, especially from Minister Künast.85 The Minister, in turn, draws upon the expertise of the community and involves the groups in stakeholder meetings, which in times has brought her into the disrepute of a ‘lobby-dependent’ agricultural Minister (Schwägerl 2003).

The biggest, mainly conventional, farmer’s organization DBV, a COPA86 member, has over time become one of the principle players in the demand for stricter regulation of GMOs. Even though the DBV represents many organic farmers, it stresses that, „it is the farmer and not the specific production orientation that is put in the foreground’ (interview DBV, 11/03).87 However, the increasing engagement of the DBV has shown that the issue of coexistence and liability is not only geared towards a minority of four percent of organic farmers, but that the legal and market insecurities of GM crop cultivation, be it as cultivator or neighbour, pose a potential economic risk for the

84 Edda Müller, both former Länder Minister of Environment and former vice president of the UN Environmental Agency. 85 The family (small scale) farming organization (AbL) has been often used as an in official think tank of Minister Kuneast (TAZ 2002). 86 Cttee of Agricultural Organizations of the EU, the main farming lobby organization on the European level 87 The Agrarwende policies and the subsequent rise in organic farming (amounting to 50 per cent within the last three years) has not gone unnoticed in the farming sector. The DBV, as mostly representing conventional farmers, seems now to have discovered its organic clientele. In 2003 the DBV held its first ‘Forum on Organic Farming’ in the history of the association.

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whole farming business. The DBV does not in principle argue against biotechnology and has in the past supported biotechnology proponents, i.e. in the Warenkette-Initiative. However, the DBV has recently become a difficult partner for the initiatives of the biotech industry by insisting on such strict regulation. For instance, in addition to demanding coexistence regulation it has supported the initiative on voluntary GMO-free zones. It has, in a rather surprising alliance with the Nature Conservation Agency (BfN), argued for an initiative on large-scale field trials. More importantly though, in October 2003 the DBV cancelled its support of large-scale industry/Länder Government-initiated field trials in Sachsen-Anhalt because of the lack of coexistence and liability rules (DBV 2003b). Thus, even though the DBV continues to play a somewhat ambivalent role in the debate on agro-biotechnology88 it has become an indirect supporter of a stricter regulatory line.89 This could be an important development in the decisions on new legislation given that the DBV’s position cannot be ignored by its principle political ally, the conservative party CDU/CSU – a strong supporter of biotechnology.

Environmental and other anti-biotech groups

There is no overall common approach within the environmental/anti-biotechnology NGO community as on how to handle the questions of GMOs in the future. In general, the NGOs still focus on a definite ban of GMOs and have thus for a long time been seemingly unwilling to start negotiations on thresholds, coexistence regulation or monitoring. However, facing the realities of a falling Moratorium, the NGOs seem to run multiple strategies of damage prevention: One strategy is to lobby for restrictive biotechnology regulation (‘regulating what we don’t want’ (GEN 2003)) thus limiting and marginalizing biotechnological applications by raising the stakes for companies and cultivators. This includes public mobilization efforts and information provision of various kinds. As a new line of argument the NGOs stress and support the opportunities of a developing quality food market, within which a GM-free Europe could stand out and serve the niche markets in the world (Boschert/Gill 2002).

The NGOs have thus taken up and further pushed the Agrarwende and quality food production rhetoric to keep transgenic material away from the fields and the markets, thereby supporting a strategy that is also used by the organic producers and ultimately the BMVEL. For instance, Greenpeace Germany has recently merged the issue of pesticide contamination with the issue of agro-biotechnology under the motto: ‘Stop poison and biotechnology in our food.’ 90 Friends of the Earth Germany (BUND) has conducted a campaign on healthy food under the motto:’ For healthy food without biotechnology.’91 Even the nature conservation movement (NABU) has come on board by lobbying for sustainable farming practices and against biotechnology under the motto: ‘Tasty country-side!’ and ‘Nature conservation with the shopping bag’ (NABU 1998). However, even though environmental/anti-biotech groups are basically supporting the new consumer protection and choice line of the Ministry, there is some unease with the shift in emphasis: There is concern that the stress on consumer protection/choice and organic agriculture weakens the environmental aspects of the introduction of GMOs.

88 Critics argue that the DBV does not have a clear stance on the issue and they wonder which farming interests the DBV stands for: the GMO cultivators or the non-cultivators. 89 The relationship between the DBV and the Künast administration is somewhat difficult. Künast has to a certain extent disempowered and greatly alienated the conventional farmer’s association with her Agrarwende policies. However, also with respect to agro-biotechnology it needs to be said that the DBV is more heterogeneous in opinion than the head of the organization is willing to concede (Unabhängige Bauernstimme 2002). 90 This new framing has had some effect on the way the subject is internally handled: Greenpeace Germany restructured its Biotechnology section as to more intensely focus on questions of food production and agriculture. At the website of Friends of the Earth Germany (BUND) the issue of agro-biotechnology is now subsumed under the topic of Agrarwende. 91 www.bund.net

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Food processors and retail sector

In the past the retail sector has played a pivotal role as gatekeeper for GM food products. On the basis of anticipated consumer refusal the retail sector has refrained from stocking GM labeled products on its shelves, at least in its own-label products. The pressure of the retail sector has in turn induced the food industry, itself vulnerable to the ‘stigmatization’ of their brands, to avoid the use of transgenic material. With the new labeling requirements and the global sourcing situation of raw material for food products, so the sector argues, this situation in the market might be up for a change. These new processed-based labeling requirements, in connection with the raw material situation in principle sourcing markets (especially soya) make it more difficult and costly to substitute for transgenic products or to modify recipes. One can also more frequently hear the argument that a negative public attitude towards GM products revealed by surveys may not actually translate into consumer boycotts of the specifically labeled product.92 It could thus become increasingly likely that instead of substitution, products will be labeled GM and put on the shelves eventually.93

However, the process of strategy discussions and decision-making between and within the members of the food chain is ongoing so that no ultimate conclusion can be reached at this point (interview BVL, 10/03; BLL, 10/03). And, not to forget, there is still the Greenpeace shopping-net initiative, which publicly and mass-media-effectively exposes respective company policies (see below). With respect to marketing, the German Federation of Food Law and Food Science (BLL) recommends that its members refrain from giving written assurances about policies which cannot in the long run be upheld in the real market situation, i.e. with respect to the use of GM-free feed. To ‘inform consumers truthfully’ about GM material being used in their food and to give them a choice is thus considered as more helpful in building consumer trust in food products than providing potentially misleading information (interview BLL, 10/03).94

Seed companies

In 1998 industry began to conceptualize cultivation programmes to gain experience in the field and to test the performance of the new crops. For instance Bayer (at this point Aventis) in cooperation with other companies had started their own privately run cultivation programmes to monitor the performance and the cultivation practice of GM maize (Degenhardt et al. 2003). These programmes had been conducted with the use of special licensed seed contingents from the Federal seed agency (up to this point no transgenic seed had been given approval for cultivation in Germany) on several hundred hectares of farmland. Permission was given for the products to be used as animal feed. These programmes scarcely touch upon safety aspects but more importantly serve the purpose of validating the company’s performance enhancement claims. For example, in a publication issued by Monsanto, Pioneer and Syngenta on a four-year cultivation programme in Germany, the issue is solely the 92 A frequently cited example is the market situation of organic products since these, although very highly valued by a majority of consumers, are rarely bought. Especially the German market has proven to be extremely cost sensitive, which leads to the suspicion that for the majority of customers it will be the price, and not the label that eventually determines purchasing decisions. 93 This is, at least, what could be concluded from the minutes of a meeting between the Metro Corporation (retailer) and some biotech companies. These internal minutes are available on the Greenpeace Shopping-Net webside at www.greenpeace.de 94 In this respect the case of Edeka Nord is illustrative of the conflict: In 2003 Edeka Nord (retail chain) has decided to start sourcing meat from animals that were fed only with GM-free fodder. Even though the GM policies are up to the companies themselves the strategy was criticized for being ‘consumer deceptive’. Edeka Nord had argued on the grounds of offering only ‘GM-free’ meat. This wording, however, does not comply with the regulation on labeling (Lebensmittelzutatenverodnung) which allows only the wording of ‘non-GM’ (meaning produced by non-intentional use of genetic engineering). The argument was thus that Edeka Nord was unjustly playing on consumer worries using unlawful advertising slogans.

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efficiency of Bt maize as compared to other pesticide methods and the subsequent profitability calculations for the farmers (ibid.). There is no, at least not in this publication, mentioning of environmental risk issues.

These programmes are hence used to gradually introduce the crops into the fields and the food chain and to convince farmers about the overall beneficial qualities of the new GM varieties. But beyond the farmer’s community the companies expect – with the help of these programmes – to cultivate trust within society by embedding their cultivation trials in networks comprised of breeders, parts of the administration and scientific institutions (Aventis 2000). Seen from this perspective the programme ‘Biosafety and monitoring’, which supports network building between public and private institutions for the sake of biosafety/monitoring efforts, is thus serving a dual purpose of public interest in safety and private interest in technology introduction (and also shows the fine borderline between safety research and application research). These programmes, however, do not go unnoticed or work friction free. The 2003 special seed licensing of the federal seed agency, concerning 50 tons of GM maize, came under attack from various institutions. Greenpeace launched an initiative to ask and inform various regional constituencies about the cultivation of the maize. A parliamentary session in the Länder parliament of Niedersachen, especially dedicated to the issue, mainly pointed to the problem of lack of information on cultivation sites, the possibility of outcrossing, and the use as feed maize.95

Science associations

The most important science association in Germany, the Deutsche Forschungsgemeinschaft (DFG), is one of the significant supporters of biotechnological applications. In 2001 the DFG published a new official statement regarding agro-biotechnology in which it recommends the ‘promotion of the responsible development of genetic engineering in plant breeding and food-related microbiology to the benefit of humans and the environment’ (DFG 2001: 46). In response to the Agrarwende the DFG highlights that ‘gene technology is not incompatible with new agriculture policies, which focuses increasingly on quality rather than on quantity’ (ibid. p. 45). The science organization has always considered itself as the rational, objective voice in the German debate, and with this statement it stresses again that, ‘the DFG would like to make an objective contribution to this discussion, which has often been extremely emotional in recent times’ (ibid. p. 44). In this respect the Diskurs grüne Gentechnik was criticised by the science organizations DFG and the umbrella organization for the science associations in agricultural, forest, food and environmental research (DAF) for not being lead by science-based facts, rather having been undermined by particular organized interests (DFG/DAF 2002).96 In fact, with the coexistence debate it has been argued by these and similar-minded scientists that the discussion on GMOs has become more ideological in nature, and that with the new foreseen regulation on coexistence the government was implementing a ‘blocking policy’ (agrar.de aktuell 2003a). This line of reasoning is not

95 Only recently these programmes have become once again the focal point of controversy. Within two years twelve cows died on a farm in the state of Hessen. The animals were fed genetically modified maize between 1997 and 2001, which the farmer tested in the framework of the mentioned cultivation programmes. The farmer speculated that the death cases could have to do with the Bt176 maize and informed the company and the authorities. Both RKI and Syngenta started investigations and came to the conclusion that the death was caused by poor fodder quality and infectious disease, hence stating that a causal connection between the cow’s death and the Bt maize was highly unlikely. NGOs have frequently warned of the safety problems of GM feed and criticized RKI’s attitude towards the case, i.e. the final report on the investigations is not publicly available. Greenpeace is calling for a full investigation into the deaths of the cows and demands an immediate ban of GM maize. For more information: www.transgen.de 96 NGOs have criticized that that the science organizations do not consider themselves as stakeholders but that they demand as speaking for the truth (Moldenhauer 2003). The NGO representative states in a comment on the Diskurs that:’ it was particularly alienating that Prof. Buhk from the Robert-Koch Institut, the competent authority, was speaking as a representative from the DAF demanding an extension of field research’ (p. 252).

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shared by the Vereinigung Deutscher Wissenschaftler (VDW), which, together with the Öko-Institut, supports a strict coexistence policy. They demand strict regulation, including liability, or the level of detectability in seed thresholds. These scientists hold that their demands are justified by science and societal considerations (agrar.de aktuell 2003b).

3.3.3 Stakeholder activities GM-free area initiatives

In November 2003, the State of Schleswig-Holstein has, together with several other European regions, demanded the right to declare itself a GM-free area. In the State of Hessen a local initiative of 13 groups puts similar demands to the regional government (Gentechnik-Nachrichten 2003). In the State of Mecklenburg-Vorpommern 15 farmers, including four organic farmers, cooperated in order to agree upon the establishment of the first voluntary GM-free cultivation zone in Germany. The area comprises almost 10.000 ha of farmland. This initiative is supported by the National farmer’s organization (DBV). In 2003 Friends of the Earth Germany (BUND) has restarted a campaign addressing the time after the lifting of the moratorium. ‘Keep GMO away from communal/church land’ is an initiative aimed at keeping church-owned land GMO free. Another initiative ‘Fair neighbourhood’ also supported by the BUND provides legal information and support to local communities and initiatives for the establishment of GM free areas.97 In Germany increasingly broad-spectrum based local groups (i.e. including Attac, farmer’s organizations, environmental, nature conservation, consumer, religious groups etc.) are forming up to initiate and support such activities.98

Industry/Länder Government cultivation programme in Sachsen-Anhalt

The Land of Sachsen-Anhalt in Eastern Germany is an economically weak state but has a well-developed infrastructure in the field of plant breeding and plant-biotechnology. The government of Sachsen-Anhalt sees a future chance in the development of biotechnology and has thus decided to give political and financial support to interested companies, including Bayer, Syngenta, Monsanto and BASF for the cultivation of genetically modified crops, and for a gathering of experience in respect to coexistence. In November 2003, when an agreement on such a joint cultivation programme was due to be signed, from the originally 16 different programme supporters only six companies have signed the agreement. The German Farmer’s Association and other farmer’s organizations stepped back from support because of still missing coexistence rules (Löhr 2003).

Parliamentary initiatives

In May 2003 the government of Sachsen-Anhalt in Eastern Germany started an initiative in the upper law-making chamber (Bundesrat) to push the red-green government for the transposition of 2001/18. The State Sachsen-Anhalt has openly declared its interest in the promotion of the technology and thus pushes for transposition of the new Directive and the lifting of the moratorium. The government of Schleswig Holstein has likewise brought in a draft initiative, however, on the basis of quite different motivations. Its draft initiative focuses on coexistence regulation. These initiatives have to be understood as political support of the respective sides, and against the current stalemate between the coalition partners in the German Government.

In October 2003 the conservative party CDU/CSU, a principle supporter in biotech policies, launched a debate in parliament (Bundestag) on the issue of agro-biotechnology. Under the title: „Taking responsibility for food security – using the opportunities in agro-biotechnology’ the CDU/CSU was stressing the beneficial

97 www.faire-nachbarschaft.de 98 BfN is also supporting the establishment of GM free areas and is planning a workshop on the issue.

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contributions of the technology for developing countries. This line of argument was, in turn, used to hit upon the coalition government’s – but most of all Green Party’s- perceived „obstructing and irresponsible attitude’ towards the technology. The debate, although being officially geared towards the global South was thus mainly about the current draft of the Genetic Engineering Act. As a result, the organic farmer’s (BÖLW) and two of the principle German Christian aid agencies „Brot für die Welt’ and „Misereor’ have issued a press release challenging the conservative party’s account and declaring that: „hunger should not be used as a pretext to promote a risky technology in Europe’ (BÖLW et al. 2003)

GM free food/feed supply

Apart from the organic producers, there is an initiative starting in the conventional feed industry to keep their supply GM free. For instance, the Raiffeisenzentrale Karlsruhe (wholesaler for agricultural supplies) has started an initiative to demand GM-free products from their maize suppliers. This initiative is based on purely economic considerations, as it was calculated that this could command a 40 percent premium over GM feed. The ZK Karlsruhe is cooperating with its French neighbour the Coopérative Agricole de Céréales (CAC) in Colmar, France (Grefe 2003). Civil society groups operating in the region have supported the initiative. Farmers in the state of Niedersachen have put similar demands to the Raiffeisen Hauptgenossenschaft Nord (Gentechnik Nachrichten 2003).

‘Save our seed’ campaign and ‘round table’ initiatives

GMO critical groups have under the lead of the Foundation on Future Farming (ZsL) participated strongly in the ‘Save our Seed’ campaign. The campaign leader Benni Haerlin, former activist of Greenpeace International and ex European Parliament member for the Green Party, has managed to gather 150 groups to support the initiative for keeping seed GMO free, as a precondition for coexistence. Haerlin has become somewhat of a multiplicator for NGO activities in the anti-biotech scene. The Round Table initiative, an initiative supported by 16 different groups consisting of environmental NGOs, the organic farming community and some conventional farming organizations (except DBV), including one Union, and the consumer organization (vzbv) has written petitions to the Government in support of strict regulation, and upholds constant talks to the BMVEL.

The Greenpeace-Shopping net

In March 1996 Greenpeace Germany started the campaign ‘Greenpeace-Shopping net’, a Greenpeace consumer service. In the context of this campaign, Greenpeace publishes on the Internet information lists on retailer and producer’s stance on GM sourcing and labeling policies. Greenpeace continuously updates this information and in 2003 commissioned another poll. Of the 216 food processors and retailers that were asked 170 assured that they continued to refrain from using GMO ingredients in their foods. However, Metro, Aldi and Tengelmann (big German retailers and discounters with great extent of own-label products) did not express a clear position. In addition internal minutes, leaked to the shopping-net in October 2003, from a meeting between the retailer Metro and the biotech companies Monsanto and Bayer gives evidence of combined strategies to gradually introduce GM labeled foods on the market. As a result of this, Greenpeace started a campaign against the Metro-corporation.99

3.4 Transposition of EU Directive 2001/18 into national law In July 2003 the EU Commission launched a lawsuit against the German and another ten European Governments for not having transposed the new directive 2001/18 into national law. However, even though the bill has not been transposed to date (December 2003) the German Government has not been passive in this respect. 99 www.greenpeace.de

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Already in 2002 a new draft version was elaborated by the BMGS but eventually fell victim to the new political constellation and subsequent changes in competency. This process of shifting of competency has taken up a great deal of time and political brokering at the highest level. In the meantime the process of drafting had been stopped and taken up under a new political constellation and with new and different political priorities.

Already in Spring 2003 a new draft version worked out under the new competency, the BMVEL, was given green light from Minister Künast and was started to circulate between the different Ministries and administrative federal and Länder bodies involved in GM regulation. Even though the Minister declared that the bill would pass in the year 2003 the process of commenting and first internal tuning already took much longer than expected. One of the biggest hurdles for the draft seems to be in overcoming the internal split between the coalition partners themselves. The Social Democratic Party (SPD) mainly considers agro-biotechnology as a key future branch and is thus generally supportive of its ‘responsible development’. The Green Party, in contrast, has shown a more hesitant and cautious attitude towards the technology and instead stresses alternative developments. Therefore, the social democratic-led Ministry of Economics (BMWi) and the Ministry of Education and Science (BMBF) have issued strong objections against the ministerial draft, which they claim is too restrictive. Since Länder competencies are involved in implementation this means that the bill needs to get consent in the upper house (Bundesrat) as well. Taking into account the reversed political majority conditions in the second law making chamber it is already foreseen that the bill might end up in the conciliation working group (Vermittlungsausschuss), a body that brokers a compromise between the two houses. Because of these political difficulties the bill is not expected to pass before the end of 2004.

3.4.1 The new features in the ministerial draft The draft is not officially available to the public at the time of writing.100 However, concerned parties are well informed and emotions seem to run high, especially on the GMO proponent side. Here one can frequently hear the wording of a ‘biotech prevention law’ and it is speculated that this was the hidden purpose of the bill to begin with. Biotech critics (environmental, consumer groups and organic farmers) in turn generally welcome the draft. This cleavage is due to the following main innovations in the draft:

Coexistence and consumer choice as protection goals

The new draft for the Genetic Engineering Act has been written against the background of the consumer protection and coexistence problematique. This understanding of the GMO problematique as fundamentally lying in the questions of guaranteeing choice for producers and consumers has been forcefully pushed by the new Ministry. Hence the draft version is basically written around the issue of rule provision for coexistence. This priority is highlighted by the fact that coexistence and consumer and producer choice has been added to the explicit protection goals of the law in paragraph one. Subsequent provisions of the text have to be interpreted in this light and there are numerous recourses made to this protection goal. This provision means that considerations other than scientific are added to the bill – a point that is frequently criticized, especially by industry and regulators.

Protection but no promotion

Another often quoted critical passage in the old version of the law – the double aim of promotion and protection – has been changed. The goal of biotech promotion has been taken out in the ministerial draft. This way the draft stresses the exclusive protective character of the bill.

100 The following outline of the ministerial draft version of the Genetic Engineering Act is thus taken from interviews, presentations and press comments.

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The introduction of economic damage

Up to this point economic damage has been acknowledged neither in the law itself nor in judicial decisions. The new draft bill aims to protect non-GMO forms of land cultivation and hence introduces the principle of economic damage. To stress this point the BMVEL calls upon a duty to precautionary practices (Vorsorgepflicht) in order to prevent economic damage (wesentliche Beinträchtigungen) being inflicted on non-GMO crops. These precautionary practices will be made concrete in the form of Good Agricultural Practices (i.e. safety margins, pollen barriers etc.). According to the polluter-pays principle, GMO introgression, if resulting in damage can trigger liability. Because of possible difficulties in finding the source of contamination, the burden of proof will be placed upon the GM-cultivator (Wollersheim 2003). Not surprisingly this point raises much opposition, especially from industry. They claim that this provision deters cultivation of GMOs. The DBV argues along similar lines. It demands also that the cultivating farmer should not be held liable if complying with cultivation rules. Harsh criticism is also coming from the Minister of Economics. He has been quoted as saying that by protecting GM-free production his colleague Künast would ‘kill a future technology’ (quoted in Moldenhauer 2003).

Publicly accessible cultivation register

In order to provide cultivation information to all participating parties, a publicly accessible cultivation register will be introduced where field trials and cultivation sites will be listed. This seems to be another hotly debated issue, as not all of the parties agree on the need for open access to information for everybody.

The precautionary principle

The ministerial draft explicitly states the recourse to the precautionary principle in the aim of the law and in several passages (i.e. duty to precautionary practices), including the part of the risk assessment. This specific reference could stretch the scope of precautionary interpretations in risk assessment. It has been contended that this multiple recourse to the PP opens up arbitrariness in risk regulation and renders practical application impossible (interview RKI, 06/03). Other voices make the criticism that in the draft the PP was applied in areas where it does not belong, i.e. liability regulation (interview BLL, 10/03).

Protection of ‘ecologically sensitive’ areas

Nature conservation concerns have been explicitly added to the draft bill. For the sake of protecting ‘ecologically sensitive’ areas the (local) nature conservation agency should be able to have a say in approval decisions. It remains, however, unclear if this proposed regulation should result in an effective veto power of the constituency. RKI holds that this decision is not adequate as BfN has no expertise in GMOs.

Minimization of outcrossing

The draft requires a minimization of outcrossing. Critics of biotechnology have pointed out that they would like to see added a ‘Good field trial’ practice.

New composition of scientific advisory body (ZKBS)

The draft version suggests changes to the composition of the scientific advising committee ZKBS. This way it has taken on board a long-standing critique on the committee’s composition in light of questions concerning environmental release. The draft plan suggests splitting the committee and changing the composition of the committee members so as to include additional expertise in the area of farming and nature conservation. This change has been welcomed by the environmental NGOs. However they make the criticism that the fundamental problem of renumeration has not been tackled, which in the past was one crucial problem in staffing the committee with ecological expertise. Another strand in critique regards these changes as a gradual ‘descientification’ (Verunwissenschaftlichung) of a hitherto highly reputable committee.

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To what extent the current outline of the ministerial draft is covered by the transformation requirements of 2001/18 and the coexistence guidelines of the Commission is highly disputed. According to a Ministry commentator, the draft was written in full awareness of the critique and difficulties this might trigger on a national or even European level. However, as a justification the Ministry believes that the problem of provisions for coexistence is so central once cultivation is started that they do not see any alternative other than taking these difficulties into account. For the alternative, the frequently used picture of the ‘wars in the villages’ cannot be in anybody’s interest. According to press sources a common position from the Government is to be issued in January 2004 and the final law is expected by the end of the year. It will then be interesting to see which accounts of precaution prevail in the final version.

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Annexes Annex I: Interviews Ministry of Health and Social Affairs (BMGS), Bonn (11.06.02)

Federal Environmental Agency (UBA), Berlin (14.06.02)

Federal Consumer Protection Agency (vzbv), Berlin (17.06.02)

Greenpeace Germany, Hamburg (09.07.02)

Union for Food Industry (NGG) Hamburg (09.07.02)

German Biotechnology Association (DIB), Frankfurt (11.07.02)

Association of organic farming (AGÖL), Lengfeld (11.07.02)

Friends of the Earth, Germany (BUND), München (14.12.02)

Competent Authority of Surveillance of the Genetic Engineering Act for Baden Württemberg (Regierungspräsidium), Tübingen (28.11.02)

Federal Ministry for Consumer Protection, Food and Agriculture (BMVEL), Bonn (02.06.03)

Federal Biological Research Centre For Agriculture and Forestry (BBA), Braunschweig (04.06.03)

Robert-Koch Institute, Berlin (05.06.03)

Green parliamentary party, German Federal Parliament, Berlin (6.6.03)

Foundation on Future Farming (ZsL), Berlin (06.06.03)

Bayer Crop Science, Frankfurt (13.6.03)

TransGen (Phone interview 18.06.03)

Federal Agency for Nature Conservation (BfN), Bonn (20.10.03)

German Representative of Ecoropa, Bonn (20.10.03)

German Federation Food Law and Food Science (BLL), Bonn (21.10.03)

Gen-ethisches Netzwerk (Biotechnology-critical NGO), Berlin (23.10.03)

National Association of German Retail Industry (BVL), Berlin (24.10.03)

Research Institute for Organic Farming (FibL), Frankfurt (27.10.03)

National farmer’s organization (DBV) (Written response to interview question, 26.11.03)

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Annex II: Key policy events 1997-2003

Sept. 1998 Election of Social Democratic/Green Party to government

April 2000 Invocation of Art. 16 regarding Bt maize 176

June 2000 Chancellor Schröder announces initiative on 3-year large scale GM field trial programme

Nov. 2000 First BSE case in Germany

Jan. 2001 Reorganization of the Ministry of Agriculture into the Ministry of Consumer Protection, Agriculture and Food (BMVEL) under a new Green Minister, Renate Künast

Jan. 2001 Schröder cultivation initiative cancelled

June 2001 BMVEL stops commercial-scale seed approval of GM maize Artius (T25)

Dec. 2001 Start of Diskurs grüne Gentechnik (End: September 2002)

Jan. 2002 Installation of two new agencies:

Federal Institute on Risk Evaluation

Federal Agency on Consumer Protection and Food Safety

Feb. 2002 Release of UBA report on ‘Green genetic engineering and organic farming’

Sept. 2002 End of Diskurs grüne Gentechnik

Sept. 2002 Re-election of red/green government

Oct. 2002 Political responsibility for GM crops changes from Ministry of Health (BMGS) to new Ministry of Consumer Protection (BMVEL)

May 2003 BMVEL thesis paper on coexistence and organic agriculture

Sept. 2003 Federal Agency for Nature Conservation (BfN) replaces UBA as consultation body in approval procedure

Oct. 2003 Sachsen-Anhalt announces plans for large scale cultivation programme

Oct. 2003 GM apple field trial stopped by BMVEL

Nov. 2003 First voluntary GM free zone declared in Mecklenburg-Vorpommern