Precautionary Expertise for GM Crops

National Report – France

Battling with Expertise

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

Claire Marris†, Stéphanie Ronda†, Christophe Bonneuil‡ and Pierre-Benoit Joly†

†INRA (National Institute for Agronomic Research) / TSV (Transformations socials et politiques liées au vivant)

65 Boulevard de Brandebourg 94205 Ivry-sur-Seine, France

marris@ivry.inra.fr ‡ CNRS

Centre Koyré d’Histoire des Sciences et des Techniques Muséum National d’Histoire Naturelle, Paris, France

May 2004

Contents LIST OF ABBREVIATIONS 2 ABSTRACT 4 MAIN FINDINGS 5

THE ELABORATION OF THE PP WITHIN THE DYNAMICS OF THE GM CONTROVERSY 5 EVOLUTION IN RISK ANALYSIS PROCEDURES, PRACTICES AND INSTITUTIONS 7 EVOLUTION IN RISK RESEARCH 11 DISCUSSION 13

PART I: PRECAUTION 15 1 ELABORATION OF THE PP THROUGH THE DYNAMICS OF THE GM DEBATE 16

1.1 PERIOD 1: 1997 – THE PP ENTERS THE POLITICAL ARENA 16 1.2 PERIOD 2: 1998-99 – THE PP ON TRIAL 18 1.3 PERIOD 3: 2000-2002 – THE DEBATE WIDENS AND SHIFTS UPSTREAM 28 1.4 PERIOD 4: 2003-2004 – CONFLICTING EXPERTISE AND REGIONAL BANS 34

PART II: THE REGULATION OF GM CROPS 38 2 INSTITUTIONAL ARRANGEMENTS FOR GM RISK REGULATION 39

2.1 SITUATION BEFORE THE IMPLEMENTATION OF DIRECTIVE 90/220 39 2.2 SITUATION UNDER DIRECTIVE 90/220, FROM 1992 TO 1996 39 2.3 SITUATION FROM 1997 TO FEBRUARY 2004 42 2.4 FUTURE SITUATION UNDER EU REGULATION 1929/2003 44 2.5 DEVOLUTION OF POWERS FROM CENTRAL GOVERNMENT 44

3 SCIENTIFIC EXPERT BODIES 45 3.1 THE CGB 45 3.2 AFSSA 52 3.3 INDEPENDENCE AND TRANSPARENCY OF AFSSA AND CGB 54 3.4 BIOVIGILANCE COMMITTEE 56 3.5 GEVES AND CTPS FOR SEED CERTIFICATION 56 3.6 NATIONAL FOOD COUNCIL (CNA) 57

4 GOVERNMENT RISK MANAGEMENT DECISIONS ABOUT GMOS 59 4.1 TREATMENT OF PART C DOSSIERS SUBMITTED IN FRANCE UNDER DIRECTIVE 90/220 59 4.2 TREATMENT OF PART B DOSSIERS 65 4.3 POST-MARKET MONITORING – BIOVIGILANCE 71

5 RA AND RM FOR PART C DOSSIERS SUBMITTED UNDER DIRECTIVE 2001/18 73

5.1 LACK OF TRANSPARENCY AT THE CGB 73 5.2 CGB MEMBERS PERCEIVE LITTLE CHANGE IN RA PRACTICES 73 5.3 CONFLICTING OPINIONS FROM THE CGB AND AFSSA 74 5.4 THE BT11 DOSSIERS 77

6 SEPARATION OF RESPONSIBILITIES FOR RA AND RM 78 6.1 EXPERT BODIES ARE RESPONSIBLE FOR RISK ASSESSMENT 78 6.2 GOVERNMENT IS RESPONSIBLE FOR RISK MANAGEMENT 78 6.3 BUT CGB STILL PERCEIVED AND PORTRAYED AS MAKING DECISIONS 78

7 BIOSAFETY RESEARCH 81 8 STAKEHOLDER ROLES 84

8.1 STAKEHOLDER IMPACT ON THE GM CONTROVERSY 84 8.2 STAKEHOLDER DIALOGUES 84 8.3 NGO INVOLVEMENT IN RISK ASSESSMENT 85

REFERENCES 87 ANNEXES 88

ANNEX I: 88 ANNEX II: 94

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List of abbreviations AFSSA Agence Française de Sécurité Sanitaire des Aliments

French Food Safety Agency

AFSSE Agence Française de Sécurité Sanitaire Environnementale French Agency for Environmental Health

AFSSAPS Agence Française de Sécurité Sanitaire des Produits de Santé French Agency for Medicines (created in 1998, replaced the Agence du Médicament, created in 1993)

AGPM Association Générale des Producteurs de Maïs Federation of maize producers

CA Competent authority

CEA Commisariat à l’Energie Atomique French Atomic Energy Commission – Nuclear Research Institute

CETIOM Centre Technique Interprofessionnel des Oléagineux Métropolitains Interprofessional Technical Centre for Continental French Oilseeds (the Technical Institute for oilseed crops)

CES Commission d’experts spécialisée Specialised committee of experts (at AFSSA)

CFDD Commission Française pour le Développement Durable Commission for Sustainable Development

CFS Confédération Française des Semenciers

CGB Commission d’étude de la dissémination des produits issus du génie biomoléculaire (better known as the Commission du génie biomoléculaire and by its acronym) Expert body responsible for the assessment of risk assessment dossiers for the deliberate release of GMOs into the environment

CNA Conseil National d’Alimentation National Council for Food

CNEVA Centre National d’Etudes Vétérinaires et Alimentaires National Centre for Veterinary and Food Studies (integrated into AFSSA in 1998)

CSCV Confédération Syndicale du Cadre de Vie Consumer NGO

CSHPF Conseil Supérieur d’Hygiène Publique de France Expert body responsible for public health issues (replaced by AFSSA in 1999)

CTPS Comité Technique Permanent de la Selection des Plantes Cultivées Expert body responsible for national seed certification

DGAL Direction Générale de l’Alimentation Food Directorate of the Ministry for Agriculture

DGCCRF Direction Générale de la Concurrence, de la Consommation, et de la Répression des Fraudes

DRD Deliberate Release Directives (90/220 and 2001/18)

EC European Commission

EU European Union

FNE France Nature Environnement An environmental NGO

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FNSEA Fédération National des Syndicats d’Exploitants Agricoles Farmers’ trade union (largest, mainstream)

GEVES Groupe d’Etude et de Contrôle des Variétés et des Semences Expert body responsible for tests prior to the certification of new varieties

GM Genetically modified

GMO Genetically modified organism

GMP Genetically modified plant

GNIS Groupement National Interprofessionnel des Semences et Plants National federation of professionals from every sector of the seed industry

IFREMER Institut Français de Recherche pour l’Exploitation de la Mer French Research Institute for Exploitation of the Sea

ITB Institut Technique français de la betterave industrielle Technical Institute for beet

OPECST Office Parlementaire d’Evaluation des Choix Scientifiques et Technologiques Parliamentary Office for Technology Assessment

NGO Non-governmental organisation

NFR Novel Food Regulation (258/97)

PEG Precautionary Expertise for GM Crops (title of this research project)

PP Precautionary principle

RA Risk assessment

RM Risk management

WTO World Trade Organisation

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Abstract Between 1986 and 1996, the French regulatory system for GM crops was in the hands of a very small set of actors: members of an expert committee (the CGB) and civil servants who served on the secretariat of this committee and who, at the same time, represented the national competent authority with respect to EC regulations. These actors were responsible for all risk assessment and risk management related to GM crops, and also acted as gatekeepers for related risk research. By 2003, the regulatory landscape for GM crops and food had radically changed. New institutions and practices had been introduced to provide a functional separation between risk assessment and risk management, and reforms also led to an increased visibility for ‘conflicting expertise’.

These evolutions could be interpreted as a broadening of precautionary expertise. However, the reforms have not necessarily led to such a broadening with respect to case-by-case risk assessment for specific GM dossiers. Deliberations within the CGB have apparently become more ‘conflicting’, but the government has taken systematic measures to try to ensure that these debates are not revealed to the outside world, and appears to have decided that this experiment in ‘conflicting expertise’ should be discontinued. Moreover, reforms in the pipeline include proposals to exclude all non-scientists from risk assessment procedures, while setting up, perhaps, a separate body for representatives from society to participate in the ‘societal’ evaluation of GM crops and food – thus suggesting that non-scientists have no role to play in challenging the framings of case-by-case risk assessments. On the other hand, the framing for risk research has broadened significantly, and the knowledge gained from this research has influenced more general policy on GM crops, especially with regard to the continued moratorium on herbicide-tolerant GM oilseed rape and sugar beet. It has also influenced EU level expertise for long-term monitoring, thresholds, and coexistence measures.

The precautionary principle (PP) has maintained a high profile in the GM debate: it has remained a key reference point for many actors, has been used in legal proceedings, and the French President has now proposed to introduce it into the French constitution. Throughout these debates, different meanings have been given to the PP by different actors, and the PP has been used both to support and to oppose the development of GM crops and food. Whereas the academic debate has focused on practices related to scientific expertise and risk analysis, invocations of the PP by actors in the real world (governments, NGOs, industry, scientists) have tended to be more general and rhetorical. For example, the PP was used by many NGOs to demand proof of safety, or decried by some scientists and industry representatives for serving as a brake on all research and innovation. These actors give no details about what the PP could imply in terms of risk research, risk assessment, risk management, or stakeholder roles. The PP is simply invoked to support or attack a particular decision on whether or not to authorise field trials or commercialisation of GM crops and food.

Thus, within the GM debate, the interpretation of the PP has remained quite open, despite efforts by lawyers and other academics to restrict its meaning. Far from emptying it of any meaning, this openness has enabled the PP to act as a point of articulation between debates on the use of science in decision-making, on institutional reforms for managing innovation and risk, on societal input into decisions about research trajectories, and on broader debates about alternative food and agricultural systems.

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Main findings The elaboration of the PP within the dynamics of the GM controversy In France, the emergence of the precautionary principle (PP) has been closely associated with the public controversy on genetically modified crops. It is therefore important to study the dynamics of the GM controversy in order to understand the way in which this principle has been invoked and elaborated. In this study, we follow the circulation of the PP across various arenas in order to describe how various ‘hurdles’ (key decisions or events which generate controversies and conflicts) contribute to this process of elaboration.

Until the autumn of 1996, there was essentially no public debate about GMOs and although the PP had been inscribed in French environmental law in 1995, it had not yet been invoked by any actors. Since then, four periods can be identified in the French GM debate.

Period 1: 1997 – the PP enters the political arena In 1997, the PP was invoked by two successive governments to justify two opposing decisions: first (in February, by the right-wing Juppé government) to ban the cultivation of GM maize Bt176 in France, then (in November, by the left-wing Jospin government) to authorise its cultivation. In both cases, reference to the PP was expected to confer legitimacy to governmental decisions in the face of growing opposition to GMOs by some NGOs and farmers’ organisations.

Period 2: 1998-99 – the PP on trial These government announcements did not bring an end to the controversy surrounding GM maize Bt176. Instead, the ‘Bt176 saga’ continued for several years and became the centre of a judicial debate about how to interpret the precautionary principle.

In 1998, the PP was debated in two court cases of rather different kinds: • The first case was the trial, held in Agen in February, of three activists from the

left-wing farmers’ trade union Confederation Paysanne who had, in January 1998, entered a Novartis warehouse by force and destroyed Bt176 maize seeds which were stored there. In this case the court decided that the PP could not be invoked to support actions against something – the storage of the Bt176 seeds – which was itself strictly legal.

• The second case followed a series of appeals to the Conseil d’Etat (the administrative high court) lodged by NGOs against the authorisation for cultivation of Bt176-derived GM maize varieties in France (issued on 05/02/98). These appeals argued that the authorisation was illegal because the risks had not been properly assessed, that the correct administrative procedures had not been adhered to, and that, overall, the precautionary principle had not been properly applied. In an initial interim ruling issued in September 1998, the court appeared to support the way in which these NGOs had invoked the PP, and this stimulated an intense debate among lawyers and other academics about this principle.

The debate among French academics (lawyers, economists, sociologists, biologists) about the interpretation of the PP focused on what it implied for the practice of scientific expertise and public decision making on risk issues, and in particular on: • How to deal with uncertainty. Various ‘scales of plausibility’ have been proposed

by different actors;

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• How to take ‘societal considerations’ into account in decision making, and the need for what is referred to as a ‘second circle of expertise’;

• The need for a formal assessment of benefits, which could be balanced with the risks.

This debate was particularly intense in 1999, when the government asked two university professors (a lawyer and a molecular biologist) to prepare a report on the PP. Although this report had a broad scope, the GM controversy was at the core of it. It was clearly an attempt to channel the PP and to submit it to a scientistic rational. This report was not followed by any initiative to define the PP better in French law. On one hand, it had a strong influence on the public debate, and its claims for a narrow use of the PP were referred to in several law suits and in governmental circles – with some similarities to the Communication on the PP of the Commission. On the other hand, it did not prevent the continued rhetorical use of the PP by actors in the public debate, who invoke the PP using narrower or wider interpretations which tend to correspond to their position in the GM debate.

Meanwhile, the French government also invoked the PP to justify a moratorium on GM oilseed rape in November 1998. It argued that because of the biological characteristics of oilseed rape, its commercialisation could possibly lead to changes in agricultural practice – due to the loss of efficacy of herbicides with relatively favourable ecotoxicological profiles – and that these changes ‘must be assessed with respect to their global impact on the environment’. This decision clearly supported the notion that the government could refer to the PP to justify a restrictive risk management decision, even after positive advice from the expert committee, because of uncertainties that were not considered in the narrow frame of analysis of this committee. In June 1999, the French government again invoked the PP at the EU-level, in the ‘de facto moratorium’ declaration, which it led and signed at the Council of Ministers.

1998-1999 was also the period during which important institutional reforms for risk evaluation and risk management occurred, with the creation of a French Food Safety Agency and modifications to the practices of the existing expert committee for GM risk assessment (the CGB). These are discussed in the next section.

Period 3: 2000-2002 – the debate widens and shifts upstream After 1999, the framing of the GM debate shifted, under the influence of some NGOs, away from risk and towards broader political issues. NGOs referred less often still to the PP, and when they did it applied to a much wider range of issues than risk assessment and scientific expertise. The dominant themes have been: labelling and traceability, patenting of life, the WTO approach to globalisation, the quality of food, and alternative agricultural systems. There has also been a debate about the legitimacy of public sector research institutes (their role, organisation, priorities and partnerships with industry). The focus of the debate also moved upstream, from commercial cultivation of GM crops to field trials; and from the approval or not of innovations from applied research to the orientation of basic research. During this period, the controversy also shifted to the local level, with an increasing number of local and regional governments attempting to ban the cultivation of GMOs (experimental and commercial) in their territories. These bans were challenged in court by the central government, who won the legal cases on the basis that decisions about the cultivation of GM crops were under the responsibility of central authorities. At the same time, however, the idea that local mayors should be able to have a say about what happens in their locality gained more legitimacy in public spheres, and in government.

Period 4: 2003-2004 – conflicting expertise and regional bans Although explicit references to the PP by all kinds of actors decreased, the academic debate on the PP did not die out and was rekindled in 2003 by the proposal of President Chirac to introduce the PP into the French Constitution. Although the

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proposed text uses the PP with reference to environmental issues, the debate is clearly about the use of science in decision making and the management of risks and innovation. The Academy of Sciences has strongly opposed the incorporation of the PP into the constitution (or any organic law), whereas a network of citizens and scientists has mobilised to support this idea.

In 2003, proposals for the commercial authorisation of GM crops and food began to be assessed by French authorities and expert committees once again, after a gap of over two years. This provided an opportunity to test the new institutions and practices for risk assessment and risk management that had been installed in 1998-1999. Our analysis of these processes has been limited by lack of access to data, in particular about the CGB, and by the fact that many of the interesting events surrounding the assessment of these dossiers have arisen after we stopped conducting field work for the PEG project, in the autumn of 2003. Nevertheless, we analyse in the next section the way in which the new institutional arrangements have led to the increased visibility of conflicts between experts, in some cases about how to interpret the same data, and in other cases related to different interpretations about what can be counted as sufficient and relevant evidence for safety.

During this period, the campaign for local and regional governments to ban GMOs from their territories also gained more impetus, and could become a key feature of the controversy in the coming months as an increasing number of regional governments taken over by the socialist party in the March 2004 elections declare themselves ‘GM free’.

Evolution in risk analysis procedures, practices and institutions

Developments in institutional arrangements The French government set up an expert scientific body to accompany the development of GMOs as early as 1986. Until 1996 France was one of the main gateways for GM crops into the EU: more than 30% of all EU field tests had taken place in France and 9 of the first 15 applications to commercialise GMOs in the EU were submitted in France. The 90/220 Directive was transposed in a GM law in 1992, and at that time the pre-existing voluntary evaluation system was further formalised. Prior governmental authorisation was required for any release of GMOs into the environment, and this was delivered after an assessment of the risks to the environment and to health conducted by a scientific expert committee, the CGB.

From 1986 to 1996, the CGB was central to GM risk regulation in France: it conducted the risk assessments and the government systematically followed its advice when deciding whether to authorise field tests, or to support proposals for the commercialisation of a GMO. Moreover, most GM risk research was framed and coordinated by the CGB. The situation has become more complex since then: • Since 1997, the government has sometimes taken decisions that are more

restrictive than implied by the advice from the CGB, with regards to both experimental releases and commercialisation of GM plants.

• In 1998, a national Food Safety Agency (AFSSA) was created and this agency became responsible for the assessment of risks to human and animal health associated with GMOs and derived products which are destined to be used as animal feed or human food. The assessment was additional to that of the CGB, but did not replace it.

• Responsibility for the risk assessment of GM food submitted under EC Novel Food Regulation 258/97 was assigned to AFSSA. These dossiers were not submitted to the CGB.

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• A system for post-market long-term monitoring of the environmental impacts of the large-scale cultivation of GM crops was set up and an additional expert body, the Biovigilance Committee, was set up to advise on the protocols.

• Funding for GM risk research was increased and was no longer determined solely by the CGB and the Ministry of Agriculture.

In addition, there has been a lot of discussion in government circles and in public debates about further reforms of the regulation system for GMOs, in particular with respect to: • A so-called ‘second circle of expertise’ or ‘societal commission’, which would

provide an opportunity for representatives of civil society to have an input into government policy on GMOs – beyond case-by-case risk assessments.

• The need for risk-benefit analysis (which could perhaps be conducted by the ‘second circle of expertise’, either by representatives of civil society and/or by social scientists).

• Procedures for public consultation about experimental field trials; and the role of local government in decisions about the cultivation (experimental or commercial) of GM crops in their territories.

• The possible advantages of a ‘vertical’ expert committee that would deal with risk assessments at all stages of GMO use: confined, experimental releases, commercial releases, and post-market monitoring.

A new GM law is expected soon, which should clarify the Government’s position on these issues.

New procedures for expert bodies and their relationship with government Until 1998, the CGB was the only expert body dealing with GM risk assessment, but by 1999, there were two more: AFSSA for food risks and Biovigilance for monitoring. The latter has not been very active, because there has been next to no commercial cultivation of GM crops in France, despite the fact that 12 varieties of GM maize are formally authorised. The creation of the national Food Safety Agency (AFSSA) has, however, transformed the regulatory landscape. The creation of the agency was motivated by a desire to separate the institutions responsible for risk assessment from those responsible for decision-making. As a result, the institutional arrangements for the agency and for its scientific expert committees are far more codified and transparent than for the CGB (see Table 1).

Institutional arrangements for the CGB have also evolved since 1998. When the government re-appointed the members of the CGB in 1998, it sought to include members with opposing positions, in order to promote what was described as ‘conflicting expertise’. The committee itself adopted more detailed internal rules, began to issue substantiated opinions, and has modified the standard formulae used in their opinions: instead of simply issuing ‘favourable opinions’, they now issue opinions which state that ‘given the information provided and within the limits of current knowledge’, the CGB considers that the proposed use of the GM plant ‘does not present any more risk for the environment or public health’ than other commercialised varieties of the same plant species. The aim of this modification is to signal that the CGB only provides a scientific opinion about the potential risks associated with the release but does not issue an opinion about the governmental decision that should follow.

On its side, the government has also introduced – at least with respect to Part B experimental releases – new procedures which attempt to clarify and emphasise the distinction between the scientific advice on risk provided by the CGB, and decisions taken by the government. Governmental decisions to authorise or not to authorise an

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experimental field test are now published, and formal decisions are even published when the government has ‘decided to suspend deciding’. Moreover, since 2003, the standard formula used for these governmental decisions mentions that considerations other than the opinion of the CGB were taken into account: consultation of the public, consultation of local mayors, and an inspection of the proposed local site. The transparency of procedures for Part B dossiers has also been greatly increased. Information which is now rapidly and systematically posted on the governmental web site includes: the CGB opinions expressed, the governmental decisions taken, and the location of field tests authorised. Since 2003, the government has organised a web-based public consultation procedure for Part B dossiers: members of the public have two weeks to make comments after the CGB has issued its opinion and before the government makes its decision.

Reduced link between scientific advice and governmental decisions Overall, the direct link between scientific expertise provided by expert bodies and governmental decision-making, which existed until 1996, has been broken. As described above, both the government and the expert bodies have introduced procedures that aim to emphasise the separation between scientific advice on risk assessment and decision making. It has therefore become easier to identify situations when governments have taken decisions or made declarations that were not directly based on advice from its own scientific expert bodies. Since 1997, the government has, on several occasions, taken decisions that were more restrictive than that implied by the risk assessment provided by the scientific expert bodies:

(i) In the mid-1990s, the government took decisions which delayed or prevented the processing of dossiers submitted in France or the commercial authorisations of GM oilseed rape lines resistant to herbicides. By 1997 the government openly announced a moratorium on the commercial cultivation of all GM oilseed rape in France, which has led to the government not issuing the final consents for two oilseed rape lines which have obtained favourable decisions from the EC, and invoking the safeguard clause to ban two other oilseed rape lines which have obtained final consents in the UK. Most of these oilseed rape dossiers received ‘favourable opinions’ from the CGB, but the committee had expressed reservations in other ways. Thus, in 1997, the formal opinions stated that the CGB issued a ‘favourable opinion’, but the accompanying letters raised issues related to problems – labelled as ‘agronomic’ – which might occur if herbicide tolerance was transferred to non-GM plants, and in particular the problems associated with the possible emergence of plants tolerant to several broad-spectrum herbicides. With respect to the moratorium on GM oilseed rape and beet, the government can therefore be seen to have followed advice from the CGB, even though this advice was issued separately from the formal case-by-case opinions.

(ii) The decision not to authorise the cultivation of Bt176 Bt maize in February 1997 was the first occasion when a French Government took a decision which was clearly not based on advice from the CGB – and was in fact in direct opposition with that advice. The event was, at the time, so remarkable that the president of the CGB resigned in protest. The precautionary principle was invoked by the government to justify this decision, but was also invoked a few months later by the succeeding government to justify the opposite decision (to authorise the cultivation of Bt176 in France).

(iii) In 1998, the Government delayed issuing the consent for two more GM maize lines for several months. Moreover, the Government had abstained from voting on these dossiers at the ‘Article 21 committee’, even though the CGB had issued favourable opinions and the dossier had been transmitted to the EC by the French authorities. Neither the vote, nor the delay in issuing the consents, were motivated by any advice from the CGB. Rather, the arguments transmitted by the French authorities to the EC referred to the need for consumer acceptability and their proposal to postpone decisions until regulations for labelling and traceability were in place.

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(iv) In 1999, the French government led and signed the ‘de-facto moratorium’ declaration at the EU council of Ministers. This decision was not motivated by any advice from the CGB. The arguments put forward concerned the ‘lack of public and market confidence’ and the need for more transparency in risk assessment procedures and for regulations for labelling and traceability. Preventing further commercial authorisations for GM crops was considered to be ‘in accordance with the preventative and precautionary principles’.

(v) Since 2001, the government has on several occasions not issued authorisations for Part B field trials which had obtained favourable opinions from the CGB. No explanation has been publicly issued for these decisions, except in a couple of cases where it was stated that the petitioner no longer planned to carry out the field trial.

There has only been one example where the government can, perhaps, be seen to have taken a decision which was less restrictive than that implied by its expert bodies: in 2003 the Government forwarded to the EC a favourable initial Assessment Report for a GM Bt maize line (Bt11) which had received a favourable opinion from the CGB but an unfavourable opinion from AFSSA. The situation was, however, more complicated than that because the Assessment Report and the CGB opinion related to a dossier submitted under Directive 2001/18, whereas the unfavourable AFSSA opinion related to a dossier for the same GM line submitted under Regulation 258/97. In accordance with this unfavourable advice, the French Government voted against this dossier at the EU-level Standing Committee for Foodstuffs meeting on 08/12/03. This contradictory position of the French government with respect to this GM maize line therefore reflects the fact that the risk assessment for dossiers submitted under Directive 2001/18 and those submitted under Regulation 258/97 are carried out by separate expert bodies. (Moreover, AFSSA was not consulted for the Bt11 dossier submitted under Directive 2001/18, whereas it has been consulted for every other dossier submitted under this Directive in 2003.) Thus, the contradictory position of the government with respect to Bt11 is in fact in line with the contradictory advice from its expert bodies.

Table 1 Comparison between CGB and AFSSA CGB AFSSA

Institutional separation from decision makers

No Fully integrated within Ministry of Agriculture; members of the secretariat are also representatives of the competent authority making decisions

Yes But the expertise of the Agency is ‘at the service of political action’; and the CES secretariat serves to some extent as a reminder of governmental priorities

Independent budget No (small allowance to pay external rapporteurs and secretarial support for President)

Yes (substantial but negotiated annually)

Own web site No (information available via government GMO web site)

Yes

Members of expert committees (including chair) appointed by government

Yes Yes

Open call for scientific experts and selection based on formal procedures

No Yes (but in practice many members still co-opted)

Systematic and rapid publication of scientific opinions on web site

No (Part B Opinions published systematically and rapidly since 2002; Part C opinions expressed from February to

Yes (but Opinion of Agency, not CES)

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September 2003 posted on web site in January 2004)

Minority opinions mentioned in published opinions

No (mentioned in minutes but these are not public)

Yes

Publication of minutes of meetings

No (until forced to by the courts in February 2004)

No

Public declaration of interest for experts

Yes Yes

Auto-referrals allowed No (Not inscribed in law, but mentioned in internal rules)

Yes

Rule of procedure Established by the committee members, on an ad hoc basis

Common rules for all the expert committees established at the Agency

Membership by representatives of society

Representatives of consumer NGOs, environmental NGOs, industry, farming organisations and trade unions appointed as full members

All members appointed for their scientific competence. This includes one sociologist. No NGO representatives. Scientists employed in private sector excluded

Committee members financially remunerated

No (External rapporteurs remunerated)

Yes

Evolution in risk researchi France’s position in Europe concerning research on GM crops has dramatically shifted in the last decade. In the 1980s, French research in plant biotechnology (to develop GM crops) was strong, and France was a key entry point for GMOs in Europe. France had, with the UK, pushed for the EC to launch research programmes in biotechnology (which led to the BAP and BEP programmes), and in the period from 1986 to 1996, France was one of the EU countries with the highest share of GM field trials. In recent years by contrast, far fewer field trials were located in France and only one request for a commercial authorisation under Directive 2001/18 has been introduced through the French regulatory pipeline. Meanwhile, French biosafety research has grown steadily, and now plays a leading role in Europe (after the UK).

From 1997 onwards, the public controversy on GM crops and food was partly nourished by risk research results from French scientists, and by the mobilisation of some of these results in public arenas (meetings, media, judicial courts). This, in return, led to an increased importance of biosafety research on the policy agenda. Important calls for projects in risk research were launched, and about 88 indexed journal articles have been published by French research teams since 1997 (compared with only 34 in 1990-96). This reflects the fact that a growing number of researchers have moved into the emerging scientific domain of biosafety research for GM crops. Hence, when EC funding on biosafety research increased from 1999 onwards, French teams who had already mobilized through national programmes were well-prepared and took a stronger share in EC-funded research.

More than mere quantitative growth, French risk research has experienced major qualitative shifts since 1997. Several inter-related trends can be identified:

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• The link between advisory committee risk assessment (and their framings) and the dynamics of risk research has become looser, and the research agenda has been negotiated in wider multi-actor spaces. In the period 1993-1996, all risk research was commissioned by the CGB and funded by the Ministry of Agriculture. Thus, a small number of civil servants and members of the CGB acted as gatekeepers for GM risk research. In recent years, however, these actors have been marginalized in a wider landscape. Many research programmes have been elaborated and funded by other national institutions (INRA, CNRS and the Ministry of Research). Faced with public opposition and public display of scientific uncertainties and controversies, these research agencies saw support for risk research as a way to re-establish their contested legitimacy in public arenas and a way to show they were putting the precautionary principle into practice. French risk research on GM crops and food has therefore, in the last ten years, moved from a technocratic regime (i.e. science pulled by regulators’- with a narrow-risk framing) to a more academic/polycentric regime (i.e. a dynamic where the push from various research groups with different epistemic cultures is articulated through various mediations/translations with expert-led demand pull expressed in various arenas by multiple actors including NGOs).

• This has helped to develop biosafety research as a more open and diverse research domain, where some public concerns could be translated into various research projects, often addressing questions of basic scientific interest. Thus this ‘regulatory science’, which tended to have a low reputation among academic scientists, has gained more legitimacy among the scientific community. Research teams that had not previously been involved – because they did not consider that there were enough funding opportunities, or because they saw little scientific interest in the field, or because their skills and epistemic approaches were out of step with the previous technocratic framing of risk research – joined up and enlarged the biosafety research community.

• This resulted in significant shifts in the disciplines (and/or epistemic cultures) involved and issues addressed. Whereas the Ministry of Agriculture calls for projects in 1993-1994 were framed by molecular biologists, the later INRA and CNRS projects were framed respectively by agricultural scientists and population biologists. They opened the way to a larger range of disciplinary skills (entomology, population biology, cropping systems modelling, soil biology, and social sciences), and investigated a wider range of problems and uncertainties, such as effects on non-target insects, development of resistance among target insects, horizontal gene transfer, impacts of gene flow from ecological and cropping systems perspectives, cumulative effects, socio-economic analyses, and public input.

In return, some developments in biosafety research have (shifted the framings of and) acquired a new place in advisory committees and policy arenas. For example, intraspecific gene flow modelling at landscape level, which was virtually non-existent as a scientific object in the early 1990s, has become a dynamic field of investigation, and some models (like GeneSys) have been used, in a context of hot public debates about contamination thresholds and co-existence, by advisory groups and committees (SCP’s opinion of March 2001; JRC study on coexistence 2001). The use of this research in public debates and by expert committees is not related to case-by-case risk assessment of specific GM products, but rather to overarching policy issues related to co-existence, labelling and traceability.

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Discussion Between 1986 and 1996, the French regulatory system for GM crops was in the hands of a very small set of actors: members of an expert committee (the CGB) and civil servants who served on the secretariat of this committee and who, at the same time, represented the national competent authority with respect to EC regulations. These actors were responsible for all risk assessment and risk management related to GM crops, and also acted as gatekeepers for related risk research. The way in which the CGB was embedded in the Ministry of Agriculture and the fact that successive governments always followed the advice of the experts meant the committee could be perceived as conducting the risk assessment and also making the risk management decisions.

By 2003, the regulatory landscape for GM crops and food had radically changed. New institutions and practices had been introduced to provide a functional separation between risk assessment and risk management. The CGB lost its monopoly on risk assessment for GM crops through the creation of the French Food Safety Agency (AFSSA), which became responsible for assessing the risks associated with GM food and feed products. The way in which AFSSA was set up signalled a clear attempt to locate risk assessment responsibilities within an institution entirely separate from ordinary government departments, with the latter responsible solely for risk management. Moreover, the agency installed a novel set of procedures for an open call and formal selection of scientific experts to sit on their committees.

The CGB has remained embedded within the Ministry of Agriculture, and members continue to be nominated by the government without any specific or transparent selection process; but modifications were made to its way of working which also attempted to clarify that its responsibility was limited to risk assessment and did not extend to risk management: the wording of opinions were changed to avoid implying any particular policy action, and government decisions derived from the advice of the CGB were made more explicit and accessible to the public. However, the fact that the same civil servants continue to act both as members of the committee’s secretariat and as representatives of the competent authority responsible for related risk management decisions means that the separation between these functions has not been fully institutionalised, since these civil servants play an important role in setting the agenda and the limits of the remit for deliberations at the CGB.

In addition, lack of transparency (very long delays in publication of opinions) has prevented the CGB from playing a more active and visible role in the public debate, especially in contrast to AFSSA, which publishes its opinions on the internet almost instantly. As a result, AFSSA informs not only policy makers in government, but also public opinion.

Beyond these reforms which aim to separate risk assessment and risk management, the reforms of the regulatory system have led to an increased visibility for conflicting expertise. Firstly, the existence of two separate expert committees (the CGB and AFSSA) examining the same GM products provides the opportunity for them to produce conflicting opinions, and this has indeed occurred in most cases (for five of the six products examined under Directive 2001/18 in 2003). Secondly, members from different disciplines, and members with known views against GMOs, were appointed to the CGB in 1998, and this has led to more virulent contradictory expert opinions within the committee. Although such internal disagreements were largely kept within the confidential confines of the committee, they were expressed in general statements published in the CGB’s annual reports, and ended up being exposed in the press, through the actions of an NGO specialising in counter-expertise for GMOs (in April 2004). Similarly, different opinions co-exist within the expert committee at AFSSA, but here, in contrast to the CGB, minority opinions are publicly recognised since they are integrated into the published opinions. Table 1 summarises and compares the procedures set up for AFSSA and the CGB to attempt to guarantee the independence of the risk assessment process from social, economic and political influences.

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In 1999, our research team identified the ‘broadening of precautionary expertise’ (Roy 2000b) as a central feature of developments in the French regulatory system for GMOs in the 1990s. However, the reforms discussed above have not necessarily led to such an opening with respect to case-by-case risk assessment for specific GM dossiers. Deliberations within the CGB have apparently become more ‘conflicting’, but the government has taken systematic measures to try to ensure that these debates are not revealed to the outside world, and appears to have decided that this experiment in ‘conflicting expertise’ should be discontinued. Moreover, reforms in the pipeline propose to exclude all non-scientists from risk assessment procedures, while setting up, perhaps, a separate body for representatives from society to participate in the ‘societal’ evaluation of GM crops and food – thus suggesting that non-scientists have no role to play in challenging the framings of case-by-case risk assessments. On the other hand, the framing for risk research has broadened significantly, and the knowledge gained from this research has influenced more general policy on GM crops, especially with regard to the continued moratorium on herbicide-tolerant GM oilseed rape and sugar beet. It has also influenced EU level expertise for long-term monitoring, thresholds, and coexistence measures.

The PP has maintained a high profile in the GM debate: it has remained a key reference point for many actors, has been used in legal proceedings, and the President has now proposed to introduce it into the French constitution. Throughout these debates, different meanings were given to the PP by different actors, which tended to reflect their position in the GM debate. The PP was used both to support and to oppose the development of GM crops and food. Whereas the academic debate has focused on practices related to scientific expertise and risk analysis, invocations of the PP by actors in the real world (governments, NGOs, industry, scientists) have tended to be more general and rhetorical. For example, the PP was used by many NGOs to demand proof of safety, or decried by some scientists and industry representatives for serving as a brake on all research and innovation. They give no details about what the PP could imply in terms of risk research, risk assessment, risk management, or stakeholder roles. The PP is simply invoked to support or attack a particular decision on whether or not to authorise field trials or the commercialisation of GM crops and food.

Invocations of the PP by the government in 1997 and 1998 could be described as ‘broad’, in the sense that they were not limited to measures related to a priori risk estimations: they referred also to measures related to labelling, biovigilance, and public debate. Despite later attempts by the Government to delimit the PP in a more narrow and scientistic way – more similar to the European Commission’s Communication on the PP – this wider interpretation gained ground as it was further mobilised and taken up by other actors and in diverse arenas.

There has been no direct explicit link between the somewhat theoretical elaborations of the PP developed by academics and the organisation and reform of regulatory practices. The academic debates did, however, probably have some more diffuse influence on reforms of the risk regulatory landscape which occurred in the late 1990s, especially since some of the authors were, or became, actors in the regulatory system. But it is difficult to measure this impact.

Thus, within the GM debate, the interpretation of the PP has remained quite open, despite efforts by lawyers and other academics to restrict its meaning. Far from emptying it of any meaning, this openness has enabled the PP to act as a point of articulation between debates on the use of science in decision-making, on institutional reforms for managing innovation and risk, on societal input into decisions about research trajectories, and on broader debates about alternative food and agriculture systems.

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Part I: Precaution

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1 Elaboration of the PP through the dynamics of the GM debate

In France, the emergence of the precautionary principle as an active concept has been closely associated with the public controversy on genetically modified crops. It is therefore important to study the dynamics of the GM controversy in order to understand the way in which this principle has been invoked and elaborated. The precautionary principle has also been prompted by public controversies surrounding the HIV-contaminated blood scandal and BSE. In this context, the PP is often invoked in France in spheres related to food safety and public health, not just with respect to environmental issues.

In this first part of the report, we follow the circulation of the PP across various arenas in order to describe how various ‘hurdles’ (key decisions or events which generate controversies and conflicts) contribute to this process of elaboration. We describe the way in which the precautionary principle circulates in these arenas and analyse how these confrontations determine which cognitive and normative framings of the PP become more or less dominant. In this way, we show how the public controversy about GM crops contributes to shape the PP and practices associated with it.

The PP was incorporated in 1995 into a lawii on the reinforcement of environmental protection, where it was defined as follows:

The precautionary principle, according to which the absence of certitudes, given the scientific and technical knowledge at the time, must not delay the adoption of effective and proportional measures aiming to prevent a risk of serious and irreversible damage to the environment, at an economically acceptable cost.

But until the autumn of 1996, there was essentially no public debate about GMOs and the PP was not yet invoked by any actors. Since then, four periods can be identified in the French GM debate.

1.1 Period 1: 1997 – the PP enters the political arena In 1997 the PP was used for the first time by the French government to justify decisions about its policy on GM crops. In fact, the PP was used twice within the same year, by two successive governments, to justify two opposing decisions related to GM crops. In February, the (right-wing) Juppé Government invoked the PP to justify the decision not to authorise the cultivation of Bt 176 maize in France, and in November, the (left-wing) Jospin Government invoked the PP to justify the reversal of that decision. Thus, from the start, the PP was invoked in French political arenas to justify opposite decisions and positions. As described below, these first invocations of the PP by the French Government occurred in the context of the emergence of a public controversy about GM crops.

Until 1996, there was essentially no public debate about GMOs, and although the PP had been inscribed in French environmental law in 1995, it was not yet invoked by any actors. By the summer of 1997, French public policy on agricultural GMOs was in total disarray and this had important economic and political implications. This surprised many stakeholders, because until 1996 there had been no serious public controversy about GMOs in France. All potential conflict seemed to have been resolved through the construction of an apparently effective science-based regulatory system. A voluntary notification system and an expert advisory committee (the CGB) had been set up for releases of GMOs into the environment in 1986, even before the adoption of Directive 90/220. This system was adapted and formalised in 1992, when the 1990 Directive was transposed into French law (see Section 2). For some, this process whereby the safety of products had to be assessed before their commercialisation is authorised represented one of the first applications of the PP (Hermitte 1993).

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As analysed elsewhere (Joly 2000; Marris 2000; Roy 2000a), a radical shift in the relationship between scientific expertise and governmental decision making on GMOs occurred in February 1997 when the (right-wing) Juppé Government decided to issue the final consent for the commercialisation of GM maize Bt176, but not to authorise its cultivation in France. This decision was particularly radical because France was the Member State which, in 1995, had submitted this application to the European Commission under Directive 90/220, and had been the only country to support this controversial dossier all the way through the application process. The President of the expert committee responsible for the risk assessment of GM products (CGB), Axel Kahn, resigned in protest, stating that this decision demonstrated that the Government did not trust the expertise of his committee. Until that time, all advice from the CGB had been unquestionably followed by the Government, giving the impression that the CGB was, in fact, the decision-making body. The seamless connection between risk assessment and risk management which existed between 1986 and 1996 was severed on this occasion.

1.1.1 Juppé-Lepage decision The PP was used to justify the decision not to authorise the cultivation of Bt176 GM maize in France: on 12th February 1997 the Juppé Government announced that ‘this decision was dictated by the precautionary principle, [because] the secondary effects of this crop are not sufficiently known’ and that INRA had been asked to conduct research ‘on the risks of dissemination of these seeds and of the pollution that this would entail on other crops or on ground water’. This statement was made at a Council of Ministers and was not widely publicised. The Minister of Environment at the time was Corinne Lepage, is credited with having lobbied for this baniii.

1.1.2 Jospin decision On 27th November 1997 the new (left-wing) Jospin Government invoked the PP in a much more public and expansive way to justify the reversal of the Juppé decision, i.e. its decision to authorise the cultivation of GM maize Bt176. Prime Minister Jospin announced that ‘the precautionary principle will apply to all decisions related to the commercialisation of GM crops’, and defined the PP as followsiv:

‘According to this principle, an authorisation for cultivation can only be given when the risks of dissemination of the transgenes or the health risks for consumers are perfectly controlled.’

On these grounds, the Government decided to authorise the cultivation of GM maize varieties derived from Bt176 in France, but decided at the same time to establish a moratorium on the commercialisation of GM beet and oilseed rape, because of the risks related to interspecific gene flow for these species. Note that, at this time, the PP was only considered to be relevant for the commercial cultivation of GM crops: field-testing was not mentioned; and the key issue raised was interspecies, not intraspecies, gene flow. As we shall see, both intraspecies gene flow and field testing later became central to the French GM debate, so it is important to note that at this point in time, these issues were largely absent from the public debate (but were already raised by the CGB, see Section 4.1.2).

Interestingly, other measures were also announced by the Government at the same time (press conference of 27/11/97), which were not directly related to pre-market risk assessment or to decisions about whether or not to authorise the commercialisation of any specific GMO: • A public debate on the use of GMOs in agriculture would be organised

• A biovigilance system would be set up

• Information of consumers would be guaranteed

In this way, the PP was associated early on, by the Government, with measures related to post-market monitoring, labelling, and public participation, and not just with a priori scientific risk assessment. As we shall see, despite later attempts by the

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Government to delimit the PP in a more narrow way, this wider interpretation gained ground as it was further mobilised and taken up by other actors and in diverse arenas.

Following the consensus conference which was held in June 1998, the Jospin Government announced in Julyv that it would authorise the commercialisation of two more GM maize transformation events (Agrevo’s T25 and Monsanto’s Mon810). This announcement essentially reiterated the announcement made by the same Government in November 1997. It again invoked the PP, and inserted these decisions about specific GMP products within a broad set of decisions and positions:

The Government has decided to complete the decisions taken last November, by following a triple imperative: a strict respect of the precautionary principle, a necessary vigilance about the large scale use of these technologies, greater transparency for the consumer and the citizen.

In the same announcement, the moratorium on the commercialisation of GM oilseed rape was reiterated and clarified:

Given the uncertainties related to the diffusion of transgenes into the environment from plants, such as oilseed rape, that present risks of crossing with other species, it is decided, within European procedures, to implement a moratorium on authorisations for commercialisation, for two years, with respect to every GM variety of such plants. For other species, such as maize, a case-by-case examination will be carried out with respect to health and the environment.

In addition, the same announcement included a renewed commitment to setting up a biovigilance system and guaranteeing ‘transparent and relevant’ information for consumers. The Government promised to set up a national system for traceability and to push for this at the international level.

With respect to expertise, the announcement stated:

In addition, in accordance with the wishes of the citizens’ conference, a reform of the system for expert assessment of GM dossiers will be carried out. This reform must increase the transparency of the work of the expert committees and ensure wide and continuous information especially for agricultural professions, NGOs, and consumers.

Thus, as in November 1997, the Government invoked the PP to support a wide range of measures, some specific to GMP products, others more general; and some related to a priori risk assessment, and other not.

1.2 Period 2: 1998-99 – the PP on trial These Government announcements and decisions did not bring an end to the controversy surrounding GM Maize Bt176. Instead, the ‘Bt176 saga’ continued for several years and became the centre of a judicial debate about how to interpret the precautionary principle. In 1998, the PP was debated in two court cases of rather different kinds: • The first case was the trial, held in Agen in February, of three activists from the

Confédération Paysanne who had, in January 1998, entered into a Novartis warehouse by force and destroyed Bt176 maize seeds which were stored there.

• The second case followed a series of appeals to the Conseil d’Etat (the administrative high court) lodged by NGOs against the authorisation for the cultivation of Bt176 derived GM maize in France (issued on 5th February 1998).

The appeal to the Conseil d’Etat had repercussions which went beyond the arena of that court, and forced the court to deal with issues of regulatory science about which it had little experience (except through affairs linked to HIV contaminated blood, which occurred in the period immediately preceding the GM controversy).

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But in recent years, it is the penal courts which have been transformed into a new type of public arena where trials of activists are turned into debates about GM policy, scientific expertise, the legitimacy of research and the precautionary principle. The first such trial was the ‘Agen trial’. At least seven other trials of activists involved in the destruction of GM field tests or other GM crop material have since taken place, and these are still ongoing today.

1.2.1 The Agen trial In January 1998, approximately one hundred activists from the left-wing farmers’ trade union the Confédération Paysanne forced entry into a Novartis warehouse at Nérac (SW France) and destroyed a stock of Bt176 seed. Three activists were arrested and charged (including José Bové and René Riesel, who became well-known figures in the anti-GM movement). They decided to transform their own trial, which occurred in February 1998 in the city of Agen, into a trial of GMOs, portraying Bt176 GM maize as ‘the very symbol of a type of agriculture and society that we refuse’ (Heller 2002; Hermitte 1998).

Heller (p.16) argued that ‘It was during this week long trial that Bové and Riesel set in motion a discourse and an activist strategy that would later counter the risk hegemony of the French GMO debate’. She showed how, although these defendants summoned the expertise of scientists in their defence (Gilles-Eric Séralini, Jacques Testart and Richard Lacey), they also invoked ‘their own expertise as paysans and as union workers uniquely situated to speak about food quality, farmer’s duties to protect and develop French seeds, and the implications of industrialized agriculture on rural peoples and cultures’. Heller’s analysis demonstrates how these activists within the CP used new strategies to bring the GMO debate into new public arenas (direct actions and the courts), thus providing opportunities for a redefinition of the cognitive framework of the very issues at stake (Heller, 2002, p.5):

As the French debate illustrates, the struggle over agricultural biotechnology is not just about genetic technoscience or risk assessment. In this struggle, there is a collision between two framings and their forms of expertise. When initially framed as a ‘risk’ issue, the GMO debate invoked scientific expertise for assessing the environmental and health hazards associated with the technology. When later defined as a ‘food quality’ issue, the debate shifted to paysan expertise.

Perhaps because these activists sought to promote a framing of the issue which went beyond ‘risk’, they did not invoke the PP in their defence. Some of their witnesses did, however, refer to the PP. Three scientists (Gilles Eric Séralini, Jacques Testart and Richard Lacey) argued for a moratorium on GM crops due to the absence of certainty about potential risks to human health or the environment. According to the published judgement, the risks which were highlighted were the dissemination of a new and harmful gene for related species and the development of Bt resistant pests.

The activists defence was based on the invocation of ‘legitimate defence’, under Article 122-5 of the Penal Codevi, which states:

Is not penally responsible a person who, faced with an unjustified attack towards themselves or others, carries out, in the same moment, an act compelled by the necessity of legitimate defence of themselves or others, except if there is a disproportion between the means of defence employed and the severity of the attack.

Is not penally responsible a person who, to interrupt the execution of a crime or offence against a good, carries out an ac of defence, other than voluntary homicide, when that act is strictly necessary to the aim pursued and so long as the means employed are proportional to the severity of the offence.

Although this article does not mention the PP, and pre-existed any notion of the concept, it is interesting to note that it would require the court to pronounce itself on: the existence of an ‘attack’, the ‘necessity’ to defend oneself against it, and the

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‘proportionality’ of the means employed. In the event, however, the judge ruled that this article did not authorise anybody to use any means against an act which was itself legal; and that since the storing of these seeds by Novartis in their warehouse was entirely legal, the defendants could not invoke legitimate defence. In order to justify that the action of Novartis was legal, the judgement refers to the favourable opinions of the CGB and of the Conseil supérieur d’hygiène publique, the ‘favourable opinion’ of the Comité de Prévention et de précaution (which had in fact been rather ambivalent, and definitely pronounced itself against the use of antibiotic marker genes such as that present in Bt176), and the favourable decision of the European Commission of 27/01/97. Interestingly, the judgement also refers here to the governmental press conference of 27/11/97 announcing its decision to authorise the commercialisation of this GM maize together with the setting up of a biovigilance system and the organisation of a public debate in the form of a consensus conference. These two points (biovigilance and public debate) are emphasised again in the conclusions, which state that the ‘cultivation of the Novartis maize was moreover subordinated by virtue of the precautionary principle to a biovigilance system’. This judgement therefore confirms that in France, around this period, biovigilance was considered to be an essential component of the PP. Moreover, the fact that the PP had, as far as the court was concerned, been applied was used to further condemn the defendants.

As pointed out by Marie-Angèle Hermitte, this court case demonstrated the way in which courts avoid, as far as possible, entering into any scientific debate:

They [the courts] must always shift the question of the scientific or historic debate onto other territories. Here, the Court starts from the fact that the defendants justify their acts by the legitimate defence of goods as defined by Article 122-5 and concludes that it cannot be invoked here [because this article does not authorise a person to act in defence against an act which is legal]. Therefore, there is no longer any need to take position between different scientific hypotheses, nor to assess the economic impact of GM crops, which were the grounds on which the defendants sought to place themselves, but only to decide whether the Novartis warehouse at Nérac legally held the seeds which were destroyed.

This illustrates how the internal rules of each public arena – in this case legal courts – constrains the types of arguments which can legitimately be raised. However, this trial, and the succession of trials of activists which followed, also demonstrates how these rules can be challenged when new actors enter with new strategies and discourses. The impact of these court trials on the GM controversy cannot be evaluated solely on the basis of how the legal arguments played out in court, and what judgements and sentences were passed. In practice, activists have lost every single one of the court trials (at least seven, some with appeals) which have occurred since 1998, in that they have always been found guilty. On the other hand, the activists can be said to have been successful in using these trials to raise the public profile of the GM debate.

Thus, even though their arguments have essentially been rejected out of hand within the legal court proceedings, they have gained credence and legitimacy outside of that arena, notably in the media which has covered these trials quite extensively. In this way, activists have used the courts as a public arena to confront their arguments with other actors, and to promote their cognitive and normative framework for the GM debate away from simply ‘risk’ issues, and towards globalisation, ‘malbouffe’, a challenge to the legitimacy of public sector research, and a debate about what constitutes a ‘democratic debate’.

Moreover, in many cases (at least until 2001) the sentences handed down were relatively lenient. With respect to the Agen trial, Hermitte suggests that the leniency of the sentences (suspended jail sentences of 8 months for CP leaders Bové and Riesel and 5 months for the 3rd defendant), compared to other cases of a similar nature suggests that the Court might have implicitly admitted that the defendants could benefit from extenuating circumstances, due to the political nature of their claims, and

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maybe to the sensitivity of the GMO issue, even though this was never explicitly stated.

Indeed, the trials of activists, and the media coverage of them, became the centre of a debate about the legitimacy (as distinct from the legality) of the direct actions of activists, especially those who were members of a trade union. This theme came to the fore in the summer of 2003, when Jose Bové was finally sent to jail for his actions.

The Agen trial, and the other trials that followed, also played a very important role in the creation and strengthening of alliances between anti-GM actors, at the national and international level. Through the presence of Indian scientist and activist Vandana Shiva to testify ‘on behalf of the Third World’’, the Agen trial catalysed the entry of the Confédération Paysanne into an international anti-globalisation network (Heller, 2002, p.18):

For months after the event, news of the trial circulated through anti-globalisation Internet list-serves, magazines, and journals, informing activists across the globe that ‘French farmers’ were heading up a new anti-GMO movement in Europe. On the national level, within the French wing of he anti-globalization movement, the CP established itself as an obligatory passage point as well, allowing in turn the French anti-globaliztion groups to increase national credibility.

At the national level, direct action and ensuing trials brought together the anti-globalisation NGO ATTAC and the Confederation Paysanne, although this alliance has not always been unproblematic (Pagis, 2003).

1.2.2 Appeal to Conseil d’Etat In February and March 1998, three environmental NGOs (Ecoropa, Greenpeace and Friends of the Earth), the left-wing framers’ trade union Confédération Paysanne and three citizens lodged appeals to the Conseil d’Etat (the administrative high court) against the authorisation for the cultivation of Bt176 derived GM maize in France, issued on 5th February 1998. These appeals argued that the authorisation was illegal because the risks had not been properly assessed, that the correct administrative procedures had not been adhered to, and that, overall, the precautionary principle had not been properly applied.

The main irregularity debated was the fact that the file submitted by Novartis in November 1994 was incomplete, in that it did not mention the presence of the ampicillin resistance marker gene, or the potential risks associated with it. This information was later provided by Novartis, following a query raised by the UK ACNFP, and was assessed by the EC-level expert committees before the EC issued its favourable Decision (on 23/01/97).

These appeals marked the advent of a new strategy for Greenpeace, the Confédération Paysanne and Friends of the Earth. Ecoropa had already lodged a previous (and successful) appeal to the Conseil d’Etat in 1997, which had focused on an irregularity in the procedure followed for nominating the members of the CGB, but did not invoke the PP.

The Conseil d’Etat responded to the appeals in three stages:

(i) In the first instance, on the 25 September 1998, the Conseil d’Etat only considered the request by Greenpeace to suspend the decision, while awaiting the final ruling. At this point, the Council decided that the means invoked in the appeals were serious enough to suspend the authorisation. The grammatical formula used is open to interpretation, but the decision appeared to state that the invocation of the precautionary principle was, in the current state of the investigation, a serious means which could justify the cancellation of the decision, and that the nature of the potential consequences of the implementation of this

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authorisation justified suspending the decision. Although the text is ambiguous, this decision was at the time widely interpreted as a great success for Greenpeace and the other applicants. It was considered that the CE had suspended the authorisation in the name of the precautionary principle, thus further inflaming debates about the legal interpretation of the PP. The CE appeared to have given great credence to the principle, and accepted the applicants’ claim that it applied in this case. Moreover, the CE decision seemed to imply that the PP could be interpreted as a prescriptive legal principle, and not just a general framing or political principle.

(ii) On 11th December 1998, the Council deliberated on the full appeals, and decided to refer the case to the European Court of Justice for clarification about the relative powers of Member States and the European Commission under Directive 90/220. (The authorisation remained suspended in the meantime.) The key question raised was whether the Rapporteur MS could decide not to issue a consent for commercialisation after a favourable EC Decision had been issued. Underlying this question was the fundamental question of who is principally responsible for the assessment of the risks associated with the commercial release of a GMO: the rapporteur Member State or the European Commission? The PP was not mentioned in this decision.

(iii) The European Court issued its ruling on 21st March 2000, essentially stating that the rapporteur MS has no leeway about whether or not to issue the final written consent – unless new information arises after the favourable EC decision is issued. In response to this ruling, the Conseil d’Etat issued its final ruling on 22 November 2000, which rejected the appeals and therefore reinstated the authorisation.

A key point raised at the initial hearing in September 1998 was whether the PP should be interpreted as a prescriptive principle, from which one can derive specific legal obligations, or only as a general principle ‘which has more political than legal content’.

This also raised the related question about whether the PP is directly operational in an autonomous way, or only applicable through specific additional legal texts. Thus, can one argue that the following the procedures laid down by the 1992 GM law which transposed directive 90/220 is sufficient to demonstrate a proper implementation of the PP? Or can one require ‘precautionary measures’ over and above those laid out in that law?

This court case was closely followed by stakeholders in the GM debate, and also by French practitioners and academics in law, who were divided more or less in two camps: • those who considered the PP solely as a general principle, which can be used as

a guide for political action, but cannot be invoked in law courts (e.g. Geneviève Viney).

• those who considered the PP as a fundamental legal principle and supported its invocation in legal proceedings (e.g. Corrine Lepage, Marie-Angèle Hermitte, Christine Noiville...).

The first ruling of the Conseil d’Etat (September 1998) appeared to support this second camp, and was interpreted as such. However, the ruling of December 1998 referred only to the question of relative competencies between Member States and the Commission and did not mention the PP at all. The final decision in November 2000 centred on legal irregularities in the administrative procedures followed and only mentioned the PP once, more or less in passing and only with respect to a specific set of points, rather than as an overall challenge to the authorisation to cultivate Bt176 maize, as in the September 1998 ruling.

But most of the debate among lawyers and other stakeholders about this case occurred in 1999, before the final ruling came out. Thus, commentaries focused especially on the way in which the PP was invoked in the September 1998 ruling by

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the court, even though this was later over-ridden by the final ruling. Thus, for some legal observers (Cans 1999) the 1998 ruling by the CE seemed to imply that the PP was awarded recognition and value only when it was associated with such legal irregularities, and could not be invoked in the absence of such irregularities. However, Kourilsky and Viney (p.156) point out that the irregularity in question (the incompleteness of the dossier submitted by Novartis) was ‘practically insignificant’ and therefore interpreted the 1998 ruling as demonstrating that, according to the Conseil d’Etat, the PP justifies a very strict control of the correct application of administrative procedures (Kourilsky 2000). Moreover, according to Kourilsky and Viney (p.135-137) subsequent rulings (unrelated to GMO), by the Conseil d’Etat and regional administrative courts in 1998 and 1999 suggested that French administrative courts tended to interpret the PP as a veritable rule of law which could be autonomously applied independently from any regulations which might be inspired from it. Moreover, the Conseil d’Etat tended to extend the use of the PP to the field of human health, even though the PP is only formally inscribed in environmental law.

Beyond this important debate about the legal scope of the PP, this case also demonstrated how debates about the relationship between expertise and decision-making, which were first raised and developed in other arenas (among scientific committee and their secretariats, or within NGOs) now entered into the courts, which were not used to dealing with such issues. As described below, this case provided information about how lawyers perceived the role of scientific controversy in the legal proceedings, and how they perceived the application of the PP in risk assessment procedures.

At the September 1998 hearing, the Commissaire du gouvernemantvii suggested that the existence of an active debate, among high-flying scientists, should lead judges to avoid taking sides at all. There is no mention of the fact that controversy among scientific experts may reflect uncertainty or ignorance. Having said that, however, he then went on to give his own judgement about four potential risks associated with Bt176 GM maize which were raised in the appeals: the appearance of resistant corn borer populations, the dissemination of genes from the GM plant to other plants (of other species), the transfer of the ampicillin resistance gene from the GM maize to bacteria in animal guts or in the soil. In each case, he concluded that the risks are not serious. The arguments put forward by the Commissaire were essentially the same as those put forward by the petitioners or the CGB at the time: • The probability of the appearance of resistant populations of corn borers is

‘significant’, but this is also the case when using chemical pesticides, and is of limited gravity given that ‘other pest management methods remain available’.

• The risk of gene flow is marginal given that maize cannot cross with any European plant species. (Note, yet again, that intraspecies gene flow is not referred to).

• For the ampicillin resistance gene, he does report the conflicting opinions of two scientists, one emphasising the risk of transfer (Courvalin), the other minimising those risks (Berche), but gives more credence to the latter. He further points to the fact that the monitoring system (which was established in the decision of 05/02/98) includes the surveillance of this risk.

Another interesting aspect of the Commissaire’s argument with respect to the PP, was that he argued, in his December 1998 speech, that the PP should imply a ‘dynamic and evolutionary’ approach to regulatory procedures. Thus, the fact that the file initially submitted by Novartis was incomplete, but that it was gradually enriched with further information during the lengthy authorisation procedure, filling in gaps as and when new questions arouse, should be taken as a positive element which complies with the PP, rather than – as argued by the applicants – an infringement of the PP. He stated that it would be paradoxical if the implementation of the PP implied that a rigid procedural approach was preferred to a more flexible, but rigorous, risk assessment.

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The proceedings related to this appeal could be considered to be confined to specific legal institutions and thus only relevant to the legal arena. The debate referred to above, among lawyers, remained largely restricted to specialised legal journals and other specialist media (academic books, other social science journals, the Kourilsky-Viney report). However, the appeal was followed by a much wider audience, from NGOs and other stakeholders including biotech firms and regulators, and was covered in the national press. Indeed, in his speech in September 1998, the Commissaire himself argued that the proceedings at the Conseil d’Etat were intricately linked to a wider debate about GMOs occurring in other arenas. He stated, in his introduction, that (our emphasis):

In Europe, reactions of [public] opinion are more reserved [than in the USA where GM seeds are ‘today used on a wide scale’]. In Europe the use of biotechnologies is perceived, among the evolution of techniques for the improvement, not as an incremental change but as a veritable change in nature, and generates, in Europe and in France, a vigorous debate in which scientific considerations, economic stakes, and political or ethical positions are intermingled. This debate is not just a debate among experts, it has become a societal debate, as demonstrated, in France, by the recent ‘citizens’ conference’ organised on 20th and 21st of June 1998 by the OPECST on the use of GMOs in agriculture and food, or, in Switzerland, the organisation on 7th June 1998 of a referendum on the continuation of genetic engineering research.

You are today urged to add your voice to this debate, in your capacity as judges of the legality of administrative decisions.

Moreover, the Commissaire implied that if the CE decided to admit the invocation of the PP, it would be responding to public opinion rather than to an ‘orthodox’ legal interpretation of the texts.

When the Conseil d’Etat announced on 22 November 2000 that, given the ruling of the ECJ, it would validate the authorisation for the cultivation of Bt176, thereby rejecting the appeals of the NGOs, this decision was highlighted by the media and NGOs as being contrary to the wishes of the public and to a responsible application of the precautionary principle.

1.2.3 Kourilsky-Viney report The appeal to the Conseil d’Etat revealed that the PP could be used in court to challenge governmental decisions about GM crops. More generally, the convoluted series of events surrounding the authorisation for GM maize Bt176 revealed the ambiguity of the interpretation of the PP, and how it could be a source of conflict between scientific expert committees and ministerial departments, as well as a lever for NGO action, thus hampering the smooth process of decision making. In response, in March 1999, Prime Minister Jospin asked two university professors, biologist Philippe Kourilsky and lawyer Geneviève Viney, to prepare a report on the PP in order to ‘clarify the meaning and the scope of the PP’ and to ‘clarify the general principles which will guide further action.’viii

The report was clearly motivated in large part by the imbroglio about GMOs. The Prime Minister’s letter commissioning the report states:

For the last few years, increasingly rapid progress in science and technology raise concerns in the public opinion in France and in Europe. The controversies which surround the cultivation and commercialisation of GM plant varieties are a symptom of this. These problems mirror that preoccupations of the population: transparency of information, respect of precautions in human health and the environment, without all the same opposing the beneficial contributions of scienceix.

The report also clearly aimed to inform French (and thereby EU) policy on the precautionary principle for WTO negotiations at Seattle:

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Your contributions could also contribute the define the French position in international arenas, in view in particular of the revision of the European Directive on GMOs and in the context of discussions on the application of the precautionary principle at the WTO.

The ensuing report (Kourilsky 2000) stated that ‘the current imbroglio’ with respect the treatment of GMOs was due in part by socio-economic considerations, but also to the fact that the ‘Ten Commandments of the Precautionary Principle’ (see Box 1) had not been correctly adhered to.

It favoured the view that the PP should be interpreted as a general principle which should guide public policy, but that it should not be applied directly and autonomously in legal proceedings. Moreover, the authors argued that ‘the notion of prudence’ had already been integrated by the courts, long before the appearance of the PP. They proposed the following definition of the PP (p.215):

The precautionary principle defines the attitude that any person who takes a decision about an activity that one can reasonably suppose engenders a serious hazard for health and security of current or future generations, or for the environment, should adopt. It applies especially to public authorities that must ensure that health and safety imperatives prevail over the freedom of trade between individuals and states. It requires that all measures be taken to enable one, for a cost which is economically and socially bearable, to detect and assess the risk, to reduce it to an acceptable level and, if possible, to eliminate it, to inform the persons concerned and to collect their suggestions on the measures proposed for dealing with it. This precautionary system must be proportionate to the extent of the risk and can be revised at any moment.

Interestingly, this definition makes no reference to uncertainty at all. In many respects, it equates the PP with what is commonly recognised as risk assessment and risk management, implemented in the context of complete knowledge about the nature and extent of the risks, and of the costs of different management options to reduce them. This probably explains why the authors see so little difference between the pre-existing concept of ‘prudence’ and the new concept of ‘precaution’. Their definition does however resemble the EC Communication on the PP when it states that the PP applies mostly to risk management, and when it refers to the proportionality of any precautionary measures taken.

This report can be seen as an attempt to channel the use of the PP and to submit it to scientistic rational. Most of the recommendations related to reforms in the organisation of scientific expertise. They recommended: • that the resources devoted to expertise be extended;

• that expertise should be ‘plural’, ‘conflicting’ and constantly updated;

• that expertise of risks should be systematically organised into ‘two circles’: the first circle would be ‘strictly scientific and technical’, while the expertise of the second circle would be ‘economic and social’;

• that a new agency specifically devoted to expertise, across all sectors, be created.

Box 1: Kourilsky’s Ten Commandments for the Precautionary Principle

(Source: Kourilsky and Viney, 2000, p. 56.)

1. All risk has to be defined, assessed and graded.

2 Risk analysis must compare different scenarios of action and inaction.

3 Before any decision is taken, risk analysis must incorporate an economic analysis which results in a cost/benefit study.

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4 Expert Committees have to be independent but coordinated.

5 As far as possible, decisions should be reversible and solutions adopted should be reversible and proportionate.

6 Removal of uncertainty imposes an obligation of research.

7 Decision-making processes and safety measures should not only be appropriate but also coherent and efficient.

8 Decision-making processes and safety measures should be reliable.

9 Risk assessments, decisions and follow-up, as well as the institutions that participate in these activities, should be transparent, which necessitates labelling and traceability.

10 The public must be informed and political authorities should adjust the level of public participation.

1.2.4 Academic debate As already mentioned, the first judgement of the Conseil d’Etat (in September 1998) stimulated much debate among academics lawyers and other academics (lawyers, economists, sociologists, biologists) bout the interpretation of the PP and what it implied for the practice of scientific expertise and public decision making on risk issues. This debate was further stimulated by the Kourilsky-Viney report, and focused in particular on: • How to dead with uncertainty? Various ‘scales of plausibility’ have been proposed

by different actors;

• How to take ‘societal considerations’ into account in decision making, and the need for what is referred to as a ‘second circle of expertise’;

• The need for a formal assessment of benefits, which could be balanced with the risks.

1.2.5 Scales of plausibility The Kourilsky and Viney report emphasised the need to qualify different levels and types of scientific uncertainty. They argued that it is necessary to ‘distinguish between potential risk and fantasy or simple apprehension’ in order to adjust the level of importance given to different hypotheses, and to avoid an attitude of abstention based on ‘vague presuppositions’. They therefore proposed a ‘scale of plausibility of scientific hypotheses’. According to them, one must first imagine all possible risks, then eliminate those which are judged to be non-plausible. The remaining risks, which are judged to be plausible, can then be termed ‘potential risk’. It is then necessary to grade these potential risks and determine a trigger threshold for alert. On this basis, the authors define two categories of ‘potential risk’:

(i) High plausibility: ‘Substantiated potential risks’ (‘risques potentiels étayés’) Risks that are supported by experience (practical observation, empirical correlations and laboratory experiments) even though they have not been demonstrated. In these cases, the majority of scientists are convinced that the risk exists.

(ii) Medium plausibility: ‘Plausible potential risks’ (‘risques potentiels plausibles’): Several facts and observations serve as a basis for assumptions that are considered valid by a substantial portion of the scientific community but still need to be confirmed or disproved by empirical observations of scientific data. In these cases, there is a minority assumption based on a procedure considered valid by the majority of the scientific community.

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Thus, ‘A minority opinion founded on a procedure which is recognised by the majority as valid should be given attention. On the other hand, a minority opinion founded on a procedure which is not recognised by the majority should be considered with caution.’

The authors admitted that this distinction was subtle, but argued that it was essential to prevent decision-makers wasting resources on ‘pure suspicions’. They proposed that the general rule should be that only ‘substantiated potential risks’ should be taken into account in decision-making, whereas ‘plausible potential risks’ would only require further research.

Scales for the qualitative differentiation of risk hypotheses have also been developed by Bernard Chevassusx. Like Kourilsky and Viney, he proposed that ‘plausibility’ should be taken into account, and distinguished from mere probability, but his reasons where rather different: Chevassus argued that the concept of ‘plausibility’ was necessary in order to avoid the pitfalls of the standard established model for risk assessment (Chevassus 2000):

Under the ‘standard’ model, the sorting out process is simple: only hazards that have been proved to be harmful are taken into consideration, the rule being related to the scientific consensus on the existence of indisputable data to justify preventative measures. Once the uncertainty factor is taken into account, the examination must be broadened to distinguish between hazards that have some likelihood from those without any basis in fact. Our suggestion is that the concept of ‘plausibility’ of an assumption should be introduced here to refer to this degree of likelihood and to distinguish it from the notion of mere probability, used in the ‘standard’ model to describe the frequency with which a proven hazard occurs.

In a latter contribution, Chevassus (2001) suggested that plausibility can be defined on the basis of two dimensions: the quantity of information available and the degree of consensus among experts. When both of these dimensions are low, one is in a situation of ‘radical uncertainty’ (an example given is the risks associated with horizontal transfer of genes from plants to bacteria). When both are high, one is closer to certainty. Two distinct intermediary situations are however possible:

(i) Consensual uncertainty: low level of information but high degree of consensus

(ii) Conflicting uncertainty: high level of information but low level of consensus

He further argued that an operational application of the precautionary principle relies on an uncertainty scale derived not only from plausibility, but also reducibility and observability:

Reducibility means the ability of research programmes to rapidly reduce the uncertainty and to increase or decrease the plausibility of the hypothesis.

Observability refers to the ability to set up or imagine realistic observation measures that would be capable of detecting the hypothetical phenomenon if it occurred.

In this model, many different types of situation are possible. For example, medium plausibility and great reducibility should lead to further targeted research, whereas low reducibility and high observability would require setting up reinforced biovigilance measures. Uncertainty characterised by low plausibility, but also low observability and low reducibility could lead to measures to restrict or ban a product under the precautionary principle. The example given by Chevassus to illustrate is the recommendation to avoid the use of antibiotic resistance marker genes in GM plants.

Another related scale of plausibility has been proposed by Olivier Godard (Godard 2001): • Maximum Plausibility

• Known and ascertained risks

• Results accepted by the majority

• Hypothesis verified in an isolated fashion, to be confirmed

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• Hypothesis substantiated empirically or by modelling

• Hypothesis substantiated, but only accepted by a minority

• Hypothesis not substantiated, not refuted, but resulting from an accepted scientific method

• Hypothesis not substantiated, not refuted, but compatible with the state of knowledge

• Pure conjecture

• Ignorance about the possible existence of risk

• Minimum Plausibility

1.2.6 PP invoked by French government at the EU level Meanwhile, during this same period, the French government invoked the PP at the EU-level to justify restricting authorisations for the commercialisation of GM crops.

In November 1998, the French government invoked the PP to justify a moratorium on GM oilseed rape. It argued that because of the biological characteristics of oilseed rape, its commercialisation could provoke possible evolutions on agricultural practices – due to the loss of efficacy herbicides with favourable ecotoxicological profiles – and that these evolutions ‘must be assessed with respect to their global impact on the environment’. This decision clearly supported the notion that the government could refer to the PP to justify a restrictive risk management decision, even after positive advice of the experts committee, because of some uncertainties which were not considered in the narrow frame of analysis of this committee. (See Section 4.1.2 for further details.)

In June 1999, the French government led and signed the ‘de facto moratorium declaration’ at the Council meeting of Environment Minister. This also referred explicitly to the PP and stated that: ‘until rules ensuring labelling and traceability of GMOs and GMO-derived products in accordance with the preventative and precautionary principle, they will take steps to have any new authorisations for growing and placing on the market suspended.’ There have not been any further explicit and official declarations to clarify what ‘accordance with the PP’ might mean.

Box 2: French declaration for the EU de-facto moratorium

Declarations signed at the Council meeting of Environment Ministers on 24-25th June 1999

concerning the suspension of new GMO authorisations

The Governments of the following Member States (Denmark, Greece, France, Italy and Luxembourg), in exercising the powers vested in them regarding the growing and placing on the market of genetically modified organisms (GMOs),

- given the need to put in place a tighter, more transparent framework, in particular for risk assessment, having regard to the specifics of European ecosystems, monitoring and labelling,

- given the need to restore public and market confidence,

point to the importance of the Commission submitting without delay full draft rules ensuring labelling and traceability of GMOs and GMO-derived products and state that, pending the adoption of such rules, in accordance with preventive and precautionary principles, they will take steps to have any new authorisations for growing and placing on the market suspended.

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1.3 Period 3: 2000-2002 – the debate widens and shifts upstream After 1999, the framing of the GM debate shifted, under the influence of some NGOs, away from risk and towards broader political issues. NGOs referred less often still to the PP, and when they did it applied to a much wider range of issues than risk assessment and scientific expertise. Until then, the debate had mostly been framed with respect to the environmental and socio-economic impacts of the commercial cultivation of GM crops, the potential health impacts of GM food, and the lack of comprehensive labelling and thus consumer choice. The new dominant themes have been: labelling and traceability, patenting of life, the WTO approach to globalisation, the quality of food and alternative agricultural systems. There has also been a debate about the legitimacy of public sector research institutes (their role, organisation, priorities and partnerships with industry). Thus, the focus of the debate broadened and also moved upstream, from commercial cultivation of GM crops to field trials; and from the approval or not of innovations issued from applied research to the orientation of basic research.

Three key events in 2001 participated in this evolution in the dynamics of the GM debate:

(i) the CIRAD trial

(ii) a large-scale NGO campaign to destroy field tests in the summer of 2001; and

(ii) the recognition, by expert bodies and the government, that contamination of non-GM crops had occurred.

These hurdles provided some activists with the opportunity for promoting a different framing of the GM problem, which focused on field trials and challenged the very legitimacy of all research on GM crops: public or private, and regardless of whether it is innovation-centred or aims to assess potential risks. These two distinctions between types of research had been strongly promoted, especially by public sector scientists and research institutions, notably during the 1998 citizens’ conference. On that occasion, the citizen panel had accepted and endorsed this separation, and recommended in its report that more resources be devoted to public sector research, especially on risks associated with GMOs (for more details of this and other aspects of the 1998 citizens conference, see (Marris 1999).

1.3.1 The CIRAD trial The Agen trial was the first time that a trial was used as a public arena for the controversy on GM crops. Since then, a series of other trials of activists have occurred, and have similarly been used as a tribune against government policy on GMOs. One of the cases, the ‘CIRAD trial’, has created the most turmoil because: • The direct action was perpetuated against a public sector institute (CIRAD).

• That institute is devoted to research for agriculture in developing countries.

• José Bové, who had by then become a cultural folk hero, was one of the defendants, and was ultimately sent to jail due to the sentence passed down for this action.

• It followed the high profile ‘Millau McDonald affair’: in August 1999, José Bové and several other activists dismantled a McDonald’s store which was under construction in the town of Millau, in protest at the US sanctions (high taxes on Roquefort imported into the USA) against France following the WTO ruling in the hormone-treated beef case. Bové was arrested and kept in jail for several weeks. It was during this period that he rose to the status of cultural hero. See (Heller 2002) for further details.

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The legal case has stretched over several years, from June 1999, when the action was perpetrated, until November 2002 when Bové’s final appeal was rejected. He was finally captured and put in jail on 22nd June 2003.

Key events in CIRAD trial: • 5th June 1999: destruction of GM rice plantlets in CIRAD greenhouses at

Montpellier

• February-March: 2001 Trial at Court in Montpellier (Judgement on 15th March)

• 20 December 2001: Sentences passed by Montpellier Appeal court: 6 months for Bové and Riesel (not suspended), 6 months suspended jail for Soullier

• November 2002: Cassation Court rejects Bové’s appeal

• 22 June 2003: Bové captured at his home with great police demonstration and put in jail

• June-July 2003: campaign by NGOs, and some scientists, to obtain Presidential pardon or José Bové

• 14th July 2003 (national day): President Chirac announces that Bové’s sentence will be reduced

• August 2003: Bové released

On 5th June 1999, José Bové, together with local activists from the Confederation Paysanne and other local groups, and supported by a ‘caravan’ of ‘Indian peasants’ touring France at the time, destroyed GM rice plantlets in greenhouses at CIRAD in Montpellier. The trial, which occurred in February-March at the Montpellier court (Tribunal de Grande Instance) became a trial of public sector research – on GM crops, but even more generally. The willingness and capacity of public research institutes to work for the public good was put on trial not only in the arena of the Montpellier court but also, through this action and the succession of trials and sentences which ensued, in many other arenas. Discussions occurred among scientists, among NGOs, and in the media about the very legitimacy of public sector research, and also about the legitimacy of this type of direct actions against research activities as a means of protest.

The PP was not at the heart of these debates, but it was used by both sides, both to condemn ongoing research on GM crops and to support it.

Philippe Kourilsky was called as a witness by CIRAD and argued that:

the precautionary principle leads one to accompany research with sufficient means of measure and not to destroy the tools of research.

On the other side, two witnesses for the defence argued that:

the PP leads one not to undertake an action if there is a suspicion of risk for which we cannot measure the extent or severity (Arnaud Apoteker, Greenpeace-France)

the PP should be implemented given the scientific uncertainties (Guy Le Fur, Confederation Paysanne)

Defendants Bové and Soullier argued that their action was, in the name of the PP ‘justified, necessary and proportional’ and insisted that ‘given the numerous uncertainties related to GMOs, the PP must lead the authorities to take all necessary measures’.

Riesel chose a different line of defence which did not rely on the PP. Indeed, this activist has increasingly situated himself on the radical margins of the anti-GM movement and regards the use of the PP with some irony. He is opposed to what he qualifies as a ‘commoditised’ conception of the PP, which is ‘respectful of the economic interests of the nation’. He does consider that the destruction of GM field

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tests corresponds to an application of the PP, although he remains dubious about its scope:

Whatever the outcome, this court will have to answer one simple question: is the infamous precautionary principle made to be applied? If so, we applied it at the CIRAD. Or is it not rather destined to remain a fiction, a pretext for false debates which certainly do not aim to determine choices, since once again they are already made, nor even to clarify the stakes or the risks, since these are methodically ignored.

In its judgement, the court underlined that any application of the PP depends on the definition given to ‘proportional and effective measures’ mentioned in the definition of the PP in the 1995 environmental protection law. It decides to reject the defendants’ interpretation as follows:

The brutal destruction and annihilation of several months of work does not in any way constitute a proportional measure, contrary to the view upheld by the accused. The accused have not justified that they envisaged other means to oppose themselves to this dissemination that they judged to be imprudent.

If the extreme interpretation of this precautionary principle should finally be consecrated, according to which one should abstain from all activity in case of doubt about safety, this should be considered to be a societal choice of such extreme importance and potential heavy consequences that a few individuals cannot unilaterally and peremptorily assume the right to impose. Moreover, the question of whom (public authorities, private firms or individuals) is responsible for the application of this principle is far from being resolved.

The judge did not therefore accept the argument of the accused and of the witnesses who supported them according to which their actions represent the implementation of the PP. Interestingly, a key argument was that the actions taken were not ‘proportional’, implying that other more proportional measures should have been envisaged.

The Montpellier Appeal Court (on 20/12/2001) confirmed this position and underlined that ‘this precautionary principle is not a total abstention principle at the level of research, as clarified by the witness Geneviève Viney’. The fact that both Kourilsky and Viney were called as witnesses by CIRAD demonstrates how these trials were used as arena to attempt to mobilise the narrow and scientistic definition of the PP put forward in their report. And from the point of view of the strict legal proceedings, this strategy was successful since their arguments were taken on board by the initial court and the appeal court.

However, as already mentioned, the debate sparked off by the CIRAD action (in combination with other anti-GM direct actions which took place in the period 1999-2001) transgressed by far the confines of the court. Both the actions and the court trials were widely covered by the media, including prime time TV news coverage, but there were more fundamental ramifications as the debate was transported into diverse non-legal arenas (in particular reverberations in the scientific community, see Section 1.4.2).

1.3.2 Contamination of non-GM crops A key event which facilitated the upstream shift in the framing of the GM issue was the official recognition by the Government, in the summer of 2001, that conventional seeds had been contaminated by GMOs for a second year running. In 2000, the Government had already admitted that fields of supposedly non-GM oilseed rape (600 hectares) and maize (7-8000 hectares) had been found to be contaminated with GM material. It had ordered the destruction of the oilseed rape crop, but not the maize crop, on grounds that oilseed rape presented a risk of gene flow, but not maize. In 2001, analysis revealed again the presence of low percentages of GMOs in conventional seeds and on 23rd July, AFSSA published an opinion that stated that:

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‘the presence of GMOs in trace amounts in seeds or harvests of conventional varieties seems to have become a reality’. This opinion was taken up by the mainstream press and stimulated substantial media coverage for several weeks.

For many actors, this demonstrated that the idea of segregation, co-existence and traceability was an illusion, as was consumer choice related to GMOs. Furthermore, since there was next to no authorised commercial cultivation of GM crops in France (the few varieties of GM Bt maize authorised were in practice hardly used by farmers), one hypothesis was that the source of these contaminations might be GM field tests. This hypothesis was later rejected as it transpired that the source of contamination was probably imported seeds, but at the time, the official admission that field test might be involved brought these tests to the fore of the controversy. Questions were asked about how they could be justified, given the potential risks associated. Conflicts about field trials were not entirely new in France but the recognition by a governmental authority (AFSSA) that genetic pollution had already occurred and would be inescapable and irreversible once GM crops were released into the environment was seen by some to confer legitimacy to the actions and arguments of activists involved in the destruction of field-tests. The recognition of the central government’s failure to prevent the GM contaminations of non-GM crops also fuelled the campaign by local councils and mayors trying to ban GMOs in their communes (see Section 1.4.1).

At the end of August 2001, an unfortunate public comment by the Agricultural Minister stating that there were ‘good and bad GM field tests’ further inflamed the controversy, and led the Government to announce, at the end of August, that a public debate on GM field tests would be organised.

1.3.3 The ‘Four wise Men’s’ debate and report Known as the ‘Four Wise Men’s debate’, this event happened in February 2002 and resulted in a report written by the four organisers, who were Presidents of four national consultative commissions dealing with food policy, technology assessment, bioethics and sustainable development (Babusiaux 2002). Their recommendations provide novel dimensions to accounts of the PP.

The report emphasised that field experiments take place in a social space, and that as a result they should be subject to measures to ensure: public information and consultation, the participation of local mayors in the decision, legal liability, and protection of organic agriculture.

Assertions about the autonomy of scientific research are not longer acceptable to justify intrusion into the social space (Babusiaux et al., 2002)

The report suggested that authorisations for field trials should be submitted to a wider appraisal. This would be based on the ‘principle of parsimony’: it would consider whether dissemination in the environment was necessary in order to obtain the results, whether all possible research in laboratory had been carried-out, and whether the potential interest of the trial justified intrusion into the social space. Furthermore, the follow up of such experiments should be reinforced:

Dissemination of GMOs into the field, open on the social space, can only occur after tests in confined environments have been carried out to gather the maximum amount of information on risks and benefits of GMPs. In addition, the genetic sequence actually introduced, which is sometimes different to what had been planned by the experimenter, must be sequenced at this stage.

Authorisations for GM field experiments should no longer be based solely on the study of risks associated with that experiment, but also on the relationship between these risks and the benefits expected from the objectives of the experiment, as is the case for biomedical research on volunteers.

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We emphasise in any case that this phase of field experiments should only be used with parsimony, in order to verify results that cannot be modelled or obtained in confined environments.

This debate was an important moment in the public controversy on GMOs and contributed to a broadened interpretation of the PP. The report contained a number of policy recommendations, but since the Government changed shortly after its publication, it has had little impact on public decision making. In July 2002, the new Government authorised field experiments without taking account, or referring to, the recommendations of the four Wise Men. Despite this limited direct impact on public policy, the ‘report of the four wise men’ continues to be cited by many different actors in different contexts and arenas, to lend support to their positions, both for and against field trials.

Thus, the PP is invoked by some to support field trials (because of the need to accumulate further knowledge about potential risks) or to oppose them (because the risk of gene flow is so certain and there are alternative confined methods to produce the necessary knowledge). Interestingly, actors from both positions argue that the public is on their side. This was particularly apparent during the ‘4 Wise Men’s debate’. For example, François Ewald, philosopher and employed in the insurance sector declared:

This obligation to experiment follows from the application of the notion of the precautionary principle that is defined above all as an obligation to know. By precaution, we understand an obligation to experiment because of the obligation to end the irresolution and to produce statements that can be proved. This obligation also corresponds to the expectations of the citizen.

A similar interpretation was proposed by Pierre Pagesse, President of the seed company Limagrain:

I would like to share with you my definition of the precautionary principle: it is desirable to avoid acting without knowing but also not to forbid due to ignorance. Experimentation is necessary for plant breeding. The associated risks are mostly economic even if it is also important not to forget the risks associated with a too strong concentration of knowledge inherent to intellectual property.

On the other hand, organisations that have participated in the destruction of field trials argued that their actions were guided by the precautionary principle. For the anti-globalisation NGO ATTAC, the field trials were totally unjustifiable. The possibility of contamination had already been demonstrated numerous times. In this situation, no scientific justification could be invoked and the Government should assume its responsibility and apply the precautionary principle. ATTAC recognised the right for scientists to conduct research, but argued that this is circumscribed by superior rights: the precautionary principle and Human Rights.

The Confédération Paysanne stated:

These actions were carried out in order to prevent the risks of genetic pollution, in conformity with the precautionary principle, but also to alert public opinion about the stakes associated with the introduction of GMOs in agriculture.

For this farmers’ union, the precautionary principle challenges the certitude that science will always succeed in finding solutions to problems that arise or that scientific discoveries generate. Researchers and policy makers should therefore assume the worst, taking into account real knowledge or fears of scientists that have not yet been validated which suggest inherent risks associated with the development of a technology. This principle should be applied in an absolute fashion, over and above all economic interests.

The mainstream farmers’ trade union, the FNSEA, adopted a different point of view:

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[the FNSEA] is against the commercial cultivation of GMOs but in favour of research, including in open fields. Research in open fields is the only means to know the real effects of the dissemination of GMOs in the environment and the effect of the environment on ‘improved’ plants as well as their agronomic behaviour. It is also the only means to be able to implement the precautionary principle if the risks of GMOs for health and the environment are verified.

As can be seen, in this debate, the ways in which the PP might imply different kinds of practices for risk assessment, risk management or stakeholder roles is not elaborated. For those that support GMOs, the PP is more or less assimilated with risk assessment, and this assessment is necessary for deciding whether or not to commercialise GM crops. Those who oppose GMOs argue that the field experiments themselves constitute a risk and will in any case not provide any additional useful information compared with what can be obtained in confined environments. In addition, they argue that GM crops should be stopped for reasons other than health and environmental risks, but they do not link these reasons with the precautionary principle. An extreme position was taken by the Greenpeace representative during the 4 Wise Men debate: he stated that scientists could carry out all the experiments they wanted to demonstrate that GM crops were safe, but that he would in any case remain opposed to their use. He did not however invoke the PP to justify this position.

Following the publication of the 4 Wise Men’s report, and the new Government’s decision to authorise 8 new field tests in July 2002, one environmental NGO issued a press release which did elaborate the kinds of measures they understood to derive from the PP:

France Nature Environment awaits clarification from the Ministry of Agriculture about the 2002 field tests and reminds the Ministry of the conclusions of the four Wise Men charged by the previous Government to organise a debate on GMOs: a democratic control of experimental conditions, the reinforcement of the prerogatives of mayors for the implantation of field tests, the remoulding of authorities for scientific expertise, the control of contaminations and the setting up of an insurance system. Admittedly, following the appeals lodged by France Nature Environnement in 2000 and 2001, the list of the 2002 field tests was made public in mid-May. It is regularly updated, but without any kind of publicity. This explains the delay in revelations about new authorisations.

This transparency is truncated because it no longer allows us to obtain minimal information such as the surface area off the tests, even from the regional authorities. It is moreover misleading due to the fact that mayors of the communes concerned are only informed a posteriori, and worse still, some field tests are set up before notification from official authorities!

1.4 Period 4: 2003-2004 – conflicting expertise and regional bans Although explicit references to the PP by all kinds of actors decreased, the academic debate on the PP did not die out and was rekindled in 2003 by the proposal of President Chirac to introduce the PP into the French Constitution. Although the proposed text uses the PP in reference to environmental issues, the debate is clearly about the use of science in decision making and the management of risks and innovation. The Academy of Sciences has strongly opposed the incorporation of the PP into the constitution (or any organic law), whereas a network of citizens and scientists has mobilised to support this idea.

In 2003, proposals for the commercial authorisation of GM crops and food began to be assessed by French authorities and expert committees once again, after a gap of over two years. This provided the opportunity to test the new institutions and practices for risk assessment and risk management which had been installed in 1998-1999. We analyse these new institutional arrangements in the next part of the report.

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During this period, the campaign for local and regional governments to ban GMOs from their territories also gained more impetus, and could become a key feature of the controversy in the coming months as an increasing number of regional governments held by the socialist party declare themselves ‘GM free’.

1.4.1 Invocation of the PP by local authorities Since 2001, and in defiance of central government, some local governments (at the level of communes and regions) have issued bans for the cultivation of GM crops in their territories (field tests and/or commercial) and/or GM food from their canteens (in school and other institutions run by local governments).

The PP has been explicitly invoked by local governments to justify these bans, through reference to the 1995 Loi Barnierxi, and article 130-R-2 of the Maastricht Treaty. In most cases, models provided by environmental NGOs are used to elaborate the texts of local council deliberations and local Arrêtés. Significantly different texts have however been adopted. For example the text proposed by the environmental NGO France Nature Environnement is relatively limited in scope and makes no reference to risks:

the cultivation in open fields of genetically modified plants of species xxx is forbidden for the current year on the entire territory of the commune.

In contrast, the text adopted by the Mayor of Coings is more general and demands that the absence of risk be ascertained before allowing cultivation of GM crops:

Article 1: In farming zones of the commune of Coings, plantations of GMO are only authorised in confined sites, excluding all risk of genetic pollution. Article 2: The plantation of GMOs in open fields will remain forbidden until the certitude of the absence of risk has been established.

The French State (via the Préfets of the Departments in question) has taken legal action against many of these bans, and until December 2003, the courts had each time sided with the State and deemed that they were illegal. The contestation of these bans has not referred to the PP: it is the authority of the mayors, as opposed to the central government, to take such a decision that has been challenged.

Following the ‘Four wise men’s’ debate’ in February 2002, the demand by mayors to have more power about such decisions on their local territory was given more credence. The four wise men supported the demand of the mayors. The necessity for mayors to play a greater role was also acknowledged in the report on GMOs by Senators Bizet and Pastor in June 2003.

In December 2003, for the first time, a local government ban of GMOs was upheld by the court, and this decision was confirmed at an appeal court in February 2004xii. To get around previous objections, this ban was limited in time, and only concerned areas surrounding organic farms.

Some regional government, natural parks and Chambers of Agriculture have also issued local bans on GMOs.

In elections held in March 2004, the socialists (who had been in opposition at the national parliament since 2002) gained power of many regional governments, and most of these regions have issued or are considering issuing bans on GMOs (by the end of April, 11 out of 22 regions had issued bans).

1.4.2 Scientific community mobilised and divided The CIRAD trial had particularly strong reverberations in the scientific arena.

The Academy of Sciences, in a Press Release of 22/11/01, invoked the PP to support the field tests and condemn those that destroy them:

The Academy of Sciences firmly condemns the destruction of experimental fields of research institutes (CIRAD, INRA), which were destined to analyse genetic transfers from transgenic crops. It also condemns the

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systematic destruction of research tools destined to assess the benefits as well as the potential risks associated with the use of transgenic plants, as required by the precautionary principle.

In the summer of 2003, in two opposing petitions signed by scientists, one to defend the actions of José Bové and other activists involved in anti-GM direct actions, the other to condemn such actions. According to a first ‘open letter to the President’, signed by employees at public research institutions in Montpellier (where the action against CIRAD took place), ‘these actions can be considered as the implementation of the precautionary principle’. However, the shorter text for the national petition entitled ‘Open Research’ (‘Ouvrons la recherche’)xiii which evolved from this local open letter dropped this explicit mention of the PP.

In response to the large-scale destructions of GM field trials in the summer of 2003, and to the ‘Open Research’ petition, another group of scientists launched a second petition in September 2003 entitled ‘Defend Research’ (‘Defendons la recherche’). This did not explicitly mention the PP. It argued that these ‘acts of destruction prevent the progression of knowledge and obscure any serene debate on GM crops’.

By October 2003, 1200 people had signed the petition ‘Defend Research’ and 800 ‘Open Research’. By February 2004, the number of signatories was 2200 and 900.

These two petitions were used in the media to portray the French scientific community as ‘torn apart’ by the debate on GM crops (Le Monde, 18/09/03). Indeed, the two petitions demonstrate two distinct framings for the issue of GM field trials (see Table 2).

In February 2004, the initiators of the petition ‘Open Research’ joined forces with the NGO Fondation Sciences Citoyennes (created in 2002 to promote democratic governance of research and technology and governmental support to NGO-based and participatory research) to organise a national debate on the orientation of agricultural research in public research institutes.

Table 2: Two framings of the controversy on GM field trials

Open research Defend research Destructions of GM field tests:

- are described as ‘collective actions’- have not seriously jeopardised

research (in the case of CIRAD, because the GM rice was not going to be planted out anyway, due to refusal of French rice farmers to grow it on their land)

- provided a useful ‘alert’ to the scientific community about the dangers of the use of GMOs

- can be seen as implementation of precautionary principle

Destructions of GM field tests: - are described as ‘ransacking’

(‘saccages’) - represent a serious loss to

research capacity for GM plants; field tests are indispensable for research

- threaten French independence and competitiveness with respect to agriculture and food

- are not legal nor legitimate - prevent the progression of

knowledge - obscure any serene debate on GM

crops The incarceration of José Bové is disproportionate with the facts. Bové represents the incarnation of the legitimate issues raised by the use and dissemination of GMOs. He should be pardoned and released from jail.

No mention of Bové.

GMOs are a war machine of multinational firms aiming to control peasants and

GM crops are being massively developed and field tested in the rest of the world

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agriculture all over the world Patents are a tool for these firms to make peasants pay for genetic biodiversity, which has always been free

(North America, China, India) without any controversy. France is loosing ground with regards to its scientific and economic competitiveness. France risks becoming dependant on imported or obsolete seeds. No mention of patents.

Basic research must be pursued. It is only the dissemination of GMOs into the environment which is challenged.

Genetic modification has become an indispensable tool for research. In the future, most commercial crop varieties will be developed using knowledge derived from plant biotechnology, even if they are not all be GM.

The dissemination of GMOs will without a doubt contaminate the environment. There are many uncertainties about the irreversibility of the diffusion of GMOs.

The field tests are carried out in conditions which present no risks to humans or the environment, have been authorised, and are under the control of the State.

Public sector research institutions must open up to a debate with consumers and citizens about the orientations of research programmes and the policy of partnerships with industry. Civil society must participate in decisions about the aims and use of the results of research. The State and Civil Society must unite to control the results of public research to prevent multinational firms gaining control.

The Government must take the necessary measures to enable crop research to fulfil its mission unimpeded. We (members of the scientific community) must:

- explain the evolution of our research;

- be attentive to the needs and wishes of society;

- guarantee freedom of choice for farmers and consumers.

Key words/concepts: - Precautionary principle,

sustainable development - Debate - Agriculture, Food, Peasant,

Diversity - GMOs (acronym)

- Dissemination, contamination

Key words/concepts: - Competitiveness, progress,

knowledge, freedom of choice - Explain - Agricultural and food issues - Plant biology, genetic

improvement, transgenesis, biotechnology (no mention of genetically modified organisms or acronym GMO, a few mentions of ‘genetically modified varieties’).

- Field trials

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Part II: The regulation of gm crops In this second part of the report, we analyse institutional practices for the regulation of GM crops and food (including animal feed) in France. The analysis follows the trail of dossiers submitted by petitioners requesting authorisations to release GMOs into the environment and describes the roles played by the institutions (some scientific, others not) which intervene at different stages. • We start by describing the institutional arrangements for processing applications

for experimental and market releases of GM crops and food, and how they have evolved in parallel with evolutions in EU-level GM legislation, the public controversy on GMOs, and broader transformations in the French risk regulation landscape.

• We then describe the legislative basis, composition and practices of the expert scientific bodies involved: the CGB, AFSSA and the biovigilance committee.

• We can then analyse in more detail the way in which specific applications have been dealt with, and tease out from this analysis the way in which different risks have been framed, and how these framings have evolved over time.

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2 Institutional arrangements for GM risk regulation

2.1 Situation before the implementation of Directive 90/220 Government oversight for GMOs began early in France. From 1973, laboratories had to obtain certification for the confined use of GMOs, and this was issued on the basis of advice from a committee of scientific experts.

For unconfined use (deliberate release into the environment), a voluntary regulatory system was set up in 1986. Although prior governmental authorisation for the release of GMOs into the environment was not statutorily required at this time, firms and research institutes were encouraged to submit proposals to the Ministry of Agriculture. The dossiers were examined by a committee of scientific expertsxiv, which was under the control (‘tutelage’ in French) of the Ministry of Agriculture.

2.2 Situation under Directive 90/220, from 1992 to 1996 For Directive 90/220, the ‘competent authority’ was the Ministry of Agriculture, and more specifically the Food Directorate within that Ministry. This information was transmitted in writing to the European Commission, but was not made explicit in any French legal text or any other not public document. It is interesting to note, however, that the different responsibilities attributed to the ‘competent authority or authorities’ under Directive 90/220 were distributed to separate bodies in France. Thus, the administrative processing of dossiers, risk assessment and responsibility for issuing authorisations are not carried out by the same bodies (see Table 3).

In 1992, a GM lawxv was adopted which transposed both Directives 90/219 and 90/220, for the confined use and deliberate release of GMOs respectively. From then on, prior governmental authorisation for both the confined use and the deliberate release of GMOs was a statutory requirement. This GM law stated that authorisations (for both experimental releases and market authorisations) would be issued by the ‘administrative authority’, but the identity of this authority was only established in subsequent ‘application decrees’, which defined how the law should be enforced, sector by sector. Responsibility for granting authorisations depended on the type of GMO concerned (see Table 3).

In practice, however, all GMO dossiers submitted for authorisations under the deliberate release directives since 1992 have been plants or medicines. Thus, the procedures described in lines 2, 3 and 5 of Table 3 have never been utilised. (There were some deliberate releases of GM bacteria in France in the late 1980s, but this was before the adoption of the 1992 GM law).

Up to 1997, the situation with respect to GM plants (to be used as crops and/or food and/or feed) was relatively simple: all proposals for the deliberate release of GM plants or seeds submitted under Directive 90/220 were submitted to the Ministry of Agriculture, who processed the dossiers. Authorisations were granted by the Minister of Agriculture, although he had to obtain the agreement of the Minister of the Environment. This applied to both experimental (Part B) and market (Part C) dossiers.

In most cases, the authority which processed the dossier was also the one which defined the contents of the dossier submitted by petitioners. However, for veterinary medicines, the CNEVA was responsible for processing the dossiers and issued the authorisations, whereas the Ministries of Agriculture and Health defined the contents of the dossiers submitted. In all cases, the opinion of the CGB was required with respect to the content of the dossiers (and this content is also largely determined by EU-level legislation).

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The 1992 GM law established that a committee, which became known as the CGB, was responsible for assessing the risks associated with the deliberate release of GMOs into the environment (see Section 3.1 for the composition an organisation of the CGB). Each of the application decrees listed in Table 3 stated that the advice of the CGB had to be requested by the authority responsible for processing the dossiers. Thus the CGB had to be consulted, regardless of the type of organism, the final use or whether it was an experimental or market release. In addition:

(i) For the commercial cultivation of GM varieties, the CTPS, which is the expert body which deals with inscriptions onto the national seed catalogue, also had to be consulted.

(ii) In cases where ‘the CGB signals the existence of a potential risk for public health related to the consumption of products issued from a GM plant’, another committee which specialises in public health, the CSHPF, also had to be consulted. Note that it was the CGB, not the Ministry of Agriculture, which decided whether or not the opinion of the CSHPF was necessary. In practice, the CGB systematically asked for the opinion of the CSHPF for all part C dossiers, but not for part B dossiers. The CSHPF constituted a Biotechnology working group to examine these GM dossiers.

Table 3: Distribution of competencies for GMOs under the Deliberate Release Directives

Year of decree

Types of GM organisms concerned

Authority responsible for issuing authorisation

Authority responsible for administrative processing

Expert body consulted up to 1999

Expert body consulted from 1999

1993xvi Plants and seeds (regardless of their final use)

Minister of Agriculture, after agreement of Minister of Environment

Minister for Agriculture CGB in all cases Also CTPS for commercialisation of seeds Also CSHPF if CGB signals potential risk for public health related to the consumption of these products

CGB Also CTPS for commercialisation of seeds

Also AFSSAxvii either : - if CGB signals potential

risk for public health related to the consumption of these products; or

- if plant or seed is destined to be consumed by farm animals

1994xviii Organisms, other than plants and seeds, which are destined to be used as human food

Jointly by the Minister for Consumers and the Minister for Agriculture, after agreement of the Minister of the Environment

Minister for Consumers CGB and CSHPF CGB and AFSSAxix

1995xx Animals Minister of Agriculture, after agreement of the Minister for the Environment

Minister for Agriculture CGB CGB Also AFSSA, if animal destined as human foodxxi

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1995xxii Human medicines, including gene therapy

Agency for Medicines (became AFSSAPS in 1998)xxiii, after agreement of the Minister for the Environment

Agency for Medicines CGB CGB

1995xxiv Veterinary medicines CNEVA (incorporated into AFSSA in 1998), after agreement of the Minister for the Environment

AFSSA CGB CGB

1996xxv All except: - those covered

by the above decrees

- phytosanitary products

- fertilisers - animal feed

products other than plants, seeds and farm animals

Minister for the Environment Minister for the Environment

CGB CGB

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2.3 Situation from 1997 to February 2004

2.3.1 Part C dossiers Two important changes occurred in 1997 and 1998. First, when the Novel Food Regulation (258/97) was adopted, responsibility for processing dossiers submitted under this Regulation was not attributed to the Minister for Agriculture, but to the Minister for Consumers and more specifically the Directorate for Competition, Consumers and Fraud, DGCCRF (which is situated within the Ministry for Industry, Finance and Economy). As for Directive 90/220, this decision about the identity of the ‘competent authority’, as defined in the EC Regulation, was transmitted to the European Commission, but was not published in any French legal text or other public document.

Second, the French Agency for Food Safety (AFSSA) was created in 1998 and was given statutory responsibility for the assessment of sanitary risks associated with food products composed of or derived from GMOsxxvi. (For more information about AFSSA, see Section 3.2) A 1999xxvii decree established that AFSSA had to be consulted: • for GM plants and seeds, if they were destined to be consumed by farm animals;

• for GM animals, if they were destined to be consumed by humans;

• for GM organisms, other than plants and seeds, which are destined to be used as human food.

Overall, this 1999 decree also established that AFSSA took over all responsibilities which had previously been attributed to the CSHPF, which meant that AFSSA also had to be consulted in cases where ‘the CGB signals the existence of a potential risk for public health related to the consumption of products issued from a GM plant’. In practice, this has been interpreted as meaning that AFSSA has to be consulted, in addition to the cases listed above, on any GMO dossier which concerns a product destined to be consumed by humans.

The combination of these two developments meant that, after 1997, the administration and assessment procedures for proposals to commercialise GM crops and food depended on whether the dossiers was submitted under the Deliberate Release Directives (90/220 then 2001/18) or the Novel Food Regulation (258/97). 1997 to 2000 was a transitional period, due to the creation and establishment of the French Food Safety Agency. But from 2000 onwards, the procedure followed was that:

(i) Dossiers submitted under the Deliberate Release Directives continued to be processed by the Ministry for Agriculture and more specifically the Food Directorate, DGAL; but risk assessment was now conducted by the CGB and by AFSSA, which examined health risks associated with use as animal feed. Decisions about how to deal with the dossiers (i.e. whether or not to raise objections at the EU-level; or, for dossiers submitted in France, whether or not to transmit dossiers to the European Commission, for Directive 90/220 dossiers; or about the content of the Initial Assessment Report transmitted to the European Commission, for Directive 2001/18 dossiers) should in theory be taken, as before, by the Minister of Agriculture, after agreement of the Minister for the Environment. However, since 1997, with the rise of the French GM public controversy, these decisions have in fact tended to be taken at inter-ministerial level rather than being left solely up to the Ministers mentioned in the statutes.

(ii) Dossiers submitted under the Novel Food Regulation 258/97 were processed by the Minister for Consumers (which is situated within the Ministry for Industry, Finance and Economy) and more specifically by the Directorate for Competition, Consumers and Fraud, DGCCRF. Risk assessment was conducted by AFSSA..

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These dossiers were not submitted to the CGB. Decisions about how to deal with the dossiers at the EU level should in theory be made by the Minister for Consumers (i.e. drawing up the Initial Assessment Report forwarded to the EC for dossiers submitted in France and deciding whether or not to raise objections for dossiers submitted in other Member States). However, since 1997, with the rise of the French GM public controversy, these decisions have in fact tended to be taken at inter-ministerial level rather than being left solely up to the Ministers mentioned in the statutes.

Thus, AFSSA was consulted in both cases, but the CGB was only consulted for dossiers submitted under the Deliberate Release Directives. However, when a DRD dossier was submitted to AFSSA, it was supposed to examine only risks associated with use a animal feed; risks associated with use as human food were dealt with by AFSSA only when a dossier was submitted under Regulation 258/97.

In practice, many GM transformation events have been submitted to both the Deliberate Release Directives and the Novel Food Regulation, which means that they were in any case assessed both by the CGB and by AFSSA; and that AFSSA has often had to carry out risk assessments for the same GM transformation event under both legislations (see Table 7). There has, however, been one notable exception to this practice, with respect to Bt11 (see Section 5.4).

The roles between the CGB and AFSSA therefore overlap. The remit of the CGB is, by virtue of the 1992 law and all its application decrees, large: it is responsible for assessing risks to both the environment and to human health associated with any type of GMO released into the environment. AFSSA’s remit is narrower: it is only responsible for risks to human health associated with (human) food and (animal) feed products. Risks to human and animal health are therefore assessed by both expert bodies, but risks to the environment are only examined by the CGB.

2.3.2 Part B dossiers There was no statutory change in the period 1997-2003 with respect to Part B dossiers: the dossiers were processed by the Ministry for Agriculture (DGAL); risk assessment was conducted by the CGB; and authorisations were granted by Minister for Agriculture, after agreement of the Minister of Environment. However, as for commercial releases, decisions have, in some cases, been made at inter-ministerial level due to the increasingly controversial nature of GM field tests.

There have however been gradual changes with respect to public information and consultation for experimental field releases:

(i) Since 2001, following a court case instigated and won by environmental NGO France Nature Environment (FNE), the location of field tests (at least to the level of the commune) have been made public, and are accessible on the government’s GMO website. Before that, information was only available on request at the local town hall, at least in theory; but FNE exposed the fact that, in practice, this information was often difficult or impossible to obtain, even at the local town hall.

(ii) Since 2003, the Ministry of Agriculture has organised internet consultations about proposed experimental releases: summary information about proposals which have obtained favourable opinions from the CGB are posted on the web site, and the public has two weeks to make comments.

Moreover, the standard formula for authorisations has evolved. Until 2003, they simply referred to the agreement of the Minister for the Environment and the opinion of the CGB, and stated that the experiment was authorised ‘under the conditions described in the CGB opinion’. Since the spring of 2003, the authorisations explicitly state the conditions which must be adhered to, rather than simply referring to the opinion of the CGB; and also state (i) ‘that the opinions expressed by the public on this dossier during the public consultation organised on the website www.agriculture.gouv do not bring any elements which challenge the awarding of this

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authorisation’, and (ii) that the results of consultation with local mayors have been taken into account (see also Section 4.2).

2.4 Future situation under EU Regulation 1929/2003 In April 2004, Regulation 1829/2003 on Novel Food and Novel Feed came into force, and replaced Regulation 258/97. It established a centralised EU-level risk assessment procedure for GMOs and their derivatives destined to be used as human food or animal feed products. National authorities will still need to be consulted, however, with respect to environmental risks in cases where the food or feed is a whole GMO (as opposed to a derivative).

A new French GM law is currently being prepared, which should implement Directive 2001/18, Regulation 1829/2003 and Regulation 1930/2003 on labelling and traceability (Directive 2001/18 has not yet been transposed into French law, but came into force anyway in October 2002).

It has been suggested that under the new GM law, it would no longer be statutorily obligatory to consult AFSSA for dossiers submitted under Directive 2001/18, because these dossiers will relate essentially to environmental risks.

Since the risk assessment for Novel Food and Feed dossiers will proceed at the EU-level, there may no loner be any need for the assessment of health risks at the national level. The role of AFSSA in this new regulatory landscape for GM feed and food products is currently unknown. The Agency may be by-passed altogether by EU-level procedures for risk assessment.

The new law should also clarify arrangements for public consultation, and may provide for more information and consultation of local mayors with respect to experimental releases.

The new law has been under discussion within government departments since 2001. Throughout the PEG project (since January 2002), we were repeatedly told in interviews with civil servants that the first draft would be published ‘within a few months’, but this has still not occurred. According to our interviewees, the main points of tension between different government departments – and in particular between the ministry for Agriculture and the Ministry for the Environment – relate to public consultation, the role of the non-scientists in risk assessment, and the power given to local governments to ban GMOs from their territory.

2.5 Devolution of powers from central government PEG studies in Austria, Germany, Spain and the United Kingdom have demonstrated the additional complexity introduced by devolution of certain responsibilities for risk assessment and/or risk management from central to regional governments. In France, all risk assessment and all decisions about authorisations for field tests or commercial use of GMOs have so far been taken by central government.

However, since 2001, and in defiance of central government, some local governments (at the level of communes and regions), have issued bans for GM crops in their territories (field tests and/or commercial) (see Section 4.2). In response to this movement, central government (the Ministry of Agriculture) began, in 2003, to consult mayors for each proposed field test in their locality, and refers to this consultation in their decisions to authorise the field test. The extent to which the Mayo can influence the decision is however unclear.

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3 Scientific expert bodies 3.1 The CGB

3.1.1 Statutory arrangements established by 1992 GM law The first scientific expert committee to deal with the deliberate release of GMOs into the environment was established in 1986xxviii. Although prior governmental authorisation for the release of GMOs into the environment was not required at that time, firms and research institutes were encouraged to submit proposals to the Ministry of Agriculture. The dossiers were examined by this scientific committee, which was under tutelage of the Ministry of Agriculture. Members were named by the Ministry for a period of 3 years.

The 1992 GM law which transposed Directive 90/220 (Article 3) established that a committee would be charged with assessing the risks associated with the deliberate release of GMOs into the environment. The name given to this committee in the law was ‘Commission d’étude de la dissémination des produits issus du génie biomoléculaire’ but it has become known under the abbreviated name ‘Commission du Génie Biomoléculaire’ and the acronym CGB. The 92 law specified that at least half the members would be scientists, but that it would also have one representative of the Parliamentary Office for Technology Assessment (OPECST), and representatives of environmental NGOs, consumer NGOs, employee organisations and relevant professional groups.

In 1993 an application decree further defined its composition and organisationxxix. The CGB would be composed of 18 members, including 11 scientists and 7 representatives of civil society (see Box 3). The members are nominated for 3 years by the Ministers for Agriculture and the Environment, but the Ministers for Health, Consumers, and Defence are also consulted. The President is nominated by the Ministers of Agriculture and the Environment. Civil servants who are members of the secretariat attend the meetings, and a representative of the Minister of Health can also attend. The CGB can call upon external advice of its choice to address specific issues.

Box 3: Composition of CGB

• 11 scientists ‘chosen according to their competence in fields connected to genetic engineering’

• 1 representative of industries developing GMOs

• 1 representative of farming production

• 1 representative of a consumer NGO

• 1 representative of an environmental NGO

• representative of employees from industries developing GMOs

• 1 representative of the Parliamentary Office for Technology Assessment (OPECST)

• 1 person chosen for their competence in the legal field

The committee was no longer under the sole authority of the Ministry of Agriculture, but under co-tutelage of the Ministries of Agriculture and Environment. The Ministry of Agriculture still, however, played the lead role. Thus, the CGB secretariat was to be run by the Ministry of Agriculture, ‘assisted by the Ministry of Environment’.

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In May 1993, the first members of the CGB were nominated by decree. Many of the members, including the President, had been members of the previous expert body responsible for deliberate releases since 1986.

In May 1996, the mandate of these members formally came to an end and the members should have been nominated again by decree. This was not done and instead, in May 1997, the existing members’ mandate was prolonged for six monthsxxx. The environmental NGO Ecoropa appealed against this irregularity at the Conseil d’Etat and won the case in 1999. This meant that the CGB was deemed to have been illegally constituted between May 1996 and July 1998 (when a new membership of the CGB was properly appointedxxxi); and thus all opinions issued during that period were annulled. It also meant that any governmental decisions taken on the basis of those opinions could be challenged. In practice, the Ministry of Agriculture asked the CGB to reconsider all the Part C dossiers submitted in France which were still outstanding in the autumn of 1998 and to reissue new opinions (see Annex I). Similarly, new opinions were issued for all Part B dossiers where the trials were still in place (approximately 50).

3.1.2 Evolutions in the composition of the CGB From 1993 to 1997, the organisation of the CGB and the expertise it generated remained uncontroversial and the committee was largely left to carry out its work in isolation from any public debate. Some controversies arose in scientific arenas, in particular with respect to interspecific gene flow for beet and oilseed rape, especially when the introduced GM trait was tolerance to a broad spectrum herbicide which some felt needed to be protected. But these controversies were confined to circles of scientists, through meetings and seminars (see Section 4.1 and Roy 2000a).

During this period the Ministry for Agriculture systematically followed the advice of the CGB with respect to both field trials and commercial use: as soon as a dossier obtained a favourable opinion from the CGB, it was granted an authorisation (for Part B dossiers) or transmitted to the EC (in the case of Part C dossiers). Indeed, during this period, it was easy to believe that it was in fact the CGB making the decisions related to risk management, as well as conducting the risk assessment (see Section 6.3).

This tranquil existence was shattered in February 1997 when the Government decided to grant the final consent for Bt176, but not to authorise its cultivation in France (see discussion of ‘Bt176 saga’ in Part I). The President of the CGB, Axel Kahn, resigned immediately, claiming that this decision demonstrated that the Government had no faith in the expertise provided by his committee.

Following this resignation and the associated emergence of the GM controversy in France, many criticisms of the CGB – and of its President – arose. These were for example discussed during the public hearings organised by the Parliamentary Office for Technology Assessment (OPECST) in May 1998, and during the consensus conference on GMOs in June 1998. Following these public debates, a general consensus emerged about the need to reform the CGB: it should be less dominated by molecular biologists, avoid being seen as mostly composed of pro-GM members, and be more transparent. The role of the representatives of civil society was also discussed (see below, Section 3.1.8)

In July 1998, a new set of CGB members was nominated, but no changes were made to the 1993 decree that establishes its composition. Thus, formally, there was no change in the composition or organisation of the CGB. In practice, however, it seemed that the Government attempted to change the nature of the membership by: • including broader scientific expertise (agronomy, population genetics); and

• appointing at least one scientific member with well-publicised views against GM crops.

This recomposed CGB was expected to be only temporary, for 6 months, pending the adoption of a new decree that would change the composition of the committee, clarify

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its mandate, and create a ‘societal commission’. In the event, five years on, no new legislation has yet been adopted, and this issue is still being discussed at inter-ministerial level (see below, Section 3.1.8).

In 1999 our analysis, based on interviews and field work carried out in 1998, was that this new CGB was more multidisciplinary, more diverse in its risk framings, and thus ‘more precautionary’ (Roy 2000b). Whereas civil servants and CGB members interviewed in 1998 tended to be proud of this new culture, recent interviews with CGB members and the secretariat deny this and suggest that the only change was the appointment of a scientist with ‘anti-GM views’. Research carried out for a recent PhD thesis (Granjou 2004) suggests that 1998-2003 represented an opening out period for the CGB, but that following the resignation of a number of key members appointed in 1998, and to changes in the membership of the secretariat in April 2003, this has now reverted back to a more closed culture.

3.1.3 An experiment in ‘conflicting expertise’? The most significant change in the ‘new CGB’ established in 1998 related to the visibility of conflicting opinions within the CGB. When the committee was recomposed in 1998, at least one member was chosen explicitly for his well known and publicly stated views against GMOs in order to introduce what is referred to in France as ‘conflicting expertise’ (‘expertise contradictoire’).

The lack of scientific controversy or ‘conflict’ (i.e. expression of opposing views) within the committee was one of the critiques addressed to the CGB around 1998, notably by academic lawyer Marie-Angèle Hermitte (Hermitte 1997; Le Roy 1996). Axel Kahn had been proud to state that nearly all decisions were consensual among members of the committee: up to 1994, the committee had examined 220 dossiers and only four had necessitated a vote. This pride demonstrated an implicit model of science and expertise, grounded in the belief that if a group of good, reasonable and rational scientists with no political or economic vested interests discuss a problem together, it is natural that they will come to a consensus, and that this consensus will reflect the best scientific knowledge available. In contrast, the new CGB admitted that members of the committee do not always agree. The new internal rules require a vote on each dossier, and the quantitative result of the vote is recorded in the minutes. The minutes of the meetings are however kept confidential, because it is feared that the public would be worried if it could see that experts disagreed. For the same reason, the final opinions expressed do not mention the results of the vote, or any minority opinions expressed: they are considered to be a consensual opinion from the CGB, even when some votes were cast against. In these ways, the procedures aim to encourage ‘conflicting’ debate within the confines of the CGB, but do not wish to expose conflicting opinions to the outside world.

The 1992 GM law stated that members of the CGB can ask for a personal contribution to be annexed to the annual report, but until 1998, no member had ever used this opportunity. One member appointed in 1998 (the one perceived as having anti-GM views) has chosen to publish statements every year that criticise the workings of the CGB, focusing in particular on: • The undue reliance on a small number of external experts, often members of the

‘old’ CGB and favourable to GMOs.

• A shared credo among the members in favour of GMOs.

• The undue consideration given to the additional costs to the petitioner that requests for further information or test would require.

• The lack of sub-chronic or chronic toxicological tests on animals in the dossiers submitted.

Even though he is Professor in a University cellular biology department, some members of the CGB denigrate the scientific credentials of this member, and believe that he was only appointed because of his anti-GM views. In interviews, they argue

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that his participation does not contribute anything positive, stating that he systematically asks the same questions again and again even though an adequate scientific response has already been given. It is also stated that he systematically votes against all favourable opinions for field test or commercial authorisations, even when he has no more specific scientific objections to raise. This is perceived as demonstrating that his position is based on ‘other’, non-scientific reasons. Others, however, argue that he plays an important positive role, asking challenging questions which push the other members, and the applicants, further in their reasoning.

3.1.4 Internal rules of the CGB The 1993 decree states that the CGB establishes its own internal rules. The first set, adopted in 1993, established that each dossier would be assessed by one external rapporteur and two internal rapporteurs. A list of potential external rapporteurs is drawn up by the CGB, and for each dossier the President proposes three names to the petitioner, who makes the final choice. External rapporteurs are auditioned by the committee, which then deliberates in their absence.

According to the rules, petitioners are also systematically auditioned; but in practice this is not always the case, especially for Part B dossiers.

These rules also state that the CGB can study ‘any question that seems important enough to justify sending an opinion to the concerned authorities’; but this capacity for self-referral was not established by law and the CGB has to date never used it.

The ‘new CGB’ adopted new rules in 1998 to define the internal procedures of the committee. Comparing these rules with those adopted by the CGB in 1993 reveals several significant modifications, especially with respect to the relative role of the President and secretariat. It is however possible that these modifications simply update the rules to describe what had already entered into the routine practices of the CGB, and may not represent real novel practices.

The role of the secretariat was increased (it was mentioned 13 times in the 1998 rules but only 3 times in the 1993 rules). Some functions which had been under the sole responsibility of the President were transferred or shared with the secretariat (convening the meetings, setting the agenda, producing minutes, and proposing names of external rapporteurs).

The new CGB has also tried to harmonise the quality of dossiers received, and of the assessment carried out. A much more detailed set of recommendations for petitioners has been produced, which clarifies what kind of evidence the committee expects to find in the dossiers submitted. In same cases (e.g. with respect to isolation distances for field tests), the expected answers are also given.

A harmonised assessment grid has been produced for use by rapporteurs, to ensure that the same criteria are used for each dossier. This grid was first based on the technical annexes of Directive 90/220, then revised according to the technical annexes of Directive 2001/18.

Overall, the new rules are far more detailed. Together with the institution of detailed guides for petitioners and the assessment grid for rapporteurs, these evolutions reflect the committee’s desire to formalise procedures for the conduct of expertise, in response to the wider debate about expertise which emerged in France in 1997/98.

3.1.5 Introduction of intermediate categories for environmental releases In 1999, the CGB established three separate categories for Part B dossiers. The first category is defined as ‘screening of GM plants in the field’. These are small-scale field tests of a number of different GMPs that the petitioner wants to test in field conditions in order to select the best ones for further work. The second category is for larger field tests, which aim to test the behaviour of a potential GM crop in several different agronomic conditions. The third category covers large scale pre-commercialisation field tests carried out to assess whether the variety meets the

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criteria established by the CTPS for inscription onto the national seed catalogue (‘distinct, homogeneous and uniform’).

These categories are therefore based on a combination of the surface area of the field test and the objectives of the release. The aim was to introduce a graduation from experimentation to commercialisation within Part B dossiers.

Different types of risk assessment evidence are required depending on the category. For category 1, detailed characterisation of the genes sequences introduced is not requested by the CGB. For category 2 and 3, this is required. Toxicological tests are mostly required for category 2 and 3.

Interviews with members of the CGB revealed that, when assessing a part B dossier for a field test, members of the CGB tends to assume that the petitioner will one day wish to commercialise the GMP in question. They therefore anticipate this and ask questions which are more relevant to market releases, even when assessing small-scale part B dossiers. In this process, the question of environmental or health benefits of the GM crop proposed enters the discussion, even when discussing Part B dossiers. In these deliberations, members of the CGB attempt to determine whether the proposed product will, overall, provide advantages compared to existing crops. The potential impacts of the GM crop on agricultural practices are also discussed, at least informally. Members of the CGB interviewed agreed that the mandate of the CGB did not formally allow them to consider such questions, but admitted that they do get discussed, and that they do sometimes influence the committee’s position on a particular dossier. In some cases the scientific interest of the experimental protocol has also been taken into account, and proposals have sometimes been made to improve it.

3.1.6 CGB seminars: the limits of case-by-case assessment A clear tension can be identified in the practices of the CGB with respect to case-by-case treatment of dossiers. The legal requirement, defined by Directive 90/220 and the 92 law, demands that each dossier be treated on a case-by-case basis, but members of the CGB admit that, in practice, this is not entirely the case. Similar questions clearly arise for separate successive dossiers, and the committee tries to give advice that does not contradict previous advice given on an earlier dossier. In some cases, members of the secretariat present at the meeting (who are also representatives of the competent authority) recall previous advice and instruct the committee that it should not express judgements which are not consistent with judgements issued in previously published Opinions.

In order to treat in more depth, some general issues that reoccur repeatedly the CGB has organised thematic seminars. External experts are invited to present the state of research on a particular question, and the seminar aims to review the state of knowledge and generate some conclusions which can then be used whenever the same question arises in committee deliberations on a particular theme. The following seminars have been organised: • Transgenic plants and antibiotic resistance marker genes (1999)

• Agricultural practices and GMOs (1999)

• Management of [insect] resistance (1999)

• Gene flow (2001)

• Toxicology tests (2002)

• Environmental risks associated with herbicide resistant GM oilseed rape (2003)

These seminars also serve to encourage common reflections between expert committees. The seminar on antibiotic resistance marker genes was organised jointly with the CGG, the committee which deals with confined use. The seminar on toxicology was organised jointly with the Commission des toxiques, which is responsible for risk assessment of toxic compounds, including pesticides.

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General questions are also occasionally addressed to the CGB by the tutelage ministries: • on the Losey et al. Nature article about the effect of Bt maize on Monarch

caterpillars, in 1999;

• on the health and environmental impacts of contamination of conventional seeds, in 2001;

• on precautionary measures for field tests, in 2002 (in preparation for the ‘Four Wise Men’s debate).

The proceeding of these seminars have in most cases been published, but with long delays (more than a year), which means that the information contained is often out of date and/or already published in academic journals.

3.1.7 Development of the standard formula for CGB opinions The format of CGB opinions was radically transformed in 1998. Until 1998, CGB opinions were extremely brief and essentially simply stated that a ‘favourable opinion’ was issued. The standard format for Part C dossiers was (bold capitals in original):

The CGB, which met on [DATE] under the presidency of [NAME OF PRESIDENT OR VICE-PRESIDENT], after having taken into account the assessment conducted by [NAME OF EXTERNAL RAPPORTEUR] issued a FAVOURABLE OPINION about dossier [TITLE] registered under reference [REF] submitted by [NAME OF PETITIONER]

The CGB stresses that this opinion relates only to the elements described in the dossiers registered as reference [REF] and that it applies only on condition that these are respected.

In contrast, opinions for Part C dossiers after 1998 are typically 4-5 pages long, and explain the basis on which the risk assessment is founded.

At first these longer, reasoned, opinions for Part C dossiers still stated that ‘the CGB issued a FAVOURABLE OPINION’, but in March 2003, the CGB decided to modify the standard text used in conclusion of their opinions, which now typically reads:

Accordingly, the CGB considers, given the information provided and within the limits of current knowledge, that the [specific uses such as import, processing, consumption by animals/humans, cultivation of varieties derived from this transformation event] of [name of plant species and transformation event] does not present any more risk for the environment or public health than other commercialised varieties of [plant species].

Similarly the previous opinions for Part B dossiers stated:

The experimentation does not present risks neither for health nor for the environment. The CGB emits a FAVOURABLE OPINION for the implantation of this test.

Whereas the new formula is:

On the basis of data supplied in the request and in the current state of knowledge the CGB considers that the experimentation presents no risk either for health or for the environment.

According to the President and vice-president of the CGB, this reformulation intends to signal to decision makers, and to the wider public, that the CGB does not issue favourable opinions that decision-makers should feel obliged to follow. Thus, whereas the old formulation could be interpreted to mean that the CGB suggested a particular action (to implant the field test or authorise the commercialisation of a GMO), the new formulation is supposed to be less action oriented. In this way, the CGB wishes to clarify that it does not participate in decision-making (‘risk management’), but only in scientific risk assessment.

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In addition, the new formulae acknowledge that residual uncertainty remains even after the committee’s assessment, and in the case of part C dossiers, introduce a comparative dimension with other crops of the same species already commercialised.

3.1.8 Stakeholder representation at the CGB and the ‘second circle of expertise’ The CGB was the first expert body in France to include members which were representatives of consumer and environmental NGOs. Within the EU, it was one of the only countries to make this choice when implementing directive 90/220 (with the UK and Italy). Representatives of industry and of employee organisations had been included in other bodies previously, but usually as observers. At the CGB, however, the representatives from civil society are full members with the same rights to deliberate and vote as the scientists. They also act as rapporteurs.

During the 1998 debates about the CGB and its failings, it was generally agreed that the NGO representatives had not been willing or able to contribute constructively to the work of the CGB. Some argued that the role of NGOs at the CGB should be strengthened, while others argued that they did not really have a role to play in a committee that discusses only scientific issues. This latter view was supported by the argument that the case-by-case procedure prevented NGO representatives from raising more general issues which applied to more than one specific application. The idea of a ‘societal commission’ or ‘second circle of expertise’ to deal with these more general issues and/or to conduct socio-economic assessments emerged at this time, in response to this observation. It was recommended by the 1998 consensus conference citizen panel and by the 1998 OPECST report (Le Déaut, 1998).

In 1997 and 1998, the position of the Government was, however, that NGO participation at the CGB should be strengthened. In November 1997, Prime Minister Jospin announced that: ‘the CGB will be renewed as early as December and its mode of function modified within 6 months in order to reinforce the participation of environmental and consumer NGOs, and to improve the conditions for debate within this committee (scientific, ethical and environmental)’ xxxii. In September 1998, the Minister for the Environment reiterated this position and announced that: ‘In the following months, the composition of the CGB will be reviewed in order to ensure that NGOs and consumers are better associated to it.’xxxiii

However, this announced reform never occurred and since then the idea that ‘scientific’ and ‘other’ considerations should be dealt with separately has gained ground among government departments and their advisers.

The Kourilsky/Viney report emphasised the need to integrate socio-economic analysis in the risk assessment procedure, arguing that this should result in cost-benefit studies in order to optimise the allocation of resources and prevent important distortions. They proposed that such analyses should be carried out by a ‘second circle of expertise’ which would be composed of ‘a few experts representing the first circle, economists, social actors and representatives of the public.’ The ‘first circle’ would be composed solely of scientists and would focus exclusively on assessment of risks to health and the environment (Kourilsky and Viney, 2000, p.69).

The Commission Française pour le Développement Durable (CFDD) has stated in one of its Opinions that the second circle should not be devoted to economic or social experts, but should be conceived as a space for public debate on risk management, provided that its composition genuinely represents the concerned publics.

The ‘Four Wise Men’s report’ (Babusiaux 2002) stated that:

Consumer and environmental NGOs are present at the CGB, but they consider that their deficit in competence leads to the marginalisation of their points of view. It is essential to escape from the confusion of categories. Only technical experts can carry out technical analyses, but representatives of civil society must be able to express themselves in some other way.

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The 2003 report from the Senate also supported this view (Bizet and Pastor, 2003).

A note sent by the President and Vice-president of the CGB to the Agriculture and Environment Ministries in February 2003 recommends restricting membership of the CGB to scientistsxxxiv:

The current organisation of the assessment system puts the CGB in an ambiguous position. It primary mission is to assess risks to health and the environment and to emit advice which is limited to this facet of decision making. However, the presence of representatives from civil society can give the impression that it should also take into account the perception of societal risks or the assessment of the benefit/risk relationship. Since these criteria, which are essential for the final decision making are not really dealt with in the current system, the opinion of the CGB takes on a meaning which sometimes exceeds its mandate. This ambiguity is sometimes reflected in the internal debates. It therefore seems to us desirable to refocus the CGB on scientific assessment of risks to health and the environment and to reconsider its composition by ‘replacing’ the representatives from civil society by scientific experts.

Interviews with civil servants at the Agriculture and Environment Ministries carried out in 2003 suggest that the new GM law will indeed remove representatives of civil society from the CGB, leaving only members selected for their scientific expertise (this may or may not allow for scientists working for NGOs); and that some kind of ‘second circle’ will be established.

3.2 AFSSA

3.2.1 The origins and creation of AFSSA The French Food Safety Agency, AFSSA (Agence Française de la Sécurité Sanitaire des Aliments) was created by law in 1998xxxv, and became operational in 1999. It regroups a number of pre-existing public sector institutions which were already involved in research and expertise on food risks, but has also been given additional means.

The creation of AFSSA was largely motivated by the BSE crisis, but it was not the first safety agency created in France. In 1993, the Government had already adopted a law to create an Agency for Blood, and an Agency for (human) Medicines, in response to the HIV-contaminated blood scandal which severely rocked France during the 1980s. The aim was to separate clearly the institutions ‘controlled’ from the ‘controller’ institutions.

These agencies would be the new ‘controllers’. They were given responsibility for issuing market authorisations on behalf of the State, and for post market control. According to Hirsch (Hirsch 2001), the creation of these first two agencies was criticised from two opposing points of view: on the one hand, it was seen as the dis-involvement of the State with regard to issues usually treated by central authorities; on the other hand, it was seen as too much State intervention in the work of private firms and non-profit organisations. This early debate demonstrated the paradox inherent to these agencies: they are part of the State and yet do not function in the same way as centralised departments. Due to the radical and controversial nature of the 1993 law, an amendment was introduced to require revision of the law after 5 years.

At the time, still according to Hirsch, it was anticipated that it may be necessary to ‘correct the audacious innovation’, but by 1998 parliament has become convinced that agencies are indeed well-adapted instruments for State action with respect to public health. Thus, rather than curtailing the activities of the first two agencies, three new agencies were created by the 1998 law: • Agence française de sécurité sanitaire des aliments (AFSSA) for food safety;

• Institut de veille sanitaire (InVS) for the surveillance of diseases;

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• Agence française de sécurité sanitaire des produits de santé (AFSSAPS), which replaced the earlier agencies for medicines and widened its remit to all health products.

The 1998 law also announced the creation of an agency dealing with ‘environmental health’, meaning (mostly) the impact of the environment on human health, which was finally established in 2001 as the Agence française de sécurité sanitaire environnementale (AFSSE)xxxvi.

AFSSA carries out risk assessment prior to market authorisations for different products, including GMOs used for human food or animal feed. It also incorporates ‘reference laboratories’ involved in diagnostics and surveillance, and laboratories conducting research. In contrast to the Agency for Medicines, AFSSA does not take any decisions about market authorisations (except in the case of veterinary medicines). This reflected the desire to establish a functional separation between ‘risk assessment’ and ‘risk management’, by situating responsibility for these two functions in clearly separate institutionsxxxvii.

3.2.2 Scientific expert committees at AFSSA Before 1998 a scientific expert committee – the ‘Biotechnology working group’ of the Conseil supérieur d’hygiène publique de France – could be consulted with respect to food-related risks associated with the release of GMOs into the environment, but this was not a statutory requirement. Apparently it was consulted for Part C dossiers, but little information is available about its role. Neither the opinions issued by this working group on GMOs nor its composition were made public.

In 2000, AFSSA established a set of ten ‘specialised committees of experts’ (CES), including one on Biotechnology. The others cover the following areas: human nutrition; microbiology; subacute transmissible spongiform encephalopathies; physical and chemical residues and contaminants; animal feed; materials in contact with foodstuffs; additives, flavourings and technological auxiliaries; animal health; drinking water. The Biotechnology CES is the only one of these are involved in the assessment of GMOs, even when the GM product is for example to be used as animal feed or as an additive, flavouring or technological auxiliary.

For a transitional period (1998-2000), the ‘Biotechnology working group’ of the Conseil supérieur d’hygiène publique de France was incorporated into AFSSA and consulted. In 2000, members were appointed to the Biotechnology CES for a three-year mandate.

According to the law, members of the specialised expert committees are appointed by the three tutelage ministers, on the basis of a list proposed by the Director of the Agency and approved by the Agency’s Scientific Board. In practice, the Agency chose to set up an open call for experts and a formal selection procedure. This was the first time such a process was adopted in the French risk regulation system.

The AFSSA expert committees are composed exclusively of scientific experts: there are no representatives of industry, government, or NGOs. These institutions are represented at the Administrative Board, which does not participate in any way in the elaboration of the agency’s scientific opinions.

Moreover, when the AFSSA expert committees were first constituted in 2000, no experts working for the private sector were appointed, thus breaking away from previous practice, where experts from private firms regularly sat on scientific advisory committees, either as scientific experts, or as representatives from industry. Although this decision has been welcomed, especially consumer NGOs, and promoted as a sign of the Agency’s independence from economic interests, it has also been criticised on the grounds that scientists employed in the private sector can provide important expertise which may not be available in the public sector. This includes some specialist disciplinary types of knowledge, as well as expertise about the day-to-day working of factories and other industrial facilities. Thus, it is argued that experts from the private sector could bring to light problems (and solutions)

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associated with real life situations on the ground, whereas scientists from public sector research institutions would be more likely to be provide advice which is too theoretical and detached from the real world. These arguments are understood by the decision-makers within the Agency, but when the membership of all the committees was renewed in 2003 it was felt that appointing private sector experts would tarnish the image of the Agency.

In 2003, it was decided that representatives of the tutelage Ministries would be formally excluded from the meetings, in order to further clarify the separation between the committee and the government. In the previous period, they had been allowed to attend the meetings as observers. Experts from the private sector continued to be excluded. The only slight change in composition was that a sociologistxxxviii was specifically recruited in 2003, in order to cover ‘wider issues’.

AFSSA opinions are issued by the Director General of the Agency, after consultation of the CES on Biotechnology. Formally, they are the opinions of AFSSA, not of the expert committee. In practice, in most cases, the DG simply reproduces the opinion produced by the CESxxxix. AFSSA opinions have to be published by law and are rapidly available on the agency’s web site. (The opinions produced by the expert committees themselves are not published).

AFSSA can also rely on scientists working at the Agency for advice. In theory it thus combines advice both internal and external experts. In practice, with regards to GM dossiers, internal experts have not been consulted.

3.3 Independence and transparency of AFSSA and CGB As pointed out by Martin Hirsch (2001), the Executive Director of AFSSA, it is somewhat paradoxical to describe AFSSA as an ‘independent agency’ – as government spokespeople often do – when it is in fact under the tutelage of three ministries (agriculture, health and consumers). He suggested that AFSSA would best be described as ‘a dependent body charged with conducting independent expertise’. According to Hirsch, six fundamental principles insure the independence of the Agency – from both government and private interests:

(i) Independent from non-health considerations. Because the mandate of the Agency is focused solely on health, it does not need to balance health consideration with other economic, diplomatic or political considerations.

(ii) Financial independence. The Agency does not depend on revenue from private firms or professional groups; 95% is from the government.

(iii) Independent expertise guaranteed by rules and procedures.

(iv) Public declaration of interests for all experts, which includes financial support to the expert’s research unit even if s/he does not receive anything directly.

(v) Publication of opinions, which is systematic, very rapid (before the corresponding decisions are taken) and accessible on the web.

(vi) Auto-referrals (‘autosaisine’). The Agency can decide to produce scientific opinions on questions it considers important, rather than relying solely on questions referred to it by central government departments. This can help avoid being entrapped by the formulation of the questions posed by ministries, and enables the Agency to address issues it considers important, even if centralised government departments do not agree.

Consumer NGOs are also allowed to refer questions to AFSSA. Industry has argued that private firms (or at least industry federations) should also have that right, but this has so far been refused. It has been argued that firms would use this means to obtain free expertise (especially when firms argue that they would require information about the processes assessed to be kept confidential), or would use it to attack competitors. This question has been hotly debated between NGO and industry representatives at the National Council for Food (CNA).

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The independence from government is however limited because:

(a) The Agency must negotiate its budget with government every year, and must justify it in detail. This provides the government with a means to sanction the Agency if it so wished, and also hinders it from developing its own independent research agenda.

(b) The Executive Director is named by the government. Moreover, in contrast to other types of authorities, the term is relatively short (3 years), and the government can dismiss the Director at any time. Members of the expert committees are also formally nominated by the government, but as mentioned above there is a prior process internal to the Agency which reduces the influence of Ministries on these appointments.

Overall, the Agency therefore performs a delicate balancing act: it aims to provide expertise which is independent from both economic and political interests, but recognises that it cannot be totally isolated from public policy: ‘The expertise must be conducted in strict conditions of independence, but must be at the service of political action’ (Hirsch, 2001: p.440).

As demonstrated in Table 1, whatever its limits, the institutional independence of AFSSA from government is greater than for the CGB. The government web site insists that the CGB, like AFSSA, is ‘a committee of independent experts’, but the expertise of the CGB is clearly enclosed within the Ministry of Agriculture. Although the CGB experts are not employees of the ministry (as is the case in other EU Member States), their deliberations are in many ways framed by the Ministry civil servants who serve on the secretariat, and who also represent the competent authority (Roy 2000a); (Granjou 2004). Some of the civil servants at the Ministry interviewed argued that this was, indeed, an advantage as it meant that the expertise of the CGB was more grounded in the real world than that of AFSSA.

In this context, it is interesting to note that the CGB relies heavily on rapporteurs who are not members of the commission. An ‘external rapporteur’ is named for each dossier, are these experts are the only ones who are financially remunerated and it is acknowledged that they are generally the only ones who have the time to devote to assessing a dossier in detail.

Paradoxically, the Agency is however often accused of not being independent, by civil servants at the Food Directorate at the Ministry of Agriculture, and by some scientists who are members of the CGB. The main criticism focuses on the fact that the published opinions are, it is said, drafted by the Directorate General and that the actual opinions drafted by the AFSSA’s expert committees are not published. The DG is therefore accused of ‘injecting elements in the opinions which are not strictly scientific and are more political’. Note that these criticisms imply that being ‘independent’ is interpreted as not incorporating ‘non-scientific’ dimensions into advice for government.

It is indeed true that the DG has the right to include ‘other considerations’ into the opinions expressed by the CES, and that, with respect to BSE policies, the DG has been known to modify the opinions of the expert committee, at least in the early days (1999-2000) when controversial AFSSA opinions about lifting the embargo on British beef were expressed (Joly 2003). But for GMOs, at least recently, this has not been the case. We have obtained copies of each of the opinions drafted by the Biotechnology CES since September 2003, and these are all strictly identical to the opinions published by the agency. Moreover, the agency has now issued rules which state that if modifications are made to the opinions drafted by its expert committees, they will be submitted to the President of the CES, who can request that the opinion be discussed again by the committee.

Particular emphasis was placed on transparency for the new agency. Thus, the law established that all opinions produced by AFSSA would have to be made public, and in practice the agency has taken this very seriously. It has its own website, which provides extensive information about the work of the agency, and all Opinions from the expert committee are posted very rapidly on this web site.

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A key novelty introduced by this new institutional arrangement was that AFSSA not only informed governmental decision makers, but also public opinion. AFSSA opinions on controversial issues were now rapidly published and picked up, publicised and discussed by NGOs and the media. This feature played an important role, for example, in the controversy on the contamination of non-GM crops in the summer of 2001 (see Section 1.3.2). The CGB produced an opinion on the same topic at approximately the same time, with a very similar content, but since it was not made publicly available it had no influence on the public controversy.

3.4 Biovigilance committee The Government announced the creation of a biovigilance system in November 1997 and established a provisional Biovigilance Committee on 10 March 1998, one month after the first inscription of a GM crop on the French seed catalogue. In 1999, the existence and mandate of the Biovigilance Committee was consecrated in a law on agricultural policyxl. However, the application decree mentioned in this law which should have set out the organisation of this committee has never been published, and the members of this committee have never been formally nominated. The mission of the biovigilance committee is to advise on the protocols for post-market monitoring of GM crops (see Section 4.3).

The committee is presided by both the Minister for Agriculture and the Minister for the Environment. The composition is unusual, with more than half the members nominated as representatives of civil society rather than as scientific experts. The law stated that half the members would be representatives from consumer NGOs, environmental NGOs, and ‘concerned professional groups’ and the other half scientists and two members (one deputy, one senator) from the Parliamentary office for Technology Assessment (OPECST). However, the members have never been formally nominated and there is no official list of members has ever been published by the government. Information (undated) provided on the website the CETIOM indicates the following composition: • 5 ‘representatives from civil society’, from an environmental NGO (FNE), a

consumer NGO (CSCV) and two farmers’ trade unions (FNSEA and the Confédération paysanne);

• 5 ‘representatives of the profession’, from the two seed industry federations (GNIS and CFS) and the Technical Institutes for maize, beet and oilseed crops (AGPM, ITB, and CETIOM);

• 5 ‘representatives from government’ [‘l’administration’], from two departments of the Ministry of Agriculture (SRPV and DPE), as well as two expert bodies (the CGB and CTPS, which are portrayed here as part of the government);

• 7 ‘representatives of research’, from INRA, CEA, GEVES, CNRS, and the University of Caen.

Overall, very little information is publicly available about the work of this committee. For more discussion of biovigilance, see Section 6.

3.5 GEVES and CTPS for seed certification The GEVES carries out the tests which are necessary before a new variety can be inscribed in the national seed catalogue. These aim to determine whether the new variety can be considered ‘distinct’, ‘homogeneous’ and ‘stable’; and to assess whether the variety represents ‘genetic progress’. The GEVES also, increasingly, works to limit health and environmental risks associated with new varieties. The GEVES works in close collaboration with the Technical Institutes (e.g. CETIOM, AGPM, ITB) and the National Institute for Agronomic Research (INRA).

The CTPS provides advice to the Ministry of Agriculture for the certification of crop varieties and manages the national seed catalogue.

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3.6 National Food Council (CNA) The Conseil National de l’Alimentation (CNA) is a consultative body created in 1985 which is consulted by government on the elaboration of all aspects of food policy. The government asks for its advice with respect to draft legislation, and the CNA can also choose to work on issues which it deems important.

With respect to issues directly related to the PEG project, the CNA has issued two opinions about labelling for GM food (in 1997 and 2001), and an opinion about the use of the precautionary principle in the food sector (in 2001).

The CNA is composed of 47 members representing all components of the food chain: • 9 representatives of consumers NGOs;

• 9 representatives of farmer organisations;

• 9 representatives of the food production and transformation industries;

• 3 representatives of distributors;

• 6 representatives of restaurateurs;

• 5 representatives of trade unions for employees in agriculture, food industries and distribution;

• 6 ‘qualified persons’, meaning scientists (both biological and social sciences are represented).

Scientific institutions involved in the assessment of risks are also members: The Food Safety Agency (AFSSA), the Agency for Medicines (AFSSAPS), the Institute for the surveillance of diseases (InVS), the National Institute for Agronomic Research (INRA) and the French Research Institute for Exploitation of the Sea (IFREMER). Representatives from the ministries of Health, Agriculture and Consumers can participate in the meetings.

The secretariat for the CNA is at the Ministry for Agriculture, and more specifically the Food Directorate, DGAL.

In recent years, it has been suggested that the CNA could – or already does – play the role of the ‘second circle of expertise’, at least with respect to risks related to agriculture and food.

In May 2000, the CNA was re-launched by the Government. A press release stated that ‘the mandate of the CNA, which is limited to reflection and dialogue, is complementary to that of AFSSA, which is responsible for the scientific expertise of risks’.

In December 2000, when concluding the Big National Debate on food organised by the Government (Etats Généraux de l’Alimentation), Prime Minister Jospin asked the CNA to develop methods for the organisation of public debates on food. A CNA report on this subject was adopted by the CNA in June 2001 (CNA, 2001).

Since 2001, the CNA has examined several opinions produced by AFSSA and has published its own opinions on the same issues, emphasising in some instances important differences. These have related mostly to BSE and to proposals for government policy on risk-related issues (e.g. whether to cull whole herds or selected individuals when a diseased cow is identified on a farm), not to case-specific GMO risk assessments issued by AFSSA or the CGB.

In April 2002 the President of the CNA (who was one of the ‘Four wise Men’ made the following statement in the CNA newsletter:

As demonstrated by recent CNA opinions on selective culling, on BSE risk in sheep, and by the debate on GMOs held on 4th and 5th February [the 4 wise men’s debate], justifying public decisions solely on the basis of a scientific assessment of sanitary risks is no longer sufficient. Neither the

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scientists, who have the impression that they are hostages of political powers and that they carry alone the responsibility for public decisions, nor the consumers who consider that science and public health might be used to hide other preoccupations, nor the decision makers who, faced with the suspicion of citizens, search for new modes of decision making, find such an exclusive prism of analysis satisfying.

Other fields of competence must be used to explore all the dimensions of a solution, of a choice, especially economics and sociology. Socio-economic expertise referred to as of the second circle has become a necessity for defining rational and proportional decisions, including using the precautionary principle with discernment.

[...]

The CNA has progressively adjusted its working method and now surrounds itself with recognised competencies in the disciplines necessary for second circle expertise. All the recent opinions include aspects of socio-economic analysis. At the same time the CNA remains, by its nature and because all groups of society involved in food are represented, a privileged place for debate and dialogue.

This description certainly overstates the nature of any socio-economic analysis carried out by the CNA, but clearly reflects the ambitious vision of the President for the evolution of this council. In 2003, however, this president was replaced and although discussions about methods for socio-economic analyses are still continuing, they are no longer as ambitious and clearly formulated.

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4 Government risk management decisions about GMOs A number of different types of decisions have needed to be taken by French governments, with respect to the deliberate release of GM crops into the environment.

(i) Decisions linked to specific DRD dossiers requesting the authorisation to release a GMO into the environment, which themselves include:

• Decisions to authorise fields tests (Part B dossiers)

• Until 2001, decisions about whether to notify to the European commission requests for commercial release (Part C dossiers) deposited in France under Directive 90/220. Since 2003, decisions about whether to transmit a favourable Initial Assessment Report to the EC for Part C dossiers deposited in France under Directive 2001/18.

• Decisions about whether to raise formal objections to Part C dossiers notified to the European Commission by another Member State under Directive 90/220 or 2001/18.

• Votes at EC-level regulatory committee about Part C dossiers

• Votes at EU Council of Ministers about Part C dossiers

• For Part C dossiers submitted in France, decision to issue the ‘final written consent’ following a favourable Decision by the EC

• For Part C dossiers which have obtained a final written consent for commercialisation in France or in another Member State, decisions about whether or not to inscribe GM varieties in the national seed catalogue

(ii) Decisions linked to specific NFR dossiers (up to April 2004):

• Decisions about whether to raise formal objections for dossiers submitted in other Member States (no dossiers have been submitted in France)

• Votes at EC-level regulatory committee

• Votes at EU Council of Ministers

(iii) Decisions of a broader nature not linked to any specific GMO product:

o National decisions about measures for post-market monitoring, labelling, traceability, co-existence, liability or insurance.

o Decisions about whether and how to organise public information and consultation about specific Part B and Part C dossiers, and about GMOs in general.

4.1 Treatment of Part C dossiers submitted in France under Directive 90/220 The table in Annex I gives details for all the Part C dossiers submitted in France under Directive 90/220.

4.1.1 Until 1996: France as the main gateway for GMOs into the EU Until 1996, France was the main entry point within the EU for GMOs. By 1996, 386 experimental releases of GMOs had taken place in France, accounting for over 30% of all field trials in the EU. Similarly, out of the first 15 EU applications for commercial release of GMOs, 9 were deposited in France (see Figures 7, 4 and 5).

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Out of the 9 Part C dossiers submitted in France from 1993 and 1995, 7 received favourable opinions from the CGB within a few (less than 6) months and were transmitted to the EC as soon as the CGB opinions were expressed. For biotech firms, the way seemed open for the commercial cultivation of GM crops in the EU, and France seemed to provide a regulatory procedure which was well set up and not unduly restrictive. However, by the end of 1995, problems arose with respect to a certain type of GM crop: herbicide resistant oilseed rape.

4.1.2 French moratorium on herbicide oilseed rape Two Part C dossiers submitted in 1995, which both related to herbicide resistant oilseed rape, were not transmitted to the EC even though they had obtained favourable opinions from the CGB (C/FR/95.06.01 and C/FR/95.07.02). Thus, the Government appeared in these cases to take decisions which were more restrictive than implied by the advice provided by its independent expert committee. The situation was, however, more ambiguous because the CGB deferred its opinion when it examined these dossiers in 1995 and 1996, and when it did finally issue favourable opinions in September 1997, it exceptionally inserted a clause in the opinions which proposed that any market authorisations oilseed rape varieties resistant to a herbicide should be limited to 3 to 5 years and should be accompanied by a biovigilance system to follow the appearance of herbicide resistance in other oilseed rape varieties or in other plant species. Moreover, these two opinions were accompanied by letters to both the petitioners and the tutelage ministries which further emphasised ‘that the large-scale use in agriculture of GM oilseed rape resistant to different herbicides, together with the selection pressure linked to the agronomic use of the herbicides, raises the question of multiple resistances in these crops’, and insisted on the urgent need for a biovigilance system which could assess the agronomic and economic consequences of the appearance of multiple resistance, if they appeared, and to set up the necessary measures to limit their appearance and to eliminate them if necessary. The CGB therefore clearly expressed reservations about these dossiers, even though they formally issued ‘favourable opinions’. In this way, they made a distinction between what were perceived at the time as ‘agronomic’ or ‘economic’ risks’ and ‘environmental’ risks. The CGB felt that only the latter could be taken into account in the formal opinion, but found other ways to express their ‘wider’ concerns. The Government responded to these concerns by not transmitting these dossiers to the EC. Indeed, in November 1997, the Government announced a general moratorium on any market release of all GM oilseed rape or beet (see Section 1.1.2 for the context of this announcement and Roy 2000a for a detailed analysis of the emergence of this moratorium on GM oilseed rape).

The Government justified the oilseed rape moratorium on the basis of the risks related to gene flow for these species. Note that the governmental declarations mentioned only interspecies hybridisation with wild relatives, with consequent impacts on biodiversity. Intraspecific gene flow was not mentioned as a potential problem in these declarations, i.e. contamination of neighbouring organic or conventional (non-GM) fields of the same species. Indeed, the concomitant decision to authorise the cultivation of GM maize in France was justified by the Minister of Agriculture on the basis that maize ‘does not cross with any wild species, which prevents gene transfer’ and that ‘it does not grow back from one year to the next, which limits problems of an agronomic order’xli.

In June 1998, the French Government re-iterated this position and announcedxlii:

Given the uncertainties related to the diffusion of transgenes into the environment from plants, such as oilseed rape, that present risks of crossing with other species, it is decided, within European procedures, to implement a moratorium on authorisations for commercialisation, for two years, with respect to every GM variety of such plants. For other species, such as maize, a case-by-case examination will be carried out with respect to health and the environment.

In practice this has meant that:

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• The two dossiers mentioned above (C/FR/95.06.01 and C/FR/95.07.02) were never forwarded to the EC by the French Government. (The first was re-submitted in the Netherlands in 1998 as dossier C/NL/98/11, and has now been re-submitted under directive 2001/18; the second was withdrawn by the notifier in January 1999, but not re-submitted elsewhere).

• For two dossiers for herbicide resistant oilseed rape which had been submitted in France earlier and forwarded to the EC in July 1995, the French Government has not issued the final written consent even though they obtained favourable EC Decisions in June 1997 (C/FR/95.05.01A and C/FR/95.05.01B).

• Two dossiers for herbicide resistant beet submitted in France were never transmitted to the EC. One of them (C/FR/96.05.07) received a favourable opinion from the CGB in September 1997, but this was accompanied with the same reservations mentioned above for the oilseed rape opinions issued at the same time. For the other (C/FR/97.10.02), the CGB requested further analyses in November 1997 (details about the presence or absence of plasmid sequences in the transformed plant, animal tests using GM plant products rather than the purified protein, and proposals for agronomic measures to diminish selection pressure). The notifier withdrew the dossier in March 2000.

• France invoked the safeguard clause (article 16 of directive 90/220) to ban the commercialisation of two herbicide resistance oilseed rape GM lines which had obtained EU-level consent (C/UK/94/M1/1, which is the same product as for dossier C/FR/05.01.01A; and C/UK/95/M5/1). These bans were first issued in November 1998 for a period of two years, then prolonged in 2001 for two years, and prolonged again (under article 23 of Directive 2001/18) in 2003 for one yearxliii. (France also voted against dossier C/UK/95/M5/1 at the ‘Article 21 committee’ on 18/03/98).

In November 1998, the French Government transmitted to the EC a note to justify the moratorium on GM oilseed rape (which applied to the invocation of the safeguard clause for C/UK/94/M1/1 and C/UK/95/M5/1 and the decision not to issue the final consent for C/FR/95.05.01A, C/FR/95.05.01B). This document is particularly interesting in three respects:

(i) It is one of the very few which explicitly mentions the precautionary principle and therefore provides some indication of the way in which the PP was interpreted by the French Government, at least at that time.

(ii) It is one of the rare instances when the French Government can be clearly seen to take a position with regard to risk assessment issues, in its own name (rather than by just citing CGB opinions).

(iii) It explicitly labels problems linked with the transfer of herbicide resistance from the GM oilseed rape to other plants as a risks to the environment, rather than categorising them as ‘agronomic risks’.

The document stated that because of the biological characteristics of oilseed rape, it has a capacity for interspecific and intraspecific hybridisation, and that the extent of such gene flows, and their consequences, are not sufficiently well known. The French authorities argued that this meant that the commercial cultivation of such GM crops could therefore lead to: (1) complications in the management of volunteers, and the ensuing need to use herbicides with less favourable ecotoxicological profiles; and (2) the loss of efficacy of herbicides with favourable ecotoxicological profiles. They added that this situation would be worsened by the possibility of accumulation of different herbicide resistant genes, leading to double-resistant plants; and the systematic introduction of such genes in all cultivated varieties. They concluded that ‘these possible evolutions on agricultural practices must be assessed with respect to their global impact on the environment’. In conclusion, they stated the application of the PP

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was justified in these cases, until a clear and complete scientific appraisal of these questions was available and announced, on this basis, a 2 year moratorium for the commercialisation of seeds from these GM crops (not for products derived from them). In the meantime, the French authorities committed themselves to reinforce and clarify the state of knowledge on these questions, and to conduct experiments.

All of these issues are derived from points discussed at the CGB, but which do not appear in specific case-by-case opinions. In 2001, the CGB produced, at the request of its tutelage ministries, a report on gene flow for oilseed rape and beet which was used to justify the prolongation of the moratorium on oilseed rape. Thus, this position can be seen to be based upon scientific advice from the government’s expert body. The same cannot be said for the governmental positions of GM maize, discussed below.

4.1.3 Ambivalent policy for GM maize dossiers Bt176 saga

February 1997 was the first time when the French Government took a decision which was clearly more restrictive than implied by the advice provided by the CGB, when the Juppé (right-wing) Government issued the final written consent for GM maize Bt176 (C/F/94.11.03), but decided not to authorise the cultivation of the crop in France. This decision was clearly not based on any advice from the CGB and the President of the committee resigned in protest.

In November 1997, the Jospin Government reversed this decision and announced that it would authorise the cultivation of Novartis’ Bt176 in France. (Accordingly, 6 maize varieties derived from Bt176 were added to the seed catalogue on 04/02/98) At the same time, it announced (i) a moratorium on the commercialisation of GM oilseed rape and other ‘such varieties’ that pose of risk of ‘gene dissemination’ (this is generally understood as covering beet), and (ii) broader measures related to biovigilance, labelling, traceability guaranteed, and public debate.

Unofficial moratorium on herbicide resistant GM maize?

The government’s ambivalent position on GM maize had in fact begun earlier than 1997, but in a less explicit way. It seems that, from the end of 1996, the French Government imposed restrictions on herbicide resistant maize lines, even though these were not formally included in the announced moratorium, which was limited to oilseed rape and beet. Thus, the Government chose not to forward to the EC four dossiers for herbicide resistant maize lines submitted in 1996 which had obtained favourable opinions from the CGB (C/FR/96.03.02, C/FR/97.01.12, C/FR/96.05.07 and C/FR/96.06.12). Bt11 (C/FR/96.05.10) (which is pest resistant but not herbicide resistant) was the only GM maize dossier submitted in France in 1996 or 1997 which was forwarded to the EC. This failure to transmit maize dossiers to the EC, even when they had obtained favourable opinions from the CGB, was never formally justified – or even acknowledged as policy (in contrast to the position on oilseed rape).

Blanket opposition, unrelated to risks

In March 1998, the French authorities issued the declaration reproduced in Box 4 at the ‘Article 21 committee’ to justify their abstention for the vote on three maize dossiers: T25 (C/FR/95.12.07), MON810 (C/FR/95.12.02) and Bt11 (C/UK/96/M4/1, for import only). The reasons given for abstaining on these dossiers were explicitly not related to risks, but rather to ‘acceptability by consumers’ and the absence of labelling regulations.

All three maize dossiers obtained the qualified majority at this meeting, which meant that a favourable EC Decision was issued in April 1998 and that, for T25 and MON810, France was supposed to issue the final consent, but the Government waited until after the consensus conference to make a decision.

In July 1998, following the consensus conference held in June, the Jospin Government confirmed the position announced in November 1997, and announced

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that it would authorise the commercialisation of Agrevo’s glyphosate tolerant T25 (C/F/95.12.07) and Monsanto’s Bt MON810 (C/F/95.12.02). In accordance with this announcement, the Government issued the final written consent for the commercialisation of T25 and MON810 on 03/08/98. On the same day, twelve varieties of GM maize were inscribed on the national seed catalogue: six varieties derived from MON810 and six derived from Bt176. No varieties derived from T25 T25, which is herbicide resistant (and not pest resistant) have to this date been inscribed in the French seed catalogue.

Box 4 Declaration by French authorities to the Commission on 18/03/98

France recognises that the scientific expertises conducted for these three maize lines, and confirmed by the Committee on Plants conclude to the absence of risks to the environment and to heath. It shares these analyses. France however attached great importance to guarantying the acceptability of these products by consumers. A consensus conference on GMOs is in being organised at the end of June by the French parliament. France therefore requests that rules about the labelling of GMOs and derived products be clarified in the shortest delays. It strongly invites the Commission and the Council to speed up the work on the draft regulation that should have been adopted at the end of 1997. Until such a regulation is adopted, France is not able to agree to the authorisation of new varieties. The abstention does not prejudge the position of France after the adoption of measures for the labelling of food products.

4.1.4 EU-level de-facto moratorium In June 1999, France led and signed the EU-level the de-facto moratorium declaration on further authorisations for the commercialisation of GM crops (see Box 2). It therefore became clear that France would no longer forward any dossiers to the EC, regardless of whether or not they had received favourable opinions from the CGB. The last Part C dossier transmitted to the EC under directive 90/220 was Bt11 (C/FR/96.05.10), transmitted on 15/04/99.

In practice, firms had stopped submitting Part C dossiers in France in 1997 (the last dossier on record submitted in France under Directive 90/220 was in October 1997). Indeed, as discussed above, France had in fact already stopped transmitting some Part C dossiers to the EC before the moratorium announcement in June 1999 (for herbicide resistant oilseed rape, beet and maize).

Part C dossiers submitted to French CA under directive 90/220

012345678

93 94 95 96 97 98 99

Year that dossier was submitted by petitionner

Num

ber o

f dos

sier

s

Dossiers not notified to ECDossiers notified to EC

Figure 1 Number of Part C dossiers submitted to French CA under directive 90/220

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Number of Part C dossiers submitted to French CA under Directive 90/220 which obtained favourable opinions from the

CGB

012345678

93 94 95 96 97 98 99

Year that dossier was submitted by petitionner (not year that favourable opinion was

expressed)

Num

ber

of d

ossi

ers

Dossiers which never obtained afavourable CGB opinionDossiers which obtained afavourable CGB opinion

Figure 2 Number of favourable and unfavourable CGB opinions for French Part C dossiers

Number of Part C dossiers submitted to French CA which received a favourable opinion from CGB but were not notified to EC

0

1

2

3

4

5

6

7

93 94 95 96 97 98 99

Year that favourabe CGB opinion was expressed

Num

ber o

f dos

sier

s

Not notifiedNotified

Figure 3 Number of Part C dossier notified to EC by French CA

Number of Part C dossiers notified to EC under directive 90/220, by France and by other Member States

0123456789

10

92 93 94 95 96 97 98

Year that dossier was submitted by petitioner

Num

ber o

f dos

sier

s

Non-FrF

Figure 4 Number of Part C dossiers notified to EC by France and other MSs

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Number of Part C dossiers notified to EC under directive 90/220, by rapporteur Member State

0

1

2

3

4

5

6

92 93 94 95 96 97 98

Year that dossier was submitted by petitioner

Num

ber o

f dos

sier

s

FNLUKESDEBESEDK

Figure 5 Number of part C dossiers notified to EC, by rapporteur MS

Number of Part C dossiers examined by the CGB (note that in some cases the same dossier is examined several times, in different years)

02

46

810

1214

16

1996 1997 1998 1999 2000 2001 2002 2003

Year that dossier was examined

Num

ber o

f dos

sier

s

Dossiers submitted in another MemberState

Dossiers submitted in France

Figure 6 Number of Part C dossiers examined by the CGB

4.2 Treatment of Part B dossiers

4.2.1 France as the gateway in the early years By 1996, 386 experimental releases of GMOs had taken place in France, accounting for over 30% of all field trials in the EU. But after 1997, when the public controversy on GMO developed, the number of dossiers submitted decreased significantly (see Figure 7). Moreover, the CGB began to issue unfavourable or deferred opinions more often, and the government did not necessarily issue authorisations for dossiers which had obtained favourable opinions.

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(Source: CGB 2002 Annual Report)

Figure 7 Number of dossiers submitted for part B to the CGB

4.2.2 CGB assessments for part B dossiers 1998-2003 Between January 1998 and June 2003, 161 part B dossiers for field trials of GM plants were submitted to the Ministry of Agriculture and examined by the CGB. Most of these (150) received favourable opinions from the CGB the first time they were examined. For the other 11 dossiers (listed in Table 4) very little information is available: neither the full dossier nor the summary information form was published. There is only a paragraph in the annual reports of the CGB describing the proposed field trial. Two received unfavourable opinions. In 7 cases, the CGB deferred their opinion and asked for further information. (No information was provided about the nature of the additional information requested). Only one of these petitioners resubmitted a more complete dossier, which then received a favourable opinion. The other 6 petitioners apparently abandoned their proposals. In 2 cases, the CGB considered that the request was outside their field of competence.

4.2.3 Governmental decisions about Part B dossiers 1998-2003 All Part B dossiers which did not receive a favourable opinion from the CGB were not issued with authorisations by the Ministry of Agriculture; and most, but not all, Part B dossiers which did obtain a favourable opinion from the CGB were issued with a governmental authorisation. Eleven dossiers received a favourable opinion from the CGB but were not issued with a governmental authorisation: 1 in 1998, 1 in 1999, 5 in 2001, 2 in 2002 and 2 in 2003 (see Table 6).

Until 2002, when a part B dossier did not receive a governmental authorisation, this just meant that no official decision was issued at all, positive or negative. In practice, this means that these dossiers were not authorised, because the law states that if an authorisation is not issued within 90 days (from the date the dossier was registered by the Ministry of Agriculture), this is equivalent to a refusalxliv. This procedure encouraged the perception that it was the CGB, rather than the government, who was making the decisions about whether or not to authorise field tests. In order to correct this perception, the Ministry of Agriculture started making decisions not to authorise explicit in 2002: for two dossiers, it issued a ‘decision not to authorise’. In 2003, it issued, for two dossiers, a ‘decision to suspend deciding’. This new practice clearly aims to clarify and emphasise the distinction between the risk assessment opinion of the CGB on the one hand, and the decision about whether or not to authorise made by the government, on the other. Moreover, since 2001, the government posts the decisions to authorise (or not) Part B field trials on its website, in order to increase the transparency of the whole process. As already mentioned (see Section 2.3.2), the decisions issued since the spring of 2003 also mention other considerations apart for the CGB opinion as a basis for the decision (consultation of the public, consultation of local mayors, and inspection of the proposed sites).

From September 2001 to March 2002, no authorisations for new field trials were awarded, on the grounds that the Government had announced a public debate on field trials, which took place in February 2002. In practice, due the parliamentary and

0

20

40

60

80

100

120

140

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

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presidential elections that took place in April-May 2002, no new authorisations were awarded until July 2002 (in many cases too late in the season for the trials to take place). This explains, to some extent, the fact that 5 Part B dossiers which received a favourable opinion from the CGB in 2001 never received an authorisation from the government. However, according to our interviews, two of these dossiers have been particularly controversial: B/FR/01.02.01, which was the first one for a GM wheat; and B/FR/01.06.05 for an alfalfa expressing an antibody, which was the first proposed trial of a plant designed to produce a pharmaceutical product.

In 2002, the Ministry issued ‘decisions not to authorise’ for two dossiers.

The first of these (B/FR/02.03.01) concerned a field trial for the seed certification procedure of GM maize Bt11. The unfavourable decision issued by the Ministry of Agriculture, with the agreement of the Ministry of Environment, was justified by the statement that ‘negotiations concerning the EU regulation about traceability and labelling have not yet been brought to a successful conclusion and that at this stage a resumption of procedures for the placing on the market of new GMOs such as Bt11 maize cannot be envisaged.’

The second dossier (B/FR/02.04.03) was for a field trial of a GM tobacco containing a capsid gene from the Cauliflower Mosaic Virus to confer virus-resistance, submitted by the firm Altadis. The reason given by the Ministry of Agriculture for issuing a decision not to authorise this field trial referred to a statement made by the CGB in its Opinion: ‘The CGB considers that the general quality of the dossier could be improved with respect to a better documentation about the question of virus resistant plants. The CGB does not however reckon that the lack of information identified is detrimental to the capacity to realise a serious risk evaluation but is on the other hand detrimental to the public’s comprehension of the dossier in particular, and to the research theme considered in general’. Whereas the CGB opinion concluded, despite this fault in the dossier, that ‘the trial presents no risk for public health nor for the environment’ and issued a ‘favourable opinion’, the Ministry of Agriculture, with the agreement of the Ministry of the Environment, decided not to authorise the trial.

In 2003, 2 dossiers were issued with decisions ‘to defer decision’, even though they had received favourable opinions from the CGB (B/FR/03.01.02 and B/FR/03.01.03). In both cases, the Decision states that the CGB opinion concluded on ‘the absence of risk to health or the environment’, that the Ministry of the Environment had granted its agreement, that the public consultation conducted had not raised any elements to challenge the authorisation, that the local mayors have been informed, and overall ‘that the conditions for the authorisation are gathered’. However, because the petitioner no longer planned to implement this release in 2003, ‘issuing an authorisation is considered to be no longer applicable’. We do not know why these two petitioners decided not to carry out their proposed field trials (both for a GM beet resistant to a virus).

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Table 4 Part B Dossiers which did not obtain favourable Opinions from the CGB 1998-June 2003

Registration number Species GM trait introduced or modified

Petitioner Year and Nature of CGB opinion

B/FR/98.05.10 maize pest and glufosinate resistance

Pioneer Genetique Deferred Opinion, 1998 (not re-submitted)

B/FR/98.07.01 beet glyphosate resistance (same product as C/DK/97.01)

Danisco Deferred Opinion, 1998 (not re-submitted)

B/FR/98.05.07 tobacco expression of a ‘planticorps’ Seita Deferred, 1998 (favourable, 1999)

B/FR/98.09.01 beet glyphosate resistance (same product as C/DK/97.01)

DLF –Trifolium A/S Deferred, 1998 (not re-submitted)

B/FR/99.02.22 maize pest resistance (CBH351) Agrevo France Unfavourable, 1999 B/FR/99.02.10 plum tree virus resistance INRA Bordeaux Deferred, 1999 B/FR/99.02.11 maize not GM

(herbicide resistance) CYANAMID Agro Outside field of competence,

1999 B/FR/99.03.02 maize pest resistance Novartis Seeds Unfavourable, 1999 B/FR/00.02.04 maize glyphosate resistance

(NK603) Verneuil Recherche Outside field of competence,

2000 B/FR/99.09.04 oilseed rape insertion of a gene to reduce

seeds dropping off the plant Biogemma Deferred, 1999

B/FR/01.05.02 poplar tree lignin INRA-Orléans Deferred, 2001 (not re-submitted)

Source: CGB annual reports and government web site on GMOs

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Table 5 Part B Dossiers which did not obtain authorisations from the CA, despite receiving a favourable opinion from the CGB, 2001-20031

Dossier registration number

Species GM trait introduced Petitioner Date of favourable opinion from CGB

Governmental decision

B/FR/01.02.01 Wheat Tolerance to fusariums Novartis 15/03/01 No decision issued B/FR/01.06.03 Beet herbicide tolerance ITB 02/07/01 No decision issued B/FR/01.06.04 Maize Bt11 Novartis 02/07/01 No decision issued B/FR/01.06.05 Alfalfa expressing the antibody

C5-1 Medicago 02/07/01 No decision issued

B/FR/01.06.06 Oilseed rape herbicide tolerant CETIOM 02/07/01 No decision issued B/FR/02.03.01 Maize Bt11

(CTPS pre-commercial trials)

GEVES 05/03/02 Decision not to authorise

B/FR/02.04.03 Tobacco Inserted gene coding for cauliflower mosaic virus

Altadis 16/04/02 Decision not to authorise

B/FR/03.01.02 Beet virus R Advanta 14/01/03 Decision to postpone deciding

B/FR/03.01.03 Beet virus R Syngenta 14/01/03 Decision to postpone deciding

Source: CGB annual reports and government web site on GMOs

1 This does not include the dossiers from 1998 and 1999, because before 2001, the government did not publish information about decisions made.

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Table 6 CGB opinions and governmental decisions for Part B dossiers from 1998 to 2003 Year dossier examined by CGB CGB opinions Governmental decision2

Number of dossiers examined

Favourable Un-favourable Deferred Outside remit Decision to authorise

Decision not to authorise

Decision to postpone decision

No decision issued

1998 12 8 0 4 0 73 0 0 5

1999 68 63 2 2 1 624 0 0 6

2000 32 31 0 0 1 31 0 0 1 2001 23 22 0 1 0 175 0 0 66

2002 10 10 0 0 0 8 2 0 0 2003 16 16 0 0 0 14 0 2 0 Total 161 150 2 7 2 139 2 2 18

Source: CGB annual reports and government web site on GMOs

2 This table only mentions governmental decisions related to dossiers examined that year. In practice, the government issues more decisions to authorise than those

mentioned in this table, because Part B dossiers for trials of GM lines which have already received a favourable opinion from the CGB for a Part C dossier are not submitted to the CGB. Moreover, in 1998 government actually issued 73 decisions to authorise, but most of them concerned dossiers which had been submitted and examined in previous years.

3 One dossier (B/FR/98.12.06) received a favourable opinion from the CGB but was never planted. We have not been able to find any trace of the governmental decision and assume that no decision was issued.

4 One dossier (B/FR/99.11.02) received a favourable opinion from the CGB but was never planted. We have not been able to find any trace of the governmental decision and assume that no decision was issued.

5 One of these decisions to authorise was issued in 2002 whereas the favourable opinion from the CGB was expressed on 02/07/01 (dossier B/FR/01.06.02). 6 Five of these 6 dossiers had received favourable opinions from the CGB.

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4.3 Post-market monitoring – biovigilance Biovigilance was discussed by the CGB as early as 1994, and France set up procedures for the long term monitoring of commercial GM crop cultivation in 1998, before they were made mandatory by Directive 2001/18.

The Government announced the creation of a biovigilance system in November 1997 and established a provisional Biovigilance Committee on 10 March 1998, one month after the first inscription of GM crops on the French seed catalogue. Moreover, both of the legal texts (arrêtés) published to add GM varieties to the seed catalogue (on 04/02/98 for varieties of Bt 176 and on 03/08/98 for varieties derived from MON810 and Bt176) contained a specific biovigilance clause. Thus in both cases, Article 3 states:

A system for the surveillance of the commercialisation of these seeds will be set up. This system will enable the surveillance of, notably, the following parameters:

• the evolution of the efficacy of these varieties against the target maize pests;

• the possible apparition of any non intended effects on populations of pests or auxiliaries hosted by maize, such as the apparition of corn borers resistant to Bt toxin;

• the possible effects on entofauna;

• the possible effects on the evolution of populations of soil bacteria

• the possible effects on the evolution of populations of bacteria in the gut flora of animals consuming the maize derived from these varieties, in particular with respect to resistance to ampicillin.

The 1999 Agricultural Law established that there would be ‘reinforced biological surveillance’ for GM crops, carried out by inspectors from the Plant Protection department of the Ministry of Agriculture. According to the law, the aim of this surveillance is to ‘identify and follow the potential appearance of non intentional effects on natural or agricultural ecosystems, especially the effects on pest populations, on wild fauna and flora, on aquatic and soil environments, and on microbial populations, including viruses’. The mission of the biovigilance committee was defined as advising on the protocols for monitoring ‘undesirable impacts’ and to alert the Ministers for Agriculture and for the Environment if such events are revealed.

Overall, very little information is publicly available about the work of this committee. One reason is that it has not had much work to do, because there has been very little commercial cultivation of GM crops in France. Although 15 varieties of GM Bt maize were inscribed on the national seed catalogue in 1998 (9 derived from Bt176 and 6 from MON810), hardly any has been grown commercially. The highest level was in 1998, and even then there were only 1500 hectares (out of 2 million hectares of maize in France). In subsequent years, there has been less than 200 hectares. Thus, there had not really been any large-scale commercial cultivation to monitor.

A document posted on the Ministry for Agriculture’s web site in January 2001 provides some very general information about the methods used and makes a distinction between to notions (apparently derived from an EU workshop): • ‘General surveillance’, which aims to identify the impact of GM crops on fauna

and flora in the GM field and those surrounding it. It necessitates defining the ‘zero point’ or base line situation before the introduction of GM crops.

• ‘Specific monitoring’, which covers specific actions to investigate a specific interrogations raised by the Biovigilance Committee.

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The role of biovigilance therefore seems to cover both verification of the appearance – or not – of negative impacts that had been postulated during the a priori risk assessment, and monitoring for unintended and unknown effects.

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5 RA and RM for Part C dossiers submitted under Directive 2001/18 5.1 Lack of transparency at the CGB In 2001 and 2002 no Part C dossiers submitted under the Deliberate Release Directives were submitted for assessment to the CGB. In January 2003, dossiers which had been submitted under Directive 90/220 but had not completed the authorisation procedure began to be re-submitted by applicants under Directive 2001/18. Six dossiers were examined by the CGB during 2003, but it has not been possible to include any in depth analysis of these risk assessments in the PEG research, because, despite repeated requests to the CGB secretariat, we were not able to obtain access to the necessary information – not even the opinions expressed by the CGB. The opinions expressed by the CGB for Part C dossiers were finally posted on the governmental web site in January 2004 – too late to be included in our PEG research. Since we did not have access to the minutes of the meetings – or even the agenda for the meetings, we did not even know which Part C dossiers, if any, were being examined by the CGB (following a court action by the NGO CRIIGEN, the minutes for the 2003 were made available in March 2004).

This lack of transparency allowed the media, in April 2004 – with information fed by to them by CRIIGEN – to talk of the ‘revelation’ of an unfavourable CGB opinion (C/DE/02.09, MON863xMON810) which was drafted by the CGB in May 2003 but not made available to the public. Titles in Le Monde were, for example: ‘Confidential expertise on a worrying maize’ (24/04/04) or ‘The opacity of expertise is unanimously criticised’ (25/04/04).

5.2 CGB members perceive little change in RA practices Our interviews members of the CGB and its secretariat were limited by this lack of access to basic data. We therefore asked the interviewees general questions about their perception of the evolution of risk assessment criteria and procedures under Directives 90/220 and 2001/18, and were not able to discuss any particular risk assessments carried out.

Some of actors expressed the belief that there has been no fundamental evolution in the way scientific expertise is used for the assessment of dossiers, and that the key reforms were the improvements in the administrative procedure at the CGB: stricter requirement for dossiers to be clear and complete, harmonisation of the assessment procedure, and increased transparency. They argued that the scientific expertise as such did not take into account any new criteria because everything that is required by Directive 2001/18 was already addressed by the CGB from the start. Others also stated that there has been no evolution, but argued that the assessments still fails to take into account important questions now explicitly requested under Directive 2001/18.

None of these actors saw a relationship between the application of the precautionary principle and their practices. Many even found this proposition laughable, and felt that the PP was simply a political statement with no scientific content introduced into the Directive to reassure the public.

CGB opinions never refer to the PP. The PP does not seem to be present in their internal deliberations either. Some scientists (members of the CGB or not) invoke the PP in public debates, in much the same rhetorical way as the social and economic stakeholders: in a very general way, to claim either that the PP has, or that it has not, been applied adequately in the risk assessment procedures. One often heard interpretation is that risk assessment prior to authorisation constitutes, in itself, an

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application of the PP. No details are however given about what an adequate application of the PP for risk assessment would mean.

5.3 Conflicting opinions from the CGB and AFSSA Table 7 provides a summary of the assessments which were carried out by French expert bodies for Part C dossiers submitted under directive 2001/18, based on information which became available (with respect to the CGB opinions) in January 2004.

As can be seen from this table the two expert bodies often gave contradictory opinions on the same dossiers and/or same GM line submitted under the DRD or NFR. In fact, out of the six dossiers for which the information is available, the two committees only gave the same overall opinion in one case (C/ES/00/01, NK603).

When the CGB opinions were finally advertised, media coverage emphasised these differences as a worrying feature of expertise (see above).

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Table 7 2001/18 Part C dossiers examined by French expert bodies in 20031

Dossier Date SNIF published

Date initial assessment report published

Event Date and nature of CGB opinion2

Date and nature of AFSSA opinion

AFSSA opinion for same product under Reg. 258/973

C/DE/02.09 17/02/03 06/05/03 Maize MON863 and MON863xMON810 Pest resistance Monsanto Importation, processing, animal feed, not growing

27/06/03, deferred4 20/06/03, deferred 06/11/03, favourable

18/07/03, deferred 02/12/03, favourable

C/ES/00/01 22/01/03 22/01/03 Maize NK603 Glyphosate resistance Monsanto Importation, processing, animal feed, not growing

14/03/03, deferred 25/08/03, favourable

07/03/03, deferred 05/01/04, favourable

21/02/03, deferred

C/ES/01/01 [Same product as

17/02/03 20/08/03 Maize TC1507

02/10/03, deferred 17/10/03, favourable

1 This table includes only those for which an Initial Assessment Report by the rapporteur Member State was published before the end of December 2003. 2 Date indicated on opinion, not date of CGB meeting when dossier was discussed (this is a different annotation than for previous 90/220 dossiers). 3 Those posted on the www.ogm.gouv website by 29/02/04. 4 ‘Deferred’ opinions are essentially unfavourable, in that they request further information and generally state that the current state of the dossier does not enable the experts

to come to any conclusion about the risks.

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C/NL/00/10] Glufosinate resistant and pest resistant Pioneer Unrestricted, including growing

C/F/96.05.10 30/06/03 29/07/03 Maize Bt11 Pest resistance Syngenta Unrestricted use, including growing, food and feed

27/02/03, favourable (update of opinion expressed on 03/12/98)

Opinion not requested by the DGAL (30/12/99, under 90/220, request further analyses)

21/07/00, requests further analyses 21/03/01, deferred 26/11/03, deferred

C/NL/98/11 22/01/03 22/01/03 Oilseed rape GT73 Glyphosate resistance Monsanto Importation, processing, animal feed, not growing

14/03/03, favourable30/09/03, favourable

07/03/03, deferred

C/NL/00/10 [Same product as C/ES/01/01]

14/02/03 01/09/03 Maize TC1507 Glufosinate resistant and pest resistant Pioneer Importation and animal feed, not growing

02/10/03, deferred 17/10/03, favourable

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5.4 The Bt11 dossiers Dossier C/F/96.05.10 concerns GM Bt11 maize by Syngenta, and includes cultivation, import, processing and food and feed uses. It was submitted in France under directive 90/220 and re-submitted under Directive 2001/18 in January 2003. At that stage, it was submitted to the CGB but not to AFSSA. This was unusual because all other dossiers submitted under Directive 2001/18 (in other Member States) have been submitted to both the CGB and AFSSA (see Table 7). During the same period, however, AFSSA has been requested to assess the same GM line under the Novel Food Regulation.

The two expert bodies came to contradictory conclusions about this GM crop. The AFSSA opinions expressed in 2000, 2001 and 2003 for Bt11 under Reg. 258/97 were all unfavourable, whereas the CGB opinions expressed in 1997, 1998, 1999 (under Directive 90/220) and 2003 (under Directive 2001/18) were all favourable. (Moreover, AFSSA had also expressed an unfavourable opinion for the 90/220 dossier in 1999, with respect to the use of Bt11 as animal feed).

The main reason for the difference in the 2003 opinions was that AFSSA considered that further toxicological tests should be carried out with a sweet maize variety derived from Bt11, whereas the CGB accepted that data collected with grain maize was sufficient evidence of safety. AFSSA argued that grain and sweet maize varieties have significantly different metabolisms, and that this might lead to unforeseen effects in sweet maize varieties which would not be detectable in grain varieties. At the same time, AFSSA recognised in its opinion that such additional testing was not required by the regulations. This case led to discussions at the Biotechnology CES about the extent to which risk assessments carried out on original GM ‘transformation events’, as opposed to the varieties which will in the end by cultivated, were relevant. They concluded that in most cases the information derived from the original transformation events would probably be sufficient – or at least that it would be unrealistic to demand testing of each new GM variety – but that the metabolic differences between grain and sweet maize were sufficient to warrant additional testing on each type.

These contradictory opinions from expert bodies have led to a contradictory position from the French government. On the one hand, in July 2003, it supported the Bt11 dossier submitted under Directive 2001/18; while on the other hand, it has, since the autumn of 2003 led an EU-level opposition to the same GM product submitted under Regulation 258/97:

(i) In July 2003, the French authorities forwarded to the EC a favourable Initial Assessment Report for the 2001/18 dossier, based solely on the positive CGB opinion, seemingly ignoring AFSSA’s negative opinion on the same product. This Assessment Report was virtually identical to the CGB opinion expressed on 27/02/03 and concluded that ‘according to present knowledge, the placing on the market of the Bt11 genetically modified line of maize on the market does not present a greater risk to human health or the environment than any other variety of maize’.

(ii) In December 2003, the French Government, based on AFSSA’s unfavourable opinion, voted against the approval of Bt11 under Regulation 258/97 at the EU-level Standing Committee for Foodstuffs meeting (France, Denmark, Greece, Luxembourg, Austria and Portugal voted against, while the UK, Ireland, the Netherlands, Sweden, Finland and Spain voted in favour, and Germany, Belgium and Italy abstained).

The dossier did not obtain a qualified majority at this meeting; and neither did it at the Council of Ministers meeting in April 2004 (France, Denmark, Greece, Luxembourg, Austria and Portugal voted against, while the UK, Ireland, the Netherlands, Sweden, Finland and Italy voted in favour, and Germany, Belgium and Spain abstained). Nevertheless, in May 2004, the European Commission decided to approve this product, thus ending the six-year de facto moratorium.

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6 Separation of responsibilities for RA and RM 6.1 Expert bodies are responsible for risk assessment It is interesting to note that, strictly speaking, the French legal texts give responsibility for risk assessment to the scientific expert bodies: the CGB and AFSSA. Thus, the Ministry of Agriculture (together with the Ministry of Environment) processes the dossier and issues authorisations, but is not strictly speaking responsible for risk assessment. This description of the division of responsibilities was established in the 1992 GM law and is also reflected in the description of the regulatory system on the governmental web site devoted to GMOs (see Box 5).

In governmental communications, the CGB and AFSSA are systematically described as ‘committees of independent experts’, even though they are under the responsibility (‘tutelage’) of government ministries (Agriculture and Environment for the CGB, Health, Agriculture and Consumers for AFSSA). In these ways, the government attempts to portray that it is not in any way responsible for risk assessment. (See Section 3.3 and Table 1 for more on the relative independence of the CGB and AFSSA).

In practice however (as in other EU Member States), it would seem more accurate to state that it is the applicants who carry out the risk assessment, and who then provide the competent authorities with the results of their assessment. The role of the CGB and AFSSA is limited to evaluating the validity of the assessment carried out by the applicant. This is indeed recognised to some extent in the legal textsxlv:

[In order to obtain an authorisation for the deliberate release of a GMO into the environment] the applicant must have carried out an assessment of risks for the environment and for health the results of which are contained in the dossier [submitted to the authorities]

6.2 Government is responsible for risk management According to the legal texts, the Minister of Agriculture (together with the Minister for the Environment) is responsible makes decisions for both Part B and Part C dossiers under the Deliberate Release Directive (i.e. whether or not to grant authorisations for GM field tests and whether or not to support Part C dossiers in EU-level negotiations), on the basis of advice from the CGB, and in some cases the CTPS and/or AFSSA. The Minister for Consumers is responsible for decisions made under the Novel Food Regulation, on the basis of advice from AFSSA (see Table 3). This separation of roles is very clear between AFSSA and the government, but despite efforts for clarification and significant evolutions in practices (see Sections 2.3.2 and 3.1.7), this functional separation between risk assessment and risk management remains less clear, at least for outside observers, with respect to the CGB, because it remains so firmly situated within the confines of the Ministry of Agriculture.

6.3 But CGB still perceived and portrayed as making decisions For DRD dossiers, it can however appear as if it is the CGB that makes such ‘risk management’ decisions. In interviews many actors, including civil servants and members of the CGB, talk about the CGB ‘authorising’ a field test; and documents produced by the CGB, the government and petitioners regularly reflect that perception. Three examples are given below.

First example: At least until 1997, communications between the petitioner and the CGB regularly occurred directly, not via civil servants at the DGAL. For example, in February 1996, the CGB sent a petitioner the CGB opinion referring to their dossier

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(which requested further analyses) and also added, in the accompanying letter, that the firm should resubmit 2 dossiers because the dossier ‘concerns two transformation events and, in accordance with Directive 90/220 these must be subject to two notifications to the European Commission’. Although this letter does not concern decision-making with respect to whether or not to transmit the dossier to the EC, it does appear as if the President of the CGB was acting as if he were responsible for processing the administrative aspects of the dossier. In other cases, letters from the Presidents to the petitioners which accompany the CGB opinion specify the additional information or analyses requested by the CGB before a definitive (favourable) opinion can be issued.

Second example: As late as January 1999, petitioners still seemed to perceive the CGB as the decision-making body: one petitioner addressed a letter directly to the President of the CGB – not the Ministry of Agriculture – asking for confirmation that this dossier was not going to be transmitted to ‘Brussels’, even though it had obtain favourable opinions from both the CGB and the CSHPF and requesting that, in this case, the dossier be withdrawn. (The response was signed by the Director of the DGAL.)

Third Example: Favourable opinions from the CGB with respect to Part B include guidance for action, because they always contain a string of recommendations about safety measures (mostly aimed at reducing pollen flow). And at least until the spring of 2003, authorisations issued by the Ministry of Agriculture systematically referred back to the CGB opinion and stated that the authorisation was subject to the petitioner adhering to the safety measures recommended by the CGB. (This practice was modified in the spring of 2003, see Section 2.3.2).

In interviews conducted for the PEG project, civil servants at the Ministry of Agriculture emphasised that they wished to clarify the distinction between the ‘competent authority’, which makes the decisions, and the CG, which carries out the risk assessments. Members of the CGB have also explained how they wished to make it clearer that the CGB provides scientific advice, but is not involved in decision-making. This was for example the reason given by members of the CGB for modifying the formula used to conclude their opinions (see Section 3.1.7)

Yet even in 2004, the governmental web site on GMOs still claims that when the opinions of the CGB and AFSSA are favourable, the government transmits Part C dossiers to the European Commission, as if the government had no independent decision-making power (see Box 5). Moreover, the CGB is described as the body which refers a dossier to AFSSA, whereas legally it is the Food Directorate of the Ministry of Agriculture which refers the dossier to AFSSA, on the basis of advice from the CGB.

Box 5 Attribution of responsibility for risk assessmentxlvi

‘The CGB is put in charge of assessing the risks linked with the deliberate release of GMOs. It moreover contributes to the assessment of risks associated with the commercialisation of products composed entirely or in part of GMOs and to the definition of their conditions of use and presentation.’

Source: 1992 GM lawxlvii.

‘It is not possible in France and in the European Union, to disseminate and to commercialise genetically modified organisms if they have not received an authorisation beforehand. This is granted only after a procedure for the complete assessment of risks for public health and the environment. This assessment is based on relevant scientific elements and is entrusted to committees of independent experts.’

Source: Government web site on GMOs, in January 2004xlviii

‘In France, the analysis of risks [analyse des risques] associated with the dissemination of a GMO into the environment is conducted by the CGB for environmental issues and by AFSSA for food aspects (toxicological, nutritional,

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and allergic problems for human and animal food). [...] In all cases [R&D or commercial releases] firms have to bring to the assessment authorities scientific proof that the new genetic construction that they wish to test or commercialise is truly harmless [inoffensive] for public health and for the environment.’

Source: Government web site on GMOs, in January 2004xlix

‘France does indeed implement the precautionary principle, in that before any authorisation, the competent scientists are questioned in order to assess the potential risks for health and the environment. It is on the basis of this scientific advice that the governmental authorities [pouvoirs publics] can manage the risks by deciding to authorise or not certain GM crops and by setting up the follow-up and control of these crops.’

Source: Government web site on GMOs, in January 2004l

‘The mission of the CGB is to assess the risks associated with the dissemination of GMOs for public health and for the environment. It is a consultative body without any power to decide, but it has to be consulted by the administrative authorities before any authorisation for the deliberate dissemination of a GMO. In this way, it represents an essential stage in the very long procedure, French and European, for commercial authorisation. The CGB examines all aspect of problems posed by GMOs in terms of the safety of the environment and for public health. [...] Its assessment takes into account all possible situations, including accidental human consumption.

AFSSA is charged with assessments with respect to the health safety of GMO products or products derived from them when they are destined to be used as human food. It participates essentially with respect to the Regulation on Novel Foods. However, for all dossiers for commercialisation that it deals with in the context of Directive 90/220, the CGB submits the dossiers to AFSSA [l’AFSSA est saisie par la CGB].

The advice from these two institutions enlightens governmental authorities about the decisions to take. When the opinions from the CGB and AFSSA are favourable, the authorities transmit the dossier to the European Commission.’

Source: Government web site on GMOs, in January 2004li

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7 Biosafety research French risk research – more commonly referred to by the actors as ‘biosafety’ research – has undergone important changes in the last ten years, both quantitatively and qualitatively: there has been a substantial increase in the overall amount of investment and results in biosafety research, and a shift in the disciplines used and issues addressed.

Until the mid 1990s, biosafety research on GM crops and food was poorly developed in France and was mostly funded by EC programmes. Better-funded programmes funded by French research institutes or ministries only emerged in 1998, after the outbreak of the public controversy on GMOs (see Table 8).

Table 8 French biosafety research programmes

Funding institution Year of launch Amount of funding in millions of eurolii

CTPS 1991 0,37 M Ministry of Agriculture 1993 and 1994 0,6 M CETIOM 1996 2 M INRA 1998 0,4 M Ministry of Research 1999 and 2002 2 M CNRS 2001 0,9 M

Before 1998, there were only limited calls for proposals, and these were issued by regulatory institutions close to the competent authority rather than academic institutions: • The Advisory committee on plant varieties registration (CTPS) launched a

programme in 1991, with 0,37 M euro.

• The Ministry of Agriculture, with support from the Ministry of the Environment launched calls in 1993 and 1994, amounting to approximately 0,6 M euro. The 1993 programme was devised and coordinated by scientific members of the CGB whereas the 1994 programme was entrusted to a lobbying group of French agrochemical companies (Chimie et écologie).

A separate major research operation was launched in 1996 by the Technical institute for oil plants (CETIOM), later joined by other technical institutes for maize and beet. This ambitious programme (more than 2 M euro spent in 1996-2002) included testing of agronomic traits (such as assessing the agronomic benefit of using herbicide tolerant crops), research on ‘agronomic risk’ (management of herbicide resistant volunteers in cropping systems, stacking of resistance to different herbicides), and supported ecological field research as well as agro-ecological modelling research on gene flow. It is interesting to note that it was such a small technical institute, rather marginal in the scientific arena, that initiated the first substantial risk research for GM crops in France.

From 1998 onwards, biosafety research grew, in parallel with the public controversy on GM crops and food. Moreover, whereas previously a small number of administrative/technocratic actors (civil servants at the Ministries of Agriculture and the Environment, industry representatives and scientific experts at the CGB) acted as gatekeepers for biosafety research, by the end of the 1990s the field was more polycentric and academic. Research teams that had not previously been involved – either because they did not consider that there were enough funding opportunities or because they saw little scientific interest in the field – joined up and enlarged the biosafety research community. This growth, supported by consistent and diversified funding (even though it was relatively modest), helped several teams to establish themselves and to be in a favourable position to seize the opportunity to take a

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stronger position in EC-funded biosafety programmes which increased from 1999 onwardsliii. If one looks at the number of research publications on biosafety for GM crops or food in CSI indexed journals, one can also see that the relative share of French publications has remained stable, whereas the shares for the UK, Denmark, the Netherlands and Belgium decreased. Germany is the country whose share increased most significantly.

Table 9 Share of biosafety publications among EU Member States Number of first-authored articles on GM crops or food biosafety 1984-2003 1990-1996

Share in EU(15) output

(1990-1996) 1997-2003

Share in EU(15) output (1997-2003)

USA 618 153 347 EU(15) 675 157 100% 394 100%

UK 213 63 40% 122 31% France 144 34 22% 88 22% Germany 105 14 9% 65 17% Netherlands 50 16 10% 25 6% Italy 37 2 1% 25 6% Denmark 20 7 4% 11 3% Belgium 19 8 5% 11 3% Austria 17 1 1% 13 3% Spain 16 1 1% 8 2% Other members states 54 11 7% 26 7%

It is striking to note how France shifted from being at the forefront, within the EU, of plant biotechnology research to develop the use of GM crops in the 1980s and 1990s to being, in 2000, one of the leaders in biosafety research. Thus, the relative position of France in plant biotechnology research to develop GM crops and biosafety in Europe shifted between 1990 and 2000. In the 1980s, French research in plant biotechnology (to develop GM crops) was strong, and France was a key entry point for GMOs in Europe. France had, with the UK, pushed for the EC to launch research programmes in biotechnology (which led to the BAP and BEP programmes). In the period from 1986 to 1996, France was one of the EU countries with the highest share of GM field trials (see Figure 7). In recent years by contrast, much fewer field test were localised in France and only one 2001/18 Part C dossier has been introduced through the French regulatory pipe line, whereas French biosafety research (most of which does not utilise field tests) has grown steadily.

Accompanying this quantitative growth, French risk research has experienced qualitative shifts since 1997. Two inter-related trends can be identified: • The rise in biosafety research as a more autonomous and well-funded research

domain, and the recognition by the scientific community that such research can indeed address questions of scientific interest. Thus this ‘regulatory science’, which tended to have a low reputation among academic scientists has gained scientific legitimacy.

• The increased legitimacy of research in population biology and systemic agronomy in regulatory debates.

Whereas the Ministry of Agriculture calls for projects in 1993-1994 were framed by molecular biologists, the later INRA and CNRS projects were framed by agricultural scientists and population biologists, respectively. They opened the way to a larger range of disciplinary skills (entomology, population biology, cropping systems modelling, soil biology and social sciences), enlarged the number and variety of laboratories involved in biosafety research and investigated a wider range of

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problems/uncertainties, such as effects on non target insects, development of resistance among target insects, horizontal gene transfer, impacts of gene flow from ecological and cropping systems perspectives, cumulative effects, socio-economic analyses, and public input.

One major trait of biosafety research in France has been the growth of research on gene flow conducted both from population biology and from cropping systems perspectives. New kinds of predictive knowledge are sought, especially about the potential impacts of gene flow on both cultivated and non-cultivated spaces. This research was favoured by the rise of discussions about how to set up an effective system for co-existence, labelling and traceability. As a result, much effort has been devoted to the development of modelling at the landscape level. The models (GeneSys and Mapod) emerged at the interface between two separate epistemological cultures: population biology modelling and cropping system modelling. These models have been the core of the JRC study on co-existence (which provided an opportunity to strengthen the interdisciplinary dimension, with the involvement of economists around the models). These models have also entered the regulatory arena since they were used for the SCP’s March 2001 Opinions on contamination thresholds, and have become elements of recent regulatory discussions in several EU countries.

Another area of research which is well-developed in France is the research on the use of Bt toxins as a biological pest control agent. The knowledge which has arisen from this research has been used to develop both national and EU protocols for Bt-resistance monitoring. It was influential in the 1999 SCP guidelines on Bt IRM, which recommended F2 screen as the preferred method for monitoring. However, when Syngenta submitted its 2001/18 demand for the release of for GM maize Bt11 to the French CA in January 2003, the monitoring plan proposed used the cheaper ‘discriminating dose’ method rather than the F2 screen, and neither the CGB nor the French CA challenged this (they also accepted that the IRM plan would be voluntary).

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8 Stakeholder roles 8.1 Stakeholder impact on the GM controversy As analysed by our team previously (Joly 2000) stakeholders played an important role in the emergence of the controversy on GM crops and food in France in 1996/97. This included actions by environmental and consumer NGOs such as direct actions against ships importing GMOs, at headquarters of large agri-food firms, in supermarkets, and issuing ‘blacklists’ of products which may contain GM ingredients. Decisions made by large-scale food distributors (to avoid GM ingredients in their products) also played a crucial role. The 1998 advertising campaign organised by Monsanto to promote GMOs further inflamed the controversy. The main farmers’ trade union (FNSEA) did not oppose the introduction of GM crops, but got involved in consultations with industry and government about labelling and about the feasibility of co-existence between GM and non-GM agriculture. The more radical left-wing trade union (Confédération paysannes) played an active role in public spheres (through direct actions and court trials), and by 1999 was one of the key actors involved. Together with the anti-globalisation NGO ATTAC, and with the support of some environmental NGOs, the Confédération paysanne shifted the focus of the French GM debate from risk issues to broader political issues.

Since 1999, NGOs have continued to play an important role in the GM controversy. The destruction of GM field tests became a focal point in the debates. They obviously had a direct impact on the researchers and firms conducting the field tests, but it has also had important indirect effects:

(i) The trials of the activists involved in these destructions have been used by NGOs, successfully, to publicise their arguments against GMOs. In this way, legal courts have become a key arena for NGOs wishing to challenge governmental GM regulations policy.

(ii) The destructions and the ensuing debates have mobilised the scientific community to express itself collectively and openly for the first time on issues related to GMOs, and in two contrasting ways: on the one hand some have complained about the prison sentences imposed on the accused, who are perceived as having justifiably and usefully alerted the scientific community about the potential risks related to GM crops and the undemocratic way in which decisions have been made; while on the other hand others have condemned the destructions and asserted the importance of such field trials for assessing the potential risks.

8.2 Stakeholder dialogues GMOs have been the subject of experimentation by the government for new procedures for public consultation. In 1998, the first consensus conference ever held in France was about the use of GMOs in agriculture and food. In 1999, the government organised a big national debate on food policy (Etats Généraux de l’Alimentation), which included the topic of GMOs. In 2002, another public debate was commissioned by government, this time specifically about field trials (Babusiaux 2002). In 2002-2003, INRA organised an interactive technology assessment exercise to inform the Institute’s decisions about research on potentially pest resistant GM vinesliv.

Alongside these more novel procedures for public participation in governmental decision making, the government has also organised more traditional consultations with stakeholders: • Inquiry conducted by the Parliamentary Office for Technology Assessment

(OPECST), which included public hearings of experts and stakeholders (Le Déaut, 1998)

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• Report by the Conseil Economique et Social (Rouvillois and Le Fur, 1999)

• Working group of the Commissariat General au Plan, which included members from a wide range of stakeholders (Chevassus-au-Louis, 2001)

The Senate also produced two reports on GMOs, published in 1998 and in 2003, both coordinated by (right wing) Senator Bizet. These reports were produced on the basis of hearings with a wide range of stakeholders and analysis of documents.

It is striking to note, however, that since the 1992 debates about the adoption of the GM law which transposed Directive 90/220, there have been no debates at all in parliament about GMOs, despite requests by some MPs (Aubert, 2001).

Industry has not organised any dialogues with NGOs. During our attempts to recruit industry representatives to participate in our PEG national workshop, we found that a common attitude was that there was no point trying to discuss with actors that they perceived as having a blanket opposition to GMOs and who would not listen to rational scientific evidence. This attitude seemed to be fairly reciprocal and NGOs do not seek dialogues with industry, although they did participate in the PEG workshop.

Biotech firms have however led initiatives to communicate with the wider public, for example through a ‘biotechnology train’ which travelled through France providing information about GMOs. More recently, an institution called DEBA has been set up, funded by 7 large plant biotech firms. DEBA has produced a number of ‘information sheets’ and distributes them to actors identified as key intermediaries such as doctors and teachers.

NGOs, in particular OGM Dangers, regularly organise public meetings where critical scientists (Séralini, Gouyon, Wan Ho, Putzaï...) present their positions.

8.3 NGO involvement in risk assessment In theory, the most direct way for NGOs to participate in expertise is through their membership of expert bodies.

Five out of the 18 members of the CGB are appointed as representatives of society (this includes environmental and consumer NGOs, biotech industry, farming organisations, employee and employer organisations from the biotech industry, and trade unions). However, both the NGOs concerned and the scientific experts at the CGB state that, at least with respect to the NGOs, the mechanism has not been effective. The reasons given by the scientific experts tend to relate to the competence and personality of the representatives: their lack of scientific competence of the NGO representatives and/or lack of interest and commitment. The NGOs, however, emphasise their lack of resources (time and money), and state that they cannot raise the general issues of most concern to them within deliberations which are based on case-by-case assessment; and that some of their questions are not related to health or environmental risks. They do not accept that the NGO representatives lack scientific competence, since in most cases the individuals chosen to sit at the CGB had relevant scientific training in molecular biology or ecology.

A general consensus seems to be emerging about the uselessness of NGO membership of the CGB, and it is likely that the new GM law currently being drafted will replace the CGB with a new committee composed only of scientific experts (some of which may come from NGOs).

One member of the CGB, who was appointed in 1998 as a scientific expert (he is professor in a university department of biochemistry and molecular biology), is also President of an NGO, the CRIGEN, which was set up in the late 1990s to provide counter-expertise on GMOs.

Representatives of society are not included in the scientific committee at AFSSA, but are represented on the Administrative Board of the Agency.

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Fifty percent of the members of the biovigilance committee are representatives of civil society, not scientists, but this committee has not, in practice, been very active because there has been no significant commercial cultivation of GM crops in France.

NGOs have also used the courts to attempt to influence procedures for risk assessment and risk regulation: • Environmental NGOs (Greenpeace, Ecoropa, Friends of the Earth) attempted to

influence regulatory measures and experts judgements through their 1998 appeal to the administrative high court, the Conseil d’Etat, against the authorisation to cultivate varieties derived from Bt176 in France.

• Ecoropa also appealed to the Conseil d’Etat in 1997 about the fact that the members of the CGB had not been properly re-appointed at the end of their mandate in 1996. The NGO won the case, and as a result all opinions expressed by the CGB between May 1996 and July 1998 (when the CGB was properly reconstituted) were annulled.

• France Nature Environment appealed to a special administrative court (CADA), which specialises in access to administrative documents, to request that the location of field tests be released to the public. The NGO won the case and since 2002 the Ministry of Agriculture publishes on its web site the list of field test authorised and the communes where they are to take place.

• CRIIGEN appealed to CADA in order to obtain the minutes of CGB meetings, and won the case in February 2004. The NGO then used the minutes to publicise in the media the internal conflicts within the CGB and what they perceive as inadequate and unscientific risk assessment judgements made by the committee.

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References Babusiaux, C., Le Déaut, J.Y., Sicard, D., Testart, J. 2002. ‘Rapport à la suite du

débat sur les OGM et les essais au champ.’ Paris: MATE.

Cans, C. 1999. ‘Le principe de précaution, nouvel élément du contrôle de légalité.’ Revue française d’administration:750-762.

Chevassus, B. 2000. ‘L’analyse du risque alimentaire : quels principes, quels modèles, quelles organisations pour demain?’ in Conférence de l’OCDE ‘La sécurité sanitaire des aliments issus d’OGM’. Edimbourg, février 2000.

Godard, O. 2001. ‘Précaution légitime et proportionalité.’ Risques 47:95-100.

Granjou, C. 2004. ‘La gestion du risque entre technique et politique. Comités d’experts et dispositifs de traçabilité à travers les exemples de la vche folle et des OGM.’ Paris: Université René Descartes, Ecole Doctorale ‘Education, lnguages, sociétés’. 516pp.

Heller, C. 2002. ‘From Scientific Risk to Paysan Savoir-Faire: Peasant Expertise in the French and Global Debate over GM Crops.’ Science as Culture 11:5-37.

Hermitte, M.A. 1997. ‘Les OGM et la précaution: comme un parfum de nostalgie.’ in Génie Génétique. Des chercheurs citoyens s’expriment, edited by Ecoropa. Paris: Sang de la terre.

—. 1998. ‘Tribunal de grande instance d’Agen, 18 février 1998.’ Gazette du Palais:34-37.

Hermitte, M.A., Noiville, C. 1993. ‘La dissémination volontaire d’organismes génétiquement modifiés dans l’environnement: une première application du principe de prudence.’ Revue juridique de l’environnement:391.

Hirsch, M. 2001. ‘L’expertise scientifique indépendante dans un établissement public : l’exemple de l’Agence française de sécurité sanitaire des aliments.’ Conseil d’Etat, Etudes & Documents:427-440.

Joly, P. B., Assouline, G., Kréziak, D., Lemarié, J., Marris, C. 2000. ‘L’innovation controversée : le débat public sur les OGM en France. Rapport à la DGAL.’ Grenoble: INRA.

Joly, P.B., Barbier, M. 2003. ‘Séparation de l’évaluation et de la gestion des risques : Les leçons de la ‘ guerre du bœuf ‘.’ in L’organisation du recours à l’expertise scientifique en situation d’incertitude, edited by O. Godard.

Kourilsky, P., Viney, G. 2000. Le principe de précaution. Paris: Odile Jacob/ La Documentation Française.

Le Roy, V. 1996. ‘La dissémination d’organismes génétiquement modifiés (OGM). La prudence est-elle possible? Colloque NSS-min. Env., 25-27 mai 1994.’ Dossier de l’Environnement de l’INRA:4-39.

Marris, C. 2000. ‘Swings and roundabouts: French public policy on agricultural GMOs since 1996.’ Politeia 60:22-37.

Marris, C., Joly, P.-B. 1999. ‘Between consensus and citizens: Public participation in Technology Assessment in France.’ Science Studies 12:3-32.

Roy, A. 2000a. ‘Expertise et appropriation du risque : Le cas de la Commission de Génie Biomoléculaire.’ Rouen: Université de Rouen, Département de Sociologie. 473 pp.

Roy, A., Joly, P.-B. 2000b. ‘France: broadening precautionary expertise?’ Journal of Risk Research 3:247-254.

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Annexes Annex I: Table of Part C dossiers submitted in France under Directive 90/220

Notification number

Plant species, GM trait, transformation event

Notifier Commercial application

CGB opinion1 Circulation by EC

EC Decision

Final consent issued by France

French seed Catalogue

Invocation of Article 16

Re-submitted under Directive 2001/182

Novel Food Reg. 258/973

C/FR/93.08.02 Tobacco Herbicide (bromoxynil) resistance ITB 1000 OX

Seita Growing, seed production (not food)

1993 23/11/93 08/06/94 n°94.385

27/07/94 None requested

None N/A Not requested

C/FR/94.11.03 Maize Pest resistance and herbicide (glufosinate) resistance Bt176

Ciba-Geigy (Novartis, Syngenta)

Growing, seed production, import, processing, food and feed

01/03/95 27/03/95 23/01/97 n°97/98

04/02/97 05/02/98 and 03/08/98

Austria, 14/02/97 Luxemburg, 17/03/97 Germany, 04/04/00

N/A [food consent under 90/220]

1 Unless otherwise stated, the opinions were favourable. An asterisk indicates that the opinion was annulled following the Ecoropa appeal to the Conseil d’Etat claiming that

the CGB was not legally composed (all opinions issued between May 1996 and July 1998). 2 Up to 28/01/04. 3 Up to 28/01/04.

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C/FR/95.05.01A [Same product as C/UK/94/M1/1 – but for breeding only – final consent 28/02/96]

Oilseed rape Male sterile and herbicide (glufosinate) resistance MS1xRF1

Plant genetic systems (Agrevo)

Growing, seed production, import, processing, food and feed

1995 25/07/95 06/06/97 n°97/392

Not issued

N/A N/A [France for C/UK/94/M1/1 on 20/11/98]

No Art. 5 (UK) 24/06/97 and again 28/07/98

C/FR/95.05.01B Oilseed rape Male sterile and herbicide (glufosinate) resistance MS1xRF2

Plant genetic systems (Agrevo)

Growing, seed production, import, processing, food and feed

1995 25/07/95 06/06/97 n°97/393

Not issued

N/A N/A No Art. 5 (UK) 24/06/97 and again 28/07/98

C/FR/95.06.01 [Re-submitted in 1998 in the Netherlands as C/NL/98/11 but not for cultivation4 – pending]

Oilseed rape Herbicide (glyphosate) tolerance GT73

Monsanto Unrestricted Examined in 1996 03/09/97*, favourable, but with reservations5

No N/A N/A N/A N/A [C/NL/98/11 SNIF published on 22/01/03 NL Assessment Report published on 22/01/03]

Art. 5 (UK) 21/11/97

4 SNIF submitted under Directive 2001/18 for dossier C/NL/98/11 on 16/01/03 states ‘‘Due to lack of official reply (and/or data requirement) from the French competent

authority, the present application was submitted in the Netherlands in 1998.’ 5 Accompanying letters to petitioner and to Agriculture and Environment Ministers dated 23/10/97 raise issue of management of multiple herbicide resistances, and of

transfer of resistance to other beet varieties and to other species, requests that a biovigilance system by urgently set up, and requests that the dossier be updated with respect to labelling and detection.

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C/FR/95.07.02 Oilseed rape Herbicide (oxynils) resistance

Rhône Poulenc

Unrestricted Examined in 1996 03/09/97* favourable, but with reservations

No Withdrawn by notifier 11/01/99

N/A N/A N/A N/A No Unknown, because name of event unknown, but probably not requested

C/FR/95.12.01B6 Maize Pest resistance, Bt MON809

Pioneer Growing seeds, production, import, processing food and feed

30/01/96, additional assessment required 26/03/96, favourable 19/10/98, deferred7

29/08/96 Pending8 (Council since 10/11/98) (France abstained at the Article 21 committee vote in October 1998)

N/A N/A N/A No Art. 5 (UK) 23/10/98

C/FR/95.12.02 Maize Pest resistance, Bt MON 810

Monsanto Growing seeds, production, import, processing food and feed

26/03/96 30/06/96 22/04/989 n°98/294

03/08/98 03/08/98 Austria 01/06/99 N/A Art. 5 (UK) 06/02/98

6 The original dossier referred to two transformation events, and was then split into dossier C/FR/95.12.01A for MON801 and dossier C/FR/95.12.01B for Mon809. Dossier

C/FR/95.12.01A, was, according to the CGB Annual Report of 1996, also transmitted to the EC with a favourable opinion, but does appears on the list received of notifications from Member States (http::/biosafety.ihe.be/TP/TPmarket.html).

7 In October 1998, and in preparation for an EU-level Council vote on this dossier (on 10/11/98), the Ministers for Agriculture and for the Environment asked the (recomposed) CGB for a new opinion. A letter from the CGB President (newly appointed Marc Fellous) to the Ministers indicates that at a CGB meeting held on 19/10/98, 2 members voted for, 4 against and 4 abstained. On the basis of this vote, the President considered that the CGB had not adopted any opinion on this dossier. He also recommended that France abstain at the EU-level vote. On 18/11/98, the President sends a letter to the petitioner requesting further analyses.

8 France abstained at Article 21 committee in October 1998. 9 France abstained at Article 21 committee meeting on 18/03/98 and issued declaration.

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C/FR/95.12.07 Maize Herbicide (glufosinate) resistance T25

Agrevo Growing, seed production, import, processing, food and feed

26/03/96 31/06/96 22/04/9810 n°98/293

03/08/98 03/08/98 Austria 08/05/00 UK 13/07/01

N/A Art. 5 (UK) 06/02/98

C/FR/96.03.02 Maize Pest resistant (Bt) and herbicide (glyphosate) resistant MON 802

Monsanto Unrestricted 01/10/96*11 No Withdrawn by the notifier 09/06/00

N/A N/A N/A N/A No Not requested?

C/F/96.04.13 Melon Virus (CMV) resistance

Tezier Unrestricted Examined in 1995 and 1996 No further info

No N/A N/A N/A N/A No Not requested

C/FR/96.05.07 Maize Herbicide (glufosinate) resistance DLL25

DEKALB Genetics corporation

Unrestricted 03/09/97*, favourable12 17/11/98, favourable

No N/A N/A N/A N/A No No Not requested?

10 France abstained at Article 21 committee meeting on 18/03/98 and issued declaration. 11 But stamped on 13/02/97 and not listed as a favourable opinion in 1996 Annual Report of CGB (nor 1997 report). 12 The CGB discussed this dossier at a meeting on 03/09/97 and drafted a ‘favourable opinion’. But on 23/10/97, the CGB President sent a letter to the petitioner stating that

the dossier, in its current state, does no enable the CGB to express a definitive opinion, and asks the petitioner to supply complements. The favourable opinion then seems to have been granted, (as far as we know without any further discussion at the CGB) on 29/11/97, according to the stamp on the opinion.

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C/FR/96.05.10 [Same product as C/ES/98.02, for cultivation – withdrawn] [Same product as C/UK/96/M4/1, for import, processing, food and feed – consent obtained 09/06/98]

Maize Pest resistance (Bt) and herbicide (glufosinate) resistance Bt11

Hilleshög (Novartis)

Growing, seed production, import, food and feed

Examined in 1995 and 1996 03/09/97*, favourable13 17/11/98, favourable Favourable opinion further confirmed in 1999

15/04/99 Pending14 (Comm.)

N/A N/Ao N/A SNIF published on 15/01/03 (Still includes growing) CGB 27/02/03 French Initial Assessment Report published on 29/07/03

Art. 5 (UK) 06/02/98 Full procedure pending (NL, submitted 11/02/99)

C/FR/96.06.01 Beet Herbicide (glyphosate) resistance Event?

Monsanto and Hilleshög

Incomplete info, but includes growing

Examined in 1996 03/09/97*, favourable but with reservations15

No N/A N/A N/A N/A Unknown, because name of event unknown

No Not requested? (No beet in list GM events authorised as food)

13 The CGB discussed this dossier at a meeting on 03/09/97 and drafted a ‘favourable opinion’. But on 23/10/97, the CGB President sent a letter to the petitioner stating that

the dossier, in its current state, does not enable the CGB to express a definitive opinion, and asks the petitioner to supply complements. The favourable opinion then seems to have been granted, (as far as we know without any further discussion at the CGB) on 29/11/97, according to the rubber stamp on the opinion.

14 For C/GB/96/M4/1, France abstained at Article 21 committee meeting on 18/03/98 and issued declaration. 15 The CGB discussed this dossier at a meeting on 03/09/97 and drafted a ‘favourable opinion’, with reservations about the possible emergence of multiple herbicide

resistances, and the transfer of herbicide resistance to other beet varieties or other plant species. On 23/10/97, the CGB President sent a letter to the petitioner stating the dossier, in its current state, does enable the CGB to express a definitive positive opinion, but asks the petitioner to supply complements.

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C/FR/96.06.12 Maize Herbicide (glufosinate) resistance TR14

Agrevo Incomplete info, but includes growing

Examined in 1996 03/09/97*, favourable16

No N/A N/A N/A N/A No No Not requested?

C/FR/97.01.12 Maize Herbicide (glyphosate) resistance MON832

Monsanto No info 11/02/97*, request further analyses

No Withdrawn by notifier 09/06/00

N/A N/A N/A N/A No Not requested?

C/FR/97.10.02 Sugar beet Herbicide (glufosinate) resistance T120-7

Agrevo Unrestricted 25/11/97*, request further analyses

No Withdrawn by notifier 07/03/00

N/A N/A N/A N/A No Not requested? (No beet in list GM events authorised as food)

16 The CGB discussed this dossier at a meeting on 03/09/97 and drafted a ‘favourable opinion’. But on 23/10/97, the CGB President sent a letter to the petitioner stating that

the dossier, in its current state, does not enable the CGB to express a definitive opinion, and asks the petitioner to supply complements. The favourable opinion then seems to have been granted, (as far as we know without any further discussion at the CGB) on 29/11/97, according to the rubber stamp on the opinion.

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Annex II: Notes

i This section draws extensively from research conducted by Christophe Bonneuil,

funded by the CNRS. Some of the results have already been published in: (i) Bonneuil, C. 2002. ‘Les recherches sur les impacts agro-écologiques des OGM dans les années 1990: défense et illustration du rôle des controverses publiques dans l’évaluation des risques et des technologies en situation d’incertitude.’ in Maîtrise des risques, prévention et principe de précaution. Paris: INRS; (ii) Bonneuil, C., F. Angevin, and N. Colbach. 2003. ‘Modelling between field studies and regulation: The genesis of GeneSys.’ paper presented at AIGM-ESF conference on interspecific geneflow, January 22-23. Amsterdam, NL; and (iii) Bonneuil, C., and C. Marris. 2002. ‘Epistemic Cultures and the Reframing of GMO Risk Expertise and Research in France.’ paper presented at EASST conference 31 July-3 August 2002. York, UK.

ii Loi n°95-101 du 2 février 1995 relative au renforcement de la protection de l’environnement, known as the ‘Loi Barnier’.

iii In 1998, after she had left Government, Lepage set up an NGO, CRII-GEN, and acted as the lawyer for the environmental NGO Ecoropa in two appeals to the Administrative High Court against procedures used for the authorisation of GMOs.

iv Government press conference on 27/11/97. v Press Release from Prime Minister, 30/07/98. vi Article 122-5 du Code Penal, Partie legislative, Chapitre II Des causes

d’irrésponsabilité ou d’atténuation de la responsabilité. vii The Commissaire du gouvernement is a member of the CE who is responsible for

impartially summarising the case and its legal context, in public. He does not take part in the deliberations.

viii Letter from the Prime Minister to P. Kourilsky and G. Viney, 29 March 1999. ix This last sentence is difficult to translate because the French doesn’t make sense

to me: I am unsure whether or not he means that ‘public opinion’ is, or is not, opposing the ‘beneficial contributions of science’. (French version : ‘Ces problèmes reflètent les préoccupations de la population : transparence de l’information, respect des précautions en matière de santé publique et d’environnement, sans pour autant que soient contrecarrés les apports bénéfiques de la science.’)

x Researcher (Directeur de Recherche) at INRA, fish geneticist, Executive Director (Directeur Général) of INRA 1992-1996; Vice-President of CGB 1998-2002, Chairman of AFSSA Board of Trustees 1999-2002...

xi Loi n°95-101 du 2 février 1995 relative au renforcement de la protection de l’environnement, known as the ‘Loi Barnier’, which mentions the PP as a fundamental principle.

xii Le 20/02/04, la cour administrative d’appel de Bordeaux a confirmé la validité de l’arrêté municipal anti-OGM du maire de la municipalité de Mouchan (Gers), Christian Touhé-Rumeau, contre l’avis du préfet du département qui en avait demandé la suspension. En décembre 2003, une première décision du tribunal administratif de Pau avait donné raison au maire de Mouchan. Selon l’avocate du Maire était Corinne Lepage, l’arrêté de Mouchan est ‘particulièrement bien rédigé car il a une durée limitée dans le temps et l’interdiction ne porte que sur un périmètre autour d’exploitations agricoles biologiques’. AFP 20/02/04.

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xiii The first petition did not have a name at first, but adopted the title ‘Open Research’

in September 2003, in response to the ‘Defend Research’ petition. xiv ‘Commission d’étude de l’utilisation des produits issus du génie biomoléculaire’,

arrêté du 4 novembre 1986, JOF du 25 novembre 1986. xv Loi n°92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la

dissémination des organismes génétiquement modifiés et modifiant la loi n° 76-663 du 19 juillet 1976 relative aux installations classées pour la protection de l’environnement.

xvi Décret no 93-1177 du 18 octobre 1993 pris pour l’application, s’agissant de plantes, semences et plants, du titre III de la loi no 92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la dissémination volontaire d’organismes génétiquement modifiés et modifiant la loi no 76-663 du 19 juillet 1976 relative aux installations classées pour la protection de l’environnement.

xvii Décret n°99-242 du 26 mars 1999 relatif à l’organisation et au fonctionnement de l’Agence française de sécurité sanitaire des aliments et modifiant le code de la santé publique; Article 13.

xviii Décret no 94-46 du 5 janvier 1994 fixant les conditions de dissémination volontaire des organismes génétiquement modifiés destinés à l’alimentation humaine autres que les plantes, les semences, les plants et les animaux, ou entrant dans la composition des produits de nettoyage des matériaux et objets destinés à entrer en contact avec des denrées, produits ou boissons destinés à l’alimentation de l’homme ou des animaux.

xix Décret n°99-242 du 26 mars 1999 relatif à l’organisation et au fonctionnement de l’Agence française de sécurité sanitaire des aliments et modifiant le code de la santé publique; Article 22.

xx Décret no 95-487 du 28 avril 1995 pris pour l’application, s’agissant d’organismes animaux génétiquement modifiés, du titre III de la loi no 92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la dissémination volontaire d’organismes génétiquement modifiés et modifiant la loi no 76-663 du 19 juillet 1976 relative aux installations classées pour la protection de l’environnement.

xxi Décret n°99-242 du 26 mars 1999 relatif à l’organisation et au fonctionnement de l’Agence française de sécurité sanitaire des aliments et modifiant le code de la santé publique; Article 25.

xxii Décret no 95-1172 du 6 novembre 1995 pris pour l’application du titre III de la loi no 92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la dissémination des organismes génétiquement modifiés, en ce qui concerne les médicaments à usage humain et les produits mentionnés aux 8, 9 et 10 de l’article L. 511-1 du code de la santé publique. Later modified by loi n°98-535 du 1er juillet 1998 relative au renforcement de la veille sanitaire et du contrôle de la sécurité sanitaire des produits destinés à l’homme.

xxiii Agence du médicament, created in 1993, transformed into Agence française de sécurité sanitaire des produits de santé in 1998.

xxiv Décret no 95-1173 du 6 novembre 1995 pris pour l’application du titre III de la loi no 92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la dissémination des organismes génétiquement modifiés, en ce qui concerne les médicaments vétérinaires.

xxv Décret no 96-850 du 20 septembre 1996 relatif au contrôle de la dissémination volontaire et de la mise sur le marché, à des fins civiles, de produits composés en tout ou partie d’organismes génétiquement modifiés.

xxvi Article 9, loi n°98-535 du 1er juillet 1998 relative au renforcement de la veille sanitaire et du contrôle de la sécurité sanitaire des produits destinés à l’homme (et Article L794-2 du code de la santé publique).

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xxvii Décret n°99-242 du 26 mars 1999 relatif à l’organisation et au fonctionnement de

l’Agence française de sécurité sanitaire des aliments et modifiant le code de la santé publique; article 13, 22, 25

xxviii Arrêté du 4 novembre 1986 instituant la commission d’étude de l’utilisation des produits issus du génie biomoléculaire.

xxix Décret n°93-235 du 23 février 1993 portant création de la commission d’étude de la dissémination des produits issus du génie biomoléculaire.

xxx Arrêté du 27 mai 1997 portant prolongation du mandat des membres de la commission d’étude de la dissémination des produits issus du génie biomoléculaire.

xxxi Arrêté du 7 juillet 1998 portant nomination à la commission d’étude de la dissémination des produits issus du génie biomoléculaire.

xxxii Press release from the Prime Minister, 27/11/97 xxxiii JO Sénat Q, 10 sept. 1998, p.2893. See also press release from Prime

Minister of 30/07/98 and La Lettre du gouvernement, 04/09/98. xxxiv ‘Quelques éléments de réflexion sur le fonctionnement actuel et l’évolution de

la CGB’. Letter from the President and Vice-President of the CGB to the Agriculture and Environment Ministries, dated 06/02/03.

xxxv Loi 98-535 du 1er juillet 1998 relative au renforcement de la veille sanitaire et du contrôle de la sécurité sanitaire des produits destinés à l’homme.

xxxvi Loi ordinaire 2001-398 du 09 mai 2001 créant une Agence française de sécurité sanitaire environnementale.

xxxvii In cases related to GM crops and food, authorisations are issued by one or more Ministers, but for GM human and veterinary medicines, authorisations are issued by safety agencies (Agency of medicines and CNEVA, respectively, from 1995 to 1998, then AFSSAPS and AFSSA). This attribution of responsibility to agencies was a radical change introduced in 1993 which is of marginal relevance to GM crops and the PEG project (see Hirsch, 2001, for an interesting discussion). However, it does mean that AFSSA has clear decision-making responsibilities usually understood as ‘risk management’ with respect to veterinary medicines. This type of responsibility was not, however, extended to food and feed when the Agency system was expanded in 1998.

xxxviii Claire Marris, co-author of this report. xxxix There have been notable exceptions with respect to opinions from the CES

which deals with prion diseases, but for GMOs the opinions of the CES and of AFSSA have so far been essentially identical.

xl Loi no 99-574 du 9 juillet 1999 d’orientation agricole, Article 91. xli Government press conference on 27/11/97. xlii Press Release from Prime Minister, 30/07/98. xliii Arrêté du 16 novembre 1998 portant suspension de la mise sur le marché de colza

génétiquement modifié au titre de l’article 16 de la directive 90/220/CEE du 23 avril 1990, suite à la décision 98/291/CE du 22 avril 1998; Arrêté du 16 novembre 1998 portant suspension de la mise sur le marché de colza génétiquement modifié au titre de l’article 16 de la directive 90/220/CEE du 23 avril 1990, suite à la décision 96/158/CE du 6 février 1996; Arrêté du 26 juillet 2001 portant suspension de la mise sur le marché de colza génétiquement modifié au titre de l’article 16 de la directive 90/220/CEE du 23 avril 1990, suite à la décision 98/291/CE du 22 avril 1998; Arrêté du 26 juillet 2001 portant suspension de la mise sur le marché de colza génétiquement modifié au titre de l’article 16 de la directive 90/220/CEE du 23 avril 1990, suite à la décision 96/158/CE du 6 février 1996; Arrêté du 25 juillet

97

2003 portant suspension de la mise sur le marché de colza génétiquement modifié au titre de l’article 23 de la directive 2001/18/CE du 12 mars 2001;Arrêté du 25 juillet 2003 portant suspension de la mise sur le marché de colza génétiquement modifié au titre de l’article 23 de la directive 2001/18/CE.

xliv Article 4 du Décret n°93-1177 du 18 octobre 1993 pris pour l’application, s’agissant de plantes, semences et plants, du titre III de la loi n°92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la dissémination volontaire d’organismes génétiquement modifiées et modifiant la loi n°76-663 du 19 juillet 1976 relative aux installations classées pour la protection de l’environnement: ‘L’accord du ministre chargé de l’environnement est réputé acquis s’il n’a pas fait connaître au ministre chargé de l’agriculture son opposition à l’autorisation dans un délai de 14 jours à compter de la date à laquelle il a reçu l’avis de la CGB. Le ministre chargé de l’agriculture notifie sa décision dans un délai de quatre-vingt-dix jours à compter de la date d’enregistrement de la demande. Le refus d’autorisation doit être motivé sous réserve des dispositions de l’article 5 ci-après; l’absence de décision à l’expiration du délai de quatre-vingt-dix jours prévu au deuxième alinéa du présent article vaut refus d’autorisation. L’autorisation peut-être assortie de prescriptions spéciales, notamment celles relatives aux mesures accompagnant la dissémination.’

xlv Article 15, Décret no 93-1177 du 18 octobre 1993 pris pour l’application, s’agissant de plantes, semences et plants, du titre III de la loi no 92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la dissémination volontaire d’organismes génétiquement modifiés et modifiant la loi no 76-663 du 19 juillet 1976 relative aux installations classées pour la protection de l’environnement

xlvi In all these documents, the French expression used is ‘évaluation des risques’. We have systematically translated this in English as ‘risk assessment’, as this seems to be the closest meaning, with respect to the definitions used in international organisations (eg. Codex Alimentarius Commission Procedural Manual, eleventh edition, FAO and WHO, 2000).

xlvii Article 3, loi n°92-654 du 13 juillet 1992 relative au contrôle de l’utilisation et de la dissémination volontaire d’organismes génétiquement modifiés et modifiant la loi no 76-663 du 19 juillet 1976 relative aux installations classées pour la protection de l’environnement.

xlviii http://ogm.agriculture.gouv.fr/savoir_plus/fiches/fiche2.htm, consulted on 28/01/04. xlix http://ogm.agriculture.gouv.fr/savoir_plus/fiches/fiche2_suite3.htm, consulted on

28/01/04. l http://ogm.agriculture.gouv.fr/experimentations/experimentations.htm, consulted on

28/01/04. li ‘Document 2: Evaluation et procédures d’autorisation’, on http://www.ogm.gouv;

consulted on 28/01/04. lii When comparing these funding figures with other countries, and in particular the

UK, one must take into account that these are additional costs only and that the research is mostly conducted by researchers who are already employed and paid for on a permanent basis by the State.

liii Among the ca 45 EC-funded research projects on the biosafety of GM crops or food between 1989 and 2003, French teams account for 14% of partners (ca 300) in 1989-98 and 19% in 1999-2003 whereas at the same UK’s share decreases from 15% to 14%, as well as Denmark’s, Germany’s and the Netherlands’ (respectively 9% to 4%, 14% to 13% and 13% to 11%). Source: C. Bonneuil’s ongoing work for another project.

liv This exercise was organised by Pierre-Benoit Joly and Claire Marris, co-authors of this report. For more information, see http://www.inra.fr/Internet/Directions/SED/science-gouvernance/ITA-Vignes/index.html.