The central question of the PARADYS project directs to the relation between procedural preconditions and the observed types of dynamics between empirically constituted types of social positions. This relation, such was our suggestion in the theoretical chapters, will shed light on the world of communicated citizenship and will therefore allow for more general conclusions regarding national and international regulation.
The argument in the following section will proceed in four steps: first, the political and socio-cultural context, in which GMO licensing is embedded in the different countries and on the European level, will briefly be reminded of. In a second step the procedural conditions will be compared with respect to their formal qualities. Summarising these qualities we will in a third step describe the interactive slots, which the procedures open for the communication of different positions. In the fourth step, the consequences for the dynamics of social positioning will be developed.
The debate about GMOs – The political and socio-cultural context of the procedure
All over Europe, the past few years have shown very intense debates about biotechnology in general, and about plant biotechnology and novel food in particular. As for instance the Eurobarometer surveys have shown, the general public is more or less reluctant in accepting the technology. In some cases, it can also be described as anti-GMO. Due to our reports, the latter holds true for the majority of the countries in PARADYS. In these countries during the course of the PARADYS research a lively debate about plant GMOs, novel food, organic farming, and the future of agriculture has re-established, whereas a few years ago this public debate almost seemed to have ceased. The “majority” group in this respect is formed by Germany, Italy, the Netherlands, Sweden, Great Britain, and Ireland. It is also to some extent representative for what characterises the EU. Only Hungary plays the role of an exception
with regard to the general political situation, since no publicly visible debate about the issue of plant biotechnology seems to have established yet.
In the course of our research, the EU legal framework for deliberate release changed.
Directive 90/220/EC was always heavily contested. When the already sceptical GMO debate in the EU was further infuriated in the ‘watershed years’ 1996/97 leading to the de-facto moratorium for market release, an intensive discussion about the revision of the directive started. While the critical aspect was market approval of GM plants (especially those intende for use in food), this affected field trials as well. In the late 1990s, applications for field trials decreased (cf. SNIF database). This second wave of a regulatory debate in the EU (the first ended with the first directives in 1990) was has strongly influenced by public protest the (cf.
Meins 2003: 103ff.). Finally, in 2001 revised European Parliament and Council Directive 2001/18/EC on Deliberate Release was adopted; it had to be transferred into national law in all member states by October 2002 (yet not all member states complied in time, e.g.
Germany). Most changes in the new directive confer to market approval and introduce a stricter regime for licensing and control. For example, the authorisation procedure is now stricter introducing a time limit for approval, and the simplified notification procedure is suspended. In addition, GMOs can now be assessed by ethical criteria. Major changes concerning our research field are the introduction of a public register for field trials, and public participation in the authorisation of field trials is now made mandatory. However, the directive does not prescribe as to what form of public participation leading to the limited variety we find in the countries that we studies. While some countries changed their form of public participation procedure (e.g. Italy), others did not (e.g. Germany).
We will now briefly sketch the situation in the countries:
The German debate might be seen as characteristic for the “majority” group in some, but not all aspects. We will describe these aspects with regard to the German case and will then turn to the other countries in order to show some differences. In Germany as in the other countries, the case is characterised by a strong polarisation between those who promote the technology as key issue for the 21st century and those who estimate it to be a prominent subject to/of risk discussions. Public opinion is in its tendency against plant biotechnology. Both aspects have coined the legal regulation of deliberate release. The governmental biotechnology policy consists of a strong promotion of genetic engineering in general. On the other hand, in
response to public perception, risk assessment and public participation played an important role in the regulation. The German genetic engineering act – as the legal provisions in all other countries and in the EU – expresses a general decision in favour of the promotion of genetic engineering, and is at the same combined with a case-by-case risk assessment.
Applicants have a “right to grow” unless concrete clues of threat or risk can be proved.
Therefore, scientific and industrial R&D in genetic engineering is generally approved. With respect to this general approach, citizen participation has been criticised by a number of voices as an unnecessary obstacle leading to disadvantages in a situation of international competition. With respect to the assumed risks of deliberate release, participation is considered an unnecessary component of biotechnology governance. As a consequence of this debate, the 1993 amendment has turned the former oral form of citizen participation in a merely written one.41 The last amendment of 2004 left the regulations of public participation untouched. Following the shift in the public discussion, the regulation is focussing on the question of coexistence between biotech farming and conventional or organic farming. The decision to foster plant biotechnology did not lead to consent in society, but rather triggered an ongoing debate on principles. This debate was accompanied by organised protest and widespread illegal actions against field trials with genetically modified crops. During our research, the public debate has shifted to the question of coexistence, which has caused another debate, because German agriculture policy tends to enlarge the part of organic farming and its products. Therefore, government policy has increasingly been occupied with issues of consumer protection and ecological farming. Thus, today the political cultural context in Germany as in most of the countries in our study is structured by three main lines: a strong promotion of new technologies, and thereby of biotechnology in particular; an ecologist line of protest, linked to risk and precaution; and a consumerist line, focussing on the protection of market interests for organic farming and on the autonomy of customers/consumers.
In addition to that, according to our partners’ view, Italy has become more hostile to agricultural biotechnologies and transgenic products, leading the group that opposes new agro food technologies at the European level. At the same time, the government policy indirectly empowered NGOs such as Greenpeace and public research in this field. Following the European moratorium, the Italian government suspended the commercialisation of certain modified products. The situation was until recently characterised by a more or less arcane
41 The problems of the former model have been analysed in Bora 1999.
policy from the side of the national government. Therefore, on a local level, only few debates could be observed, while the general controversy about GMO plants was led by NGOs. The situation might have changed slightly since the enactment of a new GMO regulation, in which a greater amount of consultation is provided for.
The situation with respect to the biotechnology debate in the Netherlands might from our comparative point of view described in a very similar way to the one in Germany. However, when talking about the political culture, it is obvious that the Dutch political system is much more and in general inclined to public debate than the German. It is insofar much more policy-oriented, by which description we mean that concrete cases in the Netherlands are more a question of national policy-making, than of a rather narrow, locally focused process of decision-making. Therefore, as far as we observed, the case-related decision in the Netherlands will very significantly be discussed as something of common (national) interest.
It will be subject to public awareness and even to big “events” like, for instance, the public debates, which are from time to time organised by the Rathenau Instituute, the Dutch Technology Assessment institution. This national public aspect from our point of view rather strongly forms the political cultural context of licensing procedures in the Netherlands.
Like in the before-mentioned cases, in Sweden there has also been a public debate on GMOs, which was characterised by a broad sense of scepticism against the issue. Insofar, the Swedish case does not show significant differences to what has been said before. But on the other side, Sweden clearly has to be viewed at as a very specific case, namely with respect to the – compared with other European countries – extraordinarily extensive right of information. This right is part of the Swedish constitution. In addition, it provides citizens with far reaching possibilities to scrutinise administration based on access to official files. We do not claim these possibilities to be sufficient in any way – a claim, which would be beyond our competence –, but we simply would like to stress the special situation, by which the Swedish case is characterised in comparison with the other countries in PARADYS.
Like the cases before, the situation in the United Kingdom is also characterised by a rather strong anti-GMO attitude and by heavy discussions about plant biotechnology. Farm scale experiments with GMOs, which have been conducted during the time, when our research was done, have also formed relevant aspect of the political context.
The situation in Ireland parallels the described situation in other European countries. The Irish government puts a great emphasis on the biotechnology sector. Government policy reflected in policy statements and voting in relevant EU debates is to create conditions for the introduction of plant GMOs within what is described as a ‘precautionary’ approach to monitor possible damage to human health and the environment. In Ireland, food biotechnology is a growth sector, which is supported by a certain “pro-business climate”, as the country report states. Sustaining strong economic growth by correctly choosing and investing in ‘industries of the future’ is given political importance. The opposition to food biotechnology is composed mainly of environmental and developmental NGOs. The success of the anti-GM coalition in Europe, and in the neighbouring UK, in turning GM foods into a contentious political issue has, together with their own actions, given the anti-GM cause in Ireland greater institutional and public standing than most protest campaigns. Much of the enhanced public standing derives from widespread public disquiet in relation to the introduction of GM plants.
A remarkable exception to this general picture of the political cultural background of what we called the “majority” group is made by Hungary, which according to the report in its nucleus is still characterised by the transition from post-communist to democratic political culture. It therefore does not show all the aspects that have been described as typical for the European situation. The report enumerates some general aspects, which can be seen as basic structures of the contemporary situation. Citizens show little interest in politics and more interest in economic issues. The chances to influence political decisions are commonly estimated by citizens to be very low. A general feature is distrust towards politics. Due to the lack of large social movements, the experience of social and political participation has not become a part of the Hungarian political culture. Altogether th report argues that the main characteristics of Hungarian political culture still indicate traces of the pre-1989 model of political culture and socialisation in Hungary. During the time of the PARADYS study there has not been any public debate on GMOs in the Hungarian printed or electronic media. According to the report, national surveys demonstrate indicate in spite of a remarkable activity from the environmental NGOs a principle disinterest on the side of the general public. The report concludes that the Hungarian political culture shows clear signs of elitism. Relevant opportunities for civil organisations to participate in decision-making processes are not provided for. Although in some areas forums do exist, where representatives of civil organisations may raise their voice, there is no real guarantee for these voices to be taken into consideration.
As a short conclusion from this section, we might say that in the overwhelming majority of the countries studied in PARADYS a visible and vivid public debate has been observed about biotechnology in General and plant GMOs in particular. Independently from the institutional and constitutional background, this debate has put forward public concern about the technology and its application in agriculture. Recently questions of compatibility with organics farming and of consumer rights have come up. They add to the earlier arguments, which in many cases have been of ecologist origin. Only Hungary builds a different case in this respect.
This debate falls on an institutional and cultural ground, which has gained a significant homogeneity over the European countries. Still a few differences might influence our results.
On the one hand, the question is, whether the debate is more linked to particular cases, based on local experiments, and their licensing, or whether it has stronger roots in a more nation-wide political debate about the GMO issue. As an example for the first could, for instance, Germany or Italy may be named. The Netherlands is an example for the second. On the other hand, the question about information rights seems to differentiate the countries in the study.
Sweden is a case with a very characteristic tradition in this respect.
The legal procedural framework for licensing GMOs
On this general background, we will now briefly describe the procedural framework for licensing GMOs. As has already been mentioned in chapter II of this report, since the end nineties a great part of harmonisation has taken place in Europe with respect to the legal regulation of citizen participation in GMO licensing procedure. The situation has more or less been developing into the direction of the mainstream model of written participation.
Nevertheless, there are some differences. We have to study them carefully, because according to our hypothesis these differences might be relevant for the understanding of the dynamics of social positioning.
From a comparative point of view, first it has to be stated that the EU legislation in the meantime has been adopted more or less perfectly in every country in our study.42 All
42 Exceptions such as the still missing provisions for liability regulation in Germany are politically relevant, but do not influence our findings, because they are not subject to the dynamics of positioning in the particular cases of GMO licensing.
countries distinguish the so-called standard and the simplified procedure (with one interesting exception in Sweden, which will be commented upon later). All have declared competent authorities, mostly a national ministry, in a few cases, such as in Germany, a central administration, which is directly subordinated to the national minister. In all cases advisory boards and biotechnology committees have been established on national level. They either have the duty to decide the case in question, or as in some countries, their duty is to give advice to the competent authority. Usually their members are scientists, sometimes accompanied by representatives of the civil society (NGOs, churches, stakeholders).
Participation is sometimes organised as consultation of NGOs and stakeholders, sometimes as the inclusion of everybody, who takes interest in the case. This might be a dimension, which could be decisive with respect to dynamics of social positioning. Another relevant issue in this respect could be the way, how the information about a particular deliberate release issue is provided to the stakeholders and the public. In this respect, we observe significant differences between the countries, although during the last years harmonisation stepped forward in this dimension, too. A third distinctive aspect could be the question, whether the procedure contains a preliminary stage of decision-making or not. This is, for instance, the case in the Netherlands and in Hungary, where the procedure provides for a draft decree, which is then subject to public consultation and comment. It might well be that this draft decree has the effect of involving citizens in a more targeted way than it would be the case in procedures without such a preliminary decision. With such draft decrees the citizens know, what they might have to challenge in order to change an administrative decision. In all other cases, they argue – at least in the beginning of a procedure – against unknown positions.
In a brief overview, the situation in the countries, can be described as follows:
In Germany, during the course of our study, the national legislation has been adjusted to the EU dirctive 2001/18. The amendment did not bring any changes is public participation. With respect to public registers some political discussion occurred, reagarding the details of these registers.
In all cases the competent authority for deliberate releases is a national administration, the Robert Koch Institute (RKI), to which applications for the deliberate release of GMOs have to be submitted. The German procedure, like most of the procedures in the European countries, enacts the type of process that will be called “standard procedure” in the following. The
decision about an application has to be taken within three months, beginning with the submission of a complete application to the competent authority. Before the “official start” of the procedure, applicants may seek advice from the competent authority. After the submission of the proposal a summary and the documents concerning questions of bio-safety are sent to an advisory committee (the so-called ZKBS – Zentrale Kommission für die biologische Sicherheit, to the Environmental Protection Agency (UBA),43 to the Federal Biological Agency (BBA), and to the Federal State where the release is intended to take place. The advisory committee gives a scientific evaluation of the intended project and a recommendation, which the competent authority has to take into account in the final decision.
The EPA and the other actors are asked for an overall consideration of the application. Their consent is compulsory for a positive decision. After a preliminary examination of formal and material correctness and completeness of the application, the competent authority chooses either to proceed with the standard procedure (involving the public), or to follow the so-called simplified procedure. The European Commission is provided with all relevant documents together with information about the intended decision. In the case of the standard procedure, the general public is to be informed about the application after preliminary examination. The application is publicly announced in the official governmental journal ("Bundesanzeiger") and in local newspaper(s). One week later, the application and some documents concerning bio-safety together with a brief description of the intended release are publicly exposed for one month in the premises of the competent authority and in the community, where the release is to be done. Within one month after the end of the exposition, written objections against the application can be submitted. The objections submitted have to be taken into account by the competent authority in the final decision. After the decision an appeal to the administrative court is possible.
TIME SCHEDULE
PARTIES AND ACTIONS
Day 1 The Robert Koch-Institut (RKI) receives an application.
The Biologische Bundesanstalt (BBA, Federal Biological Agency), the Umweltbundesamt (UBA, Federal Environmental Protection Agency), the Zentrale Kommission für die biologische Sicherheit (ZKBS, Central Advisory Committee on Biological Safety; committee within the RKI) and the concerned Bundesland get a summary of the application and the
documents concerning questions of safety in genetic engineering.
43 In 2004, the competence has been shifted from the EPA to a newly established Federal Agency for Nature Conservation.
Some days
later After preliminary examination of the application, the intended project is publicly announced in the official journal of the RKI ("Bundesanzeiger") and in local newspapers.
One week after public announce-ment
The application and the documents concerning questions of safety as well as a short popular description of the intended release are exposed to public inspection for one month, at the RKI and, 'when required', within the community where the release is intended to be done.
Within one month after the exposi-tion of docu-ments ends
Written objections can be submitted at the RKI, or at the place of exposition within the community (to be forwarded to the RKI).
3 months after day 1
The RKI decides about the application. The decision is published in the same media.
In Italy the EU legislation has fully been adopted. The licensing procedure can be divided in an ordinary procedure, which requires the involvement of technical authorities with different degrees of complexity for different processes, and in a simplified procedure, which is mainly based on the figure of “substantial equivalence” of the GMO to an earlier one that has been subject to thorough investigation. A so-called precaution clause provides the competent Ministry with the right to restrict or temporally suspend the use and trade of products estimated dangerous to human health or the environment. In august 2003 Italy adopted a new procedure for the deliberative release of genetically modified crops, adopting the EU directive 2001/18. Participation has been widened, insofar as an Interdepartmental Commission may consult interest groups or the general public in relation with a planned release. As the report says, this possibility has never been used with respect to a specific case of field trial, while environmental groups have obtained at least once to be heard by the Commission. According to the 1993 Decree no publicity is given of the received notifications. No publicity is provided for rejected notifications. Information may be requested from the Commission, but it will be limited by the protection of applicants (commercial rights). After the licensing, once the Commission had given its assent to the experiment, details are published by the Ministry on a web site. Signs are posted around the fields, where the trial is taking place. Local authorities are also given information also in order to provide appropriate field inspections. The newly amended Italian law now provides for consultation, before the licensing evaluation takes place. A list of subjects will be available, which entails actors to be consulted (institutions, associations and other organizations, and any other person that will require being included.) Members of the list will be informed at the starting of every consultation and whenever new information will be available. Public consultation lasts for 30 days