The use and cultivation of GMOs have become one of the most controversial aspects of EU policy-making, facing public unease and resistance, and the object of strong disagreements about the normative value and regulatory influence of science, the interplay between risk assessment and risk management , and the way new and emerging technologies should be controlled and become socially legitimised. The main challenge relates to the functioning of the established prior authorisation procedure for GMO approvals, in particular with regard to their cultivation.
Only two GM crops have been authorised by the European Commission since the early 2000s: the Monsanto potato Amflora in 2010 (recently annulled 1 ) and varieties of the MON810 corn in 1997. The MON810 GMO authorised for cultivation is so far cultivated in only five Member States: Spain , Portugal , the Czech Republic , RĪæmania , and Slovakia . Out of the 28 Member States, only six have GM crops on their territories: Spain , the Czech Republic , Portugal , Romania , Poland , and Slovakia (European Commission, 2011). While in 2015 almost 200 million hectares of GMO were cultivated worldwide, only 114,624 hectares of these were located in the EU (of which 97,346 were located in Spain).
The aim of this book is to examine the various ways transnational regulation deals with the challenges of controlling novel technological risks, and how it treats diverging views regarding the shaping and control of technological risk in view of the scienceādemocracy dichotomy. Against a backdrop of contesting views about the role of scientific expertise in grounding technological decisions, the analysis focuses specifically on the institutional design and operation of those decision-making structures that have been established for the evaluation and management of the risks and effects of agricultural biotechnology within the EU . This particular field of genetic engineering requires special attention because it constitutes the sole form of modern biotechnology that involves the direct and uncontained interaction of its products with the natural environment.
This introductory chapter identifies those features of this technological sector that render it a distinct object of legal and institutional focus compared with other areas. Its particularities relate to its scientific basis, the nature of its potential risks and the socio-economic debates that have been developed in relation to the interpretation of the relevant technical data. The private nature of biosafety research and the persisting divergences among those opposing and supporting the commercial development of agricultural biotechnology constitute some further novelties of the sector. In the light of the special features of this rapidly developing technological field, law is expected to serve multiple purposes. Among these, the most important are the control and management of the potential environmental risks, the creation of favourable conditions for the commercialisation of genetic engineering products, and the establishment of public trust in the Communityās efforts to assess and control the potential effects of this open-field application of modern biotechnology.
The planned release of GMOs into the environment poses particular challenges to EU decision-making structures. Owing to the limited knowledge about the behaviour of GMOs in different ecosystems and agricultural contexts, an EU-wide risk assessment model in the field of agricultural biotechnology needs to involve the consideration of the potential effects of GMO releases on the vast variety of types of natural habitats found across the continent. Moreover, the multi-sectoral character of agricultural biotechnologyāin terms of its association with several policy domains, such as agriculture and industry, public health, and environmental protectionāposes a novel challenge to an institutional framework characterised by deep-seated functional specialisation.
Further, in light of the conflicting interests involved in the development of agricultural biotechnology, EU multi-level risk governance structures face particular difficulties in formulating a harmonised ex ante authorisation framework that would also provide space for the consideration of a variety of factors. In addition, the EUās traditional foundation of its licensing decisions on a sound science risk assessment narrative is challenged in a field in which high scientific uncertainty and high potential risks coincide, calling for a rearticulation and fine tuning of the terms of the relationship between expertise and public decision-making .
This chapter is divided into four sections. The first seeks to frame the motivation for the study. It begins by discussing the main features of agricultural biotechnology as a technological sector, which is a relative newcomer in comparison not only with other fields of industrial activity, but also with other forms of modern biotechnology. Secondly, it refers to the challenges that these particular features pose to traditional science-based licensing approaches. Finally, it examines the particularities that characterise the process for the development of a regulatory structure for genetic engineering at EU level. The second section of the chapter frames the research questions, and the third section briefly outlines the research strategy. The final section offers a brief outline of the book; a road map for the read ahead.
1.1 Why Agri-food Biotechnology?
Agricultural or plant biotechnology (or, elsewhere, agri-food biotechnology ) is a set of enabling techniques for bringing about specific mandate changes in deoxyribonucleic acid (DNA) , or genetic material, in plants, animals, and microbial systems. It has been based on molecular techniques applied to traditional breeding strategies, where genetic material is mixed through natural crossing. Since the late 1980s, questions about genetic engineering have come to occupy a central place in shaping public debates about the future. While genetic engineering as a science has been utilised and applied in a similar fashion in laboratories, research projects, and industry across the globe, regulatory efforts for the formulation of the most appropriate forms of control, or even the precise identification of the object of regulation, have varied. Genetic engineering technologies have in fact aroused worldwide attention and discussions about the need for controlling the associated risks have migrated from the confines of scientific laboratories and expert control circles to public regulatory arenas and international multilateral negotiation venues. Genetic engineering has thus become an example of the emerging tendency for the regulatory control of science and technological development to be based beyond the state.
In view of the high scientific uncertainty and discrepancies about the volume and character of the risks associated with its applications and the multitude of conflicting interests and conceptualisations, agricultural biotechnology recasts the ways in which science and politics, as well as the need for efficiency and for democratic legitimacy, relate in the frame of the respective regulatory decision-making structures. In view of the particularities of agricultural biotechnology as a technological sector and as an object of regulatory attention and safety control, the study examines the Commissionās efforts to formulate a common regulatory framework for the control of open-field GMO releases. As a multi-sectoral issue, its efforts to shape an authorisation control framework on GMOs have raised the challenge of not only coordinating policy-making horizontally across a large number of public and private actors with diverse perspectives about the aims and the content of EU regulation, but also vertically within the Commission, considering the high amount of directorates general (DGs) that expressed an interest in participating in its drafting.
Since 1980, the European legal framework on genetic engineering has addressed a wide array of issue areas. Around 1986, the Commissionās regulatory interest focused on the environmental and internal market dimensions of modern biotechnology. It became associated with the drafting of a Directive on the control of deliberate releases that challenged the capacities of the Commissionās administrative structures and institutional environment to articulate a set of rules that would meet a wide variety of interests without compromising its normative and operative force. The adoption of the Directive in 1990 marked the beginning of the operation of one of the most contentious authorisation frameworks at the Community level. This has been evidenced in its deficient implementation and in the political questioning of the need for a supranational licensing approach in the field of agricultural biotechnology, as well as of its particular normative orientation.
1.1.1 What Is Particular About Agricultural Biotechnology as a Technological Field?
This section examines those features of agricultural biotechnology that evidence its atypical character in comparison with other technological applications. These special elements relate to its scientific basis, the nature of its potential risks, and the debates that have been developed in relation to its promises and perils. In examining the major scientific features of agricultural biotechnology, one should first of all make reference to the relatively limited experience of open-field application in this technological sector in a commercial context. Agricultural biotechnology has been the product of an extensive technological development that has become commercialised only since the end of the 1990s, which in turn explains the small number of its end-products. In contrast to the existence of broad databases and of well-established theories on the hazards of physical technologies in the fields of nuclear and chemical technologies, āthe study of the hazards of biotechnology is as yet in an embryonic stateā. 2 As a result of the fact that the ācommercial applications of biotechnology in plant improvement are still in their infancyā, 3 there is an absence of an integrated historical biosafety database on the behaviour of different GMOs in a variety of open-field contexts. In view of the fact that āthere is no reservoir of precedents into which one can readily dip for historical parallels to the production and use of laboratory-crafted living organismsā, 4 as well as that the timescale for the development of the effects of the interaction between genetically modified living organisms and complex ecological ecosystems is usually long, no valid long-term prediction can be made, nor can conclusive evidence be offered.
An additional idiosyncrasy of agricultural biotechnology in its scientific dimension relates to the acknowledgment of the existence of high scientific uncertainty in relation to the prediction and assessment of the long-term and indirect effects and of risks that have been associated with the introduction of GMOs into the environment. Considering that individual genes are being introduced into highly complex genetic structures and the resultant organisms are being propagated in complex ecosystems, even if a GMO has been tested and found safe in the ecosystem where it is manufactured, it may develop unintended consequences in other ecosystems. According to Gaisford et al., āGiven the complexity of natural ecosystems, it is...