3
Second, we emphasize the multi-level nature of the process, which involves
overlapping and sometimes conflicting regulations promulgated at the national,
supranational/EU, and international levels. EU policy-makers, therefore, face not only
the challenge of horizontal coordination across issue-areas, but also the vertical
coordination of EU policies with a diverse and politically sensitive set of national
policies, as well as with a growing body of international trade and environmental law
governing the release and marketing of GMOs. As we shall see, EU policy has faced
sharp political and legal challenges both from below (in the form of national revolts
against the licensing of individual GM foods and crops) and from above (in the form of
challenges from other countries within the World Trade Organization, or WTO).
Third, the regulation of GM foods and crops is an instance of a broader category
of “risk regulation,” in which government actors are called upon to adopt regulations
about the acceptable degree of risk posed to society by products or industrial processes.
Such decisions about risk regulation raise questions about the degree of risk judged to be
acceptable to society, as well as about how to regulate specific products or processes in
the face of continuing uncertainty about the risks they may pose to human health and the
environment. As we shall see, risk regulation – including the regulation of GMOs – not
only mobilizes diverse interest groups, but also raises fundamental normative questions
about the roles of science and politics in the management of risk, and hence about the
legitimacy of EU decision-making – especially at the supranational level of EU
institutions where direct democratic control is widely considered to be inadequate.
2
The chapter is organized in seven parts. Following this introduction, part 2
examines in greater detail the challenges of biotechnology as a case of risk regulation and
as a multi-sectoral and multi-level policy, requiring horizontal coordination across issue-
areas and vertical coordination among the national, EU, and international arenas. In part
3, we examine the adoption of the EU’s first binding regulations regarding the release
and marketing of GM foods and crops, examining the interactions of EU institutions,
member states, and private actors, and laying out the provisions of the EU’s landmark
1990 Directives on the deliberate release of genetically modified foods and crops into the
2
The literature on the EU’s “democratic deficit” has mushroomed in recent years. For a range of views,
see Scharpf 1999, Greven 2000, Siedentop 2000, and Moravcsik 2002.
Convention