9
2.3 Risk Regulation and the Legitimacy of EU Governance
Finally, the regulation of biotechnology also intersects two broader, vitally
important, and interrelated questions for the Union, namely the regulation of risk and the
legitimacy of EU governance. In modern societies, governmental actors are frequently
called upon to regulate the risks posed by various products or by industrial processes.
3
Risk, in this context, refers to “the combination of the likelihood (probability) and the
harm (adverse outcome, e.g. mortality, morbidity, ecological damage, or impaired quality
of life) resulting from exposure to an activity (hazard)” (Wiener and Rogers 2002: 320,
emphasis in original). In principle, therefore, regulators faced with a novel product or
process – such as the genetic modification of foods and crops – need to ascertain the
potential harm caused by such activities, as well as the probability of such harm, in order
to take a decision on the legality or illegality of that product or process.
In practice, however, risk regulation frequently requires regulators to act in the
face of uncertainty regarding the nature and extent of the risks posed by new products
and processes, raising the fundamental political question of how governments should
regulate risk in the face of such uncertainty. Frequently, regulators take precautionary
measures, regulating or even banning certain products or activities including in the
absence of complete information about the risks posed by them. More specifically,
Giandomenico Majone (2003: 18-26) argues, government regulators in the United States
and other jurisdictions have responded in four distinct ways – prohibitions, least feasible
risk, elimination of significant risk, and cost-benefit analysis – with a general trend over
time from the first and least sophisticated to the fourth and most sophisticated approach.
In the first of these approaches, regulators exercise a high degree of precaution by simply
banning any product (e.g. food additives) that can be shown to pose some level of risk to
human health (e.g. carcinogens). While clearly motivated by a concern for human health,
such outright bans ignore the potential societal benefits of the banned products, as well as
the probability of risk posed by a given product, which in the case of carcinogens can run
the gamut from significant to minor. For this reason, regulators in the United States and
3
Beck and Giddens have theorized “modernity” in terms of the emergence of a “risk society” in which
risks increasingly are “manufactured,” as opposed to being “natural” or “external” to human activity, and in
which the management of risks becomes a defining element of societal conflict and social understanding.
See Beck 1992 and Giddens 1991.
Convention