Methodological tensions in risk assessment and benefit assessment: a classification

This article analyzes some of the methodological tensions that can be observed in the regulation of science and technology, and that often manifest themselves as controversies. We offer a three-way classification of such tensions. The latter can arise from: (1) external (non-cognitive) factors that are specific to a particular regulation; (2) external (non-cognitive) factors of wider societal importance that are not related to any particular regulatory process; and (3) internal (non-cognitive, as well as cognitive) factors related to the cognitive, as well as practical limitations of a particular scientific methodology in the context of regulatory decision making. We analyze case studies of the regulation of, among other, pharmaceuticals, chemical products, health claims on foods, as well as genetically modified organisms. The analysis shows that most often such methodological tensions are driven, directly or indirectly, by different stances with respect to non-cognitive factors that underlie the fundamental choices of methods and standards, and therefore the data that underpin regulatory decisions. Our paper makes clear an important feature of regulatory science: cognitive factors (like improved scientific data or accepted best practices), that in academic science facilitate the resolution of debates, in regulatory science do not suffice for achieving closure with respect to such tensions. Any attempt at closure has to deal primarily with the relevant non-cognitive factors.