Chapter 3: From Qualifying Products to Imputing Adverse Events: A Short History of Risk Regulation
3. From qualifying products to imputing adverse events: a short history of risk regulation Evaluating risks is a primary source of regulatory standards. In the area of food and pharmaceuticals safety, evaluation of risk has become a science. Disciplines such as clinical pharmacology, regulatory toxicology or microbiological risk assessment are founded, more or less explicitly, on the principle of classifying or ranking products according to their safety, rather than simply experimenting, observing or theorising the latter. These evaluative sciences are ‘trans-sciences’ or ‘post-normal’ (see Chapter 1) in so far as they are implicitly normative: they are the source of safety criteria and specification against which this act of classification or ranking can be made. Evaluative sciences have evolved from a concern with the qualification of products and their safety to one in which they try to anticipate and attribute adverse events in spite of the uncertainty as to when and where they might occur. Qualification is a safety approach that covers the tools and criteria to evaluate the qualities of a product at a given point in time. It covers clinical trials, animal toxicity-testing models, microbiological models, all sorts of experimental techniques by which the hazardousness of a product may be predicted. A programme of qualification aims to shape markets and consumer behaviour by ascertaining through controlled and reliable knowledge, the qualities of a product – positive (‘efficacy’) and also more negative ones (‘side-effects’). It is organised by the standards it produces, such as testing guidelines to verify and project claims...
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