Risk analysis systems for veterinary biologicals: a regulator's tool box

Recent advances in biology and technology have significantly improved our ability to produce veterinary biologicals of high purity, efficacy and safety, virtually anywhere in the world. At the same time, increasing trade and comprehensive trade agreements, such as the Uruguay Round of the General Agreement on Tariffs and Trade (GATT: now the World Trade Organisation [WTO]), have put pressure on governments to use scientific principles in the regulation of trade for a wide range of products, including veterinary biologicals. In many cases, however, nations have been reluctant to allow the movement of veterinary biologicals, due to the perceived threat of importing an exotic disease. This paper discusses the history of risk analysis as a decision support tool and provides examples of how this tool may be used in a science-based regulatory system for veterinary biologicals. A wide variety of tools are described, including qualitative, semi-quantitative and quantitative methods, most with a long history of use in engineering and the health and environmental sciences.