Cg. Osborne et al., RISK ANALYSIS SYSTEMS FOR VETERINARY BIOLOGICALS - A REGULATORS TOOL BOX, Revue scientifique et technique - Office international des epizooties, 14(4), 1995, pp. 925-935
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, increas
ing trade and comprehensive trade agreements such as the Uruguay Round
of the General Agreement on Tariffs and Trade (GATT: now the World Tr
ade Organisation [WTO]), have put pressure on governments to use scien
tific principles in the regulation of trade for a wide range of produc
ts, including veterinary biologicals. In many cases, however, nations
have been reluctant to allow the movement of veterinary biologicals, d
ue 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 regu
latory system for veterinary biologicals. A wide variety of tools are
described, including qualitative, semi-quantitative and quantitative m
ethods, most with a long history of rise in engineering and the health
and environmental sciences.