QUANTITATIVE RISK ANALYSIS APPLIED TO INNOCUITY AND POTENCY TESTS ON THE OIL-ADJUVANTED VACCINE AGAINST FOOT-AND-MOUTH-DISEASE IN ARGENTINA

The authors describe the method used in Argentina for quantification o f risk in controls of the potency and innocuity of foot and mouth dise ase vaccine. Quantitative risk analysis is a relatively new tool in th e animal health field, and is in line with the principles of transpare ncy and equivalency of the Sanitary and Phytosanitary Agreement of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT: no w World Trade Organisation [WTO]). The risk assessment is presented th rough a description of the steps involved in manufacturing the vaccine , and the controls performed by the manufacturer and by the National H ealth Animal Service (Servicio Nacional de Sanidad Animal: SENASA). Th e adverse situation is considered as the lack of potency or innocuity of the vaccine, and the risk is estimated rising a combination of the Monte Carlo simulation and the application of a Bayesian model.