Risk analysis for the importation of veterinary biologicals into the United States of America

International trade in veterinary biological products has been restricted by the following factors: a) concerns that contaminated products could result in the introduction of foreign animal disease agents into the importing country b) differences between countries in the technical requirements for product registration. The provisions of the North American Free Trade Agreement (NAFTA) and the General Agreement on Tariffs and Trade (GATT: now the World Trade Organisation [WTO]) require importation decisions to be science-based and transparent. This requires regulatory agencies to implement valid, credible, and science-based risk analysis models for decision-making. The Veterinary Biologics section of the United States Department of Agriculture, Animal and Plant Health Inspection Service, currently uses a formalized risk analysis model to evaluate the safety risks associated with proposals to field test and license new and biotechnology-derived veterinary biological products. This model for evaluating field tests has been modified to evaluate proposals to import veterinary biological products into the United States of America. The authors describe this risk analysis model, which was specifically designed to evaluate the risks of importing veterinary biological products potentially contaminated with foreign animal disease agents.