Risk analysis methods and techniques for veterinary biologicals used in Australia.

Advances in modern science and technology and the globalisation of the veterinary manufacturing industry, coupled with the relaxation of trade restrictions by the General Agreement on Tariffs and Trade treaty on sanitary and phytosanitary measures, call for an international approach to standards of acceptable risk and risk analysis methodology. In Australia, different elements of risk analysis are undertaken by different agencies. The agencies employ screening risk assessment, which uses simple worst-case scenarios and conservative data to set priorities and identify issues of limited risk. The approach is multi-factorial, assessing risk to public health, animals and the environment. The major components of the analysis process are risk assessment, risk management, and procedures for communicating and monitoring risk. The author advocates the possible use of quantitative risk assessment, based on acceptable international standards, in making international trade decisions. In the absence of acceptable international standards, it is proposed that countries adopt mutual recognition of comparable standards and specifications employed by national agencies.