Models used in Australia in risk assessments for veterinary biologicals

In Australia, the development of models for risk assessment in the field of veterinary biologicals is based on the chapter on "Import risk analysis' in the Office International des Epizooties International Animal Health Code. The development process involves examination of the following: country factor (source of the product), commodity factor, nature of the product, potential to carry contaminating organisms, end-use, risk reduction features of the manufacture or nature of the product (e.g. inactivation or extraction techniques, dilution). Finally, the Australian risk model and quarantine process carefully examine the risk of domestic exposure. Consideration goes beyond potential in vivo or in vitro use of the product and encompasses the wider potential for access to animals (domestic and farm, native and feral) after arrival in Australia. Practice involves the limitation of certain agents to appropriate biocontainment facilities, or--where therapeutic or immunotherapeutic use is planned--continuous assessment of the production systems of the manufacturing company. These assessments are developed into templates or precedents which may be re-used to lend consistency and security to the manufacturing process. Australian practice and assessment recognise the wide variety of biologicals and the number of diseases which they can potentially introduce. The author examines several types of biologicals and emerging threats, including that presented by bovine spongiform encephalopathy. This paper complements the paper by J. Owusu in this issue of the Scientific and Technical Review, which addresses, in particular, the assessment of vaccines in Australia. The National Registration Authority plays a specific role which is complementary to that of the other quarantine authorities. Attitudes to risk assessment in Australia derive from the freedom of this country from many diseases, from the potential for inoculation of imported biologicals into animals with direct transmission of contaminants, and from the difficulty of identifying the original source country in many cases (due to the freedom of movement of many biologicals, particularly the substrates of many immunobiologicals).