Present systems and future needs for risk assessment of biologicals in the United States of America: the perspective of the regulator.

The authority for regulating veterinary biologicals in the United States of America (USA) is provided in the Virus-Serum-Toxin Act, enacted in 1913 and amended in 1995. The Act authorizes the Secretary of Agriculture to prescribe regulations governing the preparation and marketing of veterinary biologicals shipped into, within or from the USA. The mandate of the United States Veterinary Biologics Program is to ensure that all veterinary biological products under Government jurisdiction in the USA are pure, safe, potent and effective. The Program is based on licensing, inspection and testing. Risk assessment techniques, and effective strategies for risk management and risk communication, are essential tools for regulatory officials charged with the responsibility of developing requirements for licensing veterinary biological products and production facilities. To accommodate scientific advances, heightened consumer awareness and the international harmonization of requirements, regulatory agencies must continually review and update programme requirements. The author discusses programme updates initiated to address future needs of the United States Veterinary Biologics Program.