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Risk analysis systems for veterinary biologicals: a regulator's tool box

C G Osborne1, M D McElvaine, A S Ahl

  • 1Weinberg Group Inc., Washington, D.C. 20036-2400, USA.

Revue Scientifique Et Technique (International Office of Epizootics)
|December 1, 1995
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Summary

Risk analysis can support science-based regulation of veterinary biologicals, facilitating international trade. This approach addresses concerns about exotic disease introduction, ensuring safety and efficacy globally.

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Area of Science:

  • Veterinary medicine
  • Regulatory science
  • Risk analysis

Background:

  • Advances in biotechnology enable high-quality veterinary biological production worldwide.
  • International trade agreements pressure governments to adopt science-based regulations for veterinary products.
  • Nations often restrict veterinary biological imports due to fears of exotic disease transmission.

Purpose of the Study:

  • To explore the role of risk analysis in regulating veterinary biologicals.
  • To demonstrate how risk analysis can support science-based regulatory frameworks.
  • To provide examples of risk analysis application in this field.

Main Methods:

  • Historical review of risk analysis as a decision support tool.
  • Description of various risk analysis methodologies (qualitative, semi-quantitative, quantitative).
  • Examples of applying these tools in regulatory contexts for veterinary biologicals.

Main Results:

  • Risk analysis offers a structured approach to decision-making in veterinary biological regulation.
  • Diverse risk assessment tools, with established use in other fields, are applicable.
  • Implementation of risk analysis can help balance trade facilitation with disease control.

Conclusions:

  • Risk analysis is a valuable tool for developing science-based regulations for veterinary biologicals.
  • Adopting risk analysis can enhance international trade while managing disease risks.
  • A systematic approach using risk assessment tools is crucial for modern regulatory systems.