Regulatory Perspective in Translating Science into Policy: Challenges in Utilizing Risk Assessment for the Elaboration of Codex Standards of Shellfish Safety

This study raises and reviews issues related to the application of risk analysis in shellfish safety in the Codex Alimentarius Commission (CAC). The food standards, guidelines and other recommendations of Codex shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information, in order that the standards assure the quality and safety of the food supply. Further, health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances. CAC or any subsidiary bodies of the Commission may pose risk assessment questions to FAO/WHO. Under the umbrella of the FAO/WHO Programme for the Provision of Scientific Advice, FAO/WHO provides risk assessments and scientific advice through JECFA, JMPR, JEMRA and other ad-hoc expert consultations (e.g. marine biotoxins). By reviewing three examples related to molluscan shellfish safety: (i) Marine biotoxin Maximum levels and (ii) Salmonella microbiological criteria in the Standard for Live and Raw Bivalve Molluscs (CODEX STAN 292-2008) and (iii) the issue of Vibrio parahaemolyticus microbiological criteria in the Guidelines on the application of general principles of food hygiene to the control of pathogenic Vibrio species in seafood (CAC/GL 73-2010), the applications of risk analysis within the Codex system are examined. Finally, lessons learned through risk assessment and risk management are discussed.