Animal-free paralytic shellfish toxin testing--the Canadian perspective to improved health protection.

The performance characteristics of AOAC Official Method 2011.02 (the PCOX method) as a replacement for the AOAC mouse bioassay procedure have been well defined by validation studies, but these data do not communicate the complete story. The context provided by analyzing 9000 regulatory monitoring samples over 3 years demonstrates not only the reduction in animal use but also the increase in food safety that has been realized using a chemistry-based method. Detection of lower toxin levels provided early warning to enable directed sampling as toxin levels increased. The toxin profile information generated by a chemistry-based method was used to detect potential interferences qualitatively and can be used to assess the impact of changes recommended to monitoring programs. Such changes might include which toxins should be included in an action limit or the toxic equivalence factors used for these toxins.