Adopting alternatives for the regulatory monitoring of shellfish for paralytic shellfish poisoning in Canada: Interface between federal regulators, science and ethics

To ensure the safety of Canada’s shellfish, the Canadian Shellfish Sanitation Program (CSSP) relies on the mouse bioassay to detect toxins known to cause paralytic shellfish poisoning (PSP). This assay uses a large number of mice and requires death as an endpoint. Canadian research has led to the development of a pre-column High Performance Liquid Chromatography (HPLC) method that is more sensitive and more reliable than the mouse bioassay. However, it is not being used by Canadian regulators despite its acceptance by the AOAC and adoption by the United Kingdom. An ethnography study of stakeholders in the CSSP was conducted to determine the opportunities and obstacles to adopting analytical testing methods. The results of the study indicate that the major obstacles are a lack of certified reference materials (CRMs) and the direction of resources towards the development of new instrument-based methods rather than towards the refinement of the existing pre-column HPLC method for regulatory use. To move away from the mouse bioassay, Canada should invest in: basic research to develop a complete set of CRMs for PSP toxins; method refinement to increase sample throughput; and exercises to gain international acceptance of the pre-column HPLC method.