Adopting the AOAC 2005.06 Method for Regulatory Adopting the AOAC 2005.06 Method for Regulatory Monitoring of PSP Toxins in Canada Monitoring of PSP Toxins in Canada Allison Guy, MSc & Gilly Griffin, PhD Canadian Council on Animal Care • 1510-130 Albert, Ottawa ON, Canada K1P 5G4 • www.ccac.ca BACKGROUND • The Canadian Council on Animal Care (CCAC) is responsible for the oversight of animal use in research, teaching and testing on behalf of the people of Canada. The CCAC policy statement on: ethics of animal investigation (1989) states that animals should be used only if the researcher's best efforts to find an alternative have failed. • The Canadian Shellfish Sanitation Program (CSSP) uses the mouse bioassay (MBA) to monitor levels of paralytic shellfish poisoning (PSP) toxins in bivalve mollusks. In 2006, this program used approximately 36,000 mice. • In 2005, the Association of Official Analytical Chemists (AOAC) accepted Health Canada’s pre-column High Performance Liquid Chromatography (HPLC; AOAC 2005.06) method (Lawrence et al., 2005) as an official method to monitor shellfish for PSP toxins (AOAC, 2005). • In 2006, the UK incorporated the AOAC 2005.06 method as a screening method in its shellfish monitoring program, which reduced animal use for testing by 80%. In 2008, the UK adopted a refined AOAC 2005.06 method to detect PSP toxins in mussels (Food Standards Agency, 2007). CASE STUDY • The CCAC investigated the opportunities and challenges to incorporating the AOAC 2005.06 method into the CSSP. • An ethnographic approach, using elite interviewing and document analysis, was employed to identify relevant themes. • 10 participants were interviewed: 4 regulators and 6 scientists. DRIVERS FOR CHANGE • The variability of the MBA is high (±20%) and it is subject to false positive results. • The Government of Canada supports the use of alternative methods to detect the marine biotoxins that cause diarrhetic shellfish poisoning and amnesic shellfish poisoning. • Other countries have adopted non-animal testing methods for their PSP monitoring programs. • There is public pressure to move away from animal testing. OBSTACLES TO CHANGE • Canada’s international trading partners would need to approve of changes made to the CSSP. • Certified reference materials (CRMs) used to calibrate the HPLC instrument have not been developed for all of the PSP toxins. • Canada is investing resources in the development/validation of other alternative methods. • There is apprehension among regulators about changing the monitoring method for such a lethal toxin. • There is a belief among regulators that the MBA will detect all of the toxins in the sample, including emerging toxins. • The MBA has protected the Canadian public from PSP for over 50 years. • There is a belief among scientists that the AOAC 2005.06 method is not as efficient as the MBA. RECOMMENDATIONS • Based on our study we recommend that Canada reduce its investment in developing new alternative methods and direct its resources towards • developing a complete set of CRMs for PSP toxins, • furthering the international acceptance of the AOAC 2005.06 method, and • improving the efficiency of the AOAC 2005.06 method. Please see handout for a complete list of references. The authors wish to thank all of the people who participated in this study and Emily Verlinden and Julie Dale for their considerable assistance in the preparation of this poster. This study received ethical review and approval fr om IRB Services. 1 2 3 4 5 6 7 8 9 10 0 Themes Identified as Opportunities Number of Respondents (n=10) The results of the MBA are highly variable (±20%) Canada uses alternative methods to detect other marine biotoxins The MBA can yield false positives There is international pressure to adopt alternatives There is public pressure against animal testing by Regulators (n=4) by Scientists (n=6) 1 2 3 4 5 6 7 8 9 10 0 Themes Identified as Obstac les by Regulators (n=4) Number of Respondents (n=10) Canada has to adhere to testing requirements of importing countries There is a lack of CRMs for each PSP toxin Canada is developing/ validating other alternative methods Regulators are not willing to take risks with public health The MBA measures the general toxicity of a sample The MBA has protected public health for over 50 years AOAC 2005.06 is not efficient as the MBA by Scientists (n=6) C o u r t e s y o f J a n R i n e s