Adopting the AOAC 2005.06 Method for RegulatoryAdopting the AOAC 2005.06 Method for RegulatoryMonitoring of PSP Toxins in CanadaMonitoring of PSP Toxins in CanadaAllison Guy, MSc & Gilly Griffin, PhDCanadian 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 statementon: 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 programused 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 (Lawrenceet 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 adopteda 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 2005.06method into the CSSP.

• An ethnographic approach, using elite interviewing and document analysis, was employed toidentify 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 biotoxinsthat 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 developedfor 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 lethaltoxin.

• There is a belief among regulators that the MBA will detect all of the toxins in the sample, includingemerging 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.

RECOMMEN DATIONS

• 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 from IRB Services.

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0

Themes Identified as Opportunities

Num

ber

of R

espo

nden

ts (

n=10

)

The re

sults

of t

he M

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highly

varia

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20%

)

Canad

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The M

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yield

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There

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tern

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There

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by Regulators (n=4)

by Scientists (n=6)

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3

4

5

6

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10

0

Themes Identified as Obstacles

by Regulators (n=4)

Num

ber

of R

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n=10

)

Canad

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testi

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AOAC 200

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Courtesy of Jan R

ines