Appendix 2
Bacteriological Guidelines for Fish and Fish Products

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Test Organism1	Product Type	Number of sample units	Acceptance number (c)2	m/g2	M/g2	Criteria for action
Escherichia coli	Cooked or ready- to-eat products	5	1	4	40	Reject if 2 or more units exceed m, or if any unit exceeds M
Escherichia coli	Raw molluscan shellfish	5	1	230/100 g	330/100 g	Reject if 2 or more units exceed m, or if any unit exceeds M
Escherichia coli	All other types	5	2	4	40	Reject if 3 or more units exceed m, or if any unit exceeds M
Coagulase-Positive Staphylococci	All types	5	1	1000	10000	Reject if 2 or more units exceed m, or if any unit exceeds M
Salmonella spp	All types	5	Absent in each 25 g sample or in pooled samples of 125 g.	-	-	Reject if Salmonella spp is detected
Vibrio cholerae	Cooked or ready- to-eat products	5	Absent in each 25 g sample or in pooled samples of 125 g	-	-	Reject if Vibrio cholerae is detected.

Listeria monocytogenes

Listeria monocytogenes (From Health Canada's "Policy on Listeria monocytogenes in Ready-to-Eat Foods") available at:
http://www.hc-sc.gc.ca/fn-an/legislation/pol/policy_listeria_monocytogenes_2010-eng.php

Product Type / Category 3	Laboratory method to be applied	Action Level
RTE Fish products in which the growth of L. monocytogenes can occur and could exceed 100 CFU/g before the end of the stated shelf-life. Includes all products that do not fall in either below-mentioned product types. (Equivalent to Category 1 foods in the HC Listeria policy)*	Presence/absence in 125 g (MFHPB-30 6 or equivalent) on 5 sample units of 25 g each	Detected
RTE Fish products in which the growth of L. monocytogenes can occur but is limited to levels no greater than 100 CFU/g over the course of their stated shelf-life. RTE products that have a refrigerated shelf-life of 5 days or less fall under this category. Other products require validation data 4 demonstrating growth cannot exceed 100 CFU/g 5. (Equivalent to Category 2A foods in the HC Listeria policy*)	Enumeration in 50 g (MFLP-74 6 or equivalent) on 5 sample units of 10 g each	> 100 CFU/g 5
RTE Fish products in which growth of L. monocytogenes can not occur over the course of the stated shelf-life. Products with the following characteristics fall under this category: products that are frozen, or have a pH < 4.4 regardless of the aw, or have an aw < 0.92 regardless of the pH, or have a pH < 5.0 and an aw < 0.94 For products that don't meet the above characteristics, validation data 4 demonstrating the absence of growth is required. (Equivalent to Category 2B foods in the HC Listeria policy*)	Enumeration in 50 g (MFLP-74 6 or equivalent) on 5 sample units of 10 g each	> 100 CFU/g 5

Notes:

¹ The analysis of all fish or fishery products shall be conducted in accordance with approved methods

² m - number of bacteria per gram separating acceptable from marginally acceptable samples, c - number of samples that may exceed this number of bacteria per gram, M - no sample can exceed this number of bacteria per gram

³ For further guidance on the determination of a product category, see Figure 1 of this appendix: Decision Tree - Determination of the ready-to-eat (RTE) product category that a fish product falls under in accordance with the 2010 Health Canada (HC) Listeria Policy.

⁴ See HC's guide on "Listeria monocytogenes Challenge Testing of Ready-to-Eat Refrigerated Foods" for information on challenge testing as part of validation at:
http://www.hc-sc.gc.ca/fn-an/legislation/pol/listeria_monocytogenes-eng.php

⁵ Counts between 5 and 100 CFU/g can be an indication of a possible loss of control and should prompt the processor to verify and/or re-evaluate his process controls.

⁶ Recognized methods to determine compliance with bacteriological guidelines as outlined in Health Canada's Compendium of Analytical Methods available at:
http://www.hc-sc.gc.ca/fn-an/res-rech/analy-meth/microbio/index-eng.php

^* Health Canada's "Policy on Listeria monocytogenes in Ready-to-Eat Foods" will be referred to as the "HC Listeria Policy" validation.

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