Microbiological Criteria for L. L. Microbiological Criteria for monocytogenes - One for all - One for all monocytogenes and all for none ? and all for none ? Dr. Anna Lammerding Dr. Anna Lammerding Dr. Jeffrey M. Farber Dr. Jeffrey M. Farber Health Canada Health Canada
Outline Outline Introduction Introduction Canadian Lm data Canadian Lm data Regulatory Policies Regulatory Policies and L. monocytogenes L. monocytogenes and Same micro criteria Same micro criteria for all foods for all foods worldwide? worldwide? Summary Summary
Incidence of Listeriosis Listeriosis in in Incidence of Canada Canada 652 cases between 1993 and 2003 652 cases between 1993 and 2003 Most isolates belong to three most Most isolates belong to three most common serotypes common serotypes – 1/2a, 1/2b and 4b 1/2a, 1/2b and 4b – Three provinces, BC, AB and ON Three provinces, BC, AB and ON account for most submissions account for most submissions Not reportable! Not reportable!
Incidence in Canada Incidence in Canada 90 80 70 60 Reported Cases 50 40 30 20 10 0 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Year
Canadian outbreaks of listeriosis listeriosis Canadian outbreaks of Year r Food source Serotype # of cases Yea Food source Serotype # of cases (deaths) (deaths) 1981 Cabbage 4b 41 (17) 1981 Cabbage 4b 41 (17) 2000 Imitation crab meat 1/2b 2 2000 Imitation crab meat 1/2b 2 2001 Whipping cream 1/2a 25 2001 Whipping cream 1/2a 25 2002 Soft cheese (cheese heese 4b 48 (3) 2002 Soft cheese (c 4b 48 (3) ripening solution) ) ripening solution 2002 Soft cheese heese ( (water) water) 4b 82 2002 Soft c 4b 82
Range of Lm Policies Range of Lm Policies No policy (India, Malaysia, Thailand) No policy (India, Malaysia, Thailand) “ “Zero tolerance Zero tolerance” ” for some foods for some foods “ “Zero tolerance Zero tolerance” ” for all foods for all foods Tolerance of < 100 Tolerance of < 100 cfu cfu/g at point of /g at point of consumption consumption Tolerance of < 100 Tolerance of < 100 cfu cfu/g for some foods /g for some foods and “ “zero tolerance zero tolerance” ” for others for others and
Microbiological Criteria - Issues Microbiological Criteria - Issues Several countries use different Several countries use different sampling plans and methodologies sampling plans and methodologies Have a policy, but do not enforce it Have a policy, but do not enforce it Each Each “ “state state” ” has authority to set its has authority to set its own action levels own action levels No international agreement on No international agreement on “acceptable levels acceptable levels” ” of Lm in foods of Lm in foods “
Regulatory Policies - U.S.A. Large Jalisco cheese outbreak Quick decision needed "Zero Tolerance Policy" - Absence in 50g Policy basically unchanged 38% decrease in cases (1996-2002)
Canadian Policy Canadian Policy RTE Foods RTE Foods Policy based on combination of Policy based on combination of inspection, environmental sampling inspection, environmental sampling & end product testing & end product testing Most plants with with adequate Most plants with with adequate GMP’ ’s s in place in place usually no usually no GMP testing testing
Canadian Policy Canadian Policy Category 1 - RTE foods causally linked to Category 1 - RTE foods causally linked to Listeriosis - - Absence in 50g Absence in 50g Listeriosis Category 2 - RTE foods supporting Category 2 - RTE foods supporting growth; refrigerated shelf-life > 10d - growth; refrigerated shelf-life > 10d - Absence in 25g Absence in 25g Category 3 - RTE foods with shelf-life Category 3 - RTE foods with shelf-life # # 10d & all foods not supporting growth - & all foods not supporting growth - 10d Action level of 100 cfu cfu/g /g Action level of 100
Canadian Policy Canadian Policy Category 3 Category 3 – # 100 cfu cfu/g; adequate /g; adequate GMP GMP’ ’s s – # 100 allow sale allow sale – # 100 cfu cfu/g; inadequate /g; inadequate GMP GMP’ ’s s – # 100 class II recall possible class II recall possible – > 100 > 100 cfu cfu/g /g Class II recall Class II recall –
Danish Policy Danish Policy Danish criteria are for RTE foods at any Danish criteria are for RTE foods at any point during the shelf-life of the product point during the shelf-life of the product Lm not tolerated in foods where a killing Lm not tolerated in foods where a killing step has inactivated the organism step has inactivated the organism Lm is tolerated up to certain levels in Lm is tolerated up to certain levels in non-treated or partially treated foods non-treated or partially treated foods RTE foods divided into 6 groups RTE foods divided into 6 groups
Danish Policy Danish Policy First 3 categories First 3 categories N = 5; Absence in 25 g for: N = 5; Absence in 25 g for: I. Heat-treated in package I. Heat-treated in package II. Heat-treated and handled; supports II. Heat-treated and handled; supports growth with S.L. > 1 week growth with S.L. > 1 week III. Lightly preserved, not heat treated; III. Lightly preserved, not heat treated; supports growth with S.L. > 3 weeks supports growth with S.L. > 3 weeks
Danish Policy Danish Policy N = 5; c = 1; m = 10; M = 100 N = 5; c = 1; m = 10; M = 100 – Category IV - heat-treated; handled after; Category IV - heat-treated; handled after; – S.L. < 1 week S.L. < 1 week – Category V - lightly preserved, not heat- Category V - lightly preserved, not heat- – treated, S.L. < 3 weeks treated, S.L. < 3 weeks N = 5; c = 2; m = 10; M = 100 N = 5; c = 2; m = 10; M = 100 – Category VI (raw, RTE foods) Category VI (raw, RTE foods) –
U.K. Policy - Lm U.K. Policy - Lm Satisfactory; Borderline; Satisfactory; Borderline; Unsatisfactory; Unsatisfactory; Unacceptable/potentially hazardous Unacceptable/potentially hazardous 3 , absence/25g, 1-199 absence/25g, 1-199 cfu cfu/g, 200 - <10 /g, 200 - <10 3 , 10 3 3 cfu cfu/g ( /g ( ∃ 10 4 4 – – Listeria Listeria spp.) spp.) ∃ 10 ∃ 10 ∃
Policy - France Policy - France Impossible to guarantee Lm free in raw products Should be no Lm in products heated in final wrapping or aseptically packaged "When it does not seem possible to avoid contamination" a tolerance of 100 Lm/g of product is acceptable
Policy – – South America South America Policy Brazil, Argentina and Uruguay Brazil, Argentina and Uruguay Soft and semi-soft cheeses Soft and semi-soft cheeses Lm absent in 25g Lm absent in 25g n = 5, c = 0 n = 5, c = 0
Lm Policy - Australia Samples taken at processing or Samples taken at processing or wholesale wholesale Absence in 25g Absence in 25g Pate, RTE smoked fish, marinated Pate, RTE smoked fish, marinated smoked mussels (cooked or uncooked) smoked mussels (cooked or uncooked) Cheese made from heat-treated milk Cheese made from heat-treated milk Cheese with m.c. > 40%, pH Cheese with m.c. > 40%, pH < < 5.0 5.0
Regulatory Policies - Japan No micro criteria However, Food Safety Law, Article 4 states that no pathogenic microorganisms are allowed to be present in RTE Foods
ICMSF - Foods in Int. Trade ICMSF - Foods in Int. Trade I. Has the food received a listericidal treatment? II. Recontamination likely? III. Presence of Lm likely? IV. Will the food receive a listericidal treatment before consumption?
ICMSF - Foods in Int. Trade ICMSF - Foods in Int. Trade Is there likely to be growth to > > 100 100 cfu cfu/g /g Is there likely to be growth to at consumption? at consumption? NO YES Examine 20 samples - reject if Examine 10 samples - any contains Lm in 25g reject if any sample > 100 cfu/g
Same micro criteria for all foods Same micro criteria for all foods worldwide? worldwide? Issues Issues PEOPLE PEOPLE - Different levels of health care, - Different levels of health care, different priorities, different ALOPs ALOPs different priorities, different FOODS FOODS – – wide variety, different wide variety, different microflora, different technologies, lack of , different technologies, lack of microflora refrigeration (e.g., no selection for Lm?) refrigeration (e.g., no selection for Lm?)
Conditions which predispose Conditions which predispose people to listeriosis listeriosis people to Condition Relative susceptibility Condition Relative susceptibility Transplant HIGH Transplant HIGH AIDS HIGH AIDS HIGH Dialysis HIGH Dialysis HIGH Cancer MEDIUM TO HIGH Cancer MEDIUM TO HIGH Liver disease MEDIUM M Liver disease MEDIU Diabetes LOW Diabetes LOW Pregnancy LOW Pregnancy LOW Alcoholism Alcoholism LOW LOW Over 65 years old LOW LOW Over 65 years old
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