SLIDE 1 Microbiological Criteria for Microbiological Criteria for L. L. monocytogenes monocytogenes - One for all
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
SLIDE 2 Outline Outline
Introduction
Introduction
Canadian Lm data
Canadian Lm data
Regulatory Policies
Regulatory Policies and and L. monocytogenes
Same micro criteria
Same micro criteria for all foods for all foods worldwide? worldwide?
Summary
Summary
SLIDE 3
Incidence of Incidence of Listeriosis Listeriosis in in 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!
SLIDE 4 Incidence in Canada Incidence in Canada
10 20 30 40 50 60 70 80 90 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003
Reported Cases
Year
SLIDE 5
48 (3) 48 (3) 4b 4b Soft cheese (c Soft cheese (cheese heese ripening solution ripening solution) ) 2002 2002 82 82 4b 4b Soft c Soft cheese heese ( (water) water) 2002 2002 25 25 1/2a 1/2a Whipping cream Whipping cream 2001 2001 2 2 1/2b 1/2b Imitation crab meat Imitation crab meat 2000 2000 41 (17) 41 (17) 4b 4b Cabbage Cabbage 1981 1981 # of cases # of cases (deaths) (deaths) Serotype Serotype Food source Food source Yea Year r
Canadian outbreaks of Canadian outbreaks of listeriosis listeriosis
SLIDE 6
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 and “ “zero tolerance zero tolerance” ” for others for others
Range of Lm Policies Range of Lm Policies
SLIDE 7 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
- wn action levels
- wn action levels
No international agreement on
No international agreement on “ “acceptable levels acceptable levels” ” of Lm in foods
SLIDE 8
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)
SLIDE 9
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 GMP’ ’s s in place in place usually no usually no testing testing
SLIDE 10 Canadian Policy Canadian Policy
Category 1 - RTE foods causally linked to
Category 1 - RTE foods causally linked to Listeriosis Listeriosis -
Absence in 50g
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 10d & all foods not supporting growth - & all foods not supporting growth - Action level of 100 Action level of 100 cfu cfu/g /g
SLIDE 11
Canadian Policy Canadian Policy
Category 3
Category 3
– – # # 100 100 cfu cfu/g; adequate /g; adequate GMP GMP’ ’s s allow sale allow sale – – # # 100 100 cfu cfu/g; inadequate /g; inadequate GMP GMP’ ’s s class II recall possible class II recall possible – – > 100 > 100 cfu cfu/g /g Class II recall Class II recall
SLIDE 12
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
SLIDE 13 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
SLIDE 14
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)
Danish Policy Danish Policy
SLIDE 15
U.K. Policy - Lm U.K. Policy - Lm
Satisfactory; Borderline;
Satisfactory; Borderline; Unsatisfactory; Unsatisfactory; Unacceptable/potentially hazardous Unacceptable/potentially hazardous
absence/25g, 1-199
absence/25g, 1-199 cfu cfu/g, 200 - <10 /g, 200 - <103
3,
, ∃ ∃ 10 103
3 cfu
cfu/g ( /g (∃ ∃ 10 104
4
– – Listeria Listeria spp.) spp.)
SLIDE 16
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
SLIDE 17
Policy Policy – – South America South America
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
SLIDE 18
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
SLIDE 19
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
SLIDE 20 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?
SLIDE 21
Is there likely to be growth to Is there likely to be growth to > > 100 100 cfu cfu/g /g at consumption? at consumption?
ICMSF - Foods in Int. Trade ICMSF - Foods in Int. Trade
YES NO
Examine 20 samples - reject if any contains Lm in 25g Examine 10 samples - reject if any sample > 100 cfu/g
SLIDE 22 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 different priorities, different ALOPs ALOPs
FOODS FOODS – – wide variety, different wide variety, different microflora microflora, different technologies, lack of , different technologies, lack of refrigeration (e.g., no selection for Lm?) refrigeration (e.g., no selection for Lm?)
SLIDE 23
Conditions which predispose Conditions which predispose people to people to listeriosis listeriosis
Condition
Condition Relative susceptibility Relative susceptibility
Transplant Transplant HIGH HIGH AIDS AIDS HIGH HIGH Dialysis Dialysis HIGH HIGH Cancer Cancer MEDIUM TO HIGH MEDIUM TO HIGH Liver disease Liver disease MEDIU MEDIUM M Diabetes Diabetes LOW LOW Pregnancy Pregnancy LOW LOW Alcoholism Alcoholism LOW LOW Over 65 years old Over 65 years old LOW LOW
SLIDE 24
Same micro criteria for all foods Same micro criteria for all foods worldwide? worldwide? Issues Issues
Should there be different criteria for
Should there be different criteria for countries that have a high incidence of countries that have a high incidence of AIDS or alcoholism? AIDS or alcoholism?
Should there be different criteria for
Should there be different criteria for countries that have a large proportion of countries that have a large proportion of elderly people, or have a very high birth elderly people, or have a very high birth rate? rate?
SLIDE 25
What is the goal ? What is the goal ?
Complete Eradication of
Complete Eradication of Listeriosis Listeriosis? ?
Continous Continous improvement improvement
At What Cost?
At What Cost?
SLIDE 26
Future - Regulations Lm Future - Regulations Lm
More pressure to
More pressure to harmonize harmonize
Policy/criteria will
Policy/criteria will evolve as science evolve as science gets even better gets even better
Criteria -
Criteria - “ “zero zero tolerance tolerance” ” for some for some foods, not others foods, not others
Serotype specific
Serotype specific policies? policies?
SLIDE 27
