Different types of criteria exist - ICMSF · Nestlé Nutrition - Comm •1 Name of chairman...
Transcript of Different types of criteria exist - ICMSF · Nestlé Nutrition - Comm •1 Name of chairman...
Nestlé Nutrition - Comm
•1
Name of chairman
Relating Microbiological Testing and Microbiological Criteria to Public Health Goals
Washington 31.10. – 1.11.2005
Industry uses of microbiological testing and microbiological criteria
in the manufacturing and marketing of processed foods
J.L. Cordier NN-QS/OP
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Different types of criteria exist
They are used to determinethe acceptability of a food.
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Codex
PrinciplesCodex
Principles
IndustryIndustry
They are used to determinethe acceptability of a food or compliance with regard to a regulation or policy
Microbiological standards
Public HealthAuthorities
Public HealthAuthorities
Control AuthoritiesControl
Authorities
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Control AuthoritiesIndustry
Associations
Control AuthoritiesIndustry
Associations
Microbiological guidelines
Are advisory and may beestablished to indicate
expectations when best practices are appliedto manufacture safe foods.
Control AuthoritiesControl
AuthoritiesIndustryIndustry
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SupplierSupplier
IndustryRetail
IndustryRetail
Purchase specifications defining the microbiological limits for an ingredient or
a finished product.
CustomerCustomer
Microbiological specifications
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PRINCIPLES FOR THE ESTABLISHMENT ANDAPPLICATION OF MICROBIOLOGICAL CRITERIA FOR
FOODS
Basic Texts Codex Alimentarius
CAC/GL21 -1997
Based on principles of the ICMSF (Vol 2)
How are criteria established ?
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FSOFSO
Goal for process design to obtainacceptable food.
Applied to processing operations
Statement of conditions that diffe-rentiates acceptable from unaccep-table lots of food.
Applied to individual lots or consi-gnements of food.
New approach – From MRA
Micro CriteriaMicro Criteria
ALOP FSO/PO MC
(Comparison of a few elements only; for more see ICMSF Vol 7)
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Public health burden
primary production
manufacturing retail preparation consumption
exposure
transport
Performance objective
Performance objective
Food Safety Objective
Performance criterion
Performance criterion
Control Measure
Control Measure
Control Measure
Performance criterion
cooking
Performance objective
[Performance criterion]
Food Chain - Example
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Ho - Σ R + Σ IRC+G ≤ FSO / PO
Starting level
Reduction
Hazard levelin the
food chain
IncreaseRC: Recontamination
G: Growth Hazard levelat moment ofconsumption
How are FSO or PO used by industry?
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MANUFACTURE
Specifications
Food Chain - Ingredients
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Milk Powder
Ingredients - Specifications
Different usageDifferent specifications
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Ingredients - Specifications
Low High Confidence Level - Supplier
High
Risk
Lev
el -
Ingr
edient
• Historical data•Usage and further
processing• Type of finished
product• Requirements
• Supplier audits• etc….
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MANUFACTURE
SpecificationsCriteria
GuidelinesSpecifications
Food chain – Finished Goods
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0.1% contaminated0.1% contaminated10 samples10 samples
~1% probability of detection~1% probability of detection
10 samples10 samples
~35% probability of acceptance~35% probability of acceptance20 % contaminated20 % contaminated
Why not relying only on end product testing ?
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MANUFACTURE
SpecificationsCriteria
GuidelinesSpecifications
Food chain – Manufacturing
In processing testing
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WET
DRY
Food chain – Example of Infant Formula
CCP
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HighHygieneHigh
HygieneMedium HygieneMedium Hygiene
Zoning includes appropriate
• Design of building(s),
•Design of air handling/flow,
• Flow of people and materials
How to control Salmonella or Enterobacteriaceae?
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WET CLEANINGWET CLEANING
DRY CLEANINGDRY CLEANING
How to control Salmonella or Enterobacteriaceae?
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H 2O
H 2O
H 2O
H 2O
EN
TE
RO
BA
CT
ER
IAC
EA
E
TIME
SALMONELLA
Consequences of wet cleaning
HygieneIndicator
SALMONELLA
How to control Salmonella or Enterobacteriaceae?
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EN
TE
RO
BA
CT
ER
IAC
EA
E
TIME
EB/ E.sakazakii
H 2O
Low levels of EB can only beachieved in the total absence of water
How to control E. sakazakii ?How to control Salmonella or Enterobacteriaceae?
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MANUFACTURE
Food Chain – Manufacturing
In processing testing
Product / Semi-finished product
Line – Food contact surfaces including residues
Environment – Points close to remote from line
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Line samples - Examples
Sampling of food contact surfaces - line samples
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Environmental samples - Examples
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Sampling of the processing environment
Environmental samples - Examples
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Sampling of the processing environment
Environmental samples - Examples
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Deviations in environmental samples such as
Positive Salmonella result
Enterobacteriaceae above an defined level
Abnormal situations – maintenance, cleaning, etc.
have an immediate impact on sampling frequencies of line samples and finsihed product samples.
Environmental samples - Impact
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Line (first powder, sieve output
, first & last can)
Product (can/soft pack)
cP,t?
cL,t?
P P
n1=2
n2=4
L L
sampl
e
sam
ple
+/- +/-Proportion of
positive resultsCP,t
LL
sample
+/-+/-sample
+/-
sam
ple
+/-
sam
ple
Proportion of positive results
cL,t
How to model relationship betweenline and product samples ?
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Line
Product
cP,t?
cL,t?
P P
LL
n1=2
n2=4L L
cL,t~N(????,????)
cP,t~N(????,????)
ρP,L=???
Environment E1
n3=20E1
E1
E1
E1
E1
E1
cE1,t~N(???,???)
ρP,E1=???
How to model relationship between line, product and environmental samples ?
Perfomance ofprocessing line
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Trends of Enterobaocateriaceae in high hygiene zone after the implementation of more stringent preventive measures
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
1 2 3 4 5 6 7 8 9 10 11 12
Month
% o
f sam
ples
<10/g10-100/g≥ 100/g
Trend analysis to see effects or to detect impact of modifications or deviations
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0
20
40
60
80
100
120
Jul 0
3
Aug 03
Sep 03
Oct 03
Nov 03
Dec 03
Jan 04
Feb 04
% of c
ritic
al env
iron
men
tal s
ampl
es <1010 - 100> 100
Trend analysis to see effects or to detect impact on finished product.
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0
2
4
6
8
10
12
14
16
18
20
Jan 03
Feb 03
Mar 0
3
Apr 03
May 03
Jun 03
Jul 03
Aug 03
Sep 03
Oct 03
Nov 03
Dec 03
Jan 04
Feb 04
% o
f lot
s po
sitiv
e in
10
Trend analysis to see effects or to detect impact on finished product.
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0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
0 0.02 0.04 0.06 0.08 0.1 0.12 0.14 0.16 0.18 0.2
Concentration (cfu/g)
Prob
abili
ty o
f acc
epta
nce
Codex (new )
ICMSF-Case 15 (V=10g)
ICMSF-Case 14 (V=10g)
ICMSF-Case 13 (V=10g)
Nestec (CP-08.714)
Boué
Boué (+environmental)
Comparison of sampling plans –Performance (Enterobacteriaceae)
Prob
ability
acc
epta
nce
Concentration cfu/g
n12’=5
n = 2; c = 0, m = 0 (10g) – FP
n = 7 (+5); c = 0, m = 0 (10g) – FP + L
n = 12 (+10), c = 0, m = 0 (10g) – FP + L
Codex or EU n = 10, c = 0, m = 0 (10g) - FP
ICMSF n = 15, 30, 60
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Effective methods to test FP, L, E
0%
20%
40%
60%
80%
100%
30°C 37°C 42°C
Influence of temperature
OthersC. freundiiA. calco.E. coliE. sakazakiiE. cloacaeE.agglomerans
E. sakazakii difficult (if at all) to find in environmental samples if competitive flora (EB) important.