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
212/7/2005
Different types of criteria exist
They are used to determinethe acceptability of a food.
Nestlé Nutrition - Comm
•2
312/7/2005
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
412/7/2005
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
Nestlé Nutrition - Comm
•3
512/7/2005
SupplierSupplier
IndustryRetail
IndustryRetail
Purchase specifications defining the microbiological limits for an ingredient or
a finished product.
CustomerCustomer
Microbiological specifications
612/7/2005
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 ?
Nestlé Nutrition - Comm
•4
712/7/2005
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)
812/7/2005
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
Nestlé Nutrition - Comm
•5
912/7/2005
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?
1012/7/2005
MANUFACTURE
Specifications
Food Chain - Ingredients
Nestlé Nutrition - Comm
•6
1112/7/2005
Milk Powder
Ingredients - Specifications
Different usageDifferent specifications
1212/7/2005
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….
Nestlé Nutrition - Comm
•7
1312/7/2005
MANUFACTURE
SpecificationsCriteria
GuidelinesSpecifications
Food chain – Finished Goods
1412/7/2005
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 ?
Nestlé Nutrition - Comm
•8
1512/7/2005
MANUFACTURE
SpecificationsCriteria
GuidelinesSpecifications
Food chain – Manufacturing
In processing testing
1612/7/2005
WET
DRY
Food chain – Example of Infant Formula
CCP
Nestlé Nutrition - Comm
•9
1712/7/2005
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?
1812/7/2005
WET CLEANINGWET CLEANING
DRY CLEANINGDRY CLEANING
How to control Salmonella or Enterobacteriaceae?
Nestlé Nutrition - Comm
•10
1912/7/2005
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?
2012/7/2005
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?
Nestlé Nutrition - Comm
•11
2112/7/2005
MANUFACTURE
Food Chain – Manufacturing
In processing testing
Product / Semi-finished product
Line – Food contact surfaces including residues
Environment – Points close to remote from line
2212/7/2005
Line samples - Examples
Sampling of food contact surfaces - line samples
Nestlé Nutrition - Comm
•12
2312/7/2005
Environmental samples - Examples
2412/7/2005
Sampling of the processing environment
Environmental samples - Examples
Nestlé Nutrition - Comm
•13
2512/7/2005
Sampling of the processing environment
Environmental samples - Examples
2612/7/2005
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
Nestlé Nutrition - Comm
•14
2712/7/2005
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 ?
2812/7/2005
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
Nestlé Nutrition - Comm
•15
2912/7/2005
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
3012/7/2005
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.
Nestlé Nutrition - Comm
•16
3112/7/2005
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.
3212/7/2005
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
Nestlé Nutrition - Comm
•17
3312/7/2005
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.
