UNILEVERSEAC - Risk Analysis Group
Colworth House, Sharnbrook,
United [email protected]
Operational food safety Operational food safety
management based on riskmanagement based on riskLeon Gorris
Wageningen-UREuropean Chair in Food Safety Microbiology
Wageningen University & Research
P.O. Box 8129 6700 EV Wageningen
The Netherlands
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�Basis of safe food production
�Risk based metrics linked to HACCP
�Some examples of how to use / meet risk metrics
�Risk-based food safety management: industry impact
Outline
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A food industry’s view on food safety
� Food safety is a given; it is non-negotiable and non-competitive.
� Safe performance of foods on the market needs to be assured.
� We take on board guidance / learning's from public bodies to
optimise product safety.
� Industries share knowledge & technologies regarding safety.
� For industry to be competitive, requires major innovations and
ideas that attract customers.
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Good Practices (GAP,GMP,GHP)Good Practices (GAP,GMP,GHP)
H A C C PH A C C P
Food Safety Control (Risk Management):
– high level, generic
– policy bases guidance
– specific standards, criteria
Operation level
Country level
Food Safety Management:
Local, specific management
at supply chain level
INCLUDES ALL HAZARDS
StandardsStandards
PolicyPolicy
Public & Private roles Management of Food Safety
Food Safety Assurance
Chain of events:
� Establish Safe Product + Process design
� Validate design from lab-, over pilot- to operational-scale
� Implement design in operational management systems
� Verify control during manufacture
� Monitor & Review as appropriate
But what is / are the benchmark(s) to design safe food against?5
Benchmarks?
� Governments are responsible for articulating food safety
requirements
� They may do this
- in general terms: “industry is responsible for providing safe and
wholesome food”,
- by strongly recommending certain process criteria (“2’, 70°C”) or
product criteria (“pH < 4.5”),
- or by mandating microbiological criteria for final products at some point
in the food supply chain.
– However, it is difficult to directly relate “in-chain” values or
general guidance to the actual safety of final food products
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Evolution of Food Safety Management
Governmental / societal drivers evolved food safety management
to provide:
� More effective and efficient protection of public health
� Necessary tools to prioritize resources, considering health impact
� More responsibility & accountability to industry
� Flexibility in measures to control food safety concerns
� From HAZARD based to RISK based decision making
� From IN CHAIN to END OF CHAIN quantitative guidance
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Good Practices (GAP,GMP,GHP)Good Practices (GAP,GMP,GHP)
H A C C PH A C C P
Food Safety Control (Risk Management):
– high level, generic
– policy bases guidance
– specific standards, criteria
Operation level
Country level
Food Safety Management:
Local, specific management
at supply chain level
INCLUDES ALL HAZARDS
StandardsStandards
PolicyPolicy
ALOP - FSO - PO - PC
Improved connection of public and private roles
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�Basis of safe food production
�Risk based metrics linked to HACCP
�Some examples of how to use / meet risk metrics
�Risk-based food safety management: industry impact
Outline
primary
productionmanufacturing retail Preparation / cooking for consumptiontransport
Explicit, risk-based guidance of levels of a hazard not to be surpassed
Operational actions, building onto HACCP and Good practices
Country level
Operational food chain level
Micro
criterion
Food Safety
ObjectivePerformance
Objective
Exposure
Performance
standard
Performance
Objective
Performance
criterion
Performance
criterion
Performance
criterion
How to work with the risk-based metrics?
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Primary
production
(step 1)
Process 2 Packaging Transport
(step 3)
Process 1
Manufacturing (step 2)
Step 1
Performance
objective (PO)
Step 2
Performance
objective (PO)
Retail
(step 4)
How to work with the risk-based metrics?
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Primary
production
(step 1)
Process 2 Packaging Transport
(step 3)
Process 1
Manufacturing (step 2)
Step 2
Incoming
Hazard level
(H0)
Step 2
Performance
objective (PO)
Retail
(step 4)
Step 2
Performance
Criterion (PC)
Process criteria: e.g. pasteurisation or sterilisation time/temp
Product criteria: pH, aw, salt, acid, etc
Control measures: e.g. refrigeration, control of cross-contamination, education
HACCP
How to work with the risk-based metrics?
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Primary
production
(step 1)
Process 2 Packaging Transport
(step 3)
Process 1
Manufacturing (step 2)
Step 2
Incoming
Hazard level
(H0)
Step 2
Performance
objective (PO)
Retail
(step 4)
Step 2
Performance
Criterion (PC)
H0 - Σ R + Σ I ≤≤≤≤ PO or FSO
1Microbiological testing in Food Safety Management, ICMSF (2002); Book 7
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Integrating steps along the food supply chain
FarmProduction &
distributionKitchen
H0- ΣR + ΣI ≤≤≤≤ PO
H0-ΣR +ΣI ≤≤≤≤ PO
H0-ΣR +ΣI ≤≤≤≤ FSO
Designing safe foods
n Expertise, scientific and technical knowledge
n Historical evidence (products with history of safe performance)
n Product design performance simulation
- Predictive mathematical modelling
- MRA approaches & techniques for exposure assessment
n Validation of design
- Predictive mathematical modelling
- Challenge and shelf-life tests
n Benchmarks
- regulatory requirements (Micro-criteria, Performance standards)
- Industry standards (Performance standards)
- FSO/PO/PC as product safety targets for design.
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Role of FSO-PO-PC “hierarchy” in designing safe foods
� Allows for a quantitative benchmark that integrates the
performance of the whole food supply chain,
disregarding its make-up…..
� The FSO gives the hazard level that should not be
surpassed in the food at consumption…..
� The various players in the food chain can then
establish what the maximum hazard level can be at
the output of the step that they control (H0; PO)….
Designing a safe food at a step in the food chain
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What do we need to know?
� what level of hazard is tolerable in the output of the particular step
(= PO) or the end of the chain (= FSO) ?
� how much contamination (level of the hazard) is associated with
the incoming material (H0) from the previous step: e.g. through
ingredients, intermediate products) ?
� What is then the overall inactivation required or the tolerance to
increase (by survival/growth/recontamination) at that step (PC)
� Knowing the PC, choose the control measures (CM) that deliver
this, which need to be build into GHP/GMP & HACCP
HACCP basics….
• Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
• Monitoring: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.
• Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended.
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Design stage
Production stage
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“ H0 - ΣR + ΣI ≤ PO or FSO “
Fermented meat product:Developing control measures and aspects of the HACCP plan
Initial load (raw material)
Sum of reductions by processing / conditions
Sum of increase/growth opportunities
Target value for design
PC
Values to be given are in 10log
Hierarchy of Risk Management Options
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Food SafetyObjective
PerformanceObjective
PerformanceCriteria
Process/ProductCriteria
Target max. level at consumption
Target max. levelat specific step
Required control
on H0 at specific step
Specific process orProduct conditions
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Food SafetyObjective
PerformanceObjective
PerformanceCriteria
Process/ProductCriteria
Target max. level at consumption
?????
5D reduction in H0
?????
Target organism is E.coli O157:H7
Fermented meat product:Developing control measures and aspects of the HACCP plan
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Reducing the level of the hazard, worst case initial level
PO/FSO
0
10
20
30
40
50
60
70
80
90
1/10Kg 1/Kg 1/100g 1/10g 1/g 10/g 100/g 103/g 104/g 105/g
Frequency and/or Concentration of Hazard
Case s per 100,000
Applying a ΣR of 5 logs, brings the hazard level from +3 (H0) to -2 (PO)
H0 = +3
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Alternative control options for E.coli 0157:H7 in Fermented
Meat Products1
• Apply heat treatment (e.g. 62.8oC for 4
min).
• Apply validated process (e.g. mild heat,
∆pH, ∆aw) to give a 5D kill step.
• Apply non-thermal novel technology that
gives equivalent 5D kill step.
(modified from Nickelson, 1996)
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Target:
- There is a need for a 5 log reduction (PC) in pathogenic
Escherichia coli assuming incoming hazard level (H0) at 1000
cfu/g to achieve 0.01 cfu/g (PO)
Validation:
- The validation process indicates that industry can consistently
achieve this specified log reduction through ensuring this decrease (PC) by appropriate
- heat or non-thermal inactivation
- Suitable change of formulation during manufacturing.
Fermented meat products example
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Alternative control options for E.coli 0157:H7 in Fermented
Meat Products1
• Apply heat treatment (e.g. 62.8oC for 4
min).
• Apply validated process (e.g. mild heat,
∆pH, ∆aw) to give a 5D kill step.
• Apply non-thermal novel technology that
gives equivalent 5D kill step.
(modified from Nickelson, 1996)
CCP
CCP
CCP
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Reducing the level of the hazard, considering the initial level
PO/FSO
0
10
20
30
40
50
60
70
80
90
1/10Kg 1/Kg 1/100g 1/10g 1/g 10/g 100/g 103/g 104/g 105/g
Frequency and/or Concentration of Hazard
Case s per 100,000
H0 = +3
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Reducing the level of the hazard, considering the initial level
PO/FSO
0
10
20
30
40
50
60
70
80
90
1/10Kg 1/Kg 1/100g 1/10g 1/g 10/g 100/g 103/g 104/g 105/g
Frequency and/or Concentration of Hazard
Case s per 100,000
H0 = 0
Instead of applying ΣR = 5, a lower H0 allows for a lower ΣR, so more
mild impact on product, while delivering the original PO= -2
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Equivalent safety:
- An equivalently safe product (with PO of 0.01 cfu/g) can be
consistently achieved by
- ensuring that the raw materials (H0) have less than a 1 cfu/g
based on statistically-based microbiological testing.
coupled with
- ensuring a 2 log decrease (PC) in E.coli through a decrease in
pH during fermentation and a specific decrease in water activity
during maturation
Fermented meat products example
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Alternative control options for E.coli 0157:H7 in Fermented
Meat Products
• Apply heat treatment (e.g. 62.8oC for 4
min).
• Apply validated process (e.g. mild heat,
∆pH, ∆aw) to give a 5D kill step.
• Apply non-thermal novel technology that
gives equivalent 5D kill step.
• Combine raw material testing to control
initial level < 1/g plus a 2D kill step through
∆pH, ∆aw.
(modified from Nickelson, 1996)
CCP
CCP
CCP
CCP and monitoring
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Monitoring:• Measuring pH drop during fermentation and weight loss (or
water activity) during maturation.
Verification:• Periodic process control testing for pathogenic E. coli to verify
that incoming levels in the raw materials are within specification and that fermentation and maturation achieve the intended outcome in the semi-finished or finished product.
• Examination of monitoring records to check for continuous control over time.
Fermented meat products example
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�Basis of safe food production
�Risk based metrics linked to HACCP
�Some examples of how to use / meet risk metrics
�Risk-based food safety management: industry impact
Outline
Designing safe foods - > design HACCP plan
n Identify most heat-resistant realistic hazard
n Determine worst-case initial levels of hazard (H0), based on
literature/internal studies/expert opinion
n Determine Performance Criterion (PC) based upon
regulation/standard or risk based metric benchmark (FSO or PO)
n Consider implementation aspects
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(H0- ΣΣΣΣR + ΣΣΣΣI ≤ PO or FSO)
PC
Example: Cooked chicken & Salmonella
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1500cfu/g 1500cfu/g
Chicken intake
After storagefrozen or chill
<7C = no growth
Final productAcceptable level
0.04cfu/g
Absent in 25g
4.6 log reduction
Example: Cooked chicken & L. monocytogenes
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Acceptable level
1x104.2
cfu/g
Chicken intake Frozen storage
<0C = no growth
Final product
100cfu/g
2.2 log reduction
1x104.2
cfu/g
Hypothetical PO/FSO
Designing safe foods - > design HACCP plan
n Identify most heat-resistant realistic hazard
n Determine worst-case initial levels of hazard (H0), based on
literature/internal studies/expert opinion
n Determine Performance Criterion (PC) based upon regulation/standard
or risk based metric benchmark (FSO or PO)
n Consider implementation aspects
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(H0- ΣΣΣΣR + ΣΣΣΣI ≤ PO or FSO)
PC
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0.001
0.1
10
1000
Recept ion Heat ing Packaging Consumpt ion.
Lm./g
Incorrect process design refs.
L. monocytogenes in paté product supporting growth
Heat inactiva-
tion(CM): -4D
FSO
H0
Recontamination
Growth control
needed
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0.001
0.1
10
1000
Recept ion Heat ing Packaging Consumpt ion.
Lm./g
Incorrect process design refs.
L. monocytogenes in paté product supporting growth
Heat inactiva-
tion(CM): -4D
FSO
H0
Recontamination
PC = 1
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0.001
0.1
10
1000
Recept ion Heat ing Packaging Consumpt ion.
Lm./g
FSO
Process design refs. L. monocytogenes in paté product
Achieved by
appropriate control
measure(s)PC: <+2D
PO: 1 CFU/g
Managing L. monocytogenes on Fresh-cut Lettuce
‘From Farm to Fork’
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H0 - ΣR + ΣI ≤ FSO
• Antimicrobial washing agents
• Physical & chemical washing steps
• GHP and HACCP systems
• Environmental surveillance
Minimize initial numbers:
•Water management
•Choice of fertilizer
• Sanitation of equipment
•Rapid cooling
•Hygiene of personnel
• Temperature management
•Choice of storage atmosphere
• Shelf-life
Setting Performance and Process Criteria (Deterministic)
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H0- ∑ R + ∑ I ≤≤≤≤ FSO
0.1 - ∑ R + 2.7 ≤≤≤≤ 2
∑ R ≥ 0.8 log CFU/g
Example:
120 ppm sodium hypochlorite for 2
minutes provides ≥ 0.8 log reduction
Performance
Criterion
Process
Criterion
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Production & Primary Handling Processing & Packaging Distribution & Shelf-life
Minimizing
initial levels
Research topics
•Composting (1)
•Internalization (2)
•Cross contamination (3)
•Processing water (4)
Reducing
levels
Minimizing
an increase
in levels
H0 ΣIΣR FSO
Food Safety
Objective
- + ≤
•Physical & Chemical
Treatments (5)
•Survival & Growth (6)
Setting Performance and Process Criteria (Stochastic)
0
0.5
1
1.5
2
2.5
-4 -2 0 2 4 6
Ho
R
G
Total
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H0 - ΣR + ΣI < FSO
Log cfu/g
Washing with
120ppm POAA/H2O2
2mins at 4oC
Refrigerated storage
At 8oC or less
for 7days or less
Setting Performance and Process Criteria (Stochastic)
Example: Listeria in Fresh-cut Lettuce
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Food SafetyObjective
PerformanceObjective
PerformanceCriterion
Process/ProductCriteria
< 100 cfu/g
-0.7 log cfu/g(<1 cell per 5g lettuce)
0.8 log Reduction
120 ppm sodium hypochlorite2 minutes
-0.7 log cfu/g(<1 cell per 5g lettuce)
0.8 log Reduction
120 ppm sodium hypochlorite2 minutes
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�Basis of safe food production
�Risk based metrics linked to HACCP
�Some examples of how to use / meet risk metrics
�Risk-based food safety management: industry impact
Outline
What is the impact on industry?
n Impact in terms of industry’s input / effort?
n In terms of their output/benefits
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- A little
- A lot
What is the impact on industry: Input/effort?
Impact in terms of industry’s input / effort?
n Requires industry to understand risk-based food safety management
better
n Appreciate how different it is from hazard-based management
n Acquire skills to use it in the design of (new) food products and
implementation in operational practice
n No need to change management systems! GHP/GMP and HACCP will
still be the systems to run
n In terms of their output/benefits
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Designing safe foods
n Expertise, scientific and technical knowledge
n Historical evidence (products with history of safe performance)
n Product design performance simulation
- Predictive mathematical modelling
- MRA approaches & techniques for exposure assessment
n Validation of design
- Predictive mathematical modelling
- Challenge and shelf-life tests
n Benchmarks
- regulatory requirements (Micro-criteria, Performance standards)
- Industry standards (Performance standards)
- FSO/PO/PC as product safety targets for design.
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What is the impact on industry: Output/benefit?
n Confidence that their management of food safety……
- Contributes to consumer protection
- Is based on “tolerable level of risk” priorities
- Integrates management effort across the supply chain structure
n Promotion rather than constraining innovation
- Management requirements can be matched by industry’s capabilities
- Fostering innovation, utility of new technologies)
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Thank you !
Muito Obrig
ado !
Muchas Gracias !