operational food safety management based on...

UNILEVERSEAC - Risk Analysis Group

Colworth House, Sharnbrook,

United KingdomLEON.GORRIS@UNILEVER.COM

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

2

�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

3

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.

4

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

6

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

7

8

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

9

�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?

11

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?

12

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?

13

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

27

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

29

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

33

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

35

(H0- ΣΣΣΣR + ΣΣΣΣI ≤ PO or FSO)

PC

36

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

37

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

38

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

46

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 !