Diff Sim HA RA 1

Differences and similaritiesDifferences and similaritiesbetween HACCP and Risk Analysisbetween HACCP and Risk Analysis

Differences and similaritiesDifferences and similaritiesbetween HACCP and Risk Analysisbetween HACCP and Risk Analysis

Mike van Schothorst

Diff Sim HA RA 2

TerminologyTerminology

Diff Sim HA RA 3

CommunicationCommunicationCommunicationCommunication

HazardHazardRiskRisk

SafetySafety

HACCPHACCP

Hazard Analysis / Risk AnalysisHazard Analysis / Risk Analysis

ALOPALOP FSOFSO

MRAMRA

MRMMRM

Diff Sim HA RA 4

HazardHazardHazardHazard

A biological, chemical or physical

agent in, or condition of, food

with the potential

to cause an adverse health effect

Codex Alimentarius, 1997

Diff Sim HA RA 5

RiskRiskRiskRisk

A function of the probability

of an adverse health effect

and the severity of that effect

consequential to a hazard in food

Diff Sim HA RA 6

Risk AnalysisRisk AnalysisRisk AnalysisRisk Analysis

A regulatory tool to maintain

or enhance the supply of safe food,

both locally produced and imported,

in a certain country

It is not only an analysis, it includes also risk management

Diff Sim HA RA 7

Risk AnalysisRisk AnalysisRisk AnalysisRisk Analysis

Risk Communication

MicrobiologicalRisk Assessment

MicrobiologicalRisk Management

Policy Policy basedbased

Science Science basedbased

Interactive exchange of information and opinions

concerning risks and control measures

MRAMRA MRMMRM

Diff Sim HA RA 8

Risk Analysis and HACCPRisk Analysis and HACCPRisk Analysis and HACCPRisk Analysis and HACCP

identification

quantification

decision

control

review

Government

Industry

HACCP

Assessment

Management

RISK

FFaaccttoorryy

Market

Diff Sim HA RA 9

HACCPHACCPHACCPHACCP

An operational system to select and implement

effective control measures

to ensure the safety of a food product

Microbiological Risk Assessment ( MRA )Microbiological Risk Assessment ( MRA )Microbiological Risk Assessment ( MRA )Microbiological Risk Assessment ( MRA )

A procedure to provide data

that are used in the selection of

appropriate risk reduction measures

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The HACCP systemThe HACCP system

Risk AnalysisRisk Analysis

compared with

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Codex HACCP GuidelinesCodex HACCP GuidelinesCodex HACCP GuidelinesCodex HACCP Guidelines

1. Assemble HACCP team

2. Describe product

3. Identify intended use

4. Construct flow diagram

5. Confirm on-site flow diagram

6. List all potential hazards, conduct a hazard analysis and consider control measure

7 - 12. Apply principles 2 - 7

Diff Sim HA RA 12

1. Conduct a hazard analysis

2. Determine the CCPs

3. Establish critical limit(s)

4. Establish a monitoring system

5. Establish corrective actions

6. Establish verification procedures

7. Establish documentation

HACCP PrinciplesHACCP PrinciplesHACCP PrinciplesHACCP Principles

Diff Sim HA RA 13

(1) Assemble HACCP team(1) Assemble HACCP team(1) Assemble HACCP team(1) Assemble HACCP team

Obtain top management commitment

Appoint a leader and a secretary

Assure participation of experts in QA, microbiology, chemistry, food technology

Assure co-operation of other experts

Define scope of the study

Set priorities

Diff Sim HA RA 14

Assemble Risk Assessment teamAssemble Risk Assessment teamAssemble Risk Assessment teamAssemble Risk Assessment team

Same general principles apply,but Risk managers are mainly governmental

regulators and scientists, while a HACCPteam consists mainly of production people.

The pathogen and food of concern is often already decided upon

by the Risk Managers

MRA

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(2) Describe product(2) Describe product(2) Describe product(2) Describe product

Formulation and composition

Raw materials & ingredients

Parameters influencing safety Processing Packaging Distribution

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Products to analysedProducts to analysedProducts to analysedProducts to analysed

Same general principles apply,but the product is a commodity,

not a specific one.It is a product produced in different manners

by different manufacturers,including manufacturers in other countries

MRA

Diff Sim HA RA 17

(3) Identify intended use(3) Identify intended use(3) Identify intended use(3) Identify intended use

Food service establishments

Caterers

Hospitals

General population

Specific groups of the population

Preparation practices

Exportation

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Use of ProductsUse of ProductsUse of ProductsUse of Products

Same categories may apply,

however, products for export

may need to be treated separately

because of the differences

in use and users

MRA

Diff Sim HA RA 19

(4) Construct flow diagram(4) Construct flow diagram(4) Construct flow diagram(4) Construct flow diagram

Cover all steps which might have an influence on the safety of the product

Include important data such as time & temperature

Indicate hygiene level of areas and barriers

Indicate personnel movements etc.

Raw materials

Mixing

Heating

Filling

Diff Sim HA RA 20

Perform aPerform aProduct / Pathogen / PathwayProduct / Pathogen / Pathway

( PPP ) analysis( PPP ) analysis

Perform aPerform aProduct / Pathogen / PathwayProduct / Pathogen / Pathway

( PPP ) analysis( PPP ) analysis

The fate of the pathogen of concern

from “farm to fork”

will be described in detail,

data concerning conditions at the various steps

need to be collected and treated,

growth, survival etc. will be “modelled”

MRA

Diff Sim HA RA 21

(5) On - Site confirmation(5) On - Site confirmation of flow diagram of flow diagram

(5) On - Site confirmation(5) On - Site confirmation of flow diagram of flow diagram

Check correctness of information

Check whether important information was not overlooked

Check during all periods of operation and cleaning, but also during idle hours

Discuss practices with operators

Diff Sim HA RA 22

PPP confirmationPPP confirmationPPP confirmationPPP confirmation

The pathway and its conditions

need to be checked,

models need to be validated

and the outcomes verified as far as possible.

Uncertainties need to be identified.

the PPP in risk analysis is less specific as the one used in HACCP

MRA

Diff Sim HA RA 23

(6) List all hazards(6) List all hazardsassociated with each step,associated with each step,conduct a Hazard Analysis,conduct a Hazard Analysis,

consider any measuresconsider any measuresto control identified hazardsto control identified hazards

(6) List all hazards(6) List all hazardsassociated with each step,associated with each step,conduct a Hazard Analysis,conduct a Hazard Analysis,

consider any measuresconsider any measuresto control identified hazardsto control identified hazards

Determine which potential hazards

are significant and should be controled

Diff Sim HA RA 24

Hazard identificationHazard identificationHazard identificationHazard identification

The hazard of concern is identified by MRM.

Important aspects of the ecology and

behaviour of the pathogen are collected.

This is particularly difficult when the risk

of a “new” pathogen is assessed

in HACCP hazard identification meansdetermination which hazards are significant

MRA

Diff Sim HA RA 25

Perform a Hazard AnalysisPerform a Hazard AnalysisPerform a Hazard AnalysisPerform a Hazard Analysis

Collect and interpret information on hazards

and conditions leading to their presence

at unacceptable levels

and decide which need to be controlled

"the analysis of hazards

must be quantitative

if it is to be meaningful"

ICMSF 1988

HA is not RA

Diff Sim HA RA 26

Hazard DeterminationHazard DeterminationHazard DeterminationHazard Determination

Presence of agentin raw material probable ?

Presence of agent in lineor environment probable ?

NO NOYES

Unaccept. contaminationat this step probable ?

Unaccept. survival, persistence or increaseat this step probable ?

YES

YES

NO NOYES

Reduction, if any, at afurther step adequate ?

No hazard*

YES**

HAZARDHAZARDHAZARDHAZARD

No hazard*

NO

* Not a hazard to be controlled at this step ** Reduction step becomes thus a CCP

Questions to be answered for each potential hazard for each step

Diff Sim HA RA 27

Acceptable levels Acceptable levels ( 1 )( 1 )Acceptable levels Acceptable levels ( 1 )( 1 )

Not all levels (or sizes) of all agents

are harmful to all individuals under

all conditions

Agents (contaminants) are acceptable

as long as their levels remain

below a certain maximum

Diff Sim HA RA 28

Acceptable levels Acceptable levels ( 2 )( 2 )Acceptable levels Acceptable levels ( 2 )( 2 )

Products with a good record of safety

are used as a “benchmark”

New products, or changed products

should be as safe as the “benchmark”

Performance Objectives are “benchmarks”

set by authorities

Diff Sim HA RA 29

Hazard Analysis of aflatoxin in milkHazard Analysis of aflatoxin in milkHazard Analysis of aflatoxin in milkHazard Analysis of aflatoxin in milk

Maximum Level accepted 15 μg / kg

Q1: Presence of hazard at unacceptable levels in raw material

Q2: Persistent during processing

Q3: Recontamination

Q4: Increase during shelf-life

Q5: Reduction during preparation

Possible Probable Likely No

CCP

Diff Sim HA RA 30

HA of Listeria in hotdogs HA of Listeria in hotdogs HA of Listeria in hotdogs HA of Listeria in hotdogs

Maximum Level accepted <100 / g ?

Q1: Presence of hazard at unacceptable levels in raw meat

Q2: Survival during processing

Q3: Recontamination

Q4: Increase during shelf-life

Q5: Reduction during preparation

Possible Probable Likely No

or

CCP

Diff Sim HA RA 31

Assessment of probabilityAssessment of probabilityAssessment of probabilityAssessment of probability

Possible

Probable

Likely

Reasonably expected to occur

These are semi - quantitative expressions of probability ,based on analytical data or expert knowledge

Diff Sim HA RA 32

ProbabilitiesProbabilitiesProbabilitiesProbabilities

Risk assessors use “models”

to calculate probabilities of

survival, persistence, growth etc.

Models for recontamination

are being developed

the same models can be and are used in HACCP

MRA

Diff Sim HA RA 33

MRA componentsMRA componentsMRA componentsMRA components

Hazard identificationwhich pathogen will be assessed

Hazard characterizationwhat are the effects and what influences the effects

Exposure assessment how often and how many will be ingested

Risk characterizationwhat is the chance that the effects will happen

MRA

Diff Sim HA RA 34

HazardHazard characterization curve ofcharacterization curve ofListeria monocytogenesListeria monocytogenes

HazardHazard characterization curve ofcharacterization curve ofListeria monocytogenesListeria monocytogenes

0

1

2

3

4

5

6

2 3 4 5 6 7 8 9 10

L.m. dose-response

Log Noof casesper 100,000

Log No of ingested L.m., all servings contaminated

worst - casescenario

Buchanan e.a.1997

MRA

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Probabilistic calculation of exposureProbabilistic calculation of exposureProbabilistic calculation of exposureProbabilistic calculation of exposure

MRA

Diff Sim HA RA 36

the chance for a person of falling ill by consuming a food

the estimated number of illnesses (e.g. per year in a country) due to consumption of a specific food/pathogen combination

risk estimates for different processing, distribution and consumer use conditions and risk reduction scenarios

Outcomes of MRAsOutcomes of MRAs

HACCP in product development uses also different scenarios,but the outcome is a level of safety, not a level of risk

MRA

Diff Sim HA RA 37

7) Determine Control Measures 7) Determine Control Measures 7) Determine Control Measures 7) Determine Control Measures

Determine where measures must be taken (CCPs)

Determine how and to which extent they are to be controlled at these CCPs

Establish the critical limits and monitoring procedures

Diff Sim HA RA 38

MRM componentsMRM componentsMRM componentsMRM components

Preliminary MRM activitieswhich pathogen / food will be assessed and why

Evaluation of MRM optionsselection of control measures

Implementation of MRM decisions communicate with stakeholders and follow-up

Monitoring and Reviewcollect epidemiological and other data, revise decisions if appropriate

MRM

Diff Sim HA RA 39

Control measuresControl measuresControl measuresControl measures

Risk managers are responsible for

the evaluation and selection of

control measures.

Food business operators are responsible for

their execution

in HACCP both activities are in the same hands

MRM

Diff Sim HA RA 40

Establish Critical Limits Establish Critical Limits Establish Critical Limits Establish Critical Limits

They must assure that the required level of safety is obtained

This level can be the “benchmark”

or the “Performance Objective (PO)”

The PO may be the outcome of MRM evaluation

Diff Sim HA RA 41

Performance Objective ( PO )Performance Objective ( PO )Performance Objective ( PO )Performance Objective ( PO )

The maximum frequency and / or concentration

of a microbial hazard in a food

at a specified step in the food chain

before time of consumption

that still provides or contributes to

the achievement of an Food Safety Objective

or Appropriate Level Of Protection, as applicable.

A PO is an acceptable level of a hazardin HACCP terminology

MRM

Diff Sim HA RA 42

9) Monitoring in HACCP9) Monitoring in HACCP9) Monitoring in HACCP9) Monitoring in HACCP

The act of conducting a planned sequence of

observations or measurement of control parameters

to assess whether a CCP is under control

Monitoring and Review in MRMMonitoring and Review in MRM

Assessment of effectiveness of measures taken

Review risk management and / or assessment as necessary (new option, new information)

Diff Sim HA RA 43

An example of differencesAn example of differencesand similarities and similarities

An example of differencesAn example of differencesand similarities and similarities

Product Pathogen Pathway of

Listeria monocytogenes

in a specific paté produced

according to GHP and HACCP

and a “generic” paté, as used

in Microbiological Risk Assessment

Diff Sim HA RA 44

PPP of L. monocytogenes PPP of L. monocytogenes (paté 1)(paté 1)PPP of L. monocytogenes PPP of L. monocytogenes (paté 1)(paté 1)

-3

-2

-1

0

1

Reception Heating Packaging Consumption.

Log.Lm./g

safe level

RecontaminationRecontamination GrowthGrowth

GHP and HACCP assure safety of specific product

HACCP

Diff Sim HA RA 45

PPP of L. monocytogenes PPP of L. monocytogenes (paté 2)(paté 2)PPP of L. monocytogenes PPP of L. monocytogenes (paté 2)(paté 2)

-4

-2

0

2

4

Reception Heating Packaging Consumption.

Log.Lm./g

InputforMRA

RecontaminationRecontamination GrowthGrowth Changeconditions ?

A “generic product” under general conditions in a country

MRA

Diff Sim HA RA 46

Risk estimates of listeriosisRisk estimates of listeriosisRisk estimates of listeriosisRisk estimates of listeriosis

0

1

2

3

4

5

6

7

8

1/g 10/g 100/g 1000/g

cases oflisteriosis

per 100 Mioinhabitantsof the USA

which levelacceptable ?

level of L. monocytogenes

Diff Sim HA RA 47

Risk Acceptability conceptRisk Acceptability conceptRisk Acceptability conceptRisk Acceptability concept

Intolerable

region

Acceptableregion

ALARAregion

As low asreasonablyachievable

Severity

At which levels are these lines set ?

Diff Sim HA RA 48