emerging risk management tools -...

Emerging Risk Emerging Risk

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Martin Cole and Bob BuchananICMSF Symposium on Innovative Approaches to Microbiological Food Safety Management, Campinas, May 2008

PresentationPresentation

�� Introduction to Codex Introduction to Codex AlimentariusAlimentarius

�� Codex Committee on Food Hygiene Codex Committee on Food Hygiene (CCFH) Microbiological Risk Management (CCFH) Microbiological Risk Management FrameworkFramework

�� Concept of Appropriate Level of Protection Concept of Appropriate Level of Protection (ALOP)(ALOP)

�� Concepts of Food Safety Objective (FSO) Concepts of Food Safety Objective (FSO) and Performance Objective (PO)and Performance Objective (PO)

�� Verifying POsVerifying POs

�� WrapWrap--UpUp

Codex Codex AlimentariusAlimentarius

Basic Assumptions Basic Assumptions

�� The degree of The degree of

““regulatory regulatory

controlcontrol”” placed on placed on

a pathogena pathogen--food food

pair should be a pair should be a

function of the risk function of the risk

to public healthto public health

Risk AnalysisRisk Analysis

�� Codex has long used risk assessment as a toolCodex has long used risk assessment as a tool

�� In its new role under the WTO/SPS In its new role under the WTO/SPS Agreement, Codex has accelerated adoption of Agreement, Codex has accelerated adoption of risk analysis as the framework for dealing with risk analysis as the framework for dealing with many of its activitiesmany of its activities

�� Has had to develop and/or adapt a framework Has had to develop and/or adapt a framework wherein risk analysis principles could be wherein risk analysis principles could be effectively applied to highly complex and effectively applied to highly complex and varied food control systems varied food control systems

World Trade Organization World Trade Organization

(WTO)(WTO)

�� For international trade in For international trade in

food, two of the most food, two of the most

important agreements are the important agreements are the

““Sanitary and Sanitary and PhytosanitaryPhytosanitary

(SPS) Agreement (SPS)(SPS) Agreement (SPS)”” and and

the the ““Technical Barriers to Technical Barriers to

Trade (TBT) AgreementTrade (TBT) Agreement””

�� Recognizes Codex as Recognizes Codex as

international food safety international food safety

standards setting bodystandards setting body

SPS AgreementSPS Agreement

�� Desires of Agreement:Desires of Agreement:�� To improve public healthTo improve public health

�� To establish multilateral framework for To establish multilateral framework for development, adoption, and enforcement of development, adoption, and enforcement of SPS measures to minimize trade impactSPS measures to minimize trade impact

�� To harmonize SPS measures between To harmonize SPS measures between countries via Codex countries via Codex AlimentariusAlimentariusCommission in the case of foods Commission in the case of foods

SPS AgreementSPS Agreement

�� Country can require higher level Country can require higher level

of SPS protection than of SPS protection than

international standard if it can:international standard if it can:

��Provide scientific justificationProvide scientific justification

��Establish an Establish an ““Appropriate Level Appropriate Level

of Protectionof Protection”” (ALOP) based on (ALOP) based on

assessed riskassessed risk

Codex General Subject Matter Codex General Subject Matter

(Horizontal) Committees(Horizontal) Committees

�� Three Codex committees have Three Codex committees have

been particularly active in been particularly active in

developing risk analysis principlesdeveloping risk analysis principles

�� Food Additives and Contaminants Food Additives and Contaminants

(Netherlands)(Netherlands)

�� Food Hygiene (United States)Food Hygiene (United States)

�� General Principles (France)General Principles (France)

CCFH Framework for CCFH Framework for

Microbiological Risk ManagementMicrobiological Risk Management

Preliminary Preliminary

ActivitiesActivities

Evaluation of Evaluation of

OptionsOptions

ImplementationImplementation

Monitoring andMonitoring and

ReviewReview

General Principles of MRMGeneral Principles of MRM

�� 1. Protection of human health is the 1. Protection of human health is the primary objective of MRMprimary objective of MRM

�� 2. MRM should take into account the 2. MRM should take into account the whole food chainwhole food chain

�� 3. MRM should follow a structured 3. MRM should follow a structured approachapproach

�� 4. MRM process should be transparent, 4. MRM process should be transparent, consistent and fully documentedconsistent and fully documented

�� 5. Risk managers should ensure effective 5. Risk managers should ensure effective consultations with relevant interested consultations with relevant interested partiesparties

General Principles of MRMGeneral Principles of MRM

�� 6. Risk managers should ensure effective 6. Risk managers should ensure effective

interaction with risk assessorsinteraction with risk assessors

�� 7. Risk managers should take account of 7. Risk managers should take account of

risk resulting from regional differences in risk resulting from regional differences in

hazards in food chain and regional hazards in food chain and regional

differences in available risk management differences in available risk management

optionsoptions

�� 8. MRM decisions should be subject to 8. MRM decisions should be subject to

review and revisionreview and revision

ALOPALOP

Appropriate Level of ProtectionAppropriate Level of Protection

�� One of the concepts introduced by WTO One of the concepts introduced by WTO

SPS agreementSPS agreement

�� ““Level of protection deemed appropriate Level of protection deemed appropriate

by the member (country) establishing a by the member (country) establishing a

sanitary or sanitary or phytosanitaryphytosanitary measure to measure to

protect human, animal or plant life or protect human, animal or plant life or

health within a territoryhealth within a territory””

Appropriate Level of Appropriate Level of

ProtectionProtection

�� Most often Most often

expressed in terms expressed in terms

of a public health of a public health

goalgoal

�� Ongoing Ongoing

discussion on discussion on

whether the whether the

““Healthy People Healthy People

20102010”” report is an report is an

example of an example of an

ALOPALOP

Healthy People 2010Healthy People 2010

Infectious Agent 1997 Baseline* 2010 Goal*

Campylobacter 23.6 12.3

Listeria monocytogenes

0.5 0.25

Escherichia coli O157:H7

2.1 1.0

Salmonella spp. 13.7 6.8

* Cases per 100,000* Cases per 100,000

Food Safety GoalsFood Safety Goals



�� ALOP is ALOP is notnot a determination of a determination of ““how how

many bodiesmany bodies”” we are willing to acceptwe are willing to accept

�� Always striving to find ways to reduce Always striving to find ways to reduce

reduce the impact on public healthreduce the impact on public health

�� ALOP measures what is achievable ALOP measures what is achievable

today before today before ““costscosts”” to society become to society become

too greattoo great

�� Not just economic cost!!!Not just economic cost!!!

Risk AssessmentRisk Assessment

ExposureExposure

AssessmentAssessment

Hazard Hazard

CharacterizationCharacterization


0

1000020000

3000040000

50000

6000070000

8000090000

100000

0 0.5 1

Relative Dose

Disease cases

Increased HumanIncreased Human

CostsCosts

IncreasedIncreased

EconomicEconomic

CostsCosts


0 0.5 1

Relative Dose

Cases of Disease

Increased HumanIncreased Human

CostsCostsIncreasedIncreased

EconomicEconomic

CostsCosts

ALOPALOP

At some point, whether qualitatively or quantitatively, At some point, whether qualitatively or quantitatively,

must make a decision on the degree of must make a decision on the degree of stringencystringency requiredrequired



�� ALOP includes ALOP includes safety margins safety margins deemed deemed appropriateappropriate

�� Ideally is based Ideally is based on the level of on the level of uncertainty uncertainty associated with associated with the underlying the underlying scientific datascientific data

0 0.5 1

Relative Dose

ALOP?ALOP?

FSOsFSOs/POs/POs

Equivalence: Do two systems of food Equivalence: Do two systems of food

safety risk management (e.g. inspection, safety risk management (e.g. inspection,

HACCP, processing) provide the same HACCP, processing) provide the same

degree of public health protection?degree of public health protection?

New Approaches to Risk ManagementNew Approaches to Risk Management

ALARie ‘As low as Reasonable’

BUT:-Technological capabilities vary-Idea of ‘reasonable’ varies

Public Health Based Goals-eg yearly incidence of Listeriosis

below 4 cases/million of pop.BUT:-in terms of population-not related to specific foods

The Issue Behind the Issue:The Issue Behind the Issue:

FSO

FOODBORNE ILLNESS/DEATH

Managing the Managing the ‘‘Food Safety CliffFood Safety Cliff’’

HAZARDPROCESS VARIABILITY

DoseDose--Response Curves / Risk Response Curves / Risk

Characterization Curves Characterization Curves

0

2

4

6

8

10

12

Log (Pathogen Cells Ingested)

0.0

0.2

0.4

0.6

0.8

1.0

Probability of Illness

Log(dose) vs. response plotLog(dose) vs. response plot

DoseDose--Response Curves / Risk Response Curves / Risk

Characterization CurvesCharacterization Curves

0

2

4

6

8

10

12


-10

-8

-6

-4

-2

0

Log(Probability of Illness)

Log(dose) vs. log(response) plotLog(dose) vs. log(response) plot

ALOP vs. FSOALOP vs. FSO

0

2

4

6

8

10

12


-10

-8

-6

-4

-2

0Log(Probability of Illness)

FSOsFSOs

ALOPsALOPs

Use risk characterization curve to relate ALOP to a Use risk characterization curve to relate ALOP to a

frequency and/or concentration in foodfrequency and/or concentration in food

-0.6-0.4-0.2

00.2

0.40.60.81

1.21.41.6

0 1 2 3 4 5

Maximum Dose (Log(CFU))

Listeriosis

(Log(cases/year))

FAO/WHO FAO/WHO L. L. monocytogenesmonocytogenes Risk Risk

Assessment Assessment –– ““Current Levels Current Levels

ScenarioScenario””

-0.6-0.4-0.2

00.2

0.40.60.81

1.21.41.6

0 1 2 3 4 5

Maximum Dose (Log(CFU))

Listeriosis

(Log(cases/year))

FAO/WHO FAO/WHO L. L. monocytogenesmonocytogenes Risk Risk

Assessment Assessment –– ““Current Levels ScenarioCurrent Levels Scenario””

FSO???FSO???

Food Safety ObjectivesFood Safety Objectives

��Establishing Establishing

a FSO is a FSO is

both a both a

scientific scientific

and a and a

societal societal

decisiondecision

Food Safety ObjectiveFood Safety Objective

�� An FSO can be viewed an An FSO can be viewed an

a a ““bright shining linebright shining line””

�� By definitionBy definition

�� Below is safeBelow is safe

�� Above is not safeAbove is not safe

�� PO is the equivalent at a PO is the equivalent at a

specified point earlier in specified point earlier in

the food chain the food chain

New Risk Analysis Vocabulary New Risk Analysis Vocabulary

EmergingEmerging

�� Food Safety Objective:Food Safety Objective: ““The maximum frequency The maximum frequency and/or concentration of a hazard in a food at the time of and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the consumption that provides or contributes to the appropriate level of protection (ALOP)appropriate level of protection (ALOP)””

�� Performance Objective (PO):Performance Objective (PO): ““The maximum The maximum frequency and/or concentration of a hazard in a food at frequency and/or concentration of a hazard in a food at a specified point in the food chain before the time of a specified point in the food chain before the time of consumption that provides or contributes to an FSO or consumption that provides or contributes to an FSO or ALOP, as applicableALOP, as applicable””

�� Performance Criterion (PC):Performance Criterion (PC): ““The effect in The effect in frequency and/or concentration of a hazard in a food frequency and/or concentration of a hazard in a food that must be achieved by the application on one or more that must be achieved by the application on one or more control measures to provide or contribute to a PO or control measures to provide or contribute to a PO or FSOFSO””

Performance ObjectivesPerformance Objectives�� Ideally, PO should be a scientifically Ideally, PO should be a scientifically derived value based on the FSO and take derived value based on the FSO and take into account the impact of control into account the impact of control measures step in food chain of the measures step in food chain of the thethe PO PO and the FSOand the FSO

�� Examples:Examples:�� RTE food that supports growth: PO < FSORTE food that supports growth: PO < FSO

�� RTE food that does not support growth: PO = RTE food that does not support growth: PO = FSOFSO

�� Food that is cooked prior to consumption: PO Food that is cooked prior to consumption: PO > FSO> FSO

Microbial Risk Management Microbial Risk Management

FrameworkFramework

ALOP/FSOALOP/FSO

Food Food

ConsumedConsumed

ProductProduct

Step AStep A

Step DStep D

Step CStep C

Step BStep B

Agricultural Agricultural

CommodityCommodity

POPO

POPO

POPO

MCMC

MCMC

MCMC

PCPC

PCPC

PCPC

Verifying POs/PCsVerifying POs/PCs

Food Safety ObjectivesFood Safety Objectives

�� FSO = food safety objectiveFSO = food safety objective

�� HH00 = initial level of the hazard= initial level of the hazard

�� ΣΣI = total increase in hazard,through I = total increase in hazard,through

growth or contaminationgrowth or contamination

�� ΣΣR = total death (reduction of hazard; R = total death (reduction of hazard;

negative number)negative number)

HHoo -- ΣΣRR ++ ΣΣII ≤≤≤≤≤≤≤≤ FSOFSO

Control measures for Control measures for EnterobacterEnterobactersakazakiisakazakii in Powdered Infant Formulain Powdered Infant Formula

Ho - ΣR + ΣI < FSO

Reducing the

concentration/prevalence

of intrinsic contamination

Reducing the level of contamination

of the reconstituted PIF (e.g., heat)

prior to use

Minimise the chance of

contamination of reconstituted

formula during preparation

Minimize the growth of E. sakazakii

following reconstitution prior to

consumption

+

Managing Managing L. monocytogenesL. monocytogenes on Freshon Fresh--cut Lettucecut Lettuce

‘‘From Farm to ForkFrom Farm to Fork’’

Ho - 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

New Risk Analysis Vocabulary New Risk Analysis Vocabulary

EmergingEmerging

�� Process Criterion Process Criterion The processing conditions The processing conditions

that must be met to achieve the PO/PCthat must be met to achieve the PO/PC

�� Product CriterionProduct Criterion The The characteristic(scharacteristic(s) of a food ) of a food

that must be maintained or achieved to achieve that must be maintained or achieved to achieve

a PO/PC/FSOa PO/PC/FSO

�� Microbiological Criterion Microbiological Criterion The level and/or The level and/or

frequency detected by a specified method and frequency detected by a specified method and

sampling plan that achieves the PO/PCsampling plan that achieves the PO/PC

Performance ObjectivesPerformance Objectives

�� Whenever possible, a PO should be Whenever possible, a PO should be

quantitative and verifiablequantitative and verifiable

�� Does not have to be verifiable via Does not have to be verifiable via

microbiological testingmicrobiological testing

�� Example: Probability of a viable spore Example: Probability of a viable spore

of of C. C. botulinumbotulinum is < 0.000000000001 is < 0.000000000001

per can of low acid canned foodper can of low acid canned food

FSO/PO VerificationFSO/PO Verification

�� A FSO or PO is A FSO or PO is notnot a microbiological criterion, a microbiological criterion,

though it is a value upon which a though it is a value upon which a

microbiological criterion should be basedmicrobiological criterion should be based

�� FSO/PO are limitsFSO/PO are limits

�� MC are tools for verifying the limit is being achievedMC are tools for verifying the limit is being achieved

�� In general, a microbiological criterion would be In general, a microbiological criterion would be

more stringent more stringent

�� Have to take into account the variability and Have to take into account the variability and

uncertainty associated with the product and the uncertainty associated with the product and the

sampling / testing methodssampling / testing methods

Microbiological CriteriaMicrobiological Criteria

�� As soon as one attempts to verify a As soon as one attempts to verify a

Performance Objective and/or Performance Objective and/or

Performance Criteria through Performance Criteria through

microbiological testing, must convert to microbiological testing, must convert to

Microbiological CriterionMicrobiological Criterion

�� Have to articulate the method, sample size Have to articulate the method, sample size

and samplingand sampling planplan

�� Have to deal with variability, uncertainty, Have to deal with variability, uncertainty,

and and confidence confidence of both the food and the of both the food and the

analytical processanalytical process

WrapWrap--UpUp

�� Establish public health or technologicallyEstablish public health or technologically--based goal, based goal, understanding that understanding that ““zerozero--riskrisk”” is unattainableis unattainable

�� Evaluate system using risk analysis process to relate Evaluate system using risk analysis process to relate stringency of food control system to public health stringency of food control system to public health outcomesoutcomes

�� Target what needs to be achieved, with less emphasis on Target what needs to be achieved, with less emphasis on how it should be achievedhow it should be achieved

�� Validation and verification of efficacy of food control Validation and verification of efficacy of food control options an integral part of system options an integral part of system

�� Develop metrics for examining public health Develop metrics for examining public health effectiveness of system and periodically review (and effectiveness of system and periodically review (and correct as necessary)correct as necessary)

HACCPHACCPGMPGMPGAPGAP GHPGHP Code of practiceCode of practice

ALOP

Risk analysis Public health burden

Food Safety

Objective

Performance Objectives

??

(Leon Gorris, 2004)Leon Gorris

Hierarchy of Risk Management Hierarchy of Risk Management

OptionsOptionsFood Safety

Objective

PerformanceObjective

PerformanceCriteria

Process/ProductCriteria

Target level at consumption

Target levelat specific step

Required outcomeAt specific step

Specific process orProduct conditions

‘IncreasingFlexibilityBut also IncreasingComplexity’

Impact of Risk Analysis Impact of Risk Analysis

Framework Framework

�� Being able to better link food safety activities to Being able to better link food safety activities to public health outcomes via risk assessments has public health outcomes via risk assessments has allowed:allowed:�� New concepts emerging New concepts emerging

�� Appropriate Level of Protection (ALOP)Appropriate Level of Protection (ALOP)

�� Food Safety Objective (FSO)Food Safety Objective (FSO)

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

�� Old concepts put on a more scientific basisOld concepts put on a more scientific basis

�� Performance criteriaPerformance criteria

�� Process criteriaProcess criteria

�� Product criteriaProduct criteria

�� Microbiological criteriaMicrobiological criteria

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