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Emerging Risk Emerging Risk
Management ToolsManagement Tools
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
Appropriate Level of Appropriate Level of
ProtectionProtection
�� 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
Appropriate Level of ProtectionAppropriate Level of Protection
0
1000020000
3000040000
50000
6000070000
8000090000
100000
0 0.5 1
Relative Dose
Disease cases
Increased HumanIncreased Human
CostsCosts
IncreasedIncreased
EconomicEconomic
CostsCosts
Appropriate Level of ProtectionAppropriate Level of Protection
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
Appropriate Level of Appropriate Level of
ProtectionProtection
�� 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
Log (Pathogen Cells Ingested)
-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
Log (Pathogen Cells Ingested)
-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