buchananpresentation-final [read-only]presentation introduction to codex alimentarius codex...

1

Introduction to the Codex Risk Introduction to the Codex Risk Management Framework for Management Framework for Relating Food Safety Control Relating Food Safety Control

Measures to Public Health GoalsMeasures to Public Health Goals

Robert L. BuchananRobert L. BuchananUS DHHS Food and Drug AdministrationUS DHHS Food and Drug Administration

Center for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition

PresentationPresentation

Introduction to Codex AlimentariusIntroduction to Codex AlimentariusCodex Committee on Food Hygiene (CCFH) Codex Committee on Food Hygiene (CCFH) Microbiological Risk Management Microbiological Risk Management FrameworkFrameworkConcept 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 POsConcluding remarksConcluding remarks

2

Codex AlimentariusCodex Alimentarius

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

3

Risk AnalysisRisk Analysis

Codex has long used risk assessment as a Codex has long used risk assessment as a tooltoolIn its new role under the WTO/SPS In its new role under the WTO/SPS Agreement, Codex has accelerated Agreement, Codex has accelerated adoption of risk analysis as the adoption of risk analysis as the framework for dealing with many of its framework for dealing with many of its activitiesactivitiesHas had to develop and/or adapt a Has had to develop and/or adapt a framework wherein risk analysis framework wherein risk analysis principles could be effectively applied to principles could be effectively applied to highly complex and varied food control highly complex and varied food control systems 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 important agreements are the the ““Sanitary and Sanitary and PhytosanitaryPhytosanitary (SPS) (SPS) Agreement (SPS)Agreement (SPS)”” and the and 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

4

SPS AgreementSPS Agreement

Desires of Agreement:Desires of Agreement:To improve public healthTo improve public healthTo establish multilateral framework for To establish multilateral framework for development, adoption, and development, adoption, and enforcement of SPS measures to enforcement of SPS measures to minimize trade impactminimize trade impactTo harmonize SPS measures between To harmonize SPS measures between countries via Codex Alimentarius countries via Codex Alimentarius Commission in the case of foods Commission in the case of foods

SPS AgreementSPS Agreement

Country can require higher level of Country can require higher level of SPS protection than international SPS protection than international standard if it can:standard if it can:

Provide scientific justificationProvide scientific justificationEstablish an Establish an ““Appropriate Level of Appropriate Level of ProtectionProtection”” (ALOP) based on (ALOP) based on assessed riskassessed risk

5

Codex General Subject Matter Codex General Subject Matter (Horizontal) Committees(Horizontal) Committees

Three Codex committees have been Three Codex committees have been particularly active in developing particularly active in developing risk analysis principlesrisk 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)

Risk Analysis Risk Analysis

Three key Codex referencesThree key Codex references““Working Principles for Risk Analysis Working Principles for Risk Analysis Application in the Framework of the Application in the Framework of the Codex AlimentariusCodex Alimentarius””““Principles and Guidelines for the Principles and Guidelines for the Conduct of Microbiological Risk Conduct of Microbiological Risk AssessmentsAssessments””““Proposed Draft Principles and Proposed Draft Principles and Guidelines for the Conduct of Guidelines for the Conduct of Microbiological Risk Management (MRM) Microbiological Risk Management (MRM) ( Step 5)( Step 5)

6

CCFH Framework for CCFH Framework for Microbiological Risk ManagementMicrobiological Risk Management

Preliminary Preliminary ActivitiesActivities

Evaluation of Evaluation of OptionsOptions

ImplementationImplementation

Monitoring andMonitoring andReviewReview

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 MRM2. MRM should take into account the 2. MRM should take into account the whole food chainwhole food chain3. MRM should follow a structured 3. MRM should follow a structured approachapproach4. MRM process should be transparent, 4. MRM process should be transparent, consistent and fully documentedconsistent and fully documented5. Risk managers should ensure effective 5. Risk managers should ensure effective consultations with relevant interested consultations with relevant interested partiesparties

7

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 assessors7. 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 optionsoptions8. MRM decisions should be subject to 8. MRM decisions should be subject to review and revisionreview and revision

Impact of Risk Analysis Impact of Risk Analysis Framework Framework

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

New concepts emergingNew concepts emergingAppropriate 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 basisPerformance criteriaPerformance criteriaProcess criteriaProcess criteriaProduct criteriaProduct criteriaMicrobiological criteriaMicrobiological criteria

8

New Risk Analysis Vocabulary New Risk Analysis Vocabulary EmergingEmerging

Food Safety Objective:Food Safety Objective: ““The maximum The maximum frequency and/or concentration of a hazard in a frequency and/or concentration of a hazard in a food at the time of consumption that provides or food at the time of consumption that provides or contributes to the appropriate level of protection contributes to the appropriate level of protection (ALOP)(ALOP)””Performance Objective (PO):Performance Objective (PO): ““The maximum The maximum frequency and/or concentration of a hazard in a frequency and/or concentration of a hazard in a food at a specified point in the food chain before food at a specified point in the food chain before the time of consumption that provides or the time of consumption that provides or contributes to an FSO or ALOP, as applicablecontributes to an FSO or ALOP, as applicable””Performance Criterion (PC):Performance Criterion (PC): ““The effect in The effect in frequency and/or concentration of a hazard in a frequency and/or concentration of a hazard in a food that must be achieved by the application on food that must be achieved by the application on one or more control measures to provide or one or more control measures to provide or contribute to a PO or FSOcontribute to a PO or FSO””

New Risk Analysis Vocabulary New Risk Analysis Vocabulary EmergingEmerging

Process Criterion (Process Criterion (PrcCPrcC):): The The processing conditions that must be met to processing conditions that must be met to achieve the PO/PCachieve the PO/PCProduct Criterion (Product Criterion (PrdCPrdC):): The The characteristic(scharacteristic(s) of a food that must be ) of a food that must be maintained or achieved to achieve a maintained or achieved to achieve a PO/PC/FSOPO/PC/FSO

Microbiological Criterion (MC):Microbiological Criterion (MC): The The level and/or frequency detected by a level and/or frequency detected by a specified method and sampling plan that specified method and sampling plan that achieves the PO/PCachieves the PO/PC

9

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””

10


Most often Most often expressed in terms expressed in terms of a public health of a public health goalgoalOngoing discussion Ongoing discussion on whether the on 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

11


ALOP is ALOP is notnot a determination of a determination of ““how how many bodiesmany bodies”” we are willing to we are willing to acceptaccept

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 to society become too greatbecome too great

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

Risk AssessmentRisk Assessment

ExposureExposureAssessmentAssessment

Hazard Hazard CharacterizationCharacterization

12


0100002000030000400005000060000700008000090000

100000

0 0.5 1

Relative Dose

Dis

ease

cas

es

Increased HumanIncreased HumanCostsCosts

IncreasedIncreasedEconomicEconomic

CostsCosts


0 0.5 1

Relative Dose

Cas

es o

f D

isea

se

Increased HumanIncreased HumanCostsCosts

IncreasedIncreasedEconomicEconomic

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

13


0 0.5 1

ALOPALOP


0 0.2 0.4 0.6 0.8 1

ALOPALOP

14


0 0.2 0.4 0.6 0.8 1

ALOPALOP


ALOP includes ALOP includes safety margins safety margins deemed deemed appropriateappropriateIdeally 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?

15

FSOsFSOs/POs/POs

DoseDose--Response Curves / Risk Response Curves / Risk Characterization Curves Characterization Curves

02

46

810

12

Log (Pathogen Cells Ingested)

0.0

0.2

0.4

0.6

0.8

1.0

Prob

abili

ty o

f Illn

ess

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

16

DoseDose--Response Curves / Risk Response Curves / Risk Characterization CurvesCharacterization Curves

02

46

810

12


-10

-8

-6

-4

-2

0

Log(

Prob

abili

ty o

f Illn

ess)

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

““The ProblemThe Problem””

ALOP is typically measured in terms of a ALOP is typically measured in terms of a ““probability of diseaseprobability of disease”” or or ““number of number of cases per yearcases per year””Not something that can be directly: Not something that can be directly:

Controlled by food producers and Controlled by food producers and processorsprocessorsRegulated by food control agenciesRegulated by food control agencies

ALOP must be converted to something ALOP must be converted to something that can be controlled and measured in a that can be controlled and measured in a food production or processing facility food production or processing facility through through GMPsGMPs and HACCPand HACCP

17


CCFH has been CCFH has been exploring the exploring the concepts of concepts of Food Food Safety ObjectivesSafety Objectivesand and Performance Performance ObjectivesObjectives as a as a bridge between an bridge between an ALOP and ALOP and performance performance /process criteria/process criteria


Need these metrics Need these metrics to develop a means to develop a means of relating public of relating public health risks to the health risks to the presence of a presence of a hazard in a food in hazard in a food in order to reach order to reach agreement on the agreement on the stringencystringency of food of food safety systemssafety systems

18

ALOP vs. FSOALOP vs. FSO

02

46

810

12


-10

-8

-6

-4

-2

0Lo

g(Pr

obab

ility

of I

llnes

s)

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

00.20.40.60.8

11.21.41.6

0 1 2 3 4 5

Maximum Dose (Log(CFU))

List

erio

sis

(Log

(cas

es/y

ear)

)

FAO/WHO FAO/WHO L. monocytogenesL. monocytogenes Risk Risk Assessment Assessment –– ““Current Levels ScenarioCurrent Levels Scenario””

19

-0.6-0.4-0.2

00.20.40.60.8

11.21.41.6

0 1 2 3 4 5

Maximum Dose (Log(CFU))

List

erio

sis

(Log

(cas

es/y

ear)

)

FAO/WHO FAO/WHO L. monocytogenesL. monocytogenes Risk Risk Assessment Assessment –– ““Current Levels ScenarioCurrent Levels Scenario””

FSO???FSO???

Food Safety ObjectivesFood Safety Objectives

Establishing Establishing a FSO is both a FSO is both a scientific a scientific and a and a societal societal decisiondecision

20

Food Safety ObjectiveFood Safety Objective

An FSO can be viewed An FSO can be viewed an a an a ““bright shining bright shining lineline””By definitionBy definition

Below is safeBelow is safeAbove is not safeAbove is not safe

PO is the equivalent at PO is the equivalent at a specified point earlier a specified point earlier in the food chain in the food chain

Performance ObjectivesPerformance Objectives

Ideally, PO should be a scientifically Ideally, PO should be a scientifically derived value based on the FSO and derived value based on the FSO and take into account the impact of take into account the impact of control measures step in food chain control measures step in food chain of the of the thethe PO and the FSOPO and the FSOExamples:Examples:

RTE food that supports growth: PO < RTE food that supports growth: PO < FSOFSORTE food that does not support growth: RTE food that does not support growth: PO = FSOPO = FSOFood that is cooked prior to Food that is cooked prior to consumption: PO > FSOconsumption: PO > FSO

21

Verifying POs/PCsVerifying POs/PCs

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 of Example: Probability of a viable spore of C. botulinumC. botulinum is < 0.000000000001 per is < 0.000000000001 per can of low acid canned foodcan of low acid canned food

22

FSO/PO VerificationFSO/PO Verification

A FSO or PO is A FSO or PO is notnot a microbiological a microbiological criterion, though it is a value upon which a criterion, though it is a value upon which a microbiological criterion should be basedmicrobiological criterion should be based

FSO/PO are limitsFSO/PO are limitsMC are tools for verifying the limit is being MC are tools for verifying the limit is being achievedachieved

In general, a microbiological criterion In general, a microbiological criterion would be more stringent would be more stringent

Have to take into account the variability and Have to take into account the variability and uncertainty associated with the product and uncertainty associated with the product and the sampling / testing methodsthe sampling / 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 microbiological testing, must convert to Microbiological Criterionto Microbiological Criterion

Have to articulate the method, sample Have to articulate the method, sample size and sampling plansize and sampling plan

Have to deal with variability, Have to deal with variability, uncertainty, and uncertainty, and confidence confidence of both of both the food and the analytical processthe food and the analytical process

23

Microbiological CriteriaMicrobiological CriteriaIf based on a FSO or PO, a MC has If based on a FSO or PO, a MC has to be more stringent than the to be more stringent than the corresponding PO/FSO corresponding PO/FSO Have to provide confidence that Have to provide confidence that FSO/PO not exceeded while taking FSO/PO not exceeded while taking into account the variability and into account the variability and confidence ofconfidence of

the process/control measurethe process/control measurethe sampling and testing methodsthe sampling and testing methods

Relationship Between Microbiological Relationship Between Microbiological Criteria and Other MetricsCriteria and Other Metrics

2 4 6 8 10

FSOFSO

POPOMCMC

24

Concluding RemarksConcluding Remarks

Framework for Public Health GoalFramework for Public Health Goal--based Risk Managementbased Risk Management

Establish public health or technologicallyEstablish public health or technologically--based based goal, understanding that goal, understanding that ““zerozero--riskrisk”” is is unattainableunattainableEvaluate system using risk analysis process to Evaluate system using risk analysis process to relate stringency of food control system to public relate stringency of food control system to public health outcomeshealth outcomesTarget what needs to be achieved, with less Target what needs to be achieved, with less emphasis on how it should be achievedemphasis on how it should be achievedValidation and verification of efficacy of food Validation and verification of efficacy of food control options an integral part of system control options an integral part of system Develop metrics for examining public health Develop metrics for examining public health effectiveness of system and periodically review effectiveness of system and periodically review (and correct as necessary)(and correct as necessary)

25

Risk Analysis FrameworkRisk Analysis Framework

In a fully developed risk analysis In a fully developed risk analysis framework there is framework there is ““connectivityconnectivity””::

FSOsFSOs based on a public health goal based on a public health goal (ALOP)(ALOP)Performance criteria (PC) and/or Performance criteria (PC) and/or performance objectives (PO) based on performance objectives (PO) based on the FSO the FSO Process/Product Criteria based on Process/Product Criteria based on PC/POPC/POMicrobiological Criteria based on Microbiological Criteria based on PC/PO/FSOPC/PO/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

26

Concluding RemarksConcluding Remarks

Over the course of the last 5 years CCFH, Over the course of the last 5 years CCFH, through its members nations and in through its members nations and in consultation with FAO, WHO, and scientific consultation with FAO, WHO, and scientific organizations such as ICMSF, ILSI, IAFP, organizations such as ICMSF, ILSI, IAFP, and IFT, has devoted substantial time in and IFT, has devoted substantial time in advancing conceptual thinking about the advancing conceptual thinking about the application of risk analysis to microbial application of risk analysis to microbial food safetyfood safety

Is looking forward to further advances Is looking forward to further advances derived from conferences such as this one derived from conferences such as this one and upcoming FAO/WHO consultations and upcoming FAO/WHO consultations

buchananpresentation-final [read-only]presentation introduction to codex alimentarius codex...

Documents