《食品微生物風險評估指南》

Contents

Prefacexii

Acknowledgementsxiii

Contributorsxiv

Declarationofinterestsxvi

Abbreviationsandacronymsxvii

Introduction1

1.1FAO/WHOseriesofguidelinesonmicrobiologicalriskassessment1

1.2Scopeandpurposeoftheseguidelines2

1.3Guidingthereaderthroughthisdocument3

1.4Howtobeginwithriskassessment4

Part1Generalconsiderations5

Riskassessmentincontext7

2.1Riskanalysisframework7

2.2Riskmanagement8

2.3Riskassessment10

2.4Riskcommunication12

Foodmicrobiologicalriskassessment(MRA)14

3.1Propertiesandprinciplesofbest-practiceriskassessments14

3.2PurposeandscopeofMRA16

3.2.1Estimatingbaselinerisk17

3.2.2Comparingriskmanagementstrategies18

3.2.3Research-relatedstudyormodel20

3.3Theroleofbest-andworst-casescenarios20

3.4Assessingtheresultsofariskassessment21

3.5Choosingthetypeofriskassessmenttoperform23

3.5.1Consistency25

3.5.2Resources25

3.5.3Theoryordatalimitations27

3.5.4Breadthofapplication27

3.5.5Speed27

3.5.6Transparency28

3.5.7Stageofanalysis28

3.5.8Responsiveness28

Hazardidentification30

4.1Objectivesofhazardidentification30

4.2Theprocessofhazardidentification31

4.3Datasourcesforhazardidentification33

Exposureassessment34

5.1Theprocessofexposureassessment34

5.2Modellingspproaches36

5.2.1Introduction36

5.2.2Qualitativeandsemi-quantitativeexposureassessment38

5.2.3Quantitativeexposureassessment38

5.2.4Modellingtheproduction-to-consumptionpathway39

5.2.5Consumption51

Hazardcharacterization58

6.1Theprocessofhazardcharacterization58

6.2Descriptivecharacterization59

6.2.1Informationrelatedtothediseaseprocess60

6.2.2Informationrelatedtothehazard63

6.2.3Informationrelatedtothehost64

6.2.4Informationrelatedtothefoodmatrix65

6.2.5Relationshipbetweenthedoseandtheresponse65

6.3Quantify!ngthedose-responserelationship67

Riskcharacterization70

7.1Theprocessofriskcharacterization70

7.2Qualitativeriskcharacterizationinriskassessment71

7.2.1Introduction71

7.2.2Performingaqualitativeriskcharacterization72

7.3Semi-quantitativeriskcharacterization75

7.3.1Introduction75

7.3.2Performingasemi-quantitativeriskcharacterization76

7.4Quantitativeriskcharacterization81

7.4.1Introduction81

7.4.2Quantitativeriskmeasures81

7.4.3Integrationofhazardcharacterizationandexposureassessment89

Examples92

8.1Examplesofqualitativeandsemi-quantitativeriskassessments92

8.1.1Riskassessmentformaindeterminantsofantibioticresistance

inSouthEastAsia92

8.1.2Faecalpollutionandwaterquality,WHO94

8.1.3Drinkingwaterguidelines,AustralianNationalHealthandMedical

ResearchCouncil95

8.1.4BSE/TSEriskassessmentofgoatmilkandmilk-derivedproducts,

EFSA96

8.1.5GeographicalBSEcattleriskassessment,EFSA97

8.1.6RiskprofileofMycobacteriumbovisinmilk,NewZealandFood

SafetyAuthority98

8.1.7SeafoodsafetyusingRiskRanger,Australia100

8.1.8Animalandanimalproductimportriskassessmentmethodology,

BiosecurityAustralia102

8.1.9Multicriteria-basedrankingforriskmanagementoffoodborne

parasites,FAO/WHO104

8.2Examplesofquantitativeriskassessments105

8.2.】E.coliO157:H7intenderizedvsnon-tenderizedbeef,FSIS105

8.2.2Listeriamonocytogenesinready-to-eatfoods,FAO/WHO106

8.2.3Shigatoxin-producingE.coli0157insteaktartarepatties,

Netherlands107

8.2.4Vibriovulnificusinrawoysters,FAO/WHO108

8.2.5Histamineinfishsauce,Thailand109

8.2.6Pathogensinfreshvegetables,Rwanda110

8.2.7CampylobacterandSalmonellainchickenmeals,Senegal112

8.2.8Vibrioparahaemolyticusinbloodyclams,Thailand112

8.2.9Salmonellaintableeggs,EFSA114

8.2.10Cryptosporidiuminwater-acost-benefitanalysis,United

StatesofAmerica116

Part2Detailedconsiderations119

Qualitativeandsemi-quantitativeriskassessment:further

considerations121

9.1Qualitativeriskassessment121

9.1.1Thevalueandusesofqualitativeriskassessment123

9.1.2Qualitativeriskassessmentinfoodsafety124

9.13Characteristicsofaqualitativeriskassessment125

9.2Semi-quantitativeriskassessment127

9.2.1Usesofsemi-quantitativeriskassessment127

9.2.2Characteristicsofasemi-quantitativeriskassessment129

9.23Limitationsofsemi-quantitativeriskassessment130

Data133

10.1Literature(primaryand/ormeta-analysis)137

10.1.1Analyticalepidemiologicalstudies138

10.1.2Microbiologicalstudiesofprevalenceandcounts/concentrations138

10.13Cross-contaminationdataduringfoodprocessing140

10.1.4Foodhandlingandpreparation140

10.1.5Humanvolunteerfeedingstudies142

10.1.6Animalstudies144

10.1.7Invitrostudies145

10.1.8Biomarkers146

10.2Nationalandinternationalsurveillancedata148

10.2.1Foodsafetyrapidalertsystems148

10.2.2Outbreakdata150

10.23Foodbornediseasesurveillanceandannualhealthstatistics153

10.2.4Systematicfoodcontaminationmonitoringsurveys155

10.2.5Nationalfoodproductionstatistics157

10.2.6Nationalconsumptiondatabases157

10.2.7Nationalpopulationcensus160

10.3Industrydata160

10.3.1Descriptionofproductandsupplychain163

10.4Unpublisheddata164

10.5Datagaps164

10.5.1Modelrestructuring166

10.5.2Surrogatedata166

10.53Expertknowledgeelicitation(EKE)167

10.5.4Collectionofnewdata169

10.6Recommendationsondatacollectionandorganization170

10.6.1Searchingfordata170

10.6.2Selectionofdata171

10.6.3Formattingofdata171

10.6.4Levelofdetailrecorded172

10.6.5Combiningdatafromdifferentsources173

10.6.6Presentationofdata173

Quantitativemodellingapproaches175

11.1Deterministic175

11.2Stochastic176

11.3MonteCarlosimulation177

11.4Othermodelclassificationschemes178

Predictivemicrobiology180

12.1Modellingmicrobialgrowthandinactivation181

12.1.1Microbialecologyoffoods181

12.1.2Predictivemicrobiology184

12.1.3Modeltypesandmodellingtools185

12.2Applicationofpredictivemicrobiologywithinexposureassessment187

12.2.1Rangeofmodelapplicability187

12.2.2Spoilagemicrobiota188

12.2.3Sourcesofvariabilityanduncertainty189

Dose-response192

13.1Theinfectiousdiseaseprocesses192

13.1.1Infectionandillness194

13.1.2Sequelaeandmortality194

13.2Modellingconcepts195

13.2.1Theparticulatenatureoftheinoculum195

13.3Selectionofmodels195

133.1Dose-infectionmodels197

13.3.2Dose-illnessmodels197

1333Sequelaeandmortality197

13.4Extrapolation198

13.4.1Lowdoseextrapolation198

13.4.2Extrapolationinthepathogen-host-matrixtriangle198

13.5Dose-responsemodelfittingapproaches201

Variabilityanduncertainty203

14.1Variability203

14.2Uncertainty206

14.3Uncertaintyanalysis208

14.4Uncertaintyandvariabilitytogether209

Sensitivityanalysis213

15.1Sensitivityanalysisinqualitativeriskassessment214

15.2Sensitivityanalysisinquantitativeriskassessment215

15.2.1Statisticalmethods215

15.2.2Graphicalmethods216

15.23Evaluationofsensitivityanalysismethods216

Qualityassurance217

16.1Dataevaluation217

16.1.1Datacollection219

16.1.2Sortingandselectingdatasources221

16.2Modelqualityassuranee222

16.2.1Modelverification222

16.2.2Modelanchoringorcalibration223

16.2.3Modelvalidation224

16.3Comparisonwithepidemiologicaldata227

16.4Extrapolationandrobustness229

16.5Credibilityoftheriskassessment230

16.5.1Riskassessmentdocumentation230

16.5.2Scientificpeerreview231

Bibliography232

Glossary264

TABLES

Table1,Examplesoffactorsofimportancewhendeterminingtheimpactofthe

postprocessingenvironmentonthelevelofexposure46

Table2.Elementsthatmightbeincludedincharacterizationofadversehuman

healtheffects(AdaptedfromILSI,2000)62

Table3.Elementstoconsiderincharacterizationofthehazard(Adaptedfrom

ILSI,2000)64

Table4,Factorsrelatedtothehostthatmayaffectsusceptibilityandseverity

(AdaptedfromILSI,2000)64

Table5.Elementstoconsiderincharacterizationoftheeffectofthefoodmatrix

onthehazard-hostrelationship65

Table6,Elementstoconsiderindescribingthedose-responserelationship

(AdaptedfromILSI,2000)66

Table7.Dose-responsemodelsandparameterestimatescommonlyusedin

QMRA69

Table8,Acomparisonoftheprocessforcomputingthefinalriskestimateinrisk

characterizationinquantitativeandqualitativeriskassessments.

(TableadaptedfromTable4inWooldridge(2008))72

Table9.Exampleofapossibletabularformatforpresentingdatalinkedto

riskestimatesandconclusions73

Table10.Exampleofapossiblesectionalformatforpresentingdatalinkedto

riskestimatesandconclusions74

Table11.Examplecategorydefinitionsfortheprobabilityofaneventoccurring

andforthefrequencyofexposureperyear76

Table12,Exampledefinitionsofhealtheffect/severitycategorylabels76

Table13.Exampleofcombiningcategorylabels78

fable14.Ahypotheticalexampleofariskmatrixtocombinelikelihoodand

severityascouldbeapplicabletoriskcharacterizationusing

probabilityratingsaspresentedinTable1579

Jable15.Semi-quantitativeallocationofcategoricallabelstoprobabilityranges79

Table16.Riskmatrixusedtocombinetwoconsecutive,anddependentevents

(adaptedfromWielandeta(.,2011)94

Table17.Relativeriskpotentialtohumanhealththroughexposuretosewage

throughoutfalls(reproducedfromWHO,2003)94

Table18.Qualitativemeasuresoflikelihood96

Table19,Qualitativemeasuresofconsequenceorimpact96

Table20.Qualitativeriskanalysismatrix:levelofrisk96

Table21.GeographicalBSERisk(GBR)in2003insevencountriesasassessed

byEFSA(2004b;Table3.5).Eartierassessedlevelsarealsoshown98

Table22.ThefourgenericcategoriesproposedinNewZealandfortheincidence

(rate)withexamples(Appendix1inLakeetal.,2005)99

Table23.ThethreegenericcategoriesproposedinNewZealandforseverity

withexamples(Appendix1inLakeetal,,2005)99

Table24.ResultofusingRiskRangertoevaluatehazard-productcombinations

forvarioussubpopulationsinAustralia(fromSumnerandRoss,2002)101

Table25.Tabulationofriskasacombinationoflikelihoodandconsequence

(BiosecurityAustralia,2016)104

Table26.Averageofelicitedcriteriaweightsusedinthemulti-criteriaranking

(Table3fromFAOandWHO,2014)105

Table27.EstimatedriskfromL.monocytogenesasusedintheriskassessment

FAOandWHO,2004)107

Table28.Baselineriskmodelresultsatthestageofrawsteaktartarepatties,

fordifferentroutesofexposureandthemeansfortheNetherlands(NL)

(Pos.tartare=STEC0157contaminatedsteaktartarepatty),wherethe

columnheadersrefertospecificsegmentsoftheDutchindustry

(article10slaughterwithIndustrial*butcher,article10slaughterwith

(traditionarbutcherandarticle4slaughter)108

Table29.MeanriskofillnessduetoV.vulnificusperservingorexposure109

Table30.Riskestimatesusingprobabilisticapproach(Table5inCCFFP,2011)110

Table31.Numberofillnessesperyearandprobabilityofillnessperserving

after100000iterationsofthebaselinemodelandthewhatifscenarios

(Table6.4inSsemanda,2018)111

Table32.Datesusedinthemodelforthebaselineandalternativescenarios

(Table11inEFSA,2014b)114

Table33.SummaryoftimeandtemperatureofstorageofeggsintheEU,from

the'onfarm'tothe'transporttoretaiCstagesasderivedfromexpert

opinion(industryexperts)(Table6inEFSA,2014b)115

Table34.ExampleofaProbability-Severitytableforindividualhazards

(indicatedbythenumbersinthegrid)peryear(NIL=None,

VLO=VeryLow;Lo=Low;Med=Medium;Hi=High;VHI=VeryHigh)128

Table35.ExampleriskscorecalculationsforsomehazardsusedinTable34129

Table36.Alinearscoringsystemforprobability130

Table37.Alogarithmicscoringsystemwherethehighestscoreisassignedthe

lowestprobability131

Table38.Datarequiredforriskassessmentanddatacollectionsources135

Table39.Indicativeresponsetimesforgrowthandinactivationofvegetative

bacterialcellsasafunctionoftemperature182

Table40.Listofmostcommontypesofuncertaintyaffectingriskassessments

associatedwiththeinputsandthemethodology(EFSA,2018a)207

FIGURES

Figure1.GenericriskmanagementframeworkaspresentedbyFAO/WHO

(2006a,Figure2.1)8

Figure2.Componentsofariskassessment11

Figure3.“With”and"without”interventionscenariosandchangesinrisk

overtime(FAOandWHO,2009a,Box2.2)19

Figure4.Theepidemiologytriangle(modifiedfromColemanandMarks,1998)31

Figure5.Anexampleofanoverviewoftheconceptualmodeltodescribe

theexposurepathwayforaproduction-to-consumptionexposure

assessment.Toassessexposure,itisnecessarytoconsiderboththe

probabiUtythataunitoffoodiscontaminatedwiththehazard

(denotedP,for'prevalence*),andthelevel,ornumber,ofthat

hazardinthefood(denotedN)atthetimeofconsumption.Formicrobial

hazards,inparticular,bothprevalenceandnumbercanchangeasthe

commodityisfurtherprocessed,andastimeelapsesbeforetheproduct

isfinallyconsumed(LammerdingandFazil,2000).(Reproducedwith

permissionfromElsevier)36

Figure6.Anexample'influencediagram*ofamodelofacross-contamination

pathwayforthepreparationofcookedchickenandlettucesalad.

(Xcontam=cross-contamination)49

Figure7,Processflowdiagramforhazardcharacterizationofpathogens59

Figure8.ExampleSalmonelladose-responsemodel,includingexpected

response(solidline),approximate2.5thand97.5thuncertainty

percentilelines(dashed)andupperandloweruncertaintybounds

(dotted)(FAOandWHO,2002ap.87)onlinear-logscale(left)and

onlog-logscale(right)69

Figure9.Modeloutput(fromFSIS,2002)showingpredictedbacteriaper

servingaftercooking(Dose)andcorrespondingfrequencyofillness

(Dose-response)106

Figure10.Schematicrepresentationofthemodelframeworkforaproduction-

to-consumptionriskassessmentofV.parahaemolyticusinBloody

dam(Figure11-6inFAOandWHO,2011a)113

Figure11.DecisiontreeforBoilWaterOrdersforCryptosporidiumshowingthe

probabilitiesandestimatedcostsforillnessanddeathoutc