1 MICROBIOLOGICAL RISK ASSESSMENT SERIES Risk assessment of I f Vibrio vulnificus in raw f oysters [ft ForfurtherinformationonthejointFAOAWHO activitiesonmicrobiologicalriskassessment,pleasecontact; FoodQualityandStandardsService FoodandNutritionDivision FoodandAgricultureOrganizationoftheUnitedNations VialedelleTermediCaracalla 00100Rome,Italy Fax:(+39)0657054593 E-mail:[email protected] Website:http://www.fao.org/es/esn or DepartmentofFoodSafety.ZoonosesandFoodborneDisease WorldHealthOrganization 20AvenueAppia CH-1211Geneva27 Switzerland Fax:(+41)227914807 E-mail:[email protected] Website:http//www.who.int/foodsafety Coverdesign: FoodandAgricultureOrganizationoftheUnitedNations andtheWorldHealthOrganization ©CovDeenrnpiisctKuruen:kelMicroscopy,Inc. Copyrightedmaterial MICROBIOLOGICAL RISK ASSESSMENT SERIES Risk assessment of Vibrio vulnificus in raw oysters INTERPRETATIVESUMMARY ANDTECHNICALREPORT THi8 0H8 JCDD-B6U-K7YK WORLDHEALTHORGANIZATION FOODANDAGRICULTUREORGANIZATIONOFTHEUNITEDNATIONS 2005 Copyrightedmaterial Thedesignationsemployedandthepresentationofthematerialinthispublicationdonotimply theexpressionofanyopinionwhatsoeveronthepartoftheWorldHealthOrganizationnorof theFoodandAgricultureOrganizationoftheUnitedNationsconcerningthelegalor developmentstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthe delimitationofitsfrontiersorboundaries. Theviewsexpressedhereinarethoseoftheauthorsanddonotnecessarilyrepresentthoseof theWorldHealthOrganizationnoroftheFoodandAgricultureOrganizationoftheUnited Nationsnoroftheiraffiliatedorganizatlon(s). TheWorldHealthOrganizationandtheFoodandAgricultureOrganizationoftheUnited Nationsdonotwarrantthattheinformationcontainedinthispublicationiscompleteandshall notbeliableforanydamageincurredasaresultofitsuse. WHOLibraryCataloguing-in-PublicationData RiskassessmentofVibriovulnificusinrawoysters:interpretativesummaryandtechnicalreport. PublishedjointlywiththeFoodandAgricultureOrganizationoftheUnitedNations(FAO). (m1Mi.icVcrirobobrbiiiooollovoguglyinci4af.liOcruyissstk-earsgssr-oewsptsahmteh&ongtednseievcreiitleyos.pNm5o.e.nRti8)s2k.aVsisberisosmveulnntif6i.cuFsoo-dpcaotnhotgaemniincaittiyon3.I.OFyosotderasnd- AgricultureOrganizationoftheUnitedNationsII.WorldHealthOrganizationIII.TitleIV.Series. ISBN9241563109(WHO) (NLMclassification:QW141) ISBN9251054231(FAO) ISSN1726-5274 Allrightsreserved.Requestsforpermissiontoreproduceortranslatethematerialcontained inthispublication-whetherforsaleorfornon-commercialdistribution-shouldbe addressedtotheChief.PublishingManagementService,InformationDivision,Foodand AItgarliycu(lftaux:re+O3r9ga0ni6za5t7i0o5n2o2f56t;heeU-nmiatile:dNcaotpiyornisg,[email protected])eTorertmoeWdiHCOaraPcraelslsa,,0Wo0r1l0d0RHeoamlet,h Organization,20AvenueAppia,1211Geneva27,Switzerland(fax:+41227914806;e-mail: [email protected]). ©FAO/WHO2005 Copyrightedmaterial -lii- CONTENTS Acknowledgements vii RiskAssessmentDraftingGroup ii Reviewers xi Foreword xiil Background Xii Abbreviations xidi INTERPRETATIVESUMMARY Introduction 3 HazardIdentification 3 Exposureassessment 4 Hazardcharacterization 6 Riskcharacterization 8 Conclusions 9 References li) TECHNICALREPORT 1. Introduction li 1.1.Scope L5 2. Hazardidentification 12 3. ExposureASSESSMENT 19 3.1. Microbialecology 19 2 Cirowthandsurvivalcharacteristics 20 3.3. Consumptionofoysters 2Q 3.4. ModellingexposuretoV.vulnificus 2i 3.4.1.Harvest 21 3.4.2.Post-harvest 11 3.5. Simulationresults 12 Copyrightedmaterial -iv- 3.6. Modelvalidation 4Q 4. HazardCHARACTERIZATION 43 4.1.Descriptionofthefactorsthatinfluencethediseaseoutcome 43 4.1.1.Characteristicsofthepathogen 43 4.1.2.Characteristicsofthehost 43 4.1.3.Charactensticsofthefoodmatn.x 45 4.2.PublichealthQuicnme.s 46 4.2.1.Manifestationsofdisease 46 4.2.2.Rationalforthebiologicalendpointsmodelled 46 4.3.Dose-responserelationship 47 4.3.1.Summaryofavailabledata 42 4.3.2.Sourcesofdataused 42 4.3.3.Assumptions SO 4.3.4.Goodnessoffit 5£t 4.3.5.Uncertaintyandvariability SI 5. Rl.SKCHARACTF.RIZATION 53 5.1.Moderatesalinity 53 5.2.Effectsofinterventions 56 5.3.Highsalinity 5B. 6. Datagaps 61 7. Conclusions 65 7.1.Keyfindings 65 12 1.imitalinn«;andcaveats 65 7.3.Conclusion 66 8. Rf.kf.rf.ncf.s 62 AppendixA.Modelimplementation 22 AppendixB.F.stimatedmodhi.parametersintheexposureas.se.ssment S5 Copyrightedmaterial AppendixC.Dose-responseassessment 91 AppendixD.Comparativeresultsofassessmentbasedonalternativedata sHeAtRsVfEoSrTrelationshipbetweenV.VULNIFICUS/GANDWATERTEMPERATUREAT 101 AppendixE. FacsimileofFDAMemorandum. 109 Copyrightedmaterial ACKNOWLEDGEMENTS TheFoodandAgricultureOrganizationoftheUnitedNationsandthe World Flealth Organizationwouldliketoexpresstheirappreciationtoallthosewhocontributedtothe preparationofthisreport.Specialappreciationisextendedtotheriskassessmentdrafting grouponVibriospp.inseafood,andinparticularthecoregrouponriskassessmentofVibrio vulnificusinrawoysters,forthetimeandeffortthattheyfreelydedicatedtotheelaboration ofthisassessment.Manypeopleprovidedtheirtimeandexpertisebyreviewingthereport andprovidingtheircomments,additionaldataandotherrelevantinformation.Boththerisk assessmentdraftinggroupandthereviewersarelistedinthefollowingpages. AbpyprFeAciOatainodnWisFaIlOsoaenxdtebnrdoeudghttoatlolotuhrosaettwehntoiornesdpatoandneodttroeatdhielycalalvsaifloarbldeatiantthhaetwmeariensitsrseuaemd literatureandofficialdocumentation. TheriskassessmentworkwascoordinatedbytheSecretariatoftheJointFAOAVFIOExpert Meetings on Microbiological Risk Assessment (JEMRA). This included SarahCahill, MariadeLourdesCostarrica and Jean-Louis Jouve (2001-2004) in FAO, and PeterKarimBenEmbarek,JocelyneRocourt(2001-2004),HajimeToyoftiku(1999-2004) andJergenSchlundtinWHO.Duringthedevelopmentoftheriskassessment,additional supportandfeedbackwereprovidedbyLahsenAbabouch,HenriLorealandHectorLupin, FisheryIndustriesDivisioninFAO,andJeronimasMaskeliunas,CodexSecretariat.Sarah Cahillcoordinatedthefinalisationandpublicationofthereport.ThorgeirLawrencewas responsibleforeditingthereportforlanguageandpreparationforprinting. TFhAeOpFroepoadraQtuoarlyitwyoarnkdaSntdandthaerdpsubSleirvciactei,onthoefFtAhiOsrFeipsohretrywaInsdussutpripeosrtDeidviasnidonfaunnddetdhebWyHthOe DepartmentofFoodSafety,ZoonosesandFoodbomeDisease. Copyrightedmaterial RISKASSESSMENTDRAFTINGGROUP JohnBowers CenterforFoodSafetyandAppliedNutrition,UnitedStatesFoodandDrugAdministration, UnitedStatesofAmerica AndersDalsgaard DepartmentofVeterinaryMicrobiology,TheRoyalVeterinaryandAgriculturalUniversity, Denmark AngeloDePaola OfficeofSeafood,CenterforFoodSafetyandAppliedNutrition,UnitedStatesFoodand DrugAdministration,UnitedStatesofAmerica 1.Karunasagar DepartmentofFisheryMicrobiology,UniversityofAgriculturalSciencesCollegeof Fisheries,India ThomasMcMeekin CentreforFoodSafetyandQuality,UniversityofTasmania, Australia MitsuakiNishibuchi CenterforSoutheastAsianStudies,KyotoUniversity, Japan KenOsaka NationalInstituteofInfectiousDiseases,MinistryofHealth,LabourandWelfare, Japan JohnSumner M&SFoodConsultantsPty.Ltd., Australia MarkWalderhaug CenterforFoodSafetyandAppliedNutrition,UnitedStatesFoodandDrugAdministration, UnitedStatesofAmerica MembersofcoregrouponriskassessmentofVibriovulnifKusinrawoysters Copyrightedmaterial XI REVIEWERS Participantsinexpertconsuitations AwaKaneAldara InstitutPasteurdeDakar,LaboratoiredcBacteriologie Expmmentale,Senegal. NourredineBouchriti Department d'Hygidne et d'Industrie des Denrees Alimentaires d'Origine Animale, Institut Agronomique et VetmnaireHassanII,Morocco. Jean-MichelFournier CentreNationaldeReferencedesVibrionsetduCholera, InstitutPasteur,France. RonLee CentreforEnvironment,FisheriesandAquacultureScience, WeymouthLaboratory,UnitedKingdom. CarlosLimadosSantos PrivateConsultant, Brazil. Dorothy-JeanMcCoubrey MinistryofAgricultureandForestry, NewZealand. MarianneMiliotis CenterforFoodSafetyandAppliedNutrition,UnitedStates FoodandDrugAdministration,UnitedStatesofAmerica. NoelMurray BiosecurityAuthority,MinistryofAgricultureandForestry, NewZealand. PensriRodma DepartmentofMedicalScience,MinistryofPublicHealth, Thailand. MarkTamplin EasternRegionalResearchCenter-NorthAtlanticArea, UnitedStatesDepartmentofAgriculture,UnitedStatesof America. PaulVanderlinde FoodScienceAustralia, Australia ShigeklYamamoto NationalInstituteofInfectiousDiseases,MinistryofHealth, LabourandWelfare,Japan. Peerreviewers KimitakaSagawa DepartmentofLaboratoryMedicine,KurumeUniversity SchoolofMedicine,Japan. MarleenM.Wekell OfficeofResearch,CenterforVeterinaryMedicine, UnitedStatesofAmerica. Copyrightedmaterial