use of the benchmark dose approach in risk assessment - EFSA

benchmark dose, BMD, BMDL, benchmark response, NOAEL, dose–response modelling, BMD software. On request from: EFSA. Question Number:. Skiptomaincontent Othersites EFSA OpenEFSA EFSAJournal Connect About Howwework Values Transparency Workingpractices Trustedscience Externalexperts Governance Managementboardmembers Executivedirector OperationalManagement Partners EUMemberStates EUinstitutionsandagencies CompetentorganisationsinMemberStates International Stakeholderengagement Documents Corporatepublications Newsroom News Multimediaproducts Infographics Videos Factsheets Topics Fulllist Africanswinefever Antimicrobialresistance Beehealth Nutrition Pesticides Pesticidesandbees:guidancereview Planthealth Xylellafastidiosa Glossary Resources Datareports Datastandardisation Methodology Guidance Evidence Toolsandresources DietaryExposure(DietEx)tool Publications Applications Overview Biologicalhazards Feedadditives Foodcontactmaterials Foodimprovementagents GMO Novelfood Nutrition Pesticides Servicesforapplicants Toolkit Trackyourapplication Eventcalendar Askaquestion Engage Careers Staff Experts Secondments Youngprofessionals Selectionprocess FellowshipProgramme Procurement UpcomingTenders€139k+ Tenders€139k+ Tenders€15k-€139k Scientificandtechnicalsupport Toolbox Grants Callsfordata Consultations Observers ResearchPlatform Stakeholders Engagementplatforms Engagementinriskassessment Callsforstakeholders Stakeholderregistration TrainingProgramme Calendar Update:useofthebenchmarkdoseapproachinriskassessment Published: 24January2017 Adopted: 17November2016 Thisoutputsupersedesthepreviousoutput(s) GuidanceoftheScientificCommitteeonUseofthebenchmarkdoseapproachinriskassessment[1] ontheWileyOnlineLibrary Readthearticle AccessthePDF DOI: https://doi.org/10.2903/j.efsa.2017.4658 Metadata EFSAJournal2017;15(1):4658 Keywords: benchmarkdose,BMD,BMDL,benchmarkresponse,NOAEL,dose–responsemodelling,BMDsoftware Onrequestfrom: EFSA QuestionNumber: EFSA-Q-2014-00747 ScientificCommittee Contact: sc.secretariat[at]efsa.europa.eu Panelmembersatthetimeofadoption DianeBenford,ThorhallurHalldorsson,AnthonyHardy,MichaelJohnJeger,KatrineHelleKnutsen,SimonMore,AlicjaMortensen,HanspeterNaegeli,HubertNoteborn,ColinOckleford,AntoniaRicci,GuidoRychen,JosefRSchlatter,VittorioSilano,RolandSoleckiandDominiqueTurck. Abstract TheScientificCommittee(SC)reconfirmsthatthebenchmarkdose(BMD)approachisascientificallymoreadvancedmethodcomparedtotheNOAELapproachforderivingaReferencePoint(RP).MostofthemodificationsmadetotheSCguidanceof2009concernthesectionprovidingguidanceonhowtoapplytheBMDapproach.ModelaveragingisrecommendedasthepreferredmethodforcalculatingtheBMDconfidenceinterval,whileacknowledgingthattherespectivetoolsarestillunderdevelopmentandmaynotbeeasilyaccessibletoall.Therefore,selectingorrejectingmodelsisstillconsideredasasuboptimalalternative.ThesetofdefaultmodelstobeusedforBMDanalysishasbeenreviewed,andtheAkaikeinformationcriterion(AIC)hasbeenintroducedinsteadofthelog-likelihoodtocharacterisethegoodnessoffitofdifferentmathematicalmodelstoadose–responsedataset.Aflowcharthasalsobeeninsertedinthisupdatetoguidethereaderstep-by-stepwhenperformingaBMDanalysis,aswellasachapteronthedistributionalpartofdose–responsemodelsandatemplateforreportingaBMDanalysisinacompleteandtransparentmanner.Finally,itisrecommendedtoalwaysreporttheBMDconfidenceintervalratherthanthevalueoftheBMD.Thelowerbound(BMDL)isneededasapotentialRP,andtheupperbound(BMDU)isneededforestablishingtheBMDU/BMDLperratioreflectingtheuncertaintyintheBMDestimate.Thisupdatedguidancedoesnotcallforageneralre-evaluationofpreviousassessmentswheretheNOAELapproachortheBMDapproachasdescribedinthe2009SCguidancewasused,inparticularwhentheexposureisclearlysmaller(e.g.morethanoneorderofmagnitude)thanthehealth-basedguidancevalue.Finally,theSCfirmlyreiteratestoreconsidertestguidelinesgiventheexpectedwideapplicationoftheBMDapproach. ©EuropeanFoodSafetyAuthority,2017 Seealso DraftguidanceonBMDapproachinriskassessment:outcomeofthepublicconsul… Relatedtopic(s) Methodology