Download Environmental Fate, Effects, and Risk Assessment of Veterinary

EnvironmentalFate,Effects,andRiskAssessmentofVeterinaryMedicines
SilkeHickmann,CarolineMoermond,JasonWeeks
May9,11:05-12:45,MeetingStudio314&316
Veterinarymedicinesentertheenvironmentviasoil(applicationtoterrestrialanimals)orwater
(applicationtoaquaculture).Currently,thefateandtoxicitytestsusedwithintheregulatoryrisk
assessmentarebasedonOECDguidelines,whichweredesignedforpesticidesorgeneralchemicals.
Asscienceprogresses,ithasbecomeclearthatforsomeveterinarymedicines,especiallyionisable
chemicals,theseguidelinesmaynotalwaysfullyapply.Standardmodelsusedtopredict
environmentalconcentrations(PECs)mayalsoneedareview.Thissessionwillfocusonthe
environmentalriskassessmentofveterinarymedicines.ItwilladdressallaspectsoftheERA,i.e.
fate,exposure,andeffects.Thismayincludeimprovedmodellingforexposureassessment,
validationofexposuremodelsapplied,butalsothequestionwhetherpesticideapproachessuchas
MonteCarlosimulationwouldbeapplicabletoveterinarymedicines.Othertopicstobeincludedare
assessmentofdegradationandtheassociatedchallengessuchasextractiontechniquesandkinetic
modelling,potentialapproachesforhighertiertestingoftheeffectsofveterinarymedicines,or
testingofnovelspeciessuchasmussels(Bivalvia)fortheassessmentofbioconcentration.Inaddition
totheERAofveterinaryproductsforterrestrialanimals,presentationsontheERAofaquaculture
medicinesarehighlywelcomed.Presentationsarealsoinvitedthatcoverlesscommonlyaddressed
topicssuchastheexposureoftheenvironmenttoveterinarymedicinesusedinnon-foodanimals,e.
g.fromcompanionanimals,andthequestioniftheyareofanyrelevancefortheenvironment.The
sessionwillalsofocusontheregulatoryperspectiveandthestatusoftheriskassessmentand
guidelinedevelopmentindifferentregionsoftheworld.Specificregionalapproachestoe.g.
exposureassessmentandthedeterminationofspecificdefaultvalueswillbeaddressed.Thesession
alsoinvitespresentationsonpotentialriskmitigationmeasuresorriskmanagementplanssuchas
post-authorizationmonitoringapproaches.Approachestobettertransformtheinformationfromthe
riskassessmentstotrans-disciplinarydecisionssuchasbenefit-riskassessmentsinauthorization
proceduresorcost-benefitanalysisofmitigationmeasuresarealsohighlywelcome.Thismayalso
includepotentialimpactsofveterinarymedicinesonecosystemservices.