Chief, Veterinary Clinical Services Assistant Professor Yale School of Medicine New Haven, CT

1. EssentialComponentsofanAnimal CareandUseProgram JodiScholz,DVMDACLAM Chief,VeterinaryClinical Services AssistantProfessor YaleSchoolofMedicine NewHaven,CT AttendingVeterinarian WesternConnecticut StateUniversity Danbury,CT

2. Outline Regulations&Guidelines ProgramOversight AnimalHousing&Husbandry VeterinaryCare Facilities • • • • •

4. Regulations:Wheretobegin?? Twobasicquestions: 1.ArethereUSDA-coveredspecies? 2.Istheanimalresearchpubliclyfunded?

5. Regulations:Wheretobegin?? WhatisaUSDA-coveredspecies? •Warm-bloodedanimalsbeingusedorintended foruseforresearch,testing,experimentation,or exhibitionpurposes •Excludes:(1)birds,ratsofthegenusRattus,and miceofthegenusMus,bredforuseinresearch, (2)horsesnotusedforresearch,and(3)other farmanimalsusedintheproductionoffoodor fiber

6. AnimalWelfareAct&Regulations •AWAistheonlyFederallawintheUSthat regulatesthetreatmentofanimalsusedfor teaching,researchandexhibition •TheAWAisenforcedbyUSDA,APHIS, AnimalCare •USDAAnimalCareischargedwith developingandimplementingregulationsto supporttheAWA

7. AnimalWelfareAct&Regulations •AWRegulationsareessentiallythemanualfor complyingwiththeAct •PublishedinCodeofFederalRegulations,Title 9,Chapter1,SubchapterA-AnimalWelfare (“9CFR”) –Availableonlineonaphis.usda.gov •Regsaredividedinto4sections:Definitions, Regulations,Standards,andRulesofPractice GoverningProceedingsUndertheAnimal WelfareAct •USDAalsohas20publishedAnimalCare Policiestohelpinterpretsomeofthe requirementsoftheAWAregs

8. Whatdoesthismean? •AWA&Regulationsmustbefollowed •InstitutionsmustobtainUSDAregistrationpriorto housingUSDA-coveredspecies •AVeterinaryMedicalOfficer(VMO)employedbyUSDA APHISwillmakeunannouncedinspectionsonatleastan annualbasis •Institutionsmustfileanannualreportthatprovides assurancethattheAWAisfollowedandliststhenumbers ofanimalsusedinresearchorteaching

9. Regulations:Wheretobegin?? Twobasicquestions: 1.ArethereUSDA-coveredspecies? 2.Istheanimalresearchpubliclyfunded?

10. PHSPolicy •HealthResearchExtensionActof1985 •PublicHealthServicePolicyonHumane CareandUseofLaboratoryAnimals(PHS Policy) •ImplementedbyOfficeofLaboratory AnimalWelfare(OLAW) •Applicabletoallactivitiessupportedby PHSfunds •Coversanylive,vertebrateanimalused forresearch •InstitutionswithPHSfundingmustfollow TheGuidefortheCareandUseof LaboratoryAnimals

11. Whatdoesthismean? •InstitutionsmusthaveanAnimalWelfare AssurancewithOLAWpriortoconductingPHS- supportedresearch •Assurancemustberenewedatleastevery4years •Anannualreportmustbefiledannuallydescribing whetheranychangeshavebeenmade •AreportmustbesenttoOLAWwhenthereis: –Serious/continuednoncompliancewithPHSpolicy –Suspensionofaresearchactivityduetononcompliance –AnyseriousdeviationfromTheGuide

12. Let’sbreakitdown… Programoversight Animalhousing Vetcare Facilities • • • •

13. ProgramOversight:IACUC •InstitutionalAnimalCareandUseCommittee(IACUC) –Responsiblefortheassessmentandoversightofthe institution’sanimalprogramcomponentsandfacilities –Committeemustmeetasoftenasnecessarytofulfill responsibilities –Specificroles: Protocolreview,includingmodifications Post-approvalmonitoring Inspectionoffacilities Regularreviewoftheprogram Ongoingassessmentofanimalcareanduse Dealingwithnoncompliance Establishingamechanismforevaluatingconcernsregardinganimal careanduse • • • • • • •

14. ProgramOversight:IACUC IACUCComposition:PHS •Minimumfivemembers •OneDVMwithtrainingor experienceinlabanimalscience •Onepracticingscientist experiencedinresearchinvolving animals •Onenonscientificmember •Onepublicmemberthat representsthegeneral community •Notmorethanthreemembers fromthesameadministrative unitoftheinstitution. IACUCComposition:AWA •Minimumthreemembers •OneDVMwithtrainingor experienceinlabanimalscience •Oneunaffiliatedmember…who representsthegeneral communityinterestsinthe propercareandtreatmentof animalsandisnotalaboratory animaluser. •Notmorethanthreemembers fromthesameadministrative unitoftheinstitution.

15. ProgramOversight:AV&IO •TheAttendingVeterinarian(AV)isresponsibleforthe healthandwell-beingofallanimalsattheinstitution –Overseesveterinaryandotheraspectsofanimalcare –Needstohavetrainingorexperiencewiththespeciesbeing attended –TheinstitutionmustgranttheAVsufficientauthority •TheInstitutionalOfficial(IO)bearsultimateresponsibility fortheprogram –Representssenioradministration –Hastheauthoritytoallocateresourcesandensuresalignment oftheprogramgoalswiththeinstitution’smission –AccordingtotheAWARegulations,isauthorizedtolegally commitonbehalfoftheresearchfacilitythattheAWA Regulationswillbemet

16. ProgramOversight:Training •Allpersonnelinvolvedwiththecareanduseof animalsmustbeadequatelyeducated,trained, and/orqualified –Thisincludesresearchandanimalcarepersonnel –Itistheinstitution’sresponsibilitytoassurethat personnelaretrainedandprovideresourcesfor training –Canbeformalorinformalon-the-jobtraining –IACUCmembersshouldalsobetrainedontheirroles andresponsibilities –Trainingshouldbedocumented –Resourcesareavailableonline

17. ProgramOversight:OccHealth •Eachinstitutionmustestablishandmaintainan occupationalhealthandsafetyprogram –Focusonmaintainingasafeandhealthyworkplaceenvironment –Naturedependsonthefacility,researchactivities,hazards,and species –Hazardidentificationandriskassessmentaremajorroles –ProvisionofappropriatePPE –Occupationalhealthphysiciansandnurses,ifavailable •Healthscreening –Potentialhazards •Ergonomicissues •Allergens •Noise •Opportunisticinfections/zoonoticdisease •Chemicals(formalin,anestheticagents)

18. Disasterplan Adisasterplanshouldbeinplace –RequiredbybothPHSandUSDA –USDAmandate:planinplacebyJuly29th,training bySeptember27th •Identifypotentiallikelyemergencies •Specifictasksthatneedtobecarriedout •Chainofcommandandindividualsresponsibleforeach task •Responseandrecoveryhandling(materials,resources, training) –Animalfacilitydisasterplansshouldbepartofthe overallinstitutionaldisasterplan –Lawenforcementandemergencypersonnelshould beprovidedacopy,toincorporateintobroader planning

19. AnimalHousing&Environment •Temperature&humidity –Temprangesbyspeciesandhumidityrangeslistedinthe AWARegsandTheGuide –Tempandhumidityshouldbemonitoredandrecorded •HVAC –Animalhousingrooms:10-15airchangesperhour –Beawareofpositive/negativepressurerelativetocorridor •Illumination –Shouldbediffusedappropriatelyandprovidesufficient lightingforworkingpersonnelaswellaswell-beingofthe specieshoused –Ratsandmicegenerallypreferlowlighting Lightshouldbe325luxorbelowforalbinorodents •

20. AnimalHousing&Environment •Noise –Canbeanissuewitheither noiseproduction(dogs,pigs) orsensitivity(rodents) –Exposuretosoundsover85dB maynecessitateahearing protectionprogramfor personnel –Manyanimalshearsounds outsideofthehumanhearing range •Vibrations –Candisruptbreedingand research –Cancomefromwithinor outsidetheroom/facility JAmAssocLabAnimSci.2007Jan;46(1):20-2

21. AnimalHousing&Environment •Specialconsiderationsforaquaticspecies –Waterqualityshouldberoutinelymeasured –Watershouldbeappropriatelyconditioned –Chlorine/chloraminemustberemovedor neutralized –Roomairexchangeratesaregovernedby thermalandmoistureloadsintheroom –Full-spectrumlightingmaybenecessary

22. AnimalHousing&Environment •Cagespacerequirements –Tablesforspacerequirementsbyspeciescanbe foundintheAWARegsandTheGuide •Enrichment –Providinganenvironmentthatsupportsnormal behaviorandreducesabnormalbehavior –Allowsanimalstocopewiththestressofthe laboratoryenvironment –Social,cognitive,activity,structural –Biologicalrelevanceandchoice

23. AnimalHusbandry •Food –Commerciallyavailabledietsformostspecies –Appropriatestorageforshelflifeandvermincontrol –Openfoodbagsshouldbestoredinvermin-proof secondarycontainers –Mostdietsexpire6monthsaftermilldate –Lessthan70⁰Fandbelow50%humidityisrecommended –Foodshouldbestoredoffthefloortofacilitatesanitation •Watershouldbepalatableanddrinkingtubesshould beperiodicallycheckedforcleanlinessand functionality

24. Sanitation •Cleaning:removesexcessiveamountsof excrement,dirtanddebris •Disinfection:reducesoreliminates unacceptableconcentrationsof microorganisms •Frequencyandintensitydependsonwhatis neededtoprovideahealthyenvironment –Dependsonspecies,typeofcaging,bedding, numberofanimals,etc

25. Sanitation •Generalguidelinesforsanitation: –Enclosuresandaccessories:atleasteverytwoweeks –Solid-bottomcages,bottles,andsippertubes:atleast onceaweek •Disinfectioncanutilizechemicals,hotwater,or both –Washandrinsetempsof140-180⁰Fiseffective –Chemicalsmaybecontraindicated(e.g.aquatics) –Mechanicalwashersarerecommended;hand-washing isacceptable,butattentiontodetailisrequired –Disposablecagesareavailableifamechanicalwasheris notanoption

26. Sanitation •Allcomponentsoftheanimalfacilityshould beregularlycleanedanddisinfected •Effectivenessofsanitationshouldbe monitored –Temperaturestrips –Culture –ATPswabs –Certificationandmaintenanceofequipment

27. Otherhousingconsiderations •Wastemanagement –Hazardous,carcasses •Pestcontrolprogramshouldbeinplace •Animalsneedtobecaredfordaily,including weekendsandholidays •Animalidentification

28. VeterinaryCare •Aveterinaryprogrammustbeinplace •TheAVisultimatelyresponsiblefor thecareoftheanimals –Shouldprovideguidanceto investigatorsandallpersonnelto ensureappropriatehusbandry,medical care,handling,sedation,anesthesia, analgesia,surgery,andeuthanasia –AccordingtotheAWARegs,needsto havegraduatedfromanaccreditedUS vetschool(orequivalent) –Canbefulltime,parttimeorona consultantbasis •Ifparttimeorconsultant,visitsmustbe appropriateforprogrammaticneeds

29. VetCare:Procurement •ShouldbelinkedtoIACUCapproval •Wheneverpossible,purchasefromvendors whosupplypurpose-bredanimals •Beawareofpopulationstatusandwhether permits/oversightbyUSFishandWildlife Servicemaybeappropriate

30. VetCare:Transportation •Canbebetweenorwithinfacilities •Goals Providebiosecurity Minimizezoonotic/allergenrisk Protectagainstenvironmentalextremes Avoidovercrowding Providingforneedsandcomfortduringtransport Protectionfromphysicaltrauma – – – – – – •Transportationinpersonalvehiclesisdiscouraged •Specialconsiderationsmayneedtobemadefor aquatics

31. VetCare:PreventativeMedicine •Animalbiosecurity –Measurestocontrolinfectionsinlaboratoryanimals –Mayormaynotbeaconcerndependingonanimaluse •Quarantineandstabilization –Quarantineorconditioningmayormaynotbenecessary dependingonsource,operationsetupandexperimental needs –Acclimationdurationwilldependonthemode/durationof transportationandtheintendeduseoftheanimals •Separationbyhealthstatus •Separationbyspecies

32. VetCare:ClinicalMedicine •Animalsneedtobecheckeddaily •Needamethodforcommunicationofhealth problemstotheveterinarian •Planforemergencycareduringregularand non-workinghoursmustbeinplace •Documentationprocessformedicalrecords anddrugrecords(controlledsubstances) –Mustcomplywithstateandfederallaws

33. Nuggetstoconsider… •Makesurethateveryoneknowshowtocontactthevet (directlyorthroughsupervisor) –Disseminateorpostcontactinformation •Ifindoubt,CALLTHEVET!Wearetheretohelp! •Ifyouhaveonefull/part/consultingvet,haveabackupwith contractpre-arranged •It’sagoodideatokeepacouplecommonantibiotics, analgesicsandbasicmedicalsuppliesonhand •Workoutaheadoftimeasbestaspossiblewhatthe processisforanimalsthatneedtreatment(whopaysforit? PIs?Facility?Whocanadminister?) •Ifnotavailablein-house,formanarrangementwitha nearbyprogramfordiagnosticpathologyservices

34. VetCare:Surgery •Pertainstosurgeryformedicalorresearchneeds •Personnelperformingsurgeryorproviding perioperativecareneedtobetrained(IACUCis responsibleforensuringthis) •Adedicatedspaceshouldbeused •Aseptictechniqueforsurvivalsurgeries –Patientprep –Surgeonprep –Sterileinstruments –Properoperativetechnique •Intraopmonitoringandrecovery,including documentation

35. VetCare:PainandDistress •Painanddistress –Allpersonnelinvolvedinthecarefortheanimalsmustbe trainedinassessmentofpainanddistressforthatspecies •Anesthesiaandanalgesia –Aveterinarianshouldbeinvolvedinchoosingplans –Preemptiveanalgesiaimprovesstabilityandrecovery –Multimodalapproachestopainarebest •Euthanasia –Theactofhumanelykillinganimalsbymethodsthatinduce rapidunconsciousnessanddeathwithoutpainordistress –MethodsshouldbeconsistentwiththeAVMAGuidelines •Newversionoutin2013: https://www.avma.org/KB/Policies/Documents/euthanasia.pdf •Acceptable,acceptablewithconditions,unacceptable *otheroptionsfordestinationoftheanimalsafterteachingor experimentation:adoption,transfer,retirement*

36. Facilities •Awell-designed,properlymaintainedand managedfacilityisanimportantaspectof humaneanimalcareanduse •Idealbuildingmaterialsaredurable,moisture- proof,vermin-proof,fire-resistantandseamless •Considerspacefor: –Animalhousing,care,sanitation –Receipt(animals,supplies),quarantine –Separationofspeciesorforhealth/researchreasons –Storage –Animaluse/procedures –Personnel:offices,lockerrooms,showers,etc

37. Facilities:GeneralGuidelines •Corridors –Wideenoughformovementofpersonnelandequipment (rec.6-8feet) –Bumpersandrails,recessedtelephones,alarmsetc •Doors –Doubledoorsforsomeareas(noise,containment) –Viewingwindows(abilitytocoverorredtint) –Shouldbelargeenough –Sealed,self-closing,secure •Windows –Thegood:enrichment,naturallight –Thebad:securityrisk,tempcontrol,interferencewith photoperiod

38. Facilities:GeneralGuidelines •Floors –Moistureresistant,nonabsorbent,impactresistant –Texturedforslipresistancebutnottoomuch(difficult tosanitize) •Drainage –Floordrainsmaybeimportant –Ifnotneeded,shouldbecappedandsealed •Wallsandceilings –Smooth,moistureresistant,nonabsorbent,resistantto impactdamage –Suspendedceilingsgenerallyundesirable–ifpresent, shouldbesealedwithgasketsandclipsandshouldbe washable

39. Facilities:GeneralGuidelines •HVAC –Designedforreliability,easeofmaintenance,energy conservation,andmeetingthetemperatureandhumidity demandsofthespecieshoused –Shouldbeabletomaintainatemperature+/-2°Fand humidity+/-10% •Powerandlighting –Lightandpowerfixturesshouldbesealedtoprevent verminaccess –Time-controlledlightcycleswithmonitoringwhenever possible –Emergencypowerforessentialequipment(including aquaticslifesupportsystems) •Designfornoiseandvibrationcontrol

40. Facilities:GeneralGuidelines •Sanitationfacility Separateareaforsanitizingcagesandequipment Sufficientspaceformovementandstorage Separationofcleananddirty Ventilationandsteam/fumedissipation Personnelsafety – – – – – •Hazardousagentcontainment –Goal:reduceoreliminatehazardexposuretopersonnel andtheoutsideenvironment –Followguidelinesdescribedin“Biosafetyin MicrobiologicalandBiomedicalLaboratories”(“BMBL”)

41. Facilities:GeneralGuidelines •Securityandaccesscontrol –Rationale:containmentofallergens,hazardousagents, preventionofpathogenintroduction,preventionof terroristactsbyanimalrightsextremists –Animalfacilityshouldbelocatedwithinanother structurewithitsownindependentsetofsecurity features –Controlmeasures:securitypersonnel,physical barriers,controldevices(securitysystems,keys, electroniclocks)

42. EssentialResourceList •AnimalWelfareAct(AWA)andRegulations(9CFR) •NRC’sGuidefortheCareandUseofLaboratory Animals,8thEd.(“TheGuide”) •OLAW’sPublicHealthServicePolicyonHumane CareandUseofLaboratoryAnimals(“PHS Policy”) •CDC’sBiosafetyinMicrobiologicalandBiomedical Laboratories(“BMBL”) •AVMAGuidelinesfortheEuthanasiaofAnimals: 2013Edition

43. OtherGreatResources •OccupationalHealthandSafetyintheCareandUseofResearchAnimals (NRC) •GuidefortheCareandUseofAgriculturalAnimalsinResearchandTeaching, ThirdEdition,January2010(FASS) •ACLAMPositionstatements(aclam.org),esp: –AssessmentandManagementofPaininRodentsandRabbits –ReportontheACLAMTaskForceonRodentEuthanasiaAugust2005 •InstitutionalAnimalCareandUseCommitteeGuidebook(OLAW) •OLAW.nih.gov •AmericanAssociationforLaboatoryAnimalScience(aalas.org) •AssociationforAssessmentandAccreditationofLaboratoryAnimalCare (aaalac.org) •AnimalWelfareInformationCenter(USDA)(awic.nal.usda.gov) •AnimalWelfareInstitute(awionline.org) •TheEnrichmentRecord(enrichmentrecord.com) •CollaborativeInstitutionalTrainingInitiative(citiprogram.org) •COMPMEDlistserv(http://www.aalas.org/online_resources/listserves.aspx)

44. ThankYou! JodiScholz,DVMDACLAM jodi.carlson@yale.edu