2008

UniversityofWindsorBiologicalSafety

Committee(UWinBSC)

3/6/2008

UniversityofWindsor’sBiologicalSafetyManual

EmergencyResponseProcedureforBiologicalMaterialSpill

In case of a spill involving biological material it is important to reduce the possibility of furthercontaminationoutsidetheinitialspillarea.Bypreventingthespreadingofcontaminationyoueffectivelyreducethepotentialexposureofothers.

Allspillsofbiologicalmaterialsmustbecleanedupimmediately.

QuickReferenceSteps:

1. Treat Injured People First: Providing first aid to injured people takes priority over cleaning aradioactivespill.Informemergencypersonnelthatspillinvolvesbiologicalmaterial.

2. Alert Everyone in the Area: Inform everyonewithin the vicinity of the spill that an accidentinvolving biologicalmaterial has occurred. Identify an individual to coordinate spill response.Markthespillzoneandpostappropriatesignage(ifneeded)toreducethepotentialforfurthercontamination.

3. ControlContamination:Takeactiontopreventthespreadofcontaminatedmaterials.Ifthespillisdry–applyasmallamountofwaterfromtheoutsideofthespillworkinginwards.Ifthespilliswet,coverwithabsorbentmaterial.

4. ClearArea:Removeallunnecessaryindividualsfromtheareaofthespill.Attempttoreducethemovementofpeoplewithinthespillzone.

5. Decontamination: Apply decontamination procedures in priority order: (1) personnel; (2)laboratory;and(3)equipment.

6. SummonAid:Ifyouareunsureofhowtoeffectivelycleanthespill,contacttheBiologicalSafetyOfficer(ext.3524).

Providedispatcherwiththefollowing:yourname,phonenumber,location(room#&building),thatincidentinvolvesbiohazardousmaterials,andifanyoneisinjured.

.

Incaseofemergency,contactCampusCommunityPoliceat:

Ext.911

BIOLOGICALSAFETYMANUAL

BIOLOGICALSAFETYCOMMITTEE

UNIVERSITYOFWINDSOR

FIRSTEdition

2008

Approved:08/27/2008(UWinBSC)

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TableofContents

1 MANAGEMENTOFBIOLOGICALSAFETYATTHEUNIVERSITYOFWINDSOR....................... 11.1 UniversityofWindsor’sBiologicalHealth&SafetyPolicy...........................................................................11.2 RegulationofBiologicalAgentsattheUniversityofWindsor....................................................................11.3 Responsibilities...............................................................................................................................................................21.3.1 BiologicalSafetyCommittee(UWinBSC) ..........................................................................................................21.3.2 Vice­President,Research ..........................................................................................................................................21.3.3 AcademicAdministrativeUnit(AAU)Head.....................................................................................................31.3.4 ResponsibleOfficial–BiologicalSafetyOfficer ..............................................................................................31.3.5 PrincipleInvestigators ..............................................................................................................................................41.3.6 Individualsworkingwithbiologicalmaterials ..............................................................................................51.3.7 HazardousMaterialsLeaders ................................................................................................................................5

1.4 LicencingandBiologicalSafetyCertificates .......................................................................................................51.4.1 RequirementforUniversityofWindsorBiologicalSafetyCertificates ................................................51.4.2 TypesofBiologicalSafetyCertificates ...............................................................................................................61.4.3 ApplicationforaBiologicalSafetyCertificate ...............................................................................................71.4.4 BiologicalSafetyCertificateRenewalandValidationPeriods................................................................71.4.5 LaboratoryDecommissioning................................................................................................................................81.4.6 EnforcementofBiologicalSafetyPolicies.........................................................................................................81.4.7 Informationandinquiries........................................................................................................................................9

1.5 MaterialsSafetyDataSheets .....................................................................................................................................9

2 APPLICABLELEGISLATION,GUIDELINES,ANDSTANDARDS.............................................. 102.1 Importation,Use,andDistributionofBiologicalAgents............................................................................ 102.1.1 Importatonofbiologicalagentsaffectinghumans ................................................................................... 102.1.2 Importationofbiologicalagentsaffectinganimals.................................................................................. 11

2.2 ExportRequirementsforBiologicalAgents .................................................................................................... 122.3 TransportationofBiologicalAgents ................................................................................................................... 122.4 LaboratoryAnimals ................................................................................................................................................... 142.5 WasteManagement.................................................................................................................................................... 142.5.1 LiquidWaste............................................................................................................................................................... 152.5.2 SolidWaste.................................................................................................................................................................. 15

2.6 Autoclaves/Steamsterilizers............................................................................................................................... 192.7 Fumehoods ................................................................................................................................................................... 212.8 BiologicalSafetyCabinets:AssessmentandTesting ................................................................................... 212.8.1 Testingservices ......................................................................................................................................................... 222.8.2 Requiredproceduresandtests ........................................................................................................................... 22

3 BIOLOGICALSAFETYPRACTICESANDPROCEDURES ........................................................ 253.1 GeneralLaboratorySafetyPractices .................................................................................................................. 253.2 WorkingwithLaboratoryAnimals...................................................................................................................... 273.3 WorkingwithHumanPathogens ......................................................................................................................... 29

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3.3.1 HumanBloodbornePathogens........................................................................................................................... 303.3.2 UniversalBloodandBodyFluidPrecautions ............................................................................................... 30

3.4 PhysicalContainmentLevels ................................................................................................................................. 333.4.1 LaboratoryRequirements–BiologicalContainmentLevel1 ............................................................... 343.4.2 LaboratoryRequirements–BiologicalContainmentLevel2 ............................................................... 36

4 EMERGENCYPROCEDURES ............................................................................................. 394.1 BiologicalSpillResponse ......................................................................................................................................... 394.1.1 ClassificationofSpills ............................................................................................................................................. 404.1.2 BiohazardousSpillProcedure–MinorBiologicalSpill ........................................................................... 404.1.3 BiohazardousSpillProcedure–MajorBiologicalSpill ........................................................................... 424.1.4 BiohazardousSpillProcedure–OnBody....................................................................................................... 424.1.5 BiohazardousSpillProcedure–InsideaBiologicalSafetyCabinet................................................... 434.1.6 BiohazardousSpillProcedure–withinaCentrifuge................................................................................ 444.1.7 BiohazardousSpillProcedure–duringTransportation......................................................................... 454.1.8 BiohazardousSpillProcedure–InvolvingPrions ...................................................................................... 464.1.9 DisposalofSpillMaterials .................................................................................................................................... 464.1.10 BiologicalSpillReporting................................................................................................................................... 47

4.2 EmergencyMedicalProcedures ........................................................................................................................... 474.2.1 MedicalSurveillance&Immunioprophylaxis .............................................................................................. 484.2.2 AnimalBitesandScratches.................................................................................................................................. 484.2.3 ExposuretoHumanBloodandBodyFluids.................................................................................................. 494.2.4 ExposuretoInfectiousandCommunicableDiseaseAgents................................................................... 494.2.5 ImportantMedicalEmergencyNumbers&Contacts ............................................................................... 49

4.3 MedicalIncidentReportingRequirements...................................................................................................... 504.3.1 Individual:.................................................................................................................................................................... 504.3.2 Supervisor/PrincipleInvestigators: ................................................................................................................. 504.3.3 ChemicalControlCentre–LaboratorySafety,Compliance,andAssurance:................................. 514.3.4 OfficeofOccupationalHealth&Safety ........................................................................................................... 51

5 CLASSIFICATIONOFBIOLOGICALAGENTS ....................................................................... 525.1 GeneralInformation .................................................................................................................................................. 525.2 GeneticallyEngineeredOrganismsandCellLines ....................................................................................... 525.2.1 RecombinantDNAandGeneticManipulation............................................................................................. 535.2.2 TransgenicPlants..................................................................................................................................................... 55

5.3 AnimalCells,BloodandBodyFluids,andFixedTissues ........................................................................... 565.3.1 PrimaryCellCulturesandAnimalIissues...................................................................................................... 575.3.2 EstablishedCellLines.............................................................................................................................................. 575.3.3 BloodandBodyFluids ............................................................................................................................................ 575.3.4 FixedTissuesandTissueSections...................................................................................................................... 58

5.4 CellLineContaminationwithInfectiousAgents ........................................................................................... 585.5 BiologicalAgentRiskGroupCriteriaandCategories .................................................................................. 60

6 SECURITY ........................................................................................................................ 626.1 General............................................................................................................................................................................. 62

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6.2 PhysicalProtection..................................................................................................................................................... 626.3 PersonnelReliability&Suitability....................................................................................................................... 626.4 PathogenAccountablity ........................................................................................................................................... 636.5 Storage ............................................................................................................................................................................. 63

Appendixes .......................................................................................................................... 64AppendixA–AgentsnotindigenoustoCanada........................................................................................................ 64AppendixB–RiskGroupCategorizationofAgents................................................................................................. 66AppendixC–SafetyEquipment ....................................................................................................................................... 76AppendixD–BiologicalSafetyCabinets ...................................................................................................................... 77AppendixE–LaboratoryDesign...................................................................................................................................... 80AppendixF–References ..................................................................................................................................................... 87

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1 MANAGEMENTOFBIOLOGICALSAFETYATTHEUNIVERSITYOFWINDSOR

1.1 UniversityofWindsor’sBiologicalHealth&SafetyPolicy

“The University of Windsor is committed to providing a safe and healthy workplace and learningenvironment for its employees, students and visitors. The University is committed to preventingoccupational illnessandinjury intheworkplace,continually improvinghealthandsafetypracticesandperformanceandbelievesthatalltaskscanbeaccomplishedinasafemannerandincompliancewithrelevanthealthandsafetylegislation,codes,standardsandpractices”(UniversityofWindsorHealthandPolicyStatement,July9/2007).

The University is responsible for establishing, implementing and maintaining program, such as theBiologicalSafetyProgramthataredesignedtoprotectthehealthandsafetyofemployees,studentsandvisitors.Generalsafetypoliciesandworkplacespecificprocedureswillbedeveloped,documented,andimplemented.

ThisManual describes the requirements and procedures established by the University forworkwithpotentially hazardous biological agents. It is based upon the Public Health Agency of Canada’sLaboratoryBiosafetyGuidelines(2004/3rdedition)andreflectscurrentbestpractices.

AllworkconductedbyUniversitymemberswithpotentiallyhazardousbiologicalagentsonUniversitypremisesorunderthecontroloftheUniversityistobeperformedinaccordancewiththerequirementsofthismanual.

QuestionsregardingapplicationorinterpretationoftheBiologicalSafetyProgramorthismanualshouldbedirectedtotheBiosafetyOfficer,ChemicalControlCentre,at(519)253‐3000ext.3523orbyemailatccc@uwindsor.ca.

1.2 RegulationofBiologicalAgentsattheUniversityofWindsor

TheBoardofGovernorsof theUniversityofWindsorhasdelegated to thePresidentorhisdesignate(theVice‐President,Research)responsibilityfortheapprovalofUniversityregulationsandotheractionstoensure regulatory compliance, safeworking conditions, andaprofessional laboratoryenvironmentwhichisconducivetoresearch&teachingactivities,asitrelatestothemanagementofBiologicalAgentsoncampus.

TheVice‐President,Research(VP‐R),hasdelegatedthemanagementoftheprogramtotheUniversityof

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WindsorBiologicalSafetyCommittee(UWinBSC),anditsChair,responsibilityforthedevelopmentandpromulgationofsafetystandardsfortheconductofresearchandteachingactivitiesinvolvingpotentiallyhazardousbiologicalagentsbymembersoftheUniversity.

The Chemical Control Centre, under the direction of the Responsible Official – Biological Safety, isresponsibleforadministeringtheBiosafetyprogramonaday‐to‐daybasis,forprovidingtechnicaladviceon safety procedures and equipment, conducting laboratory compliance reviews, providing biologicalsafety training, and providing guidance and information related to compliance with pertinentregulations.

For additional information, please visit the Biosafety website at: www.uwindsor.ca/biosafety ortelephonetheResponsibleOfficial–BiologicalSafety,ChemicalControlCentre,at(519)253‐3000ext.3523orbyemailatccc@uwindsor.ca.

1.3 Responsibilities

1.3.1 BiologicalSafetyCommittee(UWinBSC)The University of Windsor Biological Safety Committee (UWinBSC) is responsible for setting andenforcingappropriatestandardsofsafety forworkwithpotentiallyhazardousbiologicalagentswithinUniversityworkplaces.TheCommitteehasformallyapprovedthecontentsofthismanualandenforcesthe standards through the issuance of Biosafety Certificates for all work with potentially hazardousbiologicalagents.

1.3.2 Vice­President,ResearchThe Vice‐President, Research (VP‐R) plays a key role in ensuring that the University of Windsor’sBiological Safety Program is being implemented according to this manual; specifically, he/she isresponsiblefor:

• NotifytheUniversityBiosafetyOfficerofanyresearchwhichutilizesbiohazardousmaterials;• Approvetermsandconditionsforresearchinvolvingbiohazardousmaterialsconductedbyother

organizations involving the use of University facilities under a service agreement with theUniversity;suchresearchshallalsobeapprovedbytheBiosafetyCommittee;

• Approveprojectsinvolvingdualuseresearch;• Administer Material Transfer Agreements involving biohazardous materials. Copies of such

agreementsshallbeforwardedtotheBiosafetyOfficer;• Establishandadministertheappealprocedure;• ReceiveandactuponrecommendationsoftheBiologicalSafetyCommittee(UWinBSC)andits

Chair;• Ordercorrectiveactionsforcasesofnon‐compliance;

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• Ensurethatresearchfundsarenotreleaseduntiltheappropriatebiosafetyprojectpermithasbeen submitted and approved by the Biological Safety Committee (UWinBSC) or Chair of theBiosafetyCommitteeasappropriate;

• Suspend funding for research projects that contravene the Public Health Agency of CanadaLaboratory Biosafety Guidelines, violate applicable federal, provincial or municipal laws orregulations,orarenotincompliancewiththepermitorthispolicy;

• RescindthesuspensionoffundingoncethecontraventionisrectifiedtothesatisfactionoftheBiologicalSafetyCommittee(UWinBSC);and

• Advise the relevant granting Agency of any changes in eligible status of Grant Holders andAward Holders and/or of serious problems in the use of research funds as required by theMemorandumofUnderstandingbetweentheUniversityandtheTheTri‐Council(NSERC,SSHRCandCIHR).TheBiosafetyOfficershallalsobeadvisedofsuchchangesofstatus.

1.3.3 AcademicAdministrativeUnit(AAU)HeadFordepartments thatutilizepotentiallyhazardousbiologicalmaterials, thedepartmentheadmustbefamiliarwithandfollowalldirectionscontainedwithinthismanual,orwithinanytrainingprogram.Inparticular,AAUHeadsareresponsiblefor:

• Ensurethatanyactivitiesinvolvingtheuseofbiohazardousmaterialsinhis/herdepartmenthas received approval prior to the acquisition of the biohazardous materials and thecommencementoftheactivities;

• Ensure thatPrincipal Investigators inhis/herdepartmentare fullyawareof theUniversitypoliciesandguidelinesregardingbiohazardousmaterials;

• Co‐signallpermitapplicationformsconfirmingthevalidityoftheinformation;• Advise the Biosafety Officer when a Principal Investigator is no longer employed by the

University;• Ensure that current inspection certificates for steam sterilizers in the department are

posted,thatsterilizationcyclesareverifiedusingbiologicalindicatorsonaregularbasis,andthatrecordsofusers,cycles,andverificationaremaintained;and

• Ensuretheactivitiesinvolvingbiohazardousmaterialsinthedepartmentareincompliancewiththepermits;and

• Report issues regarding non‐compliance to the Chair of the University of Windsor’sBiologicalSafetyCommittee(UWInBSC)andtheUniversityBiologicalSafetyOfficer.

1.3.4 ResponsibleOfficial–BiologicalSafetyOfficerThe Vice‐President – Research (VP‐R) in consultation with the Chair of the University of WindsorBiological Safety Committee (UWinBSC)will appoint a University employeewho is knowledgeable byvirtue of education, training, or experience in the handling of biological agents to be responsible onbehalfoftheinstitutionforallaspectsrelatedtobiologicalsafetywithintheinstitution’slaboratoriesorworkplace.Inparticular,thisindividualisresponsiblefor:

• ServeastheauditandcontrolmanagerfortheBiosafetyCommittee;• Co‐signapprovedbiohazardpermits;

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• Maintainandprovideinformationonallelementsofthebiosafetyprogram;• Provideadviceonbiohazardousmaterialsandworkprocedures;• Providegeneralbiosafetytraining;• LiaisewiththePublicHealthAgencyofCanada, theCanadianFood InspectionAgency,Animal

Care Services, Occupational Health Services, Student Health Services, Security Services, andPhysicalResourcespersonnelonbiohazardissues;

• Auditworkareasforcompliancewithcertificaterequirements,legislation,codes,andguidelinesandsubmitcompliancereportstotheChair;

• Performinspectionsandsigndocumentationforimportpermitapplications;• Approvepurchaseorders and co‐signmaterial transfer agreements for theacquisitionand/or

transferofbiohazardousmaterials;• Investigate incidents involving biohazardous materials including exposures and lab‐acquired

infectionsandreportthefindingstotheChair;• Maintainprojectfilesincludingpermitsandassociatedmaterial;• Coordinateandmaintainrecordsoftheannualcertificationofbiocontainmentcabinets;• Order, on advice of the Vice‐President, Finance and Administration or the Vice‐President,

Research,thesuspensionofanyactivityinvolvingbiohazardousmaterialswhenthereisreasonto suspect that the health and safety of University personnel, the public, and/or theenvironmentisatriskorthatregulatoryconditionsoftheprojecthavebeenbreached;

• RegistertheBiologicalSafetyCommittee(UWinBSC)withtheNational InstitutesofHealthandfileannualmembershipupdates.

• Prepare and submit New Substance Notifications as required by the New SubstancesNotificationRegulationsoftheCanadianEnvironmentalProtectionAct;

• Liaisewithlocalhealthandsafetycommitteesasapplicable;and• ServeontheAnimalCareCommitteeandtheResearchEthicsBoard(attheirrequest).

1.3.5 PrincipleInvestigatorsThe primary responsibility for the safety of staff, students and the public lies with the PrincipalInvestigatorinchargeoftheresearchorteachingactivities.PrincipalInvestigatorsmustbefamiliarwith,follow,andensurethatall individualsworkingwithintheirlaboratoriesfollowtheproceduresoutlinedinthismanual.Inparticular,PrincipalInvestigatorsareresponsiblefor:

• Obtainingbiologicalsafetycertificateswhererequired;• Ensuringthatallconditionsofthecertificatearefollowed;• Ensuring that the appropriate containment cabinets are functioning properly by having them

testedatthestipulatedintervals;• Ensuringthatallpersonsworkingundertheircontrolhavehadappropriatetraininginworking

safelywithpotentiallyhazardousbiologicalmaterials;• Providingappropriatepersonalprotectiveequipmentandstandardoperatingprocedures.

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1.3.6 IndividualsworkingwithbiologicalmaterialsIndividualswhoworkwithpotentiallyhazardousbiologicalmaterialsmustbefamiliarwithandfollowalldirections given to them by their supervisor, contained within this manual, or within any trainingprogram.Inparticular,Personsworkingwithpotentiallyhazardousbiologicalmaterialsareresponsiblefor:

• Followallsafetyprocedures;• Wearprotectiveequipment;and• Participateinmedicalsurveillanceprogramswhenappropriate.

1.3.7 HazardousMaterialsLeadersCompletedBiosafetyCertificateapplicationformsshouldbesubmittedtotheLocalHazardousMaterialsLeaders (HazMat Leader) for the building and/or department where the work is to be performed.HazMatLeadersareindividualswhoarefamiliarwiththeoperationofvariousprogramsandoncampusinvolvinghazardousmaterials.Theyactasa liaisonandadvocatebetweentheUniversityofWindsor’sBiologicalSafetyCommitteeandprincipleinvestigators.TheHazMatLeaderwillreviewtheapplicationandforwarditforadditionalreviewandapproval.

If a HazMat Leader is not appointed within your building and/or department, please direct allapplicationsdirectlytotheChemicalControlCentreforreviewandapproval.

1.4 LicencingandBiologicalSafetyCertificates

1.4.1 RequirementforUniversityofWindsorBiologicalSafetyCertificatesAUniversityofWindsorBiologicalsafetyCertificateisrequiredforall(researchandteaching)laboratoryactivitieswhichinvolvetheuseormanipulationofpotentiallyhazardousbiologicalagents,andmaterialscontainingsuchagents(includingviruses,bacteria,fungi,parasites,recombinantDNA,prionsandothermicro‐organisms / genetic systems, andhuman and animal tissues, cells, blood andbody fluids), andwhichare:

(i) supervisedorconductedbyemployeesormembersoftheUniversity,or(ii) conductedonUniversitypremises,orinabuildingorlocationadministeredbyorunderthe

controloftheUniversity,or(iii) supportedbyfundsprovidedbyorthroughtheUniversity,includingstart‐upandoperating

funds.

All suchactivitiesare tobeconductedandperformed inaccordancewith theUniversityofWindsor’sBiologicalSafetyManualandanyrelevantguidelinesorlegislation.

Allactivitiesinvolvingpotentiallyhazardousbiologicalagentsandmeetinganyoftheabovecriteria,andall sources of financial support for such activities whether or not directly supported by grants or

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contracts administered by the University, must be identified on the application for a University ofWindsor Biological Safety Certificate. The release of grants and supporting funds by theUniversity isdependentonaUniversityBiologicalSafetyCertificate.

Foranimalbasedactivities,acopyoftheapprovedAnimalCareUtilizationProtocol(AUPP)CertificatemustbeprovidedandattachedtotheapplicationforaUniversityBiologicalSafetyCertificate.

The submission of an application for a University of Windsor Biological Safety Certificate implieswillingnesstoallowtheUniversityofWindsor’sBiosafetyOfficertovisitthelaboratorysitesusedbytheBiologicalSafetyCertificateholder inorder todeterminecompliancewith theUniversityofWindsor’sBiologicalSafetyManual.

1.4.2 TypesofBiologicalSafetyCertificatesTheUniversityofWindsor issuesBiologicalSafetyCertificatesbasedontheclassificationoforganismsaccording to risk group has traditionally been used to categorize the relative hazards of infectiveorganisms. The factors used to determinewhich risk group an organism falls into is based upon theparticularcharacteristicsoftheorganism,suchas:

• pathogenicity• infectiousdose• modeoftransmission• hostrange• availabilityofeffectivepreventivemeasures• availabilityofeffectivetreatment.

Theseclassificationspresumeordinarycircumstancesintheresearch&teachinglaboratoriesorgrowthin small volumes for diagnostic and experimental purposes. Four levels of risk have been defined asfollows:

RiskGroup1(lowindividualandcommunityrisk)

Anybiologicalagentthatisunlikelytocausediseaseinhealthyworkersoranimals.

Examples:

RiskGroup2(moderateindividualrisk,lowcommunityrisk)

Anypathogenthatcancausehumandiseasebut,undernormalcircumstances,isunlikelytobeaserioushazardtolaboratoryworkers,thecommunity,livestockortheenvironment.Laboratoryexposuresrarelycauseinfectionleadingtoseriousdisease;effectivetreatmentandpreventivemeasuresareavailable,andtheriskofspreadislimited.

Examples:hepatitisA,B,andC, InfluenzaA,Lymedisease,Denguefever,Salmonella,Mumps,Bacillussubtilis,andMeasles,

RiskGroup3(highindividualrisk,lowcommunityrisk)

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Any pathogen that usually causes serious human disease or can result in serious economicconsequencesbutdoesnotordinarilyspreadbycasualcontactfromoneindividualtoanother,orthatcausesdiseasestreatablebyantimicrobialorantiparasiticagents.

Examples: Anthrax, West Nile virus, Venezuelan equine encephalitis, Eastern equineencephalitis, SARS,Tuberculosis,Typhus,RiftValley fever,RockyMountain spotted fever, andYellowfever.

1.4.3 ApplicationforaBiologicalSafetyCertificateApplication forms foraUniversityBiologicalSafetyCertificateareprovidedwithExplanatoryNotes toassisttheapplicantandcanbeobtainedbycontactingtheChemicalControlCentre,LaboratorySafetyTechnician,at (519)253‐3000ext.3523,option#4.Thisapplication form isalsoavailable inelectronicformat via the Biological Safety homepage at: www.uwindsor.ca/biosafety. The form may then beprinted,completed,signedbytheapplicantandsubmittedtotheLocalHazardousMaterialsLeaderordirectlytotheChemicalControlCentreforreviewandapproval.

The required information must be legibly printed or typed on the application form. In general, thePrincipal Investigatormayusea single formto identifymore thanoneproject if these require similarcontainmentconditions, insteadofcompletingaseparateapplicationforaBiologicalSafetyCertificateforeachproject.Theprojecttitlesmustbematchedwiththecorrespondinggrantingagency.

Identify and specify thehazardousbiological agents tobeused (e.g. humanwholeblood,HepatitisBvirus,chickembryoprimarycellculture,CHOcells,E.coliO157).

Followingthereviewandapprovalprocess,aphotocopyofthevalidatedBiologicalSafetyCertificatewillbe returned to the applicant. The original will be retained on file at the Chemical Control Centre.Information will also be entered into RIS (Research Information System) for review by the Office ofResearchServices.AvalidBiologicalSafetyCertificatemustbeonfilebeforetheUniversitywillreleasegrantfunds.

1.4.4 BiologicalSafetyCertificateRenewalandValidationPeriodsContainmentLevel2andContainmentLevel3(1yearonly):

A Biological Safety Certificate for activities requiring Containment Level 2 or Containment Level 3conditionsisvalidforoneyearfromthedateofapprovalbytheUniversityofWindsor’sBiologicalSafetyCommittee(UWinBSC)Chair.Inthecaseofmulti‐yearresearchorrecurringteachingprogramsinvolvingpotentiallyhazardousbiologicalagents,theBiologicalsafetyCertificatemustberenewedannually.Therenewal is valid for one year from the expiration date of the previous Certificate. The PrincipalInvestigator / Course Instructor must submit a new application form, even if the activities involvingbiologicalagentshavenotbeenalteredormodifiedsincetheprevioussubmission.

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ContainmentLevel1(2years):

ABiologicalSafetyCertificateforactivitiesrequiringonlyContainmentLevel1isvalidfor2yearsfromthedateofapprovalbytheUniversityofWindsor’sBiologicalSafetyCommittee(UWinBSC)Chairor,inthe case of a renewal, from the expiration date of the previous Certificate, after which it must berenewed.ThePrincipalInvestigator/CourseInstructormustsubmitanewapplicationformeveniftheactivitiesinvolvingbiologicalagentshavenotbeenalteredormodifiedsincetheprevioussubmission.

1.4.5 LaboratoryDecommissioningAtleast30dayspriortotheexpecteddateofvacatingthelaboratoryorlaboratoryspace,thePrincipalInvestigator(PI)mustnotify,inwriting,theBiosafetyofficer.ThePrincipalInvestigatormustensurethatappropriatedecontaminationmeasureshavebeentakenpriortotherelocationordisposaloflaboratoryequipmentusedforthemanipulationofbiologicalagents.After decontamination, the laboratory equipment may be recycled through the Facilities Services –CustodialServices.A"Safe‐To‐Work"tagshouldbecompletedandattachedtotheequipment,priortoitbeingremovedfromthelaboratory.ThetagmaybeobtainedfromtheChemicalControlCentreat(519)253‐3000ext.3523.Inspectionandretestingismandatoryifabiologicalsafetycabinetisrelocated.Movesofaminornature(i.e.withinthesameroom)maybeexemptfromthisrequirementifthemoveisobservedbythetestingtechnologistandthecabinethasnotbeensubjectedtoexcessivestressorroughhandlingwhichcouldresultindamage.

1.4.6 EnforcementofBiologicalSafetyPoliciesIn theevent thataPermitHolder fails toobserve the rulesandregulationsgoverning thesafeuseofbiologicalagents,theBSO,shalladvisesuchPermitHolderoftheviolation(s)andshallreportsametotheCommittee.TheCommitteeshallreviewreportsofviolationsandwhenappropriateissueawrittenwarningtothePermitHolderand/orsuspendorwithdrawapprovaloftheuser(s)permit.If, inthejudgmentoftheBSO,thereisanemergencysituationinvolvingabiologicalhazard(s),he/sheshall take immediateactiontoensurethesafetyofpersonnelandtheenvironment.AmeetingoftheCommitteeshallbecalledassoonaspossiblefollowingsuchasituationtoreviewthecircumstancesoftheevent.Decisions of the Committee will be reported to the Vice‐President, Research, through the BSO, foraction.DisagreementwithanyCommitteedecisionmaybeappealedtothePresidentoftheUniversity.SuchappealsmustbeforwardedinwritingtothePresidentandacopymustbesenttotheCommittee.

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1.4.7 InformationandinquiriesExplanatoryNotesofferingmoredetailareprovidedwiththeUniversityofWindsor’sBiologicalSafetyCertificate application form. Should you encounter difficulty or have any questions regarding thecompletionorsubmissionofyourapplicationform,pleasecontact:

ChemicalControlCentreManagerTEL:(519)253‐3000ext.3524

1.5 MaterialsSafetyDataSheets

Material SafetyDataSheets for infectiousmicro‐organisms (biological agents)havebeenpreparedbytheOfficeof LaboratorySecurity,PublicHealthAgencyofCanada (http://www.phac‐aspc.gc.ca/msds‐ftss/index.html).Inaddition,allMSDS,includingforinfectiousmicro‐organisms,canalsobelocatedontheUniversityofWindsor’sonlineMSDSservice(www.uwindsor.ca/msds)

TheMSDSareorganizedtocontainhealthhazardinformationsuchasinfectiousdose,viability(includingdecontamination), medical information, laboratory hazard, recommended precautions, handlinginformation and spill procedures. The intent of these documents is to provide a safety resource forlaboratory personnel working with these infectious substances. Because these workers are usuallyworking in a scientific setting and are potentially exposed to much higher concentrations of thesehuman pathogens than the general public, the terminology in theseMSDS is technical and detailed,containinginformationthatisrelevantspecificallytothelaboratorysetting.Itishopedalongwithgoodlaboratorypractises,theseMSDSwillhelpprovideasafer,healthierenvironmentforeveryoneworkingwithinfectioussubstances.

Pleasenotethatalthoughtheinformation,opinionsandrecommendationscontainedinMaterialSafetyDataSheetsarecompiledfromsourcesbelievedtobereliable,theUniversityofWindsoralongwiththeMSDSauthoracceptsnoresponsibilityfortheaccuracy,sufficiency,orreliabilityorforanylossorinjuryresultingfromtheuseoftheinformation.Newlydiscoveredhazardsarefrequentandthisinformationmaynotbecompletelyuptodate.

AccessMaterialSafetyDataSheets(MSDS)forallbiologicalagentsoncampusat:www.uwindsor.ca/msds

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2 APPLICABLELEGISLATION,GUIDELINES,ANDSTANDARDSActivities involvingtheuseofbiologicalagentsandlaboratoryanimals,theproductionanddisposalofwaste,andtheuseofcertainequipmentaregovernedbyvariouslegislation,guidelinesandstandards.Adherence to the requirements of this Manual will ensure that work is performed safely and incompliancewiththerequirementsofexternalagenciesandregulatorybodies.

2.1 Importation,Use,andDistributionofBiologicalAgents

2.1.1 ImportatonofbiologicalagentsaffectinghumansAnyonewishingto importhumanpathogensrequiringcontainment levels2,3,or4musthaveavalidPublicHealthAgencyof Canadapermit prior to importation. The importationof humanpathogens isregulated by the Importation of Human Pathogens Regulations (IHPR)(1994). Pathogens requiringcontainmentlevel1facilitiesarenotregulatedbytheIHPR,andthereforeapermitisnotrequiredfortheir importation. Permits are required for the importation of all infectious substances into Canadaregardlessofwhethertheyinfecthumans,animalsorplants.Theimportationofinfectiousagentswhichare predominantly pathogenic to animals is regulated by means of the Health of Animals Act andRegulationsadministeredbyAgricultureandAgri‐FoodCanada.

It may also be necessary to obtain permission to transfer listed pathogens within Canada from onescientist or laboratory to another. Requests for single‐entry and long‐standing permits to importinfectioussubstancesaffectinghumansshouldbedirectedto:

DirectorPublicHealthAgencyofCanada130ColonnadeRoadOttawa,OntarioK1A0K9http://www.phac‐aspc.gc.ca

AcopyoftheapplicationforapermittoimportbiologicalagentsintoCanada,ortotransferbiologicalagents within Canada, must be provided to the University of Windsor’s Chemical Control Centre tofacilitatetheacquisitionprocess.Applicationscanbe locatedontheUniversityofWindsor’sBiologicalSafety Committee website (www.uwindsor.ca/biosafety). In addition, if you require assistance orclarification please contact the Chemical Control Centre at (519)253‐3000 ext. 3523 or by email atccc@uwindsor.ca.

Iftheagentcanalsoimpactanimals,youmayrequireanimportationcertificatefromtheCanadianFoodInspectionAgency.

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2.1.2 ImportationofbiologicalagentsaffectinganimalsTheHealthofAnimalsAct(1990)anditsRegulationsgivesAgricultureandAgri‐FoodCanada(AAFC)thelegislativeauthoritytocontrolthedistributionanduseofanypathogenwhichmaycauseinfectiousorcontagious disease in animals. This includes materials of animal origin which contain potentialpathogens. Inpracticalterms,thismeansthatAAFCapprovalmustbeobtainedfortheimportationofeveryanimalpathogen. In thecaseofpathogenswhichaffectbothhumansandanimals, importationpermitsarerequiredfrombothHealthCanadaandAAFC.IfanagentwasbroughtintoCanadaunderanimportpermitwhichrestrictsitsdistribution,furtherapprovalmustbeobtainedbeforetransferringittoanotherscientistorlaboratory.Recombinantorganismsandtheirreleaseintotheenvironmentmayalsobe restricted. AAFC will also establish the conditions under which the animal pathogens will bemaintained and thework will be carried out. It is necessary to consider not only the risk to humanhealth, but also the level of containment needed to prevent escape of an animal pathogen into theenvironmentwhereitmayconstitutearisktoanyindigenousanimalspecies.

Animal pathogens, including pathogenswhich affect both humans and animals, under the control ofAAFC,arelistedinadatabasemaintainedbytheAnimalandPlantHealthDirectorate,AAFC.This isadynamic listing which is continuously amended to include emerging pathogens that may requirerestriction.Animaldiseaseagentsconsideredasnot indigenoustoCanadaformaportionof thisdatabaseandareseverelyrestricted.Foreachanimalpathogen,AAFCmustbeconsultedforitsimportation,useanddistribution.Informationonthestatusofveterinarypathogensmaybeobtainedfrom:

AgricultureandAgri‐FoodCanadaAnimalHealthDivision59CamelotDriveNepean,OntarioK1A0Y9(613)952‐8000

Informationregardingveterinarypathogensandimportpermitsmaybeobtainedfrom:

CanadianFoodInspectionAgency59CamelotDriveNepean,OntarioK1A0Y9(613)225‐2342

AcopyoftheapplicationforapermittoimportbiologicalagentsintoCanada,ortotransferbiologicalagents within Canada, must be provided to the University of Windsor’s Chemical Control Centre tofacilitatetheacquisitionprocess.Applicationscanbe locatedontheUniversityofWindsor’sBiologicalSafety Committee website (www.uwindsor.ca/biosafety). In addition, if you require assistance orclarification please contact the Chemical Control Centre at (519)253‐3000 ext. 3523 or by email atccc@uwindsor.ca.

Iftheagentcanalsoimpacthumans,youmayrequireanimportationcertificatefromthePublicHealthAgencyofCanada.

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2.2 ExportRequirementsforBiologicalAgents

PermitsarerequiredfortheexportfromCanadaofcertainmicro‐organismsandassociatedequipment.Canadapresentlyimposescontrolsoncertaintoxicologicalandbiologicalagents,aswellastheirrelatedequipment,components,materialsandtechnologyunderitem2007oftheExportControlList.Forassistanceoradvice,contact:

ForeignAffairsandInternationalTradeCanadaExportControlDivisionLesterB.PearsonBuilding125SussexDriveOttawa,OntarioK1A0G2(613)996‐2387

AcopyoftheapplicationforapermittoexportbiologicalagentsfromCanadamustbeprovidedtotheUniversity ofWindsor’s Chemical Control Centre. In addition, if you require assistanceor clarificationpleasecontacttheChemicalControlCentreat(519)253‐3000ext.3523orbyemailatccc@uwindsor.ca.

2.3 TransportationofBiologicalAgents

Thecarefulhandling,transportandshipmentofdiagnosticspecimensandinfectiousagentsisabsolutelyessential if Canada is to maintain an effective health care system. Transportation methods mustminimizeriskstoemployeesofthecarrier,thepublicandthestaffofthereceivinglaboratory.Hazardsare compoundedby improperpackaging; abroken specimencontainermay lead to contaminationofboth laboratory and non‐laboratory personnel, and an improperly labelled package may be openedinadvertentlybysecretarial,clericalorotheruntrainedstaff.

InCanada,effectiveJuly1,1985,TransportCanadahasbecomeresponsibleforregulationsconcerningthe transportation of dangerous goods. Any person handling, offering for transport or transportingdangerous goods must comply with the Transportation of Dangerous Goods Act and Regulations,RegistrationSOR85‐77,asamendedin1994. InquiriesregardingtheseRegulationsshouldbedirectedto:

DirectorGeneralTransportofDangerousGoodsDirectorateTransportCanadaCanadaBuilding344SlaterStreet14thFloorOttawa,Ontario

13|P a g e

K1A0N5(613)998‐0517

Theefficientandsafetransferofinfectioussubstancesrequiresgoodco‐ordinationbetweenthesender,carrier,andreceivertoensuresafeandprompttransportandarrivalinpropercondition.Itisimportantthatthesendermakeadvancearrangementswiththecarrierandthereceivertoensurethatspecimenswillbeacceptedandpromptlyprocessed.Inaddition,thesendermustpreparetheappropriatedispatchdocumentsaccordingtotheTransportationofDangerousGoodsActandRegulations.Thesendershouldalsoforwardalltransportationdatatothereceiver.Noinfectioussubstancesshallbedispatchedbeforeadvancearrangementshavebeenmadebetweenthesender,thecarrierandthereceiver,orbeforethereceiverhasconfirmedwithnationalauthoritiesthatthesubstancecanbeimportedlegallyandthatnodelaywillbeincurredinthedeliveryoftheconsignmenttoitsdestination.

Informationcanbeobtainedfrom:

CanadianTransportEmergencyCentre(CANUTEC)(613)992‐4624(duringbusinesshours)(613)996‐6666(Emergencies:24hoursperday)

Under the Transportation of Dangerous Goods Act and Regulations, biological agents and micro‐organismsbelongingtoRiskGroups2,3,and4asidentifiedandlistedinLaboratoryBiosafetyGuidelinesand Section5.4of this document, are classedas "infectious substances" inDivision6.2.Very specificpackaginganddocumentationrequirementsmustbemetbeforesuchmaterialsmaybeshippedfromtheUniversityofWidnsor.Acertifiedpackagingsystem(Saf‐T‐Pak,orequivalent)suitableforthelegaltransportofan"infectioussubstance"mustbeused.RiskGroup1micro‐organismsarenotsubjecttotheseregulations.

OnlyindividualswhoarecertifiedintheTransportationofDangerousGoodsarelegallyabletopreparepackages and documentation for all dangerous goods, including biological agents. The University ofWindsor’sOfficeofOccupationalHealthandSafetyoffersTransportationofDangerousGoodsTrainingpleasecontactthembyphoneat(519)253‐3000ext.2055orvisittheirwebsiteformoreinformation(www.uwindsor.ca/safety).

Contact the University of Windsor’s Chemical Control Centre for assistance in the transportation ofbiologicalagentswithinRiskGroup2or3fromtheUniversityofWindsorbyphoneat(519)253‐3000ext.3523orbyemailatccc@uwindsor.ca.

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2.4 LaboratoryAnimals

All aspects of the proposed use of vertebrate animals in research & teaching and their associatedoperationalproceduresforthecareandmaintenanceofvertebrateanimalsmustsatisfytheGuidelinesfor the Care andUse of Experimental Animals of the Canadian Council onAnimal Care and the localanimal careauthority aswell as thismanual if theanimals areexposed toor infectedwithbiologicalagents, in order to ensure not only protection for laboratory personnel and the environment, but toensure that every care is taken to avoid causing the animals unnecessary pain or suffering and toprovidetheanimalswiththehighestqualitycare.

Under theOntarioAnimals forResearchAct, and itsRegulations, it is a requirement thatallPrincipalInvestigatorswhointendtoconductresearch,testingorteachingprojectsattheUniversityofWindsorthatinvolvetheuseofvertebrateanimals,mustobtaintheapprovaloftheUniversityofWindsorAnimalCare Committee before commencing the project. To obtain such approval, the Principal Investigatormust submit theUniversityofWindsorAnimalUseProtocol Formwhich is availableelectronically at:http://www.uwindsor.ca/acc

ThecompletedprotocolformmustbesignedbythePrincipalInvestigatorandshouldthenbesubmittedtotheEthics&GrantCoordinatoroftheAnimalCareCommitteeforreviewandapproval.

Ethics&GrantCoordinatorOfficeofResearchServices519.253.3000ext.3948acc@uwindsor.ca

2.5 WasteManagement

TheUniversityofWindsor isa largediverseworkplacewhichgeneratesmanykindsofhazardousandnon‐hazardouswaste.Thehandling,packaging,transportanddisposalofwasteinOntarioaregovernedby municipal, provincial and federal government legislation. To enable compliance with theseregulations, the University has developed programs, procedures and internal services focused onspecificwastecategories.

TheChemicalControlCentre’sEnvironmentalProtectionServiceshaspreparedaLaboratoryHazardousWasteManagementManualwhichconsolidatesexisting informationand identifiesproceduresforthepackaging,labellinganddisposalofbiological,chemical,radioactive,sharp,andotherhazardouswasteattheUniversityofWindsor.

AcopyofthisdocumentmaybeobtainedfromChemicalControlCentreat (519)253‐3000ext.3523,option#2.Anelectronicversion isavailableontheirwebsiteunderEnvironmentalProtectionServicesat:www.uwindsor.ca/ccc.

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2.5.1 LiquidWaste

Vacuum lines are commonly used to aspirate culture media and other cell culture reagents. Thistechniqueservesasaconduitthroughwhichairmayleavethelaboratory.Thesemustbeprotectedinamannercommensuratewith theotherairexhausts.Reusable filterholderswith replaceableelementsandsealeddisposablefiltercartridgesareavailableforthisapplication.

Laboratorywastecontaminatedwithorcontainingbiologicalagentsshouldbeautoclavedordisinfectedto inactivate the biological agents prior to disposal. Where on‐site functioning autoclaves (steamsterilizers)arenotavailableand theconventionaluseof chemicaldisinfectants for the inactivationofhazardous biological agents in laboratory waste is not practicable or not efficacious, other wastehandlinganddisposalmethodsmustbeconsidered.

2.5.2 SolidWaste

Reusable items such as glassware should be sterilized by autoclaving whenever this is possible.Otherwise, a specific chemical disinfection procedure, proven to be effective against the particularbiological agent, must be used. Disposable items that are contaminated with biological agents only,shouldbeincineratedormustbeautoclavedorchemicallydisinfectedbeforedisposal.Disposablesharpwaste(sharporpointed itemscapableofcausingpunctures,cuts,ortears inskinormucousmembranes and including hypodermic, surgical, suture, or IV needles, syringeswith needles,lancets,scalpelsandblades)mustbecarefullycollectedinapuncture‐resistantwastecontainer.Thesecontainers are available from either the Chemical Control Centre or the Department of BiologicalSciencesStockroom.Needlesandbladesfordisposalmustbecollected inadesignated,puncture‐resistantcontainer.Afterautoclaving,ifrequired,thefilledcontainerofneedlesandbladesmustbeplacedintoayellowplastic20 litre broken glass and/or sharps pail that are provided for the collection of broken and intactglasswarefordisposal.Intact and broken glassware for disposal must be collected in puncture‐resistant containers. Yellowplastic20litrepailsareprovidedforthispurpose.Ifthematerialcollectedinthewastecontaineriscontaminatedwithviablehazardousbiologicalagents,the waste must be decontaminated, preferably by autoclaving, to inactivate the biological agents.Chemicaldisinfectionofsharpwasteisgenerallynotrecommendedsinceitrequiresadditionalhandling.Disposable non‐sharp items (gloves, empty plastic culture dishes, flasks and tubes, absorbent tissue,etc.) that are contaminated with biological agents must be collected in autoclavable bags. Afterautoclavingandcooling,thesebagsofwastemustbeplacedintoblackplasticgarbagebagsfordisposal.

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Hazardous chemical and radioactive solid wastes may require an additional procedure to inactivateviable biological agents that may be present, before removal from the laboratory. Autoclaving isgenerallynotrecommendedinallsituationsinvolvingsuchwastes,sincethehightemperature,steamandpressuremaycontributetopotentiallyhazardousreactions.

Toprovideanotheralternative,theUniversityofWindsorhasnegotiatedacontractwithacommercialfirmwhich is licensed to remove and transport biologically contaminated ("pathological") laboratorywastetoadesignateddisposalsite.Specificpackagingofwasteandspecialdocumentationisrequired.

Formoreinformation,contacttheHazardousMaterialsTechnicianChemicalControlCentre–EnvironmentalProtectionServices(519)253‐3000ext.3523,option#2.

It is dangerous and illegal to dispose of hazardous chemicals and radioactive materials in theregulargarbagegoingtolandfill.

Guide to Waste Management – Solid Waste Disposal –

NoN-hazarDouS WaSte aND recyclableS - housekeepingN o N - h a z a r D o u S W a S t e

reGular WaSte (Garbage)

Secondary container: black garbage bag

acceptable: •Allnon-hazardouscommercialsolidwaste

Prohibited: Chemicals,biologicallyactivematerial,brokenglass,and

sharpswaste

broKeN GlaSS WaSte

SecondaryContainer:Yellow-“BrokenGlass”

acceptable: •Brokenlabglass •Disposableglasspipettes •Glassbottles

Prohibited: Paper,hazardousmaterial,andgarbage

SharPS WaSte

Secondary containers: ApprovedPlastic“SharpsContainers” Do Not oVerFIll

acceptable: •Syringeneedle,scalpelblades,razorbladeswhich

havenotbeenusedwithbiologicalmaterials

Prohibited: Paper,hazardousmaterial,biologicalhazardouswaste

and garbage

r e c y c l a b l e S

PaPer

SecondaryContainer:“Bluebox”

acceptable: •Paper, •Newsprint, •Corrugatedcardboard

Prohibited: Plastics(e.g.overheads),foodwrappers,papertowels

andcups,facialtissue,blueprints,spiralandlargemetal clip bound books

beVeraGe coNtaINerS

Secondary container: “MetalCansandPlasticPopBottlesOnly”

acceptable: •Allfoodandbeveragecans

Prohibited: Chemicalcontainers,paintcans,metallidsfromglassor

plastic containers

cautIoN:

Pleaseensurethatallmaterialsareproperlysegregatedtomaintainthecontinuedsafetyofourstaffandtheenvironment.

Ifyoubelievethatwasteisimproperlysegregated,pleasecontactyoursupervisor,theChemicalControlCentreorOccupationalHealthandSafety(ext.2055).

HAZARDOUSWASTE-ChemicalControlCentreFormoreinformationonbiological,chemicalorradioactivewastecollectionanddisposalpleasecallthe ChemicalControlCentre(ext.3523).NOTCOLLECTEDBYHOUSEKEEPING.

cheMIcal WaSte

SecondaryContainers:Approvedchemicalwastecontainers,whichareprovidedfree-of-chargefromtheChemicalcontrol center.

PrincipleInvestigatorsand/orDepartmentsareresponsibleforarrangingdisposalbytheChemicalControlCentre.Itisillegaltodisposeanychemicaldowneitheradrainorbyplacingmaterialwithinthegarbage.

raDIoactIVe WaSte

SecondaryContainers:Approved“RADIOACTIVE”wastecontainers,providedfree-of-chargefromtheChemicalcontrol center.

PrincipleInvestigatorsand/orDepartmentsareresponsibleforarrangingdisposalbytheChemicalControlCentre.

bIoloGIcal WaSte

SecondaryContainers:“BIOHAZARDOUS”bagsand/or “BIOHAZARDOUS”sharpscontainer.

acceptable: •Medicalwaste(bloodorbodyfluids) •Contaminatedplasticsandgloves •Animaltissues,etc. •Sharpscontainerswithneedles,etc.

Mustbesterilizedorchemicallydecontaminatedtorenderthewastenon-hazardous.Thetreatedwastemustbeappropriatelylabeled“non-hazardous”andthencanbedisposedofasregularwaste.

coNtaMINateD artIcleS

ArrangefordisposalbytheChemicalControlCentre.

IN caSe oF caMPuS eMerGeNcyDIal ext. 4444

( 5 1 9 - 2 5 3 - 3 0 0 0 E x T . 4 4 4 4 )

Phone:519-253-3000Ext.3523•E-mail:ccc@uwindsor.ca•Web:www.uwindsor.ca/cccLocation:EssexHall/B-37•Hours:8:30amto4:30pm(M-F)

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19|P a g e

2.6 Autoclaves/Steamsterilizers

Autoclaves/steamsterilizerswhichhavesteaminthepipingatapressureof15psi(poundspersquareinch)orhigherarecoveredbyChapterB9oftheBoilersandPressureVesselsActofOntario.

ThisequipmentshouldhaveavalidcertificateofoperationissuedbyaBoilerInspectorholdingavalidCertificateofCompetency.Generally, inOntariothisservice isprovidedbythe InsurerwhichprovidesBoiler and Machinery Insurance coverage. The University of Windsor has such insurance coveragethroughCURIE,aninsurancebroker.

Everyautoclavemustbe inspectedat the timeof installationandshouldhaveavalidcertificate fromTSSA(TechnicalSafetyandStandardsAuthority)ofOntario.

Aftertheinitialinstallation,thisequipmentistobeinspectedannuallybyaBoilerInspector.Thescopeofinspectionwillincludeavisualinspection,areviewoftheconditionsofoperationandtheprotectivedevicessuchasthepressurereliefvalves,temperaturecontrols(ifany),steamqualitycontrol,andthemeasures being taken by the user for its safe and efficient operation as required by the Boilers andPressureVesselsActofOntario.

Upon satisfactory completion of the inspection, a certificate of inspection will be issued which willauthorize operation of the equipment. The user should not operate any sterilizer which has steamheating coilswith apressureof 15psi orhigherwithout a valid certificateofoperation. ThepersonsresponsiblefortheoperationshouldbefullyfamiliarwiththerequirementsoftheBoilersandPressureVesselsActofOntario.

TheUniversity’s insurermaintains a list indicating the locationsof autoclaves.Annual inspections areperformedautomatically,accordingtothis list. Ifyouhavereceivedanewautoclaveorareusingonethathasnotbeen inspectedduringtheprevious12months,pleasenotify theUniversityofWindsor’sDepartmentof Finance (Attn:Manager ‐RiskManagement& Insurance)andprovide the informationnecessary to have this equipment added to the equipment list so that the required inspections arescheduledandperformedinfuture.

Forautoclaveinspectionservicesorinformationcontact:

UniversityofWindsorDepartmentofFinance(519)253–3000ext.2080

Autoclave Standard Operating Procedures

Temperature: 121°C Pressure: 15psi Time: 30 minutes

• Waste should be placed with in a biohazard bag with autoclave indicator tape attached

• Place bag in the steel pan and then into the chamber

• Close and seal the door, and “Start” the cycle

• Once the cycle is complete carefully open the door taking care to avoid the steam

• Use autoclave gloves to remove autoclaved materials and check sterilization tape (see Validation Verification)

• Place “Treated” sticker on bag and throw in the garbage

Temperature: 121°C Pressure: 15psi Time: 20 minutes and 15 minutes for drying

• Attach autoclave tape to all labware that will be sterilized

• Neatly stack labware leaving space between the stacks to assure proper sterilization

• Close and seal the door, and “Start” the cycle

• Once the cycle is complete carefully open the door taking care to avoid the steam

• Use autoclave gloves to remove autoclaved materials and check sterilization tape (see Validation Verification)

Temperature: 121°C Pressure: 15psi Time: 20 minutes

• Always place containers in chamber, with autoclave tape attached (Container should never be more than 50% full)

• A tray must be used to avoid spilling liquid into the chamber.

• Close and seal the door, and “Start” the cycle

• Once the cycle is complete carefully open the door taking care to avoid the steam

• Use autoclave gloves to remove autoclaved materials and check sterilization tape (see Validation Verification)

• Autoclave tape indicators confirm that an item has been exposed to the stem sterilization process but does not indicate that the process was sufficient to achieve sterility

• Weekly Biological Indicator tests need to be run by technicians to verify that the autoclave is functioning properly. Should this test fail, there will be an “Out of Service” sign until a contractor has serviced the autoclave.

• Document waste stream as per University of Windsor Steam Sterilization Guidelines

• Autoclaves are subject to annual TSSA inspection

• Using a 5% bleach solution, encircle the spill

• Use gloves and move the bleach in towards the spill with paper towels

• Let sit for 2 minutes then wipe up

For more information visit www.uwindsor.ca/biosafety

IN CASE OF CAmPUS EmErgENCyDIAL ExT. 4444

( 5 1 9 - 2 5 3 - 3 0 0 0 E x T . 4 4 4 4 )

Phone: 519-253-3000, Ext. 3523 • E-mail: ccc@uwindsor.ca • Web: www.uwindsor.ca/cccLocation: Essex Hall / B-37 • Hours: 8:30 am to 4:30 pm (m-F)

Biohazardous Waste Treatment

Sample Treated Label

Pipet Tips & Labware Sterilization

Culture media & Solutions Sterilization

Validation Verification

Spill Control

Anyone using the autoclave must first be trained by a University Technician. refresher training is required once a year.

Liquids can become super saturated causing them

to boil over.

remove all items carefully!

Biological SafetyProgram

U N I V E R S I T Y O F W I N D S O R

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2.7 FumehoodsFume hoods should be tested by qualified personnel in accordancewith CSA Standard Z316.5‐94, orequivalent. TheUniversity ofWindsor’s FumeHood Standard is available from theChemical ControlCentre’sLaboratorySafety,Assurance,andCompliancewebsiteatwww.uwindsor.ca/ccc.TheChemicalControlCentre’sLaboratorySafety,Assurance,andCompliancegroupaudits fumehoodperformanceworksincollaborationwithFacilitiesServicestorecalibratetheairflowtomeetoperationalrequirementsonanannualbasis.Toreportfumehoodmalfunctionsorifyourequiremoreinformation,contact:

FacilitiesServicesHeating&Cooling‐EnergyConversionCentre(ECC)(519)253–3000ext.7027orChemicalControlCentreLaboratorySafety,Assurance,andCompliance(519)253–3000ext.3523,option#4

2.8 BiologicalSafetyCabinets:AssessmentandTestingThe purpose of an air exhaust system is to remove contaminated air from awork area, to convey itthrough a decontaminating system if necessary, and to discharge it to the outside. Its design shouldprovideadequateairexchanges,anegativepressuredifferentialbetweentheroomandtheairsourcetoensurethatcontaminatedairdepartsonlythroughtheexhaustsystem,andairflowpatternsthroughtheroomsothatallpartsoftheroomaresweptbytheairflow.Theinfluenceofopeningandclosingdoors on these air flowpatterns is of particular importance.Decontamination of air is best achievedwithahighefficiencyparticulateair(HEPA)filter.HEPAfiltersareineffectiveunlessproperlyinstalled.Testing of these filters in situ with an aerosol at the time of installation and at regular intervals isessential to ensure the integrity of the barrier. Normally, HEPA filters will require replacement onlywhentheyofferexcessiveresistancetoairflowduetoloadingorwhenirreparableleaksaredetected.Biological safety cabinets, when properly used in research and teaching activities involving themanipulationofhazardousbiologicalagents,areeffectiveincontainingandcontrollingparticulatesandaerosolsandcomplementgoodlaboratorypracticesandprocedures.

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BiologicalsafetycabinetsusedinlaboratoryactivitiesrequiringContainmentLevel2or3conditionsattheUniversityofWindsormustbe inspected, testedandapproved foruseannually,unlessotherwisenoted, by trained service personnel to ensure that the cabinet is functioning as intended by themanufacturer.Inspectionandtestingismandatoryifabiologicalsafetycabinetisrelocated.Movesofaminornature(i.e.withinthesameroom)maybeexemptfromthisrequirementifthemoveisobservedbythetestingtechnologistandthecabinethasnotbeensubjectedtoexcessivestressorroughhandlingwhichcouldresultindamage.The routine decontamination and testing of used Class II biological safety cabinets shall include thefollowing required procedures and tests which shall be conducted in accordance with, and in themannerdescribedbelow.

2.8.1 TestingservicesThetestingofbiologicalsafetycabinetsattheUniversity isconductedbyanexternalcontractor.FeesforthisservicearechargedtothePrincipalInvestigator/researcheror,inthecaseofteaching,totheinstructor'sdepartment.TheUniversityofWindsor’sChemicalControlCentrecoordinatestheannualtesting,servicingorrepairofallbiologicalsafetycabinetsoncampus.

2.8.2 RequiredproceduresandtestsDecontaminationCabinet decontamination with paraformaldehyde vapour shall be conducted prior to the testing ofbiologicalsafetycabinetswhichhavebeenusedforactivitiesinvolvingbiologicalagentsassignedtotheRisk Groups identified by Health Canada. The biological safety cabinet shall be sealed anddecontaminatedusingtheparaformaldehydevapourtechniquewhichisdescribedinNSFStandard49,and cited inCSAZ316.3‐95,or anequivalentprocedureacceptable to theUniversityofWindsor. Theparaformaldehyde holding / contact time shall be a minimum of 2 hours, after which theparaformaldehydevapourshallbeneutralizedorventedtotheexteriorofthebuilding.ContainmentSystemIntegrityContainment system integrity (pressure) testing shall be performed on all biological safety cabinetshaving air plenums which convey potentially contaminated air at positive pressure and where anyportionoftheseplenumsalsoformspartofthecontainmentshellofthecabinet.Thecabinet interiorshallbepressurizedwithair toadifferentialpressureof2"w.g.A liquid leakdetectorshallbeappliedalong allwelds, gaskets, penetrations, and seals on the exterior surfaces of the cabinet air plenums.Leakagewillbeindicatedbythepresenceofbubblesorbythefeelorsoundofescapingair.Detectedleakage shall be corrected using acceptable methods and materials and the repaired area shall beretestedtoconfirmthesuccessofthecorrectiveaction.Note:Theperformanceofthistestisrequired

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atthetimeof initialcabinet installation,followingcabinetrelocation,andat leastonce ineverythreeyearperiod.AirVelocitiesandVolumesAir velocities shall bemeasured atmultiple points on a grid, across the face of theHEPA filters. Thelocationandspacingoftheco‐ordinatesshallbeaccordingtothemanufacturer'srecommendationsand/orapplicablestandards.Additionalairvelocitymeasurementsmayberequiredbythemanufacturerofthecabinet.Theblowerspeedandairdampersshallbeadjustedasrequiredsothatthefinalmeasuredandcalculatedvaluesarewithintheacceptablerangesindicatedbythemanufacturerofthebiologicalsafetycabinet.HEPAFilterIntegrityHEPAfilterleaktestingshallbeperformedusingsufficientdioctylphthalate(DOP)aerosol(orequivalent)tochallenge theair filtrationsystem.Theaerosol concentrationupstreamof theHEPA filters shallbesampledandusedas the100%reference forphotometeradjustmentprior to testing.AllairdiffusersandprotectivegrillesdownstreamofHEPAfiltersshallberemovedtoallowdirectaccesstotheentirefilter surface and perimeter (bond area, gasket, filter frame, and mounting frame) which shall bescannedinoverlappingstrokesatatraverserateofnotmorethan2"persecond.Aerosolpenetrationexceeding0.01%of theupstreamconcentrationshallbesealedorcorrectedusinggenerallyacceptedmethodsandtherepairedareashallberetestedtoconfirmthesuccessofthecorrectiveaction.AirflowSmokePatternsThese tests shall be performed using a source of visible smoke to demonstrate the acceptability ofairflowsassociatedwiththebiologicalsafetycabinet:

(a) DownflowSupplyAirDistributionThe source of visible smoke shall be passed along the ('smoke split') centreline of the worksurface,fromonesideoftheworkspacetotheother.Thesmokeshallshowsmoothflowwithnodeadspotsorupwardflow.Nosmokeshallescapefromthecabinet.(b) SupplyAirEntrainment/ViewScreenRetentionThesourceofvisiblesmokeshallbepassedfromonesideofthecabinettotheother,behindthe view screen, and 6" above the top of the front access opening. The smoke shall showsmoothdownward flowwithnodead spotsorupward flow.No smoke shall escape from thecabinet.(c) IntakeAirEntrainment/WorkAccessOpeningRetentionThesourceofvisiblesmokeshallbepassedalongtheentireworkaccessperimeter,about1.5"outside of the workspace of the cabinet. No smoke shall escape from the cabinet once it is

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drawnin.ForClassIIcabinets,nosmokeshallpassovertheworksurfaceorpenetratetheworkzone.(d) WindowSealThesourceofvisiblesmokeshallbepassedalongtheperimeteroftheviewscreen,insidetheworkspaceofthecabinet.Nosmokeshallescapefromthecabinet.

OtherProceduresandTestsOtherproceduresandtests(electricalsafety,fluorescentandUVlightingintensity,vibration,noiselevel,etc.)mayberecommendedorperformed,dependingonthecabinetdesignandthecircumstancesofitsinstallationandusage,buttheirperformanceisnotrequiredonaroutinebasis.

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3 BIOLOGICALSAFETYPRACTICESANDPROCEDURES

3.1 GeneralLaboratorySafetyPractices

Thefollowingrequirementsarebasicforanylaboratoryusinghazardousbiologicalortoxicagents:

1. All laboratory personnel and otherswhosework requires them to enter the laboratorymustunderstand the chemical and biological hazards withwhich theywill come in contact duringtheir normal work in the laboratory, and be trained in appropriate safety precautions andprocedures.Astandardoperatingprocedure (SOP)mustbepreparedoradopted forusewithbiological agents. It is the responsibility of the principal investigator and/or laboratorysupervisortoensurethat it identifiesknownandpotentialbiologicalhazardsandspecifiesthepractices and procedures to eliminate or minimize such risks. The SOP must contain anemergency response plan. Personnel must be required to know, understand, and followstandard practices and procedures. Training in laboratory safety shall be provided by thelaboratory director / principal investigator and competence in safe technique must bedemonstratedbeforeworkisallowedwithhazardousagentsortoxicmaterial.

2. Thelaboratorymustbekeptneat,orderlyandclean,andstorageofmaterialsnotpertinenttotheworkmustbeminimized.

3. Protectivelaboratoryclothing(uniforms,coats,gowns)mustbeavailable,andwornproperlyfastenedbyallpersonnelincludingvisitors,trainees,andothersenteringorworkinginthelaboratory.Protectivelaboratoryclothingmustnotbeworninnon‐laboratoryareas.

4. Suitablefootwearwithclosedtoesandheelsandpreferablywithnon‐slipsolesmustbeworninalllaboratoryareas.

5. Glovesmustbewornforallproceduresthatmightinvolvedirectskincontactwithtoxins,blood,infectiousmaterialsorinfectedanimals.Ringsorhandjewellerywhichinterferewithgloveusemust be removed before gloving. The wearing of jewellery in the laboratory should bediscouraged. Gloves must be removed carefully and decontaminated with other laboratorywastes before disposal. Reusable gloves (e.g. insulated, chemical resistant, etc.)may be usedwherenecessaryandmustbeappropriatelydecontaminatedafteruse.

6. Faceandeyeprotection(e.g.,glasses,goggles,faceshields,orotherprotectivedevices)mustbewornwhennecessarytoprotectthefaceandeyesfromsplashes,impactingobjects,harmfulsubstances,UVlight,orotherrays.

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7. Eating,drinking,smoking,storingfoodorutensils,applyingcosmetics,andinsertingorremovingcontactlensesarenotpermittedinanylaboratoryworkarea.Contactlensesarenotprotectivedevices, and must be used only in conjunction with appropriate protective eyewear in eyehazardareas.

8. Oralpipettingisprohibitedinanylaboratory.

9. Longhairmustbetiedbackorrestrained.

10. Hands must be washed after gloves are removed, before leaving the laboratory, and afterhandlingmaterialsknownorsuspectedtobecontaminated,evenwhengloveshavebeenworn.

11. Work surfacesmust be cleaned anddecontaminatedwith the appropriatedisinfectant at theend of the day and after any spill of potentially hazardous material. Loose or cracked worksurfacesmustberepairedorreplaced.

12. All technical procedures must be performed in a manner that minimizes the creation ofaerosols.

13. Allcontaminatedorinfectiousliquidorsolidmaterialsmustbedecontaminatedbeforedisposalorreuse.Contaminatedmaterialsthataretobeautoclavedorincineratedatasiteawayfromthe laboratory must be double‐bagged or placed into containers, the outsides of which aredisinfected.

14. Access to Level 1 and 2 laboratories must be at the discretion of the laboratory director /principal investigator (e.g. only personswho have been advised of the potential hazards andmeet any specific entry requirements such as immunization should be allowed to enter thelaboratoryarea).Personsundertheageof16yearsshouldnotbepermittedinthelaboratoryorsupport areas. Pregnantwomen and immunocompromised peoplewhowork in or enter thelaboratorymustbeadvisedoftheassociatedrisks.

15. Hazardwarningsigns,indicatingthecontainmentlevelortheriskgroupoftheagentused,mustbe posted outside each laboratory operating at Containment Level 2. Where the infectiousagentusedinthelaboratoryrequiresspecialprovisionsforentry,therelevantinformationmustbe included in thedoor sign. The agent(s)must be identified in the informationprovided forsigningalongwiththenamesofthelaboratorysupervisorandotherresponsibleperson(s),andanyspecialconditionsforstaffentry.

16. Theuseofneedlesandsyringesandother sharpobjectsmustbestrictly limited.Hypodermicneedles and syringesmust beusedonly for parenteral injection andaspirationof fluids from

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laboratory animals and diaphragm bottles. Extreme caution must be used when handlingneedles and syringes to avoid autoinoculation and the generation of aerosols during use anddisposal.Needlesmustnotbebentor sheared.Disposableneedlesand syringesmustnotbereplaced in their sheath or guard. They must be placed into a puncture‐resistant yellowcontainer and autoclaved, if contaminated, before disposal, or incinerated. Sharps containersareavailableatboththeBiologicalSciencesStockroomandChemicalControlCentre.

17. Allspills,accidents(needlesticks,punctures,cuts,etc.)andovertorpotentialexposuresmustbereported inwriting to the laboratory supervisor or acting alternate as soon as circumstancespermit.ThispersonmustfilethisreportwiththeUniversityofWindsor,OfficeofOccupationalHealth& Safety.Appropriatemedical evaluation, surveillance, and treatmentmust be soughtandprovidedasrequired.Actionstakentopreventfutureoccurrencesshouldbedocumented.

18. Baseline serum or other specimens shall be collected from laboratory and other at‐riskpersonnelandstoredwhendeemednecessary.Additional serumspecimensmaybecollectedperiodically, depending on the agent handled or the function of the facility. Baseline andperiodic serum or other specimens shall be collected and maintained by the University'sOccupationalHealthServiceoranequivalenthealthservice.Confidentialitywillbemaintainedaccording to the legal obligations of the Regulated Health Disciplines Act, or its subsequentrevision.Testswillnotbeperformedwithouttheinformedconsentofthedonor.

19. Laboratoryworkersshouldbeprotectedbyappropriateimmunizationwherepossible.Levelsofantibody considered to be effective should be documented. Appropriate immunization orevidenceofexposureshouldbemaintainedinaconfidentialmanner.Particularattentionmustbegiventoindividualswhoareormaybecomeimmunocompromised,asvaccineadministrationmaybedifferentthanforimmunologicallycompetentadults.

3.2 WorkingwithLaboratoryAnimals

Animalscanharbourinfectiousorganismswhichareacquirednaturally.Someinfectiousagentscangiverisetoachroniccarrierstate,oranagentmightbeshed intermittently. If thepossibility thatsuchanagentmay be excreted, secreted, exhaled or shed by an animal during the course of an experimentcannotbeexcluded,thenallthoseanimalsshouldbekeptatthecontainmentlevelappropriatetotherisk.

For more information on various types of safety equipment use in preventing infection from biological

agents,pleaserefertoAppendixC–SafetyEquipment

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Animalsmay also be intentionally inoculatedwith viruses or other organisms in any of the four RiskGroupsorwith viablematerials (e.g., transformed cells) suspectedof containing these agents.Underthesecircumstances,theanimalsshouldbekeptatthecontainmentlevelappropriatetotheriskoftheagent,recognizingthatinsomecases,invivoworkmayincreasethatrisk.

Naturally occurringor experimentally induced infections in laboratory animalsmaybe transmitted toother laboratory animals, invertebrates and laboratory workers. Laboratory animals and insectsmayscratchorbiteormaybethesourceofanaerosol.Besidestheriskfromaninfectionthattheanimalorinsectmaybeharbouring,thereisalsoariskthatsomeofthematerialbeinginjectedmayadheretothefurorexoskeletonandremainasapotentialhazard.

In all situations, it is the responsibility of the principal investigator, laboratory supervisor and theUniversityofWindsor’sBiologicalSafetyCommittee,inconsultationwithGovernmentagenciesandtheanimalcareauthorities,todeterminetherisklevelsinherentintheproposedactivity.

Therequirementsforthemaintenanceofanimalsmaydifferinscaleanddegree,butthebasicprinciplesformicrobiological safetywill be similar to those outlined in Section 3.1 ‐ General Laboratory SafetyPracticesandshouldincludethefollowingprecautions.

1. Infectedanimalsandinsectsshouldbesegregatedfromuninfectedanimalswhereverpossible,anditispreferabletoseparateanyhandlingareafromtheholdingarea.

2. Animalsorinsectsinuseinanexperimentmustbemaintainedatalevelofcontainmentthatisat least equivalent to the containment level for the biological agent with which it has beeninfectedortreated.

3. Provisionmustbemadetoensurethatinoculatedanimalsorinsectscannotescape.

4. Deadanimalsor insectsandtherefuse fromtheanimal roomandcages (e.g.bedding, faecesandfood)mustbeplacedinaleakproofcontainerandautoclavedorincinerated.

5. All cages must be properly labelled, and procedures in the holding area must minimize thedispersalofdanderanddustfromtheanimalsandcagerefuse.

6. Protectiveclothing,includingscratch/biteresistantgloves,eyeprotection,appropriatechemicalrestraint and proper handling equipment are recommended for the handling of non‐humanprimates.

7. Disposable latex gloves should beworn by animal care providerswhile feeding andwateringanimalsorcleaningcages.

8. Non‐disposablegloves,boots,floors,wallsandcageracksshouldbedisinfectedfrequently.

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Inadditiontothepreceding,thefollowingmustalsobesatisfied:

9. All aspects of the proposed use of animals in research & teaching must meet the currentveterinarystandardsandregulationsforthecareandmaintenanceofexperimentalanimalsasdescribed by the Canadian Council on Animal Care, relevant provincial legislation, and localanimalcareauthorities.

10. Theappropriatespeciesmustbeselectedfortheanimalexperiments.

11. Theinvestigatorand/orperson(s)responsiblefortheanimalexperimentmustensurethatallthosehavingcontactwiththeanimalsandwastematerialsarefamiliarwithandawareofanyspecialprecautionsandproceduresthatmayberequired.Wherepossible,personnelshouldbeprotectedbyimmunizationwithappropriatevaccines.

12. Allincidents,includinganimalbitesandscratchesorcutsfromcagesorotherequipmentmustbedocumentedandtheemployeeshouldreporttotheOccupationalHealthServiceformedicalassessmentandfollow‐up.

13. Small laboratory rodentsorother small animals thatescape fromtheir cages shouldbekilledwhencaptured,theircarcassesincinerated,andtheareashouldbethoroughlydecontaminated.In theevent thatanimalsescapethroughthecontainmentperimeter, therelevantauthoritiesmustbenotifiedpromptlyandappropriateactioninitiated.

Unexpected illness or deaths among animalsmust be reported to the principal investigator and theveterinarian, who will be responsible for final disposition. Animals should not be touched untilinstructionsaregivenbytheperson‐in‐charge.

3.3 WorkingwithHumanPathogens

Some micro‐organisms (viruses, bacteria, fungi, etc.) are species specific, selectively infecting andcausingdiseaseinalimitednumberof,oronlyone,hostspecies.Unrelatedanddistantlyrelatedspeciesmaynotbesimilarlyaffectedbythesame infectiousmicro‐organismduetodifferences inphysiology,metabolism,biochemistry,etc. Ingeneral,therisktoa laboratorytechnicianworkingwithavirusthatonlyinfectsandcausesdiseaseinrodentsislowerthantherisktoalaboratorytechnicianworkingwithtissuesandcells fromhumansorotherprimates. If thehumanmaterialcontainsaviablepathogen, itwilllikelybeahumanpathogen,withthepotentialtoinfectandcausediseaseinanotherhuman.

Although a single mode of transmission may predominate, disease causing micro‐organisms can bespread or transmitted from one host to the next, directly or indirectly, by a number of methods,includingaerosolgenerationandinhalation,ingestionofcontaminatedfoodandwater,skinandmucous

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membranecontactwithcontaminatedsurfaces,contactcontaminationofanopenwoundorlesion,andautoinoculationviaacut,lacerationorpuncturewithacontaminatedinstrument.

3.3.1 HumanBloodbornePathogensHumanbloodisrecognizedasapotentialsourceofpathogenicmicro‐organismsthatmaypresentarisktoworkerswhoareexposedduringtheperformanceoftheirduties.AlthoughthehepatitisBvirus(HBV)andthehumanimmunodeficiencyvirus(HIV)areoftencitedasexamples,a"bloodbornepathogen"isanypathogenicmicro‐organismthatispresentinhumanbloodorotherpotentiallyinfectiousmaterialsandthatcaninfectandcausediseaseinpersonswhoareexposedtobloodcontainingthispathogen.

"Otherpotentiallyinfectiousmaterials"meansmaterialwhichhasthepotentialtotransmitbloodbornepathogens. This includes infected human tissues and the following body fluids: semen, vaginalsecretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, amnioticfluid,salivaindentalprocedures,andanyotherbodyfluidthatisvisiblycontaminatedwithblood.

Thebiosafetyrequirementsidentifiedforresearch&teachinglaboratoriesmaynotalwaysbeapplicabletoallworkplace settingswhereworkershandleorareexposed tohumanblood,body fluidsorothermaterialspotentiallycontainingbiologicalagents.

Between 1982 and 1988, the Centers for Disease Control (Atlanta, Georgia) published a series ofrecommendations and precautions for the protection of healthcare workers (physicians, nurses,phlebotomists,dentists, laboratoryworkers,etc.)whohave,orare likelytohave,contactwithhumanbloodandcertainbodyfluidsandmaybeatriskofexposuretobloodbornepathogenssuchashepatitisB virus (HBV) and human immunodeficiency virus (HIV). These recommendations became known as"UniversalBloodandBodyFluidPrecautions"orsimply,"UniversalPrecautions".

3.3.2 UniversalBloodandBodyFluidPrecautionsThepossibilityofundiagnosed infectioncombinedwith the increasingprevalenceofHBVandHIV ledtheCenterforDiseaseControl(Atlanta,Georgia)torecommendthatbloodandcertainotherbodyfluidsfromallhumansbeconsideredpotentiallyinfectiousandthatprecautionsbetakentominimizetheriskofexposure.Thisapproach,called"UniversalPrecautions",isamethodofinfectioncontrol,intendedtoprevent parenteral, mucous membrane, and non‐intact skin exposure of workers to bloodbornepathogens.Allhumanblood,certainhumanbodyfluids,andothermaterialsareconsideredpotentiallyinfectious for hepatitis B virus (HBV), human immunodeficiency virus (HIV), and other bloodbornepathogens.Precautionsmustbeconsistentlyused.

Body fluids to which universal precautions apply include blood, body fluids containing visible blood,semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardialfluid,andamnioticfluid.

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Universalprecautionsgenerallydonotapplytofaeces,breastmilk,nasalsecretions,sputumandsaliva,sweat, tears, urine, and vomitus unless they contain visible blood. Although thesematerials are notimplicated inthetransmissionofbloodbornepathogens, it isprudenttominimizenon‐intactskinandmucousmembranecontactwiththesematerials.

HepatitisBimmunizationisrecommendedasanadjuncttouniversalprecautionsforworkerswhohaveoccupational exposure tohumanbloodorotherpotentially infectiousmaterials. This immunization isprovidedtoemployeesatriskisperformedbytheemployee’spersonalphysicianandiscoveredbytheUniversityofWindsor’sextendedhealthplan. Individualswhodonothaveextendedhealth coveragewillbereimbursedbytheUniversityofWindsortofacilitateimmunization.

Inthehospitalsetting,HBVimmunizationisrecommendedforpersonnelintheseoccupationalgroups:medical technologists, operating room staff, phlebotomists and intravenous therapynurses, surgeonsandpathologists,dialysisunitstaff,emergencyroomstaff,nursingpersonnel,physicians,andstudentsinschoolsofmedicine,dentistry,nursing,laboratorytechnologyandotheralliedhealthprofessions.

Outsidethehospitalsetting,HBVimmunizationisrecommendedforhealthcareworkerswhomayhaveexposure to human blood and other potentially infectious materials, such as dental professionals,laboratoryandbloodbanktechnicians,dialysiscentrestaff,emergencymedicaltechnicians,morticians,workers in clinical / diagnostic laboratories, andworkers in research& teaching facilities that study,produceormanipulatehumanbloodwhichmaycontainHBVandHIV.

GeneralPrecautions

Allworkers should routinely use appropriate barrier precautions to prevent skin andmucousmembraneexposurewhencontactwithhumanbloodorotherbodyfluidsisanticipated.

Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses areprohibited.

Glovesshouldbewornwhentouchingbloodandbodyfluids,mucousmembranes,ornon‐intactskin, for handling items or surfaces soiled with blood or body fluids, and for performingvenipunctureandothervascularaccessprocedures.Ifagloveistornordamagedduringuse,itshould be removed and a new glove used as promptly as safety permits. Disposable glovesshould not be washed or disinfected for reuse. Washing with surfactants may enhancepenetration of liquids through undetected holes in the glove. Disinfecting agents may causedeteriorationoftheglovematerial.

Masksandprotectiveeyewearorfaceshieldsshouldbewornduringproceduresthatarelikelytogeneratedropletsofbloodorotherbodyfluidstopreventexposureofmucousmembranesofthemouth,nose,andeyes.

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Gownsorapronsshouldbewornduringproceduresthatarelikelytogeneratesplashesofbloodorotherbodyfluids.Protectiveclothingshouldberemovedbeforeleavingthearea.

Handsandotherskinsurfacesshouldbewashed immediatelyandthoroughly ifcontaminatedwithbloodorotherbodyfluids.Handsshouldbewashedimmediatelyafterglovesareremovedsince no barrier is 100% effective. Alternatively, the University ofWindsor’s Biological SafetyProgram provides Hand Sanitizer stations in all BSL‐1 and BSL‐2 facilities to be used in thedecontaminationofhandsandotherskinsurfaces.

Workers should take precautions to prevent injuries caused by needles, scalpels, and othersharp instruments or devices during procedures, when cleaning used instruments, duringdisposalofusedneedles,andwhenhandlingsharpinstrumentsafterprocedures.Needlesandsyringes should be used only in those situations when there is no alternative. To preventneedlestick injuries, needles should not be recapped, purposely bent or broken by hand,removed from disposable syringes, or otherwise manipulated by hand. After they are used,disposable syringes and needles, scalpel blades, and other sharp items should be placed inpuncture‐resistantcontainers fordisposal.Thepuncture‐resistantcontainer shouldbe locatedasclosetotheuseareaaspractical.Contaminatedreusablepointedandsharpobjectssuchaslargeboreneedlesandscalpelsshouldbeplacedinapunctureresistantcontainerfortransporttothereprocessingarea.

Mouthpieces,resuscitationbags,orotherventilationdevicesshouldbeavailableforuseinareasinwhichtheneedforresuscitationispredictable.

Workerswhohaveexudativelesions,weepingdermatitis,cuts,openwoundsorotherbreaksintheskinshouldeitherrefrainfromalldirectcontactwithbloodandotherbodyfluidsuntiltheconditionresolves,orutiliseprotectivebarrierstoreducetheriskofexposure.

Pregnant workers should be especially familiar with and strictly adhere to precautions tominimizetheriskofperinataltransmissionofbloodbornepathogens.

AdditionalPrecautionsforClinicalLaboratories

Allbloodandbodyfluidspecimensshouldbeinawellconstructedcontainerwithasecurelidtopreventleakingduringtransport.

Glovesshouldbewornbyallpersonsprocessingbloodandbodyfluidspecimens.Glovesshouldbe removed and replaced and hands should be washed upon completion of specimenprocessingsincenobarrieris100%effective.

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Masks andprotective eyewearor a face shield shouldbeworn ifmucousmembrane contactwithbloodorbodyfluidsisanticipated.

A biological safety cabinet is not necessary for routine procedures such as histologic andpathologic studies ormicrobiological culturing. However, biological safety cabinets should beusedwheneverprocedures involveactivities thathaveahighpotential forgeneratingaerosoldroplets(blending,sonicating,vigorousmixing,etc.)

Mouthpipettingisprohibited.Mechanicalpipettingdevicesshouldbeusedformanipulatingallliquidsinthelaboratory.

Laboratorywork surfaces should be decontaminatedwith an appropriate chemical germicideafteraspillofbloodorotherbodyfluidsandwhenworkactivitiesarecompleted.

Handsshouldbewashedaftercompletinglaboratoryactivitiesandprotectiveclothingshouldberemovedbeforeleavingthelaboratoryarea.

Equipmentandinstrumentsshouldbedecontaminatedandcleanedbeforebeingrepairedinthelaboratoryortransportedtothemanufacturerorrepairshop.

Contaminated materials should be decontaminated before processing for reuse. Disposablecontaminatedwastesmustbecollectedintheappropriatecontainers.

AdditionalPrecautionsforAutopsiesorMorticians’Services

Theseadditional precautions are applicable forwork completedat the Schulich SchoolofMedicine–Windsorprogram.

All persons performing or assisting in postmortem procedures should wear gloves, masks,protectiveeyewear,gowns,andwaterproofaprons.

Instruments and surfaces contaminated during postmortem procedures should bedecontaminated with an appropriate chemical germicide. Gloves should be worn during thecleaninganddecontaminatingprocedure.

3.4 PhysicalContainmentLevelsFour levels of containment (1 ‐ 4), appropriate to the four risk groups for potentially hazardousbiological agents, are defined. These levels of containment are to be regarded as adequate formostlaboratory uses of the listed agents. It remains the responsibility of the principal investigator or

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laboratorydirectorandtheUniversityofWindsortorequireahigher levelofcontainmentforspecificmanipulations,iftheseappreciablyincreasethepossibilityofinfection.Classification of organisms according to risk group is not meant to establish the actual handling ofbiological hazards in the laboratory setting. For example, the risk group system does not take intoaccount the procedures that are to be employed during the manipulation of a particular organism.Therefore, all researchers who are working with biological agents need to develop site specificinstructions which are to be followed by all individuals within their laboratory, such as personalprotectiveequipmentrequirements,spillresponse,andmethodstoreduceexposure.Containment levels are selected to provide the end‐user with a description of the minimumcontainment required for handling the organism safely in a laboratory setting. In addition to theinherent characteristics of each organism as described in Appendix B – Risk Group Categorization ofAgents the containment system includes the engineering, operational, technical and physicalrequirements for manipulating a particular pathogen. These containment levels are applicable tofacilities suchasdiagnostic, research, clinical, teaching andproduction facilities that areworking at alaboratoryscale.

3.4.1 LaboratoryRequirements–BiologicalContainmentLevel1UniversityofWindsor’sBiologicalSafetyCommitteehasdefinedwell‐characterizedagentsthatarenotknowntoconsistentlycausediseaseinhealthyadulthumansand/orposeaminimalpotentialhazardtolaboratorypersonnelandtheenvironmentasrequiringBiologicalSafetyLevel1containment.

ABiologicalSafetyCertificateisrequiredforallBSL‐1work

The following operational proceduresmust be followed at the University ofWindsor for all certifiedlaboratories that handle infectious substances that require a Level 1 Containment Level (BSL‐1),including:

1. EachlaboratorymustobtainandpostinaconspicuouslocationavalidcopyoftheirUniversityofWindsorBiologicalSafetyCertificatewhichlistsallsubstancesthatthelaboratoryisapprovedtoutilizeaspartoftheirresearchand/orteachingprogram.

2. Acopyof theUniversityofWindsor’sBiologicalSafetyManualmustbemadeavailable forallindividualsworkingwithinthe laboratory.Acopyof thismanualcanbedownloadedfromtheUniversity of Windsor’s Biological Safety Program website (www.uwindsor.ca/biosafety) orrequestedfromtheChemicalControlCentre(p:519.253.3000.3523/e:ccc@uwindsor.ca).

3. Personnelmustreceivetrainingonthepotentialhazardsassociatedwiththeworkinvolvedandthe necessary precautions to prevent exposure to infectious agents and release of containedmaterial; personnelmust showevidence that they understood the training provided; training

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must be documented and signed by both the employee and supervisor; retraining programsshouldalsobeimplemented.TheUniversityofWindsor’sBiologicalSafetyProgramiscurrentlydevelopinggeneralbiologicalsafety training programs to be delivered electronically within a web‐based format on thefollowingtopics:(1)GeneralBiologicalSafety;(2)BiologicalContainment–Level1;(3)BiologicalContainment – Level 2; and (4) Safe and effective utilization of a Biological Safety Cabinet.Principle Investigators are responsible for providinganddocumenting laboratory andagentspecifictraining.

PhysicalRequirements

• Aroomseparatedfrompublicareasbyadoorisrequired.Therearenoparticularrestrictionsonlocatingthefacilitynearpublicorheavilytravelledcorridors;however,doorsshouldremainclosed.

• Coatingsonwalls,ceilings,furniture,andfloorsshouldbecleanable.Windowsthatcanbeopenedshouldnotbenearworkingareasorcontainmentequipmentandshouldbeequippedwithflyscreens.

• Therearenospecialairhandlingrequirementsbeyondthoseconcernedwithproperfunctioningofthebiologicalsafetycabinets,ifused,andthoserequiredbybuildingcodes.

• Handwashingfacilitiesmustbeprovided,preferablynearthepointofexittopublicareas.• Separatelocationsshouldbeprovidedforhangingstreetclothingandlaboratorycoatsatthe

entrance/exit.• Eyewashstationsshouldbeavailable.

OperationalRequirements

• ThebasiclaboratorysafetypracticesdescribedinSection3mustbefollowed.• Inaddition,wherechemicaldisinfectionproceduresareemployed,effectiveconcentrationsand

contacttimesmustbeused.Chemicaldisinfectantsusedtodecontaminatematerialstoberemovedfromthelaboratorymustbereplacedregularly.

• Eating,drinking,smoking,storingoffood,personalbelongings,orutensils,applyingcosmetics,andinsertingorremovingcontactlensesarenotpermittedinanylaboratory;thewearingofcontactlensesispermittedonlywhenotherformsofcorrectiveeyeweararenotsuitable;wearingjewelryisnotrecommendedinthelaboratory.

• Oralpipettingofanysubstanceisprohibitedinanylaboratory.• Longhairistobetiedbackorrestrainedsothatitcannotcomeintocontactwithhands,

specimens,containersorequipment.• Accesstolaboratoryandsupportareasislimitedtoauthorizedpersonnel.• Doorstolaboratoriesmustnotbeleftopen(thisdoesnotapplytoanopenareawithina

laboratory).• Openwounds,cuts,scratchesandgrazesshouldbecoveredwithwaterproofdressings.

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3.4.2 LaboratoryRequirements–BiologicalContainmentLevel2

UniversityofWindsor’sBiologicalSafetyCommitteehasdefinedwell‐characterizedagentsthathaveamoderate potential hazard to personnel and the environment as requiring Biological Safety Level 2containment.ItdiffersfromBSL‐1inthat(1)laboratorypersonnelhavespecifictraininginhandlingpathogenicagentsand are directed by competent scientists; (2) access to the laboratory is limitedwhenwork is beingconducted; (3) extreme precautions are taken with contaminated sharp items; and (4) certainprocedures inwhich infectiousaerosolsorsplashesmaybecreatedareconducted inbiologicalsafetycabinetsorotherphysicalcontainmentequipment.

ABiologicalSafetyCertificateisrequiredforallBSL‐2workIn addition to the laboratory requirements stipulated in Section 3.4.1 – Laboratory Requirements –Biological Safety Level 1, the following operational proceduresmust be followed at theUniversity ofWindsor for all certified laboratories that handle infectious substances that require a Level 2ContainmentLevel(BSL‐2),including:

1. EachlaboratorymustobtainandpostinaconspicuouslocationavalidcopyoftheirUniversityofWindsorBiologicalSafetyCertificatewhichlistsallsubstancesthatthelaboratoryisapprovedtoutilizeaspartoftheirresearchand/orteachingprogram.

2. Goodmicrobiologicallaboratorypracticesintendedtoavoidthereleaseofinfectiousagentsaretobeemployed.

3. Appropriate signage indicating the nature of the hazard being used (e.g., biohazard sign,containment level) must be posted outside each laboratory; if infectious agents used in thelaboratoryrequirespecialprovisionsforentry,therelevantinformationmustbeincludedonthesign;thecontact informationofthe laboratorysupervisororotherresponsibleperson(s)mustalsobelisted.

4. Entrymustberestrictedto laboratorystaff,animalhandlers,maintenancestaffandothersonofficialbusiness.

5. All people working in the containment area must be trained in and follow the operationalprotocolsfortheprojectinprocess.Traineesmustbeaccompaniedbyatrainedstaffmember.Visitors, maintenance staff, janitorial staff and others, as deemed appropriate, must also beprovidedwithtrainingand/orsupervisioncommensuratewiththeiranticipatedactivitiesinthecontainmentarea.

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6. Emergencyproceduresforspillclean‐up,BSCfailure,fire,animalescapeandotheremergenciesmust be written, easily accessible and followed. A record must be made of other peopleenteringthefacilityduringanemergency.Formoreinformationoneachoftheseareas,pleaseseeSection4–EmergencyProcedureswithinthismanual.OperationalRequirements:

• Class Ior IIbiologicalsafetycabinets(seeAppendixD–BiologicalSafetyCabinets)arerequired for all manipulations of agents whichmay create an aerosol. The biologicalsafety cabinet must have been tested and certified within the previous 12 monthsaccordingtoacceptedstandards(seeSection3.8).

• Inspection and retesting is mandatory if the cabinet is relocated. Moves of a minor

naturemaybeexempt if themove issupervisedbythetestingtechnologist toensurethattheequipmenthasnotbeensubjectedtounduestress.Atthetimecertificationiscarriedout,thetestingtechnologistshouldascertainthattheusersarefamiliarwiththecontainment capability of the equipment under various operating conditions andfamiliarizesuchindividualswithprecautionstobetakeninitsuse.

• Air fromthesecabinetsmayberecirculatedtotheroomonlyafterpassagethrougha

highefficiencyparticulateair(HEPA)filter.

• Goodmicrobiological laboratory practices intended to avoid the release of biologicalagentsaretobeemployed.Centrifugationmustbeconductedwithclosedcontainersoraerosolproofsafetyheadsorcups.Theseshouldbeopenedonlyinthebiologicalsafetycabinet.

• Organismswhichhavebeenexperimentally infectedmust remain in the laboratoryor

appropriateanimalcontainmentfacility.

• Anemergencyplanforhandlingspillsofinfectiousmaterialsmustbeprovidedaspartofthe principle investigators application for a University of Windsor Biological SafetyCertificate(UWinBSC)andbereadyforusewheneverneeded.Laboratoryworkersmustbe educated about the emergency plans. A record must be made of other peopleenteringthefacilityduringanemergency.

• Vacuumlinesusedforworkinvolvingtheagentmustbeprotectedfromcontamination

byHEPAfiltersorequivalentequipment.

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• Laboratorycoatsshouldbewornonlyinthelaboratoryarea.Eitherfront‐buttoncoatsor wrap around gowns are acceptable. These coats shall not be worn outside thecontainmentlaboratory.

• Special care should be taken to avoid contamination of the skin with infectious

materials.Glovesmustbewornwhenhandlinginfectedorganismsorwhenhandsmaybeexposedtobiologicalagents.

• Contaminatedglasswaremustnot leave the facility.Decontaminationmustbecarried

out using procedures demonstrated to be effective. If there is no autoclave orincineratorinthelaboratory,contaminatedmaterialsmustbedisinfectedchemicallyorbedoublebaggedandtransportedtotheautoclaveorincineratorindurable,leakproofcontainerswhichareclosedandwipedontheoutsidewithdisinfectantbeforeleavingthelaboratory.

• Periodicintensivecleaningmustbedoneatregularintervals.Cleaningandmaintenancestaffshouldreceiveappropriateimmunizationandmedicalsurveillance.

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4 EMERGENCYPROCEDURES

4.1 BiologicalSpillResponseSpills, accidents or exposures to infectious materials and losses of containment must be reportedimmediatelytothelaboratorysupervisor;writtenrecordsofsuchincidentsmustbemaintained,andtheresultsofincidentinvestigationsshouldbeusedforcontinuingeducation.Emergency plans and procedures to be readily available and to include appropriate equipment andtraining for emergency response to spills or accidental release of organisms (i.e., personal protectiveequipment,disinfectants);trainingtobedocumented.Laboratorybench topsand surfacesare tobedecontaminatedafterany spill ofpotentially infectiousmaterialsandattheendoftheworkingday.Ifthereisaspillduringuse,surfacedecontaminateallobjectsinthecabinet;disinfecttheworkingareaofthecabinetwhileitisstillinoperation(donotturnthecabinetoff).Decontamination of the laboratory space, its furniture and its equipment requires a combination ofliquid and gaseous disinfectants. Surfaces can be decontaminated using a solution of sodiumhypochlorite (NaOCl); a solution containing 1 g/l available chlorine may be suitable for generalenvironmentalsanitation,butstrongersolutions(5g/l)arerecommendedwhendealingwithhigh‐risksituations.Forenvironmentaldecontamination,formulatedsolutionscontaining3%hydrogenperoxide(H2O2)makesuitablesubstitutesforbleachsolutions.Whenever possible, suitable gloves shouldbewornwhenhandlingbiohazardousmaterials.However,this does not replace the need for regular and proper hand‐washing by laboratory personnel. Handsmust bewashed after handling biohazardousmaterials and animals, and using the toilet, and beforeleavingthelaboratory,andeating.In most situations, thorough washing of hands with ordinary soap and water is sufficient todecontaminate them, but the use of germicidal soaps is recommended in high‐risk situations. Handsshouldbe thoroughly latheredwithsoap,using friction, forat least10minutes, rinsed incleanwateranddriedusingacleanpaperorclothtowel(ifavailable,warm‐airhand‐dryersarealsorecommended).

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4.1.1 ClassificationofSpills

A MINOR BIOLOGICAL SPILL is one that can be handled safely by laboratory personnel without theassistanceofsafetyandemergencypersonnel.Minorspillsinclude:

• ThereleaseofBSL‐1organismswithoutsplashingoragitation• ThereleaseofasmallvolumeofBLS‐1organismswithoutsplashingoragitation

AMAJORBIOLOGICALSPILLisonethatrequiresoutsideassistance.Theseinclude:

• Anyspillinvolvingabiologicalagentthatanindividualdoesnotfeelconfidentintheirabilitytoeffectivelymitigatethespill

• Thereleaseofanyorganismsresultinginexcessivesplashingandagitation• ThereleaseofanyBSL‐2organisms• ThereleaseofalargevolumeofBSL‐1organisms(thereisenoughpresenttoseekitsown

levelorinotherwords,toruntoalowpoint)

4.1.2 BiohazardousSpillProcedure–MinorBiologicalSpill

Thisprocedureisapplicabletospillsonanonporoussurfacesuchasatilefloororconcretefloor.

1. Notifyothersintheareaimmediately,tolimitpotentialoffurthercontaminationtoadditionalpersonnelortheenvironment.

2. Assessthesituationanddetermineclassificationofthespill:AMINORBIOLOGICALSPILLisonethatcanbehandledsafelybylaboratorypersonnelwithouttheassistanceofsafetyandemergencypersonnel.Minorspillsinclude:

• ThereleaseofBSL‐1organismswithoutsplashingoragitation• ThereleaseofasmallvolumeofBLS‐1organismswithoutsplashingoragitation

AMAJORBIOLOGICALSPILLisonethatrequiresoutsideassistance.Theseinclude:

• Anyspill involvingabiologicalagentthatan individualdoesnotfeelconfident intheirabilitytoeffectivelymitigatethespill

• Thereleaseofanyorganismsresultinginexcessivesplashingandagitation• ThereleaseofanyBSL‐2organisms• Thereleaseofa largevolumeofBSL‐1organisms (there isenoughpresent toseek its

ownlevelorinotherwords,toruntoalowpoint)

3. For a minor spill, proceed to Step 4. For major biological spills, immediately evacuate area,securearea,andcallforassistance(seeMajorSpillResponse).

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4. Removeanycontaminatedclothingandlabcoats.Washexposedskinwithantisepticsoapandwater.Getyourbiohazardspillkitandreviewspillprocedurebeforeproceedingwithcleanup.

5. Remove spill supplies from kit and line bucket/container with a biohazard bag. (Retrieve asharpscontainerfordisposalofsharpsifnecessary.)

6. Ataminimum,weartwopairsofglovesandsplashgoggles.

7. If applicable, usingmechanicalmeans (i.e. dustpan/broom, tongs), pick up any contaminatedsharp items (needles, brokenglass, etc.) andplace them in an approved sharps container fordisposal.

8. Cover the spillwith anabsorbentmaterial and carefully applydecontamination solutionpouraround the spill allowing it to mix with the material (i.e. 10% Bleach ‐ sodium hypochloritesolution containing 5000‐6000 parts per million, ppm). If using a proprietary disinfectantproduct,followthemanufacturer’sinstructionsforproperuseconcentrationandcontacttime.Makesurethedisinfectantisnotbeyondtheexpirationdate.

9. Allowacontacttimeof20minutes

10. Removetheabsorbentmaterialbyusingamechanicalmeans(i.e.dustpanandbroom,plasticscrapers)anddeposititalongwiththemechanicaltoolintoabiohazardbag.

11. Remove residualdisinfectantwith freshpaper towels.Disposeof the towels in thebiohazardbag.

12. Repeatsteps8and9forsufficientdisinfectionofcontaminatedsurfaces,ifnecessary.

13. CleanthesurfacewithanEPA‐registereddisinfectantandallowtoairdry.Ifbleachisused,wipeupbleachresiduewithwater.

14. Removeouterpairofglovesonlyanddisposeoftheminthebiohazardbag.

15. Removesplashgoggleswithinnerglovesstillon,andcleanthegogglesbyautoclaving.

16. Removeinnerpairofglovesandplacetheminthebiohazardbagfordisposal.

17. Close the bag and dispose of as biohazardous waste. (Please refer to “Safe Operations ofAutoclavesintheTreatmentofBiomedicalWaste”manual)

18. Wash your hands with soap & water and/or by using hand‐sanitization solution as soon aspossible.

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19. Returnspillkittodesignatedlocation.Ensurethatthespillkitisrestockedfornextuse.

20. Notifyimmediatesupervisor,ifyouhavenotalreadydoneso.CompleteanIncident/Accidentform to ensure that the incident is reported and medically managed in accordance withreportingrequirements

4.1.3 BiohazardousSpillProcedure–MajorBiologicalSpill

Thisprocedureisapplicabletospillsonanonporoussurfacesuchasatilefloororconcretefloor.

1. Notifyothersintheareaimmediately,tolimitpotentialoffurthercontaminationtoadditionalpersonnelortheenvironment.

2. Assessthesituationanddetermineclassificationofthespill:AMINORBIOLOGICALSPILLisonethatcanbehandledsafelybylaboratorypersonnelwithouttheassistanceofsafetyandemergencypersonnel.Minorspillsinclude:

o Thereleaseoforganismswithoutsplashingoragitationo Thereleaseofasmallvolumeoforganismswithoutsplashingoragitation(i.e.few

milliliters)o Typeofequipmentwhichisbeingutilized(i.e.sonication,vortex,etc.)o Contaminatedarea

AMAJORBIOLOGICALSPILLisonethatrequiresoutsideassistance.Theseinclude:

o Thereleaseoforganismsresultinginexcessivesplashingandagitationo Thereleaseofalargevolumeofbiologicalmaterials(500ML)o TypeofAgent(i.e.riskgroup2,2+,orabove)

3. For major biological spills, immediately evacuate area, secure area, and contact Campus

CommunityPolice(dial911)forassistance.

4.1.4 BiohazardousSpillProcedure–OnBody

1. Immediatelyremovecontaminatedclothing.Allcontaminatedmaterialsmustbetreatedofasbiohazardous. (Please refer to “SafeOperationsof autoclaves in theTreatmentofBiomedicalWaste”manual)

2. Vigorously wash exposed area with soap & water for at least 10 minutes. Alternative, anapprovedhand‐sanitizerwhichcontains65%isopropanolcanbeused.

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3. Ifeyeexposureoccurs,useeyewashperinstructions(atleast15minutes).

4. ObtainmedicalattentionbycontactingCampusCommunityPolice(dial911),ifnecessary.

4.1.5 BiohazardousSpillProcedure–InsideaBiologicalSafetyCabinet

1. AllowBSCtooperateunattendedforfive(5)minutestofacilitateaerosolpurification.

2. Callforassistanceifneeded.Itisusefultohaveasecondpersonwith“clean”handsgetallthematerialsforcleanup.

3. WhilewearingPPE(gown,safetyglassesandgloves)coverthespillwithanabsorbentmaterialandcarefullyapplydecontaminationsolutionpouraroundthespillallowing it tomixwiththematerial(i.e.10%Bleach‐sodiumhypochloritesolutioncontaining5000‐6000partspermillion,ppm). If using a proprietary disinfectant product, follow the manufacturer’s instructions forproper use concentration and contact time. Make sure the disinfectant is not beyond theexpirationdate.

4. Spray or wipe cabinet walls, work surfaces, and inside the front view sashwith disinfectant.Assumeeverythinginthecabinetiscontaminated.

a. Liftexhaustgrillandtrayandwipeallsurfaces.b. Discard contaminated disposable materials using appropriate biohazardous waste

disposalprocedures. (Pleasereferto“SafeOperationsofAutoclavesintheTreatmentofBiomedicalWaste”manual)

c. Wipedowncontaminatedreusableitemswithdisinfectantthenplaceinbiohazardbagsorautoclavepanswithlidsforautoclaving.

d. Thoseitemsthatarenon‐autoclavableshouldbewipeddownwithdisinfectantandkeptwetforaminimumof20minutesbeforeremovalfromBSC.

5. After20minutesofcontacttime,soakupthedisinfectantanddiscardtheabsorbentmaterials

intoabiohazardbagandhandleasregulatedmedicalwaste.

6. Removeouterpairofglovesonlyanddisposeoftheminthebiohazardbag.

Donotplaceyourheadinsidethecabinettocleanthespill.Keepyourfacebehindthefrontviewscreen.Ifnecessary,floodtheworksurface,aswellasthedrainpansandcatchbasinsbelowtheworksurface,withdisinfectant.

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7. Removesplashgoggleswithinnerglovesstillon,andcleanthegogglesbyautoclaving.

8. Removeinnerpairofglovesandplacetheminthebiohazardbagfordisposal.

9. Close the bag and dispose of as biohazardous waste. (Please refer to “Safe Operations ofAutoclavesintheTreatmentofBiomedicalWaste”manual)

10. Wash your hands with soap & water and/or by using hand‐sanitization solution as soon aspossible.

11. Allowthecabinettorunfor15minutesaftercleaningandbeforeshutofforre‐use.

12. Ifyouhavenotalreadydoneso,notifyyour immediatesupervisorof thespill.Thesupervisorshouldbenotifiedifthespilloverflowsintotheinteriorofthecabinet.Itmaybenecessarytoperformamoreextensivedecontaminationofthecabinet.

4.1.6 BiohazardousSpillProcedure–withinaCentrifuge

1. Shutdownthecentrifuge

2. Waitfive(5)minutesbeforeopeningthecentrifugefollowingtheendofarunwithpotentiallyhazardousbiologicalmaterial.Thiswillallowanyaerosolstosettlepriortoopeningsecondarycontainment.

3. Ifatubebreakswithinacentrifugebucketandthecontainmenthasnotbeenbreached,open

thecentrifugebucketinaBiologicalSafetyCabinetandproceedtodecontaminatethespillpertheMinorSpillprotocol.

Ifthereisnocontainmentofthespillorthecontainmenthasbeenbreached:

1. Ifcentrifugecontaminationisidentifiedafterthesafetybucketlidisopened,carefullyclosethecentrifugelidandallowaerosolstosettleforatleast30minutes.

2. Removeanycontaminatedprotectiveclothingandplaceitinabiohazardbag.Washhandsandanyexposedskinsurfaceswithsoapandwater.

3. Evacuate the laboratory for at least 30minutes. Post awarning sign on the laboratory door.Notifyyoursupervisor.

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4. After thirty (30) minutes, enter the laboratory with personal protective equipment and spillclean‐up materials. Fullf‐ace protection, a lab coat and utility gloves should be worn. Arespiratormayalsoberecommendedtobeworn.

5. Transfer rotorsandbuckets intoabiological safetycabinet. Immersewithin70%ethanoloranon‐corrosive appropriate disinfectant effective against the agent in use. A one‐hour contacttimeisrecommended.Uncappedorunbrokentubesmaybewipeddownwithdisinfectantafterthe soak and placed in a new container. Handle broken glass with forceps and place inbiohazardoussharpscontainer.

6. Carefullyretrieveanybrokenglassfrominsidethecentrifugewithforcepsandplaceinasharpscontainer.Smallerpiecesofglassmaybecollectedwithcottonorpapertowelsheldbetweentheforceps.Placeallbrokenglasswithinbiohazardoussharpscontainer.

7. Carefully wipe the inside of the centrifuge with papers towels soaked in an appropriatedisinfectant.Spraytheinsideofthecentrifugewithanappropriatedisinfectantandallowtoairdry.Avoidtheuseofsodiumhypochlorite ifatallpossiblebecauseof thecorrosivenatureofsodiumhypochloritesolutions.Ifsodiumhypochloritesolutionsareused,rinsethoroughlywithcopiousamountsofwater.

8. Removeouterpairofglovesonlyanddisposeoftheminthebiohazardbag.

9. Removesplashgoggleswithinnerglovesstillon,andcleanthegogglesbyautoclaving.

10. Removeinnerpairofglovesandplacetheminthebiohazardbagfordisposal.

11. Close the bag and dispose of along with the biohazardous sharps container (if used) asbiohazardous waste. (Please refer to “Safe Operations of Autoclaves in the Treatment ofBiomedicalWaste”manual)

12. Wash your hands with soap & water and/or by using hand‐sanitization solution as soon aspossible.

4.1.7 BiohazardousSpillProcedure–duringTransportationThisprocedureisapplicabletospillsonanonporoussurfacesuchasatilefloororconcretefloor.

1. Notifyothersintheareaimmediately,tolimitpotentialoffurthercontaminationtoadditionalpersonnelortheenvironment.

2. Assessthesituationanddetermineclassificationofthespill:

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AMINORBIOLOGICALSPILLisonethatcanbehandledsafelybylaboratorypersonnelwithouttheassistanceofsafetyandemergencypersonnel.Minorspillsinclude:

• ThereleaseofBSL‐1organismswithoutsplashingoragitation• ThereleaseofasmallvolumeofBLS‐1organismswithoutsplashingoragitation

AMAJORBIOLOGICALSPILLisonethatrequiresoutsideassistance.Theseinclude:

• Anyspill involvingabiologicalagentthatan individualdoesnotfeelconfident intheirabilitytoeffectivelymitigatethespill

• Thereleaseofanyorganismsresultinginexcessivesplashingandagitation• ThereleaseofanyBSL‐2organisms• Thereleaseofa largevolumeofBSL‐1organisms (there isenoughpresent toseek its

ownlevelorinotherwords,toruntoalowpoint)

3. If minor, follow clean‐up steps outlined within the Minor Spill Response Section. For majorbiologicalspills,immediatelyevacuatearea,securearea,andcontactCampusCommunityPolice(dial911)forassistance.

4.1.8 BiohazardousSpillProcedure–InvolvingPrions

Prions, also referred to as “unconventional” infectious agents or “agents of transmissible spongiformencephalopathies”, are believed to contain protein only. As mentioned previously, they can causeCreutzfeldt‐Jakobdiseaseinhumans,scrapieinsheep,bovinespongiformencephalopathyincattle,etc.Theseinfectiousagentsareunusuallyresistanttoinactivationbymostphysicalandchemicalagentsandmaterialssuspectedofcontainingthemrequirespecialprocessingbeforereuseordisposal.Todate,availabledataindicatethatprionscanbeinactivatedbyasolutionof2mol/lsodiumhydroxide(NaOH) containing 4.0 mol/l guanidinium hydrochloride (HNC(NH2)2.HCl) or guanidinium isocyanate(HNC(NH2)2.HNCO) and sodium hypochlorite (NaOCl) (> 2% available chlorine) followed by steamautoclavingat132°Cfor4.5h.Incinerationisalsoaneffectivemeansofdealingwithprion‐contaminatedmaterials

4.1.9 DisposalofSpillMaterials

Thedisposalof laboratoryandmedicalwaste issubjecttovariousregional,nationaland internationalregulationsandthelatestversionsofsuchrelevantdocumentsmustbeconsultedbeforedesigningandimplementingaprogrammeforhandling,transportationanddisposalofbiohazardouswaste.Ingeneral,ashfromincineratorsmaybehandledasnormaldomesticwasteandremovedbylocalauthorities.

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Autoclavedwastemaybedisposedofbyoff‐siteincinerationorinlicensedlandfillsites

4.1.10 BiologicalSpillReportingMINORBIOLOGICALSPILLS:SpillsandaccidentsthatresultinexposurestoorganismstobeimmediatelyreportedtoyoursupervisorwithanincidentreportforwardedtotheUniversityofWindsor’sBiologicalSafetyOfficer(ext.3523).Writtenrecordstobemaintained(seePathogenAccountablity).Medicalattentionandsurveillancewillbeprovidedasappropriate.

MAJORBIOLOGICAL SPILLS: Emergency procedures for spill clean‐up, BSC failure, fire, animal escapeandotheremergenciesmustbewritten,easilyaccessibleandfollowed.Arecordmustbemadeofotherpeopleenteringthefacilityduringanemergency.TheUniversity’sBiologicalSafetyOfficer(ext.3523)mustbeimmediatelynotified.

Medicalattentionandsurveillancewillbeprovidedasappropriate.

BiologicalSpillKitThekitshouldbemaintainedinawhite6‐gallonleak‐proofbucketandcontainthefollowing:

• Concentratedhouseholdbleach–checkexpirationdate• Spraybottleformaking10%bleachsolution• Forcepsortongsforhandlingsharps• Papertowelsorothersuitableabsorbent• Biohazardbagsofvarioussizes• Disposablegloves• Disposablefootcovers• Faceprotection–ataminimumsafetyglassesandmask• Spillsigntopostondoor

BiohazardousSpillKitsareavailableattheChemicalControlCentre.

4.2 EmergencyMedicalProcedures

Inlife‐threateningsituationsrequiringimmediatemedicalattention,telephonetheUniversityofWindsor’sCampusCommunityPolice(Dial911)andtheywillcontacttheappropriateauthoritiesandco‐ordinatetheresponse.

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4.2.1 MedicalSurveillance&Immunioprophylaxis

Laboratory personnel should be protected against laboratory‐acquired infections by appropriateimmunization with relevant, licensed vaccines unless documented to have pre‐existing immunity.HepatitisBimmunizationisstronglyrecommendedforallpersonswhohandleorareexposedtohumanblood,bodyfluids,organsortissues.Immunoprophylaxisandinformationpertainingtotheavailabilityandtheadvisabilityofimmunizingagentsareavailablethroughthefollowing:

WindsorEssexHealthUnit–ImmunizationUnit,1005OuelletteAvenue,Windsor,OntarioN9A4J8(519)258‐2416ext.1222.

Immunizingagentsareavailabletoprotectlaboratoryworkersagainst:

Anthrax Lymedisease RabiesBotulism Measles RubellaCholera Meningococcus TetanusDiphtheria Mumps Tuberculosis(BCG)Hemophilusinfluenzaetypeb Pertussis TyphoidHepatitisA Plague VacciniaHepatitisB Pneumococcus VaricellaInfluenzaA Polio YellowfeverJapaneseencephalitis

4.2.2 AnimalBitesandScratchesThe followingemergency responseprocedures shallbe followedwhenaworkerhasbeenexposed tozoonoticagentsviaanimalbiteorscratch,viamucousmembranecontact,orvianon‐intactskincontact.

LaboratoryWorker,Student,andVisitors

Theexposedsitemustbewashedimmediately.

A. Washwithsoapandwaterafterallowingthewoundtobleedfreely.

B. Ifmucous(eyes,nose,mouth)membraneornon‐intact(cuts,rash,eczemaordermatitis)skincontact,flushwithwateratthenearestfaucetoreyewashstation.

Theindividualmustimmediatelyinformthesupervisor/principalinvestigatoroftheexposureincident.

The individualmust seekpromptmedical attentionat thenearesthospitalemergencydepartmentoremergencyclinic,amedicalpractitioneroftheirchoosing.TheindividualmustprovideinformationforaUniversity ofWindsor Accident/Incident (obtained from her / his supervisor / principal investigator),

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describingtheincidentindetail,includingtherouteofexposureandtheemergencyactionstaken,andadescriptionoftheindividual’sdutiesastheyrelatetotheexposureincident.

4.2.3 ExposuretoHumanBloodandBodyFluidsThe followingemergency responseprocedures shallbe followedwhenaworkerhasbeenexposed tobloodorbody fluids via aneedlestick, cutorpuncturewound, viamucousmembrane contact,or vianon‐intactskincontact.

LaboratoryWorker,Student,Visitors

Theexposedsitemustbewashedimmediately.

A. Washwithsoapandwaterafterallowingthewoundtobleedfreely.

B. Ifmucous(eyes,nose,mouth)membraneornon‐intact(cuts,rash,eczemaordermatitis)skincontact,flushwithwateratthenearestfaucetoreyewashstation.

The laboratory worker, student, or visitor must immediately inform the supervisor / principalinvestigatoroftheexposureincident.

4.2.4 ExposuretoInfectiousandCommunicableDiseaseAgentsThe followingemergency responseprocedures shallbe followedwhenaworkerhasbeenexposed toinfectious or communicable disease agents via inhalation, a needlestick, cut or puncture wound, viaingestionormucousmembranecontact,orvianon‐intactskincontact.

LaboratoryWorker,Student,Visitors

Theexposedsitemustbewashedimmediately.

A. Washwithsoapandwaterafterallowingthewoundtobleedfreely.

B. Ifmucous(eyes,nose,mouth)membraneornon‐intact(cuts,rash,eczemaordermatitis)skincontact,flushwithwateratthenearestfaucetoreyewashstation.

The laboratory worker, student, or visitor must immediately inform the supervisor / principalinvestigatoroftheexposureincident.

4.2.5 ImportantMedicalEmergencyNumbers&Contacts

EmergencyNumber(Fire,Police,Ambulance) 911Hospitals:

Hotel‐DieuGraceHospital (519)973‐4444

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WindsorRegionalHospital(MetropolitanCampus) (519)254‐1661WindsorRegionalHospital(WesternCampus) (519)257‐5100PoisonControlCentre (800)268‐9017

UNIVERSITYCAMPUSEMERGENCYNUMBERS

CampusCommunityPolice(Emergency) ext.911CampusCommunityPolice(Non‐Emergency) ext.1234ChemicalControlCentre(24hrs/day) ext.3523OfficeofOccupationalHealthandSafety ext.2055UniversityMedicalOffice ext.7002

Located:(2ndFloor,CAWStudentCentre)Monday‐Thursday9:00a.m.‐5:00p.m.Friday9:00a.m.‐12:00p.m.&1:00p.m.‐5:00p.m.

4.3 MedicalIncidentReportingRequirements

4.3.1 Individual:

The laboratoryworker,student,orvisitormustseekpromptmedicalattentionatthenearesthospitalemergency department or emergency clinic, amedical practitioner of their choosing. The laboratoryworker, student, or visitor must provide information for a University of Windsor Accident/Incident(obtainedfromher/hissupervisor/principal investigator),describingthe incident indetail, includingtherouteofexposureandtheemergencyactionstaken,andadescriptionoftheindividual’sdutiesastheyrelatetotheexposureincident.

4.3.2 Supervisor/PrincipleInvestigators:

1. The supervisor must refer the affected individual(s) to the nearest hospital emergencydepartmentormedicalpractitioneroftheirchoosing.

2. Supervisorsand/orPrinciple Investigatorsmustcompleteandsign theUniversityofWindsor’sAccident/Incidentreport(www.uwindsor.ca/safety)under“ReportanAccident”.

3. Thesupervisormustensure that theexposure incidentsare reportedwithin24‐hours toboththe Chemical Control Centre (519.973.7013 ‐ fax) and the Office of Occupational Health andSafety(519.971.3671–fax).

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4.3.3 ChemicalControlCentre–LaboratorySafety,Compliance,andAssurance:

TheChemicalControlCentre’sLaboratorySafety,ComplianceandAssurancedivisionshallbeforwardedacopyoftheAccident/IncidentInvestigationReportbyOccupationalHealthandSafety.

If the individual refuses appropriate post‐exposure prophylaxis and / or testing, this shall bedocumented in themedical record by theOccupational Health and Safety and countersigned by theindividual,orarefusaldocumentshouldbesignedandforwardedtoOccupationalHealthandSafety.

Counsellingregardingpotentialexposureandinfection,immunoprophylaxisandfollow‐uptestingshallbeofferedtoanyoneifher/hisexposureisdeterminedtobeofanaturethatmaytransmitzoonoticagents.

4.3.4 OfficeofOccupationalHealth&Safety

TheOfficeofOccupationalHealth&Safetyshallconferwiththeaffectedindividual(s)and/orattendingphysician(s) / caregiver(s) to determine whether the exposure is of a nature that may transmit thebiologicalagentHBV,HIVoranyotherbloodbornepathogens.

CounsellingregardingpotentialHBV,HIVorotherbloodbornepathogenexposureandinfection,chemo/ immunoprophylaxis and follow‐up testing shall be offered to any individual if her / his exposure isdeterminedtobeofanaturethatmaytransmitHBV,HIVorotherbloodbornepathogens.AhepatitisBvaccineorotherappropriatepost‐exposureprophylaxisshallbeoffered if the individualhasnotbeenimmunizedpreviouslyordoesnotdemonstrateadequateantibodies.

If the individual refuses appropriate post‐exposure prophylaxis and / or testing, this shall bedocumentedinthemedicalrecordbytheOfficeofOccupationalHealth&Safetyandcountersignedbytheemployee,orarefusaldocumentshouldbesignedretained.

TheOfficeofOccupationalHealth&SafetywillactasthepointofcontactforallemployeerelatedWSIBclaims. In addition, they will prepare or have prepared prescribed reports concerning occupationalexposures,occupationalhygiene,and/oroccupationalhealthsurveillanceprogramsrelatedtobiologicalagents. These reports shall bepresentedasprescribed tomanagers, supervisors, employees, and theappropriateJointHealthandSafetyCommittee.

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5 CLASSIFICATIONOFBIOLOGICALAGENTS

5.1 GeneralInformation

The standards and practices described in this manual apply to all laboratory research and teachingactivitiesconductedwithintheUniversityofWindsoranditsaffiliatedinstitutionswheresuchactivitiesinvolvetheuseofknownbiologicalagentsorcultures,orwhenanagenthasbeenrecentlyisolatedorissuspectedtobepresentinthematerialhandled.

Judgementsoftheinherentrisksofapathogenaremadeonthebasisofavarietyoffactors,including:(1)severityofthediseaseitcauses;(2)theroutesofinfection;and(3)itsvirulenceandinfectivity.Thisjudgementshouldtakeintoaccounttheexistenceofeffectivetherapies,immunization,thepresenceorabsenceofvectors,quantityofagentandwhethertheagentisindigenoustoCanada,aswellaspossibleeffectsonotherspecies, includingplantsandanimals.Duetotheirunknowncharacteristics,emergingpathogensandnovelagentsmayrequiremorestringentspecializedpracticesandproceduresfortheirsafehandling.

BiologicalagentsareclassifiedaccordingtoRiskGroups,whichareanalogoustotheContainmentLevelsdescribed in Section 1.4.2. These classifications presumeordinary circumstances in the laboratory, orgrowth in small volumes for experimental, diagnostic or teaching purposes. The classifications ofbiologicalagentsreflectthejudgementsmadeontheirinherentrisks.

Large volumes andhigh concentrations of a biological agent in growthmediamaypose greater risksthansmearsofthesameagentonamicroscopeslide.Otherunusualmanipulationsmayalsoincreasethehazard.

5.2 GeneticallyEngineeredOrganismsandCellLines

The biological hazards associated with the use of mammalian or other cells in culture, and anappropriate Risk Group, will be influenced by the following criteria. Micro‐organisms that aredemonstratedtobenonpathogenic,containingnoadventitiousagentsandhavingalonghistoryofsafeindustrialusearenotconsideredhere.

1. PrimaryculturesofmammalianorothercellsmayharbourinfectiousagentsorintegratedDNAoriginally present in the animal or human from which the cultures were derived.Wheneverpossible, the donor should be tested for suspect pathogens prior to the preparation of theculture,andthecultureshouldbeconsideredtobecontaminateduntilproventobefreeofthesuspectagents. Suchprimarycultures shouldbehandled inamannerappropriate to theRisk

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Group of the suspected contaminant, and precautions should be taken to protect laboratorypersonnel.

2. CelllinesknowntocontaininfectiousagentsorintegratedDNAshouldbehandledinamannerappropriatetotheRiskGroupfortheagent.

3. Celllinesthataredeemedtobefreeofinfectiousagentsrarelyposeabiologicalhazard.Ifthereis unintentional parenteral inoculation, normal immune response should provide protection,preventprogressivegrowth,andcauserejectionofaccidentallytransplantedcells.

Foractivitiesinvolvinggeneticallyengineeredorganisms,

• thehostorganismshouldbenon‐pathogenic,withnoadventitiousagents,ahistoryofsafeuse,andlimitedabilitytosurviveintheenvironment,

• vectorswith known inserts should bewell characterized and free of sequences that result inadverseeffectstohumans,animals,plants,ortheenvironment,and

• thegenomic insertshouldbelimitedinsizetothesmallestsequencerequiredandshouldnotincreasethestabilityofthegeneproductintheenvironment.

Resistancemarkersshouldbetransferredwithcaution,topreventacquisitionofresistancethatmightcompromisethetherapeuticuseofantimicrobialagents.Theresultingrecombinantorganismshouldbenon‐pathogenic or alternatively posses limited survival characteristics and be without adverseenvironmentalconsequences.

5.2.1 RecombinantDNAandGeneticManipulationGeneticmethodssuchasselection,crossbreeding,conjugationandtransformationhavebeenusedformany years to alter animals, plants and microorganisms. These methods have recently beensupplementedwithnewerandmuchmoreefficientones,ofwhichthebestknownarethetechniquesofrecombinantDNA.Somenewertechniquesinclude:

• theproductionoftransgenicplantsandanimals,

• the cloning of microbial toxin or other virulence genes in an expression vector or in a hostbackgroundinwhichitmaybeexpressed,and

• the production of full‐length infectious viral clones, including the reconstruction of infectiousvirionsfromrecombinantconstructs(reversegeneticengineering).

Forthepurposesofthisdocument,recombinantDNAincludes:

• DNAmolecules producedoutside living cells by joining natural or syntheticDNA segments toDNAmoleculescapableofreplicationinlivingcells,

• DNAmoleculesproducedinlivingcellsbyjoiningenrichedornaturalsegmentstointracellularDNA,and,

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• DNAmoleculesresultingfromreplicationofsuchrecombinantmolecules.

GuidanceinassessingpotentialrisksinrecombinantDNAresearchcanonlybeverygeneral;eachcaserequires individual assessment. It is unrealistic to define all of the genetically engineered organismswhichmightbecreatedorused inthe laboratory.Thevastmajorityofthisresearch involvesonlytheremotestpossibilityofcreatingahazardbecausethesourceof theDNAbeingtransferred, thevectorand the host are all innocuous or have low risk characteristics. However, some geneticmanipulationdoesraiseasignificantpossibilityofrisk.

Factorstoconsiderwhendeterminingthecontainmentlevelofarecombinantorganismshouldinclude:

• containmentleveloftherecipientorganism

• containmentlevelofthedonororganism

• replicationcompetencyoftherecombinantorganism

• propertyofthedonorproteintobecomeincorporatedintotherecombinantparticle

• potentialpathogenicfactorsassociatedwiththedonorprotein

Ingeneral,containmentlevelsforactivitiesinvolvingrecombinantDNAwillbeassignedaccordingtothefollowingcriteriaandconsiderations:

1. Ifnoneofthecomponentsofthegeneticmanipulation(DNA,vector,host)presentsanyknownhazardandnonecanbereasonablyforeseenintheircombination,thennorestrictionsbeyondtherequirementsofContainmentLevel1arenecessary.

2. Ifoneofthecomponentsusedintheprocedureishazardous,then,ingeneral,determinationofthe containment level requiredwill begin at the level appropriate to the known hazard. Thelevel of containment may be increased or decreased depending on the particular genetransferred,theexpressionofthegeneintherecombinantorganism,theenvisagedinteractionsbetweenthetransferredgeneandthehost‐vectorsystem,andotherrelevantfactors.

3. Inanyactivityinvolvinggenescodingforhazardousproducts,host‐vectorsystemswithlimitedability to surviveoutsideof the laboratory (affordingbiological containment) shouldbeused.Theirusemayreducethelevelofphysicalcontainmentrequired.

4. The containment level may be reduced if it is known that the DNA or vector is mutant anddefectiveintheirdisease‐causingorreplicationcharacteristics.

5. Inthecaseofanimalvirusvectors,includingretroviruses,onemustconsiderthenatureofthehelpercellsandthelikelihoodthatreplication‐competentvirusesmaybeproduced.

Eachcaseneedstohaveariskassessment,asitisnotrealistictotrytodefineinadvanceallthepossiblegeneticallyengineeredorganismsthatmightbecreatedorused inthe laboratory.Assistancewiththe

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riskassessmentcanbeprovidedbythePublicHealthAgencyofCanada’sOfficeofLaboratorySecurity,telephone(613)957‐1779.

Thevastmajorityof recombinant research involvesonly theremotestpossibilityofcreatingahazard,becausethesourceoftheDNAbeingtransferred,thevectorandthehostareall innocuous.However,somegeneticmanipulationdoesraisesignificantpossibilityofrisk.

5.2.2 TransgenicPlantsThereisconsiderablepotentialforcommercialproductionofbiologicalproductsintransgenicplantsandanimals.Thepotentialreleaseoftransgenicorganismsintotheenvironmentandtransmissionofnovelgenestootherplantsandanimalsmustbeconsideredwhendesigningboththeproductionsystemandfacilities to contain the transgenic organisms. In each case, the risk level should be determined inconsultationwiththeappropriateGovernmentagency.

Transgenicplantsmaytransmitnovelcharacteristicstootherplants,therebymodifyingthegenepoolofexistingspecies.Sincethistransmissionismediatedbypollen,transgenicplantsshouldbemadesterileorcontainedinagrowthchamberorgreenhousedesignedtopreventpollenreleaseviaairorinsects.Ifplants are allowed to mature, care must be taken to contain seeds in the growth chamber orgreenhouse.

TransgenicanimalsshouldbehandledaccordingtotheGuidelinesof theCanadianCouncil forAnimalCare and the University ofWindsor’s Animal Care Committee guidelines (www.uwindsor.ca/acc). Animportantconsiderationistheabilityoftheanimaltotransmitgenesbybreedingwithanotheranimalof the same or a related species. Transgenic animals must be adequately contained to prevent theunintentionalspreadofgeneticmodifications.Itisrecommendedthattransgenicanimalsbeproducedusingmethodologywhichrestrictsthepotentialfortransmissionofgenestoanotherhost.

Ifviablemicro‐organismsareusedasvehiclesfortransfection,thecontainment levelfortheplantsoranimals inoculated with these viable recombinant micro‐organisms must be at least as high as thatrequired for work with that specific micro‐organism. Transgenic plants and animals produced bymicroinjection, by use of replication defective vectors, or other sequences that are not normallyhorizontallytransmitted,generallymaybehandledatContainmentLevel1.

Thefollowingrecommendationsshouldbeconsideredpriortotheinitiationoftransgenicexperiments.

• Completecopiesofthereplicationcompetentgenomeshouldnotbeused.

• The constructs should not contain genes capable of causing neoplastic transformation inanimals.

• The probability of recombination with extraneous micro‐organisms should be minimal ornonexistent.

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5.3 AnimalCells,BloodandBodyFluids,andFixedTissues

Thebiologicalhazardsofanimalcells,tissues,bloodandbodyfluidsarisefromthepossibilitythattheymight contain or transmit infectious agents. It is prudent to consider all cell lines to be potentiallyinfectious. Cells known or suspected to contain such agents, or primary cultures from animals andhumans knownor reasonably suspected to be infected, should be assigned to the risk group for thesuspectedagent.

ThefollowingshouldbehandledatContainmentLevel2:

• Primatecelllinesderivedfromlymphoidortumourtissue,• allcelllinesexposedtoortransformedbyaprimateoncogenicvirus,• allsamplesofhumantissuesandfluids,• allprimatetissues,• allcelllinesnewtothelaboratory(untilproventobefreeofadventitiousagents),• allvirus‐containingprimatecelllines,and• allmycoplasma‐containingcelllines.

Thesearefactorsthatinfluencethecontainmentlevelrequired:

• particularsourceofthematerial• thevolumeandconcentrationoftheagent• theextentofculturingandincubation• thetypesofmanipulationstobeconducted• theuseofadditionalprecautions

Non‐recombinantcelllines

Foreverynewcelllinethatismanipulatedinalaboratory,adetailedriskassessmentmustbedoneinordertodeterminetheappropriatelevelofprecautionstobetaken.Adetailedriskassessmentshouldinclude,butisnotlimited,tothefollowing:

• sourceofcellline:thecloserphylogeneticallytohumans,thegreaterthepotentialrisk(highestto lowest risk: human autologous, human heterologous, primate, other mammalian, avian,invertebrate);

• sourcetissue:providesanindicationofpossiblecontaminantsandlatent(oncogenic)viruses;• type of cell line highest to lowest risk: primary cell cultures, continuous cell cultures,

intensivelycharacterizedcellcultures;• quantityofcellsperculture;• sourcepopulationofthespecimenfromwhichthecelllinewasderived.• recombinantcelllines(inadditiontotheabovecriteria)• propertiesofthehostcellline(inthecaseofhybridomas,thepropertiesofeachofthe• contributingcellsmustbeconsidered);

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• vectorusedfortransformation(mayincreasecontainmentlevelrequirements);• transferofviralsequences(mayincreasecontainmentlevelrequirements);• transferofvirulencefactors(mayincreasecontainmentlevelrequirements);• activationofendogenousviruses(mayincreasecontainmentlevelrequirements);• recombinantgeneproduct(mayincreasecontainmentlevelrequirements);• helperviruspresence(mayincreasecontainmentlevelrequirements).

Once all the relevant information regarding the cell line has been obtained, including any hazardsassociated with themedia to be used duringmanipulation of the cell culture, it can be assessed toascertainthehazardsposedbymanipulatingtheparticularcellline.Thecelllineistobehandledatthecontainmentlevelappropriatetothelevelofriskdeterminedbytheassessment.

5.3.1 PrimaryCellCulturesandAnimalIissuesThe followingcontainment requirementsapply toprimarycell culturesand tissues fromhuman,non‐human primate and non‐primate animal sourceswhen handled in the laboratory or used for animalpassage.Cellsandtissuesknownorsuspectedtobecontaminatedor infectedwithanyof theagentsincludedinAppendixB–RiskGroupCategorizationofAgentsmustbehandledatthecontainmentlevelappropriatetothoseagents.

Humanandnon‐humanprimatematerial:ContainmentLevel2

Non‐primateanimalmaterial:ContainmentLevel1

5.3.2 EstablishedCellLinesHuman or other animal cell lines known not to be contaminated or infectedwith any of the agentsincluded in Appendix B – Risk Group Categorization of Agents (under level 1) may be handled atContainment Level 1. Cultures known or suspected to be contaminated or infected with any of theagents included inAppendixA–Agentsnot indigenous toCanadaorunderRiskGroups2andabovemustbehandledatthecontainmentlevelappropriatetothoseagents.

5.3.3 BloodandBodyFluidsTheneedforprecautionarymeasuresextendsalsotosituationsinwhichhumanblood,saliva,urineandotherbodyfluidsorfaecesmustbehandled.Theprecautionsrequiredmaybemorestringentwhenthespecimens are used for culturing purposes, but initially, their handling should be consistent withContainment Level 2. Reduction of the containment level may be acceptable if potential hazardsassociatedwiththematerialareexpectedtobediminishedbecauseofdilution,useofchemicalorothertreatmentsoradditionalprotectivemeasuresandpractices.

Culturingofspecimensinresearchlaboratory

BloodorbloodfractionsandotherbodyfluidspecimensofhumanoranimaloriginthatareknownorsuspectedtocontainanyoftheagentsincludedinAppendixA–AgentsnotindigenoustoCanadamust

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behandledatthecontainmentlevelappropriatetothoseagentswhenthesespecimensareculturedinvolumesgreaterthanthatwhichisnecessaryforroutinediagnosticwork.

Routineclinicaldiagnosticworkinlaboratory

Forroutineclinicaldiagnosticworkwithspecimensofhumanblood,serumandotherbodyfluids(urine,cerebrospinal fluid, etc.) from the general population, Containment Level 1may be acceptable if theactivity does not involve culturing of the specimen beyond the volumes necessary to allow clinicalanalysis.However, in such cases theworkersmustbemade fully awareof thepotential hazards andshouldtakeadditionalprecautions.Pre‐exposureimmunizationagainstHepatitisAandBvirusesandtheuseofappropriatefaceandeyeprotectionandglovesarerecommended.

Forroutineclinicaldiagnosticworkwithspecimenswhichareknowntobefrominfectedindividuals,thecontainmentlevelappropriatetotheagentmustbemaintained.

5.3.4 FixedTissuesandTissueSectionsTissues and tissue sections from human and animal sources are routinely fixed by treatment withchemical agents to preserve structures for later examination and study. Generally, these chemicaltreatmentsinhibitallbiologicalactivity.Most,butnotall,intracellularandintercellularbiologicalagentsareinactivatedduringthistreatment.Anotableexceptionisthegroupofunconventionalagentsknownas‘prions’.

In general, fixed tissues and tissue specimens should be handled under at least Containment Level 1conditions.Ahigherlevelofcontainmentmayberequireddependingonthesourceofthematerial,thenatureoftheagentandwhetherornotitisinactivated.

Whereabiologicalagentwhichusuallyrequiresahigher levelofcontainment ispresent inthetissue,the laboratory director / principal investigator should provide documentation to the University ofWindsor’sBiosafetyCommitteetosupportarequestforalowerlevelofcontainment.

5.4 CellLineContaminationwithInfectiousAgents

Bacteriaandfungi

Cell lines contaminated with bacteria and fungi are readily identified when grown in antibiotic‐freemediabecausetheyquicklyovergrowthecells.

Viralcontamination

Unlikebacteriaandfungi,virusesarenotreadilyidentifiedandsocanposeasignificanthazardtothosemanipulatingprimarycelllines.Becauseofthevaryingrisksassociatedwithcelllinematerial,theWorldHealth Organization proposed a classification of cell lines based on each line’s likelihood of carryingvirusespathogenictohumans.

Lowlikelihood: celllinesderivedfromavianandinvertebratetissues.

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Mediumlikelihood: mammaliannonhematogenouscells,suchasfibroblastsandepithelialcells.

Highlikelihood: blood and bone marrow cells derived from human or non‐human primates;human pituitary cells, caprine and ovine cells, especially those of neural origin;and hybridoma cellswhenatleastonefusionpartnerisofhumanornon‐humanprimateorigin.

Bothviralandcellularoncogeneshavebeenrecognized,mostnotablythehumanT‐cellleukemiavirus(HTLV‐I).HTLV‐Iisahumanoncogenicvirusthattransformsnormalcellsintomalignantcells.Celllineswithknownorpotentialviralcontaminantsaretobehandledatthecontainmentlevelappropriateforthecontaminatingagentofthehighestrisk.Oneoftheprimaryhazardsofmanipulatingcellculturesistheexpressionof latentviruses.Endogenousviralsequenceshavebeenfoundinavarietyofcell linesderived frommammalian species, includinghumans.Cell linescanbegrown inanalteredmannerbyapplying various treatments (e.g., change in pH, serum level, temperature, medium supplements,cocultivation).

Thesetreatmentsmaycausealteredexpressionofoncogenes,expressionoflatentviruses,interactionsbetweenrecombinantgenomicsegmentsoralteredexpressionofcellsurfaceproteins.Manipulationsthatmayalterthe"normal"behaviourofcelllinestoamorehazardousstatearetobeconductedatacontainmentlevelappropriatetothenewhazardousstate.

The biological hazards associatedwith primate cell linesmust also be taken into considerationwhendeterminingthe levelofcontainmentrequired.Primarycell linesderivedfromthegenusMacacamayharbourherpesvirus simiae (Cercopithecineherpes virus, B‐virus), and therefore tissues fromMacacamustbemanipulatedasfollows:

Containment level2 is tobeusedwhenhandling tissuesorbody fluids frommacaques. Ifmaterial issuspected or known to contain herpesvirus simiae, containment level 3 is required. In vitro primarydiagnostictestsaretobedoneatcontainmentlevel3.Noculturing/propagation(culturing)ofthevirusisallowedtobecompletedattheUniversityofWindsor.

Prions

The protein‐only infectious particle, or prion, is accepted as the causative agent of transmissiblespongiformencephalopathies, such as bovine spongiformencephalopathy (BSE). Cell cultures derivedfrombovinesourcesknownorsuspectedtobeBSEpositive,andinvitroprimarydiagnostictestsofcellculturesderivedfrombovinesourcesknownorsuspectedtobeBSEpositivearetobehandledusingTSEspecificguidelines.InformationandtheTSEguidelinescanbefoundbycontacting:

CanadianFoodInspectionAgency(CFIA),BiohazardContainmentandSafetyDivisionP: (613)221‐7074W: http://www.inspection.gc.ca/english/sci/bio/bioe.shtml

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Mycoplasmas

Although mycoplasmas have commonly been identified as sources of cell culture contamination,mycoplasma‐contaminated cultures have not yet been reported as a source of a laboratory‐acquiredinfection.However,becauseofthepresenceofbiologicallyactivemycoplasmaproductsandthestabilityofmycoplasmaantigensaswellasthefactthatanumberofmycoplasmasarehumanpathogens,theyareconsideredhazardous incellcultures.Cell lineswithmycoplasmacontaminantsaretobehandledatthecontainmentlevelappropriateforthecontaminatingagentofthehighestrisk.

Parasites

Freshlypreparedprimarycelllinesmaybeatriskofparasitecontaminationifthecelllinewasobtainedfrom a specimen known or suspected to be infected with a human parasite. Parasites have manylifecyclestages,andnotallstagesareinfective.Thismustbetakenintoconsiderationwhendeterminingtheappropriatelevelofcontainment.Cell linesinwhichthelife‐cyclestageoftheinfectingparasiteisnotknownaretobemanipulatedatthecontainmentlevelappropriateforthecontaminatingagentofthehighestrisk.

5.5 BiologicalAgentRiskGroupCriteriaandCategories

A risk group classification has traditionally been used to categorize the relative hazards of infectiveorganisms. The factors used to determinewhich risk group an organism falls into is based upon theparticularcharacteristicsoftheorganism,suchaspathogenicity;infectiousdose;modeoftransmission;host range; availability of effective preventive measures and the availability of effective treatment.Theseclassificationspresumeordinarycircumstancesintheresearch&teachinglaboratoriesorgrowthin small volumes for diagnostic and experimental purposes. Four levels of risk have been defined asfollows.

RiskGroupl(lowindividualandcommunityrisk)

Abiologicalagentthatisunlikelytocausediseaseinhealthyworkersoranimals.

RiskGroup2(moderateindividualrisk,limitedcommunityrisk)

Apathogenthatcancausehumanoranimaldisease,butundernormalcircumstancesisunlikelytobeaserioushazardtohealthylaboratoryworkers,thecommunity,livestockortheenvironment.Laboratoryexposures rarely cause infection leading to serious disease. Effective treatment and preventivemeasuresareavailableandtheriskofspreadislimited.

RiskGroup3(highindividualrisk,lowcommunityrisk)

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A pathogen that usually causes serious human or animal disease, or which can result in seriouseconomic consequences but does not ordinarily spread by casual contact, from one individual toanother,orthatcanbetreatedbyantimicrobialorantiparasiticagents.

RiskGroup4(highindividualrisk,highcommunityrisk)

Apathogenthatusuallyproducesveryserioushumanoranimaldisease,oftenuntreatable,andmaybereadilytransmittedfromone individualtoanother,orfromanimaltohumanorvice‐versa,directlyorindirectly,orbycasualcontact.

Appendix B – Risk Group Categorization of Agents contains a listing of Risk Group categories forbiohazardousagents.

Forthecurrentriskgroupclassificationofanagent,contactOfficeofLaboratorySecuritydirectlyat:

PublicHealthAgencyofCanadaOfficeofLaboratorySecurityP: (613)957‐1779W: http://www.phac‐aspc.gc.ca/ols‐bsl/.

Orforagentswhichcaninfectanimal,contacttheBiohazardContainmentandSafetyDivisionofCFIAat:

CanadianFoodInspectionAgency(CFIA),BiohazardContainmentandSafetyDivisionP: (613)221‐7074W: http://www.inspection.gc.ca/english/sci/bio/bioe.shtml

NOTE: Risk Group 4 agents are not approved for use at the University ofWindsor and shipmentsincludingsuchagentsshouldnotbeaccepted.

Asageneralprecaution,agentsshouldbeelevatedtothenextriskgroupwhenmanipulationmayresultintheproductionofinfectiousdropletsandaerosols.Agentswithsimilarpathogeniccharacteristicsbutwhich arenot included in the following lists, shouldbe considered tobelong in the same risk group.CertainbiologicalagentswhichareanimalpathogensareconsiderednotindigenoustoCanadaandaresubjecttocontrolbytheCFIA.AppendixA–AgentsnotindigenoustoCanadacontainsapartiallistingofagentsnotindigenoustoCanada.

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6 SECURITY

6.1 General

Biological agents have a dual‐use potential. They can be used in research & teaching for theadvancementofscienceandthediagnosisofdisease,butcanalsobemisused,stolenor intentionallyreleased. The handling of infectious disease agents requires a security plan to ensure that biologicalagentsareusedasintendedandstoredsecurely.

6.2 PhysicalProtection

Thephysicalprotectionriskassessmentshouldincludealllevelsofasecurityreview:perimetersecurity,facilitysecurity,laboratorysecurityandagentspecificsecurity,andoutlineproceduresforsecuringthearea,e.g.,cardaccess,keypads,locksetc.All laboratories shouldadopt securitypractices tominimizeopportunities forunauthorizedentry intolaboratories,animalandstorageareas,aswellastheunauthorizedremovalofinfectiousmaterialsfromtheir facility. The aim is to have a dedicated and controlled access into the laboratory limited toauthorized personnel, laboratory staff, and maintenance staff. Within the laboratory, access tobiologicalagentsshouldbecontrolledaswell.Thecontainmentperimeter(i.e.,doors,windows)shouldprovidetherequiredlevelofsecurityandshouldbekeptclosed.

6.3 PersonnelReliability&Suitability

For all laboratories which have been designated as Containment Level 3, Background checks andsecurityclearancesmaybe requiredbeforeemployeesaregrantedaccess tocontainment facilities. Itmay be appropriate to use photo identification badges for employees and temporary badges forescortedvisitorstoidentifyindividualswithclearancetoenterrestrictedareas.Proceduresmust be developed for approving and granting visitors access to controlled areas. In thiscapacitytheaccesstoagentsandstoragefacilitiesislimitedtolegitimateuse/individualsonly.Biosafetytraining should include address security issues andmust be provided to all personnelwho are givenaccess.Personnelmustdemonstratethattheyhaveunderstoodthebiosecuritytrainingprovided.

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6.4 PathogenAccountablityTheUniversity ofWindsor is required to use a system to properly label, track of internal possession,inactivation and disposal of cultures after use, and transfers within and outside the facility. Thesecontrols also assist in the tracking of pathogen storage locations and in clarifying under whoseresponsibilitythepathogenslie.TheinstitutionrequiresallpermitholderstoupdatetheirinventorieswithintheUniversityofWindsor’sHazardous Materials Information system, including any new additions as a result of diagnosis,verification of proficiency testing, or receipt from other locations as well as to remove agents aftertransfersorappropriateinactivationanddisposalmechanismshavebeenused.Disposalofagentsafteruseshouldincludeallsub‐culturesofthatagentaswell.Laboratoriesarerequiredtokeeprecordsofallpathogen inventories,whohasaccess toagents,whohasaccesstoareaswhereagentsarestoredorused,aswellastransferdocuments.Arecordofculturecollectionsandotheragentsnotcurrentlyusedforresearchshouldbeincludedininventorylistsaswell.A notification process for identifying, reporting, and remediation of security problems, i.e., inventorydiscrepancy,equipmentfailure,breachofsecurity,releaseofagents,etc.,shouldbeinplace.

6.5 Storage

Agentsstoredandmaintainedforon‐goingresearch,teaching,oraspartofaculturecollectionshouldhave adequate physical protection. Agents should be stored securely, in consideration of thecontainment levelof theagent itselfandshouldhaverestrictedaccess.An inventoryofstoredagentsshouldalsobemaintained so thatpathogen storage locationsare tracked,andalso so that it is clearwho is responsible for the pathogens. Documentation procedures should include proper labelling,trackingof internalpossession, inactivationanddisposalofculturesafteruseandtransferswithinandoutsidethefacility.Otherrecordsonwhohasaccesstotheagents,whohasaccesstowheretheagentsarestoredorusedandtransferdocuments,shouldalsobekept.

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Appendixes

AppendixA–AgentsnotindigenoustoCanadaThefollowingpartiallistisprovidedasanexampleofanimalpathogenswhicharenotindigenoustoCanadaandwhicharesubjecttocontrolbytheCanadianFoodInspectionAgency(CFIA).TheCFIAwilldeterminetheconditionsunderwhichtheseagentsareusedandmaintained.Thislistofnon‐indigenousagentsisnotcomplete.BACTERIAMycoplasmaagalactiaeMycoplasmamycoidesRickettsiaruminantiumPARASITESBesnoitiabesnoitiTheileriaannulataTheileriabovisTheileriahirciTheilerialawrenceiTheileriaparvaTrypanosomaequiperdumTrypanosomaevansiTrypanosomavivaxVIRUSESBornaviridae

BornadiseasevirusBunyaviridae

NairobisheepdiseasevirusRiftValleyfevervirus

CaliciviridaeSwinevesiculardiseasevirusVesicularexanthemavirus

FlaviviridaeHogcholeravirus

HerpesviridaePseudorabiesvirus

IridoviridaeAfricanswinefevervirus

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OrthomyxoviridaeFowlplaguevirus

ParamyxoviridaeRinderpest,Newcastlediseasevirus:mesogenic,velogenicstrainsPestedespetitsruminants

PicornaviridaeGenusAphthovirusFoot‐and‐mouthdiseasevirusGenusEnterovirusTeschendiseasevirus

PoxviridaeChordopoxvirinae(poxvirusesofvertebrates)GenusOrthopoxvirusSmallpox(Alastrim)virusGenusCapripoxvirusSheeppoxvirusGoatpoxvirusLumpyskindiseasevirusGenusSuipoxvirusSwinepoxvirusCamelpoxvirus

ReoviridaeGenusOrbivirusBluetonguevirusAfricanhorsesicknessvirus

RhabdoviridaeGenusVesiculovirusEphemeralfevervirusVesicularstomatitisvirus(animalinoculation)

TogaviridaeLoupingillvirus(animalinoculation)WesselsbrondiseasevirusVenezuelanequineencephalitis(VEE)virus

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AppendixB–RiskGroupCategorizationofAgentsRiskGroup1–Lowindividualandcommunityrisk

Thisgroupincludesthosemicro‐organisms,bacteria,fungi,virusesandparasiteswhichareunlikelytocausediseaseinhealthyworkersoranimals.Manyagentsarereferredtointheliteraturebyavarietyofnamesand,beforeassumingthatanunlistedagentisassignedtoRiskGroup1,itscharacteristicsandpathogenicitymustbeverifiedinconsultationwiththeUniversityof Windsor’s Biological Safety Committee or the Office of Biosafety, Public Health Agency of Canada.

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RiskGroup2–Moderateindividualriskandlimitedcommunityrisk

Apathogenthatcancausehumanoranimaldiseasebut,undernormalcircumstances,isunlikelytobeaserioushazardtohealthylaboratoryworkers,thecommunity,livestockortheenvironment.Laboratoryexposures rarely cause infection leading to serious disease. Effective treatment and preventivemeasuresareavailableandtheriskofspreadislimited.BACTERIA,CHLAMYDIA,MYCOPLASMAActinobacillus:allspeciesActinomycespyogenes(C.pyogenes)BacilluscereusBartonellabacilliformis,B.henselae,B.quintana,B.elizabethaeBordetellapertussis,B.parapertussisandB.bronchisepticaBorreliarecurrentis,B.burgdorferiCampylobacterspp:C.coli,C.fetus,C.jejuniChlamydiapneumoniae,C.psittaci(non‐avianstrains),C.trachomatisClostridiumbotulinum,Cl.chauvoei,Cl.difficile,Cl.haemolyticum,Cl.histolyticum,Cl.novyi,Cl.perfringens,Cl.septicum,Cl.sordellii,Cl.tetaniCorynebacteriumdiphtheriae,C.haemolyticum,C.pseudotuberculosis,C.pyogenes(A.pyogenes)EdwardsiellatardaErysipelothrixrusiopathae(insidiosa)Escherichiacoli:enterotoxigenic/invasive/hemorrhagicstrainsFrancisellatularensisTypeB,(biovarpalaearctica),F.novocidaFusobacteriumnecrophorumHaemophilusinfluenzae,H.ducreyiHelicobacterpyloriLegionellaspp.Leptospirainterrogans:allserovarsListeriamonocytogenesMycobacteria:allspeciesexceptM.tuberculosisandM.bovis(non‐BCGstrain),whichareinRiskGroup3Mycoplasmapneumoniae,M.hominisNeisseriagonorrhoeae,N.meningitidisNocardiaasteroides,N.brasiliensisPasteurella:allspeciesexceptP.multocidatypeB,whichisinRiskGroup3PseudomonasaeruginosaSalmonellaenterica(S.choleraesuis)Salmonellaentericaserovararizonae(Arizonahinshawii)Salmonellaentericaserovargallinarum‐pullorum(S.gallinarum‐pullorum)Salmonellaentericaserovarmeleagridis(S.meleagridis)SalmonellaentericaserovarparatyphiB(S.paratyphiB)(Schottmulleri)Salmonellaentericaserovartyphi(S.typhi)Salmonellaentericaserovartyphimurium(S.typhimurium)Shigellaboydii,S.dysenteriae,S.flexneri,S.sonneiStaphylococcusaureusStreptobacillusmoniliformis

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Streptococcusspp:LancefieldGroupsA,B,C,D,GTreponemacarateum,T.pallidum(includingT.pertenue),T.vincentiiUreaplasmaurealyticumVibriocholerae(includingElTor),V.parahaemolyticus,V.vulnificusYersiniaenterocolitica,Y.pseudotuberculosisFUNGICryptococcaceae

CandidaalbicansCryptococcusneoformans

MoniliaceaeAspergillusflavusAspergillusfumigatusEpidermophytonfloccosumMicrosporumspp.SporothrixschenckiiTrichophytonspp.

VIRUSESArthropod‐borne viruses are identified with an asterisk (*). Only those viruses which may be associated withhumanoranimaldiseasehavebeenincludedinthislist.Agentslistedinthisgroupmaybepresentinblood,CSF,central nervous system and other tissues, and infected arthropods, depending on the agent and the stage ofinfection.Adenoviridae

Adenoviruses:allserotypesArenaviridae

Lymphocyticchoriomeningitisvirus:laboratoryadaptedstrainsTacaribeviruscomplex:Tamiami,Tacaribe,Pichinde

BornaviridaeBornadiseasevirus

Bunyaviridae*GenusBunyavirusBunyamweraandrelatedvirusesCaliforniaencephalitisgroup,includingLaCrosse,LumboandSnowshoeharevirus

GenusPhlebovirus:allspeciesexceptRiftValleyfevervirus(seeAppendixA–AgentsnotindigenoustoCanada)

Caliciviridae:allisolates,includingHepatitisEandNorwalkvirusCoronaviridae

Humancoronavirus:allstrainsGenusTorovirusTransmissiblegastroenteritisvirusofswineHemagglutinatingencephalomyelitisvirusofswineMousehepatitisvirus

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BovinecoronavirusFelineinfectiousperitonitisvirusAvianinfectiousbronchitisvirusCanine,RatandRabbitcoronaviruses

Flaviviridae*Yellowfevervirus:17DvaccinestrainDenguevirus:serotypes1,2,3,4KunjinvirusHepatitisCvirus

HepadnaviridaeHepatitisBvirus,includingDeltaagent

HerpesviridaeAlphaherpesvirinaeGenusSimplexvirus:allisolatesincludingHHV1andHHV2,exceptHerpesBviruswhichisinRiskGroup4GenusVaricellavirus:allisolatesincludingvaricella/zostervirus(HHV3)

andpseudorabiesvirus(seeAppendixA–AgentsnotindigenoustoCanada)BetaherpesvirinaeGenusCytomegalovirus:allisolatesincludingCMV(HHV5)GenusMuromegalovirus:allisolatesGammaherpesvirinaeGenusLymphocryptovirus:EpsteinBarrVirus(HHV4)andEB‐likeisolatesGenusRhadinovirus:allisolatesexceptH.atelesandH.saimiriinRiskGroup3GenusThetalymphocryptovirus:allisolatesUnassignedHerpesviruses:includesHHV6(humanB‐lymphotrophicvirus),HHV7,HHV8,etc.

OrthomyxoviridaeGenusInfluenzavirus: InfluenzavirustypeA:allisolates

InfluenzavirustypeB:allisolatesInfluenzavirustypeC:allisolates

PapovaviridaeGenusPapillomavirus:allisolatesGenusPolyomavirus:allisolates

Paramyxoviridae

GenusMorbillivirus:allisolatesexceptRinderpestvirus(seeAppendixA–AgentsnotindigenoustoCanada)GenusParamyxovirus:allisolatesGenusPneumovirus:allisolates

ParvoviridaeGenusParvovirus:allisolates

Picornaviridae

GenusAphthovirus:(seeAppendixA–AgentsnotindigenoustoCanada)GenusCardiovirus:allisolatesGenusEnterovirus:allisolatesGenusHepatovirus:allisolates(HepatitisA)GenusRhinovirus:allisolates

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Poxviridae(seeTable1forrestrictions)Chordopoxvirinae(poxvirusesofvertebrates)GenusAvipoxvirus:allisolates

GenusCapripoxvirus:(seeAppendixA–AgentsnotindigenoustoCanada)GenusLeporipoxvirus:allisolatesGenusMolluscipoxvirusGenusOrthopoxvirus:allisolatesexceptVariolavirusandMonkeypoxviruswhichareinRiskGroup4GenusParapoxvirus:allisolates

GenusSuipoxvirus:Swinepoxvirus(seeAppendixA–AgentsnotindigenoustoCanada)GenusYatapoxvirusAllotherungroupedpoxvirusesofvertebrates

Reoviridae

GenusOrbivirus:allisolates(seeAppendixA–AgentsnotindigenoustoCanada)GenusOrthoreovirus:types1,2and3GenusRotavirus:allisolates

RetroviridaeOncovirinae

GenusOncornavirusCSubgenusOncornavirusCavian:allisolatesSubgenusOncornavirusCmammalian:allisolatesexceptHTLV‐IandHTLV‐II

GenusOncornavirusB:allisolatesLentivirinae:allisolatesexceptHIV‐IandHIV‐IISpumavirinae:allisolates

Rhabdoviridae

GenusVesiculovirus:alllaboratoryadaptedstrains(seeAppendixA–AgentsnotindigenoustoCanada)GenusLyssavirus:Rabiesvirus(fixedvirus)

TogaviridaeGenusAlphavirus*

SemlikiforestvirusSindbisvirusChikungunyavirus:high‐passagestrainsO'Nyong‐NyongvirusRossrivervirusVenezuelanequineencephalitisvirus:onlystrainTC‐83,noanimalinoculation(seeAppendixC)

GenusRubivirusRubellavirus

GenusPestivirusBovinediarrhoeavirusBorderdiseasevirus

GenusArterivirusEquinearteritisvirus

UnclassifiedvirusesOtherHepatitisvirusesAstroviruses

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Chronicinfectiousneuropathicagents(CHINAs):Scrapie,BSE(exceptKuruandCreutzfeldt‐JakobDiseaseagentsinRiskGroup3)

PARASITESInfective stages of the following parasites have caused laboratory infections by ingestion, skin or mucosalpenetrationor accidental injection. Preparationsof theseparasites known tobe freeof infective stagesdonotrequirethislevelofcontainment.PROTOZOA

BabesiamicrotiBabesiadivergensBalantidiumcoliCryptosporidiumspp.EntamoebahistolyticaGiardiaspp.(mammalian)Leishmaniaspp.(mammalian)NaegleriafowleriPlasmodiumspp.(humanorsimian)PneumocystiscariniiToxoplasmagondiiTrypanosomabrucei,T.cruzi

HELMINTHS

NematodesAncylostomaduodenaleAngiostrongylusspp.Ascarisspp.Brugiaspp.LoaloaNecatoramericanusOnchocercavolvulusStrongyloidesspp.ToxocaracanisTrichinellaspp.TrichuristrichiuraWuchereriabancrofti

CestodesEchinococcus(gravidsegments)HymenolepisdiminutaHymenolepisnana(humanorigin)TaeniasaginataTaeniasolium

TrematodesClonorchissinensisFasciolahepatica

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Opisthorchisspp.ParagonimuswestermaniSchistosomahaematobiumSchistosomajaponicumSchistosomamansoni

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RiskGroup3–Highindividualandlowcommunityrisk

A pathogen that usually causes serious human or animal disease, or which can result in seriouseconomic consequences but does not ordinarily spread by casual contact, from one individual toanother,orthatcanbetreatedbyantimicrobialorantiparasiticagents.BACTERIA,CHLAMYDIA,RICKETTSIA

BacillusanthracisBrucella:allspeciesBurkholderia(Pseudomonas)mallei,B.pseudomalleiChlamydiapsittaci:avianstrainsonlyCoxiellaburnettiFrancisellatularensistypeA(biovartularensis)Mycobacteriumbovis:non‐BCGstrainsMycobacteriumtuberculosis1Pasteurellamultocida,typeBRickettsia:allspecies(seeseeAppendixA–AgentsnotindigenoustoCanada)Yersiniapestis

1 Preparationof smearsandprimary cultureofM. tuberculosismaybeperformedat Level2physicalcontainment using Level 3 operational procedures and conditions. All other manipulations of M.tuberculosisrequireContainmentLevel3physicalandoperationalconditions.FUNGI

MoniliaceaeAjellomycescapsulatus(Histoplasmacapsulatum,includingH.capsulatumvar.duboisii)Ajellomycesdermatitidis(Blastomycesdermatitidis)CoccidioidesimmitisParacoccidioidesbrasiliensis

VIRUSESArthropod‐bornevirusesareidentifiedwithanasterisk(*).Arenaviridae

Lymphocyticchoriomeningitisvirus:neurotropicstrainsBunyaviridae

UnclassifiedBunyavirusHantaan,KoreanhaemorrhagicfeverandepidemicnephrosisvirusesincludingHantaviruspulmonarysyndromevirusRiftValleyfevervirus

Flaviviridae*

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Yellowfevervirus:wildtypeSt.LouisencephalitisvirusJapaneseencephalitisvirusMurrayValleyencephalitisvirusPowassanencephalitisvirus

HerpesviridaeGammaherpesvirinaeGenusRhadinovirus:Herpesvirusateles,Herpesvirussaimiri

RetroviridaeOncovirinaeGenusOncornavirusC

HumanT‐cellleukemia/lymphomavirus2GenusOncornavirusD

Mason‐PfizermonkeyvirusVirusesfromnon‐humanprimates

LentivirinaeHumanimmunodeficiencyviruses(HIV):allisolates2

RhabdoviridaeGenusVesiculovirus:wildtypestrains(seeAppendixA–AgentsnotindigenoustoCanada)GenusLyssavirus

Rabiesvirus(streetvirus)Togaviridae

GenusAlphavirus*EasternequineencephalitisvirusChikungunyavirusVenezuelanequineencephalitisvirus(exceptStrainTC‐83;seeAppendixA–AgentsnotindigenoustoCanada)Westernequineencephalitisvirus

UnclassifiedVirusesChronicinfectiousneuropathicagents:Kuru,Creutzfeldt‐JakobDiseaseagents(levelofprecautionsdependsonthenatureofthemanipulationsandtheamountofsera,biopsy/necropsymaterialshandled)

2 Laboratories engaging in primary isolation and identification of HTLV or HIV may perform theseactivities in Containment Level 2 laboratories (physical conditions) using Containment Level 3operationalproceduresandconditions.AllresearchandproductionactivitiesrequireContainmentLevel3physicalandoperationalconditions.

PARASITESNone

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RiskGroup4–Highindividualandcommunityrisk

Apathogenthatusuallyproducesveryserioushumanoranimaldisease,oftenuntreatable,andmaybereadilytransmittedfromone individualtoanother,orfromanimaltohumanorvice‐versa,directlyorindirectly,orbycasualcontact.NOTE:RiskGroup4agentsarenotapprovedforuseattheUniversityofWindsor.BACTERIANoneFUNGINoneVIRUSESArthropod‐bornevirusesareidentifiedwithanasterisk(*).Arenaviridae

Lassa,Junin,Machupo,Sabia,GuanaritovirusesBunyaviridae*

GenusNairovirusCrimean‐Congohemorrhagicfevervirus

FiloviridaeMarburgvirusEbolavirus

Flaviviridae*Tick‐borneencephalitiscomplexincludingRussianSpring‐SummerencephalitisvirusKyasanurforestvirusOmskhemorrhagicfevervirus

HerpesviridaeAlphaherpesvirinaeGenusSimplexvirus:HerpesBvirus(Cercopithecineherpesvirus1)

PoxviridaeGenusOrthopoxvirusVariolavirusMonkeypoxvirus

PARASITESNone

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AppendixC–SafetyEquipmentAn essential element in maintaining personal safety and environmental protection is the correctselection, use and maintenance of safety equipment in the laboratory. Safety equipment must bemaintainedandregularlyserviced.Theremustalsobearegularprogramoftestingandinspection,andaccuraterecordsmustbekept.Thefollowingisalistofsafetydevicesappropriatetothecontainmentlaboratory:

Type Application

Animalcagesorboxes partialtototalcontainmentofaerosols;provideprotectionfromcross‐contaminationandpersonnelandenvironmentalprotection

Autoclaves hightemperaturesteamsterilization

Blendersandmixers aerosol‐freeblendersprovidecontainmentofaerosols

BiologicalSafetyCabinet SeeAppendixD–BiologicalSafetyCabinets

Centrifugeequipment safetycupswithsealedheadsprovidecontainmentofaerosols

Face/eyewashstation deviceforflushingfaceandeyeswithwaterineventofsplashorsprayofbiologicalorchemicalagents

Faceandeyeprotection safetyglasses,gogglesandfull‐faceshieldsprovideprotectionfromflyingobjectsandsplashes

Fumehoods providepersonnelandenvironmentalprotection;forremovalorcontrolofgasesandvapours.

Gloves providehandprotectionofvaryingdegrees;checktechnicalspecificationstodeterminedegreeofprotection

HEPAfilters highefficiencyparticulateairfiltersavailableinvarioussizes,includingcartridges;disposable;provide99.97%removalof0.3μMparticulates

Incinerators–micro electricorgaswithside‐armtocontainsplatterswhenflaminginoculationandtransferloops

Laboratoryclothing headcovers,shoecovers,coats,gownsorventilatedsuitsappropriatetohazard

Leakproofcontainers varietyofcontainers,preferablyofstainlesssteelandautoclavable,withtight‐fittinglids,andwhichmaybeusedfortransportingwastematerialstoanautoclave

Pipettingdevices varietyofdeviceswhicheliminateneedtopipettebymouth

Respiratoryprotection partialorfull‐faceprotection;providedwithvarietyoffilters

Sharpswastecontainers autoclavable,puncture‐resistantcontainerswhichareusedforcollectionanddisposalofusedhypodermicsyringesandneedles,bladesandothersharpwaste

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AppendixD–BiologicalSafetyCabinets

AbiologicalsafetycabinetisaventilatedcabinetwhichusesavarietyofcombinationsofHEPAfiltration,laminar air flow and containment to provide personnel, product or environmental protection orprotection of all components against particulates or aerosols from biohazardous agents. It isdistinguishedfromachemicalfumehoodbythepresenceofHEPAfiltrationandthelaminarnatureoftheairflow.Therearethreekindsofbiologicalsafetycabinets,designatedasClassI,II,andIIIhavebeendevelopedtomeetvariousresearch,teaching,andclinicalapplications.

ClassI:OpenfrontedcabinetswithlaminarairflowdirectedawayfromtheuserthroughaHEPAfilter. The cabinet may be ducted to exhaust system or may exhaust into the room. Class Icabinets provide personnel and environmental protection, but no product protection. It issimilartotheairmovementwithinachemicalfumehood,buthasaHEPAfilterintheexhaustsystemtoprotecttheenvironment.SuitableforsomeworkproceduresatContainment1and2.Class II types A, B1, B2, and B3: A Class II biological safety cabinet provides personnel,environmental, and product protection. They utilize a re‐circulated HEPA filtered verticallaminar airflowwithin a partially contained cabinet with a glass sash leaving 8‐10 inch workopening.ThecomponentoftheairflowthatisexhaustedthroughHEPAfiltersmaybeductedtotheoutsideorre‐circulatedtotheroom.ClassIIcabinetsprovideahighdegreeofprotectiontotheworker,theworkandtheenvironment.SuitableforworkatContainmentLevel1,2and3.Class III: These cabinets were designed for working with microbiological agents assigned toBiosafety level 4 and providemaximumprotection to both the environment and theworker.These enclosed cabinets contain a HEPA filtered supplied air, non‐recirculated HEPA filteredlaminarflowairovertheworksurfaceandhardductedtooutside.Theworksurfaceisaccessedonlythroughgloveportsorsealedairlocks.Thesecabinetsprovideatotallycontainedareatoprotecttheworker,theworkandtheenvironment.SuitableforworkatContainmentLevel1,2,3,and4.

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HIGHEFFICIENCYPARTICULATEAIRFILTERS(HEPA):HEPA filtersareusing theexhaustand/or supply systemsofbiological safetycabinets.A typicalHEPAfilterisasinglesheetofborosilicatefiberswhichhasbeentreatedwithawet‐strengthwater‐repellantbinder.Thefiltermediumispleatedtoincreasetheoverallsurfaceareainsidethefilterframe,andthepleatsareoftendividedbycorrugatedaluminumseparatorsHORIZONTAL/VERTICALLAMINARFLOW“CLEANBENCH”:These units discharge HEPA‐filtered air across a work surface towards the user. These devices onlyprovideproductprotectionandcanbeusedforcertaincleanactivities,includethedust‐freeassemblyof sterile equipment. Theseunits arenot biological safety cabinets and shouldnot busedusedwhenhandlingcellculturematerialsordrugformulationsasindividualscanbeexposedtomaterialswhichcancausehypersensitivity.UseofBiologicalSafetyCabinets:Tohelp facilitatetheregistrationandcertificationofanybiologicalsafetycabinet, it is requestedthatyounotifytheUniversityofWindsor’sBiologicalSafetyCabinetCoordinator(ChemicalControlCentre,ext.3523Option4) if abiological safety cabinet is tobeordered, installed,movedor relocated fromanotherinstitution.Theproposedlocationforthecabinetmustbeknown.Cabinets acquired from another institution or from another laboratory on campus, must bedecontaminated before being moved to University of Windsor laboratories. Documentation will berequired.Newcabinetsorcabinetswhichhavebeenmovedmustberecertifiedaftertheyareinstalledinthenewlocation.AllClassIIbiologicalsafetycabinetsmustberecertifiedannuallybyanapprovedtestingserviceAUniversityofWindsorBiologicalSafetyCertificatemusthavebeencompletedforalloftheagentsthatwillbeusedinthecabinet.Facilitiesmustbeconsultedforinstallationrequirements.

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UseofNaturalgasandpropaneisnotpermittedinsideClassIIcabinetsandisnotrecommendedinsideClassIcabinets.

FormoreinformationonBiologicalSafetyCabinetspleaseseetheUniversityofWindsor’sguidelinesonthe“SafeoperationofBiologicalSafetyCabinets”(www.uwindsor.ca/biosafety)

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AppendixE–LaboratoryDesignThissectionisdesignedtoprovideguidanceonthedesignandlayoutrequiredtoachievethefourcontainmentlevelsdetailedinSection3.

This section divided into five matrices: Laboratory Location and Access; Surface (i.e., floors, walls,ceilings, sealants) Finishes and Casework; Heating, Ventilation and Air Conditioning (HVAC);Containment Perimeter; and Laboratory Services (i.e., water, drains, gas, electricity and safetyequipment).Informationoncommissioning,certificationandrecertificationofthecontainmentfeaturesdetailedinthematricescanbefoundinSection1.

Legend: ‐Mandatory(LaboratoryBiosafetyGuidelines,3rdedition,2004)

‐Recommended(LaboratoryBiosafetyGuidelines,3rdedition,2004)

Level 1 2 3 4

Laboratory Location & Access

1 Separated from public areas by door. 2 Access limited to authorized personnel.

3

Laboratory room doors to have appropriate signage (e.g., biohazard sign, containment level, contact information, entry requirements).

4 Size of door openings to allow passage of all anticipated

equipment.

5 Doors to the containment laboratory lockable (this does not apply

to areas within the containment laboratory).

6 Doors to provide restricted access by installation of a controlled

access system (e.g., card key) or equivalent.

7 Electronic locking systems to be backed up with a physical key-

lock system.

8

Office areas to be located outside of containment laboratory. Paperwork stations for data collection can be within containment laboratory provided they are located away from laboratory work areas.

9 Entry to laboratory to be provided via an anteroom.

10

Anteroom door(s) located between the clean and dirty change rooms not to be opened simultaneously with either the containment laboratory door or the clean change entry door. (Interlock, visual or audible alarms, or protocols are all acceptable means.)

11

Anteroom door(s) located between the clean and dirty change rooms not to be opened simultaneously with either the containment laboratory door or the clean change entry door (interlock only).

12 Interlocked doors, if present, to have manual overrides for

emergency exit.

13

Entry to laboratory zone to be provided with clothing change areas separating personal and laboratory clothing dedicated to that zone (i.e., "clean" change area separated from "dirty" change area).

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14

Exit from laboratory to be provided with a walk-through shower on the containment barrier (i.e., between “dirty” and "clean" change anterooms). (CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation, are not required to fulfil this criterion.)

15

Entry to laboratory to be provided via anteroom with airtight doors (e.g., inflatable or compression seal); for laboratories using only a Class III BSC biological safety cabinet line, airtight doors are not required.

16

Entry to laboratory zone to be provided with a suit change area, a chemical shower on the containment barrier (i.e., between the laboratory and suit change area) and water shower on exit from the zone (i.e., between "dirty" and "clean" change areas); for laboratories using only a Class III biological safety cabinet line, suit change area and chemical shower are not required.

17

Containment laboratories to be located in close proximity to supporting mechanical services to limit the amount of potentially contaminated services.

18 Containment laboratories to be located away from external

building envelope walls.

19 A laboratory support area to be provided adjacent to the

containment facility for all supporting laboratory manipulations.

Level 1 2 3 4

Surfaces, Finishes, and Casework

1 Doors, frames, casework and bench tops to be nonabsorptive

(i.e., the use of organic materials should be avoided). 2 Working surfaces of bench tops to be non-absorptive.

3 Surfaces to be scratch, stain, moisture, chemical and heat

resistant in accordance with laboratory function.

4 Surfaces to provide impact resistance in accordance with

laboratory function.

5

Surfaces to be continuous and compatible with adjacent and overlapping materials (i.e., to maintain adhesion and a continuous perimeter); wall and floor welded seams are acceptable in level 3 laboratories.

6 Continuity of seal to be maintained between the floor and wall (a

continuous cove floor finish up the wall is recommended).

7 Interior surfaces to minimize movement of gases and liquid

through perimeter membrane.

8

Interior coatings to be gas and chemical resistant in accordance with laboratory function (e.g., will withstand chemical disinfection, fumigation).

9 Interior coatings to be cleanable.

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10

Structural stability to withstand 1.25 times maximum design pressure under supply and exhaust fan failure conditions (i.e., no wall distortion or damage).

11 Bench tops to have no open seams.

12 Bench tops to contain spills of materials (e.g., with marine edges

and drip stops).

13 Benches, doors, drawers, door handles, etc. to have rounded rims

and corners.

14 Backsplashes, if installed tight to wall, to be sealed at wall-bench

junction. 15 Reagent shelving to be equipped with lip edges.

16 Drawers to be equipped with catches, i.e., to prevent the drawer

from being pulled out of the cabinet. 17 Drawers to be of one piece construction. 18 Cabinet doors not to be self-closing.

Level 1 2 3 4

Containment perimeter

1 100% outside air to be supplied.

2 Directional inward airflow provided such that air will always flow

towards areas of higher containment (e.g., ± 25 Pa differential).

3 Visual pressure differential monitoring devices to be provided at

entry to containment laboratory.

4

Room pressure differential monitoring lines penetrating the containment barrier to be provided with filters of efficiency equal to that of HEPA filtration.

5

Alarm (visual or audible) to be provided in the laboratory and outside laboratory area (i.e., to warn others and maintenance personnel) to signal air handling systems failure.

6

Where determined necessary by a local risk assessment, supply air duct to be provided with backdraft protection (i.e., HEPA filter; bubble tight backdraft damper).

7 Supply air to be HEPA filtered.

8

Supply air system to be independent of other laboratory areas. CL3 supply can be combined with areas of lower containment when provided with backdraft protection (i.e., HEPA filter, bubble tight backdraft damper) downstream from the connection. (For CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation this criterion is only recommended.)

9

Supply air system to be interlocked (i.e., fans, dampers, electrical) with exhaust air system, to prevent sustained laboratory positive pressurization.

10

Exhaust air to be HEPA filtered. (CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation are not required to fulfil this criterion.)

11 Exhaust air to be passed through two stages of HEPA filtration.

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12 HEPA filters installed into the supply and exhaust system to

conform to the requirements of IEST-RP-CC001.3(1).

13 Supply HEPA filter housings to be designed to withstand structural

change at applied pressure of 2500 Pa [10 in. w.g.].

14

Where HEPA filters are used for backdraft protection in accordance with local risk assessment, supply HEPA filter housings to be designed to withstand structural change at applied pressure of 2500 Pa [10 in. w.g.].

15

Exhaust HEPA filter housings to be designed to withstand structural change at applied pressure of 2500 Pa [10 in. w.g.] and to be provided with a method of isolation and decontamination. (For CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation this criterion is only recommended.)

16

Exhaust air system to be independent of other laboratory areas. CL3 exhaust can be combined with areas of lower containment when provided with a HEPA filter upstream from the connection. (For CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation this criterion is only recommended.)

17 Supply and exhaust systems located outside of containment to be

accessible for repairs, maintenance, cleaning and inspection.

18

Supply air ductwork that is outside the containment perimeter (e.g., between containment perimeter and HEPA filter or bubble tight backdraft damper) to be sealed airtight in accordance with Sheet Metal and Air Conditioning Contractors National Association (SMACNA) Seal Class A(2).

19

Where backdraft protection is required in accordance with local risk assessment, supply air ductwork that is outside the containment perimeter (e.g., between containment perimeter and HEPA filter or bubble tight backdraft damper) to be sealed airtight in accordance with SMACNA Seal Class A(2).

20

Exhaust air ductwork that is outside the containment perimeter (e.g., between containment perimeter and HEPA filter or bubble tight backdraft damper) to be sealed airtight in accordance with SMACNA Seal Class A(2). (CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation are not required to fulfil this criterion.)

21

Airflow control devices and duct sensors to be located downstream of the exhaust HEPA filter and upstream of the supply bubble tight backdraft damper or HEPA filter, or if located upstream, duct penetrations to be sealed in accordance with SMACNA Seal Class A(2). (CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation are not required to fulfil this criterion.)

22

Bubble tight backdraft dampers and HEPA filters to be located in close proximity to the containment perimeter. (CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation are not required to fulfil this criterion.)

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Level 1 2 3 4

Laboratory Services (i.e., water, drains, gas, electricity, and safety equipment)

1 Autoclave or other acceptable means of waste treatment/disposal

to be provided.

2

Double-door barrier autoclave with bioseal to be located on containment barrier; body of autoclave to be preferably located outside of containment for ease of maintenance. (For CL3 laboratories manipulating organisms, such as HIV, that are not infectious via inhalation it is not mandatory that the autoclave be a double-door barrier model.)

3

Barrier autoclave to be equipped with interlocking doors, or visual or audible alarms to prevent both doors from opening at the same time.

4

Barrier autoclave to be equipped with interlocking doors, and visual or audible alarms to prevent both doors from opening at the same time.

5

For materials that cannot be autoclaved (e.g., heat sensitive equipment, samples, film) other proven technologies for waste treatment (e.g., incineration, chemical, or gas) to be provided at containment barrier.

6 All penetrations to be sealed with nonshrinking sealant at

containment barrier.

7 All conduit and wiring to be sealed with nonshrinking sealant at

the containment barrier. 8 Windows, if they can be opened, to be protected by fly screens.

9 Windows positioned on containment barrier to be sealed in place;

window glazing material to provide required level of security. 10 Observation windows to be installed on containment barrier.

Level 1 2 3 4

Laboratory Services (i.e., water, drains, gas, electricity, and safety equipment)

1 Hookstobeprovidedforlaboratorycoatsatlaboratoryexit;streetandlaboratory

clothingareastobeseparated.

2 Handwashingsinkstobelocatednearthepointofexitfromthelaboratoryorin

anteroom.NotapplicabletoCL4suitlaboratories.

3 Handwashingsinkstobeprovidedwith"hands‐free"capability.

4 BSCsandotherprimarycontainmentdevicestobeprovided.

5

BSCs and other primary containment devices to be provided. Examples for useincludeprocedureswiththepotentialforproducingaerosolsandthoseinvolvinghighconcentrations,largevolumesorparticulartypesofagents.

6 Emergency eyewash facilities to be provided in accordance with applicable

regulations(i.e.,ANSIZ358.1‐1998(3)).

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7 Emergency shower equipment to be provided in accordance with applicable

regulations(i.e.,ANSIZ358.1‐1998(3)).

8

Whenit isnotpossibleto limitthequantitiesofhazardouschemicalswithinthelaboratory, emergency shower equipment to be provided in accordance withapplicableregulations(i.e.,ANSIZ358.1‐1998(3)).

9

Domestic water branch piping serving laboratory area(s) to be provided withbackflowprevention,inaccordancewithCAN/CSA‐B64.10‐01/B64.10.1‐01(4),andisolationvalve,tobelocatedincloseproximitytothecontainmentbarrier.

10

Drain lines and associated piping (including autoclave condensate) to beseparated from lower containment laboratory areas and to go directly tomainbuilding sanitary sewer at point of exit from building (downstream of all otherconnections).

11

Drain lines and associated piping (including autoclave condensate) to beseparated fromareasof lower containmentand tobeconnected toaneffluentsterilizationsystem.

12

Drains connected to effluent sterilization to be sloped towards sterilizationsystemtoensuregravityflow;considerationshouldbegiventotheinstallationofvalves to isolate sections of piping for in situ decontamination; the effluentsterilization system (e.g., piping, valves, tank) tobeheat and chemical resistantconsistentwithapplication.

13 Autoclave condensate drain to have a closed connection. For CL3, open

connectionisallowableiflocatedwithincontainmentbarrier.

14 Drainagetrapstobeprovidedtorequireddeepsealdepthinconsiderationofair

pressuredifferentials.

15 Floor drains not to be provided, except when essential (e.g., body shower and

animalrooms).

16

Plumbing vent lines (includingeffluent sterilization system) tobeprovidedwithfilter of efficiency equivalent to that of HEPA and provided with a means ofisolationanddecontamination.

17

Plumbingventlinestobeindependentoflowercontainmentplumbingventlines,or combinedwith lines from lower containmentwhen providedwith a filter ofefficiency equivalent to that of HEPA upstream from the connection. (CL3laboratories manipulating organisms, such as HIV, that are not infectious viainhalationarenotrequiredtofulfilthiscriterion.)

18 Compressedgascylinder(s)tobelocatedoutsidethelaboratory.

19 Laboratorysupplygaspiping(e.g.,carbondioxide,compressedair)tobeprovided

withbackflowprevention.

20

Portablevacuumpumptobeprovided inthe laboratory. Internalcontaminationof vacuum pump to beminimized (e.g., HEPA filtration of vacuum line, use ofdisinfectanttraps).

21

Compressedbreathingairtobeprovidedtopositive‐pressurepersonalprotectiveequipment(i.e.,forconnectiontotheairhoseofsuits),equippedwithbreathingaircompressorsandback‐upcylinders(sufficientfor30minutesperperson);airhose connections to be provided in all areas where suits are worn, includingchemicalshowerandsuitchangeroom.

22 Emergencylightingtobeprovided.

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23 Life safety systems, lighting, HVAC systems, BSCs, security systems and other

essentialequipmenttobesupportedwithemergencyback‐uppower.

24 Circuitbreakerstobelocatedoutsidebiocontainmentarea.

25 Fluorescentlightballastsandstarterstobelocatedoutsidecontainmentarea.

26 Laboratory tobeequippedwithacommunicationsystembetweencontainment

areaandoutsidesupportarea.

27

System(e.g.,fax,computer)tobeprovidedforelectronictransferofinformationanddatafromlaboratoryareatooutsidelaboratoryperimeter.(Note:paperworkfrom the containment laboratory may be removed after appropriatedecontamination, i.e., autoclaving, irradiation, microwaving; such practices aregenerallynotrecommendedforuseonaroutinebasis).

28 Work area to be monitored (e.g., closed circuit TV) from outside laboratory

perimeter(e.g.,security/biosafetyoffice).

87|P a g e

AppendixF–ReferencesCanadian Council on Animal Care. Guide to the Care and Use of Experimental Animals. 2nd edition. Vol. 1, 1993; Vol. 2. Ottawa, Ontario. Canadian Standards Association. 1995. Biological Containment Cabinets: Installation and Field Testing. Etobicoke, Ontario. Canadian Standards Association. 1995. Evaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste. Etobicoke, Ontario. Canadian Standards Association. 1994. Fume Hoods and Associated Exhaust Systems. Rexdale, Ontario. Canadian Standards Association. 1988. Handling of Waste Materials within Health Care Facilities. Rexdale, Ontario. CRC Handbook of Laboratory Animal Science. Vol. 1. 1974. Melby EC Jr, Altman NH, eds. CRC Press, Cleveland, Ohio. CRC Handbook of Laboratory Safety. 1989. Furr AK, ed. CRC Press, Boca Raton, Florida. Government of Canada. Biotechnology Regulations: A Users Guide. 1991. Supply and Services Canada, Hull, Quebec. Laboratory Centre for Disease Control. 2003. Laboratory Biosafety Guidelines. 3nd edition. Health Canada, Ottawa, Ontario. National Institutes of Health. 1974. Biohazards Safety Guide. Washington, D.C. National Institutes of Health. 1986. Guidelines for Research Involving Recombinant DNA Molecules. Federal Register 51: 16958. National Institutes of Health. 1979. Laboratory Safety Monograph: a supplement to the NIH Guidelines for Recombinant DNA Research. US Dept. of Health and Human Services, Public Health Service. Washington, D. C. National Institutes of Health. 1984. Recombinant DNA Research: Actions under Guidelines. Guidelines for Research involving Recombinant DNA Molecules. Federal Register, parts V & VI, 46256-46291. National Research Council. 1989. Biosafety in the Laboratory: Prudent Practices for the Handling and Disposal of Infectious Materials. National Academy Press, Washington, D.C. Ontario Ministry of the Environment. 1986. Guidelines for the Handling and Disposal of Biomedical Wastes from Health Care Facilities and Laboratories. Toronto, Ontario. Recombinant DNA Advisory Committee. National Institutes of Health. 1989. Minutes of Meeting, October 6. Recombinant DNA Technical Bulletin 12: 213-252. Transportation of Dangerous Goods Act and Regulations. 1992. Ottawa. World Health Organization. 1993. Laboratory Biosafety Manual. 2nd edition. WHO, Geneva.

APPLICATIONFORBIOLOGICALSAFETYCERTIFICATE

TheUniversityofWindsorrequiresthatallResearcherspossessavalidbiologicalsafetycertificatewhenperformingresearchthatinvolvesbiologicalagents.Failuretoacquireabiologicalsafetycertificatewillleadtothewithholdingoffundinguntiltheapplicationprocessiscompleted.SectionA:ApplicantInformation:

PrincipleInvestigator:

Department: Building:

MailingAddress:

EmailAddress: TelephoneExt.:

SectionB:ProjectTitle(s)/FundingSponsorand/orAgencyInformation:

Title

Agency GrantNo. Start/EndDates

Title

Agency GrantNo. Start/EndDates

Title

Agency GrantNo. Start/EndDates

SectionC:Facilities/ProjectLocation

Building Room ContainmentLevel(1‐3)1

BiosafetyOfficeUseOnly

LastSiteVisit

1–BasedonHealthCanada’s“LaboratoryBiosafetyGuidelines”,3rdEdition,2004.

SiteSpecificHandling&EmergencyResponse:Please list the site specific instructions and safety protocols, including waste handling and spills response, that all lab workers will follow when handling the biohazardous materials specified in this application.

SectionD:BiologicalSafetyCabinet(s):Pleaseattachacopyofreport(s)ontestingandcertificationperformedwithinthelasttwelvemonths.

UWinID# Building Room BiosafetyOfficeUseOnly

DBaseUpdated

Section E: Animal Utilization: Indicate if biological agents are to be used on animals. Provide attachment whichbrieflyoutlinesprocedureswhichinvolveanimalsusedinconjunctionwithbiologicalagents.

None–Noanimalswillbeusedintheprojectsoutlinedin“SectionB” Non‐primatemammals Otheranimals:specify ApprovedbyAnimalCareCommittee(ACC) AnimalResearchProtocolNo: PendingApprovalfromAnimalCareCommittee(ACC)‐applicationsubmitted

FormoreinformationpleasevisittheUniversityofWindsor’sAnimalCareCommitteewebsite:

www.uwindsor.ca/accSectionF:RadiationUtilization:Indicateifbiologicalagentsaretobeusedinconjunctionwithradioisotopes.

None–Noradioisotopeswillbeusedintheprojectsoutlinedin“SectionB” Radioisotope Othertypeofradiation ApprovedbyRadiationSafetyCommittee(UWinRSC) InternalRadiationPermitNo. PendingApprovalfromRadiationSafetyCommittee(UWinRSC)‐applicationsubmitted

FormoreinformationpleasevisittheUniversityofWindsor’sRadiationSafetyProgramwebsite:

www.uwindsor.ca/radiation

SectionG:BiologicalAgentUtilization:Provideanattachmentwhichbrieflyoutlinestheprocedureswhichinvolvetheuseofbiologicalagents.UseofMicroorganisms:Ifno,pleaseproceedtonextsection.

KnowntobeaHumanpathogen

Animalpathogen

Plantpathogen

MaxQtyCultured

SourceNameofmicrobeorparasite

Yes No Yes No Yes No

PHAC CFIARecommendedContainmentLevel:

UseofCellCulture:Ifno,pleaseproceedtonextsection.

WillbeusedCellType

Yes NoEstablished/Primary

Specificcelllines Supplier

Human

Non‐humanprimate

Rodent

Other(specify)

PHAC CFIARecommendedContainmentLevel:

UseofHumanSourceMaterials:Ifno,pleaseproceedtonextsection.

WillbeusedMaterial

Yes NoSpecifysource/use

Humanblood(whole)

Humanblood(fraction)

Humantissue/organs(preserved)

Humantissue/organs(unpreserved)

Any human source known to have an infectiousagent

PHAC CFIARecommendedContainmentLevel:

DoesyourResearchProposalalsorequireapprovalthroughtheResearchEthicsBoard.Ifyes,provideyourREBfileno:___________________________

FormoreinformationpleasevisittheUniversityofWindsor’sResearchEthicsBoardwebsite:

www.uwindsor.ca/reb

UseofGeneticallyModifiedOrganisms/CellLines:Ifno,pleaseproceedtonextsection.

Willthegeneticsequencesbefromthefollowing: Yes NoAhumanoranimalpathogenandtheirtoxin? ARiskGroupOnemicroorganism? ARiskGroupTwomicroorganism? Knownoncogenes? Genetransduction Yes NoWillyouusealivevector(s)? Ifyes,specifysource/origin(s):_______________________________ Ifviral,isit(arethey)replicationdefective? Ifno,specifysource/origin(s):_______________________________ Isthevirusinfectioustohumansoranimals?

Section H: Regulatory Oversight: Does any of the work conducted within the specified locations require anyadditionalapprovalsorpermits.Ifyes,pleaseattachacopyoftheapprovaland/orpermitforallapplicablebiologicalagents.

CanadianFoodInspectionAgency2

PermitRequired(Yes/No/Unsure):

PermitNo:

2–CFIAregulatesactivitieswhichmaycauseinfectionswithinanimals.Formoreinformation,pleasevisittheirwebsiteathttp://www.inspection.gc.ca

PublicHealthAgencyofCanada3

PermitRequired(Yes/No/Unsure):

PermitNo:

3–PublicHealthAgencyregulatesactivitieswhichmaycauseinfectionswithinhumans.Formoreinformation,pleasevisittheirwebsiteathttp://www.phac‐aspc.gc.caSectionI:Personnel:Please listallpersonnel,regardlessofemploymentstatus,whowillbeusingbiologicalagentslistedwithinthisapplication;provideattachmentifspaceisinsufficient.

Name Title Student/EmployeeID BiosafetyOfficeUseOnly

DBaseUpdated

SectionJ:Immunization:If answering ‘no’ to any of these questions, please provide explanation on an attachment to this application form.

Question Yes No Do all of the above persons demonstrate antibody titres against those hazardous biological agents identified above for which a licensed immunizing agent is available to protect workers against infection?

Are medical certificates available to attest to the immunizations and / or adequate antibody titres?

Unless known to have pre-existing immunity, are these persons encouraged to obtain relevant immunization with a licensed immunizing agent to protect against infection by the identified hazardous biological agent?

Will this work require medical surveillance? If yes, please describe what type of medical surveillance is required:

SectionK:Declaration:

I declare that I am familiar with the contents of Health Canada’s Laboratory Biosafety Guidelines, 3rd Edition (2004) and that the above describes my research program, insofar as this includes the use of hazardous biological agents and materials, in its entirety. As the legally responsible individual, I will ensure that all research conducted under my direction in the above laboratories and by the above personnel conforms to the requirements of the University of Windsor’s Biological Safety Program. In addition, I understand that if either myself and/or designated personal are found to be in breach of either institutional and/or Health Canada guidelines all funding maybe frozen until corrective action is taken. Signature of Principle Investigator Date

Biological Safety Program Use Only: Institutional Responsible Official (RO): Select and circle: AP (Approved); CA (Conditionally Approved); RS (Review & Resubmit) Signature of Institutional Responsible Official (RO) Date Conditions/Comments:

University of Windsor Biological Safety Committee – Chair (UWinBSC): Select and circle: AP (Approved); CA (Conditionally Approved); RS (Review & Resubmit) Signature of Chair - UWBSC Date

Conditions/Comments:

BiologicalSafetyCertificateNo: IssuedDate: ExpiryDate: Classification: Restrictions:

NOTES:

A valid University of Windsor Biological Safety Certificate is required for all University laboratory activities which involve the use or manipulation of potentially hazardous biological agents and materials containing such agents, including bacteria, viruses, fungi, parasites, recombinant DNA, human and animal tissues and cells, and human and animal blood and body fluids. This requirement applies to activities which are either supervised by University employees or conducted within the University, irrespective of the source of the funds used to support this activity. Biological agents need not be overtly pathogenic; even agents which are “unlikely to cause disease in healthy workers or animals” are assigned to Risk Group 1 and require Containment Level 1 conditions for their manipulation. The required information must be typed or printed clearly and as completely as possible on the application form. Illegible applications and those lacking the required information will be returned unsigned. In general, a single application form may be used to identify all projects requiring the same Containment Level. Information attachments may be required and are acceptable if space is insufficient on the application form. Since attachments will not be returned, photocopies should be provided. The original documents should be retained by the Principal Investigator. A. Applicant Information: One name is allowed per application form. In the case of projects which are supervised collaboratively, one individual must be responsible for ensuring that the conditions of the permit are maintained. Generally, only one Biological Safety Certificate is required for each Principle Investigator (P.I.). B. Project Title(s)/Funding Sponsor and/or Agency Information: Project titles must be matched with the corresponding sponsor or agency which is funding the activity. All sources of financial support for the identified activities, whether internal or external, should be listed. Financial details are not required. Activities involving potentially hazardous biological agents and materials which are not directly supported by grants or contracts must also be reported on a University of Windsor Biological Safety Certificate. C. Facilities / Project Location: All laboratory facilities used by the Principal Investigator and her / his group for activities involving hazardous biological agents and materials must be listed, whether or not these are shared with others. The required Containment Level of individual rooms may be determined by referring to Health Canada’s Laboratory Biosafety Guidelines, 3rd edition (2004). The submission of an application for a University of Windsor Biological Safety Certificate implies willingness to allow the University of Windsor Responsible Official, Biological Officer, and/or his or her designate to visit the laboratory sites used by the Biological Safety Certificate holder in order to determine compliance with the requirements of the Biological Safety Program. D. Biological Safety Cabinet(s): Biological safety cabinets used in laboratory activities requiring Containment Level 2 and higher containment must be tested and approved for use annually, unless otherwise noted. For each such biological safety cabinet, attach a copy of the report on the testing and certification performed during the previous 12 month period. If cabinet testing was not performed within the past year or the report is more than 12 months old, please make the necessary arrangements and indicate the scheduled retesting date. For information about arranging this testing, consult the University of Windsor’s Responsible Officer (RO) – Biological Safety or the Biological Safety website. E. Identification of Animal Usage with Biological Agents: Indicate by marking the appropriate boxes, whether or not animals will be used in conjunction with biological agents in the identified project(s). Provide a brief outline identifying those activities involving both animals and biological agents, and the Animal Research Protocol Number(s). For more information, please visit the University of Windsor’s Animal Care Committee website. F. Identification of Radiological Usage with Biological Agents: Indicate by marking the appropriate boxes, whether or not radioisotopes will be used in conjunction with biological agents in the identified project(s). Provide a brief outline identifying those activities involving both radiological and biological agents, and the University of Windsor Radiation Safety Number(s). For more information, please visit the University of Windsor’s Radiation Safety Committee website. G. Identification of Biological Agent Usage: Indicate by marking the appropriate boxes and then specifying the biological agents and materials to be used. Provide and attach a brief outline identifying those procedures, activities and manipulations which involve the use of biological

agents in each project. Health Canada has identified four Risk Groups and assigned biological agents to these groups. Descriptions of cell and tissue cultures must indicate the species, whether they are primary or established lines, and whether they contain, or may contain, oncogenic or other viruses. In general, activities involving human blood, organs, tissues and cells must be conducted at a minimum of Containment Level 2. In some circumstances, such work may be conducted at a lower Containment level. However, if such is desired, documentation to justify this request must be attached to the application form for review by the Biological Safety Committee. When standard recombinant DNA techniques are used and the source of the genetic material being transferred, the vector (if any), and the recipient host are all innocuous or have low risk characteristics, no additional details are required. If there is potential for producing recombinant microorganisms with a significantly elevated level of risk, or if any of the constituent parts pose a higher risk, then disclosure is required on an attachment for review. H. Other Agency Approval or Permit: If the proposed activity requires the approval of any other agency (e.g., Public Safety, Canadian Food Inspection Agency, and Agriculture and Agri-Food Canada), evidence of such approval must be provided as an attachment. Provide and attach a copy of the approval or permit. I. Personnel: All personnel, including undergraduate and summer research students, directly involved in the identified project(s) of the Principal Investigator and working within the identified facilities must be listed. If new personnel start working on the project during the validity period of the certificate, the University of Windsor’s Responsible Officer (RO) – Biological Safety must be notified and provided with the information so that the certificate may be amended. J. Immunization: Laboratory personnel should be protected against laboratory-acquired infections by appropriate immunization with relevant, licensed vaccines unless documented to have pre-existing immunity. Hepatitis B immunization is strongly recommended for all persons who handle or are exposed to human blood, body fluids, organs or tissues. Immunoprophylaxis and information pertaining to the availability and the advisability of immunizing agents are available through the following: Windsor Essex Health Unit – Immunization Unit, 1005 Ouellette Avenue, Windsor, Ontario N9A 4J8 (519) 258-2416 ext. 1222. Immunizing agents are available to protect laboratory workers against: Anthrax Lyme disease Rabies Botulism Measles Rubella Cholera Meningococcus Tetanus Diphtheria Mumps Tuberculosis (BCG) Hemophilus influenzae type b Pertussis Typhoid Hepatitis A Plague Vaccinia Hepatitis B Pneumococcus Varicella Influenza A Polio Yellow fever Japanese encephalitis K. Declaration: By signing this declaration, the Principal Investigator acknowledges full responsibility for the activities under her /his supervision, and agrees to maintain and operate her / his laboratory facilities in compliance with the University of Windsor’s Biological Safety Program. Review and Approval: The completed, signed application form must be submitted to the University of Windsor’s Responsible Officer (RO) / Biosafety Officer for review and approval. If the proposed activity requires a permit or the approval of any other agency (e.g., Health Canada, Agriculture and Agri-Food Canada, Canadian Food Inspection Agency), evidence of such approval must be provided. Biological Safety Certificate Validity, Expiration, and Amendments: University Biological Safety Certificates for activities requiring Containment Level 1 are valid for 2 calendar years from the date of approval by the University Biological Safety Committee Chair or, in the case of renewals, from the expiration date of the previous Certificate. Similarly, University Biological Safety Certificates for activities requiring Containment Level 2 or Containment Level 3 are valid for 1 year only. Only those activities and agents identified on the application form and attachments are covered. Significant changes (e.g., use of additional hazardous biological agents and materials, new personnel, animal use) must be reported to the University of Windsor’s Responsible Officer (RO) – Biological Safety so that an

appropriate amendment may be made to the Biological Safety Certificate. The submission of another application form may not be necessary. In most cases, amendments will be recorded as an attachment to the current Certificate on file. Requests for an amendment must include the following information: (A) Principal Investigator’s name; (B) Principal Investigator’s signature; (C) Current University of Windsor Biological Safety Certificate number; and (D) Description of the requested amendment. This information must be provided to:

Chemical Control Centre University of Windsor Essex Hall – B37 401 Sunset Avenue Windsor, Ontario N9B 3P4 (519) 253-3000 ext. 3523 (p) (519) 973-7013 (f) ccc@uwindsor.ca (e)

Assistance, Information, and the World Wide Web: The University of Windsor’s Biological Safety Program is available at: http://www.uwindsor.ca/biosafety This site contains the text of the University of Windsor’s Biological Safety Program, reference guides, contact information, MSDS information, and other biological safety related information. Questions remaining unanswered after accessing this site, and requests for assistance should be directed to:

University of Windsor’s Responsible Officer – Biological Safety Chemical Control Centre University of Windsor Essex Hall – B37 401 Sunset Avenue Windsor, Ontario N9B 3P4 (519) 253-3000 ext. 3523 (p) (519) 973-7013 (f) ccc@uwindsor.ca (e)