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Biosafety Program Biosafety Program DevelopmentDevelopment

Presented by:Presented by:

Lisa Wisser, CIHLisa Wisser, CIH

AIHCE - June 6, 2001AIHCE - June 6, 2001

MROE Environmental

Risk Managementand Occupational

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OutlineOutline

Who Needs a Biosafety Program?Who Needs a Biosafety Program? Program ElementsProgram Elements Program ManagementProgram Management

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You Need a Program When...You Need a Program When...

You use Risk Group 3 or 4 agentsYou use Risk Group 3 or 4 agents Otherwise:Otherwise:

– Are you using Risk Group 2 agents or Are you using Risk Group 2 agents or materials?materials?

– ……in high concentrations or large in high concentrations or large quantities? quantities?

– ……in aerosol generating procedures?in aerosol generating procedures?

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You Need a Program When...You Need a Program When...

Regulators insistRegulators insist– OSHA - Bloodborne PathogensOSHA - Bloodborne Pathogens– CDC - Select Agents and ToxinsCDC - Select Agents and Toxins– NIH - Recombinant DNANIH - Recombinant DNA– USDA APHIS - Plant PathogensUSDA APHIS - Plant Pathogens

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You Need a Program When...You Need a Program When...

No matter what agents or No matter what agents or materials are used:materials are used:– One of your employees develops a One of your employees develops a

laboratory-acquired infectionlaboratory-acquired infection– Your researchers disregard standard Your researchers disregard standard

microbiological practices or lack microbiological practices or lack training in microbiologytraining in microbiology

– Your customer requires a program Your customer requires a program

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CDC Maximum Containment Laboratory, Atlanta

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Biosafety Program GoalsBiosafety Program Goals

Assist laboratory research and Assist laboratory research and support personnel in working safely support personnel in working safely with biological agents and materialswith biological agents and materials

Meet regulatory requirements and Meet regulatory requirements and guidelinesguidelines

Provide a competitive advantage to Provide a competitive advantage to the organizationthe organization

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Go!

Tools

Committee

Needs assessment

Management support

Program DevelopmentProgram Development

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Go!

ToolsCommittee

Needs assessment Management support

Program DevelopmentProgram Development

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Program ElementsProgram Elements

Management supportManagement support– Laboratory managementLaboratory management

Responsible for safety in the laboratoriesResponsible for safety in the laboratories

– Facility managementFacility management Facility maintenance and improvementFacility maintenance and improvement

– EHS managementEHS management Technical supportTechnical support Program coordinationProgram coordination

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Program ElementsProgram Elements

Needs AssessmentNeeds Assessment– Listen to the research staffListen to the research staff– Facility walkthroughFacility walkthrough

Inspection formInspection form Keep records andKeep records and

follow upfollow up Report to CommitteeReport to Committee

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Program ElementsProgram Elements

Needs AssessmentNeeds Assessment– SurveySurvey

Mail, e-mail, in person, etc.Mail, e-mail, in person, etc. Who works with what whereWho works with what where

– Records reviewRecords review Training - identify needs such as emergency Training - identify needs such as emergency

and spill response, waste handling, hazard and spill response, waste handling, hazard identification, and exposure controlidentification, and exposure control

Medical SurveillanceMedical Surveillance

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Program ElementsProgram Elements

Institutional Biosafety Committee Institutional Biosafety Committee (IBC)(IBC)– MembersMembers

Principal Investigators / MicrobiologistsPrincipal Investigators / Microbiologists Occupational PhysicianOccupational Physician Biosafety Specialist Biosafety Specialist EHS Team / Emergency ResponseEHS Team / Emergency Response Other SpecialistsOther Specialists

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Program ElementsProgram Elements

Institutional Biosafety Committee Institutional Biosafety Committee (IBC)(IBC)– ProceduresProcedures– Risk AssessmentRisk Assessment

PathogensPathogens rDNArDNA Select agentsSelect agents Human blood and tissuesHuman blood and tissues Other hazardsOther hazards

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Program ElementsProgram Elements

Institutional Biosafety Committee Institutional Biosafety Committee (IBC)(IBC)– Coordinate with other committeesCoordinate with other committees

Animal Care and Use Animal Care and Use Human Subjects ReviewHuman Subjects Review Radiation SafetyRadiation Safety Laboratory SafetyLaboratory Safety

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Program ElementsProgram Elements

ToolsTools– Biological Use Authorization FormBiological Use Authorization Form

Researcher informationResearcher information Agents/materials usedAgents/materials used rDNA informationrDNA information Work descriptionWork description Others…Others…

– Renewal period - e.g., 2/3 yrsRenewal period - e.g., 2/3 yrs

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Program ElementsProgram Elements

ToolsTools– DatabaseDatabase

Track BUAsTrack BUAs Agents/materialsAgents/materials ResearchersResearchers LaboratoriesLaboratories OthersOthers

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Program ElementsProgram Elements

ToolsTools– Develop standard procedures, such Develop standard procedures, such

as:as: Standard microbiological practicesStandard microbiological practices Sample receipt Sample receipt and handlingand handling Decontamination Decontamination Waste handlingWaste handling Packaging andPackaging and shipmentshipment

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Program ElementsProgram Elements

ToolsTools– More standard procedures...More standard procedures...

Biological safety cabinet use and Biological safety cabinet use and maintenancemaintenance

Spill and emergency responseSpill and emergency response Ventilation requirementsVentilation requirements SharpsSharps PPEPPE

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Program ElementsProgram Elements

Go!Go!– Beta testBeta test– Roll out to all identified on databaseRoll out to all identified on database

Communicate expectationsCommunicate expectations Train on proceduresTrain on procedures

– Offer extensive helpOffer extensive help Resources - person to answer questions, Resources - person to answer questions,

web resources, web site, forms, etc. web resources, web site, forms, etc.

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Program ElementsProgram Elements

Go!Go!– More on trainingMore on training

introductory laboratory biosafetyintroductory laboratory biosafety annual BBP and biosafety refresherannual BBP and biosafety refresher IBC proceduresIBC procedures specialized situations - new lab workspecialized situations - new lab work emergency response emergency response

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Program ManagementProgram Management

ResponsibilitiesResponsibilities– ResearchersResearchers– IBCIBC– Biosafety OfficerBiosafety Officer

ProcessesProcesses– Medical Medical

surveillancesurveillance– TrainingTraining– Safety proceduresSafety procedures– Spill responseSpill response– Emergency Emergency

responseresponse– Periodic program Periodic program

reviewreview

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Program ManagementProgram Management

ElementsElements– Audits and inspectionsAudits and inspections– Quarterly reports to IBCQuarterly reports to IBC– Ongoing communication with other Ongoing communication with other

committeescommittees– Regulatory compliance - BBP, select Regulatory compliance - BBP, select

agents, medical waste, rDNA, BMBLagents, medical waste, rDNA, BMBL

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SummarySummary

Evaluate what you need in a Evaluate what you need in a “program”“program”

Roll out the program in a logical Roll out the program in a logical sequencesequence

Ensure consistent program Ensure consistent program managementmanagement

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Useful ResourcesUseful Resources

http://www.cdc.gov/od/ohs/default.htm (CDC OHS)http://www.cdc.gov/od/ohs/default.htm (CDC OHS) http://www.cdc.gov/od/ohs/biosfty/bmbl4/http://www.cdc.gov/od/ohs/biosfty/bmbl4/

bmbl4toc.htm (BMBL)bmbl4toc.htm (BMBL) http://www.cdc.gov/od/ohs/lrsat.htm (LR/SAT)http://www.cdc.gov/od/ohs/lrsat.htm (LR/SAT) http://www4.od.nih.gov/oba/rdna.htm http://www4.od.nih.gov/oba/rdna.htm http://www.absa.org/ http://www.absa.org/ http://www.hhmi.org/http://www.hhmi.org/ Biological Safety, Principles and PracticesBiological Safety, Principles and Practices. 3rd . 3rd

edition. Ed. by D. O.Fleming and D. L. Hunt. ASM edition. Ed. by D. O.Fleming and D. L. Hunt. ASM Press. Press.