Biological Risk Assessment...New York State Department of Health Wadsworth Center Biohazard Risk Assessment • What is it? – Agent-based qualitative risk estimate. • Safe when

New York State Department of Health

Wadsworth CenterWadsworth Center

Biological Risk AssessmentBiological Risk Assessment

David HillDavid HillDirector, Safety and SecurityDirector, Safety and Security

Wadsworth CenterWadsworth CenterNew York State Department of HealthNew York State Department of Health

Risk Assessment WebinarRisk Assessment WebinarJune 15, 2011June 15, 2011



Biohazard Risk AssessmentBiohazard Risk Assessment

•• What is it?What is it?–– AgentAgent--based based qualitativequalitative risk risk estimateestimate..

•• Safe when risk associated with task is considered Safe when risk associated with task is considered to be acceptable.to be acceptable.

•• What needs to be reviewed?What needs to be reviewed?–– From accessioning to waste disposal.From accessioning to waste disposal.

•• Most important component is professional Most important component is professional judgment.judgment.



Why do it and document it?Why do it and document it?

Standards & guidelines driving biohazard risk Standards & guidelines driving biohazard risk assessments:assessments:

OSHA Bloodborne Pathogen Standard (29 CFR OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030)1910.1030) ““Exposure control plans shall be update at least annually and Exposure control plans shall be update at least annually and

whenever necessary to whenever necessary to reflect new or modified tasks and reflect new or modified tasks and procedures which affect occupational exposureprocedures which affect occupational exposure..””

““Document annual consideration and implementation of Document annual consideration and implementation of appropriate and effective safer medical devices designed to appropriate and effective safer medical devices designed to eliminate or minimize occupational exposureeliminate or minimize occupational exposure..”” (Needlestick (Needlestick Safety and Prevention Act, 2000)Safety and Prevention Act, 2000)





OSHA Bloodborne Pathogen Standard (29 CFR OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030)1910.1030)

The CDC/NIH Booklet The CDC/NIH Booklet ““Biosafety in Microbiological and Biosafety in Microbiological and Biomedical Laboratories (BMBL)Biomedical Laboratories (BMBL)””, 5th Edition (2007), 5th Edition (2007)



Evolution of CDC/NIH BMBL Evolution of CDC/NIH BMBL





OSHA Bloodborne Pathogen Standard (29 CFR OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030)1910.1030)

The CDC/NIH Booklet The CDC/NIH Booklet ““Biosafety in Microbiological and Biosafety in Microbiological and Biomedical Laboratories (BMBL)Biomedical Laboratories (BMBL)””, 5th Edition (2007), 5th Edition (2007)

NYS DOH CLEP NYS DOH CLEP –– Safety Standards (Effective Safety Standards (Effective November 1, 2010)November 1, 2010) Revised to be consistent with BMBLRevised to be consistent with BMBL

CDC/APHIS CDC/APHIS -- Select Agent Regulations: Possession, Select Agent Regulations: Possession, use, and transfer of select agents.use, and transfer of select agents.



Risk AssessmentRisk Assessment



Biosafety Risk Assessment and Biosafety Risk Assessment and Management ProcessManagement Process

Five step processFive step process::Risk AssessmentRisk Assessment

1)1) Perform comprehensive hazard evaluation and Perform comprehensive hazard evaluation and determine initial biosafety level (BSL).determine initial biosafety level (BSL).

2)2) Identify laboratory procedure hazardsIdentify laboratory procedure hazards1)1) Determining riskDetermining risk2)2) Determining acceptability of riskDetermining acceptability of risk

Risk ManagementRisk Management3)3) Determine final containment (BSL) with any additional Determine final containment (BSL) with any additional

safety enhancementssafety enhancements4)4) Evaluate staff proficiency and safety equipment integrityEvaluate staff proficiency and safety equipment integrity5)5) Review with knowledgeable individualsReview with knowledgeable individuals



Biosafety Risk AssessmentBiosafety Risk Assessment

(Agent Hazards)(Agent Hazards) (Lab Procedure Hazards)(Lab Procedure Hazards)



Agent HazardsAgent Hazards

•• What are the principle hazardous What are the principle hazardous characteristics of an agent?characteristics of an agent?

–– Its capability to infect and cause diseaseIts capability to infect and cause disease–– The severity of the diseaseThe severity of the disease–– Availability of preventative measures and Availability of preventative measures and

treatments for the diseasetreatments for the disease–– Route of transmissionRoute of transmission

•• Transmission via aerosol is most serious hazard.Transmission via aerosol is most serious hazard.–– Infective dose and agent stability key factors.Infective dose and agent stability key factors.

–– History of LaboratoryHistory of Laboratory--acquired infection (LAI)acquired infection (LAI)



Determine the proper risk groupDetermine the proper risk group

RISK GROUP 1:

RISK GROUP 2:

RISK GROUP 3:

RISK GROUP 4:

Agents are not associated with disease in healthy human adults

Agents associated with human diseases that are rarely serious. Effective preventive or treatment options are often available.

Agents are associated with serious or potentially lethal diseases for which effective preventive or treatment options may be available.

Agents are likely to cause serious or lethal disease. Effective preventive or treatment options are not usually available.



Section VIIISection VIIIAgent Summary StatementsAgent Summary Statements

•• Good Source of Info:Good Source of Info:–– AgentAgent

–– Occupational InfectionsOccupational Infections

–– Natural Modes of InfectionNatural Modes of Infection

–– Laboratory SafetyLaboratory Safety

–– Containment RecommendationsContainment Recommendations

–– Special IssuesSpecial Issues•• VaccinesVaccines

•• Select AgentSelect Agent

•• Transfer of AgentTransfer of Agent

•• Post Exposure Treatment Post Exposure Treatment



Material Safety Data SheetsMaterial Safety Data Sheets

•• MSDSs are available for certain MSDSs are available for certain infectious agents.infectious agents.

•• Health Canada Office of Laboratory SecurityHealth Canada Office of Laboratory Security

•• MSDS content:MSDS content:–– Section 1: Infectious AgentSection 1: Infectious Agent

–– Section 2: Health HazardSection 2: Health Hazard

–– Section 3: DisseminationSection 3: Dissemination

–– Section 4: ViabilitySection 4: Viability

–– Section 5: Medical Section 5: Medical

–– Section 6: Laboratory HazardsSection 6: Laboratory Hazards

–– Section 7: Recommended PrecautionsSection 7: Recommended Precautions

–– Section 8: Handling InformationSection 8: Handling Information

–– Section 9: Miscellaneous InformationSection 9: Miscellaneous Information



Agent HazardsAgent Hazards

•• What about clinical specimens with What about clinical specimens with unknown risks?unknown risks?–– Past experiencePast experience

•• Have you seen high risk agents in your lab?Have you seen high risk agents in your lab?

–– Medical data on patient if available.Medical data on patient if available.–– Geographic origin of specimenGeographic origin of specimen–– Ad hoc guidelines during outbreaks (e.g., West Ad hoc guidelines during outbreaks (e.g., West

Nile Virus, SARSNile Virus, SARS--CoV, etc).CoV, etc).



Lab Procedure HazardsLab Procedure Hazards

Assess specific tasks within each method or procedure.

Consider all sources and routes of exposure:

Manipulations that produce droplets and aerosols

Pipetting, blenders, centrifuges (without primary containment), sonicators, and vortex mixers

Manipulations involving sharps

Manipulations with high potential for spills and splashes

New/emerging technologies




Assess automated systems and other emerging technology for exposure risks.




•• Important to define what constitutes an Important to define what constitutes an ““exposure incidentexposure incident”” or or ““occupational occupational exposureexposure”” in advance of incidents.in advance of incidents.–– Exposure incidentExposure incident (OSHA BBP): (OSHA BBP): ““means a specific means a specific

eye, mouth, or other mucous membrane, noneye, mouth, or other mucous membrane, non--intact skin, or parenteral contact with blood or intact skin, or parenteral contact with blood or OPIMOPIM…”…”

–– Occupational exposureOccupational exposure (CDC/APHIS Select Agent (CDC/APHIS Select Agent Regulations): Regulations): ““Any event that results in any Any event that results in any personperson…….not being appropriately protected in the .not being appropriately protected in the presence of an agent or toxinpresence of an agent or toxin…”…”



Risk ManagementRisk Management



Biosafety Risk Assessment and Biosafety Risk Assessment and Management ProcessManagement Process

Five step processFive step process::Risk AssessmentRisk Assessment

1)1) Perform comprehensive hazard evaluation and Perform comprehensive hazard evaluation and determine initial biosafety level (BSL).determine initial biosafety level (BSL).

2)2) Identify laboratory procedure hazardsIdentify laboratory procedure hazards1)1) Determining riskDetermining risk2)2) Determining acceptability of riskDetermining acceptability of risk

Risk ManagementRisk Management3)3) Determine final containment (BSL) with any additional Determine final containment (BSL) with any additional

safety enhancementssafety enhancements4)4) Evaluate staff proficiency and safety equipment integrityEvaluate staff proficiency and safety equipment integrity5)5) Review with knowledgeable individualsReview with knowledgeable individuals



•• OSHA Bloodborne Pathogen StandardOSHA Bloodborne Pathogen Standard–– Shall establish a written Exposure Control PlanShall establish a written Exposure Control Plan

•• CDC/NIH BMBLCDC/NIH BMBL–– A laboratoryA laboratory--specific biosafety manual must be prepared specific biosafety manual must be prepared

and adopted as policyand adopted as policy–– Four recommended laboratory practicesFour recommended laboratory practices

•• Biosafety levels 1 Biosafety levels 1 -- 44

•• NYSDOH CLEP StandardNYSDOH CLEP Standard–– Shall describe use of biosafety equipment, practices, Shall describe use of biosafety equipment, practices,

and procedures in laboratoryand procedures in laboratory’’s safety manual.s safety manual.–– Minimally meet biosafety level 2Minimally meet biosafety level 2

•• Describe additional procedures for suspected high risk Describe additional procedures for suspected high risk pathogens.pathogens.

Managing Risks Managing Risks



Thank You!Thank You!

David HillDavid HillDirector, Safety and SecurityDirector, Safety and SecurityWadsworth CenterWadsworth Center(518) 486(518) 486--38743874Email:Email: [email protected]@health.state.ny.us

Biological Risk Assessment...New York State Department of Health Wadsworth Center Biohazard Risk Assessment • What is it? – Agent-based qualitative risk estimate. • Safe when

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