biosafety levels and risk groups (1)

8/2/2019 Biosafety Levels and Risk Groups (1)

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Biosafety Levels and Risk

GroupsUnit I


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Objectives

Discuss the major characteristics of thefour Biosafety Levels.

Define Risk Group and give an example

of each.

Discuss how Risk Groups are used inconjunction with risk assessment to setBiosafety Levels.


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Biosafety Levels

Assignment of agent based on riskassessment

Depends on agent and conditions ofuse

Requires professional judgment

World HealthOrganization

National Institutesof Health


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Biosafety Level 1

Suitable for work involving well-characterized agents notknown to consistently cause disease inimmunocompetent adult humansminimal potential hazard to laboratory personnel and theenvironment.

laboratories are not necessarily separated from thegeneral traffic patterns in the building.Work is typically conducted on open bench tops usingstandard microbiological practices.Special containment equipment or facility design is not

required,Laboratory personnel must have specific training in theprocedures conducted in the laboratory and must besupervised by ascientist with training in microbiology or a related

science.


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Biosafety Level 1


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Biosafety Level 1


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Biosafety Level 2

Builds upon BSL-1BSL-2 is suitable for work involving agents that posemoderate hazards to personnel and the environment.Laboratory personnel have specific training in handling

pathogenic agentsPersonnel are supervised by scientists competent inhandling infectious agents and associated proceduresAccess to the laboratory is restricted when work is beingconducted

all procedures in which infectious aerosols or splashesmay be created are conducted in biological safetycabinets (BSCs) or other physical containmentequipment.


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MandatoryWarning Sign

Designate

Biosafety LevelSpecial EntryProcedures Immunizations

PPEContactInformation


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Biosafety Level 2


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Biosafety Level 3

Is applicable to clinical, diagnostic, teaching, research, orproduction facilities where work is performed with indigenous orexotic agents that may cause serious or potentially lethal diseasethrough inhalation route exposure.Laboratory personnel must receive specific training in handlingpathogenic and potentially lethal agents

Must be supervised by scientists competent in handling infectiousagents and associated procedures.Biosafety Level 2 plus all procedures involving the manipulation ofinfectious materials must be conducted within BSCs, or otherphysical containment devicesPersonnel wear additional appropriate personal protective

equipment including respiratory protection as determined by riskassessmentA BSL-3 laboratory has special engineering and design features. Directional air flow


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Biosafety Level 3


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Biosafety Level 3


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Biosafety Level 4Required for work with dangerous and exotic agents that pose ahigh individual risk of life-threatening disease, aerosol

transmission, or related agent with unknown risk of transmission.Agents with a close or identical antigenic relationship to agentsrequiring BSL-4 containment must be handled at this level untilsufficient data are obtained either to confirm continued work at thislevel, or re-designate the level.Laboratory staff must have specific and thorough training in

handling extremely hazardous infectious agents.Laboratory staff must understand the primary and secondarycontainment functions of standard and special practices,containment equipment, and laboratory design characteristics.All laboratory staff and supervisors must be competent in handlingagents and procedures requiring BSL-4 containment.

Access to the laboratory is controlled by the laboratory supervisor inaccordance with institutional policiesTwo types of laboratory providing absolute separation of the workerfrom the infectious agents Suit Laboratory Cabinet Laboratory


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Biosafety Level 4

osa ety eve ummary a e


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osa ety eve ummary a e


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BSL-2

BSL-3

BSL-1

CDC/NIH GuidelinesBiosafety Levels

(www.cdc.gov)

Lower Risk

Higher

Risk


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Factors To Consider In Classification

Pathogenicity of the agent

Modes of transmission and host range of

organism

Local availability of preventive measures

Local availability of effective treatment




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Risk Group 2 Agents

Moderate individual risk, low communityrisk

Pathogen causes human or animaldisease but is unlikely to be a serious

hazard to laboratory workers, thecommunity, livestock or the environment

May cause serious infection but effectivetreatments and preventive measures are

availableRisk of spread is limited




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Risk Group 3 Agents

High individual risk, low community risk

Pathogen usually causes serioushuman or animal disease but does notordinarily spread to others

Effective treatment and preventivemeasures are available




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Risk Group 4 Agents

High individual and community risk

A pathogen causes serious human oranimal disease; readily transmitted fromone individual to another

Effective treatment and preventivemeasures are usually not available




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Risk Groups and Biosafety Levels

RiskGroup

BiosafetyLevel

Laboratory Type LaboratoryPractices

SafetyEquipment

1

Basic Biosafety

Level 1

Basic teaching,research

GMT None; openbench work

2

Basic BiosafetyLevel 2

Primary healthservices;diagnostic

services,research

GMT plusprotectiveclothing,

biohazardssign

Open benchplus BSC foraerosols




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Risk Groups and Biosafety Levels

RiskGroup

Biosafety Level Laboratory Type LaboratoryPractices

SafetyEquipment

3

Containment-BiosafetyLevel 3

Specialdiagnosticservices,

research

Level 2 +special clothing,access control,

directed airflow

BSC and/orother primarydevices for all

activities

4

MaximumContainmentBiosafetyLevel 4

Dangerouspathogen units

Level 3 + airlockentry, showerexit, specialwaste disposal

Class III BSC,or positivepressure suiteswith class IIBSCs, doubleendedautoclave

World Health National Institutes

biosafety levels and risk groups (1)

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