Discuss the major characteristics of the four Biosafety Levels.

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• Discuss the major characteristics of the four
  Biosafety Levels.
• Define Risk Group and give an example of each.
• Discuss how Risk Groups are used in conjunction
  with risk assessment to set Biosafety Levels.

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• Assignment of agent based on risk assessment
• Depends on agent and conditions of use
• Requires professional judgment

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• Suitable for work involving well-characterized
  agents not
• known to consistently cause disease in
  immunocompetent adult humans
• minimal potential hazard to laboratory personnel
  and the environment.
• laboratories are not necessarily separated from
  the general traffic patterns in the building.
• Work is typically conducted on open bench tops
  using standard microbiological practices.
• Special containment equipment or facility design
  is not required,
• Laboratory personnel must have specific training
  in the procedures conducted in the laboratory and
  must be supervised by a
• scientist with training in microbiology or a
  related science.

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Biosafety Level 1
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• Builds upon BSL-1
• BSL-2 is suitable for work involving agents that
  pose moderate hazards to personnel and the
  environment.
• Laboratory personnel have specific training in
  handling pathogenic agents
• Personnel are supervised by scientists competent
  in handling infectious agents and associated
  procedures
• Access to the laboratory is restricted when work
  is being conducted
• all procedures in which infectious aerosols or
  splashes may be created are conducted in
  biological safety cabinets (BSCs) or other
  physical containment equipment.

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Biosafety Level 2
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• Is applicable to clinical, diagnostic, teaching,
  research, or
• production facilities where work is performed
  with indigenous or exotic agents that may cause
  serious or potentially lethal disease through
  inhalation route exposure.
• Laboratory personnel must receive specific
  training in handling pathogenic and potentially
  lethal agents
• Must be supervised by scientists competent in
  handling infectious agents and associated
  procedures.
• Biosafety Level 2 plus all procedures involving
  the manipulation of infectious materials must be
  conducted within BSCs, or other physical
  containment devices
• Personnel wear additional appropriate personal
  protective equipment including respiratory
  protection as determined by risk assessment
• A BSL-3 laboratory has special engineering and
  design features.
• Directional air flow

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Biosafety Level 3
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• Required for work with dangerous and exotic
  agents that pose a high 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 agents requiring BSL-4
  containment must be handled at this level until
  sufficient data are obtained either to confirm
  continued work at this level, 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
  secondary containment functions of standard and
  special practices, containment equipment, and
  laboratory design characteristics.
• All laboratory staff and supervisors must be
  competent in handling agents and procedures
  requiring BSL-4 containment.
• Access to the laboratory is controlled by the
  laboratory supervisor in accordance with
  institutional policies
• Two types of laboratory providing absolute
  separation of the worker from the infectious
  agents
• Suit Laboratory
• Cabinet Laboratory

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Biosafety Level 4
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CDC/NIH Guidelines Biosafety Levels (www.cdc.gov)
BSL-1
BSL-3
Lower Risk
BSL-2
Higher Risk
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• 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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• High individual risk, low community risk
• Pathogen usually causes serious human or animal
  disease but does not ordinarily spread to others
• Effective treatment and preventive measures are
  available

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• High individual and community risk
• A pathogen causes serious human or animal
  disease readily transmitted from one individual
  to another
• Effective treatment and preventive measures are
  usually not available

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Risk Group
Biosafety Level
Laboratory Type
Laboratory Practices
Safety Equipment
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Basic Biosafety Level 1
Basic teaching, research
GMT
None open bench work
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Basic Biosafety Level 2
Primary health services diagnostic services,
research
GMT plus protective clothing, biohazards sign
Open bench plus BSC for aerosols
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Risk Group
Biosafety Level
Laboratory Type
Laboratory Practices
Safety Equipment
3
Containment- Biosafety Level 3
Special diagnostic services, research
Level 2 special clothing, access control,
directed airflow
BSC and/or other primary devices for all
activities
4
Maximum Containment Biosafety Level 4
Dangerous pathogen units
Level 3 airlock entry, shower exit, special
waste disposal
Class III BSC, or positive pressure suites with
class II BSCs, double ended autoclave
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