« Community Report of the 01.10.07 WRTF Meeting | Main | Meeting Announcement - 04.11.07 »

Bio-Safety Level Explanations

Bio-Safety Level	Brief Overview of Safety Regulations
Level 1	Bio-Safety Level 1 is suitable for work involving well-characterized agents not known to consistently cause disease in healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment. The laboratory is not necessarily separated from the rest of the building. Special containment equipment of facility design is neither required nor generally used.
Level 2	Bio-Safety Level 2 is similar to BSL 1 and is suitable for work involving agents of moderal potential hazard to personnel and the environment. It differs from BSL 1 in that: Laboratory personnel have specifically training in handling pathogenic agents and are directed by component scientists; Access to the laboratory is limited when work is being conducted Extreme precautions are taken with contaminated sharp items; Certain procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets or other physical containment equipment.
Level 3	Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities. The following are regulations that make BSL 3 safer than BSL 2: Laboratory personnel have specific training in handling pathogenic and potentially lethal agents, and are supervised by competent scientists who are experienced in working with these agents. ALL procedures involving the manipulation of infectious materials are conducted within biological safety cabinets or other physical containment devices, or by personnel wearing appropriate personal protective clothing and equipment. The laboratory has special engineering and design features. (i.e., double-door access zone and sealed penetrations.)
Level 4	Bio-Safety Level 4 is required for work with dangerous and exotic agents that post a high level individual risk of aerosol-transmitted laboratory infections and life-threatening disease (e.g. Ebola). Agents with a close or identical antigenic relationship to Bio-Safety Level 4 agents are handled at this level until sufficient data are obtained either to confirm continued work at this level, or to work with them at a lower level. The facility is either in a separate building or in a controlled area within the building, which is completely isolated from all other areas of the building. A specific facility operations manual is prepared or adopted. Within work areas of the facility, all activities are confined to Class III biological safety cabinets, or Class II biological safety cabinets used with one-piece positive pressure personnel suits ventilated by a life support system. BSL 4 laboratories have special engineering and design features to prevent microorganisms from being disseminated inot the environment. The laboratory is kept at negative air pressure, so that air flows into the room if the barrier is penetrated or breached; used during personnel entry/exit.

Upgrading a BSL 2 to BSL 3

A BSL 2 laboratory can be upgraded to a BSL 3 facility if an acceptable level of safety for the conduct of routine procedures, (e.g., diagnostic procedures involving the propagation of an agent for identification, typing, susceptibility testing, etc.), is achieved in a Bio-Safety Level 2 facility. The requirement of a BSL 3 laboratory can be met by providing:

• The exhaust air from the laboratory room is discharged to the outdoors,


• The ventilation to the laboratory is balanced to provide directional airflow into the room,


• Access to the laboratory is restricted when work is in progress


• The recommended Standard Microbiological Practices, Special Practices, and Safety Equipment for Bio-Safety Level 3 are rigorously followed.

The decision to implement this modification of Bio-Safety Level 3 recommendations should be made only the laboratory director.

Summary on Bio-Safety Levels

Note: Biocontainment can be classified by the relative danger to the surrounding environment as biological safety levels (BSL). As of 2006, there are four safety levels. These are called BSL 1 through BSL 4. Higher number indicate higher safety measures in dealing with potential public health hazards.

At the lowest level of biocontainment, the containment zone may only be a fume hood that utilizes HEPA filters. At the highest level the containment involves isolation of the organism by means of building systems, seald rooms, sealed containers, personal isolation equipment similar to "space suits" and elaborate procedures for entering the room, and decontamination procedures for leaving the room. In most cases this also includes high levels of security for access to the facility, ensuring that only authorized personnel may be admitted to any area that may have some effect on the quality of the containment zone.

** The Hawaii State Laboratories and its associates do not have the capacity nor intent to upgrade the facilities beyond what it already has. The Department of Health is simply seeking BSL 3 certification to authorize rapid response to public health hazards.

Posted on March 8, 2007 3:02 PM | Permalink