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Biosafety
Refers to the hazards and potential risks of various biological factors to the country’s social, economic, human health, and ecological environments, and is an integral part of national security (Li et al., 2019).
More Defined:
Refers to the existing or potential hazards to humans, animals, or plants caused by a biological vector, by directly infecting or indirectly destroying the environment
- microbiological practices
- safety equipment
- facility safeguards
The fundamentals of containment:
Laboratory Workers
The Environment
The Public
facility safeguards that protect
Risk Assessment
the process that enables the appropriate selection of microbiological practices, safety equipment, and facility safeguards that can help prevent Laboratory- associated infections (LAI).
Safety Equipment (Primary Barriers)
Personal Protective Equipment
Facility Design and Construction (Secondary Barriers)
Facility Practices and Procedures
Biosafety Levels
SECTION III—Principles of Biosafety
Safety Equipment (Primary Barriers)
Primary barrier or primary containment is defined as physical containment measure(s) placed directly at the level of the hazard. Safety equipment such as biological safety cabinets (BSCs), enclosed containers, and other biosafety controls are designed to protect personnel, the surrounding community, and the environment from possible exposure to hazardous biological agents and toxins.
Personal Protective Equipment
Helps protect the user’s body from injury from a variety of sources (e.g., physical, electrical, heat, noise, chemical) or potential exposure to biological hazards and airborne particulate matter. PPE includes gloves, coats, gowns, shoe covers, closed-toe laboratory footwear, respirators, face shields, safety glasses, goggles, or ear plugs.
Facility Design and Construction
Provide a means of secondary containment of hazardous biological agents and toxins. The secondary barriers, together with other biosafety controls, help provide protection of personnel, the surrounding community, and the environment from possible exposure to hazardous biological agents and toxins.
- Ventilation strategies to ensure containment of the hazards
- Effluent decontamination systems
- Specialized building/suite/laboratory configurations
Facility Design and Construction (Secondary Barriers)
Design features may include, but are not limited to the following:
1. Controlled access zones to support the separation of the laboratory from office and public spaces
2. Anterooms
3. Airlocks.
Specialized building/suite/laboratory configurations
Facility Practices and Procedures
are essential to support the implementation and sustainability of a successful biosafety program. Persons working in facilities that handle and store hazardous biological agents and toxins must be able to properly identify all potential hazards and be trained and proficient in necessary safe practices and procedures. Management and leadership are responsible for providing and arranging the appropriate training of all personnel based on their functional roles and responsibilities in support of the biosafety program. Strict adherence to documented laboratory best practices and procedures is an essential element of a robust biosafety program since failure to follow the established procedures could result in an accidental exposure to personnel or unintentional release of hazardous biological agents and toxins into the surrounding community or the environment.
Biosafety Level 1 (BSL-1)
Biosafety Level 2 (BSL-2)
Biosafety Level 3 (BSL-3)
Biosafety Level 4 (BSL-4)
SECTION IV—Laboratory Biosafety Level Criteria
BSL- 1
Not likely to pose a disease risk to healthy adults.
Examples of BSL-1
Achromobacter denitrificans
Alcaligenes faecalis
Bacillus cereus
Bacillus subtilis
Corynebacterium pseudodiphtheriticum
Micrococcus luteus
Neisseria sicca
Staphylococcus epidermidis
Staphylococcus saprophyticus
BSL-2
Poses a moderate risk to healthy adults; unlikely to spread throughout community; effective treatment readily available.
Examples of BSL- 2
Enterococcus faecalis
Klebsiella pneumoniae
Mycobacterium phlei
Salmonella enterica var. Typhimurium
Shigella flexneri
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes
BSL-3
Can cause disease in healthy adults; may spread to community; effective treatment readily available.
BSL-4
Can cause disease in healthy adults; poses a lethal risk and does not respond to vaccines or antimicrobial therapy.
BSL-4
Filovirus
Herpesvirus simiae
Lassa virus
Marburg virus
Ebola virus