Biosafety level
The Biological Protection level (English biosafety level, BSL ) is a hazard classification of biological agents, especially of microorganisms. This is normalized by the EU Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, and introduced into the Biostoffverordnung in Germany. The same classification is also used by the Centers for Disease Control and Prevention in the United States. Laboratories, in which dealt with biological agents must take certain protective measures. Accordingly, the laboratories are divided into four defined levels of protection (S1 to S4). For laboratories, in which working with genetically modified organisms under the Genetic Engineering Act and the Genetic Engineering Safety Regulations a similar classification applies in four levels of security.
- 2.1 Protection Level 1
- 2.2 Protection Level 2
- 2.3 Protection Level 3
- 2.4 Protection Level 4 2.4.1 List of existing S4- laboratories
Risk groups
Through Genetic Engineering Safety Regulations ( GenTSV ) four risk groups are defined for biological agents. According to the said Directive, the biological agents are assigned to risk groups. The assignment is based on the potential severity of the disease, the risk of infection, the spread of risk and the treatment options available.
Risk group 1
Biological agents, where it is unlikely that they cause disease in humans. (eg safety Escherichia coli K12, the baker's yeast Saccharomyces cerevisiae). Group 1 includes all the biological agents, which are not included in risk groups 2 to 4.
Risk Group 2
Biological agents that can cause human disease and may be a hazard to workers; a spread to the population is unlikely; effective prophylaxis or treatment is usually possible (eg, Salmonella sp., herpes virus or some flu viruses, different strains of Escherichia coli wild- type )
Risk Group 3
Biological agents that can cause severe human disease and present a serious hazard to workers; the risk of spreading to the community, but there is usually effective prophylaxis or treatment available ( eg, Bacillus anthracis, yellow fever virus or hepatitis C and E).
Risk Group 4
Biological agents that can cause severe human disease and present a serious hazard to workers; the risk of spreading to the community is great under certain circumstances; is usually effective prophylaxis or treatment available (eg, Ebola, smallpox, Lassa or Marburg virus).
Protection levels
The Biostoffverordnung assigns the four risk groups of four protection levels. The rules are referred to as levels, because the rules of the levels below also apply to the higher levels.
Protection level 1
In laboratories, the protection level 1 are only observed the usual hygiene measures ( hand washing, no consumption of food and beverages, etc.).
Protection level 2
Access is limited to designated employees by name. In the laboratory itself adapted to the organisms disinfection procedures shall be followed. Vectors that can contribute to the spread of disease, such as rodents and insects should be checked regularly (recommendation, provision only at S 3 and 4). If necessary safety cabinets are to be used with a waterproof and easy to clean surface that should be resistant also to acids, alkalis and solvents, as well as to disinfectants. The agents are kept safe. There should be a suitable means may be available to see from the outside in the laboratories can (camera or windows in the doors ). In animal models, a combustion furnace for laboratory animal body should be present.
Protection level 3
The laboratory must be separated structurally in air- communicable diseases and the exhaust air must be filtered. For other diseases not structural, only a separation must be. In addition, the vacuum must prevail in the laboratory. On vectors should be checked regularly. The floor is lined with a waterproof, easy to clean and the surfaces must be acid-, alkali - and solvent-resistant as well as resistant to disinfectants. Observation window in the doors are required. Each laboratory should have its own equipment and it needs to be worked on safety cabinets. An easily accessible carcass incinerator must be present.
Protection level 4
The laboratory must be structurally separated, the supply and exhaust air must be filtered and access shall be restricted to three locks ( pressure cascade), so that a defined vacuum can be maintained. The laboratory must be hermetically sealed to perform disinfection. The entire laboratory must be gas-tight ( containment ). The agents must be kept under lock and carcasses must be disposed of directly in the laboratory. In addition, each laboratory must have its own equipment. All waste water is chemically and thermally inactivated.
List of existing S4- laboratories
As of 2007
Sources of law
- Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work template: § § / Maintenance / old URL
- Biostoffverordnung ( BioStoffV )
- Organisms list of BVL