Biological protection levels

Biological protection level

 

The biological protection level is a hazard classification of biological agents, especially microorganisms. For laboratories working with genetically modified organisms, a similar classification into four safety levels applies according to the Genetic Engineering Act and the Genetic Engineering Safety Ordinance (GenTSV). The GenTSV defines four risk groups for biological agents. The Biological Agents Ordinance assigns four levels of protection to the four risk groups.

  • Risk group 1

Biological agents that are unlikely to cause disease in humans (e.g. the safety strain Escherichia coli K12, the baker's yeast Saccharomyces cerevisiae).
Group 1 includes all biological agents that are not included in risk groups 2 to 4

  • Risk group 2

Biological agents that can cause illness in humans and pose a risk to employees (e.g. Salmonella spp., herpes viruses or some influenza viruses, various strains of Escherichia coli wild type).
Spread of the substance in the population is unlikely; effective prevention or treatment is usually possible.

  • Risk group 3

Biological agents that can cause serious illness in humans and pose a serious risk to employees (e.g. Bacillus anthracis, yellow fever virus or hepatitis C and E).
There may be a risk of spread to the population, but effective prevention or treatment is usually possible.

  • Risk group 4

Biological agents that cause a serious disease in humans and pose a serious risk to employees (e.g. Ebola, smallpox, Lassa or Marburg virus).
The risk of spreading to the population may be high; effective prevention or treatment is not normally possible.

  • Protection level 1

In the S1 laboratory, only the usual hygiene measures must be observed (washing hands, no consumption of food and drink, etc.).

  • Protection level 2

In the S2 laboratory, access must be restricted to named employees. Disinfection procedures adapted to the organisms must be used in the laboratory itself. Vectors that can contribute to the spread of disease, such as rodents and insects, should be checked regularly (recommendation, regulation only for S 3 and 4). If necessary, safety cabinets with an impermeable and easy-to-clean surface should be used, which should also be resistant to acids, alkalis and solvents as well as disinfectants. The working materials must be stored safely. Facilities or Institutions should be in place to be able to see into the laboratories from the outside (camera or windows in the doors). An incinerator should be available for animal experiments.

  • Protection level 3

For airborne diseases, the S3 laboratory must be structurally separated and the exhaust air must be filtered. For other diseases, there is no need for structural separation, only spatial separation. There must also be negative pressure in the laboratory. Regular checks must be carried out for vectors. The floor must be lined with a water-impermeable, easy-to-clean material and the surfaces must be resistant to acids, alkalis, solvents and disinfectants. Observation windows in the doors are mandatory. Each laboratory should have its own equipment and work must be carried out at safety cabinets. An easily accessible carcass incinerator must be available.

  • Protection level 4

The S4 laboratory must be structurally separated, the supply and exhaust air must be filtered and access must only be via three airlocks (pressure cascade) so that a defined negative pressure can be maintained. It must be possible to hermetically seal the laboratory in order to carry out disinfection. The entire laboratory must be gas-tight (containment). The working materials must be kept under lock and key and animal 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.