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This standard covers the main elements of the four biosafety levels in work with infectious microorganisms and experimental animals. The level is determined based on the protection provided to individuals, the environment, and society.
Biosafety Level 1 (BSL-1)
It is suitable for very familiar pathogens that do not often cause disease in healthy adults and have low potential hazards to laboratory personnel and the environment. The laboratory does not need to be separated from the main flow of traffic in the building.
1. Standard microbiological operations
When conducting experiments on cultures and samples, entry to the laboratory is restricted or prohibited without the consent of the laboratory director.
After handling live organisms, laboratory personnel should wash their hands and remove gloves before leaving the laboratory.
Eating, smoking, cleaning contact lenses and applying makeup are not allowed in the work area. Food and daily necessities are not allowed to be stored in the work area. In the laboratory, those who wear contact lenses must also wear a mouth or face holder. Food should be stored in a dedicated cabinet or refrigerator outside the work area.
Do not use your mouth to pipette liquids, only mechanical devices can be used for pipetting.
Develop safe use regulations for sharps.
All operations should be as careful as possible to avoid splashing and aerosols.
The countertops should be disinfected at least once a day and when live objects are splashed.
All cultures, storage materials and other specified wastes should be disinfected using feasible disinfection methods before release, such as high pressure sterilization. Materials transferred to the nearest laboratory for disinfection should be placed in durable, leak-proof containers and sealed out of the laboratory. The packaging should comply with relevant local, state and federal regulations.
When there is an infectious source, a biohazard sign should be posted at the entrance of the laboratory, and the following information should be displayed: the name of the pathogen in the experiment, the name and telephone number of the researcher.
Implement procedures for controlling insects and caries.
2. Special operations: None
3. Safety equipment (first barrier)
For BSL-1 related pathogens, their operation generally does not require special equipment or equipment such as biosafety cabinets.
It is recommended to wear lab coats, gowns, and uniforms to avoid contamination and dust on clothes.
If there are injuries or rashes on the skin of the hands, gloves should be worn.
During the operation, if microorganisms or dangerous substances are expected to splash, protective eyewear should be worn.
4. Laboratory facilities (second barrier)
The laboratory should be equipped with doors to control entry.
Each laboratory has a sink.
The laboratory design should be easy to clean, and carpets are not suitable for use in the laboratory.
The surface of the laboratory table should be waterproof, heat-resistant, organic solvent-resistant, acid-resistant, alkali-resistant, and resistant to other chemicals used for disinfection of work surfaces and facilities.
The laboratory bench should be able to withstand the expected weight and meet the use requirements. The space between the laboratory bench, safety cabinet, and equipment should be easy to clean.
If the laboratory has windows facing the outside, fly screens should be installed.
Biosafety Level 2 (BSL-2)
It is similar to BSL-1 and is suitable for pathogens that are moderately potentially dangerous to humans and the environment. The difference from BSL-1 is that:
(1) All experimenters have received special training in pathogen handling and are guided by qualified scientific workers;
(2) When conducting experiments, access to the laboratory is restricted;
(3) Special attention should be paid to contaminated sharps;
(4) Certain processes that may produce infectious aerosols or splashes should be carried out in a biosafety cabinet or other physical control equipment. The following standards and special operations, safety equipment and facilities are related to BSL-2 pathogens.
1. Standard microbiological operations
During the experiment, entry to the laboratory is restricted or prohibited without the consent of the laboratory director.
After handling live organisms, experimenters should wash their hands and remove gloves before leaving the laboratory.
Eating, smoking, cleaning contact lenses and applying makeup are not allowed in the work area. Food should be stored in a special cabinet or refrigerator outside the work area.
Do not pipette by mouth, only mechanical devices can be used for pipetting.
Develop safe use regulations for sharps.
All operations should be performed as carefully as possible to avoid splashing and aerosols.
After the experiment, before leaving get off work, and when live objects splash or spill, the table should be disinfected with disinfectants that are effective against the source of the disease.
All cultures, storage materials, and other specified wastes should be disinfected using feasible disinfection methods before release, such as autoclaving. Materials transferred to the nearest laboratory for disinfection should be placed in durable, leak-proof containers and sealed and transported out of the laboratory. Materials leaving the system for disinfection should be packaged before transfer, and their packaging should comply with relevant local, state, and federal regulations.
Implement procedures for controlling insects and caries.
2. Special operations
a. When conducting work related to infectious sources, the laboratory director should prohibit or restrict personnel from entering the laboratory. In general, susceptible personnel or personnel who will have serious consequences after infection are not allowed to enter the laboratory or animal room.
b. The laboratory director should establish rules and procedures to ensure that only those who are informed of potential risks and meet special requirements for entering the laboratory (e.g., immunization) can enter the laboratory.
c. When exogenous pathogens are present, a biohazard sign should be posted at the entrance of the laboratory and display the following information: relevant pathogens, biosafety level, immunization requirements, researcher name, telephone number, personal protective equipment that must be worn in the laboratory, and procedures required to leave the laboratory.
d. Laboratory personnel receive appropriate immunizations or tests related to the pathogens handled or to be handled in the laboratory (e.g., hepatitis B immunization or TB skin test).
e. Depending on the pathogens handled, basic serum samples suitable for laboratory personnel and at-risk personnel are collected and stored as appropriate. Basic serum samples should be collected regularly depending on the pathogens handled or the function of the facility.
f. Biosafety procedures should be included in the standard operating procedures or biosafety manual specially developed by the laboratory director for laboratory personnel. Personnel with special risks are required to read and follow the work and procedures.
g. The laboratory director ensures that the laboratory and its auxiliary personnel receive appropriate training, including possible risks related to the work, necessary measures to prevent exposure, and the risk assessment procedure. When procedures must be changed, the relevant personnel must update their knowledge and receive additional training every year.
