On 18 April 1955, fourteen representatives met at Camp Detrick in Frederick, Maryland. The meeting was to share knowledge and experiences regarding biosafety, chemical, radiological, and industrial safety issues that were common to the operations at the three principal biological warfare (BW) laboratories of the U.S. Army. Because of the potential implication of the work conducted at biological warfare laboratories, the conferences were restricted to top level security clearances. Beginning in 1957, these conferences were planned to include non-classified sessions as well as classified sessions to enable broader sharing of biological safety information. It was not until 1964, however, that conferences were held in a government installation not associated with a biological warfare program.
Over the next ten years, the biological safety conferences grew to include representatives from all federal agencies that sponsored or conducted research with pathogenic microorganisms. By 1966, it began to include representatives from universities, private laboratories, hospitals, and industrial complexes. Throughout the 1970s, participation in the conferences continued to expand and by 1983 discussions began regarding the creation of a formal organization. The American Biological Safety Association (ABSA) was officially established in 1984 and a constitution and bylaws were drafted the same year. As of 2008, ABSA includes some 1,600 members in its professional association.
Biosafety level 1 (BSL-1) is suitable for work with well-characterized agents which do not cause disease in healthy humans. In general, these agents should pose minimal potential hazard to laboratory personnel and the environment. At this level, precautions are limited relative to other levels. Laboratory personnel must wash their hands upon entering and exiting the lab. Research with these agents may be performed on standard open laboratory benches without the use of special containment equipment. However, eating and drinking are generally prohibited in laboratory areas. Potentially infectious material must be decontaminated before disposal, either by adding a chemical such as bleach or isopropanol or by packaging for decontamination elsewhere. Personal protective equipment is only required for circumstances where personnel might be exposed to hazardous material. BSL-1 laboratories must have a door which can be closed to limit access to the lab. However, it is not necessary for BSL-1 labs to be isolated from the general building.
This level of biosafety is appropriate for work with several kinds of microorganisms including non-pathogenic strains of Escherichia coli and Staphylococcus, Bacillus subtilis, Saccharomyces cerevisiae and other organisms not suspected to contribute to human disease. Due to the relative ease and safety of maintaining a BSL-1 laboratory, these are the types of laboratories generally used as teaching spaces for high schools and colleges.
At this level, all precautions used at Biosafety level 1 are followed, and some additional precautions are taken. BSL-2 differs from BSL-1 in that:
Biosafety level 2 is suitable for work involving agents of moderate potential hazard to personnel and the environment. This includes various microbes that cause mild disease to humans, or are difficult to contract via aerosol in a lab setting. Examples of pathogens classified as "Risk Group 2" in the United States include seasonal influenza, SARS-CoV-2, hepatitis A, B, and C viruses, human immunodeficiency virus (HIV), pathogenic strains of Escherichia coli and Staphylococcus, Salmonella, Plasmodium falciparum, and Toxoplasma gondii. Notably, the European Union departs from the United States and classifies HIV and hepatitis B – G as Risk Group 3 agents best handled at BSL-3.
Biosafety level 3 is appropriate for work involving microbes which can cause serious and potentially lethal disease via the inhalation route. This type of work can be done in clinical, diagnostic, teaching, research, or production facilities. Here, the precautions undertaken in BSL-1 and BSL-2 labs are followed, as well as additional measures including:
Also, the facility which houses the BSL-3 lab must have certain features to ensure appropriate containment. The entrance to the lab must be separated from areas of the building with unrestricted traffic flow. Also, the lab must be behind two sets of self-closing doors (to reduce the risk of aerosols escaping). The construction of the lab is such that it can be easily cleaned. Carpets are not permitted, and any seams in the floors, walls, and ceilings are sealed to allow easy cleaning and decontamination. Also, windows must be sealed, and a ventilation system installed which forces air to flow from the "clean" areas of the lab to the areas where infectious agents are handled. Air from the lab must be filtered before it can be recirculated.
Biosafety level 4 (BSL-4) is the highest level of biosafety precautions, and is appropriate for work with agents that could easily be aerosol-transmitted within the laboratory and cause severe to fatal disease in humans for which there are no available vaccines or treatments. BSL-4 labs are generally set up to be either cabinet laboratories or protective-suit laboratories. In cabinet laboratories, all work must be done within a class III biosafety cabinet. Materials leaving the cabinet must be decontaminated by passing through an autoclave or a tank of disinfectant. The cabinets themselves are required to have seamless edges to allow easy cleaning. Also, the cabinet and all materials within must be free of sharp edges to reduce the risk of damage to the gloves. In a protective-suit lab, all work must be done in a class II biosafety cabinet by personnel wearing a positive pressure suit. To exit a BSL-4 lab, personnel must pass through a chemical shower for decontamination, then a room for removing the positive-pressure suit, followed by a personal shower. Entry into the BSL-4 lab is restricted to trained and authorized individuals, and all persons entering and exiting the lab must be recorded.
As with BSL-3 laboratories, BSL-4 labs must be separated from areas that receive unrestricted traffic. Also, airflow is tightly controlled to ensure that air always flows from "clean" areas of the lab to areas where work with infectious agents is being performed. The entrance to the BSL-4 lab must also employ airlocks to minimize the possibility that aerosols from the lab could be removed from the lab. All laboratory waste, including filtered air, water, and trash must also be decontaminated before it can leave the facility.
Because NASA and ESA are collaborating on the Mars Sample Return campaign, due to return samples from Mars in the early 2030s, the need for a Sample Receiving Facility (SRF) is becoming more pressing. An SRF is expected to take 7 to 10 years from design to completion, and an additional two years is recommended for the staff to become proficient and accustomed to the facilities.
A North Carolina Mosquito & Vector Control Association (NCMVCA) study highlighted safety concerns. In the United States, laboratories can be funded by federal, state, private, non-profit, or academically. The last accounts for 72% of the funding.
High-containment labs that are registered with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture's (USDA) Select Agent Program must adhere to Department of Defense standards. Since BSL3 and 4 laboratories in the United States are regulated by either the CDC or USDA or another federal agency (depending on the pathogens they handle), no single federal agency is responsible for regulating or tracking the number of these labs. U.S. high-containment laboratories that handle pathogens which are declared as "select agents" must be inspected periodically by the CDC or USDA, adhere to certain standards, and maintain ongoing education on biosecurity and biosafety policies as mandated by law.
The following is a list of existing BSL-4 facilities worldwide.
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