Biosafety – Biosafety is the application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious agents or biohazards. Biosafety defines the containment conditions under which infectious agents can be safely manipulated. The objective of containment is to confine biohazards and to reduce the potential exposure of the laboratory worker, persons outside of the laboratory, and the environment to potentially infectious agents.
Biocontainment – Biocontainment is the physical containment of highly pathogenic organisms (bacteria) or agents (viruses), usually by isolation in environmentally and biologically secure cabinets or rooms, to prevent accidental infection of workers or release into the surrounding community during scientific research.
Biosafety in Microbiological and Biomedical Laboratories (BMBL) – The BMBL is a document describing standards and special microbiological, safety equipment, and facilities appropriate for work with infectious agents. The BMBL is developed by the CDC and the NIH and can be obtained at: http://www.cdc.gov/OD/OHS/biosfty/bmbl5/BMBL_5th_Edition.pdf
Biosafety level (BSL) – The BSL designation of a laboratory corresponds to a set of biosafety practices, containment measures, and other precautions that are used in keeping with the risk of the research taking place in that laboratory. BSL designations range from the lowest designation of “1” to the highest designation of “4,” corresponding to conditions suitable for the lowest risk to highest risk research, respectively. The BMBL describes the four biological safety levels in detail (see Section IV, BMBL 5th edition). The NIH Guidelines for Research Involving Recombinant DNA Research (see below) similarly describe four biosafety levels that correspond to those of the BMBL, but they use the abbreviation “BL” (see Appendix G of the NIH Guidelines at: http://oba/oba/rac/guidelines_02/Appendix_G.htm[d1] ).
Biosafety Level 1 (BSL-1) – BSL-1 is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and present minimal potential hazard to laboratory personnel and the environment. BSL-1 laboratories are not necessarily separated from the general traffic patterns in the building. Work is typically conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design is not required, but may be used as determined by appropriate risk assessment. Laboratory personnel must have specific training in the procedures conducted in the laboratory and must be supervised by a scientist with training in microbiology or a related science.
Biosafety Level 2 (BSL-2) – BSL-2 is suitable for work involving agents that pose moderate hazards to personnel and the environment. It differs from BSL-1 in that: 1) laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures; 2) access to the laboratory is restricted when work is being conducted; and 3) all procedures in which infectious aerosols or splashes may be created are conducted in BSCs or other physical containment equipment.
Biosafety Level 3 (BSL-3) – BSL-3 is applicable to clinical, diagnostic, teaching, research, or production facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents, and must be supervised by scientists competent in handling infectious agents and associated procedures.
Biosafety Level 4 (BSL-4) – BSL-4 is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission. Agents with a close or identical antigenic relationship to agents requiring BSL-4 containment must be handled at this level until sufficient data are obtained either to confirm continued work at this level, or re-designate the level. Laboratory staff must have specific and thorough training in handling extremely hazardous infectious agents. Laboratory staff must understand the primary and secondary containment functions of standard and special practices, containment equipment, and laboratory design characteristics. All laboratory staff and supervisors must be competent in handling agents and procedures requiring BSL-4 containment. The laboratory supervisor in accordance with institutional policies controls access to the laboratory.
Biosecurity – Biosecurity is a set of preventive measures designed to reduce the risk of theft or diversion of high-consequence microbial agents, which could be used by someone who maliciously intends to conduct bioterrorism or pursue biological weapons proliferation.
Biosurety –Biosurety is an integrated approach to the management of potentially hazardous biological materials and activities.
High-containment Laboratory – A High-containment laboratory is a laboratory that conforms to BSL-3 or BL-3 biosafety measures, as described in Biosafety in Microbiological and Biomedical Laboratories and the NIH Guidelines for Research with Recombinant DNA Molecules, respectively. This is the third highest level of containment out of four levels. This level is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease after inhalation. It includes various bacteria, parasites and viruses that can cause severe to fatal disease in humans but for which treatments exist, such as Leishmania donovani, Mycobacterium tuberculosis, Bacillus anthracis, Chlamydophila psittaci, West Nile virus, Venezuelan equine encephalitis virus, Eastern equine encephalitis virus, Hendra virus, SARS coronavirus, Salmonella typhi, Coxiella burnetii, Rift Valley fever virus, Rickettsia rickettsii, and yellow fever virus.
Institutional Biosafety Committee – The Institutional Biosafety Committee is a local biosafety review committee required under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA. Over time, many institutions have chosen to assign their IBCs the responsibility for reviewing a variety of experiments that involves biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens). The roles and responsibilities of IBCs are described in Section IV-B-2 of the NIH Guidelines (http://oba/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261582)
Maximum-containment Laboratory – A maximum-containment laboratory is a laboratory that conforms to BSL-4 or BL-4 biosafety measures, as described in Biosafety in Microbiological and Biomedical Laboratories and the NIH Guidelines for Research with Recombinant DNA Molecules, respectively. This is the highest level of containment out of four levels. These laboratories work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections, and agents which cause severe to fatal disease in humans for which vaccines or other treatments are not available, such as Bolivian and Argentine hemorrhagic fevers, Marburg virus, Ebola virus, Lassa fever, Crimean-Congo hemorrhagic fever, Smallpox, and other various hemorrhagic diseases. All work with these agents in these laboratories is conducted either in Class III biosafety cabinets or with the workers wearing personal protective pressurized suits.
NIH Guidelines for Research with Recombinant DNA Molecules (NIH Guidelines) – NIH Guidelines is a document that details safety practices and containment procedures for basic and clinical research involving recombinant DNA, including the creation and use of organisms and viruses containing recombinant DNA. The NIH Guidelines are a “living” document that was first drafted in 1976 as an outcome of a meeting of scientists.
Risk Assessment – Risk assessment is the process of identifying hazards and the probability that these hazards could lead to injury or exposure. Completion of a risk assessment enables the appropriate selection of microbiological practices, safety equipment, and facility safeguards that can prevent laboratory- associated infections.
Select Agents – Select agents are pathogens or biological toxins which have been declared by the U.S. Department of Health and Human Services or by the U.S. Department of Agriculture to have the "potential to pose a severe threat to public health and safety". Examples of these toxins are: Leishmania donovani, Mycobacterium tuberculosis, Bacillus anthracis, Chlamydophila psittaci, West Nile virus, Venezuelan equine encephalitis virus, Eastern equine encephalitis virus, Hendra virus, SARS coronavirus, Salmonella typhi, Coxiella burnetii, Rift Valley fever virus, Rickettsia rickettsii, and yellow fever virus.