Biosafety level

The first prototype Class III (maximum containment) biosafety cabinet was fashioned in 1943 by Hubert Kaempf Jr., then a U.S. Army soldier, under the direction of Arnold G. Wedum, Director (1944–1969) of Industrial Health and Safety at the United States Army Biological Warfare Laboratories, Camp Detrick, Maryland. Kaempf was tired of his MP duties at Detrick and was able to transfer to the sheet metal department working with the contractor, the H.K. Ferguson Co. 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 Australian Animal Health Laboratory is a Class 4/ P4 Laboratory. In 2003, the Chinese Academy of Sciences approved the construction of mainland China's first BSL-4 laboratory at the Wuhan Institute of Virology (WIV). In 2014, the WIV's National Bio-safety Laboratory was built at a cost of 300 million yuan (US$44 million), in collaboration and with assistance from the French government's CIRI lab. In 2007 a scientific review paper stated that the Canadian Science Centre for Human and Animal Health, which was designed in the early 1990s, "has become the prototype for modern BSL4 laboratories". Starting with the 2020 COVID-19 pandemic near the facilities of the WIV, work in biocontainment facilities has been politicized, especially in the US Senate for example as the result of Rand Paul's work. Russia asked questions on 25 October 2022 in the United Nations over the presence in Ukraine of biolabs. In April 2023, Sudan's descent into civil war caused worries at the World Health Organization over its National Public Laboratory as contending factions battled over its area and NPL staff were kicked out in favor of installing a military base at its premises. At the time, the facility contained organisms rated at BSL-2. == Levels ==

Biosafety level 1 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. 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. Biosafety level 2 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: • "laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientists." • Access to the laboratory is limited when work is being conducted. • Certain procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets or other physical containment equipment. 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. Prions, the infectious agents that transmit prion diseases such as vCJD, are typically handled under Biosafety Level 2 or higher. This is due to the lack of any evidence of aerosol transmission and relatively higher infective dose of prion diseases, though some circumstances (such as handling animal-infective prions in a facility which cares for vulnerable animals) would require BSL-3 conditions. The Proceedings of a Workshop on "Developing Norms for the Provision of Biological Laboratories in Low-Resource Contexts" provides a list of BSL-3 laboratories in those countries. Biosafety level 3 is commonly used for research and diagnostic work involving various microbes which can be transmitted by aerosol and/or cause severe disease. These include Francisella tularensis, Mycobacterium tuberculosis, Chlamydia psittaci, Venezuelan equine encephalitis virus, Eastern equine encephalitis virus, SARS-CoV-1, MERS-CoV, Coxiella burnetii, Rift Valley fever virus, Rickettsia rickettsii, several species of Brucella, chikungunya, yellow fever virus, West Nile virus, and Yersinia pestis. File:NIAID Integrated Research Facility - Positive Pressure Personnel Suit Inspection.jpg|Regular inspection of positive-pressure suits to locate any leaks File:NIAID Integrated Research Facility - SPECT.jpg|alt=SPECT machine at BSL-4 imaging facility that separates subjects with pathogens from the machines.|SPECT machine at BSL-4 imaging facility that separates subjects with pathogens from the machines there is a need to design a facility dedicated to curation of restricted (potentially biohazardous) extraterrestrial materials. The systems of such facilities must be able to contain unknown biohazards, as the size of any putative alien microorganism is unknown. Ideally, it should filter particles down to 10 nanometers, and release of a particle 50 nanometers or larger is unacceptable under any circumstance. 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. ==Safety concerns==

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. == List of BSL-4 facilities ==

According to a U.S. Government Accountability Office (GAO) report published on 4 October 2007, a total of 1,356 CDC/USDA registered BSL-3 facilities were identified throughout the United States. Approximately 36% of these laboratories are located in academia. 15 BSL-4 facilities were identified in the U.S. in 2007, including nine at federal labs. The following is a list of existing BSL-4 facilities worldwide. == See also ==