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Biosafety level 4 (BSL-4) organisms are dangerous or exotic agents which pose high risk of life-threatening disease, aerosol-transmitted lab infections, or related agents with unknown risk of transmission.[ citation needed ]
Biosafety level 4 laboratories are designed for diagnostic work and research on easily respiratory-acquired viruses which can often cause severe and/or fatal disease. What follows is a list of select agents that have specific biocontainment requirements according to US federal law. Organisms include those harmful to human health, or to animal health. [1] The Plant Protection and Quarantine programs (PPQ) of the Animal and Plant Health Inspection Service (APHIS) are listed in 7 CFR Part 331. The Department of Health and Human Services (HHS) lists are located at 42 CFR Part 73.3 [2] and 42 CFR Part 73.4. [3] The USDA animal safety list is located at 9 CFR Subchapter B. [4]
Not all select agents require BSL-4 handling, namely select bacteria and toxins, but most select agent viruses do (with the notable exception of SARS-CoV-1 which can be handled in BSL3). Many non-select agent viruses are often handled in BSL-4 according to facility SOPs or when dealing with new viruses closely related to viruses that require BSL-4. For instance, Andes orthohantavirus and MERS-CoV are both non-select agents that are often handled in BSL-4 because they cause severe and fatal disease in humans. Newly characterized viruses closely related to select agents and/or BSL-4 viruses (for example newly discovered henipaviruses or ebolaviruses) are typically handled in BSL-4 even if they aren't yet known to be readily transmissible or cause severe disease.[ citation needed ]
Globally, there are no official agreements on what agents must be handled in BSL-4. However, select agents and toxins originating or ending in US BSL-4 labs must adhere to US select agent laws.[ citation needed ]
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include the conduction of regular reviews of biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety is used to protect from harmful incidents. Many laboratories handling biohazards employ an ongoing risk management assessment and enforcement process for biosafety. Failures to follow such protocols can lead to increased risk of exposure to biohazards or pathogens. Human error and poor technique contribute to unnecessary exposure and compromise the best safeguards set into place for protection.
A biosafety level (BSL), or pathogen/protection level, is a set of biocontainment precautions required to isolate dangerous biological agents in an enclosed laboratory facility. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels in a publication referred to as Biosafety in Microbiological and Biomedical Laboratories (BMBL). In the European Union (EU), the same biosafety levels are defined in a directive. In Canada the four levels are known as Containment Levels. Facilities with these designations are also sometimes given as P1 through P4, as in the term P3 laboratory.
A biological hazard, or biohazard, is a biological substance that poses a threat to the health of living organisms, primarily humans. This could include a sample of a microorganism, virus or toxin that can adversely affect human health. A biohazard could also be a substance harmful to other living beings.
Orthohantavirus is a genus of single-stranded, enveloped, negative-sense RNA viruses in the family Hantaviridae within the order Bunyavirales. Members of this genus may be called orthohantaviruses or simply hantaviruses.
Bolivian hemorrhagic fever (BHF), also known as black typhus or Ordog Fever, is a hemorrhagic fever and zoonotic infectious disease originating in Bolivia after infection by Machupo mammarenavirus.
Biological agents, also known as biological weapons or bioweapons, are pathogens used as weapons. In addition to these living or replicating pathogens, toxins and biotoxins are also included among the bio-agents. More than 1,200 different kinds of potentially weaponizable bio-agents have been described and studied to date.
Coccidioides immitis is a pathogenic fungus that resides in the soil in certain parts of the southwestern United States, northern Mexico, and a few other areas in the Western Hemisphere.
Lassa mammarenavirus (LASV) is an arenavirus that causes Lassa hemorrhagic fever, a type of viral hemorrhagic fever (VHF), in humans and other primates. Lassa mammarenavirus is an emerging virus and a select agent, requiring Biosafety Level 4-equivalent containment. It is endemic in West African countries, especially Sierra Leone, the Republic of Guinea, Nigeria, and Liberia, where the annual incidence of infection is between 300,000 and 500,000 cases, resulting in 5,000 deaths per year.
Venezuelan hemorrhagic fever (VHF) is a zoonotic human illness first identified in 1989. The disease is most prevalent in several rural areas of central Venezuela and is caused by Guanarito mammarenavirus (GTOV) which belongs to the Arenaviridae family. The short-tailed cane mouse is the main host for GTOV which is spread mostly by inhalation of aerosolized droplets of saliva, respiratory secretions, urine, or blood from infected rodents. Person-to-person spread is possible, but uncommon.
The United States Army Medical Research Institute of Infectious Diseases is the United States Army's main institution and facility for defensive research into countermeasures against biological warfare. It is located on Fort Detrick, Maryland, near Washington, D.C., and is a subordinate lab of the United States Army Medical Research and Development Command (USAMRDC), headquartered on the same installation.
Under United States law, Biological select agents or toxins (BSATs)—or simply select agents for short—are bio-agents which have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". The agents are divided into (1) HHS select agents and toxins affecting humans; (2) USDA select agents and toxins affecting agriculture; and (3) overlap select agents and toxins affecting both.
Alkhurma virus (ALKV) is a zoonotic virus of the Flaviviridae virus family. ALKV causes Alkhurma hemorrhagic fever (AHF), or alternatively termed as Alkhurma hemorrhagic fever virus, and is mainly based in Saudi Arabia.
One use of the concept of biocontainment is related to laboratory biosafety and pertains to microbiology laboratories in which the physical containment of pathogenic organisms or agents is required, 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.
Mammarenavirus juninense, better known as the Junin virus or Junín virus (JUNV), is an arenavirus in the Mammarenavirus genus that causes Argentine hemorrhagic fever (AHF). The virus took its original name from the city of Junín, around which the first cases of infection were reported, in 1958.
Brazilian hemorrhagic fever (BzHF) is an infectious disease caused by Brazilian mammarenavirus, an arenavirus. Brazilian mammarenavirus is one of the arenaviruses from South America to cause hemorrhagic fever. It shares a common progenitor with Argentinian mammarenavirus, Machupo mammarenavirus, Tacaribe mammarenavirus, and Guanarito mammarenavirus. It is an enveloped RNA virus and is highly infectious and lethal. Very little is known about this disease, but it is thought to be transmitted by the excreta of rodents. This virus has also been implicated as a means for bioterrorism, as it can be spread through aerosols.
Ravn virus is a close relative of Marburg virus (MARV). RAVV causes Marburg virus disease in humans and nonhuman primates, a form of viral hemorrhagic fever. RAVV is a Select agent, World Health Organization Risk Group 4 Pathogen, National Institutes of Health/National Institute of Allergy and Infectious Diseases Category A Priority Pathogen, Centers for Disease Control and Prevention Category A Bioterrorism Agent, and listed as a Biological Agent for Export Control by the Australia Group.
The United States Biological Defense Program—in recent years also called the National Biodefense Strategy—refers to the collective effort by all levels of government, along with private enterprise and other stakeholders, in the United States to carry out biodefense activities.
Dobrava-Belgrade orthohantavirus (DOBV), also known as Dobrava virus, is an enveloped, single-stranded, negative-sense RNA virus species of Old World Orthohantavirus. It is one of several species of Hantavirus that is the causative agent of severe Hantavirus hemorrhagic fever with renal syndrome. It was first isolated in 1985 from a yellow-necked mouse found in the village of Dobrava, southeastern Slovenia. It was subsequently isolated in striped field mice in Russia and other parts of Eastern Europe. It has also been found in Germany but the reservoir host there is unknown.
CFR Title 9 – Animals and Animal Products is one of 50 titles composing the United States Code of Federal Regulations (CFR) and contains the principal set of rules and regulations issued by federal agencies regarding animals and animal products. It is available in digital and printed form and can be referenced online using the Electronic Code of Federal Regulations (e-CFR).
Pragya D. Yadav is an Indian scientist at the ICMR-National Institute of Virology (NIV), who is known for her research contributions in the field of communicable diseases and highly pathogenic viral infections, such as Crimean–Congo hemorrhagic fever (CCHF), Nipah, Ebola, leading to improvising national public health surveillance policy for interventions and management. Yadav is among the scientists who detected the first three COVID-19 pandemic cases in India. She headed the team that developed Covaxin, the first indigenous COVID-19 vaccine in India