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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 BMBL. In the European Union, 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.
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 weapons 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.
The United States Army Medical Research Institute of Infectious Diseases is the U.S 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.
The National Institute of Virology in Pune, India is an Indian virology research institute and part of the Indian Council of Medical Research (ICMR). It was previously known as 'Virus Research Centre' and was founded in collaboration with the Rockefeller Foundation. It has been designated as a WHO H5 reference laboratory for SE Asia region.
Smallpox was an infectious disease caused by variola virus, which belongs to the genus Orthopoxvirus. The last naturally occurring case was diagnosed in October 1977, and the World Health Organization (WHO) certified the global eradication of the disease in 1980, making smallpox the only human disease to have been eradicated to date.
Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.
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).
The smallpox virus retention debate has been going on among scientists and health officials since the smallpox virus was declared eradicated by the World Health Organization (WHO) in 1980. The debate centers on whether or not the last two known remnants of the Variola virus known to cause smallpox, which are kept in tightly controlled government laboratories in the United States and Russia, should be finally and irreversibly destroyed. Advocates of final destruction maintain that there is no longer any valid rationale for retaining the samples, which pose the hazard of escaping the laboratories, while opponents of destruction maintain that the samples may still be of value to scientific research, especially since variants of the smallpox virus may still exist in the natural world and thus present the possibility of the disease re-emerging in the future or being used as a bio-weapon.
The 2022–2023 mpox outbreak in Singapore is a part of the global outbreak of human mpox caused by the West African clade of the monkeypox virus. According to the Ministry of Health (MOH), Singapore's first imported mpox case was reported on 20 June 2022. It was the first ever confirmed case in Southeast Asia.
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