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Maximum Containment Facilities – Sense and Nonsense, Risks and Benefits Maximum Containment Facilities – Sense and Nonsense, Risks and Benefits Jens H. Kuhn, MD, ScD, MS Biosafety space suits virus hunters hot zones Biosafety In the life sciences, biosafety is “…the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release” This means: biosafety is primarily concerned with the laboratory researcher and not with the public Biosafety In most countries, infectious agents are classified by risk group Agent risk group classification is established to emphasize the potential risk and consequences of exposure and infection for the laboratory worker or the release into the environment with subsequent infection of the general population Risk group classification reflects the overall knowledge of a given pathogen, in particular its infectivity, mode and ease of transmission, pathogenicity and virulence (including induced morbidity and case-fatality rate), sensitivity to physical or chemical agents, and availability or absence of countermeasures, including vaccines, therapeutic remedies, and cures This means: risk group classification is different in different countries And: there is no such thing as a BSL4-agent Biosafety Depending on the risk group classification, research on infectious agents has to be performed in facilities offering varying levels of containment Containment facilities differ drastically from country to country This means: containment requirements are different in different countries Maximum Biosafety and Containment Classification Biosafety designation Designation for containment facilities Australia Physical Containment (PC)-4 pathogen, Risk Group 4 agent Biosecurity Level 4, Physical Containment (P)4 Canada Risk Group 4 Containment Level (CL) 4 France Pathogène de Classe (P)4 [Class (P)4 pathogen] Niveau de Sécurité Biologique (NSB) 4 [Biological safety level 4] Gabon Pathogène de Classe (P)4 [Class (P)4 pathogen] Niveau de Sécurité Biologique (NSB) 4 [Biological safety level 4] Germany Risikogruppe [risk group] 4 Sicherheitsstufe [Safety level] (S)4 Japan 1類感染症 [class 1 infectious disease] Maximum Biosafety Level (MBL) Russia Групп I [group I] pathogen / South Africa Class 4 pathogen Physical Containment (P)4 UK Category A pathogen in the 1980s; now Protection Level (P)- Physical Containment (P)4 4 pathogen US Class 4 pathogen Biosafety Level (BSL-)4 WHO Risk Group IV pathogen, WHO Risk Group 4 Biosafety Level 4 Maximum Biosafety and Containment Classification Biosafety designation Designation for containment facilities Australia Physical Containment (PC)-4 pathogen, Risk Group 4 agent Biosecurity Level 4, Physical Containment (P)4 Canada Risk Group 4 Containment Level (CL) 4 France Pathogène de Classe (P)4 [Class (P)4 pathogen] Niveau de Sécurité Biologique (NSB) 4 [Biological safety level 4] Gabon Pathogène de Classe (P)4 [Class (P)4 pathogen] Niveau de Sécurité Biologique (NSB) 4 [Biological safety level 4] Germany Risikogruppe [risk group] 4 Sicherheitsstufe [Safety level] (S)4 Japan 1類感染症 [class 1 infectious disease] Maximum Biosafety Level (MBL) Russia Групп I [group I] pathogen / South Africa Class 4 pathogen Physical Containment (P)4 UK Category A pathogen in the 1980s; now Protection Level (P)- Physical Containment (P)4 4 pathogen US Class 4 pathogen Biosafety Level (BSL-)4 WHO Risk Group IV pathogen, WHO Risk Group 4 Biosafety Level 4 Maximum Biosafety and Containment Classification Biosafety designation Designation for containment facilities Australia Physical Containment (PC)-4 pathogen, Risk Group 4 agent Biosecurity Level 4, Physical Containment (P)4 Canada Risk Group 4 Containment Level (CL) 4 France Pathogène de Classe (P)4 [Class (P)4 pathogen] Niveau de Sécurité Biologique (NSB) 4 [Biological safety level 4] Gabon Pathogène de Classe (P)4 [Class (P)4 pathogen] Niveau de Sécurité Biologique (NSB) 4 [Biological safety level 4] Germany Risikogruppe [risk group] 4 Sicherheitsstufe [Safety level] (S)4 Japan 1類感染症 [class 1 infectious disease] Maximum Biosafety Level (MBL) Russia Групп I [group I] pathogen / South Africa Class 4 pathogen Physical Containment (P)4 UK Category A pathogen in the 1980s; now Protection Level (P)- Physical Containment (P)4 4 pathogen US Class 4 pathogen Biosafety Level (BSL-)4 WHO Risk Group IV pathogen, WHO Risk Group 4 Biosafety Level 4 U.S. Biosafety Level Classification [Biosafety level 1 (BSL1)] [Suitable for working with microbes that pose no risk, or a very limited risk, to personnel or the environment. Work is often conducted on open lab bench tops. No special containment equipment is needed and foot traffic through the lab is not restricted. However, there are limited safety measures. For instance, contaminated work surfaces must be decontaminated; and eating and drinking is not permitted.] U.S. Biosafety Level Classification Biosafety level 2 (BSL2) Built for work with microbes of moderate risk. Access is limited, laboratory coats must be worn, and biosafety signage is required at entrances. In addition, special cabinets that contain and filter the air are used for working with microbes that can move through the air (aerosols). BSL2+: Biosafety level 2 facility + biosafety level 3 working techniques U.S. Biosafety Level Classification Biosafety level 3 (BSL3) Used for work with microbes that can cause serious injury or, in cases of an extreme exposure, death. In addition to the safety measures of level 2 labs, there are several other safeguards. People younger than 16 are not allowed in these labs; doors must be kept closed; windows are sealed. Surgical gloves and masks, or respirators, are used. The rooms are kept at a lower air pressure level than surrounding rooms, and the outdoor environment to contain aerosols. Air in the room also is continuously filtered through HEPA filters that are able to catch minute particles. These filters are regularly disinfected and changed. BSL3+: Biosafety level 3 facility + biosafety level 4 working techniques BSL3Ag: Biosafety level 3 facility + special measure to prevent release of agricultural high-consequence pathogens U.S. Biosafety Level Classification Biosafety level 4 (BSL4) Highest level of safety measures to protect those working inside them and in adjacent areas. Used for work with highly infectious or dangerous microbes. Contain the safety measures of BSL3 facilities. In addition, access is very restricted. Entry logs are kept for the labs. Lab workers must wear protective suits and undergo a disinfectant shower upon leaving. The labs have double-door airlocks. Special nonbreakable containers are used for working with the microbes. Materials in the lab are destroyed or decontaminated before leaving. Not: highly contagious! U.S. Biosafety Level Classification Examples: US Other country Alkhurma virus BSL4 BSL3 (India), P3 rather than P4 (France) Crimean-Congo hemorrhagic fever virus BSL4 Group 2 rather than Group 1 (Russia) Kyasanur Forest disease virus, Alkurma virus BSL4 BSL3 (India), P3 rather than P4 (France) Omsk hemorrhagic fever virus BSL4 Group 2 rather than Group 1 (Russia) Tick-borne encephalitis virus (CEEV and RSSEV) BSL4 S2 and S3 rather than S4 (Austria, Germany), Group 2 rather than Group 1 (Russia) Yersinia pestis BSL3 Group 1 rather than Group 2 (Russia) U.S. Class 4 Agents Family Human disease (according to ICD-10) Natural reservoir Geographic Genus distribution Species Virus(es) Arenaviridae Arenavirus [‘Chapare virus’] [‘Chapare virus’] Unnamed Rodent? Bolivia Guanarito virus Guanarito virus (GTOV) Unnamed (“Venezuelan haemorrhagic fever”) (A96.8) Rodent: Zygodontomys brevicauda Venezuela Junín virus Junín virus (JUNV) Junín (Argentinian) haemorrhagic fever (A96.0) Rodent: Calomys musculinus Argentine pampas Lassa virus Lassa virus (LASV) Lassa fever (A96.2) Rodent: Mastomys ssp. West Africa Machupo virus Machupo virus (MACV) Machupo (Bolivian) haemorrhagic fever (A96.1) Rodent: Calomys callosus Bolivia Sabiá virus Sabiá virus (SABV) Unnamed (“Brazilian haemorrhagic fever”) (A96.8) Rodent? Brazil [Whitewater Arroyo virus] [Whitewater Arroyo virus Unnamed (WWAV)] U.S. Class 4 Agents Family Human disease (according to ICD-10) Natural reservoir Geographic distribution Genus Species Virus(es) Bunyaviridae Orthobunyavirus Garissa virus Unnamed Mosquitoes? Kenya Hantavirus All hantaviruses Haemorrhagic fever with renal syndrome Rodents Essentially world-wide (A98.5) ,“Hantavirus pulmonary syndrome” Nairovirus Crimean-Congo hemorrhagic fever virus Crimean-Congo hemorrhagic fever virus Crimean-Congo haemorrhagic fever (A98.0) Ticks: Dermacentor ssp. Balkan Countries, Russia, (CCHFV) Hyalomma ssp., NIS, Middle East, Sub- Rhipicephalus ssp. Saharan Africa U.S. Class 4 Agents Family Human disease (according to ICD-10) Natural reservoir Geographic distribution Genus Species Virus(es) Herpesviridae Simplexvirus Cercopithecine herpesvirus 1 Cercopithecine herpesvirus 1 (CeHV-1) Herpesviral encephalitis (B00.4) Macaques Worldwide U.S. Class 4 Agents Family Human disease (according to ICD-10) Natural reservoir Geographic distribution Genus Species Virus(es) Filoviridae Ebolavirus Côte d’Ivoire ebolavirus Côte d’Ivoire ebolavirus (CIEBOV) Ebola virus disease (A98.4) ? Africa Reston ebolavirus Reston ebolavirus (REBOV) / ? Philippines? Sudan ebolavirus Sudan ebolavirus (SEBOV) Ebola virus disease (A98.4) ? Africa Zaire ebolavirus Zaire ebolavirus (ZEBOV) Ebola virus disease (A98.4) ? Africa Marburgvirus Lake Victoria marburgvirus Lake Victoria marburgvirus (MARV) Marburg virus
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