Biosafety level#Levels
{{Short description|Set of biocontainment precautions}}
{{Use dmy dates|date=May 2020}}
File:Structure of NIAID Integrated Research Facility.jpg level 4 (BSL-4) laboratory{{cite web|title=Integrated Research Facility|url=http://www.niaid.nih.gov/about/organization/dir/irf/Pages/facilityOverview.aspx|website=niaid.nih.gov|publisher=NIAID|access-date=14 November 2014|url-status=live|archive-url=https://web.archive.org/web/20141128061044/http://www.niaid.nih.gov/about/organization/dir/irf/Pages/facilityOverview.aspx|archive-date=28 November 2014}}]]
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).{{cite book |last1=Biosecurity & Health Security Protection [BSP] |title=Laboratory Biosafety Manual |date=2020-12-21 |publisher=World Health Organization |location=Geneva |isbn=978-92-4-001131-1 |edition=4 |url=https://www.who.int/publications/i/item/9789240011311 |access-date=2025-05-10}} 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).{{cite book |url=https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf |title=Biosafety in Microbiological and Biomedical Laboratories |publisher=Centers for Disease Control and Prevention |year=2020 |isbn=978-0-1608-5042-4 |veditors=Chosewood LC, Wilson DE |edition=6th |access-date=20 Dec 2024}} In the European Union (EU), the same biosafety levels are defined in a directive.Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) In Canada the four levels are known as Containment Levels.{{cite web|url=https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines/laboratory-biosafety-guidelines-3rd-edition-2004/chapter-2.html|title=Chapter 2: The Laboratory Biosafety Guidelines: 3rd Edition 2004 – Biological safety – Canada.ca|first=Public Health Agency of|last=Canada|website=www.canada.ca|access-date=7 May 2018|url-status=dead|archive-url=https://web.archive.org/web/20180223235144/https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines/laboratory-biosafety-guidelines-3rd-edition-2004/chapter-2.html|archive-date=23 February 2018}} Facilities with these designations are also sometimes given as P1 through P4 (for pathogen or protection level), as in the term P3 laboratory.{{cite book | publisher = Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health, National Cancer Institute, Office of Research Safety | title = Laboratory Safety Monograph: A Supplement to the NIH Guidelines for Recombinant DNA Research | pages=passim | no-pp=y | year = 1978 | url = https://books.google.com/books?id=HKU0pta6Y20C&pg=PA121 }}
At the lowest level of biosafety, precautions may consist of regular hand-washing and minimal protective equipment. At higher biosafety levels, precautions may include airflow systems, multiple containment rooms, sealed containers, positive pressure personnel suits, established protocols for all procedures, extensive personnel training, and high levels of security to control access to the facility. Health Canada reports that world-wide until 1999 there were recorded over 5,000 cases of accidental laboratory infections and 190 deaths.{{cite news |title=Biosafety at Ryerson |url=https://www.ryerson.ca/content/dam/facilities-management-development/environmental-health-safety/docs/2-biological-hazard-classification.pdf |access-date=4 February 2021 |publisher=Ryerson University Facilities Management and Design |archive-date=16 February 2021 |archive-url=https://web.archive.org/web/20210216105042/https://www.ryerson.ca/content/dam/facilities-management-development/environmental-health-safety/docs/2-biological-hazard-classification.pdf |url-status=dead }}
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History
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.{{Cite web |last=Covt |first=Norman M. |date=1997 |url=http://www.detrick.army.mil/cutting_edge/index.cfm |title=A History of Fort Detrick, Maryland |archive-url=https://web.archive.org/web/20080922133111/http://www.detrick.army.mil/cutting_edge/index.cfm |archive-date=2008-09-22 }}, 3rd edition. Kaempf retired from Fort Detrick in 1994, having completed more than 50 years service. He was chief of the mechanical branch, Directorate of Engineering and Housing.
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.{{cite web|url=http://www.absa.org/abohist1.html|title=A History of the American Biological Safety Association|access-date=2008-08-14|author=Manuel S. Barbeito|author2=Richard H. Kruse|publisher=American Biological Safety Association|archive-url=https://web.archive.org/web/20080620063212/http://www.absa.org/abohist1.html|archive-date=2008-06-20|url-status=dead}} 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.{{cite web| url = http://riley.nal.usda.gov/nal_display/index.php?info_center=8&tax_level=4&tax_subject=158&topic_id=1982&level3_id=6419&level4_id=10967&level5_id=0&placement_default=0&test| title = American Biological Safety Association Collection : NAL Collections : National Agricultural Library| access-date= 2009-02-11| date = 2009-02-11| publisher = United States Department of Agriculture: National Agricultural Library| url-status = dead| archive-url= https://web.archive.org/web/20090227023644/http://riley.nal.usda.gov/nal_display/index.php?info_center=8&tax_level=4&tax_subject=158&topic_id=1982&level3_id=6419&level4_id=10967&level5_id=0&placement_default=0&test| archive-date = 2009-02-27}}
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 American Biological Safety Association (ABSA) was officially established in 1984 and a constitution and bylaws were drafted the same year. As of 2008, ABSA includes some 1,600 members in its professional association.
In 1977, Jim Peacock of the Australian Academy of Science asked Bill Snowdon, then chief of the CSIRO's Australian Animal Health Laboratory (AAHL) if he could have the newly released United States' National Institutes of Health and the British equivalent requirements for the development of infrastructure for bio-containment reviewed by AAHL personnel with a view to recommending the adoption of one of them by Australian authorities. The review was carried out by CSIRO AAHL Project Manager Bill Curnow and CSIRO Engineer Arthur Jenkins. They drafted outcomes for each of the levels of security. AAHL was notionally classified as "substantially beyond P4". These were adopted by the Australian Academy of Science and became the basis for Australian legislation. It opened in 1985 costing AU$185 million, built on Corio Oval.{{Cite web|url=http://www.csiro.au/en/Organisation-Structure/National-Facilities/Australian-Animal-Health-Laboratory.aspx|title=CSIRO: Geelong – Australian Animal Health Laboratory}} The Australian Animal Health Laboratory is a Class 4/ P4 Laboratory.{{cite journal |last1=Lowenthal |first1=John |title=Overview of the CSIRO Australian Animal Health Laboratory |journal=Journal of Infection and Public Health |date=May 2016 |volume=9 |issue=3 |pages=236–239 |doi=10.1016/j.jiph.2016.04.007 |pmid=27118215 |pmc=7102798 }}
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.{{cite news |title=Inside the Wuhan lab: French engineering, deadly viruses and a big mystery |url=https://www.washingtonpost.com/world/asia_pacific/wuhan-lab-covid-china/2021/09/07/f293325c-fb11-11eb-911c-524bc8b68f17_story.html |newspaper=Washington Post }}{{cite journal |last1=Cyranoski |first1=David |title=Inside the Chinese lab poised to study world's most dangerous pathogens |journal=Nature |date=23 February 2017 |volume=542 |issue=7642 |pages=399–400 |doi=10.1038/nature.2017.21487 |pmid=28230144 |bibcode=2017Natur.542..399C |doi-access=free}}{{cite web |title=China Inaugurates the First Biocontainment Level 4 Laboratory in Wuhan |date=3 February 2015 |publisher=Wuhan Institute of Virology, Chinese Academy of Sciences |url=http://english.whiov.cas.cn/News/Events/201502/t20150203_135923.html |access-date=9 April 2016 |url-status=dead |archive-url=https://web.archive.org/web/20160303215545/http://english.whiov.cas.cn/News/Events/201502/t20150203_135923.html |archive-date=3 March 2016}}
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".{{cite journal |doi=10.1086/520539 |title=Dedication: Jim Orzechowski (1944–2003) and Michael Kiley (1942–2004) |year=2007 |last1=Feldmann |first1=Heinz |last2=Geisbert |first2=Thomas |last3=Kawaoka |first3=Yoshihiro |last4=Johnson |first4=Karl M. |journal=The Journal of Infectious Diseases |volume=196 |pages=S127–S128 |doi-access=free }}
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.{{cite news |title=JUST IN: Rand Paul Asks Samantha Power: 'Did USAID Fund Coronavirus Research In Wuhan China?' |url=https://www.youtube.com/watch?v=OkfaXm56mdU |agency=YouTube |publisher=Forbes Breaking News |date=26 April 2023}} Russia asked questions on 25 October 2022 in the United Nations over the presence in Ukraine of biolabs.{{cite news |last1=LEDERER |first1=EDITH M. |title=Russia seeks UN probe of claims on Ukraine biological labs |url=https://apnews.com/article/russia-ukraine-europe-united-states-nations-biological-weapons-a782591e10eae1530671500710c0b79f |publisher=The Associated Press |date=25 October 2022}} 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.{{cite news |last1=Horton |first1=Jake |title=Sudan crisis: WHO warns of biological hazard at seized lab |url=https://www.bbc.com/news/world-65390285 |publisher=BBC |date=26 April 2023}} At the time, the facility contained organisms rated at BSL-2.{{cite news |last1=Wallace |first1=Danielle |title=WHO official warns of 'high risk of biological hazard' in Sudan after fighters seize laboratory: reports |url=https://www.foxnews.com/world/who-official-warns-high-risk-biological-hazard-sudan-fighters-seize-laboratory-reports |publisher=FOX News Network, LLC |date=25 April 2023}}
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.{{cite book |title=Biosafety in Microbiological and Biomedical Laboratories, 5th ed. |publisher=U.S. Department of Health and Human Services |date=December 2009 |url=https://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf |section=Section IV-Laboratory Biosafety Level Criteria |access-date=2 April 2016 |pages=30–59 |url-status=live |archive-url=https://web.archive.org/web/20160409233223/http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf |archive-date=9 April 2016 }} 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. Potentially infectious material must be decontaminated before disposal, either by adding a chemical such as bleach or isopropanol or by packaging for decontamination elsewhere. Personal protective equipment is only required for circumstances where personnel might be exposed to hazardous material. BSL-1 laboratories must have a door which can be closed to limit access to the lab. However, it is not necessary for BSL-1 labs to be isolated from the general building.
This level of biosafety is appropriate for work with several kinds of microorganisms including non-pathogenic strains of Escherichia coli and Staphylococcus, Bacillus subtilis, Saccharomyces cerevisiae and other organisms not suspected to contribute to human disease.{{cite web |title=Health & Safety Manual – Biological Safety |publisher=Columbia University Environmental Health and Safety |url=http://ehs.columbia.edu/Policy2.2.html |access-date=2 April 2016 |url-status=live |archive-url=https://web.archive.org/web/20160327090557/http://ehs.columbia.edu/Policy2.2.html |archive-date=27 March 2016 }} 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.{{cite web |title=The 1, 2, 3's of Biosafety Levels |author=Richmond JY |url=http://www.aphl.org/aphlprograms/preparedness-and-response/Smallpox/pdf/the-1-2-3s-of-biosafety-levels.pdf |access-date=2 April 2016 |url-status=live |archive-url=https://web.archive.org/web/20150319062105/http://www.aphl.org/aphlprograms/preparedness-and-response/Smallpox/pdf/the-1-2-3s-of-biosafety-levels.pdf |archive-date=19 March 2015 }}
= 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."{{cite web |title=Principles and Concepts of Biosafety {{!}} Environmental Health & Safety {{!}} University of Missouri |url=https://ehs.missouri.edu/bio/principles |website=ehs.missouri.edu |access-date=25 January 2023}}
- 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.
- Extreme precautions are taken with contaminated sharp items.
Biosafety level 2 is suitable for work involving agents of moderate potential hazard to personnel and the environment. This includes various microbes that cause mild disease to humans, or are difficult to contract via aerosol in a lab setting.{{cite book |title=Biosafety in Microbiological and Biomedical Laboratories, 5th ed. |publisher=U.S. Department of Health and Human Services |date=December 2009 |url=https://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_iii.pdf |section=Section III-Principles of Biosafety |access-date=9 April 2016 |pages=22–28 |url-status=live |archive-url=https://web.archive.org/web/20160310185023/http://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_iii.pdf |archive-date=10 March 2016 }} Examples of pathogens classified as "Risk Group 2" in the United States include seasonal influenza,{{cite web | url=https://ehs.stanford.edu/reference/biosafety-levels-biological-agents | title=Biosafety Levels for Biological Agents | website=stanford.edu | access-date=11 November 2024}} SARS-CoV-2,{{cite web | title=Interim Guidelines for Biosafety and COVID-19 | access-date=11 November 2024|url=https://www.cdc.gov/covid/php/lab/index.html| website=cdc.gov}} hepatitis A, B, and C viruses, human immunodeficiency virus (HIV), pathogenic strains of Escherichia coli and Staphylococcus, Salmonella, Plasmodium falciparum, and Toxoplasma gondii.For a list of infectious agents and the recommended biosafety level at which they should be studied, see {{cite book |title=Biosafety in Microbiological and Biomedical Laboratories, 5th ed. |publisher=U.S. Department of Health and Human Services |date=December 2009 |url=https://www.cdc.gov/labs/BMBL.html |section=Section VIII-Agent Summary Statements |access-date=9 April 2016 |pages=123–289 |url-status=live |archive-url=https://web.archive.org/web/20160327214745/http://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_viii.pdf |archive-date=27 March 2016 }} Notably, the European Union departs from the United States and classifies HIV and hepatitis B {{endash}} G as Risk Group 3 agents best handled at BSL-3.{{cite journal |last1=European Parliament |title=Directive 2000/54/EC – biological agents at work {{!}} Safety and health at work EU-OSHA |journal=Osha.europa.eu |date=4 August 2021 |url=https://osha.europa.eu/en/legislation/directives/exposure-to-biological-agents/77 |access-date=12 March 2023 |issn=0378-6978}}
Prions, the infectious agents that transmit prion diseases such as vCJD, are typically handled under Biosafety Level 2 or higher.{{cite book |title=Biosafety in Microbiological and Biomedical Laboratories |date=June 2020 |url=https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf |section=Section VIII-H: Prion Diseases |publisher=U.S. Department of Health and Human Services |access-date=3 August 2021 |quote=...Prion Diseases...In the laboratory setting, prions from human tissue and human prions propagated in animals can be manipulated at BSL-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.
= Biosafety level 3 =
File:Influenza virus research.jpg, Atlanta, Georgia, US, working with influenza virus under biosafety level 3 conditions, with respirator inside a biosafety cabinet (BSC).]]
Biosafety level 3 is appropriate for work involving microbes which can cause serious and potentially lethal disease via the inhalation route. This type of work can be done in clinical, diagnostic, teaching, research, or production facilities. Here, the precautions undertaken in BSL-1 and BSL-2 labs are followed, as well as additional measures including:
- A laboratory-specific biosafety manual must be drafted which details how the laboratory will operate in compliance with all safety requirements.
- All laboratory personnel are provided medical surveillance and offered relevant immunizations (where available) to reduce the risk of an accidental or unnoticed infection.
- All procedures involving infectious material must be done within a biosafety cabinet.
- Lab personnel must wear solid-front protective clothing (i.e. gowns that tie in the back). This cannot be worn outside of the lab and must be discarded or decontaminated after each use.
Also, the facility which houses the BSL-3 lab must have certain features to ensure appropriate containment. The entrance to the lab must be separated from areas of the building with unrestricted traffic flow. Also, the lab must be behind two sets of self-closing doors (to reduce the risk of aerosols escaping). The construction of the lab is such that it can be easily cleaned. Carpets are not permitted, and any seams in the floors, walls, and ceilings are sealed to allow easy cleaning and decontamination. Also, windows must be sealed, and a ventilation system installed which forces air to flow from the "clean" areas of the lab to the areas where infectious agents are handled. Air from the lab must be filtered before it can be recirculated.
A 2015 study by USA Today journalists, identified more than 200 lab sites in the U.S. that were accredited biosafety levels 3 or 4.{{cite news |last1=Penzenstadler |first1=Nick |title=State incidents highlight bioterror lab concerns |url=https://www.postcrescent.com/story/news/investigations/2015/05/28/state-incidents-highlight-bioterror-lab-concerns/28089943/ |agency=USA Today Network |publisher=Post Crescent |date=28 May 2015}} 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.{{cite news |title=APPENDIX E LIST OF LABS IDENTIFIED IN LOW-RESOURCE COUNTRIES |url=https://www.nap.edu/read/25311/chapter/13 |access-date=4 February 2021 |publisher=National Academy of Sciences |date=2019}}
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.
= Biosafety level 4{{anchor|Level 4}} =
{{See also|List of biosafety level 4 organisms}}
File:Positive-pressure biosafety suit.jpg
Biosafety level 4 (BSL-4) is the highest level of biosafety precautions, and is appropriate for work with agents that could easily be aerosol-transmitted within the laboratory and cause severe to fatal disease in humans for which there are no available vaccines or treatments. BSL-4 labs are generally set up to be either cabinet laboratories or protective-suit laboratories. In cabinet laboratories, all work must be done within a class III biosafety cabinet. Materials leaving the cabinet must be decontaminated by passing through an autoclave or a tank of disinfectant. The cabinets themselves are required to have seamless edges to allow easy cleaning. Also, the cabinet and all materials within must be free of sharp edges to reduce the risk of damage to the gloves. In a protective-suit lab, all work must be done in a class II biosafety cabinet by personnel wearing a positive pressure suit. To exit a BSL-4 lab, personnel must pass through a chemical shower for decontamination, then a room for removing the positive-pressure suit, followed by a personal shower. Entry into the BSL-4 lab is restricted to trained and authorized individuals, and all persons entering and exiting the lab must be recorded.
As with BSL-3 laboratories, BSL-4 labs must be separated from areas that receive unrestricted traffic. Also, airflow is tightly controlled to ensure that air always flows from "clean" areas of the lab to areas where work with infectious agents is being performed. The entrance to the BSL-4 lab must also employ airlocks to minimize the possibility that aerosols from the lab could be removed from the lab. All laboratory waste, including filtered air, water, and trash must also be decontaminated before it can leave the facility.
Biosafety level 4 laboratories are used for diagnostic work and research on easily transmitted pathogens which can cause fatal disease. These include a number of viruses known to cause viral hemorrhagic fever such as Marburg virus, Ebola virus, Lassa virus, and Crimean-Congo hemorrhagic fever. Other pathogens handled at BSL-4 include Hendra virus, Nipah virus, and some flaviviruses. Also, poorly characterized pathogens which appear closely related to dangerous pathogens are often handled at this level until enough data is obtained either to confirm continued work at this level, or to permit working with them at a lower level. This level is also used for work with smallpox virus, though this work is only performed at the Centers for Disease Control and Prevention in Atlanta, United States, and the State Research Center of Virology and Biotechnology in Koltsovo, Russia.{{cite book |title=Biosafety in Microbiological and Biomedical Laboratories, 5th ed. |publisher=U.S. Department of Health and Human Services |date=December 2009 |url=https://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_viii.pdf |section=Section VIII-Agent Summary Statements |page=219 |access-date=4 May 2016 |url-status=live |archive-url=https://web.archive.org/web/20160513215241/http://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_viii.pdf |archive-date=13 May 2016 }}
File:NIAID Integrated Research Facility - Positive Pressure Personnel Suit Inspection.jpg|Regular inspection of positive-pressure suits to locate any leaks{{cite news|last1=Seligson|first1=Susan|title=Video Offers Glimpse of Biosafety Level 4 Lab Science webcast "threads the NEIDL"|url=http://www.bu.edu/today/2013/video-offers-glimpse-of-biosafety-level-4-lab/|newspaper=Boston University|access-date=5 December 2014|date=7 March 2013|url-status=live|archive-url=https://web.archive.org/web/20141210184637/http://www.bu.edu/today/2013/video-offers-glimpse-of-biosafety-level-4-lab/|archive-date=10 December 2014}}
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
File:NIAID Integrated Research Facility - MRI.jpg|The circular containment tube separates the patient table in the "hot" zone (pathogen present) from the "cold" zone around this MRI machine.
File:NIAID Integrated Research Facility - Air Pressure Resistant (APR) door.jpg|Air pressure resistant (APR) door to separate the hot and cold zones
File:NIAID Integrated Research Facility - Positive Pressure Personnel Suit.jpg|Working inside a BSL-4 lab with air hoses providing positive air pressure
File:NIAID Integrated Research Facility - Class III Biosafety Cabinet.jpg|Inside a Class III biological safety cabinet with an aerosol control platform
File:Effluent decontamination system.jpg|Effluent decontamination system of a BSL-4 lab of NIAID
== BSL-4 facilities for extraterrestrial samples ==
{{Main|Extraterrestrial sample curation}}
Sample-return missions that bring samples from a Category V body back to Earth must be curated at facilities rated BSL-4. Because the existing BSL-4 facilities in the world do not provide the level of cleanliness needed for such pristine samples,{{Cite web |last=Hsu |first=Hsu |date=2009-12-03 |title=How to Protect Mars Samples on Earth |url=https://www.space.com/7625-protect-mars-samples-earth.html |access-date=2024-12-19 |website=Space.com |language=en}} 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.{{Cite web|url=https://science.nasa.gov/media/medialibrary/2013/01/17/ESF_Mars_Sample_Return_backward_contamination_study.pdf|archiveurl=https://web.archive.org/web/20160602150139/http://science.nasa.gov/media/medialibrary/2013/01/17/ESF_Mars_Sample_Return_backward_contamination_study.pdf|url-status=dead|title=European Science Foundation – Mars Sample Return backward contamination – Strategic advice and requirements|archivedate=2 June 2016}}
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,{{cite report|title=Assessment of Planetary Protection Requirements for Mars Sample Return Missions|publisher=National Research Council|page=59|year=2009|chapter=7: "Sample-Receiving Facility and Program Oversight"|chapter-url=http://www.nap.edu/openbook.php?record_id=12576&page=59}}{{Cite web |url=http://planetaryprotection.nasa.gov/summary/msr |title=Mars Sample Return: Issues and Recommendations (Planetary Protection Office Summary) |work=Task Group on Issues in Sample Return. National Academies Press, Washington, DC, 1997|archive-url=https://web.archive.org/web/20111015062937/http://planetaryprotection.nasa.gov/summary/msr |archive-date=15 October 2011 }} 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.{{Cite web |title=NCMVCA study |url=http://www.ncmvca.org/sitebuildercontent/sitebuilderfiles/12andersonlab.pdf |archive-url=https://web.archive.org/web/20170131192531/http://www.ncmvca.org/sitebuildercontent/sitebuilderfiles/12andersonlab.pdf |archive-date=2017-01-31 |access-date=2017-01-19}}
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.{{Cite web |title=DoD Safety Standards for Microbiological and Biomedical Laboratories |url=http://dtic.mil/whs/directives/corres/pdf/605518m.pdf |archive-url=https://web.archive.org/web/20170125204212/http://dtic.mil/whs/directives/corres/pdf/605518m.pdf |archive-date=2017-01-25 |access-date=2017-01-19}} 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.{{Cite web |title=GAO publication |url=http://www.gao.gov/products/GAO-08-108T |archive-url=https://web.archive.org/web/20170120224803/http://www.gao.gov/products/GAO-08-108T |archive-date=2017-01-20 |access-date=2017-01-19}} 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.{{cite book |title=Microbial Forensics |date=2011 |publisher=Elsevier, Academic Press |isbn=978-0-12-382006-8 |pages=199–220 |chapter=Chapter 13 - Select Agent Regulations |doi=10.1016/B978-0-12-382006-8.00013-X |last1=Morse |first1=Stephen A. |last2=Weirich |first2=Elizabeth }}
List of BSL-4 facilities
{{incomplete list|date=March 2014}}
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.{{cite web|url=http://www.gao.gov/new.items/d08108t.pdf|title=High-Containment Biosafety Laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States|publisher=United States Government Accountability Office|access-date=26 May 2016|date=Oct 4, 2007|url-status=live|archive-url=https://web.archive.org/web/20160212182444/http://www.gao.gov/new.items/d08108t.pdf|archive-date=12 February 2016}} 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. As of May 2021, there are 42 BSL-4 facilities in operation around the world, with a further 17 planned or under construction.{{Cite web |last1=Lentzos |first1=Filippa |last2=Koblentz |first2=Gregory D. |date=May 2021 |title=Mapping Maximum Biological Containment Labs Globally |url=https://static1.squarespace.com/static/6048d7a0e9652c472e619f6f/t/60ae71cea2219b008f29d4ca/1622045135314/Mapping+BSL4+Labs+Globally+EMBARGOED+until+27+May+2021+1800+CET.pdf |access-date=3 November 2022 |archive-date=1 November 2022 |archive-url=https://web.archive.org/web/20221101184029/http://static1.squarespace.com/static/6048d7a0e9652c472e619f6f/t/60ae71cea2219b008f29d4ca/1622045135314/Mapping+BSL4+Labs+Globally+EMBARGOED+until+27+May+2021+1800+CET.pdf |url-status=dead }}
The following is a list of existing BSL-4 facilities worldwide.
See also
References
{{Reflist|30em}}
External links
- [https://www.cdc.gov/labs/BMBL.html Biosafety in Microbiological and Biomedical Laboratories], CDC publication
- [https://fas.org/programs/bio/biosafetylevels.html Federation of American Scientists: Biosafety Level 3 and 4 Labs]
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