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In many countries, including the United States, infectious agents are categorized in risk groups based on their relative risk. Depending on the country and/or organization, this classification system might take the following factors into consideration:

  • Pathogenicity of the organism
  • Mode of transmission and host range
  • Availability of effective preventive measures (e.g., vaccines)
  • Availability of effective treatment (e.g., antibiotics)
  • Other factors


*Please note, the Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition. (2009) or “BMBL” outlines biological safety levels (BSLs), which are distinct from risk group levels. A proper risk assessment for biological agents must always be conducted before establishing a biological safety level.

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Resources

CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (2019)

Four Biosafety Levels (BSLs) are described in Section 4, which consist of combinations of laboratory practices and techniques, safety equipment, and laboratory facilities. Each combination is specifically appropriate for the operations performed, the documented or suspected routes of transmission of the infectious agents, and the laboratory function or activity. The BSLs described in this manual should be differentiated from Risk Groups (RG), as described in the NIH Guidelines. RG are the result of a classification of microbiological agents based on their association with, and resulting severity of, disease in humans. The RG of an agent should be one factor considered in association with mode of transmission, procedural protocols, experience of staff, and other factors in determining the BSL in which the work will be conducted.

U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health. "Biosafety in Microbiological and Biomedical Laboratories, Six Edition.” (2020).

Biosafety Level 1 (BSL 1): suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and that present minimal potential hazard to laboratory personnel and the environment.

Biosafety Level 2 (BSL 2): builds upon BSL-1. BSL-2 is suitable for work involving agents associated with human disease and pose moderate hazards to personnel and the environment.

Biosafety Level 3 (BSL 3): suitable for work with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure.

Biosafety Level 4 (BSL 4): dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease that is frequently fatal, for which there are no vaccines or treatments, or a related agent with unknown risk of transmission.

NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES (NIH GUIDELINES) April 2024


https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf]

Section II-A describes four risk groups and criteria for doing risk assessment. It also acknowledges that risk assessment is a subjective process. The NIH Guidelines classifies agents into the following four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans:

Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans.

Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.

Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available. (high individual risk but low community risk)

Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. (high individual risk and high community risk)

See also Appendix B for the classification of Human Etiologic Agents on the Basis of Hazard

WHO Laboratory Biosafety Manual (2020)

The 2020 version of the WHO Laboratory Biosafety Manual (2020 LBM) acknowledges that classifying biological agents into risk groups has led to confusion and potential equivalence between risk group classification and biosafety level of a laboratory. The 2020 LBM emphasizes that risk assessment including scenarios, procedures used, and competency of personnel involved are the cornerstones for safely handling biological agents. In addition, table 9.1 includes risk or hazard group as one of the approaches to develop a biosafety framework:

Biological agents are classified into “risk” or “hazard groups” based upon each agent’s characteristics and epidemiological profile. The higher the risk or hazard group, the higher the likelihood that the agent will cause and spread infection in humans or animals in the country, and/or the more severe the consequences of that infection will be to individual and public health, if it were to occur. Regulations are then developed that apply to each of the risk or hazard groups.

Prior versions of the WHO LBM used risk groups to classify biological agents based on pathogenicity of the organism, modes of transmission and host range of the organism. For reference, the definitions for risk groups included in the 2004 LBM are provided below:

Risk Group 1 (no or low individual and community risk): A microorganism that is unlikely to cause human or animal disease.

Risk Group 2 (moderate individual risk, low community risk): A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory personnel, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited.

Risk Group 3 (high individual risk, low community risk): A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available.

Risk Group 4 (high individual and community risk): A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.

Australian/New Zealand

The Australia/New Zealand 2010 Standard AS-NZS 2243-3:2010. Safety in laboratories – Microbiological Safety and Containment from 2010 has been superseded by AS/NZS 2243.3:2022 Safety in laboratories - Part 3: Microbiological safety and containment. This new standard is available with the purchase of a license.

https://www.standards.govt.nz/shop/ASNZS-2243-32022

Belgium (2006)

Class of risk 1: micro-organisms known as nonpathogenic for the man, the animal, the plant and not-harmful for the environment or presenting a negligible risk for the man and the environment at the laboratory scale. This class includes, beside organisms whose harmlessness was proven, strains which can be allergens and opportunistic pathogens.

Human pathogens

Class of risk 2: micro-organisms that can cause human disease and might be a hazard for directly exposed persons; they are unlikely to spread to the community. There is usually effective prophylaxis or treatment available.

Class of risk 3: micro-organisms that can cause severe human disease and present a serious hazard for directly exposed persons. They may present a risk of spreading to the community. There is usually effective prophylaxis or treatment available.

Class of risk 4: micro-organisms that cause severe human disease and are a serious hazard for directly exposed persons. They may present a high risk of spreading to the community. There is usually no effective prophylaxis or treatment available.

Animal pathogens

Class of risk 2: micro-organisms that can cause disease in animals and present, at different levels, one or other of the following characteristics: limited geographical importance, no or weak interspecific transmission, no vectors or carriers. The economic and or veterinary significance is limited. There is usually effective prophylaxis or treatment available.

Class of risk 3: micro-organisms that can cause serious disease or epizootics in animals. Interspecific diffusion can be important. Some of these pathogenic agents require the installation of sanitary regulations for species indexed by the authorities of each country concerned. Medical and/or sanitary prophylactic measures are available.

Class of risk 4: micro-organisms that cause extremely serious panzotics or epizootics in animals with a very high mortality rate or dramatic economic consequences in the affected farmingregions. Either no medical prophylaxis is available or only one exclusive sanitary prophylaxis is possible or obligatory.

Plant pathogens

Class of risk 2: micro-organisms that can cause plant disease, but that does not present an increased risk of epidemic in the event of accidental dissemination in the Belgian environment. They are ubiquitous pathogens for whom prophylactic and therapeutic means exist. Nonindigenous or exotic phytopathogen micro-organisms which cannot survive in the Belgian environment because of absence of hosts or plant-targets, or favorable climatic conditions also belong to the class of risk 2.

Class of risk 3: micro-organisms that can cause in the plant a disease of economic or environmental importance for which treatments are non-existent, difficult to apply, or expensive. The accidental dissemination of these micro-organisms can increase the risks of local epidemics. Exotic stocks of micro-organisms usually present in the Belgian environment and not listed as quarantine micro-organisms also belong to this class of risk.

Canadian Biosafety Handbook 3rd, 2022


The 2022 Canadian Biosafety Handbook includes the following definition of risk group:
The classification of a biological agent (i.e., microorganism, protein, nucleic acid, or biological material containing parts thereof) based on its inherent characteristics, including pathogenicity, virulence, communicability, and the availability of effective prophylactic or therapeutic treatments. The risk group describes the risk to the health of individuals and the public, as well as the health of animals and the animal population.

Classified human and animal pathogens can also be found on the Public Health Agency of Canada’s ePATHogen – Risk Group Database.

Risk Group 1 (low individual and community risk)
A microorganism, nucleic acid, or protein that is either: a) not capable of causing human or animal disease; or b) capable of causing human or animal disease, but unlikely to do so. RG1 organisms capable of causing disease are considered pathogens that pose a low risk to the health of individuals or animals, and a low risk to public health and the animal population. RG1 pathogens can be opportunistic and may pose a threat to immunocompromised individuals. Due to the low risk to public health and the animal population, the CBS does not specify requirements for handling RG1 biological material. Nevertheless, it remains important to exercise due care and follow safe work practices (e.g., good microbiological laboratory practices) when handling RG1 biological material.

Risk Group 2 (moderate individual risk, low community risk)
A pathogen or toxin that poses a moderate risk to the health of individuals or animals, and a low risk to public health and the animal population. These pathogens are able to cause serious disease in a human or animal but are unlikely to do so. Effective treatment and preventive measures are available and the risk of spread of diseases caused by these pathogens is low. Examples of RG2 human pathogens are included in Schedule 2 of the HPTA.

Risk Group 3 (high individual risk, low community risk)
A pathogen that poses a high risk to the health of individuals or animals, and a low risk to public health. These pathogens are likely to cause serious disease in a human or animal. Effective treatment and preventive measures are usually available and the risk of spread of disease caused by these pathogens is low for the public. The risk of spread to the animal population, however, can range from low to high depending on the pathogen. Examples of RG3 human pathogens are included in Schedule 3 of the HPTA.

Risk Group 4 (high individual risk, high community risk)
A pathogen that poses a high risk to the health of individuals or animals and a high risk to public health. These pathogens are likely to cause serious disease in a human or animal which can often lead to death. Effective treatment and preventive measures are not usually available and the risk of spread of disease caused by these pathogens is high for the public. The risk of spread of disease to the animal population, however, can range from low to high depending on the pathogen. Examples of RG4 human pathogens are included in Schedule 4 of the HPTA.

European Economic Community (2000)

Directive 2000/54/EC and Directive 90/679/EEC (adopted 20 November, 1990; revised 18 September 2000) on the protection of workers from risks related to exposure to biological agents at work provides for the Classification of biological agents into four infection risk groups on the basis of the following criteria:

Group 1 biological agent means one that is unlikely to cause human disease.

Group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available.

Group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available.

Group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

(See also Official Journal of the European Communities No L262/21 dated September 18, 2000.) Article 2. Definitions; Article 18. Classification of biological agents; Annex III.Community Classification. Introductory Notes).

Germany (2013)


Risk Group 1: biomaterials, where it is unlikely that they cause disease in humans

Risk Group 2: biomaterials that can cause human disease and might be a hazard to workers; dispersal in the population is unlikely; effective prophylaxis or treatment is normally possible

Risk Group 3: biomaterials, which cause severe human disease and present a serious hazard to workers; the risk of spread to the community, but there is usually effective prophylaxis or treatment available

Risk Group 4: biological agents which cause severe human disease and are a serious hazard to workers; the risk of spread in the population is high under certain circumstances; there is usually no effective prophylaxis or treatment.

Singapore (guidelines are from 2012; updated list of organisms is from 2016): BATA Schedules

First Schedule Part I
Risk Group 3 Biological Agents which can cause serious disease which is of high risk to the individual.

First Schedule Part II
Description is the same as First Schedule Part I but they also have the potential to be weaponized.

Second Schedule
Risk Group 4 Biological Agents which can cause severe / lethal disease, easily transmitted and of high risk to the individual and the community. These agents have the potential to be weaponized.

Third Schedule
Risk Group 2 Biological Agents that need special attention in large scale production.

Fourth Schedule
All Risk Group 2 Biological Agents (including those in Third Schedule) which cause disease in humans.

Fifth Schedule
Microbial toxins that have the potential to be weaponized.

United Kingdom (2013)

Group 1 Unlikely to cause human disease.

Group 2 Can cause human disease and may be a hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or treatment available.

Group 3 Can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available.

Group 4 Causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available

Risk Group Database

Abiotrophia, Acetivibrio, Acholeplasma, Achromobacter, Acidaminococcus, Acidovorax, Acinetobacter, Actinobacillus, Actinobaculum, Actinomadura, Actinomyces, Aegyptianella, Aerococcus, Aeromonas, Afipia, Alcaligenes, Alloiococcus, Allomonas, Alteromonas, Amycolata, Anaerobiospirillum, Anaerorhabdus, Anaplasma, Arachnia, Arcanobacterium, Arcobacter, Arizona, Arsenophonus, Arthrobacter, Asfarviridea, Atopobium, Bacillus, Bacteroides, Balneatrix, Bartonella, Beneckea, Bergeyella, Bifidobacterium, Bilophila, Bordetella, Borrelia, Brachyspira, Brevibacterium, Brevinema, Brevundimonas, Brucella, Burkholderia, Calymmatobacterium, Campylobacter, Capnocytophaga, Cardiobacterum, Carnobacterium, Catonella, Cedecea, Cellulomonas, Centipeda, Chlamydia, Chlamydophila, Chromobacterium, Chryseobacterium, Citrobacter, Clavibacter, Clostridium, Comamonas, Corynebacterium, Cowdria, Coxiella, Curtobacterium, Cytophaga, Dermatiphulus, Dermatophilus, Dialister, Dichelobacter, Dolosigranulum, Edwardsiella, Ehrlichia, Eikenella, Empedobacter, Enterobacter, Enterococcus, Eperythrozoon, Erlichia, Erwinia, Erysipelothrix, Escherichia, Eubacterium, Eurbacterium, Ewingella, Facklamia, Faenia, Falcivibrio, Flavobacterium, Flexibacter, Fluoribacter, Francisella, Fusobacterium, Gardnerella, Gemella, Genus, Globicatella, Gordonia, Haemobartonella, Haemophilus, Hafnia, Hallella, Hartmanella, Helcococcus, Helicobacter, Herellea, Johnsonella, Jonesia, Kingella, Klebsiella, Kluyvera, Koserella, Lactobacillus, Lactococcus, Lawsonia, Leclercia, Legionella, Leptospira, Levinea, Liberobacter, Listeria, Listonella, Mannheimia, Megasphaera, Melissococcus, Microvirgula, Mima, Mitsuokella, Mobiluncus, Moraxella, Moraxella (Branhamella), Morganella, Morococcus, Mycobacterium, Mycoplasma, Mycoplasma, Myroides, Neisseria, Neorickettsia, Nocardia, Nocardiopsis, Nocarida, Ochrobactrum, Oligella, Orienta, Ornithobacterium, Paenibacillus, Pantoea, Pasteurella, Peptococcus, Peptostreptococcus, Photobacterium, Piscirickettsia, Plesiomonas, Porphyromonas, Prevotella, Propionibacterium, Proteus, Providencia, Pseudoalteromonas, Pseudomonas, Pseudoramibacter, Psychrobacter, Ralstonia, Renibacterium, Rhodococcus, Rickettsia, Riemerella, Rochalimaea, Saccharopolyspora, Salmonella, Sanguibacter, Selenomonas, Serpulina, Serratia, Shewanella, Shigella, Sphaerophorus, Sphingobacterium, Sphingomonas, Spiroplasma, Sporichthya, Staphylococcus, Stenotrophomonas, Streptobacillus, Streptococcus, Streptomyces, Sutterella, Suttonella, Tatlockia, Tatumella, Taylorella, Tissierella, Treponema, Tsukamurella, Turicella, Ureaplasma, Vagococcus, Veillonella, Vibrio, Waddlia, Xanthomonas, Xylella, Xylophilus, ycoplasma, Yersinia

Search Database

Enter any name of agent (genus, species, viral group, virus name):
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References


1. Advisory Committee on Dangerous Pathogens. 2013. “The Approved List of biological agents” 3rd Edition. Health and Safety Executive – United Kingdom.
http://www.hse.gov.uk/pubns/misc208.pdf
2. Australian/New Zealand Standard AS/NZS 2243.3:2010. “Safety in laboratories Part 3: Microbiological aspects and containment facilities”.
https://law.resource.org/pub/nz/ibr/as-nzs.2243.3.2010.pdf
3. Belgian risk group classifications: https://www.biosafety.be/content/tools-belgian-classification-micro-organisms-based-their-biological-risks
4. Bundesministerium der Justiz und für Verbraucherschutz. 2013. “Verordnung über Sicherheit und Gesundheitsschutz bei Tätigkeiten mit Biologischen Arbeitsstoffen (Biostoffverordnung - BioStoffV)”.
http://www.gesetze-im-internet.de/englisch_biostoffv/englisch_biostoffv.pdf
http://www.gesetze-im-internet.de/biostoffv_2013/BJNR251410013.html#BJNR251410013BJNG000500000
https://www.bgbl.de/xaver/bgbl/start.xav?startbk=Bundesanzeiger_BGBl
5. Centers for Disease Control and Prevention. 2020. “Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition". Government Printing Office
https://www.cdc.gov/labs/bmbl/index.html
6. Centers for Disease Control and Prevention & Animal and Plant Health Inspection Service. 2017. Select Agent Program - Select Agents and Toxins.
http://www.selectagents.gov/SelectAgentsandToxins.html
7. European Union. 2000. 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/EC Official Journal of the European Communities L262/21. October 17, 2000
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32000L0054
https://osha.europa.eu/en/legislation/directives/exposure-to-biological-agents/77
8. Government of Canada. 2016. Canadian Biosafety Handbook, Second Edition.
https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines/handbook-second-edition.html
https://www.canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/pathogen-safety-data-sheets-risk-assessment.html
9. National Institutes of Health. 2016. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) (April 2016). The current version of the NIH Guidelines can be accesses at:
https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/
10. Singapore Ministry of Health (MOH), Biological Agents and Toxins Act (BATA). Updated Biological Agents and Toxins List.
https://www.moh.gov.sg/biosafety/newsupdate/newsdetail/Index/Updated%20Biological%20Agents%20and%20Toxins%20List
11. World Health Organization. 2020. "Laboratory Biosafety Manual". 4th Edition. WHO, Geneva.
https://www.who.int/publications/i/item/9789240011311