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Classification of Human Etiologic Agents on the
Basis of Hazard
This appendix reflects the current state of knowledge and should be
considered a resource document. Included are the more commonly encountered
agents and is not meant to be all inclusive. Information on agent risk
assessment may be found in the Agent Summary Statements of the
CDC/NIH publication, Biosafety in Microbiological and Biomedical
Laboratories (see Sections V-C, VD, VE and VF,
Footnotes and References of Sections I through I\/. Further guidance
on agents not listed in Appendix B may be obtained through: Centers for
Disease Control and Prevention, Biosafety Branch, Atlanta, Georgia 30333,
Phone: (404) 639-3883, Fax: (404) 6392294; National Institutes of Health,
Division of Safety, Bethesda, Maryland 20892, Phone: (301) 496-1357;
National Animal Disease Center, U.S. Department of Agriculture, Ames, lowa
50010, Phone: (515) 862-8258. A special committee of the American Society for Microbiology will
conduct an annual review of this appendix and its recommendation for
changes will be presented to the Recombinant DNA Advisory Committee as
proposed amendments to the NIH Guidelines. Appendix B Basis for the Classification of
Biohazardous Agents by Risk Group (RG) Risk Group 1 (RG1 ) Agents that are not associated with disease in healthy adult humans Risk Group 2 (RG2) Agents that are associated with human disease which is rarely serious
and for which preventive or therapeutic interventions are often
available Risk Group 3 (RG3) Agents that 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 that 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) Appendix Bl. Risk Group 1 (RG1) Agents RG1 agents are not associated with disease in
healthy adult humans. Examples of RG1 agents include asporogenic
Bacillus subtilis or Bacillus licheniformis (see Appendix C-IVA,
Bacillus subtilis or Bacillus licheniformis HostVector Systems,
Exceptions), Escherichia coliK12 (see Appendix C-IIA,
Escherichia coil K12 HostVector Systems, Exceptions). and
adenoassociated virus types 1 through 4. Those agents not listed in Risk Groups (RGs) 2, 3 and 4 are not
automatically or implicitly classified In RG1; a risk assessment must be
conducted based on the known and potential properties of the agents and
their relationship to agents that are listed. Appendix B-ll. Risk Group 2 (RG2) Agents RG2 agents are associated with human disease which
is rarely serious and for which preventive or therapeutic interventions
are often available. Appendix BIIA. Risk Group 2 (RG2) Bacterial
Agents Including Chlamydiav Acinetobacter baumannii (formerly Acinetobacter calcoaceticus) Actlnobacillus Actinomyces pyogenes (formerly Corynebacterium pyogenes) Aeromonas hydrophila Amycolata autotrophica Archanobacterium haemolyticum (formerly Corynebacterium haemolyticum) Arizona hinshawii all serotypes Bacillus anthracis Bartonella henselae, B. quintana, B. vinsonii Bordetella including B. pertussis Borrelia recurrentis, B. burgdorferl Burkholderia (formerly Pseudomonas species) except those listed in Appendix BIIIA (RG3)) Campylobacter coil, C. fetus, C. jejuni Chlamydia psittaci, C. trachomatis, C. pneumoniae Clostridium botulinum, Cl. chauvoei, Cl. haemolyticum, Cl. histolyticum, Cl. novyi, Cl. septicum, Cl. tetani Corynebacterium diphtheriae, C. pseudotuberculosis, C. renale Dermatophilus congolensis Edwardsiella tarda -Erysipelothrix rhusiopathiae -Escherichia coli - all enteropathogenic, enterotoxigenic, enteroinvasive and strains bearing K1 antigen, including E. coli O157:H7 -Haemophilus ducreyi, H. influenza Helicobacter pylori Klebsiella all species except K. oxytoca (RG1) Legionella including L. pneumophila Leptospira interrogans all serotypes Listeria Moraxella Mycobacterium (except those listed in Appendix BIIIA (RG3)) including M. avium complex, M. asiaticum, M. bovis BCG vaccine strain, M. chelonei, M. fortuitum, M. kansasii, M. leprae, M. malmoense, M. marinum, M.paratuberculosis, M. scrofulaceum, M. simiae, M. szulgai, M. ulcerans, M. xenopi Mycoplasma, except M. mycoides and M. agalactiae which are restricted animal pathogens Neisseria gonorrhoea, N. meningitidis Nocardia asteroides, M. brasiliensis, M. otitidiscaviarum, M. transvalensis Rhodococcus equi Salmonella including S. arizonae, S. cholerasuis, S. enteritidis, S. gallinarumpullorum, S. meleagridis, S. paratyphi, A, B, C, S. typhi, S. typhimurium Shigella including S. boydii, S. dysenteriae, type 1, S. flexneri, S. sonnei Sphaerophorus necrophorus Staphylococcus aureus Streptobacillus moniliformis Streptococcus including S. pneumoniae, S. pyogenes Treponema pallidum, T. carateum Vibrio cholerae, V. parahemolyticus, V. vulnificus Yersinia enterocolitica Appendix BIIB. Risk Group 2 (RG2) Fungal Agents Blastomyces dermatitidis Cladosporium bantianum, C. (Xylohypha) trichoides Cryptococcus neoformans Dactylaria galopava (Ochroconis gallopavum) Epidermophyton Exophiala (Wangiella) dermatitidis Fonsecaea pedrosoi Microsporum Paracoccidioides braziliensis Penicillium marneffei Sporothrix schenckii Trichophyton Appendix BIIC. Risk Group 2 (RG2) Parasitic Agents Ancylostoma human hookworms including A. duodenale, A. ceylanicum Ascaris including Ascaris lumbricoides suum Babesia including B. divergens, B. microti Brugia filaria worms including B. malayi, B. timori Coccidia Cryptosporidium including C. parvum Cysticercus cellulosae (hydatid cyst, larva of T. solium) Echinococcus including E. granulosis, E. multilocularis, E. vogeli Entamoeba histolytica -Enterobius -Fasciola including F. gigantica, G. hepatica -Giardia including G. lamblia -Heterophyes -Hymenolepis Including H. diminuta, H. nana Isospora Leishmania including L. braziliensis, L. donovani, L. ethiopia, L. major, L. mexicana, L. peruvania, L. tropica Loa loa filaria worms Microsporidium Naegleria fowleri Necator human hookworms including N. americanus Onchoerca filaria worms including, O. volvulus Plasmodium including simian species, P. cynomologi, P. falciparum, P. malariae, P. ovale, P. vivax Sarcocystis Including S. sui hominis Schistosoma including S. haematobium, S. intercalatum, S. japonicum, S. mansoni, S. mekongi Strongyloides including S. stercoralis Taenia solium Toxocara including T. canis Toxoplasma including T. gondii Trichinella spiralis Trypanosoma including T. brucei brucei, T. brucei gambiense, T. brucei rhodesiense, T. cruzi Wuchereria bancrofti filaria worms Appendix BllD. Risk Group 2 (RG2) Viruses -Adenoviruses, human all
types -Alphaviruses (Togaviruses) Group A Arboviruses Eastern equine encephalomyelitis virus Venezuelan equine encephalomyelitis vaccine strain TC-83 Western equine encephalomyelitis virus Arenaviruses Lymphocytic choriomeningitis virus (nonneurotropic strains) Tacaribe virus complex -Other viruses as listed in the reference source (see Section V-C, Footnotes and References of Sections I through IV)
Bunyaviruses Bunyamwera virus Rift Valley fever virus vaccine strain MP12 Other viruses as listed in the reference source (see Section VC, Footnotes and References of Sections I through IV) Calciviruses Coronaviruses Flaviviruses (Togaviruses) Group B Arboviruses Dengue virus serotypes 1, 2, 3, and 4 Yellow fever virus vaccine strain 17D Other viruses as listed in the reference source (see Section VC,
Footnotes and References of Sections I through IV) Hepatitis A, B, C, D, and E viruses Herpesviruses - except Herpesvirus simiae (Monkey B virus) (see Appendix B-IV-D, Risk Group 4 (RG4) - Viral Agents) -Cytomegalovirus -Epstein Barr virus Herpes simplex types 1 and 2 -Herpes zoster Human herpesvirus types 6 and 7 Orthomyxoviruses -Influenza viruses types A, B, and C Other tickborne orthomyxoviruses as listed in the reference source (see Section VC, Footnotes and References of Sections I through IV) Papovaviruses All human papilloma viruses Paramyxoviruses -Newcastle disease virus Measles virus -Mumps virus Parainfluenza viruses types 1, 2, 3, and 4 Respiratory syncytial virus Parvoviruses Human parvovinus (B19) Picornaviruses -Coxsackie viruses types A and B Echoviruses all types Polioviruses all types, wild and attenuated Rhinoviruses all types Poxviruses all types except Monkeypox virus (see Appendix BIIID,
Rlsk Group 3 (RG3) Viruses and Prions) and restricted poxviruses
including Alastrim, Smallpox, and Whitepox (see Section VL Footnotes
and References of Sections I through IV) Reoviruses all types including Coltivirus, human Rotavirus, and
Orbivirus (Colorado tick fever virus) Rhabdoviruses Rabies virus all strains Vesicular stomatitis virus laboratory adapted strains including
VSVIndiana, San Juan, and Glasgow Togaviruses (see Alphaviruses and Flaviviruses) Rubivinus (rubella) Appendix B-III. Risk Group 3 (RG3) Agents RG3 agents are associated with serious or lethal human dlseases for
which preventive or therapeutic interventions may be available. Appendix B-IllA. Risk Group 3 (RG3) Bacterial
Agents Including Rlckettsia Bartonella Brucella including B. abortus, B. canis, B. suis Burkholderia (Pseudomonas) mallei, B. pseudomallei -Coxiella burnetii -Francisella tularensis -Mycobacterium bovis (except BCG strain, see Appendix B-II-A, Risk Group 2 (RG2) - Bacteral Agents Including Chlamydia), M. tuberculosis Pasteurella multocida type B - "buffalo" and other virulent strains Rickettsia akari, R. australis, R. canada, R. conorii, R. prowazekii, R. rickettsii, R. siberica, R. tsutsugamushi, R. typhi (R. mooseri) Yersinia pestis Appendix BIIIB. Risk Group 3 (RG3) Fungal
Agents Coccidioides immitis (sporulating cultures; contaminated soil) Histoplasma capsulatum, H. capsulatum var. duboisii Appendix BIIIC. Risk Group 3 (RG3) Parasitic
Agents None Appendix BIIID. Risk Group 3 (RG3) Viruses and Prions Alphaviruses (Togaviruses) Group A Arboviruses Semliki Forest virus St. Louis encephalitis virus Venezuelan equine encephalomyelitis virus (except the vaccine strain TC-83, see Appendix BIID (RG2)) Other viruses as listed in the reference source (see Section VC,
Footnotes and References of Sections I through IV) Arenaviruses Lymphocytic choriomeningitis virus (LCM) (neurotropic strains) Bunyaviruses Rift Valley fever virus Flaviviruses (Togaviruses) Group B Arboviruses Japanese encephalitis virus Yellow fever virus Other viruses as listed in the reference source (see Section VC,
Footnotes and References of Sections I through IV) Poxviruses Monkeypox virus Prions Transmissible spongioform encephalopathies (TME) agents (Creutzfeldt-Jacob
disease and kuru agents) (see Section VC, Footnotes and References of
Sections I through IV, for containment instruction) Retroviruses Human immunodeficiency virus (HIV) types 1 and 2 Human T cell Iymphotropic virus (HTLV) types 1 and 2 Simian immunodeficiency virus (SIV) Rhabdoviruses Vesicular stomatitis virus Appendix B-IV. Risk Group 4 (RG4) Agents RG4 agents are likely to cause serious or lethal
human disease for which preventive or therapeutic interventions are not
usually available. Appendix BIVA. Risk Group 4 (RG4) Bacterial Agents None Appendix BIVB. Risk Group 4 (RG4) Fungal Agents None Appendix BIVC. Risk Group 4 (RG4) Parasitic Agents None Appendix BIVD. Risk Group 4 (RG4) Viral Agents Arenaviruses (Togaviruses) Group A Arboviruses Guanarito virus Lassa virus -Junin virus Machupo virus Bunyaviruses (Nairovirus) -Crimean-Congo hemorrhagic fever virus Filoviruses Ebola virus Marburg virus Flaviruses (Togaviruses) Group B Arboviruses Tickborne encephalitis virus complex including Absetterov, Central European encephalitis, Hanzalova, Hypr, Kumlinge, Kyasanur Forest disease, Omsk hemorrhagic fever, and Russian
springsummer encephalitis viruses Herpesviruses (alpha) Herpesvirus simiae (Herpes B or Monkey B virus) Hemorrhagic fever agents and viruses as yet undefined Appendix BV. Animal Viral Etiologic Agents in Common Use The following list of animal etiologic agents is
appended to the list of human etiologic agents. None of these agents is
associated with disease in healthy adult humans; they are commonly used in
laboratory experimental work. A containment level appropriate for RG1 human agents is recommended for
their use. For agents that are infectious to human cells, e.g.,
amphotropic and xenotropic strains of murine leukemia viruses, a
containment level appropriate for RG2 human agents is recommended. Baculoviruses Herpesviruses Herpesvirus ateles -Herpesvirus saimiri -Marek's disease virus -Murine cytomegalovirus Papovaviruses Bovine papilloma virus Polyoma virus Shope papilloma virus -Simian virus 40 (SV40) Retroviruses Avian leukosis virus Avian sarcoma virus Bovine leukemia virus Feline leukemia virus Feline sarcoma virus Gibbon leukemia virus MasonPfizer monkey virus Mouse mammary tumor virus Murine leukemia virus Murine sarcoma virus Rat leukemia virus Appendix BV1. Murine Retroviral Vectors Murine retroviral vectors to be used for human transfer experiments (less than 10 liters) that contain less than 50% of their respective parental viral genome and that have been demonstrated to be free of detectable replication competent retrovirus can be maintained, handled, and administered, under BL1 containment.
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