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Appendix B: classification of human etiologic agents on the basis of hazard Biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into 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 Examples: Risk Group 2 (RG2) I- Bacterial Agents Including Chlamydia Acinetobacter baumannii (formerly Acinetobacter calcoaceticus) -Actinobacillus -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. burgdorferi -Burkholderia (formerly Pseudomonas species) except those listed in (RG3) -Campylobacter coli, C. fetus, C. jejuni - Chlamydia psittaci, C. trachomatis, C. pneumoniae - (Clostridium botulinum, C. chauvoei, C. haemolyticum, C. histolyticum, C. novyi, C. septicum, C. tetani ) -(Coxiella burnetii - specifically the Phase II, Nine Mile strain, plaque purified, clone 4) -(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) -*Francisella tularensis specifically *F.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 Examples: asporogenic Bacillus subtilis or Bacillus licheniformis - adeno associated virus (AAV - all serotypes); and recombinant or synthetic AAV constructs.tularensis subspecies novicida [aka F. novicida], strain Utah 112; *F.tularensis subspecies holarctica LVS; *F.A strain of Escherichia coli.
Original text
Appendix B: classification of human etiologic agents on the basis of hazard
Biological agents known to infect humans as well as selected animal agents that may pose theoretical risks if inoculated into humans .
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
Examples: asporogenic Bacillus subtilis or Bacillus licheniformis - adeno associated virus (AAV – all serotypes); and recombinant or synthetic AAV constructs. A strain of Escherichia coli.
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
Examples:
Risk Group 2 (RG2) I- Bacterial Agents Including Chlamydia
Acinetobacter baumannii (formerly Acinetobacter calcoaceticus) -Actinobacillus -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. burgdorferi -Burkholderia (formerly Pseudomonas species) except those listed in (RG3) -Campylobacter coli, C. fetus, C. jejuni - Chlamydia psittaci, C. trachomatis, C. pneumoniae – (Clostridium botulinum, C. chauvoei, C. haemolyticum, C. histolyticum, C. novyi, C. septicum, C. tetani ) –(Coxiella burnetii – specifically the Phase II, Nine Mile strain, plaque purified, clone 4) –(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) -*Francisella tularensis specifically *F. tularensis subspecies novicida [aka F. novicida], strain Utah 112; *F. tularensis subspecies holarctica LVS; *F. tularensis biovar tularensis strain ATCC 6223 (aka strain B38)
*For research involving high concentrations, BL3 practices should be considered
-Haemophilus ducreyi, H. influenzae -Helicobacter pylori -Klebsiella all species except K. oxytoca (RG1) -Legionella including L. pneumophila -Leptospira interrogans all serotypes -Listeria -Moraxella -Mycobacterium (except those listed in (RG3)) including M. avium complex, M. asiaticum, M. bovis BCG vaccine strain, M. chelonae, 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 gonorrhoeae, N. meningitidis – (Nocardia asteroides, N. brasiliensis, N. otitidiscaviarum, N. transvalensis )- Pseudomonas aeruginosa -Rhodococcus equi –(Salmonella including S. arizonae, S. choleraesuis, S. enteritidis, S. gallinarum-pullorum, 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. parahaemolyticus, V. vulnificus )-Yersinia enterocolitica -Yersinia pestis specifically pgm(–) strains (lacking the 102 kb pigmentation locus) and lcr(–) strains (lacking the LCR plasmid)
Risk Group 2 (RG2) II- 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
Risk Group 2 (RG2) III- 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, F. 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. peruviana, L. tropica) -Loa loa filaria worms -Microsporidium -Naegleria fowleri -Necator human hookworms including N. americanus
Risk Group 2 (RG2) IV Viruses
Adenoviruses, human - all types
Alphaviruses (Togaviruses) - Group A Arboviruses
-Chikungunya vaccine strain 181/25 -Eastern equine encephalomyelitis virus –(Venezuelan equine encephalomyelitis vaccine strains TC-83 and V3526) -Western equine encephalomyelitis virus
Arenaviruses
Junin virus candid #1 vaccine strain -Lymphocytic choriomeningitis virus (non-neurotropic strains) -Tacaribe virus complex -Bunyaviruses Bunyamwera virus
(Rift Valley fever virus vaccine strain MP-12 )-
Caliciviruses
Coronaviruses
Flaviviruses Group B Arboviruses –(Dengue virus serotypes 1, 2, 3, and 4) – (Japanese encephalitis virus strain SA 14-14-2) -Saint Louis encephalitis virus -West Nile virus -Yellow fever virus vaccine strain 17D –
Hepatitis A, B, C, D, and E viruses
Herpesviruses - except Herpesvirus simiae (Monkey B virus, Risk Group 4 (RG4) - Viral Agents) -Cytomegalovirus -Epstein Barr virus -Herpes simplex types 1 and 2 -Herpes zoster -Human herpesvirus types 6 and
Orthomyxoviruses
-Influenza viruses types A, B, and C (except those listed in, Risk Group 3 (RG3) - Viruses and Prions) –(Tick-borne orthomyxoviruses )
Papilloma viruses -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 parvovirus (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 , Risk Group 3 (RG3) - and restricted poxviruses including Alastrim, Smallpox, and Whitepox
Reoviruses - all types including Coltivirus, human Rotavirus, and Orbivirus (Colorado tick fever virus)
Rhabdoviruses --Rabies virus - all strains --Vesicular stomatitis virus non exotic strains: VSV-Indiana 1 serotype strains (e.g. Glasgow, MuddSummers, Orsay, San Juan) and VSV-New Jersey serotype strains (e.g. Ogden, Hazelhurst)
Rubivirus (Togaviruses) --Rubella virus
Risk Group 3 (RG3) Agents RG3: agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available
Examples :
Risk Group 3 (RG3)I - Bacterial Agents
Including Rickettsia -Bartonella –(Brucella including B. abortus, B. canis, B. suis )-Burkholderia (Pseudomonas) mallei, B. pseudomallei -Coxiella burnetii (except the Phase II, Nine Mile strain listed Risk Group 2 (RG2) -Francisella tularensis (except those strains listed in Risk Group 2 (RG2) ) -Mycobacterium bovis (except BCG strain, see in Risk Group 2 (RG2) ), M. tuberculosis -Orientia tsutsugamushi (was R. tsutsugamushi) –(Pasteurella multocida type B -"buffalo" and other virulent strains) –(Rickettsia akari, R. australis, R. canada, R. conorii, R. prowazekii, R. rickettsii, R, siberica, R. typhi (R. mooseri) )-Yersinia pestis (except those strains listed in Risk Group 2 (RG2)
Risk Group 3 (RG3)II - Fungal Agents
Coccidioides immitis (sporulating cultures; contaminated soil) -Histoplasma capsulatum, H. capsulatum var. duboisii
Risk Group 3 (RG3) III- Parasitic Agents : None
Risk Group 3 (RG3) IV- Viruses and Prions
Alphaviruses (Togaviruses) - Group A Arboviruses
-Chikungunya virus (except the vaccine strain 181/25 listed in Risk Group2 (RG2) Viruses) --Semliki Forest virus -Venezuelan equine encephalomyelitis virus (except the vaccine strains TC-83 and V3526, (RG2) – Viruses)
Arenaviruses -Flexal -Lymphocytic choriomeningitis virus (LCM) (neurotropic strains)
Bunyaviruses -Hantaviruses including Hantaan virus --Rift Valley fever virus
Coronaviruses -SARS-associated coronavirus (SARS-CoV) -Middle East respiratory syndrome coronavirus (MERS-CoV)
Flaviviruses - Group B Arboviruses -Japanese encephalitis virus (except those strains listed in Risk Group2 (RG2) - Viruses) -Yellow fever virus .
Orthomyxoviruses -Influenza viruses 1918-1919 H1N1 (1918 H1N1), human H2N2 (1957-1968), and highly pathogenic avian influenza H5N1 strains within the Goose/Guangdong/96-like H5 lineage (HPAI H5N1).
Poxviruses --Monkeypox virus
Prions -Transmissible spongiform encephalopathies (TSE) agents (Creutzfeldt-Jacob disease and kuru agents)
Retroviruses -Human immunodeficiency virus (HIV) types 1 and 2 -Human T cell lymphotropic virus (HTLV) types 1 and 2 -Simian immunodeficiency virus (SIV)
Rhabdoviruses -Vesicular stomatitis virus (except those strains listed in Risk Group2 (RG2) - Viruses)
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.
Risk Group 4 (RG4) I - Bacterial Agents :None
Risk Group 4 (RG4) II - Fungal Agents : None
Risk Group 4 (RG4)III - Parasitic Agents: None
Risk Group 4 (RG4)IV - Viral Agents
Arenaviruses
Guanarito virus -Lassa virus -Junin virus (except the candid #1 vaccine strain listed in Risk Group2 (RG2) – Viruses) -Machupo virus -Sabia
Bunyaviruses (Nairovirus) --Crimean-Congo hemorrhagic fever virus
Filoviruses
Ebola viruses -Marburg viruses
Flaviruses - Group B Arboviruses
Tick-borne encephalitis virus complex including Absetterov, Central European encephalitis, Hanzalova, Hypr, Kumlinge, Kyasanur Forest disease, Omsk hemorrhagic fever, and Russian spring-summer encephalitis viruses
Herpesviruses (alpha) -Herpesvirus simiae (Herpes B or Monkey B virus)
Paramyxoviruses -Equine Morbillivirus (Hendra virus) Hemorrhagic fever viruses as yet undefined
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 virus, a containment level appropriate for RG2 human agents is recommended. Baculoviruses Herpesviruses --Herpesvirus ateles --Herpesvirus saimiri --Marek's disease virus --Murine cytomegalovirus Papilloma viruses --Bovine papilloma virus --Shope papilloma virus Polyoma viruses --Polyoma virus --Simian virus 40 (SV40) Retroviruses --Avian leukosis virus --Avian sarcoma virus --Bovine leukemia virus --Feline leukemia virus --Feline sarcoma virus --Gibbon leukemia virus --Mason-Pfizer monkey virus --Mouse mammary tumor virus --Murine leukemia virus --Murine sarcoma virus --Rat leukemia virus
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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