Select Agents List
January 25, 2013 8:13:02 AM PST
Biological materials regulated as Select Agents are listed below. Read about exemptions and restrictions that may apply to these materials, and how to obtain research authorization for their use.
The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have identified bacteria, viruses, toxins, rickettsia, and fungi that pose a potential threat to public health or welfare. These organisms are considered Select Agents and High Consequence Livestock Pathogens and Toxins.
Materials regulated as Select Agents are listed below. If you use or intend to use any of these agents, read Select Agents Overview for instructions. Some exemptions and prohibitions apply.
List of Select Agents
- 1918 pandemic influenza virus (reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all 8 gene segments) 3
- African horse sickness virus 1
- African swine fever virus 1
- Akabane virus 1
- Avian influenza virus (highly pathogenic) 1
- Blue tongue virus (exotic) 1
- Camel pox virus 1
- Cercopithecine herpes virus (Herpes B virus) 3
- Classical swine fever virus 1
- Crimean-Congo haemorrhagic fever virus 3
- Eastern equine encephalitis virus 2
- Ebola viruses 3
- Foot and mouth disease virus 1
- Goat pox virus1
- Hendra virus 2
- Japanese encephalitis virus 1
- Lassa fever virus 3
- Lumpy skin disease virus 1
- Malignant catarrhal fever 1
- Marburg virus 3
- Menangle virus 1
- Monkey pox virus 1
- Newcastle disease virus (exotic) 1
- Nipah virus 2
- Peste des petits ruminants 1
- Plum pox potyvirus4
- Rift Valley fever virus 2
- Rinderpest virus 1
- Sheep pox 1
- South American haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito) 3
- Swine vesicular disease virus 1
- Tick-borne encephalitis complex (flavi) viruses (Central European Tick-borne encephalitis, Far Eastern Tick-borne encephalitis, Russian Spring and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic Fever) 3
- Variola major virus (Smallpox virus) and Variola minor (Alastrim) 3
- Venezuelan equine encephalitis virus 2
- Vesicular stomatitis virus (exotic) 1: Indiana subtypes VSV-IN2, VSV-IN3
- Bovine spongiform encephalopathy agent 1
- Abrin 3
- Botulinum neurotoxins 2
- Clostridium perfringens epsilon toxin 2
- Conotoxins 3
- Diacetoxyscirpenol 3
- Ricin 3
- Saxitoxin 3
- Shigatoxin and Shiga-like ribosome inactivating proteins 2
- Staphylococcal enterotoxins 2
- T–2 toxin 2
- Bacillus anthracis 2
- Botulinum neurotoxin producing strains of Clostridium 2
- Brucella abortus 2
- Brucella melitensis 2
- Brucella suis 2
- Burkholderia mallei 2
- Burkholderia pseudomallei 2
- Coxiella burnetii 2
- Ehrlichia ruminantium (Heartwater) 1
- Francisella tularensis 2
- Liberobacter africianus, Liberobacter asiaticus 4
- Mycoplasma capricolum / M. F38 / M. mycoides capri (contagious caprine pleuropneumonia agent) 1
- Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia agent) 1
- Ralstonia solanaceanon Race 3 4
- Rathayibacter toxicus 4
- Rickettsia prowazekii 3
- Rickettsia rickettsii 3
- Xanthomonas oryzae pv. oryzicola 4
- Xylella fastidiosa (citrus variegated chlorosis strain) 4
- Yersinia pestis 3
- Coccidioides immitis 2
- Coccidioides posadasii 3
- Peronoscleospora philippinensis 4
- Phakopsora pachyrhizi 4
- Phoma glycinicola 4
- Sclerophthora rayssiae var zeae 4
- Synchytriun endobioticum 4
|1USDA High Consequence Livestock Pathogens or Toxin
2USDA/HSS Overlap Agent
3HHS Select Infectious Agent
4APHIS Plant Pathogens (Animal and Plant Health Inspection Service,
a division of USDA)
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Genetic elements, recombinant nucleic acids, and recombinant organisms
Genetic elements, recombinant nucleic acids, and recombinant organisms listed below are regulated as Select Agents:
- Select Agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the Select Agent viruses.
- Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the listed toxins if the nucleic acids: a) are in a vector or host chromosome, b) can be expressed in vivo or in vitro; or c) are in a vector or host chromosome and can be expressed in vivo or in vitro.
- Listed viruses, bacteria, fungi, and toxins that have been genetically modified.
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- Medical use of toxins for patient treatment is exempt.
- If the aggregate amounts of the following agents or toxins under the control of a principal investigator do not, at any time, exceed the limits below, they are exempt:
- 0.5 milligrams (mg) of Botulinum neurotoxins
- 5 mg of Staphylococcal enterotoxins
- 100 mg of abrin, Clostridium perfringens epsilon toxin, conotoxin, ricin, saxitoxin, shigatoxin, shiga-like ribosome inactivating protein, and tetrodotoxin
- 1,000 mg of diacetoxyscirpenol and T-2 toxin
- Other exempted agents and toxins are:
- Any agent or toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
- Non-viable Select Agent organisms or nonfuntional toxins.
- The vaccine stains of Junin virus (Candid #1), Rift Valley fever virus (MP-12), Venezuelan Equine encephalitis virus vaccine strain TC-83.
- Attenuated strains: HHS and USDA regulations have established a procedure by which an attenuated strain of a select biological agent or toxin that does not pose a severe threat to public health and safety, animal health, or animal products may be excluded from the list of select biological agents and toxins.
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- Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug-resistance trait to the listed agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
- Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of listed toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight.
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