Select Agents and Toxins
Select Agents are federally regulated agents that have potential use in biological warfare.
List of Select Agents and Toxins Regulated by Health and Human Services (HHS) and US Department of Agriculture (USDA)
HHS SELECT AGENTS AND TOXINS (Target Humans)
Abrin
Botulinum neurotoxins
Botulinum neurotoxin producing species of Clostridium
Cercopithecine herpesvirus 1 (Herpes B virus)
Clostridium perfringens epsilon toxin
Coccidioides immitis
Coccidioides posadasii
Conotoxins
Coxiella burnetii
Crimean-Congo haemorrhagic fever virus
Diacetoxyscirpenol
Eastern Equine Encephalitis virus
Ebola viruses
Francisella tularensis
Lassa fever virus
Marburg virus
Monkeypox virus
Reconstructed replication competent forms of the 1918 pandemic influenza virus
containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 influenza virus)
Ricin
Rickettsia prowazekii
Rickettsia rickettsii
Saxitoxin
Shiga-like ribosome inactivating proteins
Shigatoxin
South American haemorrhagic fever viruses:
Flexal
Guanarito
Junin
Machupo
Sabia
Staphylococcal enterotoxins
T-2 toxin
Tetrodotoxin
Tick-borne encephalitis complex (flavi) viruses:
Central European Tick-borne encephalitis
Far Eastern Tick-borne encephalitis
Kyasanur Forest disease
Omsk Hemorrhagic Fever
Russian Spring and Summer encephalitis
Variola major virus (Smallpox virus) and Variola minor virus (Alastrim)
Yersinia pestis
OVERLAP SELECT AGENTS AND TOXINS (Target humans & animals)
Bacillus anthracis
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei (formerly Pseudomonas mallei)
Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
Hendra virus
Nipah virus
Rift Valley fever virus
Venezuelan Equine Encephalitis virus
USDA SELECT AGENTS AND TOXINS (Target Animals)
African horse sickness virus
African swine fever virus
Akabane virus
Avian influenza virus (highly pathogenic)
Bluetongue virus (Exotic)
Bovine spongiform encephalopathy agent
Camel pox virus
Classical swine fever virus
Ehrlichia ruminantium (Heartwater)
Foot and mouth disease virus
Goat pox virus
Lumpy skin disease virus
Japanese encephalitis virus
Malignant catarrhal fever virus
(Alcelaphine herpesvirus type 1)
Menangle virus
Mycoplasma capricolum subspecies capripneumoniae
(contagious caprine pleuropneumonia)
Mycoplasma mycoides subspecies mycoides small colony (MmmSC)
(contagious bovine pleuropneumonia)
Peste des petits ruminants virus
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
Vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3
Virulent newcastle disease virus*
* A virulent Newcastle disease virus (avian paramyxovirus serotype 1) has an intracerebral pathogenicity index in day-old chicks (Gallus gallus) of 0.7 or greater or has an amino acid sequence at the fusion (F) protein cleavage site that is consistent with virulent strains of
Newcastle disease virus. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.
USDA PLANT PROTECTION AND QUARANTINE (PPQ) SELECT AGENTS AND TOXINS (Target plants)
Peronosclerospora philippinensis (Peronosclerospora sacchari)
Phoma glycinicola (formerly Pyrenochaeta glycines)
Ralstonia solanacearum race 3, biovar 2
Rathayibacter toxicus
Schlerophthora rayssiae var zeae
Synchytrium endobioticum
Xanthomonas oryzae
Xylella fastidiosa (citrus variegated chlorosis strain)
GENETIC ELEMENTS, RECOMBINANT NUCLEIC ACIDS, and RECOMBINANT ORGANISMS
- 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 toxins listed if the nucleic acids are in a vector or host chromosome and/or can be expressed in vivo or in vitro
- Listed viruses, bacteria, fungi, and toxins that have been genetically modified.
Exclusions
- The select agent rule does not include any select 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.
- The select agent rule does not include non-viable select agent organisms or non-functional toxins.
- The HHS secretary may exclude attenuated strains or toxins if it is determined that they do not pose a public health threat.
Exempt Quantities of Toxins
The listed toxins are exempt from CDC and USDA registration requirements if the maximum allowable exempt quantity per Principal Investigator is not exceeded. PI’s must keep toxin locked and maintain inventories to ensure maximum exempted amount is not exceeded.
Toxin |
Maximum Exempted Amount per PI |
| Abrin | 100 mg |
| Botulinum neurotoxins | 0.5 mg |
| Clostridium perfringens epsilon toxin | 100 mg |
| Conotoxins | 100 mg |
| Diacetoxyscirpenol (DAS) | 1000 mg |
| Ricin | 100 mg |
| Saxitoxin | 100 mg |
| Shiga-like ribosome inactivating proteins | 100 mg |
| Shigatoxin | 100 mg |
| Staphylococcal enterotoxins | 5.0 mg |
| Tetrodotoxin (TTX) | 100 mg |
| T-2 toxin | 100o mg |
Possesion, Use, or Transfer of Select Agents
Before possessing, using, sending, or receiving select agents, the institution and Principal Investigator must register with CDC, APHIS, and/or USDA to receive official authorization for each individual requesting access to select agents. Documentation requirements include background checks on those authorized to access select agents, security plans, laboratory inspections, and inventories.
Immediately notify EHS if you discover select agents in your laboratory that have not been registered.
