Select Agents and Toxins List

The following biological agents and toxins have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. An attenuated strain of a select agent or an inactive form of a select toxin may be excluded from the requirements of the Select Agent Regulations. Here is a list of excluded agents and toxins.

HHS and USDA Select Agents and Toxins
7CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73

HHS SELECT AGENTS AND TOXINS


  1. Abrin
  2. Bacillus cereus Biovar anthracis*
  3. Botulinum neurotoxins*
  4. Botulinum neurotoxin producing species of Clostridium*
  5. Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)1
  6. Coxiella burnetii
  7. Crimean-Congo haemorrhagic fever virus
  8. Diacetoxyscirpenol
  9. Eastern Equine Encephalitis virus3
  10. Ebola virus*
  11. Francisella tularensis*
  12. Lassa fever virus
  13. Lujo virus
  14. Marburg virus*
  15. Monkeypox virus3
  16. 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)
  17. Ricin
  18. Rickettsia prowazekii
  19. SARS-associated coronavirus (SARS-CoV)
  20. Saxitoxin
  • South American Haemorrhagic Fever viruses:
  1. Chapare
  2. Guanarito
  3. Junin
  4. Machupo
  5. Sabia
  6. Staphylococcal enterotoxins A,B,C,D,E subtypes
  7. T-2 toxin
  8. Tetrodotoxin
  • Tick-borne encephalitis complex (flavi) viruses:
  1. Far Eastern subtype
  2. Siberian subtype
  3. Kyasanur Forest disease virus
  4. Omsk hemorrhagic fever virus
  5. Variola major virus (Smallpox virus)*
  6. Variola minor virus (Alastrim)*
  7. Yersinia pestis*

OVERLAP SELECT AGENTS AND TOXINS

  1. Bacillus anthracis*
  2. Bacillus anthracis Pasteur strain
  3. Brucella abortus
  4. Brucella melitensis
  5. Brucella suis
  6. Burkholderia mallei*
  7. Burkholderia pseudomallei*
  8. Hendra virus
  9. Nipah virus
  10. Rift Valley fever virus
  11. Venezuelan equine encephalitis virus3

USDA SELECT AGENTS AND TOXINS

  1. African horse sickness virus
  2. African swine fever virus
  3. Avian influenza virus3
  4. Classical swine fever virus
  5. Foot-and-mouth disease virus*
  6. Goat pox virus
  7. Lumpy skin disease virus
  8. Mycoplasma capricolum3
  9. Mycoplasma mycoides3
  10. Newcastle disease virus2,3
  11. Peste des petits ruminants virus
  12. Rinderpest virus*
  13. Sheep pox virus
  14. Swine vesicular disease virus


USDA PLANT PROTECTION AND QUARANTINE (PPQ) SELECT AGENTS AND TOXINS

  1. Coniothyrium glycines (formerly Phoma glycinicola and Pyrenochaeta glycines)
  2. Peronosclerospora philippinensis
    (Peronosclerospora sacchari)
  3. Ralstonia solanacearum
  4. Rathayibacter toxicus
  5. Sclerophthora rayssiae
  6. Synchytrium endobioticum
  7. Xanthomonas oryzae

*Denotes Tier 1 Agent

1 C = Cysteine residues are all present as disulfides, with the 1st and 3rd Cysteine, and the 2nd and 4th Cysteine forming specific disulfide bridges; The consensus sequence includes known toxins α-MI and α-GI (shown above) as well as α-GIA, Ac1.1a, α-CnIA, α-CnIB; X1 = any amino acid(s) or Des-X; X2 = Asparagine or Histidine; P = Proline;  A = Alanine;  G = Glycine; X3 = Arginine or Lysine;  X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, Phenylalanine or Tryptophan; X5 = Tyrosine, Phenylalanine, or Tryptophan;  X6 = Serine, Threonine, Glutamate, Aspartate, Glutamine, or Asparagine;  X7 = Any amino acid(s) or Des X and; “Des X” = “an amino acid does not have to be present at this position.”  For example if a peptide sequence were XCCHPA then the related peptide CCHPA would be designated as Des-X.
2 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.
3 Select agents that meet any of the following criteria are excluded from the requirements of this part: Any low pathogenic strains of avian influenza virus, South American genotype of eastern equine encephalitis virus , west African clade of Monkeypox viruses, any strain of Newcastle disease virus which does not meet the criteria for virulent Newcastle disease virus, all subspecies Mycoplasma capricolum except subspecies capripneumoniae (contagious caprine pleuropneumonia), all subspecies Mycoplasma mycoides except subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), and any subtypes of Venezuelan equine encephalitis virus except for Subtypes IAB or IC, provided that the individual or entity can verify that the agent is within the exclusion category.