Table 1.
Select Agents and Toxins List
| HHS and USDA select agents and toxins 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73 |
|---|
| HHS Select Agents and Toxins |
| Abrin |
| Botulinum neurotoxinsa |
| Botulinum neurotoxin producing species of Clostridiuma |
| Conotoxins (short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)b |
| Coxiella burnetii |
| Crimean-Congo hemorrhagic fever virus |
| Diacetoxyscirpenol |
| Eastern equine encephalitis virusd |
| Ebola virusa |
| Francisella tularensisa |
| Lassa fever virus |
| Lujo virus |
| Marburg virusa |
| Monkeypox virusd |
| Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all 8 gene segments (reconstructed 1918 influenza virus) |
| Ricin |
| Rickettsia prowazekii |
| SARS-associated coronavirus (SARS-CoV) |
| Saxitoxin |
| South American hemorrhagic fever viruses: Chapare Guanarito Junin Machupo Sabia |
| Staphylococcal enterotoxins A, B, C, D, E subtypes |
| T-2 toxin |
| Tetrodotoxin |
| Tick-borne encephalitis complex (flavi) viruses: Far eastern subtype Siberian subtype |
| Kyasanur forest disease virus |
| Omsk hemorrhagic fever virus |
| Variola major virus (smallpox virus)a |
| Variola minor virus (Alastrim)a |
| Yersinia pestisa |
| Overlap Select Agents and Toxins |
| Bacillus anthracisa |
| B. anthracis Pasteur strain |
| Brucella abortus |
| Brucella melitensis |
| Brucella suis |
| Burkholderia pseudomalleia |
| Hendra virus |
| Nipah virus |
| Rift Valley fever virus |
| Venezuelan equine encephalitis virusa |
| USDA Select Agents and Toxins |
| African horse sickness virus |
| African swine fever virus |
| Avian influenza virusd |
| Classical swine fever virus |
| Foot-and-mouth disease virusa |
| Goat pox virus |
| Lumpy skin disease virus |
| Mycoplasma capricolumd |
| Mycoplasma mycoidesd |
| Newcastle disease virusc,d |
| Peste de petits ruminants virus |
| Rinderpest virusa |
| Sheep pox virus |
| Swine vesicular disease virus |
| USDA Plant Protection and Quarantine Select Agents and Toxins |
| Peronosclerospora philippinensis (Peronosclerospora sacchari) |
| Phoma glycinicola (formerly Pyrenochaeta glycines) |
| Ralstonia solanacearum |
| Rathayibacter toxicus |
| Sclerophthora rayssiae |
| Synchytrium endobioticum |
| Xanthomonas oryzae |
This table is a listing of all select agents and toxins regulated by the Federal Select Agent Program as of April 3, 2013. Select agents and toxins regulated by HHS due to potential threat to human health are indicated as HHS select agents and toxins. Select agents and toxins regulated by HHS and the USDA due to potential threat to human and animal health are indicated as overlap select agents and toxins. Select agents and toxins regulated by the USDA due to potential threat to animal or plant health are listed as USDA select agents and toxins. Tier One select agents and toxins are indicated by a in the table and are subject to additional regulatory requirements due to their higher potential risk to the public as defined in the regulations.
Tier One select agents and toxins requiring compliance with additional, specific regulatory components for biological materials determined to pose higher risk to public.
C = Cysteine residues are all present as disulfides, with the first and third cysteine, and the second and fourth systeine forming specific disulfide bridges; the consensus sequence includes known toxins α-MI and α-GI as well as α-GIA, Ac1.1a, α-CnlB; 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; ” e.g., in a peptide sequence XCCHPA, a related peptide CCHPA would be designated as Des-X.
A virulent Newcastle disease virus (avian paramyxovirus serotype 2) 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 not 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.
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 M. capricolum except subspecies capripneumoniae (contagious caprine pleuropneumonia), all subspecies M. mycoides except subspecies mycoides small colony (Mmm SC; contagious bovine pleuropheumonia), any subtypes of Venezuelan equine encephalitis except for subtypes IAB or IC, and vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3, provided that the individual or entity can verify that the agent is within the exclusion category.