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Select Agents List

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 have the potential to pose a severe 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 possess any of these agents, read Select Agents Overview for instructions. Some exemptions and prohibitions apply.

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HHS Select Agents and Toxins

  • Abrin
  • Botulinum neurotoxins*
  • Botulinum neurotoxin producing species of Clostridium*
  • Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid equence X1CCX2PACGX3X4X5X6CX7)1
  • Coxiella burnetii
  • Crimean-Congo haemorrhagic fever virus
  • Diacetoxyscirpenol
  • Eastern Equine Encephalitis virus3
  • Ebola virus*
  • Francisella tularensis*
  • Lassa fever virus
  • Lujo virus4
  • Marburg virus*
  • Monkeypox virus3
  • 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
  • SARS-associated coronavirus (SARS-CoV)4
  • Saxitoxin
  • South American Haemorrhagic Fever viruses:
    • Chapare4
    • 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)*
  • Variola minor virus (Alastrim)*
  • Yersinia pestis*

Overlap Select Agents and Toxins

  • Bacillus anthracis*
  • Bacillus anthracis Pasteur strain4
  • Brucella abortus
  • Brucella melitensis
  • Brucella suis
  • Burkholderia mallei*
  • Burkholderia pseudomallei*
  • Hendra virus
  • Nipah virus
  • Rift Valley fever virus
  • Venezuelan equine encephalitis virus3

USDA Select Agents and Toxins

  • African horse sickness virus
  • African swine fever virus
  • Avian influenza virus3
  • Classical swine fever virus
  • Foot-and-mouth disease virus*
  • Goat pox virus
  • Lumpy skin disease virus
  • Mycoplasma capricolum3
  • Mycoplasma mycoides33
  • Newcastle disease virus2,3
  • Peste des petits ruminants virus
  • Rinderpest virus*
  • Sheep pox virus
  • Swine vesicular disease virus

USDA Plant Protection and Quarantine (PPQ) Select Agents and Toxins

  • Peronoscleospora philippinensis  (Peronosclerospora sacchari)
  • Phoma glycinicola (formerly Pyrenochaeta glycines)
  • Ralstonia solanacearum
  • Rathayibacter toxicus
  • Sclerophthora rayssiae
  • Synchytriun endobioticum
  • Xanthomonas oryzae

Genetic elements, recombinant nucleic acids, and recombinant organisms

Genetic elements, recombinant nucleic acids, and recombinant organisms listed below are regulated as Select Agents:

  1. 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.
  2. 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.
  3. Listed viruses, bacteria, fungi, and toxins that have been genetically modified.

Exemptions

  1. Medical use of toxins for patient treatment is exempt.
  2. 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
  3. 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.
  4. 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.

Prohibited experiments

  1. 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.
  2. 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.

Footnotes

*Denotes Tier 1 Agent

1C = 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.


2A 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 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.


3Select 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. 9/10/13


4Recent addition to Select Agents List

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