ESH is available to assist laboratories in understanding and managing Select agents, which are materials that have been identified by the U.S. Government as agents that have potential use in biological terrorism or warfare. Numerous requirements must be in place before these materials can be used in research.
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.
Select agents as described in 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73
HHS Select Agents and Toxins
- Abrin [6]
- Bacillus cereus Biovar anthracis [1]
- Botulinum neurotoxins [1][6]
- Botulinum neurotoxin producing species of Clostridium [1]
- Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7) [6]
- Coxiella burnetii
- Crimean-Congo haemorrhagic fever virus
- Diacetoxyscirpenol [6]
- Eastern Equine Encephalitis virus [4][5]
- Ebola virus [1]
- Francisella tularensis [1]
- Lassa fever virus
- Lujo virus
- Marburg virus [1]
- Monkeypox virus [4]
- 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 [6]
- Rickettsia prowazekii
- SARS-associated coronavirus (SARS-CoV) [5]
- SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors
- Saxitoxin [6]
South American Haemorrhagic Fever viruses:
-
- Chapare
- Guanarito
- Junin
- Machupo
- Sabia
Tick-borne encephalitis complex (flavi) viruses:
Overlap Select Agents and Toxins
- Bacillus anthracis [1]
- Bacillus anthracis Pasteur strain
- Brucella abortus
- Brucella melitensis
- Brucella suis
- Burkholderia mallei [1]
- Burkholderia pseudomallei [1]
- Hendra virus
- Nipah virus
- Rift Valley fever virus
- Venezuelan equine encephalitis virus [4][5]
USDA Veterinary Services (VS)
Select Agents and Toxins
- African horse sickness virus
- African swine fever virus
- Avian influenza virus [4]
- Classical swine fever virus [5]
- Foot-and-mouth disease virus [1][5]
- Goat pox virus
- Lumpy skin disease virus
- Mycoplasma capricolum [4]
- Mycoplasma mycoides [4]
- Newcastle disease virus [3][4]
- Peste des petits ruminants virus
- Rinderpest virus [1]
- Sheep pox virus
- Swine vesicular disease virus [5]
USDA Plant Protection And Quarantine (PPQ)
Select Agents and Toxins
[1] Denotes Tier 1 Agent
[2] 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 a-MI and a-GI (shown above) as well as a-GIA, Ac1.1a, a-CnIA, a-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.
[3] 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.
[4] 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.
[5] For determining the regulatory status of nucleic acids that are capable of producing infectious forms of select agent viruses.
[6] For determining the regulatory status of Recombinant and/or Synthetic nucleic acids that encode for the toxic form(s) of any select toxins if the nucleic acids (i) can be expressed in vivo or in vitro, or (ii) are in a vector or recombinant host genome and can be expressed in vivo or in vitro.
[7] Select agents or toxins that meet any of the following criteria are excluded from the requirements of this part: Any subspecies of Ralstonia solanacearum except race 3, biovar 2 and all subspecies of Sclerophthora rayssiae except var. zeae, provided that the individual or entity can identify that the agent is within the exclusion category.
For complete list visit CDC/USDA List of Select Agents
Under Maryland law (Health-General Article §§17-601-605, Annotated Code of Maryland and Code of Maryland Regulations 10.10.11), a person that possesses, maintains, and/or transfers a biological agent (select agent) listed in Title 42, Part 73; Title 7, Part 331; and Title 9, Part 121 of the Code of Federal Regulations is required to register with Maryland’s BAR Program. Visit Maryland Department of Health Laboratories Administration for more information.