Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century (2016)
Chapter: Appendix H: HHS and USDA Select Agents and Toxins
Appendix H
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 | OVERLAP SELECT AGENTS AND TOXINS |
|---|---|
| Abrin | Bacillus anthracis* |
| Botulinum neurotoxins* | Bacillus anthracis Pasteur strain |
| Botulinum neurotoxin producing species of Clostridium* | Brucella abortus |
| Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)1 | Brucella melitensis |
| Coxiella burnetii | Brucella suis |
| Crimean-Congo haemorrhagic fever virus | Burkholderia mallei* |
| Diacetoxyscirpenol | Burkholderia pseudomallei* |
| Eastern Equine Encephalitis virus3 | Hendra virus |
| Ebola virus* | Nipah virus |
| Francisella tularensis* | Rift Valley fever virus |
| Lassa fever virus | Venezuelan equine encephalitis virus3 |
| Lujo virus | |
| Marburg virus* | USDA SELECT AGENTS AND TOXINS |
| Monkeypox virus3 | African horse sickness 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) | African swine fever virus |
| Ricin | Avian influenza virus3 |
| Rickettsia prowazekii | Classical swine fever virus |
| SARS-associated coronavirus (SARS-CoV) | Foot-and-mouth disease virus* |
| Saxitoxin | Goat pox virus |
| South American Haemorrhagic Fever viruses: | Lumpy skin disease virus |
| Chapare | Mycoplasma capricolum3 |
| Guanarito | Mycoplasma mycoides3 |
| Junin | Newcastle disease virus2,3 |
| Machupo | Peste des petits ruminants virus |
| Sabia | Rinderpest virus* |
| Staphylococcal enterotoxins A,B,C,D,E subtypes | Sheep pox virus |
| T-2 toxin | Swine vesicular disease virus |
| Tetrodotoxin | |
| Tick-borne encephalitis complex (flavi) viruses: | USDA PLANT PROTECTION AND QUARANTINE (PPQ) SELECT AGENTS AND TOXINS |
| Far Eastern subtype | Peronosclerospora philippinensis |
| Siberian subtype | (Peronosclerospora sacchari) |
| Kyasanur Forest disease virus | Phoma glycinicola (formerly Pyrenochaeta glycines) |
| Omsk hemorrhagic fever virus | Ralstonia solanacearum |
| Variola major virus (Smallpox virus)* | Rathayibacter toxicus |
| Variola minor virus (Alastrim)* | Sclerophthora rayssiae |
| Yersinia pestis* | Synchytrium endobioticum |
| Xanthomonas oryzae |
*Denotes Tier 1 Agent. These agents present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety. (See http://www.cdc.gov/vhf/ebola/healthcare-us/laboratories/select-agent-regulations.html).
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 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.
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
SOURCE: Federal Select Agent Program, “Select Agents and Toxins List,” available at: http://www.selectagents.gov/SelectAgentsandToxinsList.html.
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