Prohibited Select Agents
Select agents are those that have the potential to be highly pathogenic and toxic. They are often the focus of "bio-terrorism" discussions. This is covered by Department of Health and Human Services, 42 CFR Part 72 | RIN 0905-AE70, Additional Requirements for Facilities Transferring or Receiving Select Agents
Complete information on this regulation can be obtained on the internet at http://www.cdc.gov/od/sap/index.htm
In June, 2002, this legislation was added to by the signing of Public Law 107-188, "Public Health Security and Bioterrorism Preparedness and Response Act of 2002."
THESE AGENTS MAY NOT BE PROCURED OR USED AT ST. LAWRENCE UNIVERSITY. For live organisms, DNA or genetic material of any type is also prohibited as are vaccines containing live material.
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
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HHS SELECT AGENTS AND TOXINS Abrin Botulinum neurotoxins* Botulinum neurotoxin producing species of Clostridium*Conotoxins (Short, paralytic alpha conotoxinscontaining the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)1Coxiella burnetii Crimean-Congo haemorrhagic fever virus Diacetoxyscirpenol Eastern Equine Encephalitis virus3 Ebola virus* Francisella tularensis* Lassa fever virus Lujo virus Marburg virus* Monkeypox virus3 Reconstructed replication competent forms of the1918 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) Saxitoxin South American Haemorrhagic Fever viruses: Chapare Guanarito Junin Machupo SabiaStaphylococcal enterotoxins A,B,C,D,E subtypes T-2 toxin Tetrodotoxin Tick-borne encephalitis complex (flavi) viruses: Far Eastern subtype Siberian subtypeKyasanur 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 strain 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 mycoides3 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 Peronosclerospora philippinensis (Peronosclerospora sacchari) Phoma glycinicola (formerly Pyrenochaeta glycines) Ralstonia solanacearum Rathayibacter toxicus Sclerophthora rayssiae Synchytrium endobioticum 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. 9/10/13