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What is a Select Agent?
The Anti-terrorism and Effective Death Penalty Act was passed in 1996 and built upon the Biological Weapons Anti-terrorism Act (1989) and other earlier anti-terrorism legislation. This legislation directed the Department of Health and Human Services (HHS) to develop and maintain a list of biological agents that could pose a severe threat to the public health and safety, and to regulate the transfer of such agents while maintaining the availability of these agents for research, education, and other legitimate purposes. In response to this legislation, the Centers for Disease Control and Prevention (CDC) and United States Department of Agriculture (USDA) developed a list of certain infectious agents and toxins, with additional provisions for recombinant organisms and drug resistant organisms and exemptions for research quantities and vaccine strains of organisms. This list of Select Agents can be found here.
In March of 2005, the HHS, USDA and CDC published the final rules which establish new stricter regulations for the possession, use and transfer of select biological agents and toxins that could pose a threat to human, animal and plant health and safety.
The CDC has developed regulations on the shipping of these select agents. They also require that facilities receiving these agents be registered with the federal government, that they fulfill the proper biosafety level requirements for handling, containment, and disposal, and that a person at the facility be responsible for the oversight of the transfer of such agents.
Researchers must register the laboratory with the CDC prior to purchasing or receiving any select agent. Contact the Office of Research Safety for more information.
For information regarding the possession, use, and transfer of select agents and toxins, please see:
- Read about 42 CFR Parts 72-73: Public Health (PDF)
- Read about 9 CFR Part 121: Animals and Animal Products (PDF)
- Read about 7 CFR Part 331: Agriculture (PDF)
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HHS Select Agents and Toxins
- Abrin
- Bacillus cereus Biovar anthracis*
- Botulinum neurotoxins*
- Botulinum neurotoxin producing species of Clostridium
- Conotoxins (Shorta, paralytic alpha conotoxins)
- Coxiella burnetti
- Crimean-Congo haemorrhagic fever virus
- Diacetoxyscirpenol
- Eastern Equine Encephalitis virus
- Ebola virus*
- Francisella tularensis*
- Lassa fever virus
- Lujo virus
- Marburg virus*
- Monkeypox 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)
- Ricin
- Rickettsia prowazekii
- SARS-associated coronavirus (SARS-CoV)
- 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
- South American Haemorrhagic Fever viruses
- Chapare
- Guanarito
- Junin
- Machupo
- Sabia
- Staphyloccocal enterotoxins A, B, C, D, E subtypes
- T-2 toxin
- Tetrodotoxin
- Tick-borne encephalitis (flavi) viruses
- Far Eastern subtype (formerly known as Russian Spring Summer encephalitis virus, RSSEV
- Siberian subtype
- Kyasanur Forest disease
- Omsk Hemorrhagic fever
- Variola major virus (Smallpox virus)*
- Variola minor virus (Alastrim)*
- Yersinia Pestis*
*Denotes a Tier 1 agent
Toxins are regulated based on potency and quantity. Entities that do not at any time have more than the following aggregate amounts (in the purified form or in combinations of pure and impure forms) under the control of a principal investigator are excluded from requirements of the regulation.
| HHS Toxins | Amount |
| Abrin | 1000mg |
| Botulinum Neurotoxins | 1 mg |
| Short, paralytic alpha conotoxins | 100 mg |
| Diacetoxyscirpenol (DAS) | 10,000 mg |
| Ricin | 1000 mg |
| Saxitoxin | 500 mg |
| Staphyloccocal Enterotoxins (Subtypes A, B, C, D and E) | 100 mg |
| T-2 toxin | 10,000 mg |
| Tetrodotoxin | 500mg |
USDA Select Agents and Toxins
- African horse sickness virus
- African swine fever virus
- Avian influenza virus
- Classical swine fever virus
- Foot and mouth disease virus*
- Goat pox virus
- Lumpy skin disease virus
- Mycoplasma capricolum
- Mycoplasma mycoides
- Newcastle disease virus (VVND)
- Peste des petits ruminants virus
- Rinderpest virus*
- Sheep pox virus
- Swine vesicular disease virus
*Denotes Tier 1 agent
USDA Plant Protection and Quarantine (PPQ) Select Agents and Toxins
- Coniothyrium glycines (formerly Phoma glycinicola and Pyrenochaeta glycines)
- Peronosclerospora philippinensis
(Peronosclerospora sacchari) - Ralstonia solanacearum
- Rathayibacter toxicus
- Schlerophthora rayssiae
- Synchytrium endobioticum
- Xanthomonas oryzae
Overlap Select Agents and Toxins
- Bacillus anthracis*
- Brucella anthracis Pasteur strain
- Brucella abortus
- Brucella melitensis
- Brucella suis
- Burkholderia mallei*
- Burkholderia pseudomallei*
- Hendra virus
- Nipah Virus
- Rift Valley fever virus
- Venezuela equine encephalitis virus
*Denotes a Tier 1 agent
Excluded Strains of HHS and USDA Select Agents and Toxins
Select agent regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) established a mechanism 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 requirements of the select agent regulations. The Federal Select Agent Program has determined that the attenuated select agent strains or less toxic select toxins identified below are not subject to the requirements of the select agent regulations. It should be noted that any excluded select agent strain or modified toxin will be subject to the regulations if there is a reintroduction of factor(s) associated with virulence, toxic activity, or other manipulations that modify the attenuation resulting in a restoration or enhancement of virulence or toxic activity. Additionally, excluded select agent strains or modified toxins are not exempt from the requirements of other applicable regulations or guidelines including NIH guidelines, USDA/APHIS permits, and IBC oversight at this institution.
- Attenuated Strains of USDA-only Select Agents Excluded:
- African swine fever viruses
- Avian influenza virus (low pathogenic)
- Avian influenza virus (highly pathogenic)
- Foot-and-mouth disease virus
- Excluded Attenuated Strains of HHS Select Agents:
- Botulinum neurotoxin producing species of Clostridium
- Coxiella burnetii
- Eastern Equine Encephalitis virus
- Ebola virus
- Francisella tularensis
- Junin virus
- Lassa fever virus
- Monkeypox virus
- SARS-Coronavirus
- Yersinia pestis
- Excluded Attenuated Strains of Overlap Select Agents:
- Bacillus anthracis
- Brucella abortus
- Brucella melitensis
- Burkholderia mallei
- Burkholderia pseudomallei
- Rift Valley Fever Virus
- Venezuelan Equine Encephalitis virus
- Excluded Toxins Modified to be Less Potent or Toxic:
- Tetrodotoxin
- Nontoxic HHS toxins:
- Botulinum neurotoxins
- Conotoxins
- Staphylococcal Enterotoxins (SE)