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Select Agents

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 (htm) or download the PDF.

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 7 CFR Part 331: Agriculture (PDF)
Read about 9 CFR Part 121: Animals and Animal Products (PDF)
Read about 42 CFR Parts 72-73: Public Health (PDF)

The biological agents and toxins listed below have been determined to have the potential to pose a severe thereat to both human and animal health, to plant health, or both animal and plant products. Please click one of the applicable toggle boxes below for additional information.

HHS Select Agents and Toxins

Abrin
Bacillus cereus Biovar anthracis*
Botulinum neurotoxins*
Botulinum neurotoxin producing species of Clostridium
Conotoxins (Shorta, paralytic alpha conotoxins containing the following amino acid sequence X₁CCX₂PACGX₃X₄X₅X₆CX₇))
Coxiella burnetti
Crimean-Congo haemorrhagic fever virus
Diacetoxyscirpenol
Eastern Equine Encephalitis virus
Ebolavirus*
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 (subtypes A, B, C, D, E)
T-2 toxin
Tetrodotoxin
Tick-borne encephalitis (flavi) viruses:
- Far Eastern subtype
- Siberian subtype
Kyasanur Forest disease
Omsk Hemorrhagic fever
Variola major virus (Smallpox virus)*
Variola minor virus (Alastrim)*
Yersinia Pestis*

*Denotes a Tier 1 agent

USDA Select Agents and Toxins

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
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)
Ralstonia solanacearum
Rathayibacter toxicus
Schlerophthora rayssiae
Synchytrium endobioticum
Xanthomonas oryzae

Overlap Select Agents and Toxins

Bacillus anthracis*
Brucella anthracis Pasteur strain
Burkholderia mallei*
Burkholderia pseudomallei*
Hendra virus
Nipah Virus
Rift Valley fever virus
Venezuela equine encephalitis virus

*Denotes a Tier 1 agent

Permissible Toxin Amouns

Toxins are regulated based on potency and quantity. The following toxins are not regulated if the amount under the control of the principal investigator does not exceed, at any time, the aggregate toxin limit specified in the HHS select agent and toxin regulations or the amounts indicated in the table below.

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

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. Read here for more information about the excluded strains of HHS and USDA Select Agents and Toxins.

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
- Ebolavirus
- Francisella tularensis
- Junin virus
- Lassa fever virus
- Monkeypox virus
- SARS-Coronavirus
- Yersinia pestis
Excluded Attenuated Strains of Overlap Select Agents:
- 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)