The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have identified bacteria, viruses, toxins, rickettsia, and fungi that pose a potential threat to public health or welfare. These organisms are considered Select Agents and High Consequence Livestock Pathogens and Toxins.
List of Select Agents
|1USDA High Consequence Livestock Pathogens or Toxin
2USDA/HSS Overlap Agent
3HHS Select Infectious Agent
4APHIS Plant Pathogens (Animal and Plant Health Inspection Service,
a division of USDA)
Genetic elements, recombinant nucleic acids, and recombinant organisms
Genetic elements, recombinant nucleic acids, and recombinant organisms listed below are regulated as Select Agents:
- Select Agent viral nucleic acids (synthetic or naturally derived, contiguous or fragmented, in host chromosomes or in expression vectors) that can encode infectious and/or replication competent forms of any of the Select Agent viruses.
- Nucleic acids (synthetic or naturally derived) that encode for the functional form(s) of any of the listed toxins if the nucleic acids: a) are in a vector or host chromosome, b) can be expressed in vivo or in vitro; or c) are in a vector or host chromosome and can be expressed in vivo or in vitro.
- Listed viruses, bacteria, fungi, and toxins that have been genetically modified.
- Medical use of toxins for patient treatment is exempt.
- If the aggregate amounts of the following agents or toxins under the control of a principal investigator do not, at any time, exceed the limits below, they are exempt:
- 0.5 milligrams (mg) of Botulinum neurotoxins
- 5 mg of Staphylococcal enterotoxins
- 100 mg of abrin, Clostridium perfringens epsilon toxin, conotoxin, ricin, saxitoxin, shigatoxin, shiga-like ribosome inactivating protein, and tetrodotoxin
- 1,000 mg of diacetoxyscirpenol and T-2 toxin
- Other exempted agents and toxins are:
- Any agent or toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
- Non-viable Select Agent organisms or nonfuntional toxins.
- The vaccine stains of Junin virus (Candid #1), Rift Valley fever virus (MP-12), Venezuelan Equine encephalitis virus vaccine strain TC-83.
- Attenuated strains: HHS and USDA regulations have established a procedure 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 list of select biological agents and toxins.
- See Notification of Exclusions from the CDC for the current list of excluded strains and conditions of exclusion.
- Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug-resistance trait to the listed agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
- Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of listed toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight.