Select Agents
Viruses
- Crimean-Congo haemorrhagic fever virus
- Eastern Equine Encephalitis virus
- Ebola viruses
- Equine Morbillivirus
- Lassa fever virus
- Marburg virus
- Rift Valley fever virus
- South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
- Tick-borne encephalitis complex viruses
- Variola major virus (Smallpox virus)
- Venezuelan Equine Encephalitis virus
- Viruses causing hantavirus pulmonary syndrome
- Yellow fever virus
Exemptions: Vaccine strains of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain MP-12, Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus strain 17-D) are exempt.
Bacteria
- Bacillus anthracis
- Brucella abortus, B. melitensis, B. suis
- Burkholderia (Pseudomonas) mallei
- Burkholderia (Pseudomonas) pseudomallei
- Clostridium botulinum
- Francisella tularensis
- Yersinia pestis
Exemptions: vaccine strains as described in Title 9 CFR, Part 78.1 are exempt.
Rickettsiae
- Coxiella burnetii
- Rickettsia prowazekii
- Rickettsia rickettsii
Fungi
- Coccidioides immitis
Toxins
- Abrin
- Aflatoxins
- Botulinum toxins
- Clostridium perfringens epsilon toxin
- Conotoxins
- Diacetoxyscirpenol
- Ricin
- Saxitoxin
- Shigatoxin
- Staphylococcal enterotoxins
- Tetrodotoxin
- T-2 toxin
Exemptions: Toxins for medical use, inactivated for use as vaccines, or toxin preparations for biomedical research use at an LD50 for vertebrates of more than 100 nanograms per kilogram body weight are exempt. National standard toxins required for biologic potency testing as described in 9 CFR Part 113 are exempt.
Recombinant organisms/molecules Genetically modified microorganisms or genetic elements from organisms on this list, shown to produce or encode for a factor associated with a disease. Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed in this list, or their toxic subunits.
Other restrictions The deliberate transfer of a drug resistance trait to microorganisms listed that are not known to acquire the trait naturally is prohibited by NIH “Guidelines for Research Involving Recombinant DNA Molecules,” if such acquisition could compromise the use of the drug to control these disease agents in humans or veterinary medicine.
Additional Exemptions Products subject to regulation under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C. § 136 et seq.) and the Toxic Substances Control Act (15 U.S.C. § 2601 et seq.) are exempt.