Skip to main content

Export Controlled Biologics and Materials

The following biologics consist of human, animal, and plant materials that are considered export controlled and will require a license to be exported to certain countries and regions.

Please Note: Any genetic elements or genetically modified organisms from the materials listed below are also considered export controlled for certain countries and regions. This is regardless of quantity or attenuation, including genetic elements or genetically modified organisms for attenuated strains of select biological agents or “toxins” that are excluded from the lists of select biological agents or “toxins” by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA), or the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services (HHS).

“Genetic element” – Includes, but is not limited to, chromosomes, genomes, plasmids, transposons, vectors, and inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or chemically synthesized in whole or in part. Nucleic acids from an inactivated organism, virus, or sample are considered to be “recoverable” if the inactivation and preparation of the material is intended or known to facilitate isolation, purification, amplification, detection, or identification of nucleic acids.

“Genetically modified organism” – Organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation.

See also: Export Controlled Chemicals and Mixtures

Viruses

  • African horse sickness virus
  • African swine fever virus
  • Andean potato latent virus (Potato Andean latent tymovirus)
  • Andes virus
  • Avian influenza (AI) viruses1 identified as having high pathogenicity (HP), as follows:
    • AI viruses that have an intravenous pathogenicity index (IVPI) in 6-week-old chickens >1.2 or
    • AI viruses that cause at least 75% mortality in 4- to 8-week-old chickens infected IV.
  • Blue tongue virus
  • Chapare virus
  • Chikungunya virus
  • Choclo virus
  • Classical swine fever (Hog cholera virus)
  • Crimean-Congo hemorrhagic fever virus
  • Dobrava-Belgrade virus
  • Eastern equine encephalitis virus
  • Ebolavirus (including all members of the Ebolavirus genus)/li>
  • Foot-and-mouth disease virus
  • Goat pox virus
  • Guanarito virus
  • Hantaan virus
  • Hendra virus (Equine morbillivirus)
  • Japanese encephalitis virus
  • Junin virus
  • Kyasanur Forest disease virus
  • Laguna Negra virus
  • Lassa virus
  • Louping ill virus
  • Lujo virus
  • Lumpy skin disease virus
  • Lymphocytic choriomeningitis virus
  • Machupo virus
  • Marburg virus (including all members of the Marburgvirusgenus)
  • Middle East respiratory syndrome-related coronavirus (MERS-related coronavirus)
  • Monkeypox virus
  • Murray Valley encephalitis virus
  • Newcastle disease virus
  • Nipah virus
  • Omsk hemorrhagic fever virus
  • Oropouche virus
  • Peste des petits ruminants virus
  • Porcine Teschovirus
  • Potato spindle tuber viroid
  • Powassan virus
  • Rabies virus and all other members of the Lyssavirusgenus
  • 1918 pandemic influenza virus – reconstructed replication competent forms containing any portion of the coding regions of all 8 gene segments.
  • Rift Valley fever virus
  • Rinderpest virus
  • Rocio virus
  • Sabia virus
  • Seoul virus
  • SARS-related coronavirus (SARS-CoV).
    • As per BIS guidance, SARS-CoV-2 is not yet included on this list.
  • Sheep pox virus
  • Sin Nombre virus
  • Louis encephalitis virus
  • Suid Herpesvirus 1 (Pseudorabies virus; Aujeszky’s disease)
  • Swine vesicular disease virus
  • Tickborne encephalitis virus (Far eastern subtype, formerly Russian Spring-Summer encephalitis virus). Tickborne encephalitis virus (Siberian subtype, formerly West Siberian virus)
  • Variola virus
  • Venezuelan equine encephalitis virus
  • Vesicular stomatitis virus
  • Western equine encephalitis virus
  • Yellow fever virus

Biological Toxins and Subunits Thereof

  • Abrin
  • Aflatoxins
  • Botulinum toxins
  • Brevetoxins
  • Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins
  • Conotoxin
  • Diacetoxyscirpenol toxin
  • Gonyautoxins
  • HT-2 toxin
  • Microcystin (Cyanginosins)
  • Modeccin toxin
  • Nodularins
  • Palytoxin
  • Ricin
  • Saxitoxin
  • Shiga toxin (shiga-like toxins, verotoxins, and verocytotoxins)
  • Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly Staphylococcus enterotoxin F)
  • T-2 toxin
  • Tetrodotoxin
  • Viscumin (Viscum album lectin 1)
  • Volkensin toxin

Bacterial and Rickettsial Agents

  • Bacillus anthracis
  • Brucella abortus
  • Brucella melitensis
  • Brucella suis
  • Burkholderia mallei (formerly Pseudomonas mallei)
  • Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
  • Clavibacter michiganensissubspecies sepedonicus (Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)
  • Chlamydia psittaci (formerly Chlamydophila psittaci)
  • Clostridium argentinense (formerly Clostridium botulinum Type G), botulinum neurotoxin producing strains
  • Clostridium baratii, botulinum neurotoxin producing strains
  • Clostridium botulinum
  • Clostridium butyricum, botulinum neurotoxin producing strains
  • Clostridium perfringens,epsilon toxin producing types
  • Coxiella burnetii
  • Francisella tularensis
  • Mycoplasma capricolum subspeciescapripneumoniae (“strain F38”)
  • Mycoplasma mycoides subspecies mycoides SC (small colony, contagious bovine pleuropneumonia)
  • Ralstonia solanacearum, race 3, biovar 2
  • Rathayibacter toxicus
  • Rickettsia prowazekii
  • Salmonella entericasubspecies enterica serovar Typhi (Salmonella Typhi)
  • Shiga toxin producing Escherichia coli(STEC) of serogroups:
    • O26, O45, O103, O104, O111, O121, O145, O157.
    • Other Shiga toxin producing serogroups (STEC strains include, among others, enterohemorrhagic coli (EHEC)).
    • Verocytotoxin-producing E. coli (VTEC).
  • Shigella dysenteriae
  • Vibrio cholerae
  • Xanthomonas albilineans
  • Xanthomonas citri pv. citri (Xanthomonas axonopodis pv. citri, Xanthomonas campestris pv. citri)
  • Xanthomonas oryzae
  • Yersinia pestis

Fungi

  • Bipolaris oryzae (Cochliobolus miyabeanus, Helminthosporium oryzae)
  • Coccidioides immitis
  • Coccidioides posadasii
  • Colletotrichium kahawae(Colletotrichium coffeanum virulans)
  • Magnaporthe oryzae(Pyricularia oryzae)
  • Peronosclerospora philippinensis(Peronosclerospora sacchari)
  • Phoma glycinicola(formerly Pyrenochaeta glycines)
  • Pseudocercospora ulei (Microcyclus ulei, Dothidella ulei)
  • Puccinnia graminis ssp. graminis var. graminis/Puccinia graminis ssp. graminis var. stakmanii (Puccinia graminis [syn. Puccinia graminis f. sp. tritici])
  • Puccinia striiformis(Puccinia glumarum)
  • Sclerophthora rayssiae var. zeae
  • Synchytrium endobioticum
  • Thecaphora solani
  • Tilletia indica

Vaccines, immunotoxins, medical products, diagnostic and good testing kits

  • Vaccines against any materials or items listed above.
  • Immunotoxins containing Biological Toxins or Subunits Thereof.
  • Medical products containing botulinum toxins listed under Biological Toxins or Subunits Thereof.
  • Medical products containing Biological Toxins or Subunits Thereof.
  • Diagnostic and food testing kits containing Biological Toxins or Subunits Thereof.

Footnotes

  1. Avian influenza viruses of the H5 or H7 subtype that do not have either of the characteristics described above should be sequenced to determine whether multiple basic amino acids are present at the cleavage site of the haemagglutinin molecule (HAO). If the amino acid motif is similar to that observed for other HPAI isolates, then the isolate being tested should be considered HPAI and the virus is controlled for export. Return to main text from footnote 1.