Bioagent Export

Some biological agents are regulated for export. Agents may not be exported to denied parties (restricted persons), for prohibited end-uses (e.g., biological weapons), or to sanctioned countries.

  1. Email EHS  with the name of the institution, location (city and country), and name of the end-user(s) that the material will be exported to. The information will be checked against a database to determine if the recipient is a denied person, sanctioned entity/institution, or prohibited end-user.
  2. Items may be shipped only for legitimate scientific or clinical purposes. Contact EHS Research Safety (352-392-1591) with any questions or concerns about intended use by the recipient.
  3. If you plan to ship any materials (even items not listed below) to Cuba, Iran, Sudan, Syria, or North Korea you must contact EHS Research Safety (352-392-1591) & the Division of Research Compliance (352- 392-9174) first.

Export License Requirements

Per the US Export Administration Regulations (EAR; Category 1 – Materials, Chemicals, Microorganisms and Toxins), a license will be required to export bioagents listed on the Commerce Control List (CCL), reproduced below. Other export controls may apply for possession and use in the U.S. For more information see the UF Office of Research web page on Export Controls.

Note: Export Administration Regulations control all biological agents and toxins listed below, regardless of quantity or attenuation. While many of these items are select agents, those preceded by an asterisk (*) are not, but still require an export permit.

This list is subject to change (Current as of April 9, 2020).

Human and Animal Pathogens (ECCN 1C351)

  1. African horse sickness virus
  2. African swine fever virus
  3. *Andes virus
  4. Avian influenza (AI) viruses identified as having high pathogenicity (HP), as follows:
    1. AI viruses that have an intravenous pathogenicity index (IVPI) in 6-week old chickens >1.2 or
    2. AI viruses that cause at least 75% mortality in 4- to 8-week old chickens infected IV.

Note: 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.

  1. *Blue tongue virus
  2. Chapare virus
  3. *Chikungunya virus
  4. *Choclo virus
  5. Classical swine fever (Hog cholera virus)
  6. Crimean-Congo hemorrhagic fever virus
  7. *Dobrava-Belgrade virus
  8. Eastern equine encephalitis virus
  9. Ebola virus (including all members of the Ebolavirus genus)
  10. Foot-and-mouth disease virus
  11. Goat pox virus
  12. Guanarito virus
  13. *Hantaan virus
  14. Hendra virus (Equine morbillivirus)
  15. *Japanese encephalitis virus
  16. Junin virus
  17. Kyasanur Forest disease virus
  18. *Laguna Negra virus
  19. Lassa fever virus
  20. *Louping ill virus
  21. Lujo virus
  22. Lumpy skin disease virus
  23. *Lymphocytic choriomeningitis virus
  24. Machupo virus
  25. Marburg virus (including all members of the Marburgvirus genus)
  26. Middle East respiratory syndrome-related coronavirus (MERS-related coronavirus)
  27. Monkeypox virus
  28. *Murray Valley encephalitis virus
  29. Newcastle disease virus
  30. Nipah virus
  31. Omsk hemorrhagic fever virus
  32. *Oropouche virus
  33. Peste des petits ruminants virus
  34. *Porcine Teschovirus
  35. *Powassan virus
  36. *Rabies virus and all other members of the Lyssavirus genus
  37. 1918 pandemic influenza virus – reconstructed replication competent forms containing any portion of the coding regions of all 8 gene segments.
  38. Rift Valley fever virus
  39. Rinderpest virus
  40. *Rocio virus
  41. Sabia virus
  42. *Seoul virus
  43. SARS-related coronavirus (SARS-CoV). As per BIS guidance, SARS-CoV-2 is not subject to export control regulations.
  44. Sheep pox virus
  45. *Sin Nombre virus
  46. *St. Louis encephalitis virus
  47. *Suid Herpesvirus 1 (Pseudorabies virus; Aujeszky’s disease)
  48. Swine vesicular disease virus
  49. Tickborne encephalitis virus (Far eastern subtype, formerly Russian Spring-Summer encephalitis virus). Tickborne encephalitis virus (Siberian subtype, formerly West Siberian virus)
  50. Variola virus
  51. Venezuelan equine encephalitis virus
  52. *Vesicular stomatitis virus
  53. *Western equine encephalitis virus
  54. *Yellow fever virus
Bacterial and Rickettsial Agents
  1. Bacillus anthracis
  2. Brucella abortus
  3. Brucella melitensis
  4. Brucella suis
  5. Burkholderia mallei (formerly Pseudomonas mallei)
  6. Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
  7. *Chlamydia psittaci (formerly Chlamydophila psittaci)
  8. Clostridium argentinense (formerly Clostridium botulinum Type G), botulinum neurotoxin producing strains
  9. Clostridium baratii, botulinum neurotoxin producing strains
  10. Clostridium botulinum
  11. Clostridium butyricum, botulinum neurotoxin producing strains
  12. *Clostridium perfringens, epsilon toxin producing types
  13. Coxiella burnetii
  14. Francisella tularensis
  15. Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)
  16. Mycoplasma mycoides subspecies mycoides SC (small colony, contagious bovine pleuropneumonia)
  17. Rickettsia prowazekii
  18. *Salmonella enterica subspecies enterica serovar Typhi (Salmonella Typhi)
  19. *Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157 and other Shiga toxin producing serogroups (STEC strains include, among others, enterohemorrhagic E. coli (EHEC) and verocytotoxin-producing E. coli (VTEC).
  20. *Shigella dysenteriae
  21. *Vibrio cholerae
  22. Yersinia pestis
Biological Toxins and subunits thereof
  1. Abrin
  2. *Aflatoxins
  3. Botulinum toxins
  4. *Cholera toxin
  5. *Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins
  6. Conotoxin
  7. Diacetoxyscirpenol toxin
  8. *HT-2 toxin
  9. *Microcystin (Cyanginosins)
  10. *Modeccin toxin
  11. Ricin$
  12. Saxitoxin#$
  13. *Shiga toxin (shiga-like toxins, verotoxins, and verocytotoxins)
  14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly Staphylococcus enterotoxin F)
  15. T-2 toxin
  16. Tetrodotoxin
  17. *Viscumin (Viscum album lectin 1)
  18. *Volkensin toxin
  1. *Coccidioides immitis
  2. *Coccidioides posadasii

Plant Pathogens (ECCN 1C354)

  1. *Clavibacter michiganensis subspecies sepedonicus (Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)
  2. Ralstonia solanacearum, race 3, biovar 2
  3. Rathayibacter toxicus
  4. *Xanthomonas albilineans
  5. *Xanthomonas axonopodis citri (Xanthomonas campestris pv. citri A) (Xanthomonas campestris pv. citri)
  6. Xanthomonas oryzae
  1. *Cochliobolus miyabeanus (Helminthosporium oryzae)
  2. *Colletotrichium kahawae (Colletotrichium coffeanum virulans)
  3. *Magnaporthe oryzae (Pyricularia oryzae)
  4. *Microcyclus ulei (Dothidella ulei)
  5. Peronosclerospora philippinensis (Peronosclerospora sacchari)
  6. Phoma glycinicola (formerly Pyrenochaeta glycines)
  7. *Puccinia graminis graminis var. graminis / Puccina graminis ssp. graminis car. stakmanii (Puccinia graminis [syn. Puccinia graminis f.sp. tritici])
  8. *Puccinia striiformis (Puccinia glumarum)
  9. Sclerophthora rayssiae var. zeae
  10. Synchytrium endobioticum
  11. *Thecaphora solani
  12. *Tilletia indica
  1. *Andean potato latent virus (Potato Andean latent tymovirus)
  2. *Potato spindle tuber viroid

Genetic Elements and Genetically Modified Organisms (ECCN 1C353)

Any genetically modified organism that contains, or any genetic element that codes for, any of the following:
  1. Any gene or genes specific to any virus controlled by 1C351.a or .b or 1C354.c
  2. Any gene or genes specific to any bacterium controlled by 1C351.c or 1C354.a or any fungus controlled by 1C351.e or 1C354.b and which:                                              A) In itself or through its transcribed or translated products represents a significant hazard to human, animal, or plant health                                                              B) Could endow or enhance pathogenicity
  3. Any toxins, or their sub units, controlled by 1C351.d
Technical Notes
  1. “Genetically modified organisms” include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation.
  2. “Genetic elements” include, inter alia, 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 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.
  3. This ECCN does not control nucleic acid sequences of shiga toxin producing Escherichia coli of serogroups O26, O45, O103, O104, O111, O121, O145, O157 and other shiga toxin producing serogroups, other than those genetic elements coding for shiga toxin, or for its subunits
  4. “Endow or enhance pathogenicity” is defined as when the insertion or integration of the nucleic acid sequence or sequences is/are likely to enable or increase a recipient organism’s ability to be used to deliberately cause disease or death. This might include alterations to, inter alia: virulence, transmissibility, stability, route of infection, host range, reproducibility, ability to evade or suppress host immunity, resistance to medical countermeasures, or detectability.

Vaccines, immunotoxins, medical products, diagnostic and food testing kits, as follows (1C991)

List of Items Controlled:

  1. Vaccines against items controlled by ECCN 1C351, 1C353 or 1C354
  2. Immunotoxins containing items controlled by 1C351.d
  3. Medical products containing botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6
  4. Medical products containing items controlled by ECCN 1C351.d (except botulinum toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 1C351.d.6, and items controlled for CW reasons under 1C351.d.11 or .d.12)
  5. Diagnostic and food testing kits containing items controlled by ECCN 1C351.d (except items controlled for CW reasons under ECCN 1C351.d.11 or .d.12)

International Traffic in Arms Regulations (ITAR)

US State Department Regulations, Part 121, The US Munitions List, control the export of biological materials regulated as “defense articles”. See Category XIV: Toxicological Agents including Chemical, Biological Agents, and Associated Equipment . MULTIPLE Export Controls, INCLUDING a License will be required to export, use, or possess the following:

(b) Biological agents and biologically derived substances specifically developed, configured, adapted, or modified for the purpose of increasing their capability to produce casualties in humans or livestock, degrade equipment or damage crops.

(f) Equipment and its components, parts, accessories, and attachments specifically designed or modified for military operations and compatibility with military equipment as follows:

    1. The dissemination, dispersion or testing of the biological agents listed in paragraph (b);
    2. The detection, identification, warning or monitoring of the biological agents listed in paragraph (b);
    3. Sample collection and processing of the biological agents listed in paragraph (b);
    4. Individual protection against the biological agents listed in paragraph (b);
    5. Collective protection against the biological agents listed in paragraph (b);
    6. Decontamination or remediation of the biological agents listed in paragraph (b).

Additional items associated with, or specific to, the biological agents listed in paragraph (b) are also controlled under the ITAR including medical countermeasures (pre- and post-treatments, vaccines, antidotes, medical diagnostics); modeling or simulation tools; equipment, components, parts, accessories and attachments, exclusive of incinerators specifically designed/modified for the destruction of biological agents in paragraph (b); technical data and defense services.