Biological Agents In Research Involving Export Control Regulations

For Researchers And Their Departments


There are two sets of export control regulation that govern the biological agents and shipments. The Export Administration Regulations (EAR) govern dual-use items, technologies and software with commercial and military applications. The International Traffic in Arms Regulations (ITAR) govern materials, technologies and software specifically designed for military applications. Most research at the University of Colorado Denver | Anschutz Medical Campus is considered unrestricted and considered fundamental research, which is basic or applied research in science and engineering, where the resulting information is ordinarily published and shared broadly with the scientific community. However, in certain situations, the fundamental research exemption may not apply and further analysis of the planned project is required. Persons who plan to work with biological agents governed by the export control regulations are required to contact the export control officer in advance of planned research. A license or other authorization maybe needed before work can commence. Contact the Export Control Office with any questions. Christine.Ahearn@cuanschutz.edu 303-724-0245

 

Environmental Health and Safety Links

Environmental Safety Shipping and Receiving Hazardous Materials

Select Agents and Toxins Program

Human and Animal Pathogens (ECCN 1C351 & 1C352)

Viruses

  1. 1918 pandemic influenza virus – reconstructed replication competent forms containing any portion of the coding regions of all 8 gene segments
  2. African horse sickness virus
  3. African swine fever virus
  4. *Andes virus
  5. 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.
    3. 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 under 1C352.a.2
  6. *Blue tongue virus
  7. Chapare virus
  8. *Chikungunya virus
  9. *Chikungunya virus
  10. Congo-Crimean haemorrhagic fever virus
  11. *Dengue fever virus
  12. *Dobrava-Belgrade virus
  13. Eastern equine encephalitis virus
  14. Ebola virus
  15. Foot and mouth disease virus
  16. Goat pox virus
  17. Guanarito virus
  18. *Hantaan virus
  19. Hendra virus (Equine morbillivirus)
  20. Hog cholera virus (Swine fever virus)
  21. *Japanese encephalitis virus
  22. Junin virus
  23. Kyasanur Forest virus
  24. *Laguna Negra virus
  25. Lassa fever virus
  26. *Louping ill virus
  27. Lujo virus
  28. Lumpy skin disease virus
  29. *Lymphocytic choriomeningitis virus
  30. Machupo virus
  31. Marburg virus
  32. Monkey pox virus
  33. *Murray Valley encephalitis virus
  34. Newcastle disease virus
  35. Nipah virus
  36. Omsk haemorrhagic fever virus
  37. *Oropouche virus
  38. Peste des petits ruminants virus
  39. Porcine enterovirus type 9 (swine vesicular disease virus)
  40. *Porcine herpes virus (Aujeszky’s disease)
  41. *Powassan virus
  42. Rabies virus and all other members of the Lyssavirus genus
  43. Rift Valley fever virus
  44. Rinderpest virus
  45. *Rocio virus
  46. Sabia virus
  47. SARS-associated coronavirus (SARS-CoV)
  48. *Seoul virus
  49. Sheep pox virus
  50. *Sin Nombre virus
  51. *St. Louis encephalitis virus
  52. *Teschen disease virus
  53. Tickborne encephalitis virus (Far eastern subtype, formerly Russian Spring-Summer encephalitis virus)
  54. Tickborne encephalitis virus (Siberian subtype, formerly West Siberian virus)
  55. Variola virus
  56. Venezuelan equine encephalitis virus
  57. *Vesicular stomatitis virus
  58. *Western equine encephalitis virus
  59. *Yellow fever virus

Bacterial, Fungal & Rickettsial Agents

  1. Bacillus anthracis
  2. Brucella abortis
  3. Brucella melitensis
  4. Brucella suis
  5. Burkholderia mallei (Pseudomonas mallei)
  6. Burkholderia pseudomallei (Pseudomonas pseudomallei)
  7. *Chlamydophila psittaci (formerly Chlamydia 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. *Coccidioides immitis
  14. *Coccidioides posadasii
  15. Coxiella burnetii
  16. Francisella tularensis
  17. Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)
  18. Mycoplasma mycoides subspecies mycoides SC (small colony, contagious bone pleuropneumonia)
  19. Rickettsia prowazekii
  20. *Salmonella typhi
  21. *Shiga toxin producing Eschericia coli (STEC; a.k.a. enterohaemorrhagic E. coli (EHEC) or verocytotoxin-producing E. coli (VTEC)) of serogroups O26, O45, O103, O104, O111, O121, O145, O157 and other Shiga toxin producing serogroups
  22. *Shigella dysenteriae
  23. *Vibrio cholera
  24. Yersinia pestis ​

Biological Toxins and Subunits

  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. Diacetosyscirpenol toxin
  8. *HT-2 toxin
  9. *Microcystin (Cyanginosin)
  10. *Modeccin toxin
  11. Ricin$
  12. Saxitoxin#$
  13. *Shiga toxin
  14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly Staphylococcus enterotoxin F)
  15. T-2 toxin
  16. Tetrodotoxin
  17. *Verotoxin and other Shiga-like ribosome inactivating proteins
  18. *Viscum Ablum Lectin 1 (Viscumin)
  19. *Volkensin toxin
$The following forms of ricin are CWC Schedule 1 chemicals (see 742.18 of the EAR) and require a license for CW reasons to export and reexport to all destinations including Canada:
  1. Ricin in the form of Ricinus Communis AgglutininII (RCAII; aka: ricin D or Ricinus Communis LectinIII (RCLIII)) and Ricinus Communis LectinIV (RCLIV; aka ricin E).
  2. The US Government must provide advance notification and annual reports to the OPWC of all exports of Schedule 1 chemicals (see 745.0 of the EAR for notification procedures).

$The following forms of saxitoxin are CWC Schedule 1 chemicals (see 742.18 of the EAR) and require a license for CW reasons to export and reexport to all destinations including Canada:

i. Saxitoxin identified by C.A.S. #35523-89-8 #While only saxitoxin is controlled on the CCL, other members of the paralytic shellfish poison family (e.g., neosaxitoxin) are designated EAR99 (see below).

ii. The US Government must provide advance notification and annual reports to the OPWC of all exports of Schedule 1 chemicals (see 745.0 of the EAR for notification procedures).

#While only saxitoxin is controlled on the CCL, other members of the paralytic shellfish poison family (e.g. neosaxitoxin) are designated EAR99.

 Plant Pathogens (ECCN 1C354)

 Plant Pathogens

  1. *Andean potato latent virus (Potato Andean latent tymovirus)
  2. *Clavibacter michiganensis subspecies sepedonicus (Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)
  3. *Cochliobolus miyabeanus (Helminthosporium oryzae)
  4. *Colletotrichium kahawae (Colletotrichium coffeanum var. virulans)
  5. *Magnaporthe oryzae (Pyricularia oryzae)
  6. *Microcyclus ulei (Dothidella ulei)
  7. Peronosclerospora philippinensis (Peronosclerospora sachhari)
  8. Phoma glycinicola (formerly Pyrenochaeta glycines)
  9. *Potato spindle tuber viroid
  10. *Puccinia graminis ssp. Graminis var. graminis/Puccina graminis ssp. Graminis car. Stakmanii (Puccinia graminis [syn. Puccinia graminis f.sp. Tritici])
  11. *Puccinia striiformis (Puccinia glumarum)
  12. Ralstonia solanacearum, race 3, biovar 2 (Burkholderia solanacearum, race 3, biovar 2)
  13. Rathayibacter toxicus
  14. Sclerphthora rayssiae var. Zeae
  15. Synchytrium endobioticum
  16. *Thecaphora solani
  17. *Tilletia indica
  18. *Xanthomonas albilineans
  19. *Xanthomonas axonopodis pv. Citri (Xanthomonas campestris pv. Citri A) (Xanthomonas campestris pv. Citri)
  20. Xanthomonas oryzae

Genetic Elements & Genetically Modified Organisms (ECCN 1C353)

Genetic Elements

  1. Genetic elements that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a to .c, 1C352 and 1C354.
  2. Genetic elements that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof.

Genetically Modified Organisms

  1. Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of microorganism controlled by 1C351.a to .c, 1C352 and 1C354.
  2. Genetically modified organisms that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof.

Technical Notes

  1. “Genetic elements” include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified, or chemically synthesized in whole or in part.
  2. This ECCN does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Eschericia coli, serotype O157 and other verotoxin producing strains, except those nucleic acids that contain coding for the verotoxin or its sub-units.
  3. “Nucleic acid sequences associated with the pathogenicity of any of the microorganisms controlled by 1C352.a to .c, 1C352, or 1C354” means any sequence specific to the relevant controlled microorganism that:
    1. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
    2. Is known to enhance the ability of a microorganism controlled by 1C352.a to .c, 1C352, or 1C354, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.
  4. “Genetically modified organisms” include organisms in which the genetic material (nucleic acid sequences) has been altered in a way that does not occur naturally by mating and/or natural recombination, and encompasses those produced artificially in whole or in part.

EAR99 & NLR

EAR99

As a result of recent changes to the CDC/APHIS list of Select Agents and Toxins, the following select agents that were formerly controlled by ECCN 1C360 are no longer listed on the CCL and are now classified as EAR99 instead:

  1. Central European Tickborne encephalitis viruses:
    1. Absettarov virus
    2. Hanzalova virus
    3. Hypr virus
    4. Kumlinge virus
  2. Cercopithecine herpesvirus 1 (Herpes B virus)
  3. Flexal virus
  4. Akabane virus
  5. Bovine spongiform encephalopathy agent
  6. Camel pox virus
  7. Malignant catarrhal fever virus
  8. Menangle virus
  9. Erhlichia ruminantium (a.k.a. Cowdria rumunantium)
  10. Xylella fastidiosa pv. citrus variegated chlorosis (CVC)
  11. *Rickettsia rickettsia

NLR

Items designated as EAR99 may be exported using the license exception "NLR", specifying "no license required", as long ALL of the following criteria are met:

  1. The item is not being shipped to a sanctioned destination;
  2. The item is not being shipped to a denied person, sanctioned entity or prohibited end-user; and
  3. The item will not be used for a specific end-use, subject to higher controls.

International Traffic in Arms Regulations (ITAR)

International Traffic in Arms Regulations (ITAR)

Category XIV: Toxicological Agents including Chemical, Biological Agents, and Associated Equipment

MULTIPLE Export Controls, INCLUDING a License will be required to 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. For more information on these items please refer to Category XIV – Toxicological Agents, including Chemical Agents, Biological Agents and Associated Equipment sections (g) through (m), page 486