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Guidance Document - Restricted Biological Agents

There are two sets of regulations for export restricted biological items, the International Traffic in Arms Regulations (ITAR) from Dept. of State and the Export Administration Regulations (EAR) from Dept. of Commerce. These items require export licenses to all countries. Licensing takes about 6 weeks. Fines are $284,000 to $1,094,010 per violation. It is best to share such material under a Material Transfer Agreement (MTA). Contact SPS contracting or visit https://www.purdue.edu/business/sps/contractmgmt/agrtemplates.html for more information concerning MTAs.

These listed items (and any vaccines against these items) are controlled for export regardless of quantity or attenuation, genetic elements or genetically modified organisms for such agents or “toxins”, including small quantities or attenuated strains of select biological agents or “toxins” that are excluded from the lists of select biological agents or “toxins” by APHIS, CDC, or DHHS.

Under the ITAR, all biological agents listed below, and their biologically derived substances meeting the specific technical parameters are listed in CATEGORY XIV—TOXICOLOGICAL AGENTS, INCLUDING CHEMICAL AGENTS, BIOLOGICAL AGENTS, AND ASSOCIATED EQUIPMENT. See Category XIV https://www.pmddtc.state.gov/?id=ddtc_kb_article_page&sys_id=%2024d528fddbfc930044f9ff621f961987

Certain precursor chemicals, Biosafety gear, and lab equipment are also export restricted see Categories 1 & 2 of the Commerce Control List https://www.bis.doc.gov/index.php/regulations/export-administration-regulations-ear.

Alphabetical Listing of Export Restricted Biological Items

  • Abrin 1 2 3
  • Aflatoxins 1 2 3
  • African horse sickness virus
  • African Swine fever virus
  • Andean potato latent virus (Potato Andean latent tymovirus)
  • Andes virus
  • Avian influenza (AI) viruses with high pathogenicity (HP):
    • AI viruses that have an intravenouspathogenicity index (IVPI) in 6-week old chickens greater than 1.2; or
    • AI viruses that cause at least 75% mortality in 4- to 8-week old chickens infected intravenously.
    • Note: Avian influenza (AI) viruses of the H5 or H7 subtype that do not have either of the characteristics described in above should be sequenced to determine whether multiple basic amino acids are present at the cleavage site of the haemagglutinin molecule (HA0). If the amino acid motif is similar to that observed for other HPAI isolates, then the isolate being tested should be considered as HPAI and the virus is export restricted
  • Bacillus anthracis 4
  • Bluetongue virus
  • Botulinum toxins 1 2 3 4
  • Brucella abortus
  • Brucella melitensis
  • Brucella suis
  • Burkholderia mallei (Pseudomonas mallei) 4
  • Burkholderia pseudomallei (Pseudomonas pseudomallei) 4
  • Chapare virus
  • Chikungunya virus
  • Chlamydophila psittaci (formerly Chlamydia psittaci)
  • Choclo virus
  • Cholera toxin 1 2 3
  • Classical swine fever virus (Hog cholera virus).
  • Clavibacter michiganensis subspecies sepedonicus (syn. Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum);
  • Clostridium argentinense (formerly known as Clostridium botulinum Type G) botulinum neurotoxin producing strains
  • Clostridium baratii, botulinum neurotoxin producing strains
  • Clostridium botulinum 4
  • Clostridium butyricum, botulinum neurotoxin producing strains 4
  • Clostridium perfringens, epsilon toxin producing types
  • Clostridium perfringens alpha, beta 1, beta 2, epsilon and iota toxins 1 2 3
  • Coccidioides immitis
  • Coccidioides posadasii
  • Cochliobolus miyabeanus (Helminthosporium oryzae)
  • Colletotrichum kahawae (Colletotrichum coffeanum var. virulans)
  • Conotoxins 1 2 3
  • Coronavirus, SARS-associated (SARS-CoV)
  • Coxiella burnetii
  • Crimean-Congo hemorrhagic fever virus
  • Diacetoxyscirpenol toxin 1 2 3
  • Dobrava-Belgrade virus
  • Eastern Equine Encephalitis virus
  • Ebolavirus (includes all members of the Ebolavirus genus) 4
  • Encephalitis:
    • Eastern equine, Japanese, Murray Valley, St. Louis, Tick-borne, Venezuelan equine, Western equine
    • Enterohaemorrhagic Escherichia coli (E Coli), Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups
    • Note: Shiga toxin producing Escherichia coli (STEC) is also known as enterohaemorrhagic E. coli (EHEC) or verocytotoxin producing E. coli (VTEC).
  • Equine Morbillivirus (Hendra Virus)
  • Foot-and-mouth disease virus 4
  • Francisella tularensis 4
  • Goatpox virus
  • Guanarito virus
  • Hantaan virus
  • Hendra virus (Equine morbillivirus)
  • Herpes virus (Aujeszky’s disease)
  • Hog cholera virus (Swine fever virus)
  • HT-2 toxin 1 2 3
  • Influenza virus, Reconstructed 1918
    • Note: This includes reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments.
  • 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 (LCV)
  • Lyssa virus (aka Rabies)
  • Machupo virus
  • Magnaporthe oryzae (Pyricularia oryzae)
  • Marburgvirus (includes all members of the Marburgvirus genus) 4
  • Microcyclus ulei (syn. Dothidella ulei)
  • Microcystins (Cyanginosins) 1 2 3
  • Modeccin toxin 1 2 3
  • Monkeypox virus
  • Murray Valley encephalitis virus
  • Mycoplasma capricolum subspecies capripneumoniae (“strain F38”).
  • Mycoplasma mycoides subspecies mycoides SC (small colony) (a.k.a. contagious bovine pleuropneumonia);
  • Newcastle disease virus
  • Nipah virus
  • Omsk hemorrhagic fever virus
  • Oropouche virus
  • Peronosclerospora philippinensis (a.k.a. Peronosclerospora sacchari);
  • Peste-des-petits ruminants virus
  • Phoma glycinicola (formerly Pyrenochaeta glycines)
  • Porcine herpes virus (Aujeszky's disease)
  • Porcine Teschovirus
  • Potato Andean latent tymovirus (Andean potato latent virus)
  • Potato spindle tuber viroid.
  • Powassan virus
  • Puccinnia graminis ssp. graminis var. graminis/Puccinia graminis ssp. graminis var. stakmanii (Puccinia graminis [syn. Puccinia graminis f. sp. tritici])
  • Puccinia striformis (syn. Puccinia glumarum)
  • Rabies virus and all other members of the Lyssavirus genus
  • Ralstonia solanacearum, race 3 biovar 2
  • Rathayibacter toxicus;
  • Reconstructed 1918 influenza virus
    • Note: This includes reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments.
  • Ricin 3 (including Ricin D and Ricin E)
  • Rickettsia prowazekii
  • Rift Valley fever virus
  • Rinderpest virus 4
  • Rocio virus
  • Sabia virus
  • Salmonella enterica subspecies enterica serovar Typhi (Salmonella typhi)
  • Severe acute respiratory syndrome-related coronavirus (SARS-related coronavirus)
  • Saxitoxin 3
  • Sclerophthora rayssiae var. zeae;
  • Seoul virus
  • Sheeppox virus
  • Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups;
    • Note: Shiga toxin producing Escherichia coli (STEC) includes, inter alia, enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytotoxin producing E. coli (VTEC) 1 2 3
  • Shigella dysenteriae
  • Sin Nombre virus
  • St. Louis encephalitis virus
  • Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphylococcus enterotoxin F) 1 2 3
  • Suid herpesvirus 1 (Pseudorabies virus; Aujeszky’s disease)
  • Swine fever virus (Hog cholera virus)
  • Swine vesicular disease virus
  • Synchytrium endobioticum;
  • T-2 toxin 1 2 3
  • Tetrodotoxin (TTX) 1 2 3
  • Tick-borne encephalitis complex viruses (Russian Spring-Summer encephalitis virus aka Far Eastern subtype) and (Siberian subtype, formerly West Siberian virus)
  • Thecaphora solani
  • Tilletia indica
  • Vaccines against items in this alphabetical list (ECCNs1C351, 1C353, or 1C354)
  • Variola virus (major - Smallpox virus; minor – Alastrim) 4
  • Venezuelan Equine Encephalitis virus
  • Verotoxin & Verocytotoxins: other Shiga like ribosome inactivating proteins 1 2 3
  • Vesicular stomatitis virus
  • Vibrio cholerae
  • Viscum Album Lectin 1 (Viscumin) 1 2 3
  • Volkensin toxin 1 2 3
  • Western equine encephalitis virus
  • Xanthomonas albilineans
  • Xanthomonas axonopodis pv. citri (Xanthomonas campestris pv. citri A) (Xanthomonas campestris pv. citri)
  • Xanthomonas oryzae pv. oryzae (syn. Pseudomonas campestris pv. oryzae); proteobacteria
  • Yellow fever virus
  • Yersinia pestis 4

Genetic elements, as follows:

  • Genetic elements that contain nucleic acid sequences associated with the pathogenicity of microorganisms on this list,
  • Genetic elements that contain nucleic acid sequences coding for any of the “toxins” on this list or “sub-units of toxins” thereof.

Genetically modified organisms, as follows:

  • Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of microorganisms on this list;
  • Genetically modified organisms that contain nucleic acid sequences coding for any of the “toxins” on this list or “sub-units of toxins” thereof.
  • “Genetic elements” include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified, or chemically synthesized in whole or in part.

Footnotes

  1. Any diagnostic & food testing kits containing these agents are controlled under the Commerce Control List
  2. Any immunotoxins containing these agents are controlled under the Commerce Control List
  3. Any medical products containing these agents are controlled under the Commerce Control List
  4. These biological agents, and any biologically derived substances and genetic elements thereof meeting the specifications of ITAR category XIV are controlled by the ITAR-Part 121. Category XIV also includes certain listed antibodies, recombinant protective antigens, polynucleotides, biopolymers, or biocatalysts (including their expression vectors, viruses, plasmids, or cultures of specific cells modified to produce them), and equipment for the dissemination, dispersion, or testing of these controlled agents.

Acknowledgments

Special thanks to Brittany Whiting, Export Control Officer of University of California - San Diego for sharing this resource.

Need Help?

Contact the Purdue export control/information assurance team by email at exportcontrols@purdue.edu, by phone at (765) 494-6840, or in person on the 3rd floor of Hovde Hall.

Purdue University, West Lafayette, IN 47907 (765) 494-4600

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