Biologics on export control lists:
1C351 Human and zoonotic pathogens and "toxins"
(1) Certain forms of ricin
(2) All vaccines and "immunotoxins" are excluded from the scope of this entry.
(3) For the purposes of this entry, only saxitoxin is controlled under paragraph d.6; other members of the paralytic shellfish poison family (e.g. neosaxitoxin) are classified as EAR99.
(4) Clostridium perfringens strains that produce epsilon toxin.
(5) APHIS, CDC, HHS controls possession, use, and transfer within the United States of certain items controlled by this ECCN.
a. Viruses, as follows:
a.1. Chikungunya virus;
a.2. Congo-Crimean haemorrhagic fever virus (a.k.a. Crimean-Congo haemorrhagic fever virus);
a.3. Dengue fever virus;
a.4. Eastern equine encephalitis virus;
a.5. Ebola virus;
a.6. Hantaan virus;
a.7. Japanese encephalitis virus;
a.8. Junin virus;
a.9. Lassa fever virus
a.10. Lymphocytic choriomeningitis virus;
a.11. Machupo virus;
a.12. Marburg virus;
a.13. Monkey pox virus;
a.14. Rift Valley fever virus;
a.15. Tick-borne encephalitis virus (Russian Spring-Summer encephalitis virus);
a.16. Variola virus;
a.17. Venezuelan equine encephalitis virus;
a.18. Western equine encephalitis virus;
a.19. White pox;
a.20. Yellow fever virus;
a.21. Kyasanur Forest virus;
a.22. Louping ill virus;
a.23. Murray Valley encephalitis virus;
a.24. Omsk haemorrhagic fever virus;
a.25. Oropouche virus;
a.26. Powassan virus;
a.27. Rocio virus;
a.28. St. Louis encephalitis virus;
a.29. Hendra virus (Equine morbillivirus);
a.30. South American haemorrhagic fever (Sabia, Flexal, Guanarito);
a.31. Pulmonary and renal syndrome haemorrhagic fever viruses (Seoul, Dobrava, Puumala, Sin Nombre); or
a.32. Nipah virus.
b. Rickettsiae, as follows:
b.1. Bartonella quintana (Rochalimea quintana, Rickettsia quintana);
b.2. Coxiella burnetii;
b.3. Rickettsia prowasecki (a.k.a. Rickettsia prowazekii); or
b.4. Rickettsia rickettsii.
c. Bacteria, as follows:
c.1. Bacillus anthracis;
c.2. Brucella abortus;
c.3. Brucella melitensis;
c.4. Brucella suis;
c.5. Burkholderia mallei (Pseudomonas mallei);
c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
c.7. Chlamydia psittaci;
c.8. Clostridium botulinum;
c.9. Francisella tularensis;
c.10. Salmonella typhi;
c.11. Shigella dysenteriae;
c.12. Vibrio cholerae;
c.13. Yersinia pestis;
c.14. Clostridium perfringens, epsilon toxin producing types; or
c.15. Enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing serotypes.
d. "Toxins", as follows, and "subunits" thereof:
d.1. Botulinum toxins;
d.2. Clostridium perfringens toxins;
d.3. Conotoxin;
d.4. Microcystin (Cyanginosin);
d.5. Ricin;
d.6. Saxitoxin;
d.7. Shiga toxin;
d.8. Staphylococcus aureus toxins;
d.9. Tetrodotoxin;
d.10. Verotoxin and other Shiga-like ribosome inactivating proteins;
d.11. Aflatoxins;
d.12. Abrin;
d.13. Cholera toxin;
d.14. Diacetoxyscirpenol toxin;
d.15. T-2 toxin;
d.16. HT-2 toxin;
d.17. Modeccin toxin;
d.18. Volkensin toxin; or
d.19. Viscum Album Lectin 1 (Viscumin).
e. "Fungi", as follows:
e.1. Coccidioides immitis; or
e.2. Coccidioides posadasii.
IC352 Animal pathogens
a. Viruses, as follows:
a.1. African swine fever virus;
a.2. Avian influenza virus that are:
a.2.a. Defined in EC Directive 92/40/EC (O.J. L.16 23.1.92 p.19) as having high pathogenicity, as follows:
a.2.a.1. Type A viruses with an IVPI (intravenous pathogenicity index) in 6 week old chickens of greater than 1.2; or
a.2.a.2. Type A viruses H5 or H7 subtype for which nucleotide sequencing has demonstrated multiple basic amino acids at the cleavage site of haemagglutinin;
a.3. Bluetongue virus;
a.4. Foot and mouth disease virus;
a.5. Goat pox virus;
a.6. Porcine herpes virus (Aujeszky's disease);
a.7. Swine fever virus (Hog cholera virus);
a.8. Lyssa virus;
a.9. Newcastle disease virus;
a.10. Peste des petits ruminants virus;
a.11. Porcine enterovirus type 9 (swine vesicular disease virus);
a.12. Rinderpest virus;
a.13. Sheep pox virus;
a.14. Teschen disease virus;
a.15. Vesicular stomatitis virus;
a.16. Lumpy skin disease virus;
a.17. African horse sickness virus.
b. Bacteria, as follows:
b.1 Mycoplasma mycoides.
b.2 [RESERVED.]
1C353 Genetic elements and geneticallymodified organisms
a. Genetic elements, as follows:
a.1. Genetic elements that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a to .c, 1C352, 1C354, or 1C360;
a.2. Genetic elements that contain nucleic acid sequences coding for any of the "toxins" controlled by 1C351.d or "sub-units of toxins" thereof.
b. Genetically modified organisms, as follows:
b.1. Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a to .c, 1C352, 1C354, or 1C360;
b.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 Note: 1. "Genetic elements" include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified.
2. This ECCN does not control nucleic acid sequences associated with the pathogenicity of enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing strains, except those nucleic acid sequences 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 1C351.a to .c, 1C352, 1C354, or 1C360" means any sequence specific to the relevant controlled microorganism that:
a. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
b. Is known to enhance the ability of a microorganism controlled by 1C351.a to .c, 1C352, 1C354, or 1C360, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.
1C354 Plant pathogens
a. Bacteria, as follows:
a.1. Xanthomonas albilineans;
a.2. Xanthomonas campestris pv. Citri including strains referred to as Xanthomonas campestris pv. citri types A,B,C,D,E or otherwise classified as Xanthomonas citri, Xanthomonas campestris pv. aurantifolia or Xanthomonas campestris pv. citrumelo;
a.3. Xanthomonas oryzae pv. oryzae (syn. Pseudomonas campestris pv. oryzae);
a.4. Clavibacter michiganensis subspecies sepedonicus (syn. Corynebacte r i um michiganensis subspecies sepedonicum or Corynebacterium sepedonicum);
a.5. Ralstonia solanacearum Races 2 and 3 (syn. Pseudomonas solanacearum Races 2 and 3 or Burkholderia solanacearum Races 2 and 3);
b. Fungi, as follows:
b.1. Colletotrichum coffeanum var. virulans (Colletotrichum kahawae);
b . 2 . Cochliobolus miya b e a n us (Helminthosporium oryzae);
b.3. Microcyclus ulei (syn. Dothidella ulei);
b.4. Puccinia graminis (syn. Puccinia graminis f. sp. tritici);
b.5. Puccinia striiformis (syn. Puccinia glumarum);
b.6. Magnaporthe grisea (pyricularia grisea/pyricularia oryzae);
c. Viruses, as follows:
c.1. Potato Andean latent tymovirus;
c.2. Potato spindle tuber viroid.
1C360 Select agents not controlled under ECCN 1C351, 1C352, or 1C354
Note: The control status of items listed in this ECCN is not affected by the exemptions or exclusions contained in the domestic possession, use, and transfer regulations maintained by APHIS (at 7 CFR part 331 and 9 CFR part 121) and/or CDC (at 42 CFR part 73).
a. Human and zoonotic pathogens, as follows:
a.1. Viruses, as follows:
a.1.a. Central European tick-borne encephalitis viruses, as follows:
a.1.a.1. Absettarov;
a.1.a.2. Hanzalova;
a.1.a.3. Hypr;
a.1.a.4. Kumlinge;
a.1.b.Cercopithecine herpesvirus 1 (Herpes B virus);
a.1.c. Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments;
a.2. [Reserved];
b. Animal pathogens, as follows:
b.1. Viruses, as follows:
b.1.a. Akabane virus;
b.1.b. Bovine spongiform encephalopathy agent;
b.1.c. Camel pox virus;
b.1.d. Malignant catarrhal fever virus;
b.1.e. Menangle virus;
b.2. Mycoplasma, as follows:
b.2.a. Mycoplasma capricolum;
b.2.b. Mycoplasma F38;
b.3. Rickettsia, as follows:
b.3.a. Erhlichia ruminantium (a.k.a. Cowdria ruminantium);
b.3.b. [Reserved];
c. Plant pathogens, as follows:
c.1. Bacteria, as follows:
c.1.a. Candidatus Liberobacter africanus (a.k.a. Liberobacter africanus);
c.1.b. Candidatus Liberobacter asiaticus (a.k.a. Liberobacter asiaticus);
c.1.c. Xylella fastidiosa pv. citrus variegated chlorosis (CVC);
c.2. Fungi, as follows:
c.2.a. Peronosclerospora philippinensis;
c.2.b. Sclerophthora rayssiae var. zeae;
c.2.c. Synchytrium endobioticum