Biological Research and Export Controls
Export controls are federal government regulations that restrict the transfer of certain materials, technology or software abroad or to non-US Persons in the United States. There are two sets of export controls that govern biological research and shipments: the Export Administration Regulations (EAR) that govern dual-use items, technologies and software with commercial and military applications and the International Traffic in Arms Regulations (ITAR) that govern materials, technologies and software specially designed for military applications.
Most biological research at universities, including Boston University, is fundamental. In other words: unrestricted research. Fundamental research is basic and applied research in science and engineering, where the resulting information is ordinarily published and shared broadly within the scientific community. The techniques used during the research are normally publicly available or are part of the published information.
- For example: university-based research on vectors for salmonella typhi that is broadly published is considered fundamental research and uncontrolled.
It is not considered fundamental research when there are restrictions placed on the outcome of the research or restrictions on methods used during the research. This includes proprietary research; industrial development; design, productions and product utilizations the results of which are restricted or government funded research that specifically restricts the outcome for national security reasons.
- For example: University-based research on Bacillus anthracis that has restrictions on publication of scientific and technical information resulting from the research.
- In addition, research with materials or equipment specifically designed for military application and biological weapons is restricted.
If you plan to carry out research that falls into any of these categories, you will be required to work with the University Export Control Officer to develop a plan to manage such research and ensure compliance with export controls.
Moreover, when you use proprietary technology that is not publicly available, you will need to determine if deemed exports licenses are required for your international colleagues. The technology transfer analysis is technical and the University Export Control Officer will help you with that determination.
There are no exceptions available to researchers for shipping or taking controlled materials, samples, technologies abroad. Transport of materials across U.S. border may require special handling, U.S. export or foreign import licenses and special Customs clearance. The University Export Control Officer works closely with the Office of Environmental Health and Safety and will assist you with material shipping.
The following instances invoke an export control review:
- You accept publication or foreign national restrictions on your research;
- You plan to transfer non-publicly available technology/software/technique to an international student or scholar in your laboratory;
- You plan to work with materials that are listed on the U.S. Munitions List
- You plan to ship or take samples or materials that are controlled on the Commerce Control List or U.S. Munitions List abroad.
Following are lists of controlled materials, technologies and software used in biological research. These lists are updated periodically so be sure to review the actual regulations or call the University Export Control Officer to assist you prior to shipping abroad or accepting controlled research. Export controls apply regardless of quantity or attenuation, including small quantities or attenuated strains of Select Agents or toxins that are excluded from the lists administered by APHIS or CDC.
Note: importing select agents/toxins or pathogens typically requires an import license by CDC or the USDA. You should contact the Office of Environmental Health and Safety or the University Export Control Officer to provide assistance with import shipments.
Commerce Control List: Category 1 (Dual-Use Biological Agents)
1C351 Human and zoonotic pathogens and toxins:
Controlled Materials on the Australia List:
- African horse sickness virus
- African swine fever virus
- Andes virus
- Avian influenza
- Bluetongue virus
- Chapare virus
- Chikungunya virus
- Choclo virus
- Classical swine fever virus
- Crimean-Congo haemorrhagic fever virus (a.k.a. Crimean-Congo haemorrhagic fever virus)
- Dengue fever virus
- Dobrava-Belgrade virus
- Eastern equine encephalitis virus
- Ebola virus
- Foot-and-mouth disease virus
- Goatpox virus
- Guanarito virus
- Hantaan virus
- Hendra virus (Equine morbillivirus)
- Japanese encephalitis virus
- Junin virus
- Kyasanur Forest virus
- Laguna Negra virus
- Lassa fever virus
- Louping ill virus
- Lujo virus
- Lumpy skin disease virus
- Lymphocytic choriomeningitis virus
- Machupo virus
- Marburg virus
- Monkey pox virus
- Murray Valley encephalitis virus
- Newcastle disease virus
- Nipah virus
- Omsk haemorrhagic fever virus
- Oropouche virus
- Peste-des-petis ruminants virus
- Porcine Teschovirus
- Powassan virus
- Rabis virus and all other members of the Lyssavirus genus
- Reconstructed 1918 influenza virus
- Rift Valley fever virus
- Rinderpest virus
- Rocio virus
- Sabia virus
- Seoul virus
- SARS related coronavirus
- Sheeppox virus
- Sin nombre virus
- St. Louis encephalitis virus
- Tick-borne encephalitis virus (Far Eastern subtype, formerly known as Russian Spring-Summer encephalitis virus – see 1C351.b.3 for Siberian subtype)
- Variola virus
- Venezuelan equine encephalitis virus
- Vesicular stomatitis virus
- Western equine encephalitis virus
- Yellow fever virus
APHIS/CDC Select Agent List
- Tick-borne encephalitis virus (Siberian subtype, formerly West Siberian virus – see 1C351.a.35 for Far Eastern subtype)
Bacteria on the Australia List
- Bacillus anthracis
- Brucella abortus
- Brucella melitensis
- Brucella suis
- Burkholderia mallei (Pseudomonas mallei)
- Burkholderia pseudomallei (Pseudomonas pseudomallei)
- Chlamydophila psittaci (formerly known as Chlamydia psittaci)
- Clostriduim argentinense (formerly known as 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
- Mycoplasna capricolum subspecies capripneumoniae
- Mycoplasma mycoides subspecies mycoides SC
- Rickettsia prowazekii
- Salmonella typhi
- 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).
- Shigella dysenteriae
- Vibrio cholera
- Yersinia pestis
“Toxins” on the Australia Group
- Abrin
- Aflatoxins
- Botulinum toxins
- Cholera toxin
- Clostridium perfringens toxins
- Conotoxin
- Diacetoxyscirpenol toxin HT-2 toxin
- HT-2 toxin
- Microcystin (Cyanginosin)
- Modeccin toxin
- Ricin
- Saxitoxin
- Shiga toxin
- Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphylococcus enterotoxin F)
- T-2 toxin
- Tetrodotoxin
- Verotoxin and other Shiga-like ribosome inactivating proteins
- Viscum Album Lectin 1 (Viscumin)
- Volkensin toxin
“Fungi”
- Coccidioides immitis
- Coccidioides posadasii
Animal Pathogens
Viruses
- African swine fever virus
- Avian influenza (AI) viruses identified as having high pathogenicity (HP), as follows:
- AI viruses that have an intravenous pathogenicity 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
- Bluetongue virus;
- Foot and mouth disease virus;
- Goat pox virus
- Porcine herpes virus (Aujeszky’s disease)
- Swine fever virus (Hog cholera virus)
- Lyssa virus (a.k.a. Rabies)
- Newcastle disease virus;
- Peste des petits ruminants virus;
- Porcine enterovirus type 9 (swine vesicular disease virus)
- Rinderpest virus
- Sheep pox virus
- Teschen disease virus
- Vesicular stomatitis virus
- Lumpy skin disease virus
- African horse sickness virus
Bacteria
Mycoplasma mycoides, as follows:
- Mycoplasma mycoides
- subspecies mycoides SC (small colony) (a.k.a. contagious bovine pleuropneumonia)
- Mycoplasma capricolum
- subspecies capripneumoniae (“strain F38”)
Plant Pathogens
Bacteria
- Xanthomonas albilineans
- Xanthomonas axonopodis pv. citri (Xanthomonas campestris pv. citri A) (Xanthomonas campestris pv. citri)
- Xanthomonas oryzae
- Clavibacter michiganensis subspecies sepedonicus (syn. Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum)
- Ralstonia solanacearum, race 3, biovar 2
- Raythayibactor toxicus
Fungi
- Colletotrichum kahawae (Colletotrichum coffeanum var. virulans)
- Cochliobolus miyabeanus (Helminthosporium oryzae)
- Microcyclus ulei (syn. Dothidella ulei)
- Puccinnia graminis ssp. graminis var. graminis / Puccinia graminis ssp. graminis var. stakmanii (Puccinia graminis [syn. Puccinia graminis f. sp. tritici])
- Puccinia striiformis (syn. Puccinia glumarum)
- Magnaporthe oryzae (Pyricularia oryzae)
- Peronosclerospora philippinensis (Peronosclerospora sacchari)
- Sclerophthora rayssiae var. zeae
- Synchytrium endobioticum
- Tilletia indica
- Thecaphora solani
- Phoma glycinicola (formerly Pyrenochaeta glycines)
Viruses
- Andean potato latent virus (Potato Andean latent tymovirus)
- Potato spindle tuber viroid
Genetic Elements and Genetically Modified Organisms
Genetic Elements
Genetic elements that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a to .c, 1C352, or 1C354 Genetic elements that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d 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.
Genetically modified organisms
Genetically modified organisms that contain nucleic acid sequences associated with the pathogenicity of microorganisms controlled by 1C351.a to .c, 1C352, or 1C354 Genetically modified organisms that contain nucleic acid sequences coding for any of the “toxins” controlled by 1C351.d or “sub-units of toxins” thereof
Export Control Classification Number 1C353
Review the Export Control Classification Number 1C353 for further information on controls on generic elements and genetically modified organisms.
Technology and Equipment
Commerce Control List: Category 1
(dual-use biological agents)
1E001 Technology for the development or production of materials, pathogens, toxins listed in categories above
1E351 Technology for the disposal of microbiological materials controlled by categories above
Commerce Control List: Category 2
(technologies used in biological research)
2B352 Equipment capable of use in handling biological materials
2E001 technology for the “development” of controlled equipment
2E002 technology for the “production” of controlled equipment
2E301 technology for the “use” of controlled agents/pathogens/toxins
U.S. Munitions List Category XIV: Toxicological Agents
Toxicological Agents, including biological agents and associated equipment
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 Equipment and its components, parts, accessories, and attachments specifically designed or modified for military operations and compatibility with military equipment as follows:
- The dissemination, dispersion or testing of biological agents
- The detection, identification, warning or monitoring of controlled biological agents
- Sample collection and processing of controlled biological agents
- Individual protection against controlled biological agents
- Collective protection against controlled biological agents
- Decontamination or remediation of controlled biological agents
- Antibodies, polynucleoides, biopolymers or biocatalysts specifically designed or modified for use with articles controlled in this category
- Medical countermeasures, to include pre- and post-treatments, vaccines, antidotes and medical diagnostics, specifically designed or modified for use with the chemical agents listed in and vaccines with the sole purpose of protecting against biological agents identified in this category. Examples include: barrier creams specifically designed to be applied to skin and personal equipment to protect against vesicant agents; atropine auto injectors specifically designed to counter nerve agent poisoning.
- Modeling or simulation tools specifically designed or modified for biological weapons design, development or employment. The concept of modeling and simulation includes software specifically designed to reveal susceptibility or vulnerability to biological agents or materials
- Test facilities specifically designed or modified for the certification and qualification of articles controlled in this category
- Equipment, components, parts, accessories, and attachments, exclusive of incinerators (including those which have specially designed waste supply systems and special handling facilities), specifically designed or modified for destruction biological agents of this category. This destruction equipment includes facilities specifically designed or modified for destruction operations.
- Tooling and equipment specifically designed or modified for the production of articles controlled by paragraph (f) of this category