Biological Research and Export Controls
The guidance below is to assist Boston University faculty and employees when assessing activities to determine whether they are covered by export control license requirements. Please contact the Export Control Officer for assistance at export@bu.edu.
Most biological research at universities, including Boston University, is considered to be fundamental, which is unrestricted research.
Fundamental 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 which is published broadly 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.
Research involving 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 Export Control Officer to develop a plan to manage such research and ensure compliance with export controls.
When using proprietary technology that is not publicly available, you will need to determine if deemed exports licenses are required for international colleagues. The technology transfer analysis is technical and the Export Control Officer will help you with that determination.
Contact the Export Control Office to determine the feasibility of accepting controlled research in your laboratory. 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 Environmental Health and Safety and will assist you with material shipping.
The following examples are when you should contact the Export Control Officer for an export control review:
- You accept publication or foreign national restrictions on your research;
- Your research involves industrial development results of which are restricted from publication;
- You plan to transfer 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.
Please note that 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.
What is NOT Fundamental Research?
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.
The following types of research activities are NOT considered fundamental research:
- Proprietary Research
- Industrial Development
- Design, production and product utilization the results of which are restricted
- Government funded research that specifically restricts the outcome for national security reasons
Example: University based research on bacillus anthracis that has restrictions on publications of scientific and technical information resulting from the research.
Example: A university has a collaborative research agreement with a private company. The company releases its proprietary technology to the university to conduct the research with the condition that it not be released to the public. The university agrees to a non-disclosure statement as part of the collaborative agreement. The company proprietary information, if subject to the Export Administration Regulations (i.e., not subject to the jurisdiction of another Agency, e.g., the Department of State and the International Trade in Arms Regulation), may require deemed export licensing authorization if released to a foreign national.
Commerce Control List
Commerce Control List – Category 1 (Dual-Use Biological Agents)
1C351 Human and zoonotic pathogens and toxins:
For the current list of items subject to this ECCN, notes, and availability of licenses exceptions, refer to 1C351 in the Commerce Control List (download).
1C352 Animal pathogens as follows
Viruses as follows:
- 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 as follows:
Mycoplasma mycoides, as follows:
- Mycoplasma mycoides subspecies mycoides SC (small colony) (a.k.a. contagious bovine pleuropneumonia)
- Mycoplasma capricolum subspecies capripneumoniae (“strain F38”)
1C354 Plant pathogens as follows
Bacteria, as follows:
- 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 as follows:
- 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 as follows:
- Andean potato latent virus (Potato Andean latent tymovirus)
- Potato spindle tuber viroid
1C353 Genetic elements and genetically modified organisms as follows
Genetic elements as follows:
- 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
Genetically modified organisms as follows:
- 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
“Genetic elements” include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified, or chemically synthesized in whole or in part.
Review the Export Control Classification Number 1C353 for further information on controls on generic elements and genetically modified organisms.
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 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:
(1) The dissemination, dispersion or testing of biological agents
2) 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
- Modeling or simulation tools specifically designed or modified for biological weapons design, development or employment.
- 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
- Tooling and equipment specifically designed or modified for the production of articles controlled by paragraph (f) of this category.
(h) 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.
The concept of modeling and simulation includes software specifically designed to reveal susceptibility or vulnerability to biological agents or materials 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.
Deemed Exports and Fundamental Research for Biological Items
The guidance below was developed by Bureau of Industry and Security (BIS), the agency that regulates dual-use items and administers the Export Administration Regulations (EAR) to help the research community with the application of the fundamental research exclusion.
What is a Deemed Export?
Any release of technology or source code subject to the Export Administration Regulations (EAR) to a foreign national. This does not apply to Green Card Holders and individuals under the political asylum or refugee status.
What Technology is Subject to the EAR?
All technology in the United States is subject to the EAR except for the following:
- technology under the jurisdiction of another agency (ITAR, NRC, DOE)
- printed books
- publicly available technology
- technology that has been or will be published
- technology that arises during or results from fundamental research
- educational technology
- technology in certain patent applications
Is Biological Research subject to the EAR?
Research in the United States is subject to the EAR unless it meets one of the exclusions noted above. Research in University laboratories is often not subject to the EAR because it falls under the fundamental research exclusion but this should be determined on a case by case basis.
For research that is NOT fundamental research
If your research is NOT fundamental Research, then your technology may be subject to the EAR, but does it require a license? Does your biological research involve a controlled pathogen (1C351, 1C352, 1C353, 1C354, 1C360, 1C991) or controlled equipment (2B352)?
Please review the Commerce Control List Category 1 & Category 2.
If you are working with controlled pathogens or equipment, then the technology being shared with the foreign national needs to be determined.
There are 5 main technology ECCNs that need to be reviewed for biological research:
1E001 which is technology for the “development” or “production” of controlled biological agents
1E351 which is technology for the disposal of controlled biological agents
2E001 which is technology for the “development” of controlled equipment
2E002 which is technology for the “production” of controlled equipment
2E301 which is technology for the “use” of controlled items
Examples of types of technology:
1E001: “development” or “production” technology – If most of the technology being shared with the foreign national on how to grow, maintain, quality check a pathogen is in the public domain and the research is going to be published, then this research is not subject to the EAR and no deemed export license is required
Alternatively, if the researcher was working on a sensitive project involving biodefense or some other type of research that would not be allowed to be published without strict review and involved proprietary or non-standards technology regarding the pathogen (not in the scientific literature), then 1E001 might apply.
1E351: disposal technology – Most biological agents are destroyed through autoclave, chemicals, and other publicly available techniques and therefore it is not subject to the EAR.
2E001 and 2E002 technology controls – These would only apply if the researcher was developing 2B352 controlled biological equipment. They would be producing or developing controlled equipment. The same exclusion applies, that if the research will be broadly published, then it would be considered fundamental research and not subject to the EAR.
2E301 which is “use’ of controlled biological equipment. In order for technology to be considered use it must have all six elements of the definition of use: operating, installing, maintaining, repairing, overhauling, and refurbishing. This is not the normal activity of researchers. They are typically operating, maintaining and maybe repairing a controlled item such as a fermentor. The operation of a piece of equipment is not “use” technology as defined in the EAR.
General Technology Note
“The export of “technology” that is “required” for the “development,” “production,” or “use” of items on the Commerce Control List is controlled according to the provisions of each Category.
Definitions
Source: Bureau of Industry and Security