What triggers a requirement for a deemed export license in the Export Administration Regulations (EAR) for biological research:
Any release of technology or source code subject to the EAR to a foreign national (Part 734.2(b)(2)(ii). (This does not apply to permanent residents or protected individuals.)
All technology in the United States is subject to the EAR except for the following:
Technology under the jurisdiction of another agency, printed books, publicly available technology, technology that has been or will be published, technology that arises during or results from fundamental research, educational technology, and technology in certain patent applications (Part 734.3)
Research in the United States would be subject to the EAR unless it met one of the exclusions noted above. Much of the research in University laboratories is not subject to the EAR if it is fundamental research.
Fundamental research means research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons.
- Example: University based research on vectors for salmonella typhi which is published broadly
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. Proprietary research, industrial development, design, production, and product utilization the results of which are restricted and government funded research that specifically restricts the outcome for national security reasons are not considered fundamental research.
- 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.
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 which can be found at www.bis.doc.gov.
If you are working with controlled pathogens or equipment, then the technology (information) being shared with the foreign national needs to be determined. There are 5 main technology regarding ECCNs that need to be reviewed for biological research that is subject to controls:
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
Let's go through each type of technology and give examples:
1E001: "development" or "production" technology – If most of the technology (information) 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. (Physical exports of items however, may require a license.) 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 publically 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 (information) 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 (Supplement Number 2 to Part 774)
"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.