Most life science research which is published and considered fundamental research is not subject to export license requirements in the Export Administration Regulations (EAR), administered by the Bureau of Industry and Security (BIS) of the Department of Commerce (DOC), or to export license requirements in the International Traffic in Arms Regulations (ITAR), administered by the Directorate of Defense Trade Controls (DDTC) of the Department of State. However, recent events in collaborative research on H5N1 avian influenza have emphasized the importance of evaluating possible unintended results in research.
Before research begins, a careful review of the risk that the research could veer in a direction away from fundamental and fully published research and into unpublished and/or controlled technology should be done by involved parties. A possible situation that needs to be reviewed is the presence of laboratory personnel who are foreign nationals. If foreign nationals are working on controlled technology that has been released to them in the United States, this creates a requirement for a “deemed export “ license. If the same controlled technology is exported to a foreign country, it is considered a technology export. Any foreign national being provided controlled technology is subject to the deemed export rule except a foreign national who (1) is granted permanent residence, as demonstrated by the issuance of a permanent resident visa (i.e., “Green Card”); (2) is granted U.S. citizenship; or (3) is granted status as a “protected person” under 8 U.S.C. 1324(b)(a)(3). Criminal penalties for export regulation violations can reach $1,000,000 and 20 years imprisonment per violation and the administrative penalties can reach the greater of $250,000 per violation or twice the amount of the transaction that is the basis of the violation. Cases of deemed export violations resulting in penalties can be found on the BIS website.
The types of non-published technology subject to controls under the EAR are development, production and manipulation of a Commerce Control List (CCL) pathogen, which includes all Select Agents plus other pathogens as well as the development, production or use of certain biological production equipment technology.
The mere fact that a foreign national works in a lab with a controlled pathogen does not, in itself, generate the need for a deemed export license. The need for a deemed export license is triggered if the foreign national doing research in the US will be transferred controlled technology (i.e. technology which will not be published, when research is non-fundamental, or under terms from sponsors).
To stay in compliance: evaluate research projects to ensure foreign nationals are not being transferred controlled technology; evaluate the risk potential of research data release; monitor visa statuses of foreign national researchers; and as projects change or workers are reassigned, reevaluate the technology to be transferred.