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Deemed Exports and Licenses in Biological Research

Relevant to recent events regarding communication of dual use research of concern, technology controls may also apply to technical data transmitted in oral or written form.

Export control regulations are federal laws that restrict the passage of certain materials, de­vices and technical information outside of the United States or to foreign nationals within the United States. These regulations apply to research activities that are not considered “fundamen­tal” research, or that which “is defined to mean basic and ap­plied research in science and engineering where the resulting information is ordinarily pub­lished and shared broadly within the scientific community.” Bio­logical research, including the agents studied, the equipment used, and the technology applied may be regulated by export con­trols. Relevant to recent events regarding communication of dual use research of concern, tech­nology controls may also apply to technical data transmitted in oral or written form. Discussion of export-controlled technology at conferences or even in labo­ratory settings should be evalu­ated for possible requirements for export control.

Export controls also apply to the release of controlled technol­ogy to a foreign national inside the United States. The term for such a release of technology is “deemed export”. Any foreign na­tional 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”); or (2) is granted U.S. citizenship; or (3) is granted status as a “protected person” under 8 U.S.C. 1324b(a)(3). Much more information is avail­able on the Bureau of Industry and Security website.

Many people have questions on what triggers a requirement for a deemed export license for biological research. There are several factors and Export Con­trol Classification Numbers (EC­CNs) to consider. The ECCNs that cover pathogens of con­cern are 1C351, 1C352, 1C353, 1C354, and 1C360. These agents are Australia Group listed or are Select Agents. However, it is not the pathogen itself that is the subject of control for a deemed export license, but the technology association with that pathogen. If the pathogen were to be shipped from the US to the foreign national, that would be a regular export license. A deemed export license is for a foreign worker in the US. If technology is to be exported to a foreign country, that is considered a technology export – the differ­ence is where the technology is imparted.

ECCN 1E001 is technology for the development or production (definitions below) of controlled biological agents. The key ques­tion is if the foreign national is learning how to “grow” a con­trolled pathogen using tech­niques that are not in the public domain or are not fundamental research. There are also exclu­sions from licensure based on publications (please review 734.8 through 734.12 and the appendix to 734 of the Export Administra­tion Regulations (EAR)). Release of controlled 1E001 technology would necessitate a deemed ex­port license if the scientist was learning “development” or pro­duction” of a controlled organ­ism. When you look at the EAR definition of these terms, it would mean the researcher would be licensed for how to grow, main­tain, quality check, etc a pathogen. Most of this technology is in the public domain. If the researcher was working on a sensitive proj­ect where they were working on biodefense or some other type of research that would not be allowed to be published and in­volved a controlled listed patho­gen being grown in non-standard conditions (not in the scientific literature), then 1E001 might ap­ply. There is also 1E351 disposal technology but it doesn’t really apply because biological agents are destroyed through autoclave, chemicals, etc, in standard uni­versal techniques.

Another area of concern is 2E001 and 2E002 technology controls for development and production - these would only apply if the re­searcher was developing 2B352 controlled biological equipment (fermenters, cross flow filtra­tion equipment, class 3 glove boxes, for example). The third area to look at is 2B301 which is “use’ of biological equipment. (see below). All six parts of the components of use as defined in the EAR must be met. Of course the technology might be public domain depending on what type of item they were learning to use. If someone from a CB2 country on the CCL country list (supplement 1 to part 738) country comes to the United States to learn how to operate, install, maintain, repair, overhaul, and refurbish 2B352 equipment then they should get a deemed export license. This is not the normal activity of researchers. In conclusion, a deemed ex­port license is only required for a foreign national in the United States learning technology controlled by the Export Administration Regulations.

Definitions

Production: (General Technology Note) (All Categories)—Means all production stages, such as: product engineering, manufacture, integration, assembly (mounting), inspection, testing, quality assurance.

Development: (General Technology Note)—“Development” is related to all stages prior to se­rial production, such as: design, design research, de­sign analyses, design concepts, assembly and testing of prototypes, pilot production schemes, design data, process of transforming design data into a product, configuration design, integration design, layouts.

Use: (All categories and General Technology Note)—Operation, installation (including on-site installation), maintenance (checking), repair, over­haul and refurbishing.

More information is available here.

Kimberly Orr, DVM, PhD: Kimberly.Orr@bis.doc.gov