The specific classes of technology restricted under the EAR are described in the Commerce Control List (CCL) set forth at 22 CFR Part 774. The category most likely relevant to biotech businesses would be Category 1—Materials, Chemicals, Microorganisms, and Toxins. With respect to Genetic Transduction’s business, under this category, the regulations address materials constituting “Genetic elements and genetically modified organisms.”
However, the regulations only extend to information identified in this category that involves genetic sequences related to the pathogenicity or toxicity of an organism. If Genetic Transduction’s research might generate this type of information, its technology might well be considered sensitive. However, if confusion exists as to whether the EAR classifies materials or information as sensitive, the BIS will provide an advisory opinion.
If the relevant technology is covered by the regulations, access by most foreign nationals is restricted. This includes tourists, students, businesspeople, scholars, researchers, technical experts, sailors, airline personnel, salespeople, military personnel, and diplomats, among others.
Disclosure of the technology to any such person (even by giving a demonstration or oral briefing) constitutes the export of the technology to the country where the foreign national is a citizen or a permanent resident.
However, it is important to note that the hiring of foreign nationals is not prohibited nor regulated by the EAR. If an individual is properly documented for work in the U.S., a company may employ him or her. But where the technology is sensitive, its disclosure to restricted persons is only permitted if the company developing the technology has obtained an appropriate license from the BIS under its rules governing that individual’s home country.
To get such a license, the company would have to submit a letter of explanation, including basic personal information about the foreign national; a detailed job description; proposed employment; a description of the technology intended for release to the employee; the commodity to be produced with the controlled technology; and an explanation of how the company will benefit by employing the foreign national.
Even if a student is already conducting cutting-edge (and potentially sensitive) research at his or her academic institution, it should not be assumed that the institution’s existing license will cover the work that the student will be doing for the private company. A university may have a general license permitting properly documented foreign nationals enrolling in an academic program to engage in particular programs of “fundamental research”.
Under National Security Decision Directive 189 (NSDD 189), which was issued in 1985 and confirmed in 2006, fundamental research is defined as being “basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community.” In other words, if there are no conditions placed on the academic research, and it is the intent of the research team to publish its findings in scientific literature, then it is considered fundamental research, and the foreign student can participate under the university’s general license.
However, NSDD 189 distinguishes fundamental research from proprietary research on the basis that the publication of results of proprietary research ordinarily are restricted for commercial reasons. Therefore, if a contract between a commercial biotech company and an academic institution requires that the private corporation review the findings of the research team with the intent of controlling what results are to be released in open literature, then the research is considered proprietary, and either the university or the research sponsor may need to obtain an additional or different license.
It should be clear that companies involved in biological research should take care to comply with the regulations pertaining to deemed exports. The good news is that the Department of Commerce views its role as working in partnership with private industry.
In short, the Bureau does not perceive its job as denying licenses but rather as obtaining information about sensitive research and the ways in which companies may be making that research available to others.