Applying Export Controls in a Practical Fashion to Biomedical Research

Abstract

Much confusion surrounds the practical application of Department of Commerce (DoC) export control regulations in biomedical research. Institutions must consider how to properly export potential dual-use commodities, be aware of instances when foreign nationals might require a validated deemed export license, and decide whether scientific activities qualify as fundamental research. The complexity of the Export Administration Regulations (EAR) can make careful adherence a difficult challenge. The purpose of this article is to provide succinct guidance on how to successfully navigate the EAR with respect to biomedical research involving etiologic agents, foreign nationals, specialized equipment, and high- or maximum-containment laboratories. Although export compliance is always required, it is usually non-applicable to most of the aforementioned biomedical research endeavors.

References

Bureau of Industry and Security (BIS). (2010). Questions and Answers to Supplement Clarification of Deemed Export Related Regulatory Requirements. Available at: www.bis.doc.gov/deemedexports/deemedexportssupplementqa.html. Accessed online 2010.

Department of Commerce (DoC). (2009). Part 734—Scope of the Export Administration Regulations. Available at: www.access.gpo.gov/nara/cfr/waisidx_09/15cfr734_09.html. Accessed online 2010.

Department of Commerce (DoC). (2009). Part 772—Definitions of terms. Available at: www.access.gpo.gov/nara/cfr/waisidx_09/15cfr772_09.html. Accessed online 2010.

Department of Commerce (DoC). (2009). Part 774—Supplement No. 2 to Part 774—General Technology and Software Notes. Available at www.access.gpo.gov/nara/cfr/waisidx_09/15cfr774_09.html. Accessed online 2010.

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& Lee

(2009). Demystifying Department of Commerce export controls for the biosafety professional. Applied Biosafety: Journal of the American Biological Safety Association, 14(2), 70–71.