Background

The Bureau of Industry and Security is seeking public comments by Oct. 28 on (1) the potential uses of certain instruments for the automated synthesis of peptides, particularly with respect to any impact on U.S. national security (e.g., whether such technology could provide the U.S. or any of its adversaries with a qualitative military or intelligence advantage), and (2) how to ensure that the scope of any export controls that may be imposed on this technology would be effective (in terms of protecting U.S. national security interests) and appropriate (with respect to minimizing their potential impact on legitimate commercial or scientific applications).

Under the Export Control Reform Act BIS must establish appropriate controls on the export, reexport, or transfer (in-country) of technology identified pursuant to Section 1758 of that law (formerly referred to as emerging and foundational technologies). While BIS has discretion to set the level of export controls, at a minimum a license must be required for the export of such technologies to countries subject to a U.S. embargo.

Peptides and polypeptides are polymeric chains of amino acids linked together by peptide bonds, and proteins are three-dimensional macromolecules composed of one or more folded large chains of polypeptides. According to BIS, most protein toxins controlled under ECCN 1C351 on the Commerce Control List are over 100 amino acids in length and have an average length of 300 amino acids. Consequently, BIS states, absent the imposition of additional controls on the export, reexport, or transfer (in-country) of certain peptide synthesis technology and instrumentation (e.g., automated peptide synthesizers), there would be an increased risk that such technology and instrumentation could be used to produce controlled toxins for biological weapons purposes.

Among the issues on which BIS is seeking input are the extent to which the establishment of Section 1758 technology export controls on automated peptide synthesizer instruments and related software and technology would (1) impact U.S. technological leadership in this field and whether this impact would be distinctly different if controls were placed primarily on software as opposed to hardware or vice versa and (2) be effective in terms of limiting the proliferation of these items abroad (including their potential use to produce controlled toxins for biological weapons purposes). BIS is also interested in whether such export controls should be implemented multilaterally rather than unilaterally in the interest of increasing their effectiveness and minimizing their impact on U.S. industry.

For more information U.S. export controls and how to ensure your company is in compliance, please contact attorney Kristine Pirnia at (202) 730-4964 or via email.

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