The Bureau of Industry and Security is proposing to impose export controls on instruments for the automated synthesis of peptides, which have been identified as a Section 1758 emerging and foundational technology. Comments on this proposal are due by May 22.
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 automated peptide synthesizers, there would be an increased risk that such technology could be used to quickly produce controlled toxins for biological weapons purposes.
BIS notes that there has been some concern that the proposed export controls could have a dramatic impact on the leadership of U.S. technology in this field because customers would simply obtain the technology from Europe, where it is unrestricted. However, BIS said only that it will work with international partners to provide multilateral controls for these technologies.
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.
Copyright © 2025 Sandler, Travis & Rosenberg, P.A.; WorldTrade Interactive, Inc. All rights reserved.