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BIS proposes designating automated peptide synethesizers as a section 1758 technology – Lexology


Sep 15, 2022

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On September 13, 2022, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published in the Federal Register (87 FR 55930) an Advance Notice of Proposed Rulemaking (ANPRM) and request for comments regarding certain instruments for the automated synthesis of peptides (automated peptide synthesizers). This proposed rule seeks to identify such automated peptide synthesizers as emerging and foundational technologies pursuant to section 1758 of the Export Control Reform Act of 2018 (ECRA) (“Section 1758 Technologies”).
Section 1758 Technologies
Under the proposed rule, BIS identified automated peptide synthesizers for evaluation as Section 1758 Technologies. Section 1758 of ECRA requires BIS to establish appropriate export, reexport, or transfer (in-country) controls on “emerging and foundational technologies” essential to national security.
Automated Peptide Synthesizers
BIS seeks to designate automated peptide synthesizers as a Section 1758 Technology because they pose an increased risk to the proliferation of biological weapons. Peptides and polypeptides are polymeric chains of amino acids, linked together by peptide bonds. Proteins are three-dimensional (3D) macromolecules composed of one or more folded large chains of polypeptides. Advances in peptide synthesis technology and instruments enable more efficient production of peptides and proteins with a length of more than 100 amino acids. Most protein toxins that are controlled under Export Control Classification Number (ECCN) 1C351 on the Commerce Control List (CCL) are over 100 amino acids in length and have an average length of 300 amino acids (with the exception of conotoxins, which range between 10-100 amino acids). The technology and instrumentation for certain peptide synthesis could be used to produce controlled toxins for biological weapons purposes.
Public Comment Period
Parties wishing to submit a comment may do so either through the Federal eRulemaking Portal at http://www.regulations.gov, or by submitting an email to [email protected]. The docket number for this proposed rule is BIS-2022-0023 or RIN 0694-AI84. Comments are due no later than October 28, 2022.
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