United States: BIS Proposes Automated Peptide Synthesizers For Section 1758 Critical Technology Controls

On September 13, 2022, the U.S. Department of Commerce's Bureau of Industry and Security ("BIS") published an advance notice of proposed rulemaking ("ANPRM") to impose export controls on automated peptide synthesizers and associated software and technology under Section 1758 of the Export Control Reform Act. BIS noted in the ANPRM that Export Control Classification Number ("ECCN") 1C351 currently contains mostly advanced peptides and proteins that could be used as toxins for biological weapons purposes, but there is no appropriate control on the automated synthesizers or associated software and technology capable of producing those toxins.

If implemented, companies producing such hardware, software, or technology in the U.S. or outside the U.S. under more limited circumstances would need to comply with the Export Administration Regulations ("EAR") with respect to the automated peptide synthesizers. At a minimum, the export controls imposed under Section 1758 would require a license for export, reexport, or transfer to or within countries subject to a comprehensive U.S. embargo, including the wider group of countries subject to the U.S. arms embargoes. Additionally, designation of the automated peptide synthesizers and related software and technology under Section 1758 will result in any U.S. company that produces, designs, tests, manufactures, fabricates, or develops these items or associated software or technology fitting the definition of a "TID U.S. business" for Committee on Foreign Investment in the United States ("CFIUS") purposes.

The ANPRM requests comments on eight (8) subjects by October 28, 2022. Please contact the authors or your Winston relationship partner if you have questions, would like assistance submitting a comment, or wish to be added to our mailing list. Winston's international trade lawyers located in offices around the world have expertise in export controls, sanctions, import requirements, anti-corruption and anti-bribery laws, anti-money laundering laws, and Committee on Foreign Investment in the United States national security reviews.

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