The Bureau of Industry and Security (BIS) is soliciting further comment on control measures for automated peptide synthesizers. Peptides and polypeptides are chains of amino acids, and proteins are composed of one or more large chains of polypeptides.
The proposed rule intends to control emerging and foundational technologies identified as essential to U.S. national security. The rule would apply to all persons engaged in the export, reexport, or transfer of automated peptide synthesizers and related technology. The proposal would primarily impact research and development activities in the biotechnology field. These items will retain reasons for control relating to the proliferation of chemical and biological weapons and anti-terrorism.
On September 13, 2022, BIS published an Advance Notice of Proposed Rulemaking (ANPRM) on the imposition of Section 1758 Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides.
BIS received five comments in response to the ANPRM, as follows:
The proposed regulatory changes will add a new item paragraph (.k) with three subparagraphs (.k.1, .k.2, and .k.3) to ECCN 2B352. This paragraph will control peptide synthesizers that are partly or entirely automated, capable of generating continuous peptide sequences greater than 75 amino acids, and capable of producing 100 mg of peptide at 75% or greater purity in a single run.
BIS estimates that it will receive 40 license applications per year for the items described in this proposed rule. The proposed rule includes provisions for reporting, recordkeeping, and compliance requirements.
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