Thursday, March 30, 2023

BIS Sends Protein Synthesizer NPRM to OMB

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a notice of proposed rulemaking from the DOC’s Bureau of Industry and Security (BIS) for “Section 1758 Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides”. The advanced notice of proposed rulemaking (ANPRM) for this action was published on September 13th, 2022.

The Fall 2022 Unified Agenda entry for this rulemaking notes:

“The Bureau of Industry and Security (BIS) has identified instruments for the automated synthesis of peptides (automated peptide synthesizers) for evaluation according to the criteria in section 1758 of the Export Control Reform Act of 2018 (ECRA) pertaining to emerging and foundational technologies. On September 13, 2022, BIS published an advance notice of proposed rulemaking (87 FR 55930) that requested public comments on the potential uses of this technology, particularly with respect to its impact on U.S. national security (e.g., whether such technology could provide the United States, or any of its adversaries, with a qualitative military or intelligence advantage). Taking into consideration the public comments on BIS's September 2022 ANPRM, this rule proposes to implement export controls on certain automated peptide synthesizers, consistent with the criteria in section 1758 of ECRA”

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