OMB Approves BIS Peptide Synthesis NPRM

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a notice of proposed rulemaking from the Bureau of Industry and Security on “Section 1758 Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides”. The NPRM was sent to OIRA for review on March 29^th, 2023. With the advanced notice of proposed rulemaking (ANPRM) for this action being published on September 13^th, 2022, the Biden Administration is certainly expediting this rulemaking.

There is an interesting discussion of the trade-offs involved in pursuing this rulemaking in the listing for the action in the Fall 2022 Unified Agenda:

“The imposition of overly broad (or otherwise improperly targeted) Section 1758 export controls on peptides or peptide synthesizers could impair the ability of companies in the United States to compete effectively with potential competitors in other countries, which could adversely affect the leadership of U.S. companies in the field of peptide manufacturing.  On the other hand, failure to impose controls that effectively target those automated peptide synthesizers that could be of concern for biological weapons purposes, could increase the potential threat of terrorist attacks involving toxins produced by such synthesizers.”

I expect that we will see the publication of the NPRM in the Federal Register sometime next week.