BIS Floats New Potential Export Controls Over Automated Peptide Synthesizers

The Bureau of Industry and Security is seeking public comments on potential export controls over certain instruments for the automated synthesis of peptides, the agency said in an advance notice of proposed rulemaking this week. The agency, which has been drafting the ANPRM since at least June (see 2206270007 and 2208290019), said automated peptide synthesizers may warrant export restrictions as foundational or emerging technologies because of their potential impact on American national security. Comments are due Oct. 28.

BIS said it’s specifically seeking feedback on the potential uses of the synthesizers, including whether they could provide the U.S. or any of its adversaries with a “qualitative military or intelligence advantage.” Although the agency said it controls some “protein toxins” on the Commerce Control List, more restrictions may be needed to better prevent certain technology and instrumentation from being used to “produce controlled toxins for biological weapons purposes.”

Commenters should describe to BIS the “current state of development of automated peptide synthesizers” in the U.S., including those with primarily academic or commercial uses, and how that compares with other countries. BIS said it wants to know whether the U.S. is at “the forefront” of the development of the synthesizers.

The agency is also requesting information on the “current availability and predominate application(s) of automated peptide synthesizers in the United States” and how that compares with other countries; the availability of custom peptide synthesis services in the U.S. and other countries; and to “what extent are current or near-term developments in peptide synthesis technology expected to address the challenges of peptide length, sequence fidelity, and protein folding.”

BIS also wants to know how export controls would affect synthesizer instruments, and how the controls would differ if they were imposed primarily on either “software” or “hardware.” The agency also asked whether it should pursue the controls multilaterally or unilaterally, stressing that the Export Control Reform Act expresses a preference for multilateral restrictions.