BIS Proposes New Export Controls on Automated Peptide Synthesizers

The Bureau of Industry and Security this week proposed new export controls on automated peptide synthesizers that may be used to produce biological weapons (see 2304170010). Although several U.S. companies and a Chinese academy last year warned BIS against imposing new license requirements, the agency said the synthesizers qualify as emerging or foundational technologies and may need to be restricted.

The agency proposed amending Export Control Classification Number 2B352 to add new language that would control 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. The items would be controlled for chemical and biological weapons (CB) reasons and anti-terrorism (AT) reasons. BIS is accepting public comments on the proposed controls through May 22.

BIS sought feedback last year as it prepared to craft the proposed restrictions, saying the synthesizers could provide the U.S. or its adversaries with a “qualitative military or intelligence advantage” (see 2209120021). Several American firms told the agency that restrictions would only hurt U.S. technological leadership and wouldn't do much to limit the proliferation of biological weapons, with one Chinese national academy saying new license requirements could stifle global research and innovation (see 2211080020).

In the proposed rule released April 19, BIS acknowledged commenter concerns that unilateral controls “could have a dramatic impact on the leadership of U.S. technology in the field.” The agency said it will try to control the synthesizers multilaterally but noted that it “can take unilateral action regarding these technologies going forward, as necessary.”

BIS also addressed a comment that said automated peptide synthesis “is not viable, with the minor exception of conotoxins.” The commenter also said the synthesis of those conotoxins “would not be possible at quantities necessary to cause a significant environmental or terroristic threat.” Although the agency agreed that “automated peptide synthesizers are currently limited to the production of shorter peptide toxins,” including conotoxins already listed on the Commerce Control List, it disagreed that the synthesizers couldn’t be used to cause a big enough of a threat.

“BIS believes that the current instrumentation can produce enough peptide toxin to cause mortality and morbidity within a given population,” the agency said.

Another commenter told BIS that “new technological developments” for peptide synthesizers help make “many different types of peptides faster, more efficiently, and at lower cost,” adding that this is “useful for research for screening many different peptides for drug candidates.” BIS said it “concurs with the usefulness of multiplexed automated peptide synthesizers for potential therapeutic development,” but “notes that these features can also be useful for other, more dangerous purposes, such as in a weapons program.”

Other commenters said the “majority of large-scale production of peptides occurs manually” and are not automated. “While this may be true, and worth looking at for further possible regulatory response, BIS is not inclined to halt the proposal of regulatory text for automated peptide synthesizers,” the agency said. “However, BIS notes that this and other related information is relevant to fully understanding the automated peptide synthesizer market and appreciates the information.”