Bio Research Export Rule Advances

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:

1. One commenter argued that automated peptide synthesis is not viable for producing toxins, except for conotoxins. BIS agreed that the current instrumentation is limited, but believes it can still produce enough peptide toxin to cause mortality and morbidity within a population.
2. Another commenter stated that controlled toxins can be produced manually and suggested export controls for reagents and consumables. BIS acknowledged the comments and will investigate potential export controls for peptide synthesis consumables.
3. One commenter emphasized the benefits of new technological developments in peptide synthesizers for drug candidate research. BIS agreed with the usefulness of these technologies, but noted that they could also be used for dangerous purposes, such as in weapons programs.
4. Several commenters suggested that BIS should not unilaterally control these technologies, as it could impact U.S. technology leadership in the field. BIS will work with international partners to provide multilateral controls but may take unilateral action if necessary.
5. A commenter noted that most large-scale peptide production occurs manually. While BIS acknowledged this, they still intend to propose regulatory text for automated peptide synthesizers.

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.