BIS Publishes Peptide Synthesis Equipment ANPRM

Sep 13, 2022

Today the DOC’s Bureau of Industry and Commerce (BIC) published an advanced notice of proposed rulemaking (ANPRM) in the Federal Register (87 FR 55930-55932) on “Imposition of Section 1758 Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides”. BIS is soliciting public comments on the potential uses of this technology, particularly with respect to its impact on U.S. national security.

Background

BIS is tasked, under 50 USC 4817, with identifying emerging and foundational technologies that are essential to the national security of the United States. BIS has identified automated peptide synthesizers (APS) as potentially falling into that category. DOC already regulates a number of protein toxins on the Commerce Control List under Export Control Classification Number (ECCN) 1C351(d) [pgs 65-70]. BIS is concerned that the APS equipment makes it easier to produce these and other such toxins in sufficient quantities to pose a potential threat to national security.

Information Requested

In this ANPRM BIS is looking for information to determine if the application of export control regulations should be made with respect to automated peptide synthesizers. It is specifically looking for discussions about the following questions:

What is the current state of development of automated peptide synthesizers in the United States, including those having primarily academic or commercial applications, and how does this compare with that of other countries?
What is the current availability and predominate application(s) of automated peptide synthesizers in the United States and how does this compare with that of other countries?
To what extent are custom peptide synthesis services available in the United States and other countries?
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?
To what extent would the establishment of technology export controls on automated peptide synthesizer instruments, and related “software” and “technology,” impact U.S. technological leadership in this field?
To what extent would the imposition of technology export controls on automated peptide synthesizer instruments, and related “software” and “technology,” likely be effective in terms of limiting the proliferation of these items abroad?
To what extent has the increased availability of lower cost coupling reagents, together with recent advances in automated peptide synthesizers and related technology, overcome economic or technological factors that previously might have limited the availability and use of this technology, abroad?
To what extent should technology export controls on peptide synthesizer technology be implemented multilaterally (rather than unilaterally)?

Public Comments

BIS is soliciting public comments on this ANPRM. Comments may be submitted via the Federal eRulemaking Portal (www.Regulations.gov; 220826-0174). Comments should be submitted by October 28th, 2022.

Commentary

I have a little bit of an editorial difference with BIS in regards to labeling the peptide toxins listed in (ECCN) 1C351(d) as potential biological weapons. Most people think of infectious agents as potential biological weapons since they provide for the spread of disease. Bio-toxins require direct contact of some sort with the toxin for their affect. The toxins in 1C351(d) are considered to be ‘bio-toxins’ because they are produced and isolated from active living organisms.

The advent of commercial scale automated protein synthesis equipment takes these toxins out of the ‘bio-toxin’ category and into the chemical weapon category. This takes these toxins into a completely new area of concern and should be acknowledged as such.