Tuesday, September 13, 2022

Review – BIS Publishes Peptide Synthesis Equipment ANPRM

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.

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.


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.

For more details about what information BIS is looking for in this ANPRM, see my article at CFSN Detailed Analysis - https://patrickcoyle.substack.com/p/bis-publishes-peptide-synthesis-equipment - subscription required.

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