The Commerce Department’s Bureau of Industry and Security (BIS) has issued an Advance notice of proposed rulemaking (ANPRM) regarding potential new federal regulations concerning automated peptide synthesizers and has requested comments to the ANPRM by October 28, 2022. Mason is considering providing comments to the government (itself, or anonymously via a trade association) that could affect how and when the federal government places export control restrictions on these synthesizers and related technology. We are contacting you, because we think you may be interested in helping Mason frame such comments and questions. The government has asked for information about the effects potential export regulation in this area would affect academic research and teaching. This is a great opportunity to educate federal regulators about Mason’s research using this technology and to help them understand how additional export controls might impact this research or our ability to collaborate with colleagues around the world.
If your teaching or research involves synthesizing peptides and proteins greater than 100 amino acids in length, and you use machinery at Mason to produce such products, please consider contacting us to discuss how the proposed rule might affect your work (email@example.com).
BIS has identified certain instruments for the automated synthesis of peptides (automated peptide synthesizers) for evaluation as “emerging and foundational technologies” under the Export Control Reform Act of 2018 (ECRA). The ECRA directs the Secretary of Commerce to establish appropriate export controls on the export of emerging and foundational technologies identified by the Secretary.
BIS is concerned that recent advances in peptide synthesis technology and instrumentation have increased both the speed of peptide synthesis and the length of peptide products, including peptides and proteins greater than 100 amino acids in length. It appears that the proposed export restrictions would be applied to such technology and instrumentation. BIS believes that, absent the imposition of additional controls on the export of such peptide synthesis technology and instrumentation that can create such peptides and proteins, there would be an increased risk that such technology and instrumentation could be used to produce controlled toxins for biological weapons purposes.
Government Request for Comments
BIS is seeking public comments regarding:
- The potential uses of this technology, particularly with respect to its impact on U.S. national security (e.g., whether such technology could provide the United States, or any of its adversaries, with a qualitative military or intelligence advantage).
- How to ensure that the scope of any export controls that may be imposed on this technology would be effective (in terms of protecting U.S. national security interests) and appropriate (with respect to minimizing their potential impact on legitimate commercial or scientific applications).
BIS also welcomes comments on any of the following questions:
(1) 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 (e.g., is the United States at the forefront of such development in the academic and commercial fields)? Where possible, please identify any publicly available studies that support your position.
(2) 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 (e.g., how common is the use of these instruments in life sciences laboratories/institutions and other academic or commercial settings)?
(3) To what extent are custom peptide synthesis services available in the United States and other countries, and would the availability of such services (particularly for academic or commercial applications) be likely to impact domestic or foreign demand for automated peptide synthesizers?
(4) 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 (e.g., are efforts currently underway to integrate protein folding into the automation process)?
(5) To what extent would the establishment of Section 1758 technology export controls on automated peptide synthesizer instruments, and related “software” and “technology,” impact U.S. technological leadership in this field (e.g., within the academic or commercial spheres) and would this impact be distinctly different if controls were placed primarily on “software” as opposed to hardware, or vice versa?
(6) To what extent would the imposition of Section 1758 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 (including the potential use of such items to produce controlled toxins for biological weapons purposes)?
(7) 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?
(8) To what extent should Section 1758 technology export controls on peptide synthesizer technology be implemented multilaterally (rather than unilaterally), in the interest of increasing their effectiveness and minimizing their impact on U.S. industry?
For more information about the request for comments, please see:
To discuss your comments or concerns about the proposed rule, please contact Melissa Perez or Becky Hartley at firstname.lastname@example.org.