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The Bureau of Industry and Security (BIS) has identified instruments for the automated synthesis of peptides (automated peptide synthesizers) for evaluation according to the criteria in section 1758 of the Export Control Reform Act of 2018 (ECRA) pertaining to emerging and foundational technologies. On September 13, 2022, BIS published an advance notice of proposed rulemaking (87 FR 55930) that requested public comments on 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). Taking into consideration the public comments on BIS's September 2022 ANPRM, this rule proposes to implement export controls on certain automated peptide synthesizers, consistent with the criteria in section 1758 of ECRA.

Statement of Need:

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.   Most protein toxins that are controlled under Export Control Classification Number (ECCN) 1C351 on the Commerce Control List (CCL) (see Supplement No. 1 to part 774 of the EAR) are over 100 amino acids in length and have an average length of 300 amino acids (with the notable exception of conotoxins, which range between 10-100 amino acids in length).  Consequently, absent the imposition of additional controls on the export, reexport or transfer (in-country) of certain peptide synthesis technology and instrumentation (e.g., automated peptide synthesizers), there would be an increased risk that such technology and instrumentation could be used to produce controlled toxins for biological weapons purposes.

Summary of the Legal Basis:

Certain instruments for the automated synthesis of peptides (automated peptide synthesizers) have been identified by BIS for evaluation according to the criteria in Section 1758 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852) pertaining to emerging and foundational technologies.

Alternatives:

Consistent with 5 U.S.C. § 603(c), BIS is considering significant alternatives to the imposition of controls on automated peptide synthesizers and will assess whether the alternatives would:  (1) accomplish the stated objectives of this rule (consistent with the Section 1758 requirements in ECRA); and (2) minimize any significant economic impact of this rule on U.S. industry and academia.  BIS could impose broad controls on automated peptide synthesizers that would capture most of these instruments.  However, that option would have a greater impact not only on small businesses, but also on research and development laboratories (both academic and corporate), which are involved in advancing biological technology.  BIS is considering focused controls on automated peptide synthesizers that are determined to be capable of posing a greater risk of diversion to biological weapons activities. BIS considers that this approach would be the least disruptive alternative for implementing export controls in a manner consistent with controlling technology that has been determined, through the Section 1758 technology interagency process authorized under ECRA, to be essential to U.S. national security.

Anticipated Costs and Benefits:

BIS estimates that it will receive roughly 15 license applications per year if Section 1758 export controls are imposed on automated peptide synthesizers.  To the extent that compliance with these controls would impose a burden on U.S. industry and academia, BIS believes the burden would be minimal.  In addition, the reclassification process would need to be done only once per license applicant for exports, reexports or transfers (in-country) of these items and, consequently, would constitute a one-time burden for each applicant.  Similarly, assessing the availability of license exceptions and/or applying for and using BIS licenses would impose some minimal burden on affected persons.  The benefit, from a national security perspective, would be the imposition of export controls on those automated peptide synthesizers that are determined to be capable of posing a greater risk of diversion to biological weapons activities.

Risks:

The imposition of overly broad (or otherwise improperly targeted) Section 1758 export controls on peptides or peptide synthesizers could impair the ability of companies in the United States to compete effectively with potential competitors in other countries, which could adversely affect the leadership of U.S. companies in the field of peptide manufacturing.  On the other hand, failure to impose controls that effectively target those automated peptide synthesizers that could be of concern for biological weapons purposes, could increase the potential threat of terrorist attacks involving toxins produced by such synthesizers.