BIS Adopts New Chem-Bio Controls, Finalizes Automated Peptide Synthesizers Rule
The Bureau of Industry and Security is placing new export controls on certain toxins, chemicals and other items that can be used to make bioweapons as part of a final rule to align its restrictions with allies'.
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The rule, effective Dec. 23, implements decisions made during the 2023 and 2024 meetings of the Australia Group, a multilateral export control forum that looks to control chemicals, equipment and technology used in chemical or biological weapons. The rule includes new controls on automated peptide synthesizers, dipropylamine and neosaxitoxin, and it revises restrictions for botulinum toxins, toxic gas monitors and centrifugal separators, among other changes.
The new controls on certain automated peptide synthesizers come after BIS proposed controlling them in April 2023 (see 2304190060) and after several U.S. companies told BIS, in response to a prerule the year before, that they feared the new restrictions would only hurt U.S. technological leadership and wouldn't do much to limit the proliferation of biological weapons (see 2211080020).
BIS said this new rule “finalizes those proposed changes” and “includes additional changes outside of the scope of the” 2023 proposed rule. It adds automated peptide synthesizers under two new “.k.1” and “.k.2” subparagraphs within Export Control Classification Number 2B352, which will place license requirements on synthesizers that are “partly or entirely automated (.k.1) and capable of generating peptides at a ‘system synthesis scale’ of 1 mmol or greater (.k.2).” The paragraph also includes a new definition for “system synthesis scale.”
Australia Group members decided to move forward with these restrictions during their 2024 meetings because “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,” BIS said. Without new controls, “there would be an increased risk that such technology and instrumentation could be used to produce controlled toxins for biological weapons purposes.”
The final rule also makes several export control changes agreed to during the Australia Group’s 2023 meetings, including a new license requirement for dipropylamine, a compound used in the “synthesis” of certain export controlled chemical weapons precursors. BIS is adding dipropylamine to ECCN 1C350.
BIS also added new controls for neosaxitoxin, a “potent neurotoxin” that can also be used in biological weapons, by revising language in ECCN 1C351. It also removed language in ECCN 1C351 describing “botulinum toxins” and replaced that with “botulinum neurotoxins,” which BIS said highlights the “greater risk of their use in chemical and biological weapons activities relative to other botulinum toxins.”
The agency also said it added control language to restrict exports of “single-use centrifugal separators” as opposed to just “centrifugal separators.” BIS said single-use centrifugal separators are “new to market and are increasingly used in the biopharmaceutical industry,” and they have a “potential for abuse comparable to that of the” centrifugal separators that BIS already controls. The changes make revisions to ECCN 2B352.c.
Australia Group members also agreed to a more “uniform way” of applying export restrictions for toxic gas monitors and monitoring systems after determining that AG members weren’t assessing those gas detection systems “with the same criteria.” BIS said “this made it unclear if a gas detection system with a noise level near 0.3 mg/m3 was controlled, without taking into account the instrument detection limit." Members eventually agreed to a new term called “minimum detection limit,” along with a definition for that limit.
Those changes make revisions to ECCN 2B351, including by defining “minimum detection limit” as the “lowest detectable concentration of the analyte required to produce a signal greater than three times the standard deviation of the toxic gas monitor’s or monitoring system’s signal when measuring a blank sample.” And if a toxic gas monitor or monitoring system has a “deadband or programmed zero suppression, the ‘minimum detection limit’ is the lowest detectable concentration required to produce a reading,” BIS said.