Implementation of Certain Australia Group Decisions

<RULE> DEPARTMENT OF COMMERCE <SUBAGY>Bureau of Industry and Security</SUBAGY> <CFR>15 CFR Parts 742 and 774</CFR> <DEPDOC>[Docket No. 241212-0324]</DEPDOC> <RIN>RIN 0694-AJ83</RIN> <SUBJECT>Implementation of Certain Australia Group Decisions</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Bureau of Industry and Security, Department of Commerce. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to implement changes agreed to by Australia Group (AG) member countries at recent meetings. These include controlling: instruments for the automated chemical synthesis of peptides (automated peptide synthesizers), dipropylamine, and neosaxitoxin; and revising the controls for botulinum toxins, toxic gas monitors, and centrifugal separators. This rule also makes minor conforming changes for the new controls and revisions to existing controls. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective December 23, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For questions on pathogens and toxins discussed in this rule, contact Dr. Lauren Reynolds, Chemical and Biological Controls Division, Office of Nonproliferation and Foreign Policy Controls, Bureau of Industry and Security, Telephone: (202) 482-2794, Email: <E T="03">Lauren.Reynolds@bis.doc.gov.</E> For all other questions pertaining to this rule, contact Logan Norton, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security, U.S. Department of Commerce, (202) 482-1762, Email: <E T="03">RPD2@bis.doc.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">The Australia Group</HD> BIS is amending the Export Administration Regulations (EAR) (15 CFR parts 730-774) to reflect the decisions made at the 2023 Intersessional Meeting in Rome, Italy, the 2023 Plenary Meeting in Paris, France, the 2024 Intersessional Meeting in Berlin, Germany and the 2024 Plenary Meeting in Paris, France. The Australia Group (AG) is a multilateral forum consisting of 42 participating countries and the European Union. These participants maintain export controls on a list of chemicals, biological agents, and related equipment and technology that could be used in a chemical or biological weapons program. The AG periodically reviews items on its control list to enhance the effectiveness of participating governments' national controls and to achieve greater harmonization among these controls. <HD SOURCE="HD1">Regulatory Changes</HD> As stated above, this rule implements changes agreed upon at the 2023 and 2024 Intersessional and Plenary Meetings of the AG. The changes made at each meeting are described below in chronological order. <HD SOURCE="HD2">2023 Intersessional</HD> The AG meeting of the 2023 Intersessional determined that not all AG members assess gas detection systems with the same criteria. Prior to this rule, the control text only referred to the ability to detect chemical warfare agents or AG controlled precursors at a concentration of less than 0.3 mg/m <SU>3</SU> . This made it unclear if a gas detection system with a noise level near 0.3 mg/m <SU>3</SU> was controlled, without taking into account the instrument detection limit. As a result, the AG agreed to a uniform way of applying the control language on toxic gas monitors and monitoring systems. To clarify the text, the AG agreed to the new term called `minimum detection limit' and a corresponding definition, both detailed below, to the control text. The AG agreed to two changes to ECCN 2B351. First, in item paragraph .a, “at concentrations of less than” is replaced with “`minimum detection limit' of”, which is still followed by the 0.3 mg/m <SU>3</SU> concentration measurement. Second, it adds a technical note 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; alternatively, in the case of toxic gas monitors or monitoring systems having a deadband or programmed zero suppression, the `minimum detection limit' is the lowest detectable concentration required to produce a reading. <HD SOURCE="HD2">2023 Plenary</HD> In the 2023 Plenary Meeting, the AG reached consensus on three primary revisions, mostly impacting ECCNs 1C350.d and 1C351.d. ECCN 1C350.d had multiple changes. In February 2020 the AG added a number of precursors to the chemical weapons precursors control list. However, dipropylamine, which is also useful for the synthesis of the corresponding AG-controlled precursors, was not yet controlled. The AG determined that it was important to address this issue by controlling dipropylamine. Under ECCN 1C350, (C.A.S. #142-84-7) Dipropylamine was added as .d.11. The items that had been listed in item paragraphs .d.11 through .d.49 remain, with their item paragraphs shifting up by a factor of one. Botulinum toxins can be neurotoxins or non-neurotoxins. Previously, the AG had not specifically stated if only botulinum neurotoxins should be captured by ECCN 1C351.d.3 or if all botulinum toxins are included. The AG agreed to update the language to “botulinum neurotoxins” noting the greater risk of their use in chemical and biological weapons activities relative to other botulinum toxins. Under ECCN 1C351, item paragraph .d.3 was revised to read as “botulinum neurotoxins” as opposed to previously reading “botulinum toxins.” Conforming changes were made in ECCN 1C991.c.1, .c.2, .d.1, and .d.3. Neosaxitoxin is a potent neurotoxin causing similar symptoms to saxitoxin and gonyautoxins, both of which were controlled at the 2022 Plenary Meeting, in humans and animals. The AG found that the high toxicity of neosaxitoxin has been demonstrated in scientific models, as well as its resistance to heat; these factors make this toxin a potential threat as it could be used as a biological weapon like saxitoxin. Therefore, the AG agreed to control neosaxitoxin under the “List of Human and Animal Pathogens and Toxins for Export Control.” BIS details the toxins on this list under ECCN 1C351.d. To facilitate this addition, item paragraph .d.12 was redesignated to control neosaxitoxin (NEO), which shifted what had been in item paragraphs .d.12 through .d.21 up by a factor of one. Given this new control, license requirement note 2 to ECCN 1C351, which discussed neosaxitoxin, is removed, shifting notes 3 through 5 down by a factor of one. Additionally, multiple references to the item paragraphs for ricin and saxitoxin (now item paragraphs .d.15 and .d.16, respectively), had to be updated; these conforming changes occurred in: § 742.2(a)(1)(i), (a)(2)(ii), and (a)(2)(vi)(B); § 742.18(a)(1), (b)(1)(i), (b)(1)(ii), and (b)(1)(iii); ECCNs 1C351, 1C353, 1C991, 1E001, and 1E351. <HD SOURCE="HD2">2024 Intersessional</HD> Prior to the publication of this rule, centrifugal separators were already controlled under ECCN 2B352.c. Since these controls were put into place, the technology and characteristics of newly available single-use centrifugal separators shows a potential for abuse comparable to that of the listed centrifugal separators. Single-use centrifugal separators are new to market and are increasingly used in the biopharmaceutical industry. Single-use centrifugal separators are mainly designed for the separation of protein expressing cell cultures. Available single-use centrifugal separators create new ways of processing cell culture-based fermentations with a yield of 98% or more. Most single-use centrifugal separators systems are flexible in usage and simple for scaling. Therefore, the AG felt it necessary to revise the control text for these items, accounting for single-use centrifugal separators. To best facilitate these revisions, structural changes were made to the existing ECCN 2B352.c. Prior to this rule, item paragraph .c comprised of c.1 through c.4, controlling multiple-use centrifugal separators. These parameters are now combined into a single .c.1, with new item paragraphs .c.1.a through .c; one parameter, what was .c.2 (a flow rate greater than 100 liters per hour), has been shifted up into the introductory text of .c, such that it applies to both single-use and multiple-use centrifugal separators. Now, item paragraph .c.2 will detail control text for single-use centrifugal separators, in which all components that come in direct contact with the substances being processed are disposable or single-use. As a conforming change, the technical note to item paragraph .c is revised to include single-use centrifugal separators. <HD SOURCE="HD2">2024 Plenary</HD> At the 2024 Plenary Meeting, the AG reached consensus on controlling instruments for automated peptide synthesizers. 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. <SU>1</SU> <FTREF/> Most protein toxins that are controlled under ECCN 1C351 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 T="03">e.g.,</E> 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. <FTNT> <SU>1</SU>  Sameer S. Kulkarni et al., <E T="03">Rapid and Efficient Protein Synthesis Thro ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 89k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━