Controls on Certain Laboratory Equipment and Related Technology To Address Dual Use Concerns About Biotechnology

<RULE> DEPARTMENT OF COMMERCE <SUBAGY>Bureau of Industry and Security</SUBAGY> <CFR>15 CFR Parts 740, 742, 758, and 774</CFR> <DEPDOC>[Docket No. 250108-0012]</DEPDOC> <RIN>RIN 0694-AJ95</RIN> <SUBJECT>Controls on Certain Laboratory Equipment and Related Technology To Address Dual Use Concerns About Biotechnology</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Bureau of Industry and Security, Department of Commerce. <HD SOURCE="HED">ACTION:</HD> Interim final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> With this interim final rule (IFR), the Bureau of Industry and Security (BIS) is revising the Export Administration Regulations (EAR) to address the accelerating development and deployment of advanced biotechnology tools contrary to U.S. national security and foreign policy interests. This rule institutes new controls on certain biotechnology equipment and related technology. It further solicits public comments on the changes it implements. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective January 16, 2025. Comments must be received by BIS no later than March 17, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Comments on this rule may be submitted to the Federal rulemaking portal ( <E T="03">www.regulations.gov</E> ). The <E T="03">regulations.gov</E> ID for this rule is: BIS-2024-0050. Please refer to RIN 0694-AJ95 in all comments. All filers using the portal should use the name of the person or entity submitting the comments as the name of their files, in accordance with the instructions below. Anyone submitting business confidential information should clearly identify the business confidential portion at the time of submission, file a statement justifying nondisclosure and referring to the specific legal authority claimed, and provide a non-confidential version of the submission. For comments submitted electronically containing business confidential information, the file name of the business confidential version should begin with the characters “BC.” Any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL” on the top of that page. The corresponding non-confidential version of those comments must be clearly marked “PUBLIC.” The file name of the non-confidential version should begin with the character “P.” Any submissions with file names that do not begin with either a “BC” or a “P” will be assumed to be public and will be made publicly available through <E T="03">https://www.regulations.gov</E> . Commenters submitting business confidential information are encouraged to scan a hard copy of the non-confidential version to create an image of the file, rather than submitting a digital copy with redactions applied, to avoid inadvertent redaction errors which could enable the public to read business confidential information. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> For all questions pertaining to this rule, contact Theodore Curtin, Director of Chemical Biological Controls Division; phone: 202-482-1979; <E T="03">Theodore.Curtin@bis.doc.gov</E> . </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Background</HD> As noted in Executive Order (E.O.) 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (87 FR 56849, September 15, 2022), advances in biotechnology possess great promise but are inherently dual-use in nature. Accordingly, the E.O. calls for safeguarding the United States from foreign adversaries that could acquire technologies and data that threaten our national security, while also promoting the ethical and responsible development and deployment of biotechnology globally. The E.O. provides a framework to ensure that biotechnologies do not contribute to global instability through irresponsible or malicious use. The United States recognizes that ensuring the responsible use of biotechnology, particularly when combined with advances in artificial intelligence (AI) and data science, is essential to safeguard public health, agriculture and food production, and the environment. At the same time, the United States needs to address the benefits and risks of dual-use biotechnology given the potential that its use, particularly when coupled with AI and biological design tools, could strengthen the military capabilities of countries of concern and lower barriers to the design, deployment, and use of novel weapons. As described in the 2024 Annual Threat Assessment from the Office of the Director of National Intelligence, “new technologies—particularly in the fields of AI and biotechnology—are being developed and are proliferating at a [challenging] rate” and that the consolidation of “these emerging technologies is likely to create breakthroughs, which could lead to the rapid development of asymmetric threats . . . to U.S. interests.” Certain countries are actively pursuing a strategy to exploit the combination of biotechnology with other enabling technologies for asymmetric military advantage through applications such as human performance enhancement and advanced biologically-derived materials for military-industrial use. Given the dual-use nature and relevance of specific biotechnology equipment to contribute to the research and development of certain militarily relevant technologies, calibrated export controls on these categories of equipment are necessary to limit immediate risks and protect against long-term national security threats in a field that could greatly impact security and defense capabilities. This IFR identifies two categories of equipment for additional U.S. export controls necessary to help protect U.S. national security. These categories of equipment are: (1) high parameter flow cytometers, which are used to simultaneously measure several characteristics of individual cells or particles, and (2) liquid chromatography mass spectrometers specially designed for top-down proteomics, which are analytical instruments used to elucidate and quantify unknown biomolecular structures, characterize molecules, and aid in the study of molecular interactions. The field of proteomics generally aims to identify and characterize proteins and study their structures, functions, interactions, and post-translational modifications. All the items described can be used towards innovative solutions in health, climate change, energy, food, and agriculture. However, they can also be used for research and development of concern to U.S. national security, including through the generation of large amounts of high-quality biological datasets that can be misused by countries of concern. This misuse includes training artificial intelligence systems for the development of certain militarily relevant applications, including as well as but not limited to human performance enhancement, brain-machine interfaces, biologically-inspired synthetic materials, and possibly biological weapons. To address the national security concerns described above, this IFR establishes new controls narrowly focused on a subset of biotechnology equipment. This IFR creates specific Export Control Classification Numbers (ECCNs) for high-parameter flow cytometers and certain mass spectrometry equipment. These items generate high-quality, high-content biological data including that which is suitable for use to facilitate the development of AI and biological design tools. The new ECCNs facilitate identification of the items being controlled and will provide more transparency in trade flows for this equipment. Moreover, these controls will only apply to destinations that present a concern of potential misuse or diversion to activities of national security concern. <HD SOURCE="HD1">Regulatory Changes</HD> <HD SOURCE="HD2">New Export Control Classification Numbers and Corresponding Changes</HD> Given the above-described national security concerns, BIS is moving high-parameter flow cytometers and certain mass spectrometry equipment from their current control under ECCN 3A999 into new ECCN 3A069. ECCN 3A069 contains two paragraphs as follows: paragraph .a identifies flow cytometers and cell sorters that are “specially designed” for spectral analysis or contain 26 or greater detectors or channels; and paragraph .b identifies liquid chromatography mass spectrometry instruments (LC/MS and LC-MS/MS) “specially designed” for top-down proteomic analysis. Flow cytometers and mass spectrometers that are devices, as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 321(h), that have been authorized for marketing by the Food and Drug Administration under section 510(k), section 513, or section 515 of the FD&C Act, 21 U.S.C. 360(k), 21 U.S.C. 360c, 21 U.S.C. 360e, or are exempt from the requirement of premarket notification under section 510(k) of the FD&C Act, 21 U.S.C. 360(k), and that are included in a list required by section 510(j) of the FD&C Act, 21 U.S.C. 360(j). are excluded from the scope of ECCN 3A069; the exclusion appears as a license requirement note to ECCN 3A069. This rule also makes two conforming changes. First, ECCN 3A999 is updated to reference ECCN 3A069 as a related control. Second, the heading of ECCN 3E001 is updated to reference ECCN 3A069 in the list of 3A items excepted. Relatedly, BIS is creating ECCN 3E069 to describe “technology” for the “development” or “production” of ECCN 3A069 items. The list of items controlled is contained in the ECCN heading. ECCNs 3A069 and 3E069 have the same reasons for control and licensing policies, described below. <HD SOURCE="HD2">Reasons for Control, Authorizations, and EEI Filing Changes</HD> ECCNs 3A069 and 3E069 are controlled for National Security, Regional Stability, and Anti-Terrorism reasons. No licenses are required for Country Group A:1 for these items. As described below, certain lic ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 38k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━