On January 16, 2025, the US Commerce Department’s Bureau of Industry and Security (“BIS”) published an interim final rule (the “IFR”) revising the Export Administration Regulations (“EAR”) to impose new controls on certain biotechnology equipment and related technology. As stated in the IFR, the new controls are necessary to protect against US national security and foreign policy interests “given the dual-use nature and relevance of specific biotechnology equipment to contribute to the research and development of certain militarily relevant technologies.” The press release is available here.
The IFR is effective January 16, 2025. BIS will accept public comments until March 17, 2025, which can be submitted via the Federal rulemaking portal here.
- New Export Control Classification Numbers (“ECCNs”) and Corresponding Changes
The IFR moves the following biotechnology equipment from their current control under ECCN 3A999 into the new ECCN 3A069:
- High parameter flow cytometers, which are used to simultaneously measure several characteristics of individual cells or particles; and
- 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 IFR excludes from the scope of ECCN 3A069 certain flow cytometers and mass spectrometers that are medical devices that have been authorized for marketing or are exempt from premarket notification requirements by the Food and Drug Administration.
The IFR also makes other conforming changes, including creating new ECCN 3E069 to capture technology for the development and production of ECCN 3A069 items.
- License Requirements and License Review Policy
ECCNs 3A069 and 3E069 are controlled for National Security (NS), Regional Stability (RS) to or within Macau or a destination in Country Group D:5 of supplement no. 1 to part 740 of the EAR, and Anti-Terrorism (AT) reasons. There is a licensing policy of presumption of denial for destinations listed in both Country Group D:1 and D:5, Macau, or destinations in Country Group E. Applications for other destinations are reviewed on a case-by-case basis.
ECCN 3A069 commodities are eligible for License Exception Shipments to Country Group B countries (GBS) under EAR § 740.4, except to destinations subject to the RS control described in ECCN 3A999 (i.e., Iraq and Pakistan). ECCN 3E069 technology is eligible for License Exception Technology and software under restriction (TSR) under EAR § 740.6, except to destinations in Country Group D:5, destinations subject to the RS control described in ECCN 3A999 (i.e., Iraq and Pakistan), or Macau.
- EEI Filing Changes
To better track the export of the ECCN 3A069 items, this IFR adds new paragraph (b)(11) to EAR § 758.1 to require Electronic Export Information (“EEI”) filings for exports of all items in ECCN 3A069 when destined for a Country Group D destination.
- Savings clause
The savings clause included in the IFR provides that shipments of items that could previously have been shipped without a license (NLR) or under a license exception and that were en route aboard a carrier to a port of export, reexport, or transfer on January 16, 2025 pursuant to actual orders, may proceed under the rules in existence prior to the IFR, provided the export, reexport, or transfer is completed before February 18, 2025.
