On 16 January 2025, the Bureau of Industry and Security (“BIS”), U.S. Department of Commerce issued an Interim Final Rule (“IFR”) on Controls on Certain Laboratory Equipment and Related Technology To Address Dual Use Concerns About Biotechnology. The IFR is effective January 16, 2025, and the public is invited to provide comments to BIS by March 17, 2025.
The IFR enhances export controls on two categories of equipment:
- 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.
Specifically, these items generate high-quality, high-content biological data including that which can be used to facilitate the development of AI and biological design tools.
The enhanced controls will apply to destinations that present a concern of potential misuse or diversion to activities of national security concern.
PSA BDP's Global Trade Management (GTM) team has also provided some recommendations and actions you may wish to take following this change.
Enhanced Controls
Currently, high-parameter flow cytometers and certain mass spectrometry equipment are controlled under ECCN 3A999. Under the enhanced controls, such equipment will be classified into new ECCN 3A069.
Under the new ECCN 3A069:
- 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.
Exclusions from ECCN 3A069 include flow cytometers and mass spectrometers:
- 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
- Exempted 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).
Separately, there will be a new ECCN 3E069 to describe “technology” for the “development” or “production” of ECCN 3A069 items.
License Requirements
3A069 and 3E069 items will require a license to all destinations, except those in Country Group A:1 (Wassenaar Arrangement Participating States, except for Malta, Russia and Ukraine).
There is a presumption of denial for license applications for:
- Destinations in both Country Group D:1 (National Security concerns) and D:5 (U.S. Arms Embargoed Countries), i.e., Belarus, Myanmar, Cambodia, China, Iraq, North Korea, Russia and Venezuela;
- Macau; or
- Destinations in Country Group E (i.e., Cuba, Iran, North Korea, and Syria).
Electronic Export Information (“EEI”) Filings
To better track the export of the items in ECCN 3A069, EEI filings are required for all such exports to Country Group D destinations.
Recommendations
Companies may want to take the following actions:
- Check whether you have any items currently classified under ECCN 3A999, and whether such items fall within the scope of the new ECCN 3A069.
- Check whether you are exporting and/or re-exporting the ECCN 3A069 items to the countries identified above.
If you currently have ECCN 3A069 shipments on the way, which are not eligible for License Exception or export, reexport, or transfer (in-country) without a license (NLR) under the enhanced controls, such shipments can continue before February 18, 2025. However, any such items not actually exported, reexported or transferred (in-country) before midnight, on February 18, 2025, will require a license.
Sources: Federal Register, PSA BDP
