Feds Crack Down on Lab Equipment Over Bioweapon Fears
Published Date: 1/16/2025
Rule
Summary
Starting January 16, 2025, new rules will control certain biotech lab equipment and tech to keep them from being misused and protect U.S. security. Companies and researchers working with advanced biotech gear will need to follow these updated export rules. The government also wants your feedback by March 17, 2025, so get ready to share your thoughts!
Analyzed Economic Effects
7 provisions identified: 1 benefits, 5 costs, 1 mixed.
New Controls on Specific Biotech Equipment
Starting January 16, 2025, the rule creates ECCN 3A069 and places new export controls on (a) flow cytometers and cell sorters that are specially designed for spectral analysis or contain 26 or greater detectors or channels, and (b) liquid chromatography mass spectrometry instruments specially designed for top-down proteomic analysis. These items now generally require a license for export, reexport, or transfer (in‑country) except to destinations in Country Group A:1.
New Controls on Technology for Those Items
The rule creates ECCN 3E069 to control "technology" for the development or production of the ECCN 3A069 items (the flow cytometers and top-down proteomics mass spectrometers). Technology for these items is controlled for National Security, Regional Stability, and Anti-Terrorism reasons.
Increased Licensing and Paperwork Burden
The rule is expected to increase licensing workload by approximately 1,170 licenses per year and add about 580 burden hours per year for licensing, raising the total estimated PRA burden to 39,406 hours under OMB control number 0694-0088.
FDA-Authorized Medical Devices Excluded
Flow cytometers and mass spectrometers that are devices as defined in the FD&C Act and that have been authorized for marketing by FDA under section 510(k), 513, or 515, or are 510(k)-exempt and included in the list required by section 510(j), are excluded from the scope of ECCN 3A069.
Presumption of Denial to Certain Destinations
License applications for ECCNs 3A069 and 3E069 destined for destinations that are in both Country Group D:1 and D:5, Macau, or countries in Country Group E will be reviewed under a presumption of denial; other required licenses will be reviewed case-by-case.
EEI Filing Requirement for Certain Destinations
For all exports of items in ECCN 3A069 destined for any Country Group D destination, filers must submit Electronic Export Information (EEI) in the Automated Export System (AES) as required by the rule.
Transition Window for Shipments Already En Route
Shipments that were en route aboard a carrier to a port of export, reexport, or transfer (in-country) on January 16, 2025, pursuant to actual orders, may proceed under previous eligibility until February 18, 2025. Any such items not exported, reexported, or transferred before midnight on February 18, 2025, require a license under the new rule.
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Key Dates
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