On January 16, 2025, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published an interim final rule (IFR) revising the Export Administration Regulations (EAR) to impose new controls on specific biotechnology equipment and related technologies. The revised regulations are aimed at addressing national security and foreign policy concerns due to the dual-use nature of certain biotechnology equipment, which can contribute to the development of militarily relevant technologies.
The new controls, effective immediately, will remain open for public comment until March 17, 2025. Comments can be submitted through the Federal rulemaking portal.
Changes to Export Control Classification Numbers (ECCNs)
As part of the IFR, BIS has moved certain biotechnology equipment from ECCN 3A999 to the newly established ECCN 3A069. This includes high parameter flow cytometers, which are used for measuring individual cells or particles, and liquid chromatography mass spectrometers specifically designed for top-down proteomics, which help in characterizing molecules and studying molecular interactions. The new classification excludes certain flow cytometers and mass spectrometers that are FDA-approved medical devices or exempt from premarket notification requirements.
In addition, a new ECCN, 3E069, has been created to control technology related to the development and production of items in ECCN 3A069.
License Requirements and Review Policy
The new ECCNs 3A069 and 3E069 are controlled for national security, regional stability, and anti-terrorism reasons. A presumption of denial applies for exports to destinations listed in Country Groups D:1 and D:5, Macau, or Country Group E. Applications for other destinations will be reviewed on a case-by-case basis.
Certain items classified under ECCN 3A069 are eligible for License Exception Shipments to countries in Country Group B under specific conditions, except for destinations subject to regional stability controls. Likewise, technology classified under ECCN 3E069 may qualify for License Exception Technology and Software under Restriction, with some exceptions.
EEI Filing Changes
To improve tracking of exports, the IFR introduces a requirement for Electronic Export Information (EEI) filings for exports of items under ECCN 3A069 destined for Country Group D destinations.
Savings Clause
The IFR also includes a savings clause, allowing shipments that were en route as of January 16, 2025, and which could have previously been shipped without a license, to proceed under the prior regulations as long as the export, reexport, or transfer is completed by February 18, 2025.
This regulatory change aims to enhance the U.S. government’s ability to monitor and control exports of sensitive biotechnology equipment that could be used for both civilian and military purposes.
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