BIS Issues New Biotech Export Controls, Asks for Public Comments
The Bureau of Industry and Security is placing new export controls on certain laboratory equipment that can be used for biotechnology purposes that may threaten U.S. national security, the agency said in an interim final rule released this week.
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
The rule, which takes effect Jan. 16, will introduce new license requirements for certain “high-parameter and spectral flow cytometers and cell sorters” and certain “liquid chromatography mass spectrometers.” BIS said the high parameter flow cytometers can be used to simultaneously measure “multiple features” of individual cells or particles, “allowing scientists to rapidly produce large, high-information biological datasets.” The spectrometers are specially designed for “proteomics,” the study of proteins “produced and/or modified by an organism to elucidate the interactions, function, composition, and structures of proteins and their cellular activities.”
BIS said both instruments can be used to come up with new solutions in the fields of health and climate change, but they also can be “misused by countries of concern,” including through training AI systems for military purposes. They are specifically used to generate “large, detailed biological datasets” that can be exploited by foreign militaries for an “asymmetric military advantage.”
BIS Undersecretary Alan Estevez said the agency has “strategically crafted these controls to focus on countries of concern while preserving the global community’s ability to responsibly use these laboratory instruments to advance the significant beneficial uses of biotechnology.”
Public comments are due March 17.
The rule will create two new Export Control Classification Numbers, including new ECCN 3A069, which will control both the high-parameter flow cytometers and certain mass spectrometry equipment. New ECCN 3E069 will capture “technology” for the “development” or “production” of those ECCN 3A069 items.
Items captured by those ECCNs will be controlled for national security, regional stability and anti-terrorism reasons, and they will require a license for all destinations except nations in Country Group A:1, which includes member states of the multilateral Wassenaar Arrangement, excluding Russia, Malta and Ukraine. Certain nations outside A:1 countries, including China and other countries subject to a U.S.-arms embargo, will face a license review policy of presumption of denial. Other countries will face a case-by-case review policy based on whether the exports “would make a significant contribution to the military potential of any other destination or combination of destinations that would prove detrimental to the national security of the United States,” BIS said.
Certain license exceptions will be available for the ECCNs, including License Exception Shipments to Country Group B Countries (GBS) and License Exception Technology and Software Under Restriction (TSR).
BIS also will require exporters to file electronic export information in the Automated Export System for certain 3A069 shipments. Those EEI filings will be mandatory if the export is destined to a Country Group D nation.
All exports that now require a license as a result of this rule but were aboard a carrier to a port as of Jan. 16 may proceed to their destinations under the previous eligibility as long as the items are exported before Feb. 18, BIS said. Any items not exported before midnight Feb. 18 will require a license.