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Biosensor Systems Now Subject to Export Administration Regulations

Thursday, March 28, 2013
By Shawn McCausland
Sandler, Travis & Rosenberg Trade Report

The Bureau of Industry and Security has issued an interim final rule that, effective March 28, makes certain biosensor systems subject to the Export Administration Regulations and imposes on those items a license requirement for exports and reexports to all destinations except Canada. Specifically, this rule classifies specified biosensor systems and related software and technology under Export Control Classification Numbers 0A521, 0D521 and 0E521, respectively, on the Commerce Control List.

ECCN 0A521 covers biosensor systems and dedicated detecting components capable of detecting certain aerosolized bioagents and having the following characteristics: capable of showing results in three minutes or less, containing an integrated bioaerosol collector and identifier, containing antibodies to the bioagents listed in the entry, and utilizing bioluminescence as a process. This entry also includes a paragraph that differentiates 1A004.c detection systems and 2B351 toxic gas monitoring systems and their dedicated detecting components controls from 0A521 biosensor systems. That paragraph also refers exporters to USML Category XIV(f)(2) for equipment for the detection, identification, warning or monitoring of biological agents that is subject to the licensing jurisdiction of the State Department’s Directorate of Defense Trade Controls. Finally, two technical notes are provided for this entry defining the term “dedicated” and clarifying that the entry does not control biosensor systems that detect foodborne pathogens.

ECCN 0D521 is software for the function of biosensor systems controlled by ECCN 0A521.

ECCN 0E521 is technology for the development or production of biosensor systems controlled by ECCN 0A521.

The above items are controlled for regional stability Column 1 reasons, and the only license exception available for these items is for official use by personnel and agencies of the U.S. government. Comments on this rule are due no later than May 28.

BIS notes that it established the ECCN 0Y521 series to identify items that warrant control on the CCL but are not yet identified in an existing ECCN. Items are added to the ECCN 0Y521 series upon a determination that an item should be controlled because it provides at least a significant military or intelligence advantage to the U.S. or because foreign policy reasons justify such control. The ECCN 0Y521 series is a temporary holding classification equivalent to U.S. Munitions List Category XXI (miscellaneous articles). Items classified under ECCN 0Y521, including the items identified in this rule, remain so classified for one year from the date a final rule identifying the items is published in the Federal Register unless the item is reclassified under a different ECCN or an EAR99 designation or the 0Y521 classification is extended (which may be done for up to two one-year periods).

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