BIS Publishes Advisory Opinion Involving Genetic Element Export Controls
The Bureau of Industry and Security recently published an advisory opinion that offers guidance on its genetic elements export controls under Export Control Classification Number 1C353.
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The four-page opinion, which BIS sent to the requestor Sept. 25 but which it recently posted publicly on its website, provides insight into how BIS determines what “length of sequence” constitutes a gene and when those genetic elements would generally not require an export license because they would be controlled under the Export Administration Regulations as EAR99. It also provides guidance on a scenario that would be a red flag to an exporter in this space, and it offers guidance on the classification of highly pathogenic avian influenza, the scope of control for ECCN 2B352.j and more.
BIS noted that the advisory opinion requester asked BIS to define the word “gene” within the context of ECCN 1C353 because that term “is not defined within the text of the ECCN” or in the EAR’s definition section. “The word ‘gene’ can have a variety of definitions depending on the practical or technical context of its use,” the agency said, “and BIS is currently considering whether and how to provide public guidance.”