A final rule issued by the Bureau of Industry and Security (BIS) on October 5, 2021 will place new controls on the export of certain biotech software designed for nucleic acid assemblers and synthesizers by establishing new Export Control Classification Numbers or “ECCN” to regulate the export. The BIS is the arm of the U.S. Department of Commerce responsible for the regulation and licensing of exports of commercial and so-called, “dual-use” technology.

On July 30, 2021, the Biden Administration issued a proposed amendment to the Federal Acquisition Regulations (FAR), the comprehensive and overarching regulatory framework for federal government contracts, in support of President Biden’s Executive Order 14005 issued on January 25, 2001 (“Executive Order”). The objective of the Executive Order – aptly entitled “Ensuring the Future is Made in America by All of America’s Workers” - is to “maximize the use of goods, products, and materials produced in, and services offered in, the United States.” The proposed amendment to the FAR (“FAR Amendment”) is intended to bolster this policy objective, as well as support the fulfillment of Biden’s promise to strengthen the nation’s manufacturing base.