BIS Issues Final Rule for Export Controls Over Biological Equipment Software

The Bureau of Industry and Security will add export controls on certain biological equipment software that may be exploited for biological weapons purposes (see 2109290011), the agency said in an Oct. 5 final rule. The rule, issued in proposed form in November 2020, will align U.S. controls with the multilateral Australia Group by placing restrictions on exports of “nucleic acid assembler and synthesizer” software “capable of designing and building functional genetic elements from digital sequence data,” BIS said. The agency said the software will be added to the Commerce Control List as an emerging technology and falls under BIS’s efforts under the Export Control Reform Act (see 2109080062).

The software will require a license for chemical and biological weapons (CB) reasons and anti-terrorism (AT) reasons for destinations in CB Column 2 and AT Column 1 on the Commerce Country Chart. A license may also be required for other embargoed countries.

BIS said it received four comments on its November proposed rule, including calls for the agency to issue all emerging and foundational technology controls multilaterally or else risk inadvertently harming U.S. competitiveness. One commenter expressed concerns that the control could “damage trade and collaboration in this field with certain U.S. allies and thereby decrease the United States’ global competitiveness in this field.” But BIS said the software “generally” doesn’t require a license for exports to other Australia Group countries and “should not impair the ability of the United States to trade in intermediate goods with most of its allies.”

All exports, reexports and transfers that now require a license as a result of the increased export restrictions and that were aboard a carrier to a port as of Oct. 5 may proceed to their destinations under the previous eligibility as long as they are exported by Dec. 6, BIS said. Any items not exported before midnight Dec. 6 may require a license.

In addition, all deemed exports of technologies and source code that now require a license may continue without a license before Dec. 6. Beginning at midnight Dec. 6, those technologies and source code will require a license before being released to a foreign national when a license would be required to the home country of the foreign national.