Trade Sanctions and Export Controls Alert

Department of Commerce Expands Export Controls Related to Certain Life Sciences Software

October 8, 2021

Effective October 5, 2021, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) released a final rule applying export controls to software (a) designed for certain nucleic acid assemblers and synthesizers and (b) that is capable of designing and building functional genetic elements from digital sequence data. Such software is now subject to the Export Administration Regulations (EAR) under Export Control Classification Number (ECCN) 2D352. BIS has also amended a related ECCN (2E001) to extend export controls to the “technology” for the development of such software, which could include such items as proprietary algorithms or design specifications.

The nucleic acid assemblers and synthesizers to which the software relate were already subject to EAR’s export controls under ECCN 2B352.j and include nucleic acid assemblers and synthesizers that are both:

  1. Partly or entirely automated; AND
  2. Designed to generate continuous nucleic acids greater than 1.5 kilobases in length with error rates less than 5% in a single run.

Although this software has significant civilian applications, BIS is implementing the new controls as part of a multilateral agreement to control certain biotechnology software that could be misused to make biological weapons.

The new export controls associated with the software and technology related to the development of the software will require a license to export such software and technology to all countries except the following:

Argentina

Estonia

Japan

Poland

Australia

Finland

Korea, South

Portugal

Austria

France

Latvia

Romania

Belgium

Germany

Liechtenstein

Slovakia

Bulgaria

Greece

Lithuania

Slovenia

Canada

Hungary

Luxembourg

Spain

Croatia

Iceland

Malta

Sweden

Cyprus

India

Mexico

Switzerland

Czech Republic

Ireland

Netherlands

Turkey

Denmark

 

Italy

New Zealand

Norway

Ukraine

United Kingdom

The scope of the new licensing requirement could significantly impact life sciences companies, universities and other research institutions in the U.S. that export such software and related development technology to countries not included on this list. Even entities that do not send such software or technology outside of the U.S. must remember that the U.S. export control laws also apply to access granted to a foreign person located in the U.S. – such access to source code or technology is deemed to be an export to the country or countries of which the foreign person is a national. Thus, an export license may be required to provide access to the software or technology to a foreign-person employee, student, or contractor, even if the individual is based in the U.S.

Life sciences companies with questions about the new export controls or how to ensure continued compliance with the export control regulations should contact a member of Foley Hoag’s Trade Sanctions & Export Controls practice.