New screening requirement and export controls for certain biotechnology-related software

On 5 October 2021, the Department of Commerce (Bureau of Industry and Security, BIS) published new regulations enacting export controls for certain types of biotechnology-related software capable of designing functional genetic elements.

This new regulatory measure on export controls marks the addition of this type of biotechnology-related products to the list of 'critical technologies' considered essential for national security, as defined by the Foreign Investment Risk Review Modernization Act of 2018 (FIRRMA).

As a result, all foreign direct investment in US companies involved in the production, design or development of this type of software will now be subject to a screening procedure under the jurisdiction of the CFIUS (Committee on Foreign Investment). In accordance to FIRRMA, foreign investment in software covered by the new BIS regulation are now subject to mandatory declaration without any minimum amount threshold.

• Type:

  • Entry and establishment (Approval and admission)
  • Treatment and operation (Trade, Investment related trade measures)

• Industry:

  • Manufacturing (Other manufacturing)
  • Services (Computer programming, consultancy and related activities, Other professional, scientific and technical activities)

• Sources:

  • Federal Register - United States Government, Commerce Control List: Expansion of Controls on Certain Biological Equipment “Software”, https://www.federalregister.gov/documents/2021/10/05/2021-21493/commerce-control-list-expansion-of-controls-on-certain-biological-equipment-software, 05 Oct 2021
  • Mondaq - Sidley Austin LLP, U.S. Department Of Commerce Expands Controls On Biotech Software In Final Rule , https://www.mondaq.com/unitedstates/inward-foreign-investment/1131082/us-department-of-commerce-expands-controls-on-biotech-software-in-final-rule?email_access=on, 12 Nov 2021