US BIS Biotechnology Security Risks

Published on: Jan 20, 2025

On Jan. 16, US BIS issued export controls related to biotechnology.

  • US BIS released an interim final rule implementing targeted laboratory export controls.
  • Rule makes amendments to 15 CFR 740, 15 CFR 742, 15 CFR 758, and 15 CFR 774.
  • Interim Final Rule
  • Implements new controls to address national security risks related to biotechnology.
  • Instruments controlled by this interim rule include high-parameter and spectral flow cytometers and cell sorters; and certain liquid chromatography mass spectrometers.
  • New license requirements for these instruments, with certain destination exceptions.
  • These controls will only apply to destinations that present a national security concern.
  • Exporters required to file electronic export information in Automated Export System.
  • Effectiveness
  • Interim final rule comes into immediate effect, i.e. Jan. 16, 2025.
  • Consultation
  • Comments on the interim final rule are due on or before Mar. 17, 2025.
Regulators
US BIS
Entity Types
Corp
Reference
90 FR 4612, 1/16/2025; PR, 1/15/2025; RIN 0694-AJ95; Docket No. 250108-0012; Citation: *15 CFR* 740, 742, 758, 774;
Functions
Compliance; Legal; Operations; Registration/Licensing; Risk; Sanctions
Countries
United States of America
Category
State
N/A
Products
Corporate
Rule Type
Final
Regions
Am
Rule Date
Jan 16, 2025
Effective Date
Mar 17, 2025
Rule ID
240549
Linked to
N/A
Reg. Last Update
Jan 16, 2025
Report Section
US Investment