Introduction to the New Regulations on Export Control of Biotechnology Related Laboratory Equipment and Technologies of US (Mainland China)

On January 16, 2025, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce published an interim final rule titled "Controls on Certain Laboratory Equipment and Related Technology to Address Dual-Use Concerns about Biotechnology" (hereinafter referred to as the "New Rule"), which took effect immediately upon publication. ^[1] This article will briefly introduce the background, items and technologies involved, restrictive content, and the possibility of applying for a license under the New Rule.

I. Background

The New Rule is justified as necessary to protect the US from foreign adversaries who may acquire technologies and data that threaten US national security and to promote the ethical and responsible development and deployment of biotechnology globally.  It aims to prevent biotechnology from causing global instability due to irresponsible or malicious use.  Notably, biotechnology, especially when combined with AI and bio-design tools, can enhance the military capabilities of adversarial states and lower the barriers to designing, deploying, and using new weapons.  These biotechnologies include AI systems for military applications such as human performance enhancement, brain-computer interfaces, bio-inspired synthetic materials, and potentially biological weapons.^[2]  Given this, the New Rule calls for controls on two types of equipment: 1) high-parameter flow cytometers for measuring multiple characteristics of single cells or particles simultaneously; 2) liquid chromatography mass spectrometers specifically designed for top-down proteomics, which are used to clarify, quantify unknown biological molecular structures, characterize molecules, and assist in studying molecular interactions.

II. Items and Technology Involved

A. High-parameter flow cytometers^[3]
B. Liquid chromatography mass spectrometers for proteomics
C. Technology related to the controlled items
III. Restriction Content

A. Export Control Classification Number (ECCN)
1. 3A069: Covers the two types of controlled biotechnology equipment mentioned above.
2. 3E069: Covers technology for the development or production of items in ECCN 3A069.

B. Control Reasons
1. National Security (NS): All regulated items and technologies are controlled for national security reasons.
2. Regional Stability (RS): Exporting these items to certain countries or regions (such as China and India) requires a license.
3. Anti-terrorism (AT): All regulated items and technologies are controlled for anti-terrorism reasons.

C. Licensing Requirements
1. Country Group A:1: No license required for these countries.
2. Country Group D:1, D:5 (including China), E: License applications for these countries or regions will be presumptively denied.
3. Other countries requiring licenses: Licenses will be reviewed on a case-by-case basis to determine if the items would significantly contribute to the military potential of other countries or country combinations, thereby harming U.S. national security.

D. License Exceptions
1. Goods to Country Group B (GBS): Items in ECCN 3A069 are generally eligible for the GBS license exception, except for destinations controlled by RS in 3A999.
2. Technology and software under restriction (TSR): Technology in ECCN 3E069 is eligible for the TSR license exception, except for Country Group D:5, destinations controlled by RS in 3A999, or Macao.

E. Other Relevant Requirements
1. Electronic Export Information (EEI) filing: For all ECCN 3A069 items exported to destinations in Country Group D, an EEI filing is required in the Automated Export System (AES).
2. Transitional Provisions: For goods already in transit before January 16, 2025, if they are actually exported before February 18, 2025, they may continue to be transported under the previous license exception or No License Required (NLR) eligibility.

Ⅳ. Practical impact
According to the New Rule, exports of such equipment and technology to China (a Category D:5 country) will generally be subject to a "presumption of denial" policy for license applications. Only with solid proof that the exports won't threaten US national security or regional stability may a "Specific License" be granted.  And the equipment must only be used for civilian and research purposes.
 

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[1]   https://www.federalregister.gov/documents/2025/01/16/2025-00723/controls-on-certain-laboratory-equipment-and-related-technology-to-address-dual-use-concerns-about#action

[2] See Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 4613.

[3] According to Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), devices defined in 21 USC 321(h) that have been authorized for marketing by the Food and Drug Administration under Sections 510(k), 513, or 515 of the FD&C Act, or exempted from pre-market notification requirements under Section 510(k) of the FD&C Act, and are included in the list required by Section 510(j) of the FD&C Act, are not included in ECCN 3A069.