Department of Commerce cracks down on biotechnology exportsDepartment of Commerce cracks down on biotechnology exports

The US Department of Commerce instituted a new rule on Wednesday to control exports of specific biotechnology equipment and related technology. The rule was instated to “address the accelerating development and deployment of advanced biotechnology tools contrary to US national security and foreign policy interests.” The Bureau of Industry and Security (BIS) is allowing public comment on the ruling until 17 March 2025.

The new rules move high-parameter flow cytometers and certain mass spectrometry equipment from their previous control category to the newly created ECCN 3A069, with some exceptions made for US Food and Drug Administration (FDA) authorization.

Although the ruling acknowledges the uses that such equipment has in healthcare, the BIS said that misuse by “countries of concern” can generate datasets that run contrary to national interests. “This misuse includes training artificial intelligence (AI) systems for the development of certain militarily relevant applications, including as well as but not limited to human performance enhancement, brain-machine interfaces, biologically-inspired synthetic materials, and possibly biological weapons.”

As reported by Reuters, the ruling seeks to mitigate Beijing’s ability to use American data to fuel the Chinese military. 

Shades of BIOSECURE

Though narrow in scope, the ruling reflects the sentiment behind the BIOSECURE Act, that may have missed its window for passage into law.

But BIOSECURE itself is long from forgotten. During the JP Morgan Healthcare Conference in San Francisco, California, Marc Casper CEO of Thermo Fisher Scientific was asked about how the Act has affected the biotechnology business.

“I don't think the dialogue is going to end,” he said. “And that is leading to a shift in focus to more work moving to Western-based facilities and some Indian facilities.”

He said that although the dialogue has provided a slight tailwind for his company, such changes “can be disruptive to the customer base, which is never a good thing.”