On September 9, 2024, the House of Representatives passed H.R. 8333, the BIOSECURE Act (the “House Bill”). The text of the passed House bill was unamended from the version approved by the House Committee on Oversight and Accountability in May of this year.
If passed by the Senate, the BIOSECURE Act would:
- Prohibit federal agencies from procuring or obtaining any biotechnology equipment or service produced or provided by a “biotechnology company of concern”;
- Prohibit federal agencies from contracting with a company that uses equipment or services produced or provided by a “biotechnology company of concern”; and
- Prohibit recipients of a loan or grant from a federal agency from using federal funds to purchase equipment or services from a “biotechnology company of concern.”
“Biotechnology company of concern” means any entity that:
- is subject to the jurisdiction, direction, control, or operates on behalf of a foreign adversary (defined as China, Cuba, Iran, North Korea, and Russia);
- is involved in the manufacturing, distribution, provision, or procurement of a biotechnology equipment or service; and
- poses a risk to U.S. national security based on certain factors.
The House bill, as passed, specifically names BGI, MGI, Complete Genomics, Wuxi Apptec, WuXi Biologics, and any subsidiary, parent, affiliate, or successor of such entities as “biotechnology companies of concern.”
The House bill also contains additional mitigating provisions compared to the first version of the bill, including a grandfathering clause for contracts entered into with biotechnology companies of concern prior to the BIOSECURE Act’s effective date and a safe harbor provision that clarifies that “biotechnology equipment or services” will not include equipment or services that were formerly, but no longer, produced or provided by biotechnology companies of concern.
The House bill was sent to the Senate Committee on Homeland Security and Governmental Affairs, which is the Committee that approved the Senate version of the bill in March of 2024. However, the Senate bill likely will not pass as a standalone measure and will instead likely be tacked onto the Senate version of the National Defense Authorization Act later this year.
