Biosecure Act
Under the Biosecure Act, US government agencies cannot:
(1) Buy or obtain biotechnology equipment or services provided by a BCC
(2) enter into, extend, or renew a contract with any entity using biotechnology equipment or services provided by a BCC to perform a government contract; or
(3) expend loan or grant funds for biotechnology equipment or services provided by a BCC, whether directly or through a loan or grant recipient.
What is “biotechnology equipment or service”?
The definition of “biotechnology equipment or services” is broad, and encompasses any instrument or service in “research, development, production, or analysis” related to “biological materials”:
- Equipment encompasses genetic sequencers and any other instruments, devices, components, accessories, as well as necessary software and firmware for operation.
- Services cover data storage and transmission concerning biological materials, including disease detection, genealogical information, and related services, along with consulting, advising, and support for biotechnology equipment.
- The Office of Management and Budget (OMB) will also be given the authority to classify any other “service, instrument, apparatus, machine, component, accessory, device, software, or firmware” as biotechnology equipment or services, as deemed “appropriate.”
What is a BCC?
BCC stands for “Biotechnology Company of Concern.”
To be assigned as a BCC, a company must:
- Be subject to the administrative governance, direction, and control of, or act on behalf of, a foreign adversary's government;
- Be involved in the manufacturing, distribution, provision, or procurement of biotechnology equipment or services to any extent;
- Present a US national security risk — for example, through links to foreign military, security, or intelligence agencies — by sharing multiomic data with a foreign adversary’s government or collecting such data without explicit informed consent.
Subsidiaries, parents, affiliates, and successors of named BCCs are also considered BCCs if they are directed or controlled by, or act on behalf of, the government of a foreign adversary.
Timelines for the ACT
The prohibitions set forth in the Act will not apply immediately upon enactment. The following is the maximum estimated timeline:
- OMB must publish the BCC list within one year of enactment (December 2026)
- Within 180 days of publication of the list, OMB must issue guidance to implement the provisions of the Act.
- Within one year after guidance is issued (June 2028), the Federal Acquisition Regulatory Council must revise the Federal Acquisition Regulation (FAR) to implement the requirements of the prohibitions.
