The BIOSECURE Act of 2025 prohibits federal agencies from contracting with or using funds to support biotechnology providers identified as national security risks.
Gary Peters
Senator
MI
The BIOSECURE Act of 2025 prohibits federal agencies from contracting with or using federal funds to support biotechnology providers identified as national security risks. This measure aims to safeguard sensitive biological data by restricting the use of equipment and services from designated "biotechnology companies of concern." The Director of OMB is tasked with establishing and maintaining a list of these prohibited entities. The Act includes specific waiver authorities and exceptions for national security and overseas healthcare needs.
The new BIOSECURE Act of 2025 is setting up firewalls between the federal government and certain foreign biotechnology firms. Essentially, this bill bans federal agencies from buying, obtaining, or contracting for any biotechnology equipment or services from companies designated as a “biotechnology company of concern.” This isn't just about the government; federal grant and loan money also can’t be used to purchase this banned equipment, meaning research institutions and universities that rely on federal funding will have to clean house.
This whole process centers on the Director of the Office of Management and Budget (OMB) creating a list of these “companies of concern” within one year, based on suggestions from national security experts. A company earns a spot on this blacklist if it’s involved in biotech and is either on the Department of Defense’s list of Chinese military companies or if it’s controlled by a foreign adversary and poses a national security risk. The risk is defined by things like engaging with a foreign adversary’s military or intelligence agencies, or, crucially for the average person, obtaining human multiomic data (that’s fancy talk for genetic, protein, and metabolic data) without express and informed consent.
For most people, the headline here is data security. When we talk about "biotechnology equipment or services," the bill defines this broadly, including everything from genetic sequencers to software for biological research and even genealogical services. The concern is that foreign adversaries could use these services to vacuum up massive amounts of sensitive U.S. genetic data. If you’ve ever sent off a swab for a health or ancestry report, this bill is trying to ensure that the tools and companies handling that kind of sensitive biological information for the government—or through federally funded research—are not compromised.
If you’re a federal contractor or a university researcher, this bill creates immediate compliance headaches. Not only can you not buy the banned equipment, but if you enter into a new federal contract, you can’t use any of the banned equipment or services at all to perform that contract. This means contractors need to audit their entire supply chain, down to the lab equipment they use. The prohibition takes effect 60 to 90 days after the Federal Acquisition Regulation (FAR) is revised, which must happen within a year of the OMB publishing its list. The bill gives a five-year grace period for equipment already in use under existing contracts, but anything new is off-limits.
While the ban sounds absolute, agency heads can grant case-by-case waivers for up to 365 days, with a possible 180-day extension, if it’s deemed necessary for national security or if it involves overseas health care services. This flexibility is important, especially for military or diplomatic personnel abroad who might need specialized care. However, the requirement is only to notify Congress, not get their approval, which means the waiver process could become a significant loophole if not carefully managed by the OMB.
Finally, the bill mandates that the Director of National Intelligence must assess the national security risks posed by foreign adversaries collecting this human multiomic data from U.S. citizens. This required assessment confirms that the core issue here isn't just equipment; it's the massive, sensitive datasets being generated by the biotech boom. In short, this act is a major push to secure the federal biotech supply chain and protect American genetic data, but it comes with significant implementation costs and compliance burdens for anyone doing business with the federal government or receiving federal research funds.