WASHINGTON, Feb 4, 2026, 14:05 EST
- The bill instructs the Commerce Department to establish mandatory screening regulations for gene synthesis providers
- The measure also pushes for a NIST “governance sandbox” alongside a federal review of biosecurity oversight
- Sponsors claim the rules are designed to keep up with AI-powered DNA design and affordable benchtop tools
Two U.S. senators have put forward a bill aiming to establish federal regulations on synthetic DNA sales. The proposal would require gene-synthesis companies to vet customers and orders for genetic sequences that might be used to create hazardous pathogens. (Reuters)
This shift comes as designing DNA becomes more straightforward. More researchers are turning to artificial intelligence to create new genetic sequences, while compact “benchtop” devices convert digital instructions into actual material, narrowing the space between concept and sample.
This also highlights a recurring concern in Washington: a rapidly evolving biotech supply chain that fuels drug research and crop development but can be exploited. Oversight, meanwhile, is fragmented across agencies and remains largely voluntary in critical sectors.
The proposal, named the Biosecurity Modernization and Innovation Act of 2026, mandates that the Commerce Department draft regulations within a year after it becomes law. It also directs the department to keep a federal list of “sequences of concern” that providers are required to screen against.
“Covered providers” refers not just to labs that create and sell synthetic nucleic acids—the DNA and RNA building blocks—but also to firms that manufacture or resell nucleic acid synthesis equipment, such as benchtop synthesizers.
The bill outlines a screening system that moves past one-time checks. It demands a method to submit order details in a “privacy-preserving” way to catch “split orders,” where someone divides a suspect request among several providers. Screening efforts should focus on sequences that could produce pathogens with “pandemic potential.” (Senate)
It also relies heavily on compliance tools typically seen in cybersecurity rather than biology. The proposal calls for a conformity assessment regime featuring audits and “red teaming”—adversarial tests designed to find ways to bypass screening—and includes the possibility of revoking a provider’s conformity status.
Enforcement comes with serious financial stakes. The bill allows the U.S. attorney general to bring civil lawsuits, imposing statutory damages up to $500,000 for individuals and $750,000 for organizations, with provisions for inflation adjustments detailed in the text.
To reduce friction for legitimate research, it offers an expedited review option for select institutional clients and considers exemptions for sequences clearly identified as non-hazardous, relying on scientific literature and industry standards.
Another part proposes a “biotechnology governance sandbox” managed by the National Institute of Standards and Technology, Commerce’s standards division. It would pilot biosecurity and biosafety tools and investigate governance strategies, reporting back to Commerce every year.
The bill mandates the head of the White House Office of Science and Technology Policy to review federal biosecurity and biosafety oversight within 90 days after enactment. It also requires creating an implementation plan to streamline authorities and fix any gaps, the bill text states.
The bill, designated S.3741, was introduced by Senator Tom Cotton and lists Senator Amy Klobuchar as its sole cosponsor. It has been sent to the Senate Commerce, Science, and Transportation Committee, according to records on Congress.
Cotton called the legislation “an important first step towards a comprehensive framework for biosecurity and biosafety.” Klobuchar pushed for tougher standards so sellers “know who their customers are and how they will use genetic material,” they said in a joint statement. Their office noted the bill has backing from the National Security Commission on Emerging Biotechnology, along with companies like Twist Bioscience, Integrated DNA Technologies, and Ginkgo Bioworks. (Senate)
Lawmakers have already been eyeing gene synthesis from different angles, focusing on links to China and pushing to clamp down on gene-sequence data sharing. This new bill shifts more responsibility to domestic providers for screening.
But a lot depends on details yet to be finalized: how Commerce defines “sequences of concern,” the speed at which the list can be updated, what data-sharing rules are needed to detect split orders, and the cost for providers to clear audits and adversarial testing without hindering genuine research.
