White House Finalizes Certified Supplier Screening for Nucleic Acids

By Marcus Bennett

What did the White House decide?

About 460 days after a 90-day deadline, the White House Office of Science and Technology Policy announced the final U.S. policy on Thursday for federally funded researchers. The deadline came from an executive order President Donald Trump signed on May 5, 2025. The order addressed dangerous gain-of-function research.

Researchers who receive federal tax dollars for research must buy synthetic nucleic acids from certified suppliers. Those suppliers agree to ensure that customers are neither bad actors nor hostile foreign governments.

The policy targets an AI-assisted biological weapon by controlling critical inputs. These inputs include raw materials used to build viruses in laboratories. White House officials present this as a technical answer to Silicon Valley’s longstanding fear of an extinction-scale biological disaster.

The policy does not announce broad restrictions on AI systems. White House Office of Science and Technology Policy Director Michael Kratsios wrote in the Thursday letter: “Through this Policy, the Administration is building a dynamic biosecurity defense centered on strong controls over the materials that enable synthetic biology misuse.”

How will the screening system operate?\n

The National Institute of Standards and Technology (NIST) is expected to set operating details, while Health and Human Services (HHS) will identify eligible vendors as federal restrictions move from policy to practice.

• NIST is expected to issue detailed standards and evaluation protocols within the next 90 days.
• HHS will then publish a list of certified suppliers.
• Suppliers must vet purchasers of dangerous genes as good stewards.
• Within a little over a year, the government expects federally funded scientists to purchase synthetic nucleic acids and DNA synthesis equipment only from certified suppliers.

For grantee laboratories, the immediate task is vendor selection. Counsel should map purchases to the forthcoming certified list. Research teams should document supplier status and prepare for vendor certification checks. The regime reaches federally funded scientists, not every private laboratory. Institutions should track the proposed congressional extension before treating private research as covered.

What changed from the 2024 policy?

A 2024 Biden administration policy pursued the same goal. It had no enforcement mechanism for verifying that vendors followed the rules.

Gerry Parker, a biodefense expert who drafted the gain-of-function executive order while serving on the National Security Council, called the new policy a big step forward. He said it puts strong safeguards in place. He said it protects Americans from the misuse of biological materials. He praised independent verification and customer screening. He said the system replaces an honor system with verifiable accountability. He also said it keeps American industry competitive and cutting-edge.

Why does the rule focus on AI and biology?

In September, Anthropic CEO Dario Amodei called for the industry to pace the frontier, beginning a push by Silicon Valley and Washington to prevent an AI apocalypse. He identified narrow AI restrictions against biological weapons as the most feasible policy change.

Amodei wrote: “Bioterrorist attacks are bad for everyone, including both the US and US adversaries, so an agreement here is probably possible.”

AI safety advocates also welcomed the policy. Nathan Calvin is chief strategy officer of Encode AI. He described the group as youth-led. Calvin called gene-synthesis screening common-sense and worthy of bipartisan support. He said the need grows more urgent as AI capabilities rise.

How does the global biosecurity context fit?

Kratsios said the United States can set the global standard through soft power. He called America the original pioneer of biotechnology. That field lets scientists read, describe and edit genes. The United States is also the leading supplier of synthetic nucleic acids to researchers worldwide.

A United Nations working group will meet in early December to strengthen the Biological Weapons Convention, the 1972 treaty that bars offensive biological weapons programs. Biotechnology has advanced rapidly since then. The treaty exempts biodefense programs that create more dangerous viruses to protect Americans.

One such project brought together nonprofit EcoHealth Alliance, the University of North Carolina and the Wuhan Institute of Virology. Its grant proposal said the collaborators intended to make viruses with the precise features of COVID-19 at the pandemic’s epicenter.

The FBI, CIA and Department of Energy assess the most likely origin of the COVID pandemic. Their assessment is a laboratory leak. The department houses the U.S. National Laboratories.

What gaps remain for Congress?

Biosecurity experts and advocates see the policy as momentum for further risk controls. It tasks the Department of Agriculture and Health and Human Services with reviewing some genetic sequences. The review would consider sequences encoding dangerous viruses and genes. Any inclusion in the Federal Select Agent Program remains under examination.

Congress could eventually consider the Biosecurity Modernization and Innovation Act, which would extend screening to private laboratories, regulate DNA printers and consolidate fragmented gain-of-function rules.

For suppliers, clear guidance has been a 20-year demand. Clear guidance reduces liability risks and insurance costs. A 2025 United Kingdom cost-benefit analysis found that mandatory screening would produce a net increase in investment and innovation. The current distinction remains clear: the policy reaches federally funded purchasing, while private-laboratory screening, DNA-printer regulation and unified gain-of-function rules remain proposals.