Risky Business

New U.S. DNA screening policy covers federal grantees. What about everyone else?

The executive branch has designed a workable screening system for federally funded science. Congress can close the gap for everyone else.

Why it matters: The U.S. just replaced its 2024 DNA synthesis screening framework with a policy that has verification and penalties behind it. But it still only applies to people and organizations who take federal research money.

Driving the news: On November 5, 15 months after the executive order’s deadline, the White House issued NSTM-6, the 2026 National Policy for Nucleic Acid Synthesis Screening, under Executive Order 14292. Its implementation will be phased, going into full force in October 2027.

What it does:

  • Requires recipients and subrecipients of federal life sciences funding to buy synthetic DNA (and RNA) and benchtop synthesizers only from certified “Adherent Suppliers.”
  • To qualify, suppliers must screen every order of 50+ nucleotides through a screener verified by the National Institute of Standards and Technology (NIST). They must also verify customers, report flagged orders, and keep records for at least eight years.

The strengths:

  • It covers benchtop synthesizers. These machines print DNA inside a lab, beyond the reach of controls placed on commercial suppliers. The 2024 framework covered their sale, but the new policy goes further by requiring the machine to refuse any job a verified screener hasn’t authorized. Limited offline use must meet NIST-verified conditions.
  • It sets baseline standards. NIST will write screening and verification standards and maintain the list and algorithm for determining sequences of concern (stretches of DNA linked to dangerous pathogens or toxins). It will also red-team screeners and suppliers, testing their capabilities in place of a patchwork of self-attestation.
  • It standardizes reporting. The 2024 framework already asked suppliers to report suspicious orders. Now verified screeners will also report flagged orders directly to federal authorities such as the FBI. Suppliers report unresolved concerns, and NIST will standardize timelines and procedures.
  • It has consequences. Compliance is tied to federal payment decisions under the False Claims Act, the law that punishes fraud against the government. Violations can mean immediate loss of funding and up to five years of ineligibility to receive federal funding. Importantly, a single researcher’s violation can count against their whole institution.

The limited scope: The policy’s teeth come from federal funding. Privately funded labs, companies, and individuals aren’t covered. The text says the policy should be implemented in a way that “encourages its applicability to all synthetic nucleic acid orders,” but that’s an aspiration with no implementation detail or enforcement mechanism behind it.

Between the lines:

  • Suppliers that serve both federally funded and private customers may screen everyone, but nothing requires it.
  • Suppliers that serve only private customers have little reason to bear the cost. The policy’s own preamble notes that responsible firms have been forced to compete against those that skip safeguards. A funding-based rule can narrow that gap but can’t close it. Major U.S. synthesis companies have endorsed legislation covering the entire U.S. market.
  • It’s also executive policy, which a future administration can revise. The text calls for review at least every four years, and NIST’s duties are “subject to the availability of funding.”

What’s next: Congress should pass legislation to close the gap.

Bipartisan bills in both chambers, S. 3741 and H.R. 10197, each have strengths. Sponsors and committee leadership should reconcile them into one bill that does the following, with a target of enactment early in the 120th Congress:

  • Cover all suppliers. Apply verified screening and customer checks to every provider, reseller, and benchtop manufacturer selling to U.S. and foreign customers, whether or not the buyer receives federal funds.
  • Have Commerce write the rules and NIST test the screeners. Direct Commerce to issue binding screening rules within one year of enactment and review them every two years. Authorize NIST to test and verify screeners, including against AI-designed sequences as screening missed in a 2025 study prior to release of a patch. Appropriators should give NIST dedicated funding for these efforts.
  • Back enforcement. Tie violation penalties to government audits and conformity assessments, not just grant conditions.
  • Make it sustainable. A bipartisan statute would outlast any single administration.

Bigger picture: It’s important to remember that the gap is global. Closing it at home would help protect our products and technologies against misuse. It would also make the U.S. a more credible partner as other countries build screening systems that fit their own laws.

Bottom line: The new policy covers federally funded science. It’s up to Congress to cover everyone else, and the text to do it has already been written.

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