Biosecurity standards for synthetic DNA screening require oversight and real consequences for providers that choose not to follow them.
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Companies do not usually ask the government to regulate them. Synthetic DNA providers do.
The ability to order long stretches of DNA sequences has accelerated biomedical research, but it has also increased the risk for people—either accidentally or with malintent—to request genetic sequences that could create dangerous pathogens.
When it comes to biosecurity screening, responsible companies across our industry agree that the current system is insufficient. We need national standards, oversight, and real consequences for providers that choose not to follow them.
Today, companies like mine screen both the DNA sequences customers order and the customers themselves. Many of us are members of the International Gene Synthesis Consortium, an industry-led organization that developed a common screening protocol based on Screening Framework Guidance developed by the US Department of Health and Human Services and the Office of Science and Technology Policy.
It is a useful system. It is also largely an honor system.
We have agreed on how responsible companies should behave and asked one another to comply. That is better than having no standards. But voluntary cooperation cannot secure an industry when one provider’s failure can undermine everyone else’s work.
The process is straightforward. A provider checks an order for sequences associated with pathogens, toxins, or other biological risks. If a sequence of concern arises, the provider investigates the customer, the institution, and the intended use before deciding whether to manufacture it.
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Screening is operationally costly, delays some orders, and occasionally requires a company to turn away revenue. Responsible providers accept that burden because the alternative is unacceptable.
But providers that skip screening may win the order. When the choice is between guaranteed revenue and voluntary guidance, someone will eventually decide that the money matters more.
The problem is becoming more urgent as artificial intelligence changes how biological systems are designed. AI is helping scientists create sequences that are longer, more complex, and less obviously related to anything found in nature. That will accelerate drug development, engineered biology, agriculture, and other beneficial applications.
It may also make conventional screening less effective.
Most current systems compare ordered sequences with databases of known pathogens and toxins. That works when a threat resembles something we already know. It becomes less reliable when AI can redesign a sequence while preserving a dangerous function or help someone divide a concerning design into components that appear harmless when reviewed separately.
Biosecurity therefore has two problems to solve: Participation must become mandatory, and screening technology must improve.
The bipartisan Biosecurity Modernization and Innovation Act of 2026 would move us in the right direction by requiring synthetic nucleic acid providers to screen orders and customers and by directing federal agencies to establish a national framework. California’s Assembly Bill 1864 seeks similar requirements within the state.
California deserves credit for acting. But biosecurity does not stop at the state line, and DNA is remarkably indifferent to legislative geography. A patchwork of state rules would be difficult to administer and easy to route around. The United States needs one strong federal standard across providers, technologies, and jurisdictions. In support of that effort, I and others recently signed an open letter urging Congress to make nucleic acid synthesis screening, including recordkeeping, mandatory in the US.
That standard must have real enforcement. A regulation without auditing or consequences is simply a voluntary guideline wearing a government-issued name tag.
Regulation alone will not be enough. Future screening systems must identify biological risk based on predicted function and context, not merely sequence similarity. They should detect attempts to fragment or disguise concerning designs without obstructing legitimate research.
Customer verification also needs to become more consistent. Today, deciding whether someone has a legitimate reason to obtain a sequence of concern can involve subjective judgment calls. We need objective, auditable standards that distinguish legitimate researchers from customers whose identities, affiliations, or stated purposes do not withstand scrutiny.
The synthetic DNA industry has shown that screening is practical. Responsible providers are doing the work. What we need now is a level playing field that makes responsible behavior mandatory and tools that keep pace with the science.
Biosecurity is too important to depend on every company voluntarily choosing safety over revenue. Congress should act before someone exploits the gaps we already know are there.
