US Lawmakers Push Bill to Screen Sales of Potentially Dangerous Synthetic DNA

In a move reflecting growing concern over the rapid advances in biotechnology, U.S. lawmakers have introduced legislation that would regulate the sale of synthetic DNA, a step experts say is essential to prevent potentially dangerous materials from falling into the wrong hands. The proposed bill, unveiled last week in Congress, would establish stricter screening requirements for companies that synthesize and sell DNA sequences, particularly those that could be used to create harmful pathogens.
Synthetic DNA, often referred to as “gene fragments,” is a tool widely used in research laboratories, medical development, and biotechnology industries. While the technology has revolutionized medicine, allowing scientists to create vaccines, engineer microbes for environmental cleanup, and develop personalized therapies, it also carries inherent risks. Certain DNA sequences can be misused to produce viruses or toxins, making them a potential bioterrorism threat.
Currently, the United States has guidelines in place for screening DNA orders, primarily led by the International Gene Synthesis Consortium (IGSC), a voluntary industry group. However, lawmakers and biosecurity experts have argued that voluntary compliance is insufficient to prevent malicious actors from obtaining harmful genetic material. The new bill seeks to codify these screening processes into law, ensuring that companies selling synthetic DNA are legally obligated to verify the identity and intent of customers.
The legislation specifically targets sequences that could be used to manufacture dangerous pathogens, including those listed as select agents by the Centers for Disease Control and Prevention (CDC). Companies would be required to conduct thorough background checks and maintain detailed records of all orders. Violations could result in significant fines, criminal charges, or revocation of business licenses.
“Advances in synthetic biology are outpacing the regulatory framework,” said Senator Elizabeth Warren, one of the bill’s co-sponsors. “We have a responsibility to ensure that these powerful tools are used to save lives, not put them at risk. This legislation is about striking a balance between scientific innovation and public safety.”
Supporters of the bill argue that it is a proactive measure. The accessibility of DNA synthesis technology has grown exponentially over the past decade. Previously, creating genetic material for research was limited to well-funded laboratories, but now, small startups and even hobbyists can order custom sequences online. While this democratization of science has many benefits, it also raises the potential for misuse. Experts warn that without proper oversight, individuals or groups could theoretically synthesize harmful viruses, making biosecurity a critical concern.
The bill also emphasizes collaboration with federal agencies such as the Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI). These agencies would provide guidance on threat assessment and help ensure that companies follow rigorous screening protocols. Additionally, the legislation calls for periodic audits and reporting requirements, ensuring transparency and accountability in the rapidly evolving synthetic biology sector.
Industry response to the proposed legislation has been mixed. Some biotech firms support the measure, recognizing that standardizing safety protocols could prevent dangerous incidents and increase public trust in synthetic biology. “We welcome clear guidelines,” said Dr. Amy Chen, CEO of Genomic Solutions Inc. “The vast majority of scientists are responsible, but having enforceable standards protects both the public and the integrity of the field.”
However, some smaller companies and independent researchers have expressed concerns that overly strict regulations could stifle innovation. They argue that compliance costs may disproportionately impact startups and academic labs, potentially slowing progress in areas like gene therapy, synthetic vaccines, and agricultural biotechnology. The lawmakers behind the bill have acknowledged these concerns and are reportedly considering exemptions or support programs for small businesses to mitigate the impact.
Biosecurity experts also note that legislation alone cannot completely eliminate risk. “No system is foolproof,” said Dr. Michael O’Connor, a synthetic biology policy specialist. “Determined actors could still attempt to bypass regulations. But a legal framework for screening orders creates accountability and reduces the chances of accidental or malicious misuse. It’s an important step forward.”
The bill has bipartisan support, reflecting a shared recognition of the potential threats posed by synthetic biology. In recent years, concerns over biosecurity have intensified due to high-profile incidents involving laboratory accidents, unauthorized research, and discussions about engineered pathogens in academic publications. Lawmakers see the legislation as a timely response to a technological landscape that is changing faster than existing regulatory structures.
Beyond national security, advocates argue that the legislation could have broader benefits. By establishing clear standards, it could foster international collaboration, encouraging other countries to adopt similar measures. Standardized screening could also reassure the public that synthetic biology is being conducted responsibly, potentially reducing fear and misinformation about emerging biotechnologies.
The legislative process is expected to take several months, with committee hearings scheduled to explore both the technical aspects of DNA screening and the potential economic impacts on the biotech sector. Lawmakers are seeking input from scientists, industry representatives, bioethicists, and public health officials to ensure that the final version of the bill strikes an appropriate balance between safety and innovation.
As synthetic biology continues to advance, the introduction of this bill highlights the ongoing challenge of governing powerful new technologies. The goal is to prevent misuse while allowing legitimate research and innovation to flourish. If passed, the legislation would represent a significant step in ensuring that synthetic DNA—one of the most powerful tools in modern science—is handled responsibly and safely.
Ultimately, the bill underscores a broader principle: as science pushes the boundaries of what is possible, society must develop mechanisms to manage risk without stifling discovery. Striking that balance is never easy, but proponents argue it is necessary to protect public health, maintain national security, and support the continued growth of the biotechnology industry.
With Congress taking these measures seriously, the U.S. could set a global precedent for regulating synthetic DNA sales, showing that responsible oversight can coexist with scientific progress. As lawmakers, scientists, and industry leaders continue to collaborate, the hope is that society will benefit from the promise of synthetic biology while minimizing the risks inherent in its misuse.