Two U.S. senators unveiled legislation this week that would impose new requirements on the sale and manufacture of synthetic gene sequences that could be exploited to create biological weapons. The measure seeks to address safety concerns as laboratory-made sequences - strings of nucleic acids that form DNA - are increasingly designed with the help of artificial intelligence and produced on compact synthesizers that can sit on a benchtop.
The bill, introduced by Senator Tom Cotton, a Republican from Arkansas, and Senator Amy Klobuchar, a Democrat from Minnesota, would direct the U.S. Department of Commerce to require laboratories that perform gene synthesis to screen their customers and specific orders. The aim is to prevent ‘‘bad actors’’ from obtaining sequences that could be used for harmful purposes.
Under the proposed legislation, the Commerce Department - working with other federal agencies - would be responsible for assembling a list of genetic sequences considered potentially dangerous. That catalog would serve as the basis for screening and compliance by companies that synthesize gene sequences for legitimate research uses, medical therapies, agricultural development and other applications.
Proponents argue the change responds to technological shifts that have broadened access to synthetic biology tools. Scientists now increasingly rely on artificial intelligence to discover or design new sequences, and synthesis equipment that can produce those sequences has become smaller and more widely available, raising concerns about misuse if safeguards are not strengthened.
"While access to genetic material allows scientists to study diseases, develop lifesaving medicine, and improve crops, without safety standards it could be misused, including to create bioweapons," Klobuchar, the No. 3 Democrat in the Senate, said in a statement.
The bill also seeks to begin consolidating federal biosecurity rules that are currently dispersed across agencies. Its sponsors say streamlining regulations would help federal policy keep pace with rapidly evolving technology and close safety gaps.
"American innovations in biotechnology are too important to fall into the hands of bad actors or be hamstrung by outdated federal policies," Cotton, the No. 3 Republican in the Senate, said in a statement.
Lawmakers have examined gene synthesis policies before. Last year, the U.S. House of Representatives committee on China sent a letter to the directors of the FBI and the Office of the Director of National Intelligence raising concerns about GenScript Biotechnology’s partnerships with U.S. companies because of its ties to China. Also last year, a bipartisan group of congressional members in both chambers put forward a bill that would require U.S. firms to obtain an export license before transferring gene sequence data to China.
The current proposal focuses on tightening domestic controls over who can order synthesized sequences and which sequences should trigger enhanced scrutiny. It does not alter the existing facts about past congressional actions or the concerns previously raised, but it represents a new federal effort to set uniform screening expectations for gene synthesis providers.
The legislation's next steps - committee consideration, potential hearings and any amendments - will determine whether the screening requirements and the list of hazardous sequences are implemented as drafted. The bill places the initial responsibility on the Commerce Department to coordinate across agencies and establish the technical criteria for identifying sequences that warrant restriction or additional oversight.