Japan to develop DNA synthesis guidelines to curb biosecurity risks amid AI advances

Tokyo announced that the Cabinet Office will convene a new biosecurity expert panel to formulate regulations for contract DNA synthesis services. These services, where specialized firms produce DNA sequences on behalf of researchers and companies, are vital for fields such as medicine, drug discovery, agriculture and livestock. However, advances in artificial intelligence now allow the design of novel pathogens, prompting fears of bioterror misuse.

Recent U.S. research showed AI-generated viral DNA could be assembled into a virus not found in nature, and another study reconstructed a historic flu virus by splitting its genome among multiple providers. While the United States and Britain have guidelines and the EU is moving toward legislation, Japan has relied on voluntary industry practices. The upcoming guidelines will draw on overseas models and be ready for consultation by January 2027, reflecting the government's view that rulemaking is urgent under its growth strategy for synthetic biology.