Executive Order on Safety and Security in Biological Research Holds Promise But Leaves Crucial Gaps

President Trump this week continued a longstanding bipartisan tradition of prioritizing a world safe and secure from catastrophic biological threats when he signed Executive Order 14292 on “Improving the Safety and Security of Biological Research.”  The order suggests some promising actions toward protecting modern bioscience and biotechnology against misuse, at a time when preventing accidental and deliberate misuse of biology is vital to American public health, economic, and national security interests. However, it also threatens crucial research that protects Americans from biological threats and provides scientific advances essential for global pandemic preparedness.

On a positive note, the order includes actions to strengthen nucleic acid synthesis screening requirements, which can help protect the vital technology against misuse.  However, to keep U.S. industry competitive and foster responsible innovation, the administration must take further action and create incentives for compliance in the revised nucleic acid screening policy framework, especially as the Administration explores expanding screening beyond federally funded research.

The executive order also seeks to bolster oversight of dual-use research that could pose pandemic risks; this is another potentially positive step, but the Office of Science and Technology Policy must move quickly to finalize clearly defined policy guidance on oversight of dual-use research of concern, so scientists can conduct lifesaving research safely and securely.

However, our main concern is that the executive order threatens to undermine U.S. capabilities to protect the American public from biological threats by requiring a pause in gain-of-function research. A pause in this area of work—which is not well defined in the order but can involve a broad range of experiments that change features of pathogens, such as the ability to spread among humans, virulence, or resistance to vaccines—could grind large areas of life science research to a halt in the United States. Combined with major cuts to federal research funding, this could threaten U.S. competitiveness in bioscience and biotechnology research and development, depending how “gain of function” is interpreted.

NTI will continue to engage with senior leaders in government, the scientific research community, and the private sector to advance smart governance of bioscience and biotechnology that guards against deliberate and accidental misuse, while supporting scientific innovation that is vital for saving lives and supporting economic development.