Framework for Nucleic Acid Synthesis Screening

Today, as directed by President Biden's Executive Order on the Safe, Secure, and Trustworthy Development of Artificial Intelligence (AI), the White House Office of Science and Technology Policy (OSTP) is releasing a Framework on Nucleic Acid Synthesis Screening to encourage providers of synthetic nucleic acids to implement comprehensive, scalable, and verifiable screening mechanisms. This framework helps manage the risks of AI so that we can seize its benefits in synthetic biology.

Through the AI executive order, President Biden has directed action on AI across the economy, including AI applied to biotechnology and synthetic biology. Nucleic acids serve as the critical building blocks for life science research and development (R&D) -including the development of new biomedical products, novel strategies for recycling and energy production, and the creation of new classes of materials. It is essential that nucleic acid synthesis technologies are appropriately managed to promote positive outcomes and prevent nefarious uses. Nucleic acid synthesis screening is an effective, targeted measure to mitigate the potential for misuse of AI-enabled biotechnologies.

This framework recommends that providers of synthetic nucleic acids screen purchases to prevent misuse, building on recent guidance from the Department of Health and Human Services. The National Institute of Standards and Technology will further support implementation of this framework by engaging with industry to develop technical standards for screening, as directed by the Executive Order.

As directed by the Executive Order, within 180 days of the release of this framework, federal research funding agencies will require recipients of federal R&D funds to procure synthetic nucleic acids only from providers that implement these best practices. While this framework establishes requirements for federally funded research, it is anticipated that these requirements may be adopted more broadly by other research funders.

The Framework for Nucleic Acid Synthesis Screening can be found here.

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