OSTP Framework for Nucleic Acid Synthesis Screening

S3: Science Safety Security

As directed by Executive Order 14110 on Safe, Secure, and Trustworthy Development and use of Artificial Intelligence, the White House Office of Science and Technology Policy (OSTP) released the Framework for Nucleic Acid Synthesis Screening on April 29, 2024. This Framework establishes requirements – as a condition of receiving U.S. governmental life sciences research funding – that synthetic nucleic acids, and benchtop devices capable of synthesizing them, are only procured from providers and manufacturers that comply with the requirements of the Framework. Funding agencies must begin implementing this Framework for synthetic nucleic acids of 200 nucleotides or more by October 26, 2024, and for synthetic nucleic acids of 50 nucleotides or more by October 13, 2026.

These screening requirements build on the recommendations in the 2023 HHS Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids. Both documents are focused on preventing access to synthetic genetic materials by individuals without a legitimate need for them.

The National Institute of Standards and Technology is undertaking work to establish conformity assessment standards for providers and manufacturers of synthetic nucleic acids. Life science researchers should consult with their funding agencies to determine which providers and manufacturers have made attestations available regarding their compliance with the Framework.