Synthetic Nucleic Acid Screening

S3: Science Safety Security

Continuing advances in nucleic acid synthesis technology and the open availability of genetic sequence data pose concerns that individuals with ill intent could exploit biotechnology for harmful purposes. Purchasing or synthesizing nucleic acids could enable individuals without a legitimate and peaceful purpose to possess genetic sequences that would pose risks if misused.

To address these risks, and in accordance with Executive Order 14110 on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, in 2024 the White House Office of Science and Technology Policy (OSTP) issued the OSTP Framework for Nucleic Acid Synthesis Screening. This Framework establishes compliance with sequence screening requirements as a condition of receiving U.S. governmental life sciences research funding. Funding agencies must begin implementing this Framework by October 26, 2024.

The OSTP Framework builds on the 2023 HHS Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids in 2023. This guidance sets forth recommended baseline standards for the nucleic acid synthesis industry (providers) and for manufacturers of benchtop nucleic acid synthesis devices.

HHS Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids

OSTP Framework for Nucleic Acid Synthesis Screening

Reference Material and Related Resources