OSTP Framework for Nucleic Acid Synthesis Screening
The White House Office of Science and Technology Policy (OSTP) released the Framework for Nucleic Acid Synthesis Screening on April 29, 2024 and is effective on April 29, 2025. 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.
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 containing Sequences of Concern (SOC)s by individuals without a legitimate need for them.
SOCs are defined as a nucleotide or amino acid sequence that is a Best Match to a sequence of federally regulated agents (Biological Select Agents and Toxins) or the Commerce Control List, except when the sequence is also found in an unregulated organism or toxin. This includes sequences known to contribute to pathogenicity or toxicity.
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.
Beginning April 26, 2025, all providers and manufacturers of synthetic nucleic acids must adhere to the following:
- Write a statement attesting to the adherence to the new policy, posted publicly
- Screen POs to identify SOCs
- Screen customers to verify legitimacy
- Report potentially illegitimate POs
- Retain records of POs for a minimum of three years
- Take steps to ensure cybersecurity and informational security
The framework applies to all synthetic nucleic acids (RNA and DNA) and whole organism genomes. At a minimum, DNA or RNA of 200 nucleotides or longer should be screened. Beginning October 13, 2025, the screening window will be decreased to 50 nucleotides.
If you are synthesizing nucleic acid sequences at UCF, please contact EHS to identify what steps you need to take to remain compliant with these new regulations.
Contact EHS if you have questions on how these new regulations impact your research: E-mail Melina.Kinsey@ucf.edu.
Information regarding this policy was gathered from the Administration for Strategic Preparedness & Response and Wayne State University.