Screening Requirements

Regulatory changes related to the manufacturing of nucleic acid sequences are scheduled to be implemented in April, 2025.  The goal of these new requirements is to reduce the risks and increase the biosecurity associated with the misuse of synthetic nucleic acids. As a result, manufacturers of nucleic acids who receive federal funding are required to screen purchase orders (PO) of synthetic nucleic acids to identify sequences of concern (SOC) and assess customer legitimacy.

Sequences of concern 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.

The definition will be expanded to include sequences known to contribute to pathogenicity or toxicity on October 13, 2025.

Beginning April 26, 2025, all providers and manufacturers of synthetic nucleic acids must adhere to the following:

1. Write a statement attesting to the adherence to the new policy, posted publicly
2. Screen POs to identify SOCs
3. Screen customers to verify legitimacy
4. Report potentially illegitimate POs
5. Retain records of POs for a minimum of three years
6. Take steps to ensure cybersecurity and informational security

The framework applies to all synthetic nucleic acids (RNA and DNA) and whole organism genomes. At 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 Wayne State University, please contact OEHS to identify what steps you need to take to remain compliant with these new regulations.

Contact OEHS if you have questions on how these new regulations impact your research:  E-mail OEHS@wayne.edu, or call 313 577 1200.