In May 2025, two new federal policy frameworks impacting research are scheduled to be implemented. More information will be provided prior to implementation. We understand that these new policies are proceeding based on the current information that we have. However, with the federal government administration change, the policies and timelines are subject to change.
We recognize that this message comes at a time of uncertainty for the UW research community, and we are committed to supporting research as efficiently as possible. Please feel free to contact EH&S Biological Safety with questions at ehsbio@uw.eduor
- Framework for Nucleic Acid Synthesis Screening
The Framework for Nucleic Acid Synthesis Screening establishes screening processes for purchases of synthetic nucleic acids and synthesis equipment to help minimize the potential for misuse and ensure biosecurity for life sciences research. Starting in May 2025, it will be a federal funding requirement that purchases of synthetic nucleic acids or synthesis equipment are only made from providers and manufacturers that attest to screening purchases for sequences of concern and potential misuse. EH&S is coordinating with UW Procurement and the Office of Research to implement this policy for all research within the scope conducted at the University.
Scope: This framework applies to research involving the procurement of all types of synthetic nucleic acids – including but not limited to both single- or double-stranded DNA and RNA as well as whole organism genomes containing any synthetic sequences of concern (e.g., whole genomes of federally regulated pathogens such as select agents). It also applies to federally funded life sciences research involving the procurement of any benchtop equipment capable of synthesizing nucleic acids.
What to expect:
- Purchases for synthetic nucleic acids and equipment within the scope will be limited to a list of vendors that attest to following this framework (list to be provided by UW Procurement).
- Specific spend categories or resource tags may be required for these purchases.
- Updated information on relevant websites (i.e., EH&S, Procurement)
Review the Framework for Nucleic Acid Synthesis Screening.
-
U.S. Government Policy for Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP)
The DURC/PEPP framework is for unified oversight of research on biological agents and toxins that, if misused or enhanced, have potential to pose risks to public health, agriculture, food security, economic security, or national security. The new framework has an expanded scope of agents and toxins that are subject to oversight (listed below). This policy framework supersedes the previous DURC and P3CO (Enhanced Potential Pandemic Pathogens) policies.
Scope: The expanded scope of agents and toxins subject to the policy will include:
- All select agents and toxins, including select toxins in any amount
- All Risk Group 4 and most Risk Group 3 pathogens as listed in the NIH Guidelines (exempted Risk Group 3 pathogens include HIV, HTLV, Mycobacterium tuberculosis, Mycobaterium bovis, and others)
- Pathogens recommended to be handled at BSL-3 and BSL-4 in the CDC’s Biosafety for Biomedical and Microbiological Laboratories (BMBL)
- Any biological agent that will be modified (genetically or by other means) to reasonably create a pathogen with pandemic potential
- Any use, generation, reconstitution, or transfer of an extinct or eradicated pathogen with pandemic potential (e.g., smallpox or 1918 influenza virus)
What to expect:
- Expanded reviews by the UW Institutional Review Entity (IRE), which is a standing subcommittee of the UW Institutional Biosafety Committee (IBC), to include the expanded scope of biological agents and toxins
- Select toxins in amounts that are considered exempt from the Federal Select Agent Program will be subject to review for DURC/PEPP
- New DURC/PEPP online training module
- New investigator worksheet to self-assess research for DURC and PEPP Updated process and application forms on the EH&S website
Review the DURC/PEPP Policy Framework. The National Institutes of Health (NIH) has also released their NIH implementation plans for the policy.