For conformity with the federal April 2024 Framework For Nucleic Acid Synthesis Screening issued by the Office of the President, Yale has implemented the program required by this mandate and also in alignment with the October 2023 Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids from the U.S. Department of Health & Human Services Administration for Strategic Preparedness and Response.
Screening purchase orders for nucleic acids to identify sequences of concern (SOCs)
Yale’s Core Facility that synthesizes and provides nucleic acid sequences as a transactional service (Keck Facility) is screening orders > 200 nucleotides for SOCs. In 2026, they will screen orders > 50 nucleotides for SOCs.
Yale University’s EShipGlobal shipping program screens Exports of nucleic acid sequences for SOCs from biohazardous agents that appear on the United States Department of Commerce’s Commerce Control List. This screening mechanism will also be utilized on incoming shipments of nucleic acids. All shipments from Yale must utilize EShipGlobal.
Screening customers submitting purchase orders of synthetic nucleic acids with SOCs, and purchase orders of benchtop nucleic acid synthesis equipment, to verify legitimacy
For purchases of nucleic acids:
- Yale’s Keck Facility and any other locations creating synthetic nucleic acids for transactional purposes will screen customers for the legitimacy of each order orders (the customer and their institution) if there are any SOCs identified by either the customer self-identifying or from hits on the screen for SOCs.
- Records of evaluations for customer legitimacy on orders over 200 nucleotides that contain SOCs must be retained by the Keck Facility and other locations for 3 years.
For purchases of benchtop nucleic acid synthesis equipment:
- Benchtop nucleic acid synthesis equipment has been added to the Yale SciQuest Restricted Items Purchase List, which will require review and approval by EHS prior to purchase.
- EHS will review these equipment order requests for legitimacy and keep records of all approvals.
Report potentially illegitimate purchase orders of synthetic nucleic acids involving SOCs or of benchtop nucleic acid synthesis equipment
Keck Facility and Yale EHS will:
- Report any potential illegitimate orders of synthetic nucleic acids involving SOCs (Keck Facility with assistance from Yale EHS) and benchtop nucleic acid synthesis equipment (Yale EHS) to the local New Haven FBI Office and their Weapons of Mass Destruction Coordinator.
- The Keck Facility must utilize EShipGlobal for all outbound shipments, and every shipment in ESHIP Global will use visual compliance that will check the people and the institution for legitimacy.
Retain records relating to purchase orders for synthetic nucleic acids and benchtop nucleic acid synthesis equipment
- Yale EHS and the Keck Facility will retain records of purchases of benchtop nucleic acid synthesis equipment and nucleic acid sequences respectively for a minimum of 3 years.
Take steps to ensure cybersecurity and information security
- The Keck Facility will protect databases of SOCs, especially SOCs that code for sequences associated with virulence or toxicity, from access by the public.
- The Keck Facility and Yale EHS will contact the New Haven FBI Field Office if we suspect that we have been the victim of a network intrusion, data breach, or ransomware attack related to the synthesis of nucleic acid sequences.