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Framework for Nucleic Acid Synthesis
Attention: An Executive Order released on May 5, 2025 has paused implementation of the Framework for Nucleic Acid Synthesis Screening. We are awaiting new guidance from the federal government within 90 days of the Order to replace the 2024 Framework for Nucleic Acid Synthesis Screening.
Overview
The federal government is expanding regulation of nucleic acid synthesis. Current regulation applies to sequences from organisms and toxins on the select agents list but will be expanded to include any sequences that are known to contribute to the pathogenicity or toxicity of a biological agent.
Beginning in April 2025, federally funded researchers who work with synthetic nucleic acids and benchtop nucleic acid synthesis equipment will need to procure these materials from suppliers that adhere to the Framework for Nucleic Acid Synthesis Screening. Penn State researchers should ensure that they are obtaining these materials from approved vendors. Approved vendors will be able to provide a form attesting adherence to the Framework upon request or have one publicly available on their website.
Framework for Nucleic Acid Synthesis
In October 2023, President Biden issued an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, one goal of which is to reduce the risk of harms from the misuse of nucleic acid synthesis. The Framework for Nucleic Acid Synthesis Screening (“Framework”) was developed in response to this Executive Order.
The Framework was revised on September 30, 2024. The federal government is expected to provide additional updates and guidance to support implementation of these requirements. This webpage will be updated over time as more information becomes available.
Starting April 26, 2025, federal agencies funding life sciences research will require synthetic nucleic acids and benchtop nucleic synthesis equipment to be procured through Providers or Manufacturers that adhere to the Framework as a condition of funding. This applies to all types of synthetic nucleic acids (e.g., single- or double-stranded DNA and RNA, whole organism genomes such as viruses and bacteria) containing any synthetic sequences of concern.
Sequences of Concern (SOCs)
The Framework applies to sequences of concern (SOCs), defined as “a nucleotide sequence or its corresponding amino acid sequence that is a Best Match to a sequence of federally regulated agents (i.e., the Biological Select Agents and Toxins List (BSAT), or the Commerce Control List (CCL)), except when the sequence is also found in an unregulated organism or toxin.” This definition will be expanded on October 13, 2026, to include sequences known to contribute to pathogenicity or toxicity, even when not derived from regulated biological agents.
Information for Customers/Researchers
“Customer” is defined as an “individual or entity (such as an institution) that orders or requests synthetic nucleic acids from a Provider or purchases nucleic acid synthesis equipment from a Manufacturer.” Customers should ensure that they purchase from Providers or Manufacturers that adhere to the Framework. This requirement takes effect on April 26, 2025, but Penn State researchers should start preparing for compliance now. Customers can check the Provider or Manufacturer’s website to locate their self-attestation form or request one directly.
Approved Vendors
The federal government is expected to provide more information about approved vendors who attest to complying with the Framework. The approved vendor list is pending release from the federal government; this page will be updated once the list is available.
Provider and Manufacturer Requirements
Penn State does not currently serve as a Provider of synthetic nucleic acids or Manufacturer of benchtop nucleic acid synthesis equipment. If this were to change, Penn State and individual researchers would need to comply with the requirements listed below.
The Framework outlines customer screening requirements for Providers of synthetic nucleic acids and Manufacturers of benchtop nucleic acid synthesis equipment.
Additional Information for Providers and Manufacturers
Providers and Manufacturers must:
- Attest to implementing the Framework through a statement either posted on a public website or provided to the customer or federal funding agency upon request.
- Screen purchase orders for synthetic nucleic acids to identify SOCs.
- Screen customers who submit purchase orders of synthetic nucleic acids with SOCs or benchtop nucleic acid synthesis equipment to verify legitimacy.
- Report potentially illegitimate purchase orders of synthetic nucleic acids involving SOCs or of benchtop synthetic nucleic synthesis equipment.
- Retain records relating to purchase orders for synthetic nucleic acids and benchtop nucleic acid synthesis equipment.
- Take steps to ensure cybersecurity and information security.
Resources
The US government has released additional guidance on the Framework for Nucleic Acid Synthesis.
- Frequently Asked Questions: 2023 Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids
- Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids (October 2023)
- Companion Guide to Assist in Implementing the Recommendations of the Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids (October 2023)
- Notification of NIH Requirements Regarding Procurement of Synthetic Nucleic Acids and Benchtop Nucleic Acid Synthesis Equipment
- Department of Energy Financial Assistance Letter: Implementation of the Framework for Nucleic Acid Synthesis Screening
Additional information outlining adherence to this federal requirement will be provided on this webpage once it is available.
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