Understanding and Implementing Nucleic Acid Synthesis Screening Policies in the US
According to the White House, “[N]ucleic acids serve as the critical building blocks for life science research and development (R&D)—including the development of new biomedical products, novel strategies for recycling and energy production, and the creation of new classes of materials. It is essential that nucleic acid synthesis technologies are appropriately managed to promote positive outcomes and prevent nefarious uses.” Nucleic acid synthesis screening, colloquially referred to as gene synthesis screening, “is an effective, targeted measure to mitigate the potential for misuse of AI-enabled biotechnologies.”
Providers & Manufacturers
Do you provide synthetic DNA or RNA to US federally funded researchers? Do you manufacture synthesis equipment for use in US federally funded research labs? If so, starting October 26, 2024, you are required to take 6 key actions in compliance with the Framework before you can serve US-funded customers. → See Information For Providers & Benchtop Manufacturers
Customers
Are you expecting to conduct life sciences research supported by the National Institute of Allergy and Infectious Diseases, National Science Foundation, Department of Defense, Department of Agriculture, Department of Energy, or other US federal funding agency? If so, starting October 26, 2024, you will likely be required to check that your Provider or Manufacturer complies with the Framework. → See Information For Customers
Quick Links:
List of Framework-Attesting Nucleic Acid Synthesis Providers & Benchtop Manufacturers
Providers: 6 Key Actions for Compliance (PDF)
Manufacturers: 6 Key Actions for Compliance (PDF)
Customers: Actions for Compliance (PDF)
Sample Attestation Form (PDF)
List of Nucleic Acid Synthesis Screening Tools
Compliance Table for Nucleic Acid Synthesis Providers & Benchtop Manufacturers
This Information Hub serves as a resource for:
Providers of synthetic nucleic acids (Providers) and manufacturers of benchtop nucleic acid synthesis equipment (Manufacturers) that need to screen purchase orders to identify sequences of concern and assess customer legitimacy; and
Individuals or entities (such as research institutions) that order or request synthetic nucleic acids from a Provider or that purchases a Manufacturer’s nucleic acid synthesis equipment (Customers).
This Information Hub provides resources to assist users in complying with §4(b) of the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI EO) and the resulting US Framework for Nucleic Acid Synthesis Screening (Framework).
The Framework established that federal funding agencies that fund life sciences research will require that procurement of synthetic nucleic acids and benchtop nucleic acid synthesis equipment using federal life sciences funding be conducted through Providers and Manufacturers that adhere to the Framework.
Parts of the Framework come into effect October 26, 2024, and this Information Hub can help entities adhere to this new policy. The Hub is also informative for international policymakers, Providers, and Manufacturers who do not serve US government-funded customers, and others who are interested in the new US policy.
This website is for informational purposes only and does not constitute legal advice. Users should not rely on the information provided as a substitute for consultation with qualified counsel.
Please note: If you:
- Place orders for synthetic nucleic acids within the California State University (CSU) or University of California (UC) systems, including researchers, lab managers, students, and local procurement offices (Purchasers), and receive federal funding for life sciences research; or
- Are a Provider or Manufacturer that wants to sell your products to those Purchasers enumerated in (1),
additional requirements may apply to you. Please see California State Policy for more details.
Basic Background on Nucleic Acid Synthesis Screening
Nucleic acid synthesis has revolutionized the life sciences industry, enabling breakthroughs and faster development of medicines and agricultural products that can save lives and feed the world. This technology allows for the on-demand production of user-specified nucleic acids (eg, genes) that can serve as medicines or be used to biomanufacture commodity chemicals.
Legitimate research using these techniques occurs to develop new vaccines, treatments, and research methods. Combined with synthetic biology, nucleic acid synthesis is used to manipulate naturally occurring pathogens to support these medical countermeasure development efforts. The same methods, however, can be used for nefarious purposes. The recreation of known pathogens, particularly small viruses, was listed as one of the most pressing biodefense risks in a 2018 report by the National Academies of Sciences, Engineering, and Medicine. Nucleic acid synthesis can support one of the two major steps in performing this type of recreation work. There are also potential risks that could lie in the convergence of artificial intelligence (AI) and biotechnology. For instance, there is a concern that AI-enabled in silico designs may be used in the future to create harmful physical products in the lab.
The dual-use nature of synthetic biology with nucleic acid synthesis—where the ability to design and produce pathogens could be used to develop important medical countermeasures or to cause harm—underscores the need for effective governance mechanisms. Establishing targeted nucleic acid synthesis screening programs and practices could improve biosecurity and help to mitigate the potential for misuse of this type of research.