Resources on Nucleic Acid Synthesis Screening
The resources provided in this Information Hub may be useful to assist in compliance 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), which established that federal funding agencies will, as appropriate and consistent with applicable law, 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.
Key Resources to Assist with Compliance
The White House, Framework for Nucleic Acid Synthesis Screening (April 2024)
ASPR, Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids (October 2023)
From the CHS Information Hub
For Providers or Manufacturers:
- List of Nucleic Acid Synthesis Screening Tools (August 2024)
- Providers: 6 Key Actions for Compliance (PDF) (August 2024)
- Manufacturers: 6 Key Actions for Compliance (PDF) (August 2024)
- Compliance Table for Nucleic Acid Synthesis Providers & Benchtop Manufacturers (August 2024)
- Sample Attestation Form (PDF) (August 2024)
For Customers:
Other Resources
For Providers or Manufacturers:
- Aclid, Nucleic Acid Synthesis Screening Guide (August 2024)
Other Relevant US Policy Documents
US Federal Government Materials
Executive materials
- The White House, Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (October 2023)
- US Department of Homeland Security, Artificial Intelligence: Roadmap 2024 (March 2024)
- US Department of Commerce, National Institute of Standards and Technology, NIST, Nonprofit Research Consortium to Develop Safety Tools for Synthetic Biology to Defend Against Potential Misuse of AI (February 2024)
- National Institute of Standards and Technology, Biosecurity for Synthetic Nucleic Acid Sequences (August 16, 2024)
US Federal Government Materials
Legislative materials
- Representatives Yadira Caraveo and Rich McCormick, Rep. Caraveo Introduces Bipartisan Legislation to Promote Nucleic Acid Biosecurity Measures (August 29, 2024)
- National Security Commission on Emerging Biotechnology, Strengthening Gene Synthesis Security: Desired Outcomes and Capabilities (June 2024)
- Bipartisan US Senate AI Working Group, Driving US Innovation in Artificial Intelligence: A Roadmap for Artificial Intelligence Policy in the United States Senate (May 2024)
- National Security Commission on Emerging Biotechnology, Gene Synthesis Security (April 2024)
- Representative Julia Brownley et al., Brownley Leads Bipartisan, Bicameral Effort to Establish Biosecurity Guardrails In DNA Research (April 10, 2024)
- National Security Commission on Emerging Biotechnology, Interim Report (January 2024)
- Senator Ed Markey, S.2400 (118th Congress), Securing Gene Synthesis Act (July 19, 2023)
- Representative Anna Eshoo, H.R.4702 (118th Congress), Securing Gene Synthesis Act (July 18, 2023)
- Senators John Hickenlooper and Ted Budd, S.2356 (118th Congress), Gene Synthesis Safety & Security Act (July 18, 2023)
- Representative Anna Eshoo, Eshoo Urges NSA & OSTP to Address Biosecurity Risks Caused by AI (October 25, 2022)
US State Government Materials
- California Assemblymember Rudy Salas, AB-1963, California State University and University of California: gene synthesis providers (California Educational Code §§ 66360 and 66361 as of August 26, 2022)
- University of California, Guidance Memo 23-02: Guidance on Purchasing Gene Synthesis Equipment or Products (April 26, 2023)
- University of California, Guidance Memo 23-02, Appendix I: Sample Attestation Form (April 26, 2023)
- University of California & The California State University, AB-1963 Gene Synthesis Suppliers (living document)
Other Center for Health Security-Produced Resources
- Amanda K. Mui, Johns Hopkins Center for Health Security, Increasing Gene Synthesis Security: Global and US Perspectives, poster presentation at Global Health Security Conference 2024 (June 17, 2024)
- Johns Hopkins Center for Health Security, Response to the NSCEB’s Interim Report and AIxBio Policy Options (April 9, 2024)
- Johns Hopkins Center for Health Security, BWC Global Forum: Biotech, Biosecurity & Beyond podcast, Episode #11: Gene Synthesis Screening (February 6, 2024)
- Gigi Gronvall, Johns Hopkins Center for Health Security, Strengthening Security for Gene Synthesis: Recommendations for Governance (November 2022)
- Gigi Gronvall, Johns Hopkins Center for Health Security, California Legislature Senate Committee on Education 8 June 2022 Hearing to Discuss AB1963 “Gene Synthesis Providers”: Testimony of Gigi Gronvall, PhD (June 8, 2022)
- Amanda Kobokovich (Mui) et al. Strengthening Security for Gene Synthesis: Recommendations for Governance, Health Security (November 22, 2019)
International Resources
- International Organization for Standardization, ISO 20688-2:2024, Biotechnology — Nucleic Acid Synthesis — Part 2: Requirements for the Production and Quality Control of Synthesized Gene Fragments, Genes, and Genomes (March 2024)
- Responsible AI x Biodesign, Community Values, Guiding Principles, and Commitments for the Responsible Development of AI for Protein Design (March 8, 2024)
- World Health Organization, Global Guidance Framework for the Responsible Use of the Life Sciences: Mitigating Biorisks and Governing Dual-use Research (September 13, 2022)
- International Gene Synthesis Consortium, Harmonized Screening Protocol© v2.0 (November 19, 2017)
Noteworthy Reports & Presentations
- RAND, Securing Commercial Nucleic Acid Synthesis (July 1, 2024)
- Applied Biosafety, Special Issue on Synthetic Genomics: Part 1 (June 2024)
- Stephanie Batalis et al., Safeguarding Mail-Order DNA Synthesis in the Age of Artificial Intelligence, Applied Biosafety (June 20, 2024)
- Council on Strategic Risks, Supporting Follow-Up Screening for Flagged Nucleic Acid Synthesis Orders (May 7, 2024)
- Blueprint Biosecurity, Developing a Customer Screening Framework for the Life Sciences (March 2024)
- Centre for Long-Term Resilience, Synthetic Nucleic Acid Screening: Overcoming challenges with implementation (November 21, 2023)
- Center for Security and Emerging Technology, Breaking Down the Biden AI EO: Screening DNA Synthesis and Biorisk (November 16, 2023)
- Nuclear Threat Initiative, The Convergence of Artificial Intelligence and the Life Sciences: Safeguarding Technology, Rethinking Governance, and Preventing Catastrophe (October 2023)
- Nuclear Threat Initiative, Preventing the Misuse of DNA Synthesis Technology (last updated August 2023)
- Helena, Biosecurity in the Age of AI (July 2023)
- Nuclear Threat Initiative, Benchtop DNA Synthesis Devices: Capabilities, Biosecurity Implications, and Governance (May 10, 2023)
- Institute for Progress, Preventing the Misuse of DNA Synthesis: The risk of engineered viruses increases as synthetic biology gets cheaper (February 15, 2023)
- Cambridge Centre for the Study of Existential Risk, Safe DNA Synthesis (September 2022)
Podcasts & Videos
- Nuclear Threat Initiative, The International Common Mechanism for DNA Synthesis Screening (February 5, 2024)