Security

• Enabling Quality, Measurable Synthetic DNA Sequence Screening

  This project aims to improve DNA synthesis screening by enabling the development of better tools and mechanisms for screening performance evaluation. Synthetic DNA enables life sciences research that can be applied to pressing societal challenges across many sectors, but could also be used in the development of biological parts, systems, or organisms that cause great harm to human, public, or environmental health. Many companies that produce and sell synthetic DNA screen ordered sequences to prevent customers from inappropriately accessing Sequences of Concern (SOCs). However, they lack tools to evaluate the performance of their screening systems. Such tools are crucial as technical capabilities in engineering biology, artificial intelligence, and other areas grow.

  • Report Released ⇓
  • Project Summary ⇓
  • Background ⇓

  Report Released

  The report resulting from this work, Strengthening a Safe and Secure Nucleic Acid Synthesis Ecosystem: Outcomes of EBRC Stakeholder Engagement, was published in January 2025 and presents findings, best practices, and recommendations for quality, measurable nucleic acid synthesis screening. Read it here and stay tuned-in to other EBRC efforts to support and enable quality nucleic acid synthesis screening:

  • Building International Best Practices For Robust Synthetic Nucleic Acid Screening
  • Stress Testing of Nucleic Acid Synthesis Screening

  Project Summary

  EBRC, in partnership with National Institute of Standards and Technology (NIST), seeks to convene stakeholders to i) articulate the structure and properties of a SOC database(s), with consideration for security and access controls, and the screening tools that will be needed for its use by the nucleic acid synthesis industry; ii) develop a test dataset—or describe the characteristics of a test dataset—that can be continuously updated, to support standards for, and conformity assessment of, effective nucleic acid synthesis screening; and iii) support and/or advise NIST, the DNA synthesis community, and/or the Customers and Users of synthetic DNA in the implementation and use of new frameworks, tools, and/or best practices.

  Working with NIST and the engineering biology community, EBRC will:

  • Identify key issues and considerations that effectively address project aims.
  • Hold a series of virtual, 1-2 hour-long workshops to discuss the identified issues with the wider stakeholder community, beginning in the spring of 2024.
  • Convene an in-person workshop in the fall of 2024 to give identified challenges and issues dedicated discussion and work time.
  • Publish a project report and/or white paper(s) with the project findings and recommendations.

  For more information or to sign up for the project mailing list, please click here. This project is sponsored by NIST. See the press release here.

  Background

  Defining nucleic acid sequences of concern (SOC) is a significant challenge. In 2010, the U.S. Government’s Department of Health and Human Services (HHS) issued the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA. “The Guidance” set forth voluntary baseline standards for screening, including recommendations that were largely focused on identifying “sequences derived from or encoding Select Agents and Toxins” and sequences that may be subject to export controls. Even then, it was recognized that many sequences beyond those coding for listed agents or toxins could cause harm. In October 2023, HHS released Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids, which seeks to address the technical advances that have occurred in the past 13 years. It recognizes that defining and determining which sequences constitute a SOC is challenging and that a database of known SOC may not yet exist, and it encourages industry consortia and/or any other interested parties to continue to develop such a database for screening SOCs. The Biden-Harris Administration Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, also released in October 2023, directs Federal Agencies to establish a framework to encourage nucleic acid screening, including through the development of standards. The EO specifically directs NIST to engage with industry and other stakeholders to develop specifications for effective screening, best practices for managing SOC databases, and best practices for conformity-assessment.