Building International Best Practices For Robust Synthetic Nucleic Acid Screening

Advances in nucleic acid synthesis continue to propel life sciences research forward, enabling innovation across health, agriculture, sustainability, and more. Yet, these advancements also bring biosecurity risks, as synthetic nucleic acids could be misused to create harmful biological agents. While nucleic acid synthesis providers commonly screen customer orders and sequences to manage these risks, the adoption of screening practices remains inconsistent both within countries and around the world. Additionally, the emergence of new tools such as artificial intelligence and machine learning are accelerating biological design capabilities, further increasing the ability to generate or conceal harmful sequences.

This project aims to establish a set of internationally recognized best practices for nucleic acid synthesis screening through a coordinated global approach. By engaging with academic, industry, government, and non-profit stakeholders, this initiative will build on EBRC’s previous work to enhance biosecurity and ensure screening practices are robust and resilient to evolving technological risks.

Upcoming Workshops

A series of international in-person and virtual workshops will support the development of these best practices. Further details will be announced as locations and dates are confirmed.

Project Goals

This project seeks to:

  • Build international consensus on best practices for the nucleic acid synthesis industry, focusing particularly on customer and sequence screening methods that will be resilient to current and emerging evasion techniques, leading to greater adoption and implementation of robust screening methods.
  • Establish an informal global consortium of stakeholders representing industry, government, academia, and the non-profit sector to engage in ongoing dialogue to adapt or revise these practices as the risk landscape changes.

Background

The ability to synthesize nucleic acids is revolutionizing research and innovation, offering powerful tools to address pressing global challenges, from developing novel medicines to creating resilient crops. However, as these capabilities grow, so does the need for safeguards that prevent misuse. Nucleic acid screening is a cornerstone of these biosecurity efforts, allowing providers to identify and restrict access to sequences of concern (SOCs) that could be exploited to create harmful biological agents.

Globally, initiatives such as the International Gene Synthesis Consortium (IGSC) have been pivotal in establishing screening standards for member organizations. The IGSC’s voluntary guidelines are widely adopted by these synthesis providers, which has enabled more secure handling of nucleic acids. However, while these standards set an important precedent, gaps remain. Screening practices are inconsistently applied across different regions, and rapid advancements in emerging and converging technologies continue to present new challenges. Furthermore, stakeholders outside of industry may have important contributions to make to the development of best practices for providers of nucleic acids and their customers.

In collaboration with the U.S. National Institute of Standards and Technology (NIST), EBRC has worked with stakeholders to refine best practices in synthetic nucleic acid sequence screening, focusing on harmonizing standards and enhancing security protocols to address emerging risks. This partnership has underscored the value of coordinated efforts, taking the needs, capabilities, and priorities across industry, customers/researchers/institutions, and policymakers into account.

Given diverse regulatory landscapes and region-specific research environments, a unified global strategy is essential to close gaps in screening practices and establish consistent, effective biosecurity standards worldwide. This project builds on these previous efforts, aiming to develop an internationally aligned framework for nucleic acid synthesis screening. By bringing together stakeholders across industry, government, academia, and nonprofits, we seek to ensure that screening practices are robust, adaptable, and globally coordinated to support both security and innovation.