The primary goal of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA is to minimize the risk that unauthorized individuals or individuals with malicious intent will obtain “toxins and agents of concern” through the use of nucleic acid synthesis technologies, and to simultaneously minimize any negative impacts on the conduct of research and business operations. The Guidance was developed, in light of providers’ existing protocols, to be implemented without unnecessary cost and to be globally extensible, both for U.S.-based providers operating abroad and for international providers.
Providers of synthetic dsDNA have two overriding responsibilities in this context:
- Providers should know to whom they are distributing a product
- Providers should know if the product that they are synthesizing and distributing contains, in part or in whole, a “sequence of concern"
The Guidance outlines a screening framework that will assist providers in meeting both of these responsibilities. Though certain guidance provided in this document is necessarily framed by U.S. policy and regulations, the Guidance was composed so that fundamental goals, provider responsibilities, and the screening framework could be considered for application by the international community. In particular, though the Select Agents and Toxins and the Commerce Control List items that are the primary focus of the Guidance may not be relevant for all countries, the sequence screening framework can be applied to other categories of agents and toxins that may be relevant for other regions.
2022 Request for Comments: Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides
2010 Final Guidance: Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA