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Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

Request for C​omments on the Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides


The public comment period is now open to gather perspectives from experts in the field on proposed revisions to the ​2010 Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA​. Insight from experts will help keep the Guidance relevant and appropriate. This Guidance was issued in 2010 to reduce the risk that unauthorized individuals or individuals with malicious intent may exploit the application of nucleic acid synthesis technology while maintaining an appropriate balance between safety, security, and scientific innovation. 


​​The proposed updates in the Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides are based, in part, on feedback from the public received through a formal Request for Information (RFI). Comments on the proposed revisions published in the Federal Register must be submitted by 5 p.m. EDT June 28.


Learn More and Submit Comments

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 Provide​rs and Users of Synthetic Oligonucleotides​


2010 Final Guidance: Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA​




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