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Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

This guidance has been superseded by the 2023 Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids.

The primary goal of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA – issued by HHS in 2010 – was 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, taking into consideration 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, items included in the Biological Select Agents and Toxins List and the Commerce Control List 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

Reports

2009 Screening Framework Guidance for Synthetic Double-Stranded DNA Providers: This guidance was made available for public consideration and comment in the Federal Register for a period of 60 days beginning on November 27, 2009.​

Response to Public Comments: This Response to Public Comments document provides a general review of the decisions made to alter the Guidance in response to public comments.

Customer Screening References - Guidance Section: V(A)

Sequence Screening Resources - Guidance Section: V(B)

Processes for Domestic and International Orders - Guidance Section: VI












































Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids