Request for Comments on the Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides
Public Comment Submission Period Has Closed
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 U.S. Government issued guidance in 2010 providing a framework for screening synthetic double-stranded DNA (dsDNA). This document, the
Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (or Guidance), sets forth recommended baseline standards for the gene and genome synthesis industry − and other providers of synthetic dsDNA products − to screen orders so that they are filled in compliance with U.S. regulations prohibiting the possession, use, and transfer of specific pathogens and biological toxins (42 CFR part 73, 7 CFR part 331, 9 CFR part 121, and 15 CFR part 774).
Rapid and continued advances in nucleic acid synthesis technologies and synthetic biology applications necessitate periodic reevaluation of associated risks and appropriate mitigation measures. To determine how risk mitigation measures should be balanced with the need to support both scientific progress and the success of the U.S. biotechnology enterprise, the HHS Office of the Assistant Secretary for Preparedness and Response issued a Request for Information for the
Review and Revision of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA in the U.S. Federal Register, on August 26, 2020. Comments received in response to this Notice were considered by HHS.
In response to public comments, and considering developments in modern biotechnologies, HHS developed a draft Revised Guidance document. In support of this draft Revised Guidance, HHS also produced a summary of the stakeholder feedback and
Frequently Asked Questions. In order to promote transparency, an anonymized version of the public comments are also available. The
Federal Register Notice, requesting comments on the Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides, was published on April 29, 2022, and was open for public comment for 60 days.
Notable technological developments that were considered as part of the draft Revised Guidance include: the ease of conversion between different types of oligonucleotides (e.g., RNA to DNA), the ease of fabricating longer genomic sequences from very short oligonucleotides with high accuracy, and the notion that modern synthetic biology is not limited to naturally derived genetic material. Additionally, the draft Revised Guidance seeks to minimize the burden on all stakeholders. ASPR sought stakeholder comments on these updates to evaluate the suitability and impacts of the proposed changes between April 29 and June 28, 2022. Public comments are currently under consideration.