Review and Revision of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA
To reduce the risk that individuals with ill intent may exploit the application of nucleic acid synthesis technology to obtain genetic material derived from or encoding
Select Agents or Toxins and, as applicable, agents on the Export Administration Regulations’ (EAR’s)
Commerce Control List (CCL), 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 the U.S. Government.
In response to public comments, and considering developments in modern biotechnologies, the U.S. Government developed a revised draft Guidance document. A summary of the stakeholder feedback in response to the 2020 Federal Register Notice and of the considerations made while drafting updates is included in a Frequently Asked Questions. The Federal Register Notice, requesting comments on the
Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides, was published on
DATE and is open for public comment for 60 days.
Notable technological developments that were considered as part of the revised draft Guidance include: the ease of conversion between different varieties of oligonucleotides (e.g., RNA to DNA), the ease of fabricating longer genomic sequences from very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 Revised Guidance seeks to minimize the burden on all stakeholders. ASPR seeks stakeholder comments on these updates to evaluate the suitability and impacts of the proposed changes.
Comment submission will close on
DATE.
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