Review and Revision of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

Résumé

Synthetic biology is a multidisciplinary field of research that involves the design, modification, and creation of biological systems and holds broad promise to advance both basic and applied research in areas ranging from materials science to molecular medicine. However, synthetic nucleic acids and associated technologies may also pose risks if misused. 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 and 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 (Guidance), sets forth recommended baseline standards for the gene and genome synthesis industry and other providers of synthetic dsDNA products, regarding the screening of orders, so they are filled in compliance with U.S. regulations prohibiting the possession, use, and transfer of specific pathogens and biological toxins. Th