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Addressing Biosecurity Concerns Related to the Synthesis of Select Agents

DNA synthesis technology, in combination with other rapidly-evolving capabilities in the life sciences, such as directed molecular evolution and viral reverse genetics, has galvanized segments of the scientific community.1 It also has captured the attention of the general public and policymakers, and prompted far-reaching questions about the potential uses of these techniques—including the synthesis of novel forms of life. These techniques promise to accelerate scientific discovery and provide access to previously-unexplored biological and molecular diversity.. This technology also is employed in the field of Synthetic Genomics 2 to
create sophisticated live vaccines and to discover new therapeutics for infectious diseases. However, this same technology can be misused to generate dangerous pathogens de novo that are subject to oversight, thus circumventing the extant regulatory framework for controlling the possession and use of such organisms. This dichotomy illustrates the dual use nature of synthetic genomics and underscores the need to develop strategies to address the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security.

This report describes the biosecurity concerns identified by the NSABB Working Group on Synthetic Genomics that are raised by the ability to reconstruct Select Agents de novo, the Working Group’s assessment of the adequacy of the current regulatory framework to safeguard against the misuse of this science and its recommendations for addressing these concerns. These recommendations were approved by the NSABB on October 25, 2006 for submission to the USG.


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