More individuals than ever before have access to the reagents and techniques needed to develop lifesaving medicines, materials with new and useful properties, and innovative approaches to producing complicated chemistries. This democratization has also increased the risk of malign or irresponsible use of biotechnologies. In particular, the increasing availability of synthetic genetic materials may pose public health risks ranging from de novo synthesis of dangerous viruses to the enhancement of other microorganisms through the transfer of hazardous genes. This may warrant new approaches to ensuring that certain genetic materials are accessible only to legitimate researchers.
In this volume of a two-volume report, the authors consider how regulations can be extended to encompass genetic components of microorganisms or toxins that are not currently regulated by the Federal Select Agent Program (FSAP) and offer recommendations for implementing new regulations. The recommendations are framed in terms of maximizing the benefits of biosecurity risk reduction and minimizing the unintended burdens on industry and the research community.
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