Technology Factsheet: Synthetic Biology

Executive Summary

Synthetic biology (sometimes referred to as “SynBio”) is broadly defined as the application of engineering principles to biology, and in practice, refers to emerging technology that allows living organisms to be modified to serve user-defined purposes. While traditional biotechnology involves the transfer of smaller amounts of genetic material from one biological species to another, synthetic biology will permit the inten- tional construction of an entire organism.1 It has the potential to allow scientists to design living organisms distinct from any found in nature and to redesign existing organisms to have novel or enhanced qualities.2 The use cases of synthetic biology range from developing new therapeutics and vaccines for infectious disease to manufacturing novel biomaterials, biosensors, and biofuels. As scientists better understand biological systems, the potential applications of SynBio are anticipated to expand in scale and scope.

The continued growth of the bioeconomy—defined as the “production, utilization and conservation
of biological resources, including related knowledge, science, technology, and innovation, to provide information, products, processes and services across all economic sectors”—is giving space for synthetic biology technology to become a more significant part of the overall economic landscape.3 As with any technology that has a high potential for impact, SynBio presents a variety of pronounced opportunities, as well as risks. As the technology continues to mature and the number of market-ready applications grows, it is important for policymakers to consider how to promote the large number of opportunities the technology presents in the space of health and medicine, energy production, environmental recovery, food production, and more, while simultaneously protecting the public from foreseeable negative impli- cations and risks, such as weaponization, consumer safety, and ecological stability.

Since synthetic biology bears significant similarities to previous biotechnology research on genetical- ly-modified organisms and recombinant DNA, existing regulations in the United States place the majority of synthetic biology products into the current biotechnology regulatory framework. As SynBio becomes more prominent though, it will be important for regulatory schemes to uniquely target the technology and its implications beyond those captured through biotechnology frameworks. Policymakers must continue to engage in the progression of the technology, understanding how regulation and governance must evolve to ensure the public can realize the opportunities, while being protected from the risks.