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Synthetic biology promises to be one of the most exciting developments in bioengineering. Through synthetic biology, scientists can now recreate the genomes of extinct organisms, modify existing organism to give them functions that they previously never possessed, and eventually create novel organisms entirely. Synthetic biology has attracted the attention of both professional scientists as well as the attention of a growing movement of amateur biologists, a testament to the increasing democratization of previously rarefied science. As a result, while this powerful new technology, along with the increased dissemination of its techniques and methods, may lead to greater influence in the future and to substantial benefits for society, it also raises concerns for biosecurity. Consequently, scientists and policy makers have begun to seriously consider the issues posed by this developing science in the context of a world where such knowledge and technology is becoming widely accessible to the general population. Part one of the paper will provide background on synthetic biology and do-it-yourself biology, briefly describing their nature, prospects, and risks to biosecurity. Part two of the paper will shift the focus from description to evaluation. It will summarize some of the existing policy responses to this issue and legal infrastructure within the United States before arguing for a holistic approach to addressing this issue. Then the focus will be upon three separate areas of possible regulation while noting some of the interconnections between these areas.

The Mad (and not so Mad) Scientist Next Door: A Holistic Approach to Addressing Do-it-Yourself Biology