Oversight policy in synthetic biology

Abstract

Researchers in the emerging field of synthetic biology strive to lower the economic barriers-to-entry into genetic engineering by drawing parallels to the historical development of the semiconductor and computer industries. Standardized engineering methodologies are being developed to create “biological circuits” akin to basic electronic computing functions such as Boolean logic gates, switches, time clocks, communication ports, and environmental sensors. Higher level processing is also being developed by employing common biological molecules such as ribosomes, proteins, amino acids, and nucleotides as computing elements akin to data inputs and outputs, software programming, data memory, and data processing. Researchers are developing standardized, open source engineering methodologies to increase the efficiency and efficacy of biological product development in a manner that draws inspiration from open source software development. With these advancements in synthetic biology come important public policy issues. This paper is designed to uncover a diversity of broad oversight issues by examining case studies from the historical development of the semiconductor industry, information technology, and biotechnology to anticipate future oversight issues with synthetic biology. Similarities and differences between synthetic biology, biotechnology, and semiconductors are examined to determine where it is appropriate to draw oversight comparisons. The issues presented in the cases are framed in the context of four specific biomedical ethical values - autonomy, justice, benevolence, and nonmaleficence. Oversight issues identified in this work include informed consent concerns, biocrimes, bioterrorism, intellectual property rights, product negligence, technology access, and socioeconomic considerations. The current U.S. regulatory framework is examined in terms of its capability to cope with the anticipated sharp increase in synthetic biology and biotechnological capabilities in the private and public sectors. This work concludes that oversight policy may anticipate a dramatic rise in the number of practitioners of advanced genetic engineering as well as the number of bioengineered products as a result of synthetic biology. The sophistication of bioengineered products may also increase as genetic engineers adopt efficient development and manufacturing methods inspired from the semiconductor and information technology industries. Also possible to emerge is amateur bioengineering, or so-called “garage biology”. In many cases, risks from synthetic biology can exceed risks from semiconductor technology due to the ability of living organisms to reproduce, evolve, and interact with human and natural environments in an unpredictable manner.