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.
Tanji, Todd. Oversight Policy in Synthetic Biology. Sept 25 2009. Oct 5 2009. Hubert H Humphrey Institute of Public Affairs
Plan A paper in partial fulfillment of the requirements for the degree of Masters of Science in science, technology, and environmental policy
Oversight Policy in Synthetic Biology.
Hubert H. Humphrey Institute of Public Affairs.
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