People within the life sciences often use the term “synthetic biology” but still disagree on exactly how to define it. One running joke is that if you ask five scientists, you’ll get six different definitions. The term was coined by biotech researchers who wanted to set their efforts apart from ongoing biotech applications. But while synthetic biology represents the latest advances in harnessing the power of genetic code, it actually is part of a continuum in the development of metabolic engineering, genomics, proteomics and bioinformatics. It is indeed noteworthy because it seeks to integrate the principles of engineering with the practice of biotechnology.

Some of the primary synthetic biology naysayers define it as “extreme genetic engineering.” One aspect of this definition rings true: synthetic biology is genetic engineering. “Extreme” isn’t necessarily a pejorative term, either; it can just as easily signify that new genetic engineering techniques are extremely precise, extremely efficient or extremely useful.


One ongoing governmental effort to define “synthetic biology” outlines criteria that distinguish it from traditional genetic engineering – including chemical synthesis and computer-aided design of genetic material. Those two criteria, however, would capture nearly every biotechnology endeavor today. With the help of modern computers and gene sequencing machines researchers can now write genetic code just like computer code. They can then transcribe those genetic sequences into useful biological products such as new drugs or biofuels. Chemical synthesis of genetic code stored on computers is close to standard operating procedure in the biotechnology industry. It is simply more efficient than replicating genetic code in living cells.

There are additional proposed criteria for distinguishing synthetic biology, such as the chemical synthesis of entire genomes and the construction of nucleotides that did not previously exist in nature. People agree that these are characteristics of synthetic biology, primarily because they have been developed by researchers who identify their research as synthetic biology. But such efforts are difficult and rare at present. Narrowing the definition of synthetic biology to this activity would make it a much smaller field, indeed – at least until success and demonstrated utility make these more common practices.

Synthetic biology is part of an ongoing evolution of genetic engineering technology. Therefore, the U.S. government’s oversight of any products produced with synthetic biology falls under the Coordinated Framework for Regulation of Biotechnology. This Coordinated Framework – in place for decades – involves multiple federal agencies and is grounded in science-based assessment of the potential hazards of products that are introduced to the market for consumers. Federal oversight of biotechnology is also rooted in the understanding that genetic engineering does not pose a hazard in and of itself, so products from the biotechnology industry are evaluated on a case-by-case basis for potential risk of hazard.

The J. Craig Venter Institute in May 2014 published a gap analysis of U.S. regulators’ oversight of synthetic biology. While never defining exactly where genetic engineering crosses into synthetic biology, the report authors conclude that there is a key challenge for regulating synthetic biology under the Coordinated Framework. The authors note that genetic engineering of agricultural seeds has evolved in a way that eliminates one potential hazard. Researchers now use mechanical means to effect changes in the DNA of crop seeds instead of genetic code from plant viruses – which was assumed to present the same risk of hazard as the original plant viruses. This particular evolution, however, actually has nothing to do with synthetic biology. But opponents of biotechnology aim to raise suspicion of these new scientific advances by associating them with an undefined term.

The evolution of genetic engineering – whether you call it synthetic biology or not – presents prospects for not only reducing other potential hazards, but also producing new societal benefits. Synthetic biology has been used to produce artemisinin, a treatment for some types of malaria. Another company has used synthetic biology to make nylon from renewable resources, reducing the use of petroleum. Yet another company is using synthetic biology to develop photosynthetic organisms – cyanobacteria, or blue green algae – that can produce biofuels directly from sunlight and carbon dioxide.

The Biotechnology Industry Organization (BIO) has for many years called out the many ways that biotechnology is used to produce greener consumer products – everything from laundry detergent to clothing and food to vitamins. We hope Americans will become more familiar with genetic engineering technologies. Biotechnology processes are inherently cleaner and healthier for the environment than petrochemical processes, because they enable use of renewable resources, are more energy efficient, and eliminate unwanted byproducts. Synthetic biology techniques solve additional manufacturing challenges and have been used to develop renewable chemicals that displace fossil fuels in everyday products like tires, toothbrushes, and running shoes. The reduction of potential hazards and maximization of potential benefits is not a gap in regulation – it is an extremely good thing.

Erickson is executive vice president of the Biotechnology Industry Organization (BIO).