The fact of the matter is that there is no consensus definition of what synthetic biology is. However, genetic engineering is generally defined as modifying an organism’s genotype (its DNA) in order to produce changes in its phenotype (its physical nature/appearance/physiology). The use of the word extreme implies that synthetic biology has more pernicious goals than “traditional” genetic engineering. In reality synthetic biology is the rational, widespread application of genetic engineering. The goal of synthetic biology is to compile a list of standardized parts, DNA sequences with known function, which can be used to modify the function of existing organisms. Far from having a detrimental effect, synthetic biology has led to many triumphs such as the production of artificial insulin, which has saved the lives of countless diabetics.
Now that’s insulting. Synthetic biologists are like any other scientists. They are fueled by curiosity and attempts to solve problems. That means that they follow the same ethics and rules as everyone else. “Playing god,” would mean, at the least, losing funding. Also, developed countries where a lot of this research is taking place have policies allowing for research to be shut down if it is dangerous (3).
Synthetic biology is all about using genes from one organism to alter another, as opposed to creating new organisms from scratch. There has only been one instance where a new species was created from scratch using synthetic biology. An experiment to create a minimalistic but still self replicating bacteria cell was undertaken by the J. Craig Venter Institute. In 2016 they succeeded in synthesizing and assembling the parts needed to build a single bacterial cell. It is important to note that this was the whole purpose of the experiment. It would be very difficult to accidentally create a new organism from scratch. If the bioethical philosophy around this type of research shifts and this kind of research is forbidden, it would be very unlikely that new organisms would develop. To learn more about the JCVI minimal cell project, see their website, (2).
With these claims we seek to define the scope of Synthetic Biology.
Synthetic biology is regulated in the US. Synthetic biology relies heavily on the use of recombinant DNA and all facilities that receive NIH funding must comply with the National Institutes of Health (NIH) Guidelines for Research Using Recombinant DNA Molecules. These guidelines mandate that research be carried out under the appropriate risk-based physical confinement conditions. This is put into place not only to protect researchers but to prevent the release of synthetic organisms into the environment. In addition, synthetic biology is regulated by the Coordinated Framework. Under the Coordinated Framework, products produced by genetic engineering are to be regulated by already existing federal legislation. For example, drugs produced by genetic engineering would be regulated by the FDA and any other agency involved in drug regulation. The OSTP acknowledged that products produced through synthetic biology are not inherently more dangerous than products produced by other methods. The ramifications of this policy is that synthetic biology and its products are regulated based on the risk that they pose rather than the process by which they are produced. The United States’ risk based method is entirely different than the EU’s practice of placing more regulation on synthetic biology products simply because they are produced by genetic engineering. The EU’s approach has resulted in the approval of very few genetically engineered products, even though many pose little risk. The FDA, EPA, and APHIS all have existing legislation in place to regulate synthetic biology (1).
Below is a table from the J Craig Venter Institute outlining the regulation of synthetic biology products.
Type Synthetic biology products are not inherently more harmful than products produced through other means. This claim was even supported by the White House Office of Science and Technology Policy (OSTP) when they instituted the Coordinated Framework with the goal of regulating the products of genetic engineering. For an example of the safety and effectiveness of synthetic biology, one has to look no further than the production of insulin. For years, it took literal tons of pig pancreases to produce small amounts of insulin. Through the use of synthetic biology, scientists were able to modify yeast to produce human insulin. The insulin produced by yeast was not only safe and effective, but it no longer required harvesting tons of pig pancreases for very little product. Furthermore, synthetic products that are potentially harmful are subject to regulation by a number of different bodies including the EPA, FDA, and APHIS (1).