Following the thought of the creation of new nucleotides, the x-y pair (see Synthetic Biology Advances With No Oversight, 7/15/14), synthetic biologists at Yale and a separate group at Harvard have constructed genetically altered organisms that require special synthetic amino acids to live. Synthetic biologists reason this makes the synthetic organisms safer since they would die if released into the environment that lacks the amino acid.
This breakthrough would eventually allow synthetic organisms to be raised in laboratories for use in experimentation. According to an article in the January 22, 2015 volume of Nature entitled Safety boost for GM organisms “The microbes also do not swap their engineered DNA with natural counterparts because they no longer speak life’s shared biochemical language.” The article continued with a quote from a Yale synthetic biologist, Farren Isaacs who said, “Establishing safety and security from the get-go will really enable broad and open use of engineered organisms.”
While this does provide another layer of security to the development of synthetic organisms, it still begs the question of when there will be proper regulation of synthetic biology. This is not to say there is no regulation today, for there is. It is as if we have a bedspread that has been pulled in many different directions as we try to cover a synthetic biology spot by expanding existing coverage of a wide array of bureaucratic organizations each of which are designed to respond to other priorities.
This is like stating that in an environment where everyone is responsible, no one is. The closest anyone comes to directly regulating this area is the National Institute of Health (NIH). The law requires that any entity that receives money for research from the NIH must adhere to its guidelines that cover synthetic biology. Everyone else is free to follow the guidelines or not, or worry about another governmental agency with a regulatory role that can be extended to synthetic biology.
The Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), the Food and Drug Administration (FDA), the Commerce Department and the Department of Health and Human Services (HHS) all have overlapping responsibility for Synthetic Biology. It is doubtful that any of them has been given any additional budget to extend their regulation to include synthetic biology. Let us reiterate that when all are responsible, no one is responsible.
There is a thorough description of the patchwork quilt of regulation of synthetic biology which can be found by accessing “synberc.org/safety-and-security-resources” and selecting the “The Regulation of Synthetic Biology: A Guide to U.S. & European Regulations, Rules & Guidelines.”
Synthetic biologists are working to solve humanity’s problems. Today they are largely self-regulated. This must change. There must be regulation but it should be one regime that is worldwide (maybe from the U.N.) and assures that humans will not unleash a foreign organism into the world’s environment.
Use the following sites to gain additional information or access the original documents that were used to generate this article.
Access “synberc.org/safety-and-security-resources” and select the “The Regulation of Synthetic Biology: A Guide to U.S. & European Regulations, Rules & Guidelines.”