This was a small project that I prefer to do early in process development or no later than the start of manufacturing plant design, rather than after manufacturing has started. A client had purchased a fermentation manufacturing process and strain and begun manufacturing. As part of a review of the process, they had provided me with a document from the company that originally developed the strain. This document used the word “engineered” when referring to the strain. This immediately raised a warning flag. Upon further investigation, it turned out that the strain had, in fact, been genetically engineered to improve product yield and not everyone that needed to know this was aware if this fact.

I was asked to review the documentation and provide an opinion as to what, if any, US regulations might apply to manufacturing using this strain. After reviewing the documentation, it was apparent that the company that did the strain development understood the US regulatory environment. In the US, the Environmental Protection Agency (EPA) regulates the use of genetically modified microorganisms in commerce or commercial research under the Toxic Substances Control Act (TSCA). In developing and promulgating these regulations, the EPA specifically limited them to “intergeneric microorganisms”. The EPA defines an intergeneric microorganism as “a microorganism that is formed by the deliberate combination of genetic material originally isolated from organisms of different taxonomic genera.”

In this particular case, the strain developers had clearly documented that they had removed all foreign DNA from their construction except for a gene from another member of the same genus. Therefore, use of the strain is not subject to the TSCA regulations. This was independently confirmed by the client’s outside legal counsel as well. However, the client was well into developing an organic version of their product based on this strain and the discovery that the strain was a GMO required that they stop all work and find a non-GMO strain to use for the organic version of the product. As genetically modified organisms become more common in bioprocessing and biorefining, it is critical that anyone acquiring a new strain have complete documentation of its provenance.

The sciencemag.org article How the transgenic petunia carnage of 2017 began provides several examples of what can happen when transgenic organisms are released without the necessary regulatory approvals. As genetically engineered organisms become more common in commerce, so too does the technology to detect them. Some companies are avoiding GMO entirely, and certainly, no company wants to make the news for releasing an unapproved genetically modified organism.