Current Food Production Methods

By Lane Highbarger, EAS Consulting Group Independent Consultant

The past 50 years of research in microbiological pathways have taught us much about genes and the resultant protein products. The discovery of restriction enzymes in the 1970s and the ‘simple’ enzymatic-cut-and-paste of genes that first permitted the ‘simple’ excising of genes from a host to plasmid-based fermentation systems gave way to the current change in fermentation pathways.

The next step was genome-based systems to produce products of interest to researchers and industrial food ingredient producers. Modern sequencing methods, the use of PCR systems to clone genes from any origin sources to generate new microorganisms with new end-point fermentation products, has created a new way to produce many of the food ingredients that are divested from traditional chemical synthesis. There was a brief period when manufacturers thought that plasmid-based systems were good, but too many of those systems required other additional controls.

As research advanced, along with the discovery of thermal-stable DNA polymerases that could be used in multi-pass thermal-cycling PCR systems to amplify a gene, food researchers started to use those new methodologies to produce new ingredients. The use of PCR-based amplification systems permitted the high-volume-generation of genes that could be transposed into microorganisms.

The food industry then shifted to a new paradigm. By inserting into, and removing genes from a host’s genome, industry has generated new pathways that can produce a specific ingredient regardless of the host’s original terminal fermentation product. Many companies have developed ingenious cassette based cloning techniques that permit them to swap out/ insert new pathways to generate the food ingredient of interest.

The next step of the development of food ingredients will likely be unique enzyme mixtures that are no longer dependent on a microbiological fermentation system. Specifically, we have decoded enzymatic pathways and can decouple those pathways from any microbiological or fungal source. As such, industry can develop acellular system that can produce any desired food ingredient.

So, what is the difference? There is a fallacy of one system being better than the other, and that is intrinsic to understanding what is different. FDA has been slow to recognize that – outside of certain parameters – enzymes perform one function. They bind a substrate and convert it to a product. And as such, a manufacturer can pick and choose among many of the off-the-shelf enzymes, or enzymes that the manufacturer can generate – effectively designing their own unique enzymatic pathway that they need to produce their product.

Most importantly, FDA needs to understand that ingredient / manufacturers can modify the known microbial processes of generating an ingredient, and that is secondary to the final terminal fermentation of a microorganism.

A GRAS ingredient or any ingredient that goes through the FAP or CAP process is not about how you produce the ingredient, but rather that the final specifications are met: purity, chemical parameters, and toxicological safety. Fundamentally, there is no difference between a GE microorganism producing an ingredient and one that is generated using an acellular / pure enzyme system.

The challenge for FDA and industry will be to find the best median.