Jamie Valenti-Jordan is the CEO of Catapult Commercialization Services, a US-based consulting group focused on commercializing new food and beverage products, including emerging brands. Their primary focus is the execution of the technical and operational solutions that bring ideas to life.

Many in the Startup CPG community have wondered about irradiation as a means for sterilizing food, but it’s a risky endeavor given the challenging regulations on the process.

Food Irradiation Defined

Irradiation of food, or the treatment of food with ionizing radiation, is a highly effective form of sterilization of product, even inside its final packaging. It works on the principle of targeting all DNA in the treatment zone and destroying it, specifically its ability to replicate. This technology targets pathogenic and spoilage organisms, regardless of their ability to form spores. It also destroys the DNA in the product, but since the body’s digestive system does this as well, there is no real incidental impact to the digestibility of the food. Likewise, products are generally kept inert through their shelf lives, so there is no impact on quality since no DNA expression or replication is desired during the shelf life of most foods.

Irradiation is Banned for Most Applications

That said, the general fear of irradiation (due to Cold War associations) has led to an extremely limited authorized use of irradiation in food applications. Furthermore, anything treated with irradiation must be labeled as such. In fact, several other preservation technologies (such as HPP) have since been developed and more widely and rapidly accepted by the industry. This slow adoption has been primarily driven by the strict language in the Code of Federal Regulations (CFR), or the regulations passed by several groups within the US Federal Government (who also have Cold War-length memories).

The section of the CFR that generally deals with the irradiation of foods is 21CFR179, but the most important section is 21CFR179.26b. This section refers to the current allowed uses of irradiation in products intended for human consumption. Note that the use is specific for the food and if you do not use irradiation for the very specific material + use combinations, you will be out of compliance. Out of compliance means that you have generated a food that the CFR does not necessarily deem to be safe because it is “adulterated with radiation”. The food may actually be safe, but without the blessing of a CFR protected material + use case, it is not allowed to be sold in the US. Anyone caught selling such products would be subject to a complete product recall, costs for product destruction, a fine, and possible personal criminal liability.

The Barrier to Novel Applications

In order to get additional uses approved and added to 21CFR179.26b, there is a process that looks not too dissimilar to GRAS certification of new ingredients. The difference is the need to codify the results and safety parameters, which involves dealing with multiple branches of the US Government. The process takes years. So for all its virtues, irradiation remains a technology mostly inaccessible by the food industry to this day.

Given how long it would take to cut through the red-tape to get approval for this processing technology, most brands opt for traditional thermal sterilization or HPP + cold chain distribution.

Additional Background

Good technical primer from IFT (Institute of Food Technologists) written by a researcher with the USDA:

https://www.ift.org/news-and-publications/food-technology-magazine/issues/2019/september/columns/processing-food-irradiation