FDA’s Hostile Take-Over of GRAS, Part III: It Started Earlier Than We Think

You would think any application of the GRAS1 process would be a legitimate pathway to federal compliance unless expressly prohibited by statute (e.g., color additives, dietary supplements) or by regulation (e.g., 21CFR2§184.1(b)(2));3 the latter of which requires a food additive petition (FAP) be filed for any additional use, use levels or changes to the manufacturing process of an otherwise GRAS affirmed substance.4 So far, so good for many food ingredients, until you get to the subject of irradiation5 of foods — as a process in and of itself or even a means to an end.

A Short History of Food Irradiation

The idea of the benefits of irradiation of foods became popular in the early 1950s although it had been used as early as the 1920s to kill insects in cigars (use for cigars was discontinued as the source of irradiation was from x-ray machines that constantly broke down from the work load). The use of ionizing radiation of food became popular once again under President Eisenhower’s “Atoms for Peace” program initiated in 1953. High energy (ionizing) radiation was applied to food using gamma rays (e.g., cobalt-60 or cesium-137), electron beams and improved x-ray equipment. Initial results were successful with demonstrable delays in ripening of food, pathogen reduction and food-borne illness, controlling pests and allowing long-term food storage. However, when tests were initiated on the effects on food, it was found that in response to high energy irradiation, “radiolytic products” were formed and some B-type vitamins were destroyed. Although many of the same effects were seen in conventional food processing involving heat, revelations of less nutritious food and myths about “radioactive food” were enough (even in a pre-internet world) for timorous souls to prod Congress to include a mention of irradiation in the Food Additives Amendment of 1958. Congress defined “…any source of radiation…” as a food additive, unless it is generally recognized as safe (GRAS). However, FDA has declared that all forms of irradiation, including all sources of high energy (io