Reducing Allergen Recalls Under FSMA

With the Food Safety Modernization Act’s preventive controls rule now in effect, it’s the perfect time to explore one of the most widespread issues in the food industry—allergen recalls. Let’s explore the issues at hand, the challenges, and the solutions.

The Issues

Food allergens are a scary reality for many consumers. Roughly 3-6 percent of children and 2-4 percent of adults are allergic to one or more of the eight common foods that cause 90 percent of all food allergen reactions in the U.S. Known as “The Big 8,” these food groups include milk, egg, peanut, tree nuts (14 of them including coconut), fish (species specific), crustacean shellfish (species specific), wheat, and soy. The Big 8 are used in tens of thousands of food products that use one or more of these allergens as an ingredient in their formulation.

An allergic reaction can be triggered by a minuscule amount of any one of these allergens and the reactions vary, ranging from a tingling of the mouth and lips to vomiting and diarrhea, to respiratory difficulties, blood pressure issues, and even death due to anaphylactic shock. Every year, about 3,000 consumers die and tens of thousands seek emergency medical treatment to reverse the effects of their allergic reactions.

The only way allergic consumers can protect themselves is by completely avoiding the allergen they are allergic to. In order to succeed, this involves three fundamental principles:

1. Allergic consumers are responsible for reading the ingredient statement of the food to determine whether or not the particular item contains the allergen they must avoid;
2. Allergic consumers must always be prepared for accidental exposure by carrying an epinephrine injector and emergency contact information; and
3. Those manufacturing, preparing, and serving food must provide safe food by preventing cross-contact, as well as accurate information to enable consumers to avoid allergen exposure.

The Challenges

In spite of the obvious associated health hazards and the seemingly simple solutions to allow consumers to avoid specific allergens, the food industry is still struggling to bring this issue under control. The pie chart containing the annual Reportable Food Registry for fiscal year 2015 shows that allergen recalls continue to be the number one reason for food recalls in the U.S., with 47 percent of total recalls. This is followed by two pathogens, which combined, account for another 44 percent of the recalls.

Perhaps more importantly would be to know why allergens are the number one reason for food product recalls in the U.S.

A search for root causes leads us to two basic operational failures, one dealing with label control and the other to allergen cross-contact. First, and most common, is the failure to declare the allergen(s) contained in the product on the information panel of the package, as required by labeling regulations. Examples include outright omission of the allergen or not using the common name. Such labeling errors are the result of lack of controls at the supplier of labels or computer errors in the in-house printing of finish product labels. Another example is putting a product containing an allergen in the wrong packaging material, say of another similar product, which does not contain the allergen. The omission of declaring an allergen at the supplier level can result in a carry-through of such “hidden” allergen into the final product, again resulting in a misbranded finished product in the market. Another example of labeling failure is the result of a product formula change that is not carried through to the label.

The second type of failure that leads to a misbranded product subject to recall is the result of allergen cross-contact. Basic root causes include ineffective allergen cleanups of food contact surfaces of shared equipment and utensils; inappropriate cleaning practices, such as the use of high air or water pressure; not using dedicated utensils for allergens; inappropriate personnel practices and clothing; lack control of rework (like-into-like); and the accidental use of a wrong ingredient containing an allergen. Unfortunately, these types of operational failures are invisible to the consumer who will buy the product based on reading the content of the ingredient declaration.