Food allergies are a real and growing public health issue. The U.S. Centers for Disease Control and Prevention (CDC) estimates that 15 million Americans—3.5 to 4 percent of the population—have food allergies. That breaks down to nearly 6 million children and 9 million adults (8 percent of children and 4 percent of adults).[1]

The severity of food allergic reactions varies. A reaction could be relatively mild, or it could result in a trip to the hospital. Severe food allergic reactions send one person to the hospital every 3 minutes; every 6 minutes, that person is experiencing anaphylaxis.

Despite the increasing prevalence of food allergies, many people have not witnessed or experienced anaphylaxis. Here’s the Mayo Clinic’s description of what happens during this life-threatening reaction:

“The flood of chemicals released by your immune system during anaphylaxis can cause you to go into shock; your blood pressure drops suddenly and your airways narrow, blocking normal breathing. Signs and symptoms of anaphylaxis include a rapid, weak pulse, a skin rash, and nausea and vomiting.”[2]

The most common allergens for infants and children are milk, eggs, tree nuts, peanuts, wheat and soybeans, whereas adults most often have allergies to fish, crustacean shellfish, tree nuts and peanuts. Gluten intolerance continues to be a common issue as well. Food Allergy Research & Education notes that even though young children tend to outgrow allergies to milk, eggs, wheat and soy, that process appears to be taking longer than in previous decades. Peanuts, tree nuts, fish and shellfish tend to be lifelong allergies.

Labeling to Avoid the Problem
If you have a food allergy, you have to know what’s in the products you eat. While there are treatments for a reaction, such as antihistamines like Benadryl or an epinephrine injection (e.g., EpiPen), there’s no cure. The only option is to avoid the allergen, and for that, the label is the first line of defense.

In 2004, the U.S. Food and Drug Administration (FDA), reacting to a sharp increase in the number of product recalls, adopted the Food Allergen Labeling and Consumer Protection Act, requiring manufacturers to identify sources of major allergens in the food’s ingredient list in simple language. The act focuses on the eight most common allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans).

According to the rule, unless the allergen is part of the ingredient’s common and usual name (e.g., milk), the label must call it out, either by listing it in parentheses after the ingredient, such as “whey (milk), flour (wheat),” or in a “contains” statement, such as “Contains milk and wheat.”

Food recalls are an expensive business. In my experience, even a “minor” recall can cost a manufacturer as much as $1 million, not including the damage to your brand’s reputation!

Mislabeling is the major culprit in allergen-related food product recalls, accounting for as many as half of the incidents. Quite often, therefore, the solution is as simple as getting the right label on the right product. Common sense is one of your guides here.

Check the labels.
As soon as the labels for your product are received in-house, your receiving clerk needs to check them and read the barcodes. Is the information correct? Assuming all is correct, store the labels in the proper area. And before you load them in the labeler, check them again.

Check the labeling machine.
Neglecting to unload unused labels from a labeling machine can result in mislabeling, so make sure the machine is clear before you load new labels. Also, at the end of the run, remove any excess stock and store it in the proper location.

Use vision-inspection systems.
Vision-inspection technology can also defend against the mislabeling of product. These systems will pick up the shape, size and characteristics of a product and read the label, then compare the data with the known standard.

Precautionary allergen labeling, for example, “May contain milk,” is a voluntary practice that warns consumers of the potential for unintentional and unavoidable cross-contact during the manufacturing process. However, it should be reserved for occasions when you’ve followed Good Manufacturing Practices (GMPs) and still conclude that sporadic cross-contact with an allergen cannot be avoided.

Employ Good Manufacturing Practices
According to the Federal Register, FDA recently revised its current GMPs and preventive controls provisions as required by the Food Safety Modernization Act (FSMA). The preventive controls include requirements for a food safety plan, a Hazard Analysis and mitigation of any risks detected. Facilities also are required to monitor and verify the effectiveness of their controls.[3,4] The Food Allergy Research and Resource Program recommends an allergen control plan that applies the same principles.[5] 

Some companies are using separate manufacturing lines to process products with and without particular allergens. A lock-out/tag-out system helps if you use a common line. The bottom line there is that you’re restricting and safeguarding equipment so that there are machines in the plant that have never been used with a specific allergen, such as peanuts.

The benefit is clear. But what if lock-out/tag-out isn’t practicable in your facility? Then you’re down to basics such as cleaning and some serious incorporation of sanitary design features to reduce cross-contact. Put an allergen control plan in place to establish Standard Operating Procedures (SOPs) for sanitation, cleaning validation and cleaning verification. These SOPs will include clear protocols, sampling procedures and reasoning. They’ll also assign responsibility. The control plan may also include labeling safeguards as described above for prevention of mislabeling.

Teach Your Team
One of the major initiatives within FSMA is a requirement for training. Anyone who manufactures, processes or packages foods will have to have food safety training. That’s a good thing.

Your company probably trains its workers properly. Unfortunately, many do not. A good training program will heighten workers’ awareness of why they’ve been asked to conduct a certain procedure in a specific manner. Without that understanding, the risk of their cutting corners is too great. They need to understand that when it comes to preventing food-allergic reactions, “good enough” is neither good nor enough!

What’s more, the training you need to provide will have to go beyond your full-time staff. Transitional and temporary workers need much the same training as the permanent members of the team, and getting there will have to start with management.

You’ll need a curriculum and training processes. It’s a major initiative. But think about the end results:

•    Consumers stay healthy, with fewer allergic reactions.

•    Your company stays healthy, with fewer avoidable recalls.

That’s worth a lot.   

Jeffrey Barach, Ph.D., is a food scientist who has been responsible for research and development, regulatory liaison activities, teaching, problem solving and troubleshooting. He is a subject-matter expert on issues related to food safety, biotechnology, food irradiation, nanotechnology and other new processing and testing technologies, and serves as a FSMA-qualified individual. He serves as a consultant on FSMA to PMMI, The Association for Packaging and Processing Technologies.

References
1. www.foodallergy.org; “Food Allergy Facts and Statistics for the U.S.”
2. www.mayoclinic.org/diseases-conditions/anaphylaxis/basics/definition/con-20014324.
3. www.federalregister.gov/articles/2013/01/16/
2013-00125/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human#h-13.
4. www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Key_Requirements.
5. farrp.unl.edu; “Components of an Effective Allergen Control Plan.”