Undeclared allergens caused 60% of food and beverage recalls from the Food and Drug Administration and 65% of the meat and poultry recalls from the U.S. Department of Agriculture during the second quarter of 2013, according to a quarterly recall index published by Stericycle ExpertRecall, Indianapolis, in mid-August. The issue of undeclared allergens has been one of the leading sources of recalls during the past few years. As full implementation of the Food Safety Modernization Act nears, food and beverage manufacturers will be challenged to develop programs that minimize the potential for cross contamination or product mislabeling.

“Allergens continue to be a top recall trend that we see quarter over quarter,” said Mike Rozembajgier, vice-president of Stericycle ExpertRecall. “Manufacturers should make sure that they are reviewing labels and formulations related to a company’s allergen control program before an inspector arrives onsite.”

A study published Sept. 16 in the Journal of the American Medical Association’s Pediatrics calculated the economic impact of childhood food allergies to be an estimated $25 billion annually. The report said food allergy is a growing public health issue in the United States that affects about 8% of children. The condition results in significant medical costs to the health care system but also inflicts substantial costs on families for special diets and allergen-free foods.

The issue of allergens in food has not gone unnoticed by regulatory agencies. In December 2012, the Food and Drug Administration took steps to develop regulatory thresholds or action levels for such major food allergens as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts and soybeans as well as food ingredients that contain protein derived from such foods. The agency’s goal in developing the action levels is to determine what type of enforcement action is appropriate when specific problems are identified at manufacturing plants. The thresholds also will help the F.D.A. determine when the presence of an allergen in a product does not pose a risk to human health or does not contain an allergenic protein.

Allergens also have been identified as a hazard reasonably likely to occur under the Food Safety Modernization Act. As a result, companies that use allergens in their products must include allergen control in their preventive control program. Such a program may include a written hazard analysis that shows what the risks may be of handling allergens and the appropriate measures required to prevent contamination of products with an undeclared allergen.

Supply chain control

Gale Prince, president of SAGE Food Safety Consultants L.L.C., Cincinnati, and an adviser to Stericycle ExpertRecall, said the issue of undeclared allergens is a problem that extends throughout the product development, production and packaging operations of a food company. He also said the issue is somewhat universal.

“I think it’s interesting to note that when you look at recalls for undeclared allergens, whether it is through F.D.A., U.S.D.A. or Canada, the trend lines are about the same,” he said. “It’s clear this is an issue many food manufacturers are struggling with.”

Mr. Prince said an allergen control program starts with product development.

“If I am thinking about adding an allergen to a new product then I need to make sure it fits within the manufacturing process,” he said.

The manufacturing process does not simply include production, Mr. Prince said. A focus needs to be paid to education and training.

“Once it’s determined the ingredient is needed, then it’s important to make sure the processes are in place to control it,” he said. “This includes receiving, product development, formulating, training the processing staff, the Q.A. staff and even the people who are buying the ingredients. Someone needs to take a look at the supplier of an ingredient and understand the risk of working with a particular supplier. Are they handling other allergens in their operations, and what are they doing to avoid cross contact?”

Within manufacturing, it is imperative the processing staff is knowledgeable about the handling and use of ingredients that are considered allergens.

“Employees need to be familiar with the ingredient and the control measures that relate to it,” Mr. Prince said. “To avoid cross-contact with products that do not contain the allergen everything must be considered. This can include the scoops used to put the ingredient into a product to how the product and ingredient flow through the production process.

“After production, then cleaning and sanitation become important. In the end, it comes down to how well a cleaning crew cleans a piece of equipment to ensure the allergen’s protein residue is removed. This can involve a visual inspection to make sure the cleaning has been done properly, and a testing procedure to verify the cleaning has been done properly.”

Packaging line checkpoints

Mr. Prince was emphatic that once an operation has its receiving, ingredient handling and manufacturing process developed to control products that include allergens, it is important for manufacturers to not let their guard down. Packaging and labeling are the sources of many recalls for undeclared allergens.

“Many times a recall occurs simply because the wrong product is in the wrong package,” Mr. Prince said. “There needs to be multiple checkpoints making sure this doesn’t happen, because the consequences can be very serious if someone with a severe allergy consumes a mislabeled product.”

Areas within packaging that need to be addressed include the receiving of new labels, he said.

“They need to be inspected to make sure the allergen is listed properly,” he said.

Extra attention also must be paid at the end of a production run to ensure all of the film is removed from the machine and stored properly.

“It’s also important to have a Q.A. step at the end of the packaging line to make sure the labels on products are correct,” Mr. Prince said.

Sanitary equipment design has been a focus across food manufacturing categories and it is another element of an allergen control program.

“I am currently dealing with a project of sanitary design of bakery equipment,” Mr. Prince said. “Since bakeries are high on the list of recalls related to allergens, it is very important to be able to clean the equipment. Ledges that can’t be reached or spaces where a residue may get trapped are all issues. Many bakers deal with nuts and could end up with a piece of nut in a product that became stuck in a piece of equipment and then dislodged during manufacturing.”

While only a small percentage of the U.S. population has a food allergy, as the Pediatrics study shows the cost to those with a food allergy is high. Mr. Prince looked at the situation a bit differently. He noted that consumers with a food allergy tend to be very brand loyal once they find a product that fits their needs.

“That has value,” he said. “That brand loyalty comes from confidence in a company and a specific product. A key to getting that value is a strong allergen control program.”