Allergen Alert: Proper labeling, rigorous manufacturing can help processors avoid problems

Drew McDonald knows the importance of accuracy in labeling allergens in foods all too well.

The vice president of quality, food safety and regulatory affairs at Church Brothers Produce in Salinas, California, has a 10-year-old daughter who is allergic to peanuts.

“She can’t breathe,” he said. “It’s a very bad reaction. Fortunately, it’s only happened once.”

But that means he and his wife, a food scientist, ask questions when they go into restaurants. And they read food labels, which the Food and Drug Administration requires clearly list in plain language all ingredients – or any protein derived from – the “big eight” responsible for 90 percent of U.S. food allergies: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.

“Under the Food Allergen Labeling and Consumer Protection Act of 2004, those foods must be identified on the label of a packaged food,” said FDA spokesman Douglas Karas.

According to McDonald, labels with ingredients spelled out – backed by good manufacturing practices – are key for people like his daughter.

“The goal is not necessarily to avoid allergens,” he said. “The goal is to make sure we do everything to help allergic consumers to identify offending foods or ingredients so they can avoid them.”

In addition, the Food Safety Modernization Act calls for companies to have preventive controls in place for allergens. Coinciding with that, FDA’s proposed Preventive Controls for Human Food Rule currently out for public comment would require that the hazard analysis of a facility handling food allergens address whether they present significant hazards.

“If so, allergen preventive controls would need to be implemented to prevent cross contact from food allergens and ensure all allergens are properly labeled,” Karas said.

Issues in Fresh-Cut

Steve Taylor, a professor in the Department of Food Science and Technology and co-director of the food industry-funded Food Allergy Research and Resource Program based at the University of Nebraska-Lincoln, said dealing with allergens is relatively new to the fresh-cut segment in comparison to the food processing industry as a whole because the concept of salad kits and produce snack packs has only emerged in recent decades.

“The Food Allergy Research and Resource Program … has 80-plus member companies,” he said. “Most of the big ones who you would see their brands at the grocery store belong … not the fresh-cut industry very much because I think this issue is a little bit newer to them.”

And not all of the eight identified allergens are issues in fresh-cut operations.

“I think the list of allergens most relevant to fresh-cut products could be any of the major and many minor sources, but dairy, tree nuts, gluten, wheat, peanuts and perhaps, egg, would be most common,” said Trevor Suslow, Extension research specialist at the University of California, Davis. He conducts training on topics that include issues of intentional and unintentional presence of allergens in value-added fresh-cut and packaged salads and meal solutions, for which he has developed a detailed PowerPoint presentation.

“Fresh-cut processors have to have a compliant allergen declaration/labeling and contamination preventive control plan in place that includes their suppliers and in-house management activities,” Suslow said.

In general, Taylor said, the most common problems occur with peanuts, tree nuts and milk.

“Milk happens because it’s such a ubiquitous ingredient,” he said. “Peanuts and tree nuts are very potent allergens; people tend to react to pretty darn small doses, so it doesn’t take a very large mistake before someone gets sick.”

Mistakes are probably the biggest culprits in recalls over allergens, which is why internal control plans should include making sure the right label gets put on the right product.

“Industry has and does get that 99.9 percent correct,” Taylor said. “But every time they make a mistake, they have a gigantic amount of undeclared allergen in the wrong package, so it always leads to a recall.

“If you put the walnut-containing salad in the almond salad box, you’re going to have a problem. If you put the walnut salad in a container that’s not supposed to have any allergens in it at all, you’ve got an even bigger problem.”

Good Manufacturing Practices

While Church Brothers does not currently produce salad kits, the company has in the past and McDonald has also worked for others who do. He said the type of product and packaging makes a difference in handling when it comes to allergens.

Kits that have vegetable items with a separate bag or package produced by another manufacturer with a dressing that may contain milk or eggs, or croutons are easier to address.

“Consider labeling – for the retail consumer package, this must be declared, of course, and for the foodservice customer (not common), it must be made clear in a product specification,” he said. “The challenge is to make sure your supplier has clearly identified the ingredients.

“(Although these items) are in a separate package, it is prudent to have them stored separately from other produce ingredients.”

If the kits are assembled on the same line as products that don’t contain ingredient packs, companies should have a separation step of some kind involving a rinse or wash of the equipment between runs.

“A best practice would be to validate that (separation step) is effective in addressing any residual dust from the manufacturer,” McDonald said. “In many cases, the ingredient pack is introduced at the final packaging step so the control point is usually fairly isolated.”

Anticipating the possibility that an ingredient pack could possibly break, companies should also have a spill prevention or control procedure to address the spill, cleanup, produce disposal and process improvement.

It gets more complicated when processors are adding ingredients containing allergens directly to products. Here, separation during storage, control of cross-contamination with other lines and equipment, and procedures that address airflow and related issues are essential.

“The facilities that have exposed allergenic ingredients must have a comprehensive program that focuses on aggressive separation and control of these ingredients,” McDonald said.

At East Coast Fresh in Savage, Maryland, a strict allergen control plan is in place. According to Quality Assurance Manager Bhavini Patel, components include making sure that no allergens are processed on the production floor; instead, they are processed in a separate room. Dips must be in sealed containers to be used in platters and kits. In addition, allergens can only be handled at the end of a shift, after which the production area is thoroughly sanitized.

Taylor advocates using test methods to detect residues.

“Some are lateral flow strips that work like pregnancy tests,” he said. “If you get one line that means the test worked, two lines means you have the allergen you don’t want to have on this equipment surface, so you can test the effectiveness of cleaning within a few minutes.”

Accidental Exposure

Cross-contact can occur when a residue or trace amount of an allergenic food becomes incorporated into another food not intended to contain it. According to McDonald, FDA says that advisories such as “produce in a facility that also uses (insert allergen)” should not be a substitute for adhering to good manufacturing practices.

“According to FDA, they are considering ways to best manage the use of these types of statements by manufacturers to better inform consumers,” he said.

To McDonald, it’s a no brainer.

“It should either be stated that it is there or not,” McDonald said. “For products that contain a separate salad ingredient pack with allergens in it, it should of course be declared.

“For those items that do not, the process and procedures should be implemented and executed in a manner that allows confident label declarations on non-allergenic products.”

Kathy Gibbons, contributing writer



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