'Food Allergies are a Public Health Issue.'

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With about 32 million Americans allergic to at least one ingredient or food, airtight allergen risk management protocols can make all the difference to a vulnerable population.

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October 12, 2021

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As a food allergy mom, Hillary Carter goes several steps beyond scrutinizing package labels. She calls companies that manufacture products her family wants to eat to learn about their allergy testing practices and how they make sure ingredients are truly safe.

“We are not the family that goes to restaurants — and we are not the family that chooses to try any brand without researching it,” said the mother of two boys, ages 8 and 10, who have a number of food allergies, from peanut to banana and gluten.

The Carters had always trusted one company for bacon, hot dogs and deli meat. So when she saw the certified-organic brand’s gluten-free chicken nugget, Carter carefully read the packaging and purchased the product with confidence. On a Sunday night in December last year, she made them for dinner.

“Immediately, my youngest started coughing,” she said. “I tried not to panic, took a deep breath and I’m thinking, This is a trusted brand. We are OK. There is nothing unsafe in this. Well, three or four coughs later, I noticed he was getting worse, and his nose was running, and he was getting hives around his eyes. As a family, we follow the rule that any two body systems constitute an anaphylactic reaction.”

Carter quickly ran for the medicine kit that includes an Auvi-Q epinephrin injector. Her son, Grayson, said his throat and chest felt tight. She used his Auvi-Q, called 911 and administered his inhaler while waiting for the ambulance to arrive to take him to the hospital. During the short ride, Grayson needed two more epinephrine shots and Carter was frantic that the medicine wasn’t working against his near-fatal reaction to the chicken nuggets.

Ultimately, Grayson was given four doses of epinephrine, steroids, antihistamine, Pepcid, albuterol, oxygen and a fluids drip before his reaction was controlled in the emergency room. He finally stabilized and was transferred to nearby Yale Hospital in New Haven, Conn., where there is a pediatric intensive care unit. Fortunately, he never had to be admitted into the intensive care unit.

After returning home the next morning, Carter contacted the company and they immediately responded with an apology, and a promise to perform testing and quality control measures to get to the bottom of the issue. Carter had kept the packaging, so it was tested for peanut, tree nuts, gluten, milk, egg, soy, sesame, mustard, chickpea and green pea. Eventually, they discovered the gluten-free nuggets did contain gluten.

“They were as shocked as we were,” Carter said. “They were incredibly transparent and because of this, they did a pilot program and changed their testing. They entered in a relationship with FARE to provide food allergy education. They are proactively making sure they are a safe producer for the food allergy community. But, at the end of the day, they lost my family as loyal customers.”

“Knowing what we are eating is not a ‘nice to have,’ it’s a ‘have to have.’” Hillary Carter, food allergy mom

Unfortunately, situations such as this occur when the most rigorous allergen testing processes are in place. There are three ways allergens can slip through even stop-gap food safety protocols: an unexpected allergen in ingredients (possibly from a supplier), cross-contact in the facility and mislabeling.

“Each of these situations is very real and happens,” said Emily Kaufman, president at Emport, which supplies allergen test kits for the food industry. “Each requires a different set of questions, answers and procedures to safeguard against them.”

The Supply Side.

How do you know suppliers’ ingredients are allergen-free? “There are a lot of questions that can be asked to minimize the risk,” Kaufman said. “If your suppliers aren’t the ones growing, processing or creating the ingredient, what assurances are they getting from their suppliers?”

The key is to trace back ingredients to their source. And find out what controls your suppliers have in place.

“If you are getting dried fruit from a facility that also handles nuts, you should know that and find out what they do to confirm that they are separating those,” Kaufman said. “It is worth the time to run some quick tests when the product comes in … to get a ‘traffic signal’ to bring it in or hold up. Or, you can send a sample to a lab by lot number, pallet or shipment. There’s no hard and fast rule on how much testing is enough testing.”

If you ask a supplier about how they verify ingredients from their sources and they say, “We know it’s fine,” this is a red flag, Kaufman warned. “A reputable vendor should be happy to talk with you about the safety plans they have in place,” she said. “If all they can give you is blanket assurance that an ingredient is not a problem and they can’t tell you how they know this, that’s a problem.”

Preventing Cross-Contact.

Cleaning processes are key to prevent cross-contact. “If you are running granola bars on one processing line and some have nuts while others do not, how do you manage that through sanitation, scheduling, label checks and awareness?” asked Hilary Thesmar, chief food and product safety officer and senior vice president of food safety at FMI, the food industry association.

Thesmar emphasized this fact: “Food allergies are a public health issue.”

About 10% of the United States population has a food allergy of some kind. “For the 32 million Americans whose lives depend on testing protocols, knowing what we are eating is not a ‘nice to have,’ it’s a ‘have to have.’ We need to know what is in our food and where it comes from,” Carter said.

For one, employees should be empowered to stop the line if they recognize there is a contamination or cross-contact issue, Thesmar said. “There needs to be a communication system and employees need to be trained and given the authority to stop the line if they notice a mistake,” she said. “Companies need to trust their people to do the right thing and flag issues that could be a problem so they don’t become a bigger problem.”

Review every part of your process and ask, “What if?” Kaufman advised. How are you confirming that allergen-containing ingredients are separated from other ingredients? From shelving to coding, there are some simple protocols that can go a long way toward preventing cross-contact. You don’t need high-end software or technology. “You can use color coding on ingredients and equipment, and you can design isolated areas to store your allergenic ingredients. If that’s impossible, you can at least store them on the bottom shelf to minimize the risks from spillage,” Kaufman suggested.

Put systems in place to ensure the correct ingredients are pulled for the recipe. “It could be as simple as matching a symbol on the box or tote to a symbol on the recipe,” Kaufman said. “Maybe everything that goes into chocolate chip cookies has a triangle.”

Test ingredients, not just the final product. Testing should be conducted at various points of the production process. “What’s tricky about unexpected allergens is they are usually unevenly dispersed; there can be hot spots. Testing at multiple stages gives you a better chance of catching any problems,” Kaufman said.

Cleaning is another aspect of preventing cross-contact. Protocols will vary based on the type of products you produce, Kaufman pointed out. “A factory that works with sticky dough will need different cleaning processes than a factory that works with whole nuts or a facility that works with very small pieces of nut,” she said.

Regardless of what you make, you must prove that the cleaning processes are effective, and this also requires testing. “How can you confirm and prove that your system works?” Kaufman asked.

Right Ingredients, Right Package.

In 2020, the Food and Drug Administration (FDA) reported that 52% of recalls were due to undeclared allergy labeling. The Department of Agriculture (USDA) reported a rate of 42%. This year, the FDA recorded 48% of recalls due to labeling, with the USDA at just under 30%.

“You have probably seen recalls where a product is put in the wrong package and it contains an allergen, and we see this with all different products, a classic example being ice cream,” Thesmar said. “You open a chocolate ice cream package and, oops, it’s rocky road and now your allergen profile has changed completely.”

A silver lining: Since many allergen-related recalls are due to labeling and packaging, “this should be reassuring for manufacturers and individuals that companies are, in fact, doing a really good job of maintaining safety practice,” Kaufman said.

But the labeling issue must be addressed. And again, the simplest systems can be put into place. Kaufman shared how one suggestion she heard was to print out a transparency of the packaging ingredient list. Before the product is released from the line, someone’s job is to take the transparency, lay it over the box and make sure the ingredients match. “It takes a few seconds to do, there’s no training required, and it helps if you pulled the wrong package for the product,” she said.

Package labeling errors can include when a design is updated, too. “A level of checking should happen before the package is even produced,” Kaufman said.

Perform visual checks. “Take the item out of the package and make sure it looks as it should,” Kaufman said. And, have an extra set of eyes on packaging. “Confirm that the ingredient list matches a transparency, do a visual check and possibly a rapid test and have someone sign off on that combination — document it,” she advised.

Allergen risk management practices are a must-do — and the cost and time required to test ingredients and verify suppliers’ protocols is nothing compared to the food waste, economic loss, reputational damage and health risks of not doing so.

Carter wants to know that the food companies her family entrusts in “go beyond what is required,” she said. “We all deserve to know what we are eating. It’s as simple as that.”

The author is a frequent contributor to Quality Assurance & Food Safety magazine.