Food recalls in the US increased 50 percent in the fourth quarter of 2011 compared to the previous quarter, and undeclared allergens remained the leading factor, accounting for more than a third of total recalls, according to Stericycle’s ExpertRECALL Index. Preventing pathogen contamination of food can be a challenge, but in many cases, allergen recalls can be easily prevented by careful examination of labels—both on incoming ingredients and on products going out the door. Of course, allergen control goes beyond labels and involves several good manufacturing practices, such as segregating allergens in storage from non-allergen ingredients, implementing proper cleaning techniques, dedicating processing equipment lines, including allergens in a HACCP plan, designing recipes and batches to accommodate production schedules, allergen testing, careful monitoring of rework and employee training.

According to FDA, approximately 2 percent of adults and about 5 percent of infants and young children in the US suffer from food allergies. Each year, more than 30,000 individuals require emergency room treatment, and 100 to 150 people die because of allergic reactions to food. FDA lists eight major foods or food groups—milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans— which account for 90 percent of food allergies.

Although the European Codex Alimentarius considers major allergens to be the same ones FDA lists, various European states have added allergens beyond “the big eight.” For example, the EU lists celery, mustard, sesame seeds, lupin, mollusks (the list separately includes crustaceans and mollusks) and sulfur dioxide/sulfites in excess of 10ppm.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires food and beverage processors to add an allergens list to package labels. FALCPA also set in motion further study on gluten and the separate labeling of it in succeeding years. According to University of Chicago’s Celiac Disease Center, 97 percent of celiac disease sufferers remain undiagnosed, and at least 1 percent of Americans are affected by the disease, which is caused primarily by wheat, barley and rye gluten.

FDA reopened its comment period on a proposed gluten-free food labeling rule in August 2011. The proposed rule stipulates that the term “gluten-free” can be applied to foods containing no more than 20ppm gluten; this standard has been adopted by 27 member states of the European Community. The FDA Final Rule on gluten-free is expected sometime later this year.

Although FALCPA has some legal teeth, it does not apply to processors that produce meat products. According to USDA’s website, “The FALCPA passed by Congress did not amend or implement regulations and policies for meat, poultry and egg products in the acts related to them: the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act. FSIS encourages the use of allergen statements, consistent with FALCPA, and other statements that highlight the presence or absence of ingredients of public health concern, particularly the ‘big-eight’ allergens.”

Control begins with education

Most processors have a handle on allergens and know they belong in a separate list on the label beginning with the word, “Contains ….” However, according to Tom Ambrosia, SQF certified auditor, consultant and trainer, some processors have allergens in their ingredient listings, but don’t realize they are allergens. Ambrosia points to a sausage company he visited that was interested in SQF certification. He asked the processor if an allergen program was in place, and the reply was, “We don’t have any allergens.” Upon reading the ingredient list, which included wheat and soy, Ambrosia explained they are allergens and need to be on a separate listing on the label if the processor wanted to comply with GFSI certification (e.g., SQF or BRC). GFSI certification requires both allergen labeling and an allergen program.

Kettle Cuisine’s Director of Quality Assurance Karen Bishop-Carbone points out that an allergen control program starts with incoming ingredients and their specifications. “We want to know what’s in the ingredient, and what the vendor says are the allergens.” Then, she’s off to the receiving area to check the ingredients against the paperwork, making sure specifications and labels match. From the receiving area, all allergens are color-coded with special labels so everyone in the facility knows what they are. Some pastas get two color-coded labels: one for wheat and one for eggs. In a noisy plant environment, the use of color codes prevents accidental contamination. “Wheat flour is put in yellow barrels. It has the allergen label, and the bright color sticks out like a sore thumb. So people know if it’s in a place where it doesn’t belong.” With seafood, crustaceans go into red barrels. Allergens are stored so cross-contamination will not occur.

Kettle Cuisine recently renewed its SQF 2000 certification, and allergen training is an important factor in the certification process. Prior to SQF, the processor made the conscious decision to hold employees responsible for manufacturing operations, and training was held once a year, which included GMP; chemical training; HACCP; and allergen awareness, control and testing. A DVD is shown to new employees who are given a quiz on what they’ve learned. In addition, employees practice spotting allergens on labels and practice what-if scenarios.

Segregating allergens in storage

“There should always be dedicated allergen storage areas specific to the types of allergen with like-over-like storage practices in both dry warehouse storage and refrigerated/frozen storage, where applicable,” says Jeff Chilton, principal of the Chilton Consulting Group. “The architectural/plant solutions must allow sufficient space for these designated allergen storage areas to accommodate the inventory levels required,” Chilton says.

“But there are practical examples where this approach does not work so well,” according to Steve Taylor, PhD, professor and co-director of the Food Allergy Research & Resource Program (FARRP) at the University of Nebraska Department of Food Science & Technology. For example, these combinations can be problematic in breadings: 1) wheat; (2) wheat, milk; (3) wheat, milk, egg; (4) wheat, egg; (5) gluten-free, milk; (6) wheat, milk, soy, etc. “I have seen a company that had three dozen various combinations. Separate storage for each? Very difficult,” adds Taylor.

Of course, architectural solutions are much easier with a new plant than with an existing one that may run both allergen and non-allergen products, according to Kurt Warzynski, Stellar Group food and beverage manager of process engineering. Storage areas may contain more than one allergen, but there should be a system with dedicated storage bays for each allergen. Dry-mixing and dry-blending areas for specific allergens should be segregated in separate rooms while ensuring HVAC systems don’t spread dust. In facilities that produce sauces and soups, elevated platforms with kettles can be used with some separation between each kettle. Because these workstations are raised, the possibility of cross-contamination is small, says Warzynski.

The dust issue is somewhat over-rated and easily solved in dry blending and mixing rooms, Taylor states. Covering up unused equipment while other machines are running keeps out the dust. Plus, if an employee sees accumulated dust in a machine, it has to be cleaned before it is used. But if all the equipment is operating at prime speed, the dust doesn’t settle fast enough to be a problem, according to Taylor.

Dedicating lines

With today’s shorter production runs and frequent line changes, dedicated lines are nice to have from an allergen standpoint, but not always practical. “It certainly makes sense to dedicate a single production line or even an area of the facility to a single product or family of products with similar allergens if the volume can warrant and justify it,” says Chilton. “This can add a significant level of protection to prevent cross-contamination and minimize downtime and changeover expenses considerably.”

In operations such as chocolate manufacturing, dedicated lines are preferred because it’s almost impossible to get good cleaning results, according to Taylor. With a plant that makes both milk chocolate and dark chocolate, shared equipment is not recommended unless processors are willing to use advisory labeling (e.g., manufactured on shared equipment with milk). Because chocolate is very viscous, push-through cleaning doesn’t work; with milk chocolate, after many push-through cycles, milk residues will still be detected, advises Taylor.

In the real world, dedicating a single line is not so easy. In fact, scheduling can be a bear as well, especially for a company dependent upon fresh produce and fresh-frozen seafood, for example. According to Bishop-Carbone, at Kettle Cuisine, non-allergen soups are normally run early in the day and allergen-based products follow, minimizing cleanup. But, there are times when ingredients don’t make it in when planned, and allergen products may have to be run first. Of course, additional cleaning and testing are required to make sure the equipment is free of allergens before it is used to produce non-allergen products.

Eliminating one or more of the big-eight allergens from a plant can make operation a little easier. One allergen not used at Kettle Cuisine is peanuts. Had it not been for FDA’s classification of coconuts as tree nuts, Bishop-Carbone says the facility would be completely nut free.

Scheduling and cleaning

“Scheduling plays a key role in controlling the possibility of allergen cross-contamination,” says Chilton. “Non-allergenic products should be scheduled first, followed by single-allergen products, then multiple-allergen products.” Chilton recommends that processors have a scheduling matrix that defines cleaning requirements between products, such as none, scrape-down, purge or full clean-up.

“Production scheduling can play a role in organizing the production requirements to minimize the changeover requirements,” says Tom Nessen, Plex Systems senior solutions engineer. If like products with similar allergen profiles are scheduled back to back, it may minimize clean-in-place (CIP) and changeover requirements between batches, suggests Nessen. “A production control system that has the capability to use finite capacity scheduling with constraints would be a good solution to this problem and may help improve overall efficiency and minimize downtime,” he adds.

Because of the variability in equipment, each piece in the CIP process must be tested and validated, according to Tony Lupo, Neogen director of technical service. Depending on food types and proteins, different detergents with varying pHs are needed for effective cleaning. “Some of the chemical providers, like Ecolab, are very good at coming in, evaluating and offering specific solutions based on the residue that needs to be removed,” says Lupo.

Many processors run an allergen test on the final CIP rinse, according to Lupo. If they observe a positive, they know they have a drift somewhere. “Maybe one of the spray balls became clogged, or the temperature of the water dropped, or the chemical is being consumed earlier than they thought,” suggests Lupo.

Testing methods

Practically speaking, testing for the presence of allergens can include CIP rinse water, equipment surfaces, environmental surfaces, in-process product and push-through cleaning systems. While FSMA requires processors to have an allergen control plan that is validated and verified, FDA hasn’t yet given any clues about how it will evaluate processors, according to Taylor. While many processors just use “visually clean” as their standard, eventually FDA will require some analytical validation.

Four detection methods are available to obtain analytical results. They range in cost from a couple of dollars to upwards of a half-million dollars, making the right choice a critical decision. The methods are: enzyme-linked immunosorbent assay (ELISA), general protein tests, ATP/bioluminescence tests and polymerase chain reaction (PCR). ELISA kits include lateral flow devices (dipsticks) and swabs, are specific to a single allergen and involve a five-minute to a six-hour analytical process. Available commercially for several allergens, ELISA assays can detect allergen levels lower than 5ppm.

General protein tests verify the presence of protein (all allergens are proteins), but cannot determine what protein/allergen is found in a positive sample. They can also be used to verify whether a surface was cleaned effectively. Their limit of detection is 3-20 µg protein.

ATP/bioluminescence tests to check for residues are not specific for allergens and do not prove the presence of protein, according to Taylor. In addition, they have not been shown to correlate with specific ELISA tests in research to date.

PCR (DNA) tests are specific to the source, but not to the allergen, according to Taylor. Therefore, they don’t prove the absence or presence of a protein/allergen. The test is very sensitive, semi-quantitative and not practical for in-plant use as the equipment is very expensive.

Lupo believes the PCR instrument-based method is a great confirmatory tool, but field-based methods will be around for some time to come. Since field-based methods can detect levels down to 5ppm, they can ensure equipment and environmental surfaces are clean enough to protect the vast majority of the consumer population.

Labeling issues

Because levels haven’t yet been set for allergens, many processors put precautionary/advisory labeling on products, according to Taylor. The words “May contain” or “Packaged in a facility that also packages _____” sometimes show up on products that wouldn’t seem to fit at all, such as a box of baking soda.

While these statements may legally protect processors, for allergy sufferers, they increase shopping time and often increase costs as well.

On the other hand, what doesn’t appear on the label can be the cause for an expensive recall. “All incoming labels from the printer should be checked for proper ingredients, and the allergens as well,” says Jack Payne, CDC Software vice president of enterprise software.

“Processors need to make sure they’re not making any changes to the formulation that won’t be reflected on the label,” says Ambrosia. In many cases, this happens when production people pull the wrong ingredients.

A batch control or recipe system that requires feedback from operators when they add ingredients can prevent the addition of wrong ingredients or substitutions that may contain allergens, according to Payne. Labeling errors are also preventable. “Does the current label match the current recipe? Does it include all the ingredients? Does it list all the allergens? These are the three major control points,” he adds.

For processors that ship outside the US, software systems can provide the ability to define country-specific labeling, Payne says. For example, a product being shipped to Canada must have its own lot number and meet Canadian labeling requirements.

Life or death situations hinge on proper allergen management. Control begins with education and correct procedures and ends in fewer costly mistakes and increased product safety. 


For more information:

Tom Ambrosia, Tom Ambrosia Consulting, 570-925-2614,

Jeff Chilton, Chilton Consulting Group, 706-694-8325,

Kurt Warzynski, Stellar Group, Inc., 715-952-5091,

Stephen Taylor, FARRP, University of Nebraska, 402-472-2833,

Tom Nessen, Plex Systems, 248-391-8010,

Tony Lupo, Neogen, 517-372-9200,

Jack Payne, CDC Software, 770-351-9600,