Getting Ready for FSMA’s Allergen Guidelines

The Food Safety Modernization Act (FSMA) is requiring significant changes for food companies, and allergen controls are one area of focus. Although the U.S. Food and Drug Administration (FDA) hasn’t yet released its final guidance on allergens, it’s never too early for businesses to take a closer look at what they’re doing to make sure allergens aren’t introduced inadvertently into products.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 already lays out the basics about labeling of foods containing allergens. The “Big Eight” allergens—milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans—are still the major focus, as they account for some 90 percent of food allergies.

What’s new is the emphasis on undeclared allergens, now described as hazards that should be controlled. Although products containing allergens are occasionally misbranded, “undeclared allergens” often refers to allergens that were never supposed to be there in the first place. Allergens could be introduced into a food product many ways, most involving accidental cross-contact of some kind.

In the past, many companies were required to have in place Hazard Analysis and Critical Control Points (HACCP) plans, which are evolving under FSMA into Hazard Analysis and Risk-based Preventive Controls (HARPC) plans. HACCP plans focused on analysis and control of biological, chemical and physical hazards to minimize risk. HARPC plans focus on preparing for a wider variety of risks or hazards, including allergens.

The Danger of Allergens
In fact, there are myriad reasons besides FSMA to strive to be meticulous about allergen control. Undeclared allergens are the number one cause of recalls, and recalls can have a devastating economic impact on a company. Expenses associated with a recall could even bankrupt a small business. Costs include notifying consumers, removing food from shelves and paying damages that could potentially result from lawsuits. Short-term revenue evaporates when a product is recalled and destroyed, and depending on the nature of the recall, damage done to a brand can also be costly.

Even more serious, undeclared allergens can kill. Although most reactions to food allergens are mild and self-limiting, about 20 percent of reactions lead to anaphylaxis—a systemic reaction that can cause breathing passages to swell shut and blood pressure to plummet, resulting in shock and, too often, death. There are some 30,000 cases of anaphylaxis per year in the United States, causing some 2,500 hospitalizations. About 150 people per year die from anaphylactic shock. When someone shows up at an emergency room with anaphylaxis, the most likely cause is a food allergy, with tree nuts and peanuts being the most common culprits.

A high-profile case that illustrates how quickly an allergen can kill is that of Natalie Giorgi, a 13-year-old girl who, in 2013, took a bite of a Rice Krispies square that contained a trace of peanut butter. Natalie knew she was allergic to peanuts and was careful about what she ate, but the dessert bars were unlabeled and the kitchen staff, although alerted to her allergy, didn’t tell her family about the ingredient. Natalie’s father, a physician, couldn’t save her. The incident occurred at a family camp run by the city of Sacramento, CA; the family recently reached a $15 million settlement with the city.

In Great Britain, food manufacturers have been warned to ensure comprehensive risk management over allergens after the owner of an Indian restaurant was sentenced to 6 years in prison after a customer died from anaphylactic shock. The customer ate curry containing peanuts. The restaurateur had switched almond powder for a cheaper ground-nut mix that contained peanuts.

The Role of Preventive Controls
Retail food establishments are under no obligation to prepare and serve allergen- or gluten-free food (see “What about Gluten?”). These two cases, however, show the danger posed by carelessness with allergens. The good news is that food processors and manufacturers have done their job if products are labeled correctly under FALCPA. When products are correctly labeled, people with serious allergies can check to be sure the food is safe for them to consume.

Problems arise, however, when food products are accidentally contaminated, and that’s why preventive controls are so important. As noted, undeclared allergens—not pathogens—drive the overwhelming majority of recalls. Between 2005 and 2014, some 12 million pounds of product were recalled because of undeclared allergens, and many of those allergens were present because of cross-contact in the manufacturing process.

The maximum amount of an allergenic food that can be tolerated in a product without producing any adverse reaction is called the “threshold,” and at present, there are no regulatory allergen thresholds or action limits for any of the Big Eight food allergens. Thus, finding any allergenic protein-containing ingredient that is not declared on the label or misbranded is problematic, and that product is potentially subject to recall. Manufacturers should identify steps in their process where prevention and control of allergen cross-contact can be implemented as well as identify methods to ensure that the finished product is properly labeled.

Preventing Cross-Contact
Utilizing dedicated locations, times, systems, equipment and personnel throughout the manufacturing process can be very beneficial in preventing cross-contact. A dedicated step in the process refers to a location, time, system, piece of equipment or employee that is prepped (cleaned and inspected) for use with an allergen-containing ingredient and used solely for that purpose. Employing allergen test kits can also help identify where problem areas might exist along the line in terms of cross-contact. Prevention and control of allergen cross-contact should be emphasized throughout the process, including in research and development, equipment design, receiving of raw ingredients, storage of ingredients, “rework” practices, sanitation practices, product changeover and production scheduling. Looking at each of these steps provides a good guide to where a food processor might find problems.

R&D: Research and development is the point at which alternative ingredients can be identified that do not contain an allergen but create the same end product. If there are no allergens in the process, chances of cross-contact are minimized. The product can also be formulated so a known allergen is added at the latest possible point in the manufacturing process.

Equipment design: All parts of processing equipment should be accessible and cleanable. Equipment that uses sanitary design principles should be designed and purchased, then scrupulously maintained. Also, the facility must be large enough to accommodate processing and traffic patterns, and airflow must be designed to prevent allergen cross-contact. Ventilation and airflow are important in preventing dust particles from transferring allergens onto products. Keeping product ingredients separate from known allergens is key and can be accomplished by having a dedicated location in the plant and different times of processing and by utilizing airflow and enclosed systems. Workflow is also important, because the manner in which ingredients, equipment, people and finished product flow through the facility can lead to recontamination.

Receiving raw ingredients: Manufacturers need to be sure that raw ingredients are free of allergens. It is important to secure a letter of guarantee from the supplier, inspect raw ingredients upon receipt and review labels of incoming raw materials for appropriate allergen information or any changes in the product. It is also a good idea to conduct occasional on-site inspections of suppliers or else reference any inspection reports or audits the supplier might have available. It is advisable to include in the supplier’s contract a clause saying that the receiving facility will be notified whenever there are changes involving the ingredient or food purchased from the supplier. At receipt, any damaged containers of allergens should be handled appropriately to minimize cross-contact. Clean-up procedures for spills or damaged containers of allergens should be routine and documented. Proper inventory control procedures also should be in place for packaging materials.

Storage: When storing ingredients and product, manufacturers should be aware of the dangers of allergen cross-contact. Raw ingredients should be labeled, segregated and stored appropriately, with allergens always kept separate from nonallergenic ingredients and products in clean and closed containers. When segregated storage is not possible, other methods should be used, such as not storing allergens above nonallergens or storing like allergens (milk and whey) together. A milk icon sticker could be placed on a pallet of bagged ingredients containing milk powder.

Several methods are available for labeling containers of ingredients containing allergens. International food allergen icons are easily recognizable and can be understood by someone who doesn’t read or speak English fluently. The icons are available from the International Association for Food Protection. Commercially available icons also are available. Color-coding is another possibility and can be very helpful where language barriers exist. Training materials should include a thorough explanation of color-coding and why keeping allergens isolated is so important. Color-coding also may be utilized to provide “zone control” in a facility, with different colors assigned to different zones or to each step in the process, or even to dedicated manufacturing lines.

Specific cleaning equipment, such as brooms, brushes, dustpans and rags, should be designated for use only on certain equipment or at specific times to prevent cross-contact, and assigning colors to zones or processes makes it easy to confirm that a tool is misplaced. Tracing the tool back to its point of origination is quick, and this level of traceability can help prevent costly recalls. Color-coding also may be useful where zones aren’t necessary.

Rework: “Rework” refers to clean, unadulterated food that has been removed from processing for reasons other than unsanitary conditions or that has been successfully reconditioned by reprocessing and is suitable for use as food. All rework should be clearly labeled, and control should be exerted by making sure rework is only “like into like.” Rework should be segregated to prevent allergen cross-contact, and workers should be instructed to report incidents and audit procedures. Color-coded tags may be used to identify and record when reworked products with allergenic ingredients are produced and where these products are stored. The tags should also show the products into which they are reworked when these products are added back into the line and how much is used.

Sanitation: Obviously, cleaning methods are considered a first line of defense for preventing allergen cross-contact on shared processing lines. Inadequate sanitation can leave residues on surfaces in the plant. Inadequate cleaning of both food contact surfaces and nonfood contact surfaces can lead to potential cross-contact. For that reason, every plant should have documented Standard Operating Procedures (SOPs) and Sanitation SOPs (SSOPs), which may vary from facility to facility. The purpose of the SOPs and SSOPs is to provide enough detail so employees can perform tasks correctly by reading the procedure without any additional instruction.

Adequate training for all staff, including seasonal or temporary employees, should introduce them to SOPs and SSOPs. Employees at every level also should receive general training on allergen awareness and control, with specific training to particular employees as dictated by their job responsibilities. In all training, employees should learn why these procedures are required and the very serious potential consequences should the plan not be followed. Personnel should understand why proper hygiene, handwashing, glove use, clean outer garments and movement through the facility are all important.

Equipment cleaning: Adequate time must be allowed for proper cleaning, and all equipment should be inspected after cleaning and before use. Special attention should be given to:

•    Food contact surfaces that have come into contact with an allergen at some point.

•    Totes, pails, etc., used to transport allergens, if not dedicated.

•    All cleaning utensils used to clean production equipment that has come into contact with an allergen, such as brushes, rags, scrubbers and dust collectors, if not dedicated.

•    All sampling devices used to draw samples from a run containing an allergenic ingredient.

•    Any push-through product used for clean-out prior to running a product containing an allergen.

•    All rework (if not from a like product).

•    Final clean-in-place rinse.

The nature of the allergen, the product and the processing equipment will dictate appropriate cleaning protocols. Depending on the product, the choice of cleaning method might be wet cleaning, dry cleaning or use of sanitizing agents.

Product changeover: Product changeover, when a manufacturing line transitions from creating one product to creating another product, is a time when cross-contact may occur. It is important that enough time be allowed between processes to allow for proper cleaning. Labels should be monitored, documented and verified at all changeovers as they occur.

Whenever possible, products with similar allergens should be made on the same equipment. For production lines with crossover points, prevent allergenic foods from falling onto nonallergenic production lines. When processing lines are in close proximity, adding physical barriers to separate allergenic and non-allergenic production lines may mitigate the risk of allergen cross-contact.

It would be best if personnel working on processing lines containing allergenic ingredients did not work on nonaller-genic production lines, because they may carry allergenic residues on their clothing or hands. Employees working on a line that contains allergens may be identified with a different-color uniform or some other visual cue.

Scheduling of processing runs: If possible, segregate production areas for allergenic and nonallergenic products. Otherwise, schedule manufacturing of nonallergenic foods before processing of foods with allergens, because proper scheduling of processing runs may help minimize allergen cross-contact. For example, long runs of products containing allergenic ingredients should be scheduled to minimize changeovers.

When product design permits, add allergenic ingredients as late in the process as possible. If necessary, run times should be lengthened and changeover minimized. Cleaning should be scheduled immediately after production of foods containing allergenic ingredients.