A quick-service restaurant (QSR) chain engaged a candy manufacturer to make a new milk chocolate-coated pecan ingredient for the restaurant to use in a limited-time-only (LTO) specialty salad. The chocolate-coated pecan manufacturer could offer the restaurant chain a lower price for the candied pecans if it could be manufactured in its current facility, which also produced milk chocolate-covered peanuts and other nuts. The restaurant chain desired the lower cost to boost its margin on the specialty salad, but also wanted to ensure that this ingredient in the specialty salad would be free from peanut allergen.

To further reduce costs of the product, the restaurant chain planned to sell the specialty salad in single-use paper bowls that the chain currently used for other types of salads and products. Since these bowls were used for many different products, they were not labeled with any ingredient or product information, and the company's marketing department did not want to include avoidance messaging, such as "may contain peanuts," on the bowls or menu boards, as it would have increased the cost of the product.

The restaurant chain's Food Safety and Quality Assurance (FSQA) department was responsible for ensuring the safety of the products manufactured by its suppliers. The FSQA department developed the food safety specifications for the new product that included:

• Segregation of ingredients in storage and flow of product from all peanut-containing ingredients.
• Verification that processing equipment was free of peanut allergen, following cleaning and sanitation, by conducting onsite rapid peanut protein testing before the chain's product was run on a predetermined production line. These testing data results were to be retained for each lot of product produced for one year.
• Additional peanut protein testing on every lot of finished product with a hold-and-release protocol in place, so that product lots could not be released for distribution until a negative test result for peanut protein for that lot was obtained. These testing data results were required to be associated with each lot shipped, and provided to the FSQA department each week.

Shortly after the rollout of the new product, a health department called the QSR chain to inform them of terrible news. A mother had just lost her 11-year-old son due to an anaphylactic reaction to the new specialty salad. The local health department and hospital doctors traced the reaction back to the QSR chain's chocolate-covered pecans in the specialty salad, as the child was allergic to peanuts but not tree nuts. Despite all the efforts to ensure the absence of undeclared peanuts in the product, testing confirmed the presence of peanut proteins in the chocolate ingredient used by the candy manufacturer. Upon recommendation from the FSQA department, the QSR chain's leadership stopped all sales of the new product, and all other restaurant operators were told to immediately destroy all quantities of the remaining ingredient to prevent any additional cases.

When the FSQA department investigated the records of the manufacturer, data showed that peanut allergen testing on cleaned equipment was performed before each product was processed; however, in some cases the corrective actions (recleaning all surfaces when a positive test was returned) were not performed, and the final product testing for these lots was not always performed. When asked why testing was not performed according to the specifications, the manufacturer's quality assurance manager said the company thought it had reduced the probability of the potential hazard by using new, color-coded cleaning equipment and storage segregation. The manufacturer made sure the first few product runs were negative for peanut protein, and since the ingredient was a nut, it said that most customers would already know it could have a risk of peanut protein contamination. As a result, the manufacturer decided to only test product lots on a weekly basis to reduce the costs associated with testing. Since the QSR chain's FSQA department did not make any facility visits nor evaluate the expected data on the specifications (testing results), these changes were undetected.

This scenario that led to the death of a child is fictitious, but it is a common event in the foodservice industry where an undeclared allergen is present in a food product and consumed by an unsuspecting customer. In this scenario, the food safety specifications required by the restaurant chain were good, but they were not robust enough, since they were not verified for each lot to ensure they were executed. They also did not include a supplier preventive control of a hazard by the business to ensure that the source of the pecans did not already have peanut protein contamination via prior pecan nut processing from their suppliers. Of course, the restaurant chain could have provided avoidance messaging of the product (on its menu board, ingredient list on packaging, etc.) that an ingredient was processed in a facility with peanuts. Avoidance messaging using this type of language has not been proven to be effective as a control in the foodservice industry, however.

"The CDC states that one in three persons experience an allergic reaction to foods prepared in restaurants."

Prevalence of Undeclared Allergens in Foodservice Foods

Food allergies in the U.S. affect an estimated 26 million adults and 6 million children annually (10.8 percent and 8 percent of the U.S. population, respectively).¹ The U.S. Centers for Disease Control and Prevention (CDC) states that one in three persons experience an allergic reaction to foods prepared in restaurants.² The corresponding medical costs are very significant; the healthcare burden includes direct costs of $4.3 billion annually.³ The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and CDC do not currently perform active surveillance of food allergy reactions by consumers that occur from foodservice. However, based on the number of food recalls due to undeclared allergens, as well as the numerous scientific reports and surveys of significant increases in the number of allergic reactions of the population after eating foods from restaurants (see below), it is a significant public health issue.

A study published in the Journal of Allergy and Clinical Immunology: In Practice highlights the prevalence and serious risks of food allergy reactions in U.S. restaurants, based on survey data from 1,248 adults and parents of 1,579 children with food allergies.⁴ Some of the key findings were:

• The study showed that food allergy reactions can cause serious acute illness. Reactions in restaurants resulted in hospitalization for 6.2 percent of patients, of which nearly one in three was admitted to intensive care.
• For both adults and children, restaurants are the second most common location for food allergy reactions. Homes are the only location where more reactions take place. Interestingly, the fraction of food allergy reactions that take place in restaurants is much higher for adults (31 percent) than children (13 percent).
• Cafes, fast food establishments, Asian restaurants, ice cream parlors, and bars are the types of restaurants where most reactions were reported.
• Peanut, tree nuts, and milk were the foods most commonly blamed by patients and parents for triggering allergic reactions in restaurants. Egg was another common allergen for children, while shellfish was a common allergen for adults.
• Only about half of the customers who had a reaction (53.9 percent) informed restaurant staff beforehand about the allergy.
• In roughly one-quarter of the reactions (26.2 percent), restaurant menus informed patrons beforehand by listing ingredients or allergens, or by including precautionary language.
• Only 13.7 percent of reactions occurred when customers informed restaurant staff about their allergies and/or when menus contained information about allergens. While reaction risk was not eliminated by both steps, the danger was clearly diminished by two-way communication between the customer and the restaurant.
• Nearly three in ten reactions (28 percent) were treated with epinephrine. Two doses of epinephrine were required in 6.2 percent of reactions, highlighting the importance of carrying two epinephrine auto-injectors at all times.

The increasing reliance on food prepared away from home, including takeout and delivery, is likely to result in a growing number of allergic reactions linked to restaurant food in the U.S. (Figure 1). This concern is compounded by the fact that many studies, including those referenced above, do not account for allergic reactions resulting from takeout or delivery meals, focusing only on dine-in experiences.

The shift toward food away from home (FAFH) spending is significant: in 2023, Americans allocated 55.7 percent of their food budget to FAFH—a record high—while food at home (FAH) spending dropped to 44.3 percent. Total expenditures on FAFH reached $1.5 trillion, outpacing the $1.1 trillion spent on FAH. Digital ordering for delivery has become a dominant trend, with approximately 40 percent of restaurant sales now occurring online, a figure that has grown 300 percent faster than dine-in sales since 2014. The U.S., the second-largest online food delivery market globally, generated $218 billion in delivery revenue in 2022, with projections nearing $500 billion by 2027. This surge in digital and delivery-driven consumption reflects a consumer preference shift, as 57 percent of Americans favor takeout or delivery over dine-in options.

Fair Health, a national independent nonprofit, examined the amount of private healthcare insurance claims made for food allergies and found that allergic reactions that required anaphylactic treatment in the U.S. increased by an astounding 377 percent from 2007 to 2016.⁵ They found that peanuts and tree nuts were a significant cause of the proportion of the increase. Combined with the ongoing rise in FAFH spending, this shift underscores the growing risk of food allergy reactions occurring in connection with restaurant meals, whether consumed onsite or at home.

Regulations of Allergen Risk Management in Foodservice

FDA regulates allergens in packaged foods via the Food Labeling and Consumer Protection Act (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act). The FALCPA and FASTER Act labeling requirements do not apply to foods prepared by foodservice establishments because the foods are placed in wrappers or containers for immediate service or consumption. The FALCPA does apply to foodservice establishments wherein all bulk foods sold to these businesses must have food labels that meet the requirements of the law. FDA provides guidance for the regulation of allergen risk in the foodservice industry to U.S. states via the Food Code. FDA calls the Food Code the agency's "best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in foodservice." The model Food Code is not binding unless it is adopted by a state or local government as part of that jurisdiction's law governing retail foodservice establishments.

FDA updated the Food Code⁶ in late 2022 to include sesame as the ninth major food allergen, reflecting the FASTER Act. To reduce the risk of unintentional allergen exposure in retail foodservice establishments, the 2022 Food Code introduced a new requirement mandating food businesses to inform consumers in writing about the presence of any of the nine major food allergens in unpackaged food served or sold to customers [Section 3-602.12(C)]. In its announcement, FDA emphasized the serious risk that unintended allergen exposure poses to individuals with food allergies and noted that these consumers rely on allergen information provided by food establishments, whether verbally or in written form. FDA further clarified that written allergen notifications can be delivered through physical or electronic formats such as brochures, deli case signage, menu notifications, label statements, table tents, placards, or other effective written means.

In addition to requiring allergen disclosures, the 2022 Food Code outlines responsibilities for foodservice operators to ensure that staff are adequately trained in food allergy awareness [Section 2-103.11(O)]. This training should cover the identification of the nine major allergens, recognition of allergic reactions and appropriate responses, and strategies to prevent cross-contact. Supporting this guidance, the Conference for Food Protection recommends that food establishments (1) provide a list of menu items and ingredients for staff reference, (2) train both front-of-house and back-of-house employees on allergen management and cross-contact prevention, and (3) designate at least one staff member per shift to address customer inquiries about food allergens.⁷

According to FDA, 35 states have adopted one of the three most recent versions of the FDA Food Code (2022, 2017, and 2013 versions), representing 63.36 percent of the U.S. population, but only four of these states have adopted the most recent (2022) version that includes improved allergen risk management guidance for the industry (representing only 7.65 percent of the U.S. population).⁸ California, the sole outlier, does not have a state agency that has adopted the FDA Food Code and maintains its own California Retail Food Code.⁹

When a foodservice business operates in a state that does not regulate or require allergen risk management via adoption of the current FDA Food Code, it is a best practice to develop foodservice operational requirements (standard operating procedures, employee training requirements, etc.) based on the most current FDA Food Code and any supplements. This is especially helpful to foodservice chains with locations in multiple states, where harmonization of all operational requirements reduces cost and ensures maximum risk reduction.

"The two primary root causes of undeclared allergens are contamination of ingredients/products with allergens during food manufacturing or contamination of the food product with allergens during food preparation in the foodservice establishment."

Hurdles in the Prevention of Undeclared Allergens in Foodservice

All allergens that get into a food product that is prepared and served by a foodservice establishment and not declared to the customer are undeclared allergens. The two primary root causes of undeclared allergens are contamination of ingredients/products with allergens during food manufacturing or contamination of the food product with allergens during food preparation in the foodservice establishment. Therefore, the primary controls to prevent undeclared allergens must start in the supply chain and continue in the foodservice establishment, using multiple controls to prevent the hazard until customer purchase.

Food served in foodservice establishments, especially quick-service and fast-casual foodservice establishments, is normally produced and packaged for immediate consumption. In line with this service model, most food packaging does not contain a list of product ingredients or include any precautionary or advisory statements that the food may contain undeclared allergens. This is different from packaged food found at a retail or grocery store, where customers can review the declared ingredients in the product and precautionary statements about how the product was produced (e.g., manufactured in a facility that also processes tree nuts), and make decisions before they buy, consume, or serve the food.

Likewise, while manufactured packaged foods can be tested for the presence of undeclared allergens prior to distribution, there is neither time nor the appropriate technology in a restaurant to conduct any kind of food allergen testing after the final food product is prepared, other than a cursory visual inspection.

The major contributing factors of allergen exposure to allergic customers in restaurants include:

• Cross-contact with allergenic ingredients or other foods with allergens during food prep in the kitchen (including by hands and gloved hands).
• Touching other nonfood contact surfaces like refrigerator handles, hand sink knobs, etc. with hands or gloved hands that are contaminated with allergens, which can easily lead to the transference of these allergens to foods by other employees who touch these surfaces.
• Using food utensils or cooking equipment that are not segregated to be allergen-free (e.g., cooking fish in a fryer that is used to cook chicken or other non-allergen ingredients, mistakenly believing that cooking will remove any allergens).
• Cross-contact of allergens on foods from food packaging materials exposed to allergen ingredients during storage (e.g., peanut flour stored and dispensed in the same room as food packaging materials).
• Cross-contact of foods with allergens stored above or next to uncovered foods while in storage.
• Use of reusable towels to clean and sanitize surfaces not segregated for allergen-free food prep areas.
• Absence of allergen avoidance information (e.g., "may contains" or "made in a facility with" statements) on the menu, including digital ordering platforms.
• Supplier ingredients and foods sourced by the foodservice establishment that contain undeclared allergens (e.g., made in a facility with allergens but not declared).
• Food allergens can be present in many food ingredients and are not always obvious from their name. The list in Table 1¹⁰ is a guide to identify basic food ingredients and food additives that may contain or be derived from one or more of these allergens.
• Lack of allergen awareness training by employees that incorrectly answer customer questions about whether a menu item has an allergen in it.
• Many staff members are misinformed about the severity of food allergies. Some restaurant staff in a large survey incorrectly believed that small portions of allergens might be safe and admitted to using the same oil for allergen-containing and allergen-free foods. Some thought that cooking temperatures destroy allergens.¹¹
• Lack of emergency care training by employees when a customer experiences an allergic reaction in a foodservice establishment.¹²

Best Practices to Prevent Undeclared Allergens in Ingredients/Products from Suppliers

Just as supplier verification systems are essential for biological hazard control in a foodservice operation, so are supplier/vendor programs aimed to reduce and/or eliminate undeclared allergens, which are classified as a chemical hazard. Foodservice companies should have expertise on staff that are engaged directly with vendors on consistently verifying that operations upstream are controlling for the potential of undeclared allergens that could cause adverse customer reactions, death(s), and/or recalls. Allergen cross-contact risks in the foodservice establishment kitchen are hard to manage due to space constraints, switching tasks, high turnover, and often a wide menu variety. Therefore, reducing undeclared allergen risks upstream or before the ingredients/products get into the foodservice establishment must be a vital component of the organization's food safety culture, as well as its business continuity plans to prevent disruptions.

Declared allergen transparency is critical to consumers. So, while the effort is aimed to inform customers to make the safe decision (if they are allergic to an item) while ordering at the front counter, there must be constant focus with vendors to ensure they are providing products that match the label ingredients. A solid food safety risk assessment should also include allergen control among suppliers and measuring them based on performance. Remember, even if an undeclared allergen gets into an ingredient or product and does not cause adverse customer reactions, the product is still adulterated and must be recalled. Allergen control is so critical because small mistakes like mislabeling could lead to massive product outages and disruptions—neither of which are going to help any business gain trust with customers.

Supplier programs should be accessed based on risk and performance of controlling the hazards. Facilities that store and process allergens that are not declared in their operation should be considered higher risk, as they have multiple steps to prevent cross-contact. Supplier programs that need to be closely assessed, verified, and validated include:

• Specification management and testing
• Receiving and storage
• Production
• Cleaning and sanitation
• People, equipment, and travel
• Label management
• Recall programs
• Training
• Food safety culture and leadership.

The product specification should clearly state what, if any, allergens are declared and expected to be in the product. Making this language bold and/or underlined is helpful so that the lab technicians and receiving staff are aware of what is coming into the facility. These staff should also be aware of any possible past issues with this vendor or commodity and be alert in case of elevated risk. Testing of raw material onsite is also a critical step to verify that the product received matches the specification. If it passes, then the product should be sent to storage. If raw materials come into the facility and test for an undeclared allergen, then it should be rejected or stored in a secure area with clear instructions to not use it. Allergen testing at this step helps ensure specification compliance and also assists with supplier monitoring and risk assessments.

If the incoming ingredients meet specifications, then storage of the ingredients until production must be done in a safe manner to reduce cross-contact. Best practices are to store ingredients in designated areas based on the type of allergen. Clearly marking this designation to the allergen type is also critical, and the use of additional color codes further informs workers of what and where specific ingredients should be stored. These designated color codes matching each allergen type should be consistent across the entire facility, including tools, totes, and other tools designated for the allergen. Liquid ingredients should be stored on the lowest level to prevent leakage onto other packaging or items. Dry ingredients should be stored above liquid ingredients. In the event of leaking packages or busted cases and ingredient spills, it is paramount to identify the leaking/spilled ingredient(s) quickly and resolve the problem. Using designated and color-coded equipment for the leaking/spilled allergen is essential in removal and reduction of cross-contact to other ingredients.

Managing cross-contact risk with production and in production areas is complex and must be constantly monitored, verified, and ultimately validated with product and environmental data (Figure 2). Food safety culture and behaviors also play a major role in consistently executing safely for every lot produced. Three top focus areas are scheduling of products to avoid allergen cross-contact, swabbing equipment prior to production, and final product testing (hold and release) for high-risk items.

Let us break this down with an example using peanuts and a foodservice company that has no peanut ingredients on its menu. Proper scheduling of items that will use shared equipment and processing lines for multiple allergens that will not be declared is critical. If the facility processes peanuts but the restaurant company does not declare them, for example, then influencing that product to be run on dedicated non-peanut equipment or a dedicated room/line is one method to avoid cross-contact. If products must be run on shared equipment, then dedicating certain days to specific allergen-containing products is also a good way to reduce risk.

If multiple allergens will be run on the same equipment/lines, then there must be a robust changeover program involving cleaning and sanitation to remove the undeclared allergens from the last production run. This process should be detailed and executed properly to ensure that residues are removed and will not transfer to other products. An effective allergen swabbing program to verify the absence of undeclared allergens performed by a third party serves as the validation process to provide confidence through data that any undeclared allergen residues are removed.

Final product testing for high-risk items ensures no presence of undeclared allergens and adds the final touch to a complete and robust program to ensure that a safe food product has been made. Since most items sold in restaurants are pre-packaged or minimally handled, this may be the last control point in the process. One challenge is that hold-and-release testing for most suppliers is not something they are requested to do or desire to do. While adding a declaration that an allergen may be present or was produced in a facility that also processes "X allergen" is the easiest route to meet regulatory standards, it may not meet the foodservice brand's standards. If the decision is to not declare an allergen, then final product sampling must be a collaborative effort with the manufacturer, restaurant leadership, and the lab (internal or third party). Testing a sample size that gives the best confidence, methodology, and training must be agreed upon and committed to. It is important that the foodservice brand decides how far it wants to go with allergen declaration based on its customers and what is operationally feasible. However, if the brand does choose to test each lot of final product, it must ensure that data analytics are in place to track each lot of product results during the hold and release,  and enable this data reporting in real time during manufacturing and distribution of the ingredient.  Otherwise, the scenario in our fictitious case above is much more probable.

Undeclared allergen prevention must also focus on cleaning, sanitation, ventilation, and controlling traffic in high-risk areas. Besides the complexity of programs already mentioned, several other key factors must be continuously monitored and controlled for allergen prevention. Cleaning and sanitation are major ones. This program should not only be aimed at eliminating biological hazards, but also chemical hazards like allergenic protein residues that may remain on equipment, tools, and within the production environment. Sanitation programs should be executed and verified with swabs for specific allergens to ensure removal. Air systems should also be included in a best-in-class program, as air movement between rooms may cause airborne allergen residues to move throughout the facility and contaminate equipment or product. Finally, controlling traffic of people, clothes, tools, equipment, and even forklifts needs to be assessed and controlled. Designated people, rooms, equipment, etc. should be designed in a way to prevent cross-contact from moving vectors.

Labeling management and accuracy are other critical checks, as they provide the end user with information on what allergens are (or could be) in the product. Clear declaration of a known allergen should be bold and easy to identify. The use of "may contain" or "produced in a facility that also uses…" are also acceptable in being transparent to the consumer or end user. However, if full process control and management can be verified and validated to not have an allergen, then it should not be declared. Each facility should consistently do a "deep dive" risk assessment to understand if its control programs and testing can fully give confidence that an allergen stored in the facility has not made it into a product that does not contain that allergen. If an allergen cannot be 100 percent controlled, then the use of the two statements above is acceptable; however, this should not be an excuse for poor allergen management programs.

Label verification should be a critical control point (CCP) for allergen control to ensure accurate information and prevent unnecessary recalls due to being adulterated. It is incredibly frustrating if every process upstream has been perfectly managed and verified, but then the wrong label is used and an illness claim or recall occurs. Overlooking this critical step can have severe consequences for supply disruptions, customer reaction claims, and negative press.

"A best-in-class process and allergen control program are only as good as those people who own them and are responsible for executing them. Your people can be your biggest asset, but they can also be your biggest liability."

Recall readiness is a must when assessing supplier safety programs and the confidence in their ability to quickly execute a recall. Recalls happen even with the best suppliers and programs, and many are simply due to labeling errors or packaging with the incorrect labels. Full ingredient traceability to every batch and lot is critically important. Suppliers should be able to confidently demonstrate their ability to recall batches/lots with several key measurements. Time to initiate recall is one, and it should be well within two hours of notice. Full transparency of where these lots are held or distributed is another key measurement to assess. Can the supplier find 100 percent of the impacted lot? Finally, a plan must be in place to either take the product back or destroy it, and also retain evidence in case of an FDA investigation.

A best-in-class process and allergen control program are only as good as those people who own them and are responsible for executing them. Your people can be your biggest asset, but they can also be your biggest liability. Why is that? It all depends on how well they are trained on allergen programs and how much they understand about why their role is critical for safety. When partnering with suppliers, it is important to dive deep into their people culture. How often do they train? Is there a leader on the production floor that can continuously coach? What is the culture around continuous improvement, as well as rewarding positive behaviors? When assessing the facility, the company's culture around allergens should be evident with visual signs, visual controls, and deep conversations that provide the customer with full confidence that undeclared allergens can (and are) being fully controlled.

Allergen control is an important risk that food safety business leaders must continue to assess and mitigate, whether it is related to new menu items to launch, new regulations, or new production facilities. Food safety culture is another key factor with allergens, as people and their behaviors drive so much of the controls around the risk. A comprehensive program must be routinely assessed, verified, and validated at the supplier level from every step, starting at specification compliance with receiving and extending through to the final label being placed on the product. Product testing goes a long way toward validating that programs are working and helps prove that people and programs are executing safely. The supplier should embrace allergens as a challenge—one that can be controlled—and provide that confidence to the foodservice business.

Best Practices to Prevent Undeclared Allergens in Products During Foodservice Food Prep

Even when very good supply chain controls are in place to reduce the risk of undeclared allergens in ingredients and products sourced from suppliers, declared allergens in foods that are stored and prepared in foodservice establishments are an equal risk. Like microbial hazards that can get into prepared foods due to cross-contamination (e.g., handling raw chicken and then touching food contact surfaces used to prepare ready-to-eat foods), allergens can also get into foods via cross-contact (e.g., preparing peanut butter smoothies and then preparing a banana smoothie with the same mixer). When this cross-contact of allergens gets into a prepared food, it becomes an undeclared allergen in the product if the customer is not provided any avoidance messaging, such as ingredient or allergen declaration on menus or wrappings/cups.

The emphasis on speed of service and just-in-time production of foods for many foodservice establishments can make it difficult to establish segregation of allergen-containing ingredients/products from foods prepared without allergens, especially if the design of the facility does not accommodate separation (Figure 3).¹³ Multiple controls must be in place to prevent undeclared allergens in prepared foods. These controls include training of managers and staff, food storage and food prep separation, monitoring of the controls by managers, and avoidance messaging for customers.

Recently, the Conference for Food Protection published a comprehensive guidance document, titled, "Major Food Allergen Framework,"¹⁴ for industry to serve as a voluntary operational guidance for food allergen prevention and control. This document covers food allergy training specifications for food handlers and managers, food handling policies and practices to help customers with food allergies, consumer notification tools for the major food allergens, and a food allergy reaction and emergency response guidance.

The guidance on how food handler employees need to be trained to reduce the risk of undeclared allergens in foods is especially useful. This section includes tasks that most food handlers perform in a foodservice establishment that align with the procedures most likely to cause undeclared allergen cross-contact or allergen inclusion in prepared foods. Brief descriptions of some of these tasks are listed below; consult the Framework¹⁴ for detailed guidance:

• Food and ingredient storage
  • Label and segregate unpackaged foods containing one or more of the major food allergens away from each other, and store separately from other foods and ingredients. (Make sure to read ingredient labels to check for the presence of allergens before labeling and segregating.)
  • Spills of any of the major food allergens should be cleaned up immediately, following the usual cleaning procedures used in the foodservice establishment. If any major food allergen accidentally comes into contact with other food ingredients that do not contain that allergen, then these ingredients should be excluded from use.
• Self-service items
  • For food items that were made onsite, either label the food items or place signs next to the food items that clearly identify the presence of one or more of the major food allergens, or keep ingredient lists onsite that identify the presence of one or more of the major food allergens.
  • Labels and signage should be in both English and Spanish, and/or other languages appropriate to the establishment or the geographic area.
• Taking a food order
  • Encourage staff to ask consumers about any food allergies they might have.
  • When a consumer informs staff that they have a food allergy, intolerance, or sensitivity, immediately notify the person in charge ("PIC") or designated person (manager, chef, or key employees).
  • Provide a list of menu items and their ingredients for food handlers and consumers as a reference.
  • Help the consumer identify menu items that contain ingredients to which they are allergic and offer suggestions for alternative menu items.
  • If no alternative menu options are available, politely inform the consumer.
  • If it is possible to modify a menu item so that it does not include ingredients the consumer must avoid, inform the consumer and ask if the modification would suit their needs.
  • Verify with the food handler that the proposed menu item modification is possible, feasible, and can be done safely for the consumer.
  • Make a note on the consumer's order that they have a food allergy/intolerance/sensitivity and note the ingredients they must avoid, so that other food handlers are aware.
• Preparing a food order
  • Thoroughly clean all areas and equipment that will be used for preparing the allergic consumer's meal, even if those areas have already been cleaned for normal use.
  • Wash hands thoroughly before preparing the allergic consumer's meal. It is also necessary to change an apron or chef coat, if previously soiled with potential allergens.
  • Use dedicated equipment, or physically separate products to prevent cross-contact.
    • Use color-coded or specially marked supplies, uniforms, equipment, and utensils designated for preparing allergen-free meals.
    • Avoid using the same cooking medium (e.g., oil or water) and surface (e.g., grill, prep table) when handling ingredients with and without allergens.
  • Use ingredients that do not contain the allergen(s) to which the consumer is allergic. Check ingredient labels for packaged foods.
  • Prepare foods in a manner that eliminates cross-contact. All preparation, including garnishes, should be done by only one food handler who is dedicated to ensuring the meal is allergen-free, and who is not preparing other consumers' meals at the same time.
    • If a mistake is made, and an ingredient to which the consumer is allergic is accidentally included in the meal, it is not sufficient to simply remove the offending ingredient, because cross-contact will have occurred. If this happens, the consumer's meal must be remade.
    • Wash hands with soap and water before continuing preparation to avoid potential or additional cross-contact.
  • Cover the meal with a clean lid to prevent cross-contact and mark the meal as "allergy" so other staff are aware.
  • Notify the PIC, or designated food handler, once the allergen-free meal is prepared and ready for service.
  • Wash, rinse, and store special equipment for allergen-free meals to be ready for next use.
  • Wash hands with soap and water before touching anything else if a food allergen has been handled.
• Delivering a food order
  • Verify with the food handler who prepared the meal that it does not contain the allergen specified by the consumer.
  • Ensure that no cross-contact with other meals occurs during transport of the meal to the consumer.
  • Use a separate meal tray to deliver the meal.
  • Verify with the consumer that the meal meets their needs.
  • Discard the meal and offer to re-make it for the consumer if the meal contains ingredients to which the consumer is allergic. Notify the PIC. Review procedures and retrain the food handler(s) who prepared and handled the meal on these procedures before allowing them to remake the consumer's meal.
• If someone reports an allergic reaction: when in doubt, call 911
  • Clearly direct one person to dial 911 and report an allergic reaction.
  • Follow the directions of emergency services personnel and the food establishment's food allergy emergency response plan.

"Foodservice establishments that develop and execute allergen controls can find that it is also good for business and can grow sales due to brand loyalty."

Since cleaning and sanitation are critical to the prevention of allergen cross-contact, it is important to ensure that the proper procedures, cleaning chemicals, and tools are used. FDA conducted a study¹⁵ to determine if the current recommendations in the FDA Food Code were sufficient to reduce cross-contact of allergens in a foodservice establishment. To determine the effectiveness of these wiping and cleaning recommendations at preventing allergen cross-contact, FDA investigated allergen removal from surfaces by wiping with paper wipes, terry cloths and alcohol/quaternary ammonium chloride (quat) sanitizing wipes; by cleaning of allergen-contaminated surfaces using a wash-rinse-sanitize-air dry procedure; and by allergen transfer from contaminated wipes to multiple surfaces. Food contact surfaces (stainless steel, textured plastic, and maple wood) were contaminated with peanut-, milk-, and egg- containing foods and subjected to various wiping and cleaning procedures.

The study showed that the nature and amount of allergen on a surface, as well as the type and state of wipe cloth, food contact surface texture, and material composition influenced the effectiveness of wiping and cleaning on allergen removal and the extent of allergen transfer on surfaces. Allergens were more difficult to remove from textured plastic than stainless steel or wood surfaces. Overall, the complete cleaning of a surface (using a wash-rinse-sanitize-air dry method) as recommended in the FDA Food Code was shown to be effective at allergen removal and minimizing allergen transfer using these additional considerations:

• Pre-scraping food from surfaces prior to full cleaning aided allergen removal.
• Wet cloths/wipes and alcohol/quat wipes were more effective in allergen removal from surfaces than dry wipes.
• Storing cloths in sanitizer solution minimized allergen transfer between surfaces.

Of course, even having trained employees and managers and a well-designed facility that enables allergen storage and preparation segregation is not enough to reduce the risk of undeclared allergens in prepared foods. A food safety management system¹⁶ must be in place to ensure that managers are monitoring the controls and taking corrective action. However, even with all the proper training, controls, and use of a food safety management system, it may be difficult to declare (i.e., statements via customer messaging) that any product prepared in a foodservice establishment where several allergens are used as ingredients is allergen-free—especially considering how many of the major allergens are in different ingredients (refer to Table 1). Therefore, it is always important to ensure that a foodservice establishment provides the customer with avoidance messaging if there is any risk of an undeclared allergen, and also provides information about all declared allergens in final products.

Foodservice establishments that develop and execute allergen controls described in this article can find that it is also good for business and can grow sales due to brand loyalty.¹⁷ See the article in this issue from Food Allergy Canada on strategic business opportunities for allergy-aware restaurants here.

Acknowledgment

The authors thank Janet Riley of Janet Riley Strategies, Andrew Clarke of Loblaw Companies Ltd., and Mark Beaumont of Danone for their insights shared at the “Food Safety Culture and Communication” session at the 2024 Food Safety Summit.

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