The 2014 Global Food Safety Conference (GFSC) in Anaheim, CA, featured a session sponsored by SGS United Kingdom Ltd. on allergen management as an integral part of a safe food supply chain, which was followed by the dissemination of a white paper summarizing the results of an industrywide survey on current allergen management practices across the food supply chain.[1] The findings prompted a number of questions that Food Safety Magazine (FSM) presented to a distinguished panel of industry experts aimed at identifying the key elements of an effective allergen control plan as well as building awareness, and sharing and promoting best practices to help direct the food supply chain to consistently and effectively implement best practices for allergen management (see “Allergen Management and the VITAL® Tool”) .

The panel included Joseph Scimeca, Ph.D., vice president, global regulatory and scientific affairs, Cargill; R. Craig Wilson, vice president of QA, food & product safety, merchandise services at Costco Wholesale; Steven M. Gendel, food allergen coordinator, U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN); Stefano Luccioli, M.D., scientific adviser and reviewer, CFSAN’s Office of Food Additive Safety; Michael A. Pascucilla, M.P.H., REHS, CEO/director of health, East Shore District Health Department, Branford, CT; Dan Skrypec, Ph.D., chief toxicologist, food safety, Mondelëz International; David Crownover, product manager, ServSafe, National Restaurant Association; and Joseph Baumert, Ph.D., assistant professor in the department of food science & technology and codirector of the Food Allergy Research & Resource Program at the University of Nebraska, Lincoln.

FSM: What do you feel is the top reason for inconsistency in allergen risk interpretation and management? How would you propose addressing this knowledge gap in the food industry?

Scimeca: My sense is that the food industry generally understands and appreciates the potential health risk associated with food allergens, but that the nature of the hazard, inherently a food ingredient, makes its management and control within a dynamic food manufacturing environment very challenging. Unlike other food hazards, where detection plays a significant role in the control of the hazard, with food allergens, the chief reason for food allergen control failure is not primarily one of hazard detectability and control, but one of faultless compliance with control measures that ensure alignment between the formula, product and package label. Hence, the greatest challenge of allergen risk management is one of operational excellence within a rapidly and frequently changing manufacturing environment.

To address this knowledge gap requires a greater recognition by the industry of the principle cause of allergen control failures. Unlike many chemical hazard control failures in food manufacturing, the true risk from allergen control failure is not due to challenges in detectability and lack of operational control through separation, albeit these are not without some importance. Rather, it lies with errors involving management systems. The vast majority of allergen risk to the consumer, and consequently the greatest cause of recalls, stems from the relatively minimal use of automated management systems for allergen control by the industry. The effective use of automated systems that flawlessly verify allergen ingredient declaration through ensuring alignment between formula, the product as manufactured and the package label will provide the greatest reduction of allergen control failures. By way of example, the use of an automated in-line label scanner will ensure an unfailing match between the product and the package label. To the extent that the broad food industry can be educated on the true cause of allergen failures, and taught about the effectiveness of automated systems to prevent human errors, the knowledge gap can be addressed, which in turn will lead to enhanced measures taken by the industry to reduce food allergen risk.

Wilson: This is a twofold issue:
1. Clear understanding of what an allergen is and

2. Appropriate item labeling for consumer awareness.

Gendel: The risk posed by unlabeled allergens for food-allergic consumers has received increased attention and is much better understood today than it was before the implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA). At the same time, our understanding of the complexity of the problem has increased. In the future, it will be important to reduce the gap between academic and clinical research and the real-world problems faced by manufacturers.

Luccioli: I find there is a lack of consistent, clear understanding by the food industry, consumers and the medical community of the hazard/risk posed by small amounts of allergens in food. There must be better consideration of what ppm levels or other analytical results depicting the presence of allergens signify in relation to total exposure and potential for reactions to the product. Also, there is inconsistency among product labels in communicating risks posed by allergen exposures from different cross-contact scenarios.

It is my observation that some companies employ a zero-allergen-tolerance policy and thus tend to place an allergen label or warning on any product, even when the risk is negligible or possibly nonexistent. This may reduce risk but may not be beneficial to consumers, as it limits the number of potentially nutritious products available to them. Other companies use risk management strategies that may underestimate the hazard. These companies argue that they are doing a good job by keeping allergens at less than 1% in the finished product. Less than 1% could still signify hundreds of ppm of allergen in the finished product. This could easily lead to exposures to allergens in the mg protein range per serving—doses shown to cause reactions in allergic consumers and to be associated with severe reactions.

I find there is also a lack of consistency in use/intent of precautionary statements and how these statements are applied to specific cross-contact scenarios. The food industry maintains a position that a precautionary statement should be viewed as a warning to an allergic person not to consume the product. However, by allowing a multitude of different precautionary statements on food products that convey different risk information to consumers, the food industry appears to be endorsing a policy aiming to provide consumers a choice about which products may be consumed or not. This policy sends a mixed message. Also, the food industry does not consistently define what these statements represent and for which products or cross-contact risk scenarios they should be used. Thus, the same type of statement may be used for both high- and low-risk products. Since consumers may look for and rely on certain types of precautionary statements as denoting products that are safe to eat, should they choose to consume the high-risk product, this increases the chances for adverse outcomes.

Information on allergen “threshold” doses in relation to health-risk endpoints (i.e., percentage of individuals in the allergic population likely to react to and/or have severe allergic reactions to a given allergen dose exposure) will help fill knowledge gaps by giving risk managers a clearer understanding of adverse health consequences to the consumer posed by varying allergen residue levels in products. This information, in combination with actual data on allergen levels in products from various ingredients or cross-contact scenarios, would also help identify and stratify products based on low vs. high risk for allergic reactions—knowledge that can be used to better inform consumers and the medical community about true allergenic hazards posed by certain products. Thus, limiting the number of precautionary label statements to only a few statements that can convey specific product risk would lead to more effective communication about allergic reaction risks to products and better acceptance of/compliance with precautionary statements by allergic consumers.

Pascucilla: Food allergies are misunderstood, and in general, they are not considered a significant problem by the general public, as there is a lack of understanding and knowledge about this worldwide food supply safety problem. However, foodservice stakeholders at all levels understand (or are starting to realize) that food allergies must be addressed, as both consumers and food industry regulators have demanded change. Food allergies are a food safety concern that impacts people’s quality of life. In fact, food allergies are not just an inconvenience, but have been proven to be harmful and at times deadly. People also need to understand the difference between an allergy, intolerance and preference.

Food allergies are a public health concern that must be addressed from the farm to table. Like any other public health matter, prevention starts with education. All foodservice industries must educate their employees on food allergies, as this issue is a food safety matter. Food allergy reactions, like food poisonings, are preventable, and management must make this a priority and set food allergy educational expectations and lead the way for their businesses/organizations.

There is also a consumer responsibility. The consumer must be honest with the food establishments as far as what their allergies are and how severe [they are], and they need to ask the right questions to keep themselves safe. In the same respect, the food establishments must be honest with the consumer and have the knowledge to properly respond to food-allergic individuals. Training staff to have the understanding of allergens and ingredients is essential and a key step toward prevention and awareness. In restaurants, this food allergy safety awareness is everyone’s duty and needs to be seamless from servers to chefs, as well as the consumer.

Skrypec: Typically, food safety hazards are evaluated and managed through risk assessment practices with the objective of protecting the public. In the United States, FALCPA requires labeling of the presence of so-called major food allergens. By default, the law requires use of a “zero threshold,” meaning that any detectable level of a major food allergen triggers the labeling requirement. Consequently, industry relies on analytical results of “none detected” to provide assurance of allergen management. However, there are sound scientific data to show that the safe level of allergens is higher than zero and that there are “thresholds” below which an allergen does not constitute a food safety hazard. Over time, we expect that FDA’s regulatory policy will account for these thresholds in order to bridge the gaps in allergen risk interpretation and management within industry. Importantly, education and training regarding the appropriate consideration and application of these thresholds within the production environment, including sanitation practices, will be necessary for meaningful labeling changes, which could provide greater product choice for the allergic consumer.

Crownover: For the foodservice industry, general awareness and understanding the importance of food allergens continue to be the biggest issue. In 2012, the National Restaurant Association [NRA] commissioned a survey of restaurants and their awareness of food allergies and their use of training in their restaurants: 87% of the respondents stated that food allergy training is extremely important, yet 43% do not do any formal food allergy training. There was also 1% that claimed that they do not serve any “allergic” food. So while there is recognition of importance, there is still a fairly large gap in actually identifying whether they can and will accommodate individuals with food allergies or that they even have food allergens in their operations.

Based on the results of the 2012 survey, NRA identified the need to offer a food allergen awareness course to its customers. It also partnered with Food Allergy Research and Education, the leading voice of the allergic consumer, to demonstrate the importance of this issue to the foodservice industry. This course is specifically designed for the foodservice industry and addresses general food allergy information, front-of-the-house and back-of-the-house issues. NRA also actively speaks at various conferences across the country to help raise the general awareness of food allergens in restaurants and ultimately demystify the concept of food allergy management in foodservice.

Baumert: My observation is that much of the food industry understands the importance of food allergens and the critical need to carefully manage allergens to ensure the safety of allergic consumers. With that said, there are certainly differences with which individual companies assess and interpret allergen risks, and these differences are often apparent with the various precautionary statements that are used on packaged food labels. Declaration of ingredients derived from the eight priority allergenic foods is required by food manufacturers with the passage of FALCPA; however, the law does not dictate when labeling should be used in the event of potential cross-contact situations. FALCPA did, however, essentially establish a zero threshold for labeling as well as for cross-contact potential. It is operationally impossible to guarantee the complete removal of every molecule of allergenic residue (a true zero-threshold scenario) in a facility that produces numerous products with varying allergen profiles on shared equipment. As a result of this uncertainty, precautionary or advisory statements have increased in use and complexity.

I do not think that this is a knowledge gap that contributes to the inconsistency in allergen risk interpretation and management, but rather uncertainty surrounding congressional labeling laws and interpretation and enforcement of these laws. The food industry as a whole needs a single standard by which they can systematically assess allergen risks. The Voluntary Incidental Trace Allergen Labeling [VITAL] program developed by the Allergen Bureau of Australia and New Zealand could prove to be this single standardized approach; however, the program will unfortunately not be widely adopted by food companies in the U.S. unless it receives some acknowledgment by regulators as an acceptable approach for allergen risk assessment and labeling decision making. To do so, however, would require regulators to acknowledge that a population “threshold” or reference dose does exist, something that the agencies have been reluctant to do at this point in time.

FSM: What do you believe is the weakest link in the food supply chain with regard to allergen management, and how do you propose improvements should be made?

Scimeca: The weakest link in the consumer packaged food supply chain is the need for the consistently accurate flow of allergen-related information about the food from one supplier in the supply chain to the next. To the extent that the final manufacturer of a consumer packaged food product has received full disclosure of all food allergens present in the ingredients used in the formulated product, and has effective systems and manufacturing control measures to prevent cross-contact and mislabeling, then the manufacturer should be able to accurately disclose the presence of allergens in the finished product. Too often, a manufacturer is focused on their operational control measures and fails to adequately devote the resources necessary to ensure that their suppliers have fully disclosed allergens in their products and maintained operational allergen control. In addition, customers need to set clear expectations from their suppliers about the need to adequately convey any changes in their products that might impact the presence of allergens.

Wilson: Certainly allergen identification and standards along the complete supply chain are an ongoing problem. It may well be time for stronger regulatory intervention; catching a problem after the fact and doing recalls seems too late.

Gendel: An analysis of food allergen recalls for FDA-regulated food products suggests that one of the most significant supply chain problems lies in the communication links between suppliers and manufacturers, particularly when there are changes in ingredient formulations. This may be a reflection both of the variety of ways that suppliers provide information (e.g., through certificates and analysis, ingredient specifications, labels, information on invoices, etc.) and of the separation between development and production functions at manufacturers.

Allergen Management and the VITAL® Tool

Globalization of the food industry has created a complex food supply chain, bringing with it the risks associated with cross-contamination (or cross-contact) of allergens prior to supply, in process and during storage and distribution. Contamination of foods with allergens and/or mislabeled product is now one of the most common causes for food recalls. Other common causes include:

•    Inadequate assessment, identification and management of direct and cross-contact allergen risks in storage and processing environments

•    Poor assessment of ingredient specifications and presence of allergen in trace amounts across a range of ingredients

•    Lack of control or awareness of labeling ingredient declarations and appropriate risk-based, cross-contamination precautionary statements (i.e., may be present)

•    Poor management of label or packaging change controls on production lines at product changeover

Management and verification of allergens in processing are challenged by the allergen thresholds or “acceptable level.” Currently, there are no thresholds (except Japan: 10 ppm); as a result, industry works on an “operationally zero” impossible threshold.

To further complicate the issue, clinical threshold studies have previously presented data in an inconsistent format, such as mg or ppm of protein vs. units of whole food. Threshold levels vary based on dosage, with data gaps noted particularly for tree nuts (almonds, walnuts). Considerations for likelihood of a reaction in allergic consumers are based on prevalence, threshold and consumption of a specific product. There is also considerable variation globally with regard to regulatory requirements for allergen labeling; for example, sesame is not required to be labeled as an allergen in the U.S. but is required in Canada; the reverse situation is noted for Crustacea.

In 2007, the Australian Allergen Bureau released the Voluntary Incidental Trace Allergen Labeling (VITAL®) tool, revised in 2012, based on scientifically determined action levels for key allergens. VITAL provides a risk-based assessment process inclusive of allergen assessments for ingredients and through to the manufacturing, production and packing processes. VITAL not only allows food producers to assess the impact of allergen cross-contact but also specifies the precautionary allergen statement according to the level of allergen cross-contact identified. The aim is to provide consistency in allergen declarations to enable allergic consumers to make accurate, informed decisions. The VITAL tool and training in its effective application are a mandatory requirement for suppliers to some Australian retailers.
–Margaret Balfour, managing director,
Integrity Compliance Solutions (ICS), and Leanne Singleton, executive manager, program development, ICS

Luccioli: If one associates poor allergen management with increased number of food allergen-related recalls, then the weakest link in the supply chain is likely human error/inattention at the product label stage. This is difficult to control, but additional safeguards at this stage may be warranted. Another obvious weak link in the allergen management of the food supply chain is not having an effective allergen control program with Good Manufacturing Practices [GMPs] in place. These control programs do not appear to be consistently applied throughout the food industry. Even with effective controls and GMPs in place, presence of an unintended allergen occurs often by way of cross-contact. In addition, sampling and analysis of allergen levels in ingredients continue to be problematic, especially for ingredients with particulate allergens.

Improving allergen management of the supply chain is difficult, but having an allergen preventive control program is paramount. Frequent analytical testing to obtain information on allergen levels in all raw ingredients used in manufacturing and of the final products may improve management, but this type of analysis is costly and may not be feasible for all companies. Moreover, a lack of a standardized approach for the number of food samples and sampling frequency to ensure absence of allergens, especially particulates, is a limitation. In essence, many allergen cross-contact scenarios cannot be easily controlled in the food supply chain. Thus, there is a need to look carefully at any and all factors that may lead to potential presence of allergens in products and to carry this information through to the product label. It is at the product label stage where the risk of allergen exposure can and should be more effectively communicated to consumers.

Pascucilla: In its simplest form, risk management starts with risk assessment. Food production as it relates to food allergies must begin with raw ingredients, and food production/preparation needs to be followed through all processes to the point of packing to human consumption. This is not new to the food industry and is a common/best practice and a mandated requirement in food safety known as Hazard Analysis and Critical Control Points [HACCP].

In addition, in foodservice establishments, a huge problem exists as chefs do not always have all the ingredients listed in their food products. There are too many fillers and additives that are not properly listed. We also need to know what our animals are consuming in their diets. We need to know what “natural flavoring” really means—what is it made of? We shouldn’t have to call manufacturers to find out the hidden ingredients, even if it’s a minuscule amount. We need to have a clear understanding of what the food ingredients are in all food products and that all labeling must list everything on the product label.

Skrypec: Most major manufacturers implement stringent health and quality processes and procedures, especially during sanitation and product changeovers. However, there is an opportunity to continue to build training and awareness of allergen management practices across the entire food supply chain, which would further minimize the risk of error, and ensure that allergens remain top-of-mind. The food industry should continue to take steps to improve efforts in this area and require allergen training for employees as part of an overall food safety program. Training is available through programs and organizations such as the Food Allergy Research & Resource Program [FARRP] and the Grocery Manufacturers Association.

Crownover: Top to bottom, the weakest link is education/training. I say that not just for the restaurant industry, but for the food industry as a whole. While the training required for food processing has been in place for some time, and allergen management has been written into GMPs and is specifically called out in various regulations [FALCPA, HACCP, etc.], once it leaves the producer, the awareness and control of allergens in distribution and then foodservice drops off. Continued emphasis on training by the industry is the easiest and most impactful improvement that can be made.

Baumert: The diversity of ingredients used in packaged food products and the global nature by which these ingredients are sourced pose a difficult challenge for the food industry to ensure that allergen cross-contact has not occurred throughout the supply chain. Some ingredients are sourced from regions of the world where allergen awareness and regulatory oversight may be lacking. With the passage of the Food Safety Modernization Act [FSMA] and the proposed Foreign Supplier Verification Program, domestic and international suppliers will need to assess allergen cross-contact risks of imported ingredients. In the long term, this will help to broaden allergen awareness and management practices across the supply chain. Continuous allergen training both domestically and internationally is essential.

FSM: In the absence of consistent allergen standards, is precautionary labeling of allergen content likely to change?

Scimeca: No, the use of precautionary labeling will likely remain a means to inform the food-allergic consumer about the potential for trace levels of unlabeled allergens. However, greater adoption and use of a single standard, like that under the VITAL program, will provide for more consistency across the industry in the use of precautionary labeling and thus improve their reliability to the food-allergic consumer. Having said this, still lacking are consistent test standards along with the necessary test methodology to ensure the validation of the various analytical methods used for the measurement of food allergens. Only then can test results from a particular analytical test method conducted by a particular laboratory be compared with other methods and/or laboratories.

Wilson: It should—we all need to keep the consumer as our primary focus?.

Gendel: It is clear that questions regarding the meaning and use of various advisory statements have received a great deal of attention from consumers, industry and government in the U.S. and around the world. FDA has advised that such statements must be truthful and not misleading and should not be used as a substitute for GMPs. The use of preventive controls will play a significant role in providing a consistent approach to allergen controls and their integration into GMPs, which should help provide a basis for industry to assess the appropriate use of advisory labels.

Luccioli: My impression is that this labeling will not change. If anything, precautionary labeling may become even less meaningful. A review of food allergen advisory labels in 2008 found over 20 different types of precautionary statements being used in products. We know from consumer surveys that consumers are not happy with the proliferation of many different types of statements. Consumers often report ignoring or disregarding these statements altogether, which limits the importance of these statements in the first place. Although there is value in being transparent and providing as much information to consumers as possible about the risk posed by the presence of unintended allergenic ingredients, use of precautionary labeling statements to convey very low-risk or low-allergen content may not be an effective strategy when there is no standard in place allowing consumers to know what risk these statements aim to convey or mitigate. A majority of consumers are told to avoid any product with a precautionary statement. Moreover, since most consumers may not completely understand their own sensitivity for reaction to low-level allergens, they will be confused by the variety of different statements reporting low allergen levels.

Pascucilla: Again, clear and honest labeling is not optional; it must be a mandated requirement. Precautionary labeling is an important and continually changing field as more research is conducted and provides essential information so consumers can make an informed decision on their food choices.

Honestly, there is no defendable reason why food manufacturers cannot provide proper labeling of all ingredients. It only makes sense to get on board with where the food culture is headed. In short, people have a right to know what they are eating.

When you see allergen warnings at the bottom of the ingredients with no apparent allergen in the actual ingredient list, the questions arise: “What is it?” and “Why is it there?” It appears that some food companies do not want to list all the ingredients. For the safety of others, labeling needs to become clearer and allergens need to stop being hidden, as food allergy reactions are a type of food poisoning.

Skrypec: Manufacturers continue to apply strict allergen practices. In the absence of consistent standards (science-based thresholds or action levels), precautionary labeling is likely to remain prevalent in the market, especially in certain challenging food categories, such as confectionary. Indeed, this practice may even increase.

Crownover: Hard to comment on this as it relates to the foodservice industry, as there really are no labeling laws directly impacting it. Restaurants are in a unique position where not only is accommodation not mandatory, it is sometimes just not possible depending on the foods that are being prepared at the facility. No can be the right answer as it relates to a restaurant being able to accommodate someone’s food allergy. For instance, a seafood restaurant might not be able to accommodate someone that has a fish or crustacean shellfish allergy. While individuals with a severe fish or crustacean shellfish allergy will likely not go to such an establishment, the concept is still valid. By allowing restaurants to focus on food allergies they believe they can accommodate for, the customer gains confidence in that establishment, and they can then have a potential for higher success and minimize the potential for error which can have catastrophic consequences.

Baumert: Without the implementation of a consistent allergen standard such as VITAL and, more importantly, regulatory acceptance of an industry approach to risk assessment and allergen management, I do not think that the use of precautionary labeling for allergens will decrease. In fact, I believe with the eventual implementation of allergen preventive controls that are mandated by FSMA, we may even see an increase in the use of precautionary statements for allergens because additional regulatory focus will be placed on allergen control and management. Without regulatory acknowledgement or implementation of food allergen reference doses or “thresholds,” the reality of trying to achieve the operationally impossible zero level of allergen residue on shared equipment will result in more companies using precautionary statements.

FSM: What should the next steps be for the industry to move forward in allergen management and reduction of risk (recalls related to allergens)?

Scimeca: Education and training across the broad food industry, from large to small businesses, remains the most effective means to inform manufacturers about the need and means to adequately manage and control food allergens. A deeper understanding of the relative risks associated with the various failures associated with the management and control of allergens will permit manufacturers to appropriately devote food safety resources where they can result in the greatest reduction in food allergen risk and recalls, and hence the largest improvement in public health. Such training and education can be accomplished through a number of means, but should be made available at a local level or through distance learning since many small manufacturers lack the resources or ability to send employees to national or even regional meetings.

Wilson: Simple–know what goes in your items and label appropriately to inform the consumers.?

Gendel: The development and implementation of allergen preventive controls as part of an overall food safety plan will provide a central focus for industry and government efforts to reduce both consumer risk and the number of allergen recalls in the future. Allergen preventive controls, which include both label controls and process controls, coupled with improved research on allergen hazard characterization will translate into significant levels of risk reduction.

Luccioli: Zero allergenic risk is nearly impossible unless one decides not to use allergens at all. Thus, I believe the food industry needs to accept and work with the fact that there will always be some risk from low allergen exposures and to keep allergen levels from cross-contact as low as possible. I believe that consumers are increasingly frustrated by the lack of transparency or meaning for many products with precautionary statements. Thus, the food industry could find better ways to distinguish products that present low, intermediate or high risk for reactions in the allergic community and better communicate that risk to consumers. Agreement on well-defined precautionary statements to convey these different risks could become an effective communication tool. Better communication should minimize consumer reactions and other factors that may lead to product evaluation and recall.

Ultimately, there needs to be improved education and communication about risks posed by low-level allergen residues in foods/food products. I believe the food industry needs to continue working closely with regulators, consumers and the medical community to establish allergen thresholds or action levels that can be used to better convey allergen hazards on food labels. Establishing a universally accepted and practicable threshold or action level that is associated with zero reaction risk and no need for precautionary or other allergen labeling is difficult to achieve. Thus, precautionary labeling efforts should focus on thresholds defined by certain risk standard(s). The risk standard would define both the maximum amount of allergen that may be present in a product and the level-of-reaction risk expected for the allergic population if the product were consumed. The risk standard may also vary depending on the type and distribution (i.e., homogenous vs. particulate) of allergen present. Thus, products that meet a certain risk standard would carry one statement, whereas products with another risk standard would carry another type of statement. Defining these risk standards is only the first step. Communicating the specific information (i.e., label information, levels and distribution of allergen, etc.) on food products meeting each risk standard to consumers and the medical community is the next important step. Once this information is effectively communicated, it will be up to the medical community to find ways to evaluate and test allergic consumers (possibly by food challenge to levels of allergen found in these products) so as to help consumers understand their relative sensitivity to products meeting each risk standard. I believe that effective labeling of products that meet defined risk standards has the potential not only to simplify allergen dietary avoidance practices and ameliorate quality of life for allergic consumers but to significantly improve consumer understanding of risks conveyed by food allergen labels, thus minimizing the chances for adverse health outcomes.

Pascucilla: It is a shared responsibility between the food industry and food safety regulators. While mandating rules and regulations is necessary, food industry providers need to be part of the process so as to assist food safety regulators in passing practical, common-sense laws that prevent food allergy exposures. There also has to be a balance that does not put undue hardship on private businesses. Federal, state and local food safety agencies need to be overseeing these important food allergy safety processes and find out where all products are sourced from farm to table. Companies need to be honest and thorough with their products and production, and when they are not following the rules, they must be held accountable.

There needs to be openness and honesty in the food industry, and a food allergy training and awareness commitment needs to be part of the food culture at all levels. In addition, fad diets cannot overshadow the reality of allergies, and this can only be accomplished through education. It must be understood that even small amounts of allergens should not overshadow the reality of how dangerous and harmful they could be to someone with a food allergy.

Personal responsibility and common sense are also a key component to preventing food allergy exposures. Parents must understand their children’s food allergies and teach/provide them the tools they need to prevent/protect themselves. The food industry can and should be part of this food safety allergy promotion and awareness campaign initiative.

Skrypec: Based on the data collected by FDA, the vast majority of allergen recalls are not related to cleaning and sanitation practices during food manufacturing, but rather mislabeling of product. Thus, greater focus on proper label development and packaging material management in order to eliminate undeclared allergens would significantly reduce the number of recalls related to allergens.

Crownover: For the foodservice industry, the concept of recalls only comes into play when the customer steps into the restaurant and is only relevant to the product that is made for that allergic customer. Therefore, as stated before, continued emphasis on training within the restaurant on food allergy awareness is paramount. Through training, the restaurants can minimize the potential of errors and more importantly, know their limitations when it comes to accommodating customers with food allergies. By demonstrating this confidence to the allergic consumers, they can, in turn, build a loyal following.

Baumert: Allergen training and education across the supply chain, from ingredient suppliers to finished product manufacturers, is essential to build awareness of food allergen control and management practices. In addition to continued allergen training and education, the next steps for allergen management and reduction of risk will be the implementation of a single standard for allergen risk assessment, and management will be pivotal to ensure consistency with allergen labeling practices. This will require regulatory acceptance of a program such as VITAL or the implementation of regulatory thresholds or reference doses. Experts from regulatory agencies, the food industry, healthcare, allergic consumer advocacy groups and academics need to engage in a multi-stakeholder discussion to define a level of accepted risk and effectively communicate this to a broader audience.

Food Safety Magazine thanks all the panelists for sharing their expertise.A special thank-you goes to Evangelia Komitopoulou, Ph.D., systems & services certification, global technical manager–food, SGS United Kingdom Ltd., for the informative session at GFSC 2014 and sharing the results of the white paper.

Joseph Scimeca, Ph.D., is vice president, global regulatory and scientific affairs, corporate food safety and regulatory affairs at Cargill.

R. Craig Wilson is vice president of QA, food & product safety, merchandise services at Costco Wholesale.

Steven M. Gendel is the food allergen coordinator at FDA, CFSAN.

Stefano Luccioli, M.D., is the senior medical officer in CFSAN’s Office of Food Additive Safety. His answers reflect his personal opinion as an FDA medical officer but should not be construed to represent the views of FDA.

Michael A. Pascucilla, M.P.H., REHS, is CEO/director of health at the East Shore District Health Department, Branford, CT. Home Restaurant has been actively providing assistance in the department’s food allergy awareness initiative.  

Dan Skrypec, Ph.D., is chief toxicologist in the food safety group at Mondelëz International.

David Crownover is product manager, ServSafe, at the NRA.

Joseph Baumert, Ph.D., is an assistant professor in the department of food science & technology and codirector of the FARRP at the University of Nebraska, Lincoln.