From prediction to prevention

by Joanie Spencer
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Over the past decade, the world of allergens and recalls has drastically changed for the baking industry. With the Food Safety Modernization Act (FSMA) looming on the horizon, the evolution isn’t over. So, how can bakers get their minds — and their processes — around allergen control? The Food Allergy Research and Resource Program (FARRP) at the University of Nebraska, Lincoln, led by co-directors Stephen Taylor, PhD, and Joe Baumert, PhD, is a resource for information, expert opinions, tools and services relating to allergens in the food industry. 

As FARRP co-founder and professor with the Department of Food Science and Technology, Dr. Taylor’s research interests involve food allergies and allergy-like illnesses including the development, evaluation and improvement of immunochemical methods for the detection of allergens and allergenic foods; the determination of threshold doses for allergenic foods and implementation of risk assessment approaches for allergenic foods; and the effect of food processing on food allergens.

An assistant professor at the University of Nebraska, Dr. Baumert’s research interests include the examination of the digestive stability of major food allergens, the examination of processing effects on food allergens and more.

Together in this exclusive Q&A, Drs. Taylor and Baumert share with Baking & Snack some of the most pressing allergen and ­allergen-related issues facing the industry today.

Baking & Snack: Why is the baking industry so prone to allergen-related recalls? Why are some products, such as cookies, at more risk than others?

Stephen Taylor: The baking industry is more prone to allergen recalls for multiple reasons: the widespread use of ingredients from commonly allergenic sources (peanuts, tree nuts, milk, eggs, soy, wheat), the widespread use of shared equipment and facilities within the baking industry, the frequency of changeovers from allergenic to non-allergenic formulations, the particulate nature of some allergenic ingredients used in bakery formulations and the challenges associated with allergen cleaning in the baking industry.

Particulates often have sufficient mass to elicit allergic reactions in sensitive consumers. It can be difficult to remove every single particle from shared baking equipment. Wet cleaning is generally the most effective approach to removal of allergen residues from shared equipment surfaces, but wet cleaning cannot generally be practiced in the baking industry. Dry cleaning approaches are difficult and sometimes inefficient. However, the No. 1 reason for allergen recalls involves putting the incorrect product in the package. With the frequency of product changeovers in the baking industry, proper procedures should be in place to ensure that the product gets matched with the correct package.

How have advances in testing, training, audits and regulations affected the number of recalls?

Dr. Taylor: Consumers are more alert to allergens than at any time in history. Those who believe they have suffered an allergic reaction are much more likely to contact the manufacturer or the Food and Drug Administration (FDA) than in years past. FDA is also very responsive now to such consumer complaints and is likely to initiate an investigation. The Reportable Food Registry (RFR) requires that food manufacturers must quickly alert FDA to any concerns regarding undeclared allergens whether from consumer complaints or other sources, such as a supplier informing a company that their ingredient may contain undeclared allergen.

Joe Baumert: Undeclared allergens are the leading cause of RFR reports in recent years. The existence of specific and sensitive methods for detecting allergen residues means that regulators and the food industry have analytical approaches to verify the presence of allergens when any suspicions arise. In the absence of regulatory thresholds, any amount of detectable allergen residue is going to lead to an RFR report and a likely product recall. Consumer complaints likely do not occur with all recalls. The Food Allergen Labeling & Consumer Protection Act (FALCPA) has increased the focus on proper labeling of allergenic foods and ingredients derived from allergenic foods. When errors are made in the implementation of FALCPA stipulations, then recalls will ensue.

Why are there so many recalls despite efforts to improve food safety?

Dr. Baumert: Allergenic food ingredients are ubiquitous in the baking and snack industries. In most facilities, such ingredients are present in large amounts. By contrast, other food-safety hazards are present in trace amounts, making them easier to control. Other factors also contribute to allergen-control issues. The frequency of use of shared equipment, the frequent use of rework and the frequency of changeovers mean that allergen control must be consistently and frequently practiced in baking facilities.

Dr. Taylor: The difficulty in the removal of allergens from the surfaces of shared equipment is another factor. The equipment in many baking facilities is not well designed for allergen cleaning. Because wet cleaning cannot usually be applied, less efficient dry-cleaning methods (brushing, wipe-downs, vacuuming, etc.) are needed. Packaging controls seem to be a particular concern based on their frequent involvement in allergen recalls. Obviously, the baking industry probably puts the right product in the package about 99.999% of the time, but every error of this type is likely to become a recall because the level of undeclared allergen is usually going to be quite high.

How would you assess the baking industry’s food-safety record today vs. a decade ago?

Dr. Baumert: The awareness of both consumers and the baking industry regarding allergens has increased markedly over the past 20 years. Many baking companies have instituted excellent allergen control programs within that timeframe. However, because of the increased awareness, undeclared allergens are more likely to rise to the level of a recall than in years past. When specific and sensitive peanut assays entered the market about 15 years ago, it was much easier to find bakery products with undeclared peanuts than is true today (it would be quite difficult to find a violative product in the market today).

What sort of training is needed to reduce the number of allergen-related recalls?

Dr. Taylor: The baking industry must continue to place an emphasis on employee training. Allergen control is everyone’s job. Thus, it is important to institute allergen training across all job functions within a company. We could cite many examples where vigilant, well-trained employees have prevented a recall by alerting management to some situation that would have resulted in a recall if not corrected.

Beyond the need for widespread training and allergen awareness, the baking industry needs to be better trained in allergen preventive controls and their validation to meet the upcoming FSMA requirements. We don’t yet know exactly what FDA will expect in the way of allergen preventive controls or their validation, but preparedness will be key.

How can FARRP experts help companies minimize the risk of allergen cross-contact in their production facilities?

Dr. Baumert: FARRP offers several services to the baking industry. The ISO-certified FARRP Laboratory offers confidential analytical services for allergen residues. Companies can use the analytical services to qualify ingredients and ensure that these ingredients do not contain undeclared allergens. Many companies have used such testing services to validate the effectiveness of allergen cleaning procedures although lateral flow strips exist for in-house use by companies that are typically the first step in validation. FARRP also offers training, both workshops and webinars, to provide in-depth training for the leaders of corporate allergen teams.

What sort of analysis and testing should be done on a regular basis?

Dr. Taylor: The nature and frequency of testing depends on the specific manufacturing situation. We recommend that companies validate the effectiveness of their allergen control measures. This should be done for each vulnerable product on each line and in each facility because individual circumstances will be different. Validation of allergen cleaning can involve several approaches including visual examination of equipment surfaces, swab testing of surfaces for surrogate markers of general cleanliness (ATP or protein) and swab/lateral flow strip testing for specific allergen residues.

Dr. Baumert: Obviously, swab/lateral flow strip testing is the most specific and probably the most sensitive in many situations. FARRP recommends that the ultimate validation should involve quantitative ELISA detection of allergen residues in the next product manufactured on the shared equipment. In general, FARRP recommends that companies should clean the equipment and evaluate with visual examination and in-house test methods followed by quantitative ELISA. FARRP would recommend that, if no allergen residues are detected on two to three separate occasions for a given product on a specific line, then the company has a validated SSOP for allergen cleaning. The company may not need to then do regular testing if it can determine a procedure to verify that allergen cleaning is always done in a consistent manner for that product and line. Additionally, more and more frequent testing will be needed when making a “free” claim such as “gluten-free” on a product.

There’s talk of a “hypoallergenic peanut” on the horizon. Is this realistic? If so, what could that mean for other allergens?

Dr. Baumert: The “hypoallergenic” peanut remains in development and on the horizon. The lack of allergenicity of some of the peanuts that have recently made the news remains to be confirmed with clinical testing of peanut-allergic individuals. Such testing is essential in our view before making the claim that it is a “hypoallergenic” peanut. Genetic engineering approaches likely offer the best possibility for production of hypoallergenic peanuts but the effectiveness of this approach will be hampered by the presence of multiple peanut protein allergens in the peanut kernel. In our opinion, this development is yet some years away.    

How can FARRP experts help companies minimize the risk of allergen cross-contact in their production facilities?

Dr. Baumert: FARRP offers several services to the baking industry. The ISO-certified FARRP Laboratory offers confidential analytical services for allergen residues. Companies can use the analytical services to qualify ingredients and ensure that these ingredients do not contain undeclared allergens. Many companies have used such testing services to validate the effectiveness of allergen cleaning procedures although lateral flow strips exist for in-house use by companies that are typically the first step in validation. FARRP also offers training, both workshops and webinars, to provide in-depth training for the leaders of corporate allergen teams.

What sort of analysis and testing should be done on a regular basis?

Dr. Taylor: The nature and frequency of testing depends on the specific manufacturing situation. We recommend that companies validate the effectiveness of their allergen control measures. This should be done for each vulnerable product on each line and in each facility because individual circumstances will be different. Validation of allergen cleaning can involve several approaches including visual examination of equipment surfaces, swab testing of surfaces for surrogate markers of general cleanliness (ATP or protein) and swab/lateral flow strip testing for specific allergen residues.

Dr. Baumert: Obviously, swab/lateral flow strip testing is the most specific and probably the most sensitive in many situations. FARRP recommends that the ultimate validation should involve quantitative ELISA detection of allergen residues in the next product manufactured on the shared equipment. In general, FARRP recommends that companies should clean the equipment and evaluate with visual examination and in-house test methods followed by quantitative ELISA. FARRP would recommend that, if no allergen residues are detected on two to three separate occasions for a given product on a specific line, then the company has a validated SSOP for allergen cleaning. The company may not need to then do regular testing if it can determine a procedure to verify that allergen cleaning is always done in a consistent manner for that product and line. Additionally, more and more frequent testing will be needed when making a “free” claim such as “gluten-free” on a product.

There’s talk of a “hypoallergenic peanut” on the horizon. Is this realistic? If so, what could that mean for other allergens?

Dr. Baumert: The “hypoallergenic” peanut remains in development and on the horizon. The lack of allergenicity of some of the peanuts that have recently made the news remains to be confirmed with clinical testing of peanut-allergic individuals. Such testing is essential in our view before making the claim that it is a “hypoallergenic” peanut. Genetic engineering approaches likely offer the best possibility for production of hypoallergenic peanuts but the effectiveness of this approach will be hampered by the presence of multiple peanut protein allergens in the peanut kernel. In our opinion, this development is yet some years away.

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