Allergen management is not easy. Errors can occur throughout the process causing a final packaged food to contain an allergen that is not declared. There also are many pieces and parts that need to be strategically arranged to ensure the ingredient list is accurate.
It is for those very reasons that it is critical that facilities have a fully developed, and communicated, allergen management plan. “The first error that can enable the undesired presence of an allergen is when an allergen management plan is inadequately communicated to all involved parties, thus thwarting the correct implementation and execution of the plan,” said 3M Food Safety Senior Microbiologist Gabriela Lopez-Velasco. To ensure this, everyone involved in executing the plan should be identified during the risk assessment. Then, in plan implementation: “Every function or operation should ensure that the required actions to minimize the undesired presence of allergens are being adhered to and are working,” she said.
What are the errors that can occur throughout the process? And, more importantly, what practices or procedures can be put in place to reduce the potential of each and/or detect an error further down the line? The following provides a walk-through from incoming goods to packaging to provide insights on areas that can be of concern in allergenic contamination in each.
INCOMING GOODS AND INGREDIENTS. “The fact that a food processing facility has a well-implemented allergen management plan does not necessarily mean that the suppliers they utilize will follow the same practices,” Lopez-Velasco said. Thus, allergen requirements need to be clearly communicated and supplier practices verified.
Incoming goods and ingredients have been the root cause for several contamination issues that BiaDiagnostics has seen, added CEO Thomas Grace. In one case, he said, “The only way the customer was able to track down the source was sending us all ingredients of the offending final product.”
To help prevent such contamination, both Grace and Emport LLC President Emily Kaufman advise facilities to require Certificates of Analysis (CoA) from all suppliers. But, Kaufman added, “Even conscientious suppliers can miss hot spots.” Allergen contamination is rarely homogenous, and if only one or two samples are pulled from a very large production run, allergens can sneak through, she said. “Unless you are entirely confident that you understand every single place your ingredients have been, you might want to supplement the CoA with rapid testing.”
Even if the supplier is someone who has been sending the same product to you for a long time, things happen, Grace added. Thus, he recommends sequestering the incoming ingredient until your testing confirms that it does not contain an allergen. But, he added, “If you are using your own method, be sure it is validated for that matrix and is fit for purpose.”
It also is critical to analyze the composition of incoming products and their commercialization, Lopez-Velasco said. With this knowledge, procedures should be established to ensure ingredients known to be a source of allergens are segregated, stored, and handled separately from allergen-free ingredients to prevent contamination. “Working closely with the suppliers to ensure that correct allergen management has also been implemented or considered is a good practice and requires suppliers to give notification of a change in materials, procedures, or handling of ingredients,” she said.
Another potential source of a problem described by Lopez-Velasco is new product development which can result in a reformulation of a current product and, consequently, the source and type of ingredients are not the same. “Once a facility goes through risk analysis, the known allergens that are utilized are identified. Therefore, if a change in formulation occurs, and it is not communicated, there is a chance that this change increases the risk of having an allergen that was not previously considered,” she said.
To help prevent this, processors should ensure that product developers and purchasing staff are aware of the risk of allergen contamination and understand, analyze, and communicate the risk of a new ingredient or product change that was not considered during the risk assessment, she said.
IN PROCESS. Inadvertent cross-contact is one of the most common issues of allergen management during the processing of foods and beverages. Using dedicated tools, equipment, or even areas for allergenic foods may be the best way to help prevent this, but it is not always possible, particularly in small-scale operations. In such cases, Lopez-Velasco said, “Scheduled production, adequate plant and equipment design to facilitate cleaning, effective physical barriers, and cleaning procedures may be implemented to minimize cross-contamination.”
In all food facilities, cleaning procedures should be validated to demonstrate they are effective and a verification tool selected and tested to enable regular monitoring of the cleaning procedure’s efficacy, she said. “Validation may take a large effort by the facility and their personnel, but it generates supporting data that shows that the cleaning steps are appropriate for the operation.” It also shows that, under regular conditions of manufacturing, the source of a food allergen is removed from the equipment after a cleaning procedure.
Food safety teams should provide guidance to manufacturing personnel to manage production properly. Lopez-Velasco provided the example of running allergen-free products first and implementing longer production runs for allergenic products so they can run at one time, thus reducing the number of changeovers.
In addition to such process issues, plant-floor allergenic contamination can be caused by employee handling and lack of knowledge. Having seen such issues several times, Grace gave the example of a night-shift employee who ran out of margarine as an ingredient so replaced it with butter. But because the product was labeled as milk-free, half of the lot had to be discarded. “Likewise we have seen this where a manufacturer was transporting a finished product across the floor of the factory, and milk powder fell on the raw product and caused contamination,” Grace said.
While some errors (such as an chance fall) may be unpreventable, others (such as an allergenic ingredient substitution) could be prevented through education. Thus, Lopez-Velasco said, “Every effort should be made to ensure that communication channels are working so every department function and individual understands the important role they play to ensure that the products they are manufacturing are safe for consumers. More importantly, they should understand the impact that an error in any step of the manufacturing process will have to an allergic consumer.”
Continuous training and education, appropriate to each group, also should be implemented to raise awareness about food allergy and food safety, she said. This should include specific training and clear procedures for cleaning equipment, handwashing, attire requirements, product formulation, segregation activities, etc.
To ensure the processing area and equipment are not introducing allergens to products, a good allergen environmental monitoring program should be designed, accompanied by a sampling plan and procedures that are correctly performed by trained personnel. “Sampling is always a challenging task,” Lopez-Velasco said. “However, insufficient sampling, improper sampling techniques, or inadequate selection of sampling sites will not fully describe or expose critical areas where allergens may be present.” Generating the sampling plans may require input from a statistician and other key personnel with deep knowledge of the plant design and manufacturing process, she added.
IN THE LAB/TESTING. A critical aspect of allergen testing is ensuring that the test is applicable to the sample. Grace noted a situation in which a manufacturer used a certified method to detect gluten in its product, but the method was certified only for wheat, so it did not detect the barley malt in an ingredient that was added by mistake. The error caused the entire lot to be discarded.
Kaufman also has seen the compatibility between test and sample as a point of confusion in some testing. “Some matrices are just easier than others, whether because of heat, fat, pH, hydrolyzation, or other factors,” she said. “Complex matrices can cause false negatives in allergen testing. Upon request, a reputable lab or test kit provider should be more than happy to review your formulations and help you make a good plan.”
Additionally, Lopez-Velasco said, “Information about method performance provided by suppliers is important as it lets the user know that the method has been thoroughly validated to detect a specific analyte.” But, she said, “A single method may not be applicable for all sample types, but this will only be realized after a sample is analyzed with the selected method.”
Products also can get to market with undeclared allergens when proper due diligence is not employed to rule out false positive or negative results, Grace added. To prevent this, “We re-run the original extracted sample, then run a newly extracted sample from the original aliquot, and make a new extract from a new aliquot,” he said. To assess the results, consider:
- If the initial result was due to a bad test well, all results will be negative.
- If the original extract and aliquot is positive and the new aliquot is negative, it most likely is due to sample heterogeneity.
- If all three are positive, the sample is likely relatively homogenously contaminated.
When a reoccurring positive happens, each new matrix should be spiked to show good recovery (60%-120%) with a known amount of allergen to prove there is nothing in the matrix that could interfere with the method of analysis producing a false negative result, he said. “Also, if there’s any doubt about a possible positive result, the lab should run serial dilutions of the sample to show analyte linearity; this is to rule out non-specific binding to a non-relevant or similar protein.”
However, the facility also needs to ensure it is using the correct test for the situation. “Sometimes, different test methods are used for routine verification and the cleaning validation process, causing mistakes and problems,” Lopez-Velasco said. During cleaning validation, for example, a variety of methods can be chosen to assess that the implemented cleaning procedure reduces the amount of the allergenic food. But using, say, an ELISA or other specific allergen testing during the cleaning validation, then later utilizing ATP swabs for routine verification could pose a dilemma. “The method that will be utilized for cleaning verification should also be included during cleaning validation (for example, a rapid immunoassay or total protein swab),” she said. “This will ensure that the chosen method is an adequate verification tool and appropriately reflects the results obtained during cleaning validation.”
PACKAGING. A common cause of allergen recalls is a mismatch between the food and its packaging, which is “a perfect missed opportunity for many facilities,” Kaufman said. “It takes less than 20 minutes and $20 to confirm the correct packaging, but surprisingly few companies do so.” Thus, Kaufman suggests that once you think you’re done with everything, you give the item in question one last two-question test:
- Does the item look like it should?
- If so, does a rapid test prove that is it truly free of the allergens it should be free of?
There is always a chance of packaging being used for the wrong product, especially in facilities which manufacture multiple varieties of a product, Lopez-Velasco said. “Implementing systems to verify that the food production run and primary and secondary packaging (if applicable) are consistent helps reduce this risk.” Additionally, she said, outdated packaging should be destroyed to ensure against its accidental use. The packaging itself also may be a source of an allergen, so the risk assessment should include materials and coatings — such as protective edible coatings used for fruits or vegetables, with analysis of whether any components could add a risk to the final food product.
“Good allergen management programs combine process and proof,” Kaufman said. “They’re really two sides of the same coin: facilities need to have a thorough process in place for minimizing allergen risk, but they also need to identify points in the process where validation is possible. When you have the opportunity to prove that your process is working — why not take it?”
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.