Explore our comprehensive guide to understanding and implementing a successful food allergen environmental monitoring plan. Our guide includes:
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Each year millions of consumers can have an adverse allergic reaction to foods. Food allergies can be mild or severe; in some instances, exposure can cause extremely serious reactions and even death. Because there is no permanent cure for food allergies, avoidance and early treatment of symptoms are the only management strategies available to affected individuals. There are over 160 different types of food known to trigger an allergic reaction in people with food allergies. Components in food that cause food allergy reactions are select, species-specific proteins. Improper label declaration of the presence of allergenic foods and ingredients is the leading cause of product recalls and contributes to unnecessary consumer exposure to allergens.
In the United States, the law identifies nine major allergenic foods and ingredients made from such foods that must be properly declared on food labels. These foods and ingredients derived from these foods account for 90 percent of food allergic reactions:
According to European Union (EU) regulations, the following foods and ingredients derived from these foods are identified:
Health Canada and the Canadian Food Inspection Agency (CFIA) identify the below as priority food allergens or key substances most frequently associated with food allergies and allergic-type reactions. These must be properly declared on labels.
It is important to conduct regular ingredient testing to ensure that cross contamination from common food allergens is not occurring. For example, oats can be contaminated with wheat residues due to common use of harvesting and processing equipment. Other common incidental agriculture or processing pairs include corn with soybean and tree nuts with peanuts.
Primary goal: Finding allergens in the food-processing environment before they cross contact products
Secondary goal: Assess the effectiveness of current cleaning, sanitation, and employee hygiene practices
A well-designed allergen environmental monitoring program will include samples from various areas throughout your production process. It is important to consider equipment that is used for both allergen-free products and allergen-containing products. Consideration of employee traffic patterns and behaviors also is important to identify areas that are easily contaminated. Equipment that can carry dust, such as vacuum cleaners, brooms, and compressed air are also potential sources for food allergens in the processing environment.
The simplest way to organize your sampling program is to map the processing environment and identify multiple sampling sites based on your specific facility design and processes. The number of samples to collect will depend on line complexity. If the final number of sampling sites is substantial, you can rotate sites at each sampling interval to increase coverage. For example, if you have identified 60 potential sampling sites, you can randomly select 10 to 15 sites each week, making sure that each site is sampled at least once per month. This system will help you stretch your testing budget while making sure you sample all sites needed to maintain program effectiveness. Keep a detailed sampling site log and facility map that details locations of sampling sites. The log should contain written detail on how to collect samples from difficult to access areas such as within processing equipment.
When considering sites to sample, those sites that are direct product contact surfaces – those surfaces where product is exposed to the environment before final package closure – are considered most important. Suggested sampling locations include tables, conveyor belts, buckets, fillers, hoppers, utensils, employee hands, and gloves. It is important to note that all product produced on the line tested should be held until final results are received when testing any direct food contact surface sites for allergens. Items and surfaces directly over or in close proximity to direct food contact surfaces such as areas within enclosed equipment, brooms, vacuums, and compressed air lines are also important areas for testing consideration. Product holds may not be required for testing these sites.
ATP quick tests may be useful in assessing the cleanliness of surfaces; however, these kits do not directly measure allergenic proteins or pathogens. ELISA based methods are developed specifically to determine the presence of specific allergenic food proteins. Each assay targets a certain allergenic protein or class of proteins specific to an allergenic food, with limited cross reactivity to other food proteins. For example, an ELISA that targets the milk protein, Casein (milk solids), will not detect another milk allergen, such as Beta-lacto-globulin (whey protein). Additionally, when target proteins (such as egg or gluten) are denatured due to heat treatment (baking, frying, or pasteurization) or fermentation, ELISA-based methods may not detect them properly, so it is necessary to select kits that are appropriate for the matrix at hand. Likewise, certain sample types may give false negative results when using ELISA-based methods. In such cases, DNA-based methods may be appropriate. Finally, ELISA methods do not exist for some allergenic proteins, but PCR can provide an alternate, source-specific detection method in these situations.
Collecting environmental samples in an aseptic manner is critical to ensuring the quality of the testing results. If the person collecting the samples contaminates the specimen, the laboratory results will not accurately reflect the condition of your manufacturing environment. In addition, they type of swab you use, matters. There are multiple commercial sampling tools available for use. Your best tool is to source sterile and dry swabs resembling a Q-tip stored in individual plastic coverings.
Swabs to not use:
If you prefer to source a pre-moistened swab for convenience, it should only be stored in distilled or HPLC-grade water.
Keeping accurate up-to-date records is important for the success of any environmental monitoring plan. Good record keeping can help provide the necessary information on which decisions regarding future allergen monitoring can be based. A log book or spreadsheet could be used to track these key areas.
In the event that a food allergen cross contact has occurred, it is very important to determine the cause of the cross contact, so that improved control strategies can be established. Here is a list of steps to take when a cross contact occurs.
Please contact us to learn more about how we can help you with your food and dietary supplement allergen environmental monitoring plan. To help you ensure regulatory compliance and eliminate product recalls, we provide customized strategic environmental monitoring plans, certification programs, audits, nutritional labeling expertise, and testing services that will help you protect your brands.