Editor’s note: This is part 2 of a two-part series on allergen residue results. Part 1, which published in our December 2020/January 2021 issue, focused on how to confirm a positive result. Part 2 focuses on steps to take once a result has been affirmed.
Recipients of positive allergen test reports often leap toward recalling the product if it is already in distribution. To some degree, the food industry commitment to recalling products with undeclared allergens is laudable. However, this situation can be viewed as a major decision point. If the positive result shows high levels of undeclared allergen in a consumer-ready food product, the decision is easy and a recall is appropriate.
Many in the food industry seem to believe that recalls are required when any undeclared food allergens are found, especially with confirmation by testing. However, FDA Reportable Food Registry requirements indicate that an RFR notice should be filed with FDA “when there is reasonable probability that an article of food will cause serious health consequences or death to humans.”
In situations where very low levels of allergen residue are present, especially in ingredients and more especially in minor-use ingredients, the probability of serious health consequences may be low. We would recommend a quantitative risk assessment (QRA) in such situations. QRA takes into account the known level of sensitivity of the population allergic to a specific food, the analytical result(s), and knowledge of consumption of the particular food from surveys such as NHANES (National Health & Nutrition Examination Survey). Serving size can be used in QRA, but some consumers are likely to eat multiple servings, so use of NHANES data is preferred. FDA does not officially recognize QRAs but, in our experience, may consider QRA when risks are genuinely low. QRAs can also be used as one of the supporting pieces of information needed during a thorough risk assessment and root cause investigation, which will aid in determining if it is even necessary to contact FDA about the need to file a RFR notice. This corporate decision should be made under advisement from internal and/or external legal counsel.
Special considerations arise when the allergen residue testing is initiated by a consumer complaint of an allergic reaction. In these situations, FDA, USDA FSIS, or other regulatory agencies may already be aware of the complaint. FDA may show up and take samples for their own analysis, because they strongly prefer FDA laboratory results over results that come from any other laboratory.
If FDA does take samples, you should take duplicate samples at the same time. If positive analytical results are obtained with samples related to a consumer complaint, then FDA may strongly suggest a recall even if the results are not strongly positive. Testing samples provided by consumers who have experienced allergic reactions is a process fraught with uncertainties but can also yield valuable information. Obviously, testing an opened sample of food can yield unreliable results because the consumer may have advertently or inadvertently contaminated the sample.
Years ago, we investigated a case where a very young, milk-allergic child experienced an allergic reaction to sorbet that should have been milk-free. Our analysis of the remaining sorbet provided by the consumer revealed a very low level of detectable milk, and the product was recalled from the market. However, a conversation with the mother revealed that her older child was served ice cream at the same time, and the two children were left alone in a room to eat their ice cream and sorbet. Many circumstances could have occurred in that room that contributed to the allergic reaction. In such situations, the Food Allergy Research and Resource Program (FARRP) Laboratory recommends that affected companies prepare to conduct a very thorough analytical investigation involving testing of the consumer’s product sample, retain samples from the same and other manufacturing runs, and perhaps gather additional retail samples of the product. If companies believe that the complaint has absolutely no basis (e.g., no peanuts in that product or the manufacturing plant), they might wait for analysis of the consumer’s sample before conducting additional analyses. Certainly, if you test a sample obtained from a consumer, a non-detect result will ease your anxiety and likely preclude any further testing.
Testing Can Provide Clues to Root Cause
If you have received a positive allergen test result and perhaps have recalled a product, you should try to determine the root cause of the situation. Sometimes the cause may be clearly identifiable, but not always. The chance of subsequent episodes will be substantially lessened if you can identify this root cause and take corrective action.