Reducing Allergen Recalls Under FSMA

Let’s now take a look at the failures resulting in misbranded food products. The most troublesome mistakes (not declaring the allergens, using the wrong package or label, and wrong terminology) account for over half of failures and can be minimized, if not eliminated, with some straightforward labeling-related preventive controls.

By comparing the samples representing each shipment of labels with their proofed versions, this simple verification procedure should lead to a correction at receiving if any labels arrive with printing errors. In such a case, the shipment would be returned to the supplier or destroyed. This assumes that other potential causes such as splices and mixed lots have been addressed as well. This preventive control at receiving should minimize, if not prevent, entry of non-compliant labels into the facility.

Being reassured that only correct labels are stored in the warehouse is no guarantee that these will end up with the right product. Consider implementing another potential preventive control at packaging/labeling of the finished product. This effort constitutes a verification procedure to assure a proper match between the label/package/container and the product that will be added. There are many ways of achieving this goal that are dependent on the technology used, the complexity of the manufacturing process, the quantity of products, the number of allergens, and other factors. Similar procedures can be applied to avoid failures with in-house label printing processes.

Using these two potential labeling Preventive Controls, one at receiving and another at the process step where the label and the product come together, will go a long way in minimizing the risk to allergic consumers and the costs of recalls.

The possibility of designating these two measures as Preventive Controls under Part 117 is quite reasonable, depending on the complexity of the manufacturing process. Again, the key question would be to ask, “What is the likelihood of the hazard, namely a misbranded product, in the absence of the Preventive Control?” In the first case, a misprinted label would be received and accepted. Such mistake could still be caught and prevented from going further in the packaging/labeling step. Still, catching the mistake at receiving is far less costly than catching it when a product has already been packaged in mislabeled containers. In the second case, that is, in the absence of a labeling verification activity at packaging/labeling, the likelihood of a misbranded product reaching the consumer increases dramatically. So identifying the measure as a Preventive Control at this process step would be a prudent decision under Part 117.

A resource for companies wanting or needing to challenge their allergen control program is AIB’s Consolidated Standards for Inspection. It contains many requirements that are directly or indirectly associated with allergen control, as seen in Standards table.

Future success in preventing misbranded food products due to cross-contact or inaccurate labels will go a long way in reducing the number one reason for food recalls in the U.S. This can be achieved by elevating a couple of current practices to the level of a Preventive Control under Part 117, and managing them similar to a Critical Control Point, with monitoring, correction/corrective action, verification, validation (for allergen cleanup procedures), and documentation. Employee education and training to become Qualified Individuals related to allergen control and the production of safe, legal food will be of uppermost importance for these modifications to your Food Safety Plan to succeed.

Hugo is manager of Global Innovation Food Safety at AIB International. Reach him at [email protected].