Publications : 2016

Lau A. 2016. Allergen preventive controls. Chapter 4 in: Industry Handbook for Safe Processing of Nuts. Grocery Manufacturers Association and Peanut and Tree Nut Processors Association.



FDA’s Food Safety Modernization Act (FSMA) sets requirements for a written food safety plan to include preventive controls, which includes allergens. Facilities must have an effective program in place to evaluate, identify, and control food allergens to assure that specific allergens are not inadvertently incorporated as an undeclared component of any product. These measures are required to ensure that hazards requiring a preventive control will be eliminated, minimized or prevented. The final rule provides flexibility in the steps needed to ensure that preventive controls are effective and to correct problems that may arise. The FSMA final rule requires preventive controls to include monitoring, corrective actions and verification as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Monitoring is designed to provide assurance that preventive controls are consistently performed. Corrective actions are taken to timely identify and correct a minor, isolated problem that occurs during food production. Corrective actions must be documented with records. Verification activities are required to ensure that preventive controls are consistently and effectively implemented. They include reviewing records to verify that monitoring and corrective actions (if necessary) are being conducted. The rule does not require that allergen controls be validated; however some facilities choose to do this. A robust, thorough, and comprehensive allergen management program has the following main components: avoiding allergens, having allergen preventive controls and verification procedures to minimize the potential for inadvertent allergen cross-contact by undeclared allergens, and label controls.

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