Reducing Allergen Recalls Under FSMA

In short, the problem of allergen recalls can be reduced to two basic issues. First, failures that lead to inaccurate labels and second, failures that lead to unintended allergens being in the final product. Both issues can be very detrimental to allergic consumers, and invariably lead to costly recalls.

The Solutions

Some solutions include more effective label or package control at packing/labeling process steps. For others problems, such as omitting allergens from labels, thorough root cause analysis is needed. The unintended presence of an allergen in products due to cross-contact or other processing/operational failures will also need root cause analysis to identify the basic issues that lead to these failures.

I’ll start by looking into ways and means to prevent allergen cross-contact during manufacturing operations. The Preventive Controls Rule, namely Part 117, revised several provisions of the current Good Manufacturing Practices (cGMP), Part 110 to address and control potential allergen cross-contact as part of the preventive controls. These new requirements are contained in the new Part 117, Subpart B—cGMP.

On more than 20 occasions, the phrase “to protect against cross-contact” was added to the different components of the new cGMP, aiming to reduce failures that result in unintended allergens being added to a product. These additional preventive controls were added to:

• Personnel hygienic practices;
• Outer garments;
• Design and construction of plant equipment and utensils (including location, materials, construction and finishing, seams of food contact surfaces, separation/partition of operations, ventilation systems, dust control, enclosed systems, and timing of manufacturing and non-manufacturing activities);
• Sanitation of equipment and utensils with special emphasis on food-contact surfaces;
• Sanitation of nonfood-contact surfaces;
• Control of single-service articles such as utensils, paper cups, and paper towels;
• Storage and handling of cleaned portable equipment and utensils with food-contact surfaces; and
• Processes and controls (such as manufacturing procedures, testing and segregation of raw materials and ingredients, reuse of water for washing, rinsing and conveying of food, inspection of containers, handling and storing of raw materials and ingredients, identification and segregation of ingredients that are food allergens, work-in-process and rework, transfer of food allergens to other foods during manufacturing, and protection of finished product against cross-contact during warehousing and distribution).

A great way to approach these newly regulated allergen cross-contact preventive controls and update your current Allergen Control Program is:

• Obtain a copy the FDA’s summary revisions to the cGMP and additional requirements to address allergen cross-contact;
• Have your food safety team review and understand the scope and intent of these new allergen cross-contact preventive measures;
• Carefully walk the plant with these regulations in mind to verify conformance;
• Identify non-conformance issues, address them, and update your Allergen Control Program, including new documentation and records, as necessary;
• Identify new education/training needs and make them part of your allergen control training;
• Carry out such training and document it; and
• Implement verification activities to ensure compliance with new allergen cross-contact preventive controls.

As the team walks the plant, it is critical that shared equipment and production schedules designed to minimize allergen cleanup after unique allergens have been used be kept in mind to identify specific allergen cleanup as potential preventive controls in the Food Safety Plan. In other words, by asking “What is the likelihood of the hazard (allergen cross-contact) in the absence of the preventive control (cleanup after the unique allergen)?,” the team will be able to identify specific allergen cleanups that are essential for food safety, and those should be treated as Preventive Controls under Part 117.

While some operational changes and adjustments may be easier to implement, in some cases changes to the design, maintenance, and operations of equipment may be necessary. These may take more time and capital to develop and implement.