Tip of the Week: A Closer Look at Allergen Cross-Contact – One GMP Provision at a Time

July’s Tip of the Week series will uncover FSMA’s revised GMPs and how they focus on food allergen cross-contact. FSMA’s Hazard Analysis and Risk Preventive Controls (HARPC) rule recently revised several provisions – 24 to be exact – of the cGMP, Part 110, to address and control potential allergen cross-contact as part of the preventive controls. These new requirements are contained in Part 117 - Current Good Manufacturing Practices, Hazard Analysis and Risk Prevention Controls.

Throughout July, our Tip series will uncover the area of focus, the section number and clarification of reasoning, action requirements, and ways you can apply them for each of the 24 allergen cross-contact provisions.

This week we're looking at plant construction and design provisions.

 Plant construction and design § 110.20(b)(2)

Clarification: Inadequate construction and design of a plant can result in the transfer of food allergens to food. Separation of operations is a key means of preventing cross-contact.

Proposed 117.20(b)(2)

Would require that plants must take proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food packaging materials with microorganisms, chemicals, filth, and other extraneous material, and to reduce the potential for cross-contact.

The potential for cross-contact and contamination must be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which cross-contact and contamination are likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means. Separation of operations is a key means of preventing cross-contact.

One method to decrease the risk is through dedicated production lines. Different types of allergens are simply not processed on the same lines. However, one possible method of allergenic contamination is by air. A dusty allergenic powder can fill the air, then settle to the area below. Dust can permeate the smallest cracks and crevices. Re-bagging dusty ingredients, batching multiple ingredients, or milling operations can create allergenic dust. This puts neighboring lines at risk even if they are dedicated lines.

If your facility process dusty allergens, consider impermeable physical barriers. Some facilities may even consider 100% dedication to specific or no allergens to prevent contamination. A risk assessment of each individual operation should be performed in order to determine what measures should be implemented.

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