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

August's Tip of the Week series continues to 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 August, 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’s Tip focuses on preventing allergen cross-contact with proper warehousing and distribution handling, process controls, and operations. It is advisable to read and think about the reasoning provided by the FDA to justify including allergen cross-contact prevention in the updated GMPs. 

Processes and controls—manufacturing operations, § 110.80(b)(13)

Clarification. Manufacturing operations may result in the transfer of food allergens to food.

Proposed § 117.80(c)(13)

Would require that filling, assembling, packaging, and other operations be performed in such a way that the food is protected against cross-contact, contamination, and growth of undesirable microorganisms.

Example:

Manufacturing controls during filling, assembling, and packaging

One of the biggest concerns during the filling, assembling, and packaging of food products is to ensure that all packaging materials are available online for the correct product being packaged and that all of the previous product is removed from the packaging production equipment.

A checklist should be developed for operators to use too ensure that all previously run product and packaging materials, including labels, are removed from the area before packaging of the next product begins.

A specific equipment allergen cleaning procedure/checklist should be developed for operators to follow prior to starting the next packaging run. The procedure should include all equipment used to package the product. Once the cleaning procedure is complete and documented, validation is necessary to confirm that the cleaning was effective. This should be visual inspection and some type of protein test. Elisa test kits are a common type of allergen test kit that are used for this type of validation. Once cleaning verification is complete the next step can be conducted.

Once all previous production packaging materials and labels are removed from the packaging line, cleaning is conducted, and validation testing is confirmed, the next step is to bring all new packaging and labels for the next run to the packaging line. There should be a checklist to verify that all correct packaging is in place along with verifying that the correct label with correct allergen information is printed on the label.

The first several containers of the new production run should be tested for previous allergen materials. This should be conducted by an accredited laboratory with recognized methods. If these steps are followed the potential of allergen cross contamination during packaging will be low. 

Warehousing and distribution, § 110.93

Clarification. Inadequate storage and transportation conditions may result in the transfer of food allergens to food.

Proposed § 117.93

Would require that storage and transportation of food be under conditions that will protect against cross-contact and biological, chemical, physical, and radiological contamination of food as well as against deterioration of the food and the container

Example:

Handling LTL or LCL materials during receiving

Less-than-load or less-container-load materials are mixed cargoes that include goods that may not belong to the site. The potential of allergen cross-contact is higher if the packaging or protection on the received goods is not in optimum condition or any damage occurs. Sites should provide specification for received items so that staff members can check on the correct goods, quantity, packaging, damage, pest, odor, and food security requirements. These should correspond with the agreement signed with the supplier and transporter prior purchase. Photos could be included to facilitate checks.

Currently there is no specification for the amount of allowed allergens (other than sulfites on chemical sensitivity at 10 ppm) to cause a negative reaction to the human body. Minor amounts spilled onto received goods if not removed could be introduced accidentally into the product stream during discharge or other manufacturing steps. When the outer packaging on goods received is damaged or not sufficient for protection, this needs to be highlighted for a risk assessment prior acceptance and escalated to management for supplier improvement.

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