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’s Tip focuses on preventing allergen cross-contact with proper structural and equipment sanitation and processes and controls in general, as well as with raw materials and ingredients. 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. 

Storage and handling of cleaned portable equipment and utensils, 110.35(e)

Clarification: Failure to properly store and handle cleaned portable equipment and utensils could lead to cross-contact of the equipment and utensils and then to cross-contact of food if the equipment and utensils come in contact with food.

 Proposed § 117.35(f)

Would recommend that cleaned and sanitized portable equipment with food-contact surfaces and utensils be stored in a location and manner that protects food-contact surfaces from cross-contact and contamination.

Example: Portable equipment is designed to be carried or moved from one location to another. As a result, portable equipment can pose a risk of allergen cross-contact to the area the equipment is moved to, as well as any additional equipment stored in this location, if it was not properly cleaned prior to placement in storage. Consequently, this could lead to cross-contact of food during operation. Best practices include thorough cleaning and verification that the equipment and utensils are clean of food residues prior to placing in storage. It’s also important to ensure the equipment and utensils remain clean once in storage so ensure that they’re not stored in production or raw material storage areas. These storage areas should be clean, well ventilated, and dry in order to protect the stored equipment and utensils from contaminants. Verify that the equipment and utensils are still acceptable prior to next use in order to inhibit the risk of allergen cross-contact. Further measures may also include using portable equipment that is dedicated to specific allergen-containing products to further reduce the risk of cross-contact.

Equipment and utensils, 110.40(b)

Clarification. Equipment and utensils that are improperly designed, cleaned, and maintained may result in the transfer of food allergens from equipment and utensils to food.

Proposed § 117.40(a)(5)

Would require that food-contact surfaces be maintained to protect food from cross-contact and from being contaminated by any source, including unlawful indirect food additives.

Example: Equipment and utensils should be designed and made of materials that are capable of being easily cleaned, inspected, and maintained. Surfaces should be smooth, corrosion-free, and durable to eliminate potential food residue harborage points. If equipment and utensils are not properly designed then allergen-containing residues could collect in these affected areas making it difficult to clean and consequently increasing the risk of allergen cross-contact to food products. Facilities can benefit from developing and implementing design standards that apply to all structural and equipment designs, repairs, modifications, or purchases to reduce the potential for allergen cross-contact, as well as facilitate cleaning and pest control practices.

Equipment and utensils, 110.40(b)

Clarification. Equipment and utensils that are improperly designed, cleaned, and maintained may result in the transfer of food allergens from equipment and utensils to food. See section XI.I for the proposed requirement.

Proposed § 117.40(b)

Would require that seams on food-contact surfaces be smoothly bonded or maintained to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and cross-contact.

Note: Example for 110.40(a) captured this element.

Processes and controls, General 110.80

Clarification. Inadequate processes and controls practices may result in the transfer of food allergens to food.

Proposed § 117.80(a)(4)

Would require that reasonable precautions be taken to ensure that production procedures do not contribute to cross-contact and contamination from any source.

Proposed § 117.80(a)(5)

Would require that chemical, microbial, or extraneous-material testing procedures be used where necessary to identify sanitation failures or possible cross-contact and food contamination.

Example: Ongoing monitoring practices are encouraged to ensure processes and control practices are adequate to prevent cross-contact from any sources. The monitoring approach should be selected as appropriate to the cross-contact risk(s). For instance, if a facility just completed production of a product containing peanuts then measures should be implemented to thoroughly clean the area and remove any residual allergenic proteins to inhibit the risk of introducing allergens to a non-allergen product. It would not be beneficial to monitor the effectiveness of these cleaning activities by performing ATP swabbing which provides no indication of whether allergen proteins are still present on the equipment surfaces. A better approach would be a visual examination of the applied cleaning methodology and newly cleaned surfaces combined with appropriate allergen-specific swabbing to verify that the performed cleaning was effective and accomplished the intended purpose. This approach allows a facility to identify cross-contact risks that are specific to their operations, implement adequate control measures, and monitor these controls to demonstrate they’re being effectively managed to inhibit cross-contact risks. 

Processes and controls – raw materials and ingredients, 11.80 (a)(1)

Clarification. Raw materials and ingredients subject to cross-contact due to improper segregation prior to receipt or during storage may result in undeclared allergens in food.

Proposed § 117.80(b)(1)

Would require that raw materials and ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and be stored under conditions that will protect against cross-contact and contamination, and minimize deterioration. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food or cause cross-contact. Would continue to recommend that containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to cross-contact, contamination, or deterioration of food.

Example: Preventing cross-contact of raw materials and ingredients begins as early as selecting reliable suppliers that implement segregation practices during transportation. At the point of receipt step should be taken to verify that the received materials were properly stored and segregated, and that their condition at receipt has not contributed to cross-contact, contamination, or deterioration of food. Any raw materials found to be damaged or received on damaged, infested, or dirty transports should be rejected and isolated. Allergen containing raw materials and ingredients should be identified and segregated from non-allergen products. Control practices generally include dedicated storage locations for allergens, storage on lower levels only, and like ingredients above like to reduce risks of cross contact in the event of damage while in storage.

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