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 general structural and equipment maintenance and sanitation (cleaning). 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. 

General maintenance, 110.35(a)

Clarification: Improper cleaning and sanitizing that leaves food residues on utensils or equipment may result in the transfer of food allergens from utensils or equipment to food, food-contact surfaces, or food packaging materials that come in contact with the improperly cleaned and sanitized surfaces.

Proposed § 117.35(a)

Would require that cleaning and sanitizing of utensils and equipment be conducted in a manner that protects against cross-contact and contamination of food, food-contact surfaces, or food-packaging materials.

Sanitation of food contact surfaces, 110.35(d)

Clarification: Inadequate sanitation of food-contact surfaces may leave residues of food containing allergens on the surfaces and result in the transfer of food allergens from food-contact surfaces to food.

Proposed § 117.35(d)

Would require that all food-contact surfaces, including utensils and food-contact surfaces of equipment, be cleaned as frequently as necessary to protect against cross-contact and contamination of food.

Sanitation of food contact surfaces, 110.35(d)(2)

Clarification: Inadequate sanitation of food-contact surfaces may leave residues of food containing allergens on the surfaces and result in the transfer of food allergens from food-contact surfaces to food.

Proposed § 117.35(d)(2)

Would require in wet processing, when cleaning is necessary to protect against cross-contact and the introduction of microorganisms into food, all food-contact surfaces be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated.

Sanitation of food contact surfaces, 110.35(d)(3)

Clarification: Inadequate sanitation of non-food contact surfaces may leave residues of food containing allergens on the surfaces and result in the transfer of food allergens from such surfaces to food-contact surfaces or food.

Proposed § 117.35(e)

Would recommend that non-food-contact surfaces of equipment used in the operation of a food plant be cleaned in a manner and as frequently as necessary to protect against cross-contact and contamination of food, food-contact surfaces, and food-packaging materials.

Sanitation of food contact surfaces, § 110.35(d)(4)

Clarification: Failure to properly store single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) could lead to cross-contact.

Proposed § 117.35(d)(3)

Would provide that single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and must be handled, dispensed, used, and disposed of in a manner that protects against cross-contact and contamination of food, food-contact surfaces, or food-packaging materials.

Four of the five requirements to prevent allergen cross-contact have to do with sanitation, that is allergen cleanup. The first step is to evaluate and document where, when, and how allergen cross-contact could take place in the manufacturing process. Keep in mind that allergen cross-contact can occur in food-contact surfaces and utensils, non-contact surfaces, and packaging materials. Such risk evaluation is essential to define and implement the corresponding specific preventive allergen cleaning measures.

At each process step where such a risk has been identified the appropriate written allergen preventive control measures need to be developed and implemented to prevent cross-contact. These include:

  • Validated allergen cleanup procedures, with particular focus on shared equipment and wet process cleaning. Also, attention should be given to equipment such as breather socks and cloth conveyors in the processing areas which are contaminated with a given allergen and need to be changed during changeovers.
  • Appropriate frequencies to optimize production runs and prevent allergen cross-contact, considering planning of production runs to reduce the changeover times needed between production with allergens and non- allergens or different kinds of allergens.
  • Documented education and training of assigned personnel.
  • Appropriate verification activities to assure adequate allergen cleaning. At a minimum these would be visual inspections after allergen cleanup. Better yet would be to use enzyme-linked immunosorbent assays (ELISAs) and strip tests, which provide current scientific limits of allergen detection. Product testing can also be used as a verification activity to demonstrate effectiveness of allergen cleanups.

Documentation is required for allergen cleanup, verification activities, correction (product was not affected) and corrective actions (product was subject to cross-contact), and personnel training.

Finally, single-service articles, such as utensils intended for one-time use, paper cups, and paper towels can contribute to allergen cross-contact if not properly protected throughout the manufacturing process. Carefully consider where, when, and how these single-service articles are present and being used to evaluate the risk of allergen cross-contact. Appropriate preventive measures can then be implemented, such as controlled staging, protection against contamination, and assured single-use only. 

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