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 Practice, 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.
We’re first looking at the cleanliness provisions:
Cleanliness § 110.10(b) & (b)(9)
Clarification: Poor hygiene may result in the transfer of food allergens from persons working in direct contact with food, food-contact surfaces, and food packaging materials to food.
Would require that all persons working in direct contact with food, food-contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against cross-contact and contamination of food.
Would require taking any other necessary precautions to protect against the contamination of food, food-contact surfaces, or food packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin) and to protect against the cross-contact of food.
Cleanliness § 110.10(b) (1)
Clarification: Appropriate use of outer garments protects against the transfer of food allergens from food to person to food.
Would require that the methods for maintaining cleanliness include wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food packaging materials, and to protect against the cross-contact of food.
A Closer Look
An effective Allergen Control Program depends on keeping allergenic and non-allergic food and ingredients separate from receiving to shipment and all steps in the process. When it comes to people, training is the most frequent go-to option for controlling allergen cross-contact with foods. There may be individuals in our organization who are allergic to or they may have family members who are allergic to the ingredients or products manufactured. Simply being in certain parts of the facility can trigger an automatic awareness. These folks are often very tuned into how to handle allergens.
However, individuals who have never suffered from an allergic reaction may be unaware of how their actions may cause a cross-contact event; even with employee training. Common activities, such as eating lunch, carrying allergen particles on uniforms, or tracking allergens through the facility by walking through allergen specific areas, can all promote allergen cross-contact. If an individual is unaware of the effects of an allergen, they may be desensitized to the opportunity for cross-contact.
A couple of ways to mitigate the risk is to have different colored uniforms, hairnets, gloves, or even allergen-specific signage that provides a visual awareness that allergens are present. Typically, people want to do the right thing but we often need simple reminders that help make the awareness automatic rather than voluntarily reactive.