FSMA’s GMPs: Blocking Risks of Cross-Contamination

Secondly, include an environmental monitoring system that has a site list consisting of product contact (Zone 1), non-contact (adjacent to product contact; Zone 2), and indirect contact (floors, motors, chain drives, walls; Zone 3) for each piece of production equipment and test all vehicular traffic and traffic ways into/out of a post-lethality and/or exposed product production room. Additionally, the program is to include specific activities to be conducted when there is an out-of-specification result, such as an investigation by a multifunctional team, and implement corrective and preventative actions. A corrective action is an activity conducted immediately to reduce the risk, such as an intensified cleaning procedure. This procedure is above and beyond the routine cleaning and sanitizing. A preventative action is an activity that will prevent future adverse results. We refer to preventative actions as one of the “4Rs,” namely, repair, redesign, replacement, and/or removal. All too often, an adverse event means that the site is cleaned and sanitized, as per the usual procedure, and that is all. On the contrary, this is a call to investigate, immediately reduce risk, and implement one of the 4Rs. Further, all activities are to be documented. We will outline a few of the cGMP programs followed by components that we know are the “secrets” to their success.

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Table 1: Cross-Contamination Vehicles and Methods.

Food Allergen Controls

Currently, there are no cures for those with food allergies or sensitivities. Avoidance is needed to prevent allergic reactions. The FDA recommendations will include that food processing establishments handling any of the major food allergens develop and adopt a food allergen control plan that emphasizes the prevention of cross-contact during processing. Since allergens are part of a food and itself not a contaminate, FDA will be reserving the term “cross-contact” as the unintentional transfer of allergenic proteins from a food containing that protein to food that does not. The terms “contamination” and “cross-contamination” will then be reserved for food that has been adulterated with bacteria, foreign matter, or other-than-allergen proteins.

Allergen Best Practices. Verify the cleaning of food contact equipment after allergen use. Do not verify allergens using ATP, which is not a protein, unless the ATP is validated against specific allergen ELISA (enzyme-linked immunosorbent assay) test kits. ATP indicates the presence of adenosine triphosphate or a component of biological material, whereas an allergen is a protein. An ATP assay will not be as specific as an ELISA test and further, it may not be as sensitive. ATP assays are cheaper, which is part of their popularity. When testing for allergens, use a test kit that will identify the allergen in question. For example, barley, rye, and wheat cannot be distinguished with some of the commercial gluten methods. However, there are some commercial methods that are not suitable for barley so verification using barley as a control is a critical component of the verification. Similarly, some processing will destroy the test kit’s ability to recognize an allergen.

Personal Hygiene

Driving up to some plants, we have witnessed employees taking breaks outside wearing lab coats and hair nets; walking into production rooms after going on the roof, loading dock, trash compactors; and sitting on picnic tables and leaning on or sitting in their cars with hair nets and ID tags. All of these seemingly innocent activities reduce the effectiveness of a lab coat, hair net, bump helmet, gloves, and shoes. Having an emphasis on protection against cross-contamination of food contact surfaces starts with limiting non-production room exposure.

Personal Hygiene Best Practices. Many biological contaminates, such as Listeria, are carried in to food manufacturing rooms, either via people or equipment. Outer garments, such as smocks or lab coats, and shoes must be restricted to the more sensitive areas of the plant, such as ready-to-eat (RTE) rooms, and offer the best protection when they are not removed from production area. An anteroom, located just prior entering the RTE room, or an area immediately inside the production will allow employees to don, doff, store their outer garments and shoes, and wash and sanitize hands and shoes. If there is no space for an anteroom, another alternative is to allow an area for donning and doffing of shoes in exchange with captive footwear. This practice will assist with Listeria ingress.

Plants and Grounds

The facility must employ adequate food safety controls and operating practices or implement an effective design to include separation of operations in which cross-contact and contamination is likely to occur. Separation can be achieved by location, time, partition, air flow, enclosed systems, or other effective means.