Welcome to a series of informational blogs where I will describe, decode and demystify the FDA "Control of Listeria monocytogenes (Lm) in Ready-to-Eat Foods: Guidance for Industry Draft Guidance" (henceforth, The Guidance). These blogs will offer translations of The Guidance for minimizing Listeria incidence in your ready-to-eat (RTE) production environment and products. In this series, I will provide a section-by-section analysis translating the FDA recommendations into usable English and offering techniques to go above and beyond for those that are so inclined.
In January, 2017 the FDA published The Guidance that is intended to assist with compliance of cGMP's and Preventative Controls for Human foods (21 CFR 117). The Guidance clearly states that it contains "non-binding recommendations". It is the agency's posture is that The Guidance represents the best practices from their perspective that will control or prevent Lm contamination. It may not be far reaching to say that the FDA expects these recommendations to be followed. Come to think of it, they could have said this: We are offering the industry what we believe to be the best methods to reduce Lm in your production environment. While they are non-binding, they are proven techniques to reduce Lm incidence. Therefore, should Lm be found in your products, on a product contact surface or even within your production environment and we also find that you have not implemented these practices we will use our authority to press forward with regulatory actions.
Forewarned is forearmed starting with: Since best practices start with personnel, let's start with Part IV Controls on Personnel (starting on p.6 of The Guidance Hands, Gloves and Footwear (p.7): The FDA advises that hands be washed before entering the production room; donning gloves for those who touch product contact surfaces (PCS) and changing gloves whenever non-PCS's are touched.
Glove Use Translation: Employees who touch PCS's are to wash and sanitize their hands, put on gloves and then sanitize their hands-in that order. Plants can have sinks immediately before or immediately after entering the production room but this does not mean that hand washing can occur and then the employees walk down a hallway, down some stairs and finally through a series of doors to get to the production area. Nor does this mean that ear plugs and hair nets are put on after hand washing-invoking the yuk factor. The concept also expands into washing hands in a sink that is foot operated to prevent contamination of the handles and then the employee walks directly to their work station with washed, gloved and sanitized hands. The sink area should be equipped with warm to hot water (~100-110°F), paper towels, a trash container that does not require touching of the lid, and hand sanitizer.
Going above and beyond: Use gloves that are a different color than the product so when they break, any plastic bits are easy to see if they fall into a product. Purple may be a good color as not many foods are purple. I also suggest that there are hand sanitizing stations and boxes of gloves stationed close to workers so when they need to change their gloves, everything is close to encourage compliance.
Footwear Use Translation: It is also recommended that footwear only be worn in exposed ready-to-eat (RTE) production areas. Said another way, provide footwear for your employees that are not just captive to the plant, but captive to the RTE areas. This is significant because it has so many implications. Like what, you ask? Well, let's begin with providing an area immediately outside the RTE room where street shoes can be removed, stored and exchanged with captive footwear when entering the RTE room. Then let's move on to providing benches for changing and having enough space for shift change chaos. And then, you will want to designate where the RTE area starts (on the side of the bench where the captive boots touch the floor) and yes, it does not mean that footwear can be worn all over the plant (breakrooms, restrooms). And even further it means that someone has to clean those darn boots (sanitation?) within this room. My goodness, Is there anything good here? Well, yes, non-RTE employees do not need captive footwear and this is one of the factors that will significantly reduce the incidence of Lm in the RTE rooms.
Going above and beyond: Having a ante-room immediately outside of the main (or better yet, only) employee entrance that has sinks, GMP gear (lab coats, hair nets, safety glasses, bump caps etc), a bench to divide the street shoes from the captive boots and a boot scrubber to walk through prior to entering the RTE.