Almost every food manufacturer must manage a food safety program that includes an environmental monitoring program (EMP). Initially, it might sound straightforward—pick some testing sites, take some sponges/swabs, and run pathogen testing—but, as you build a program or start to analyze your data, you may realize that running an EMP is not as easy as it seems.
There is no one-size-fits-all approach to starting an environmental monitoring program. Most regulation or auditing bodies are not going to give the best testing details on how much, how often, when, or sometimes even what to test for. Most of the time you are only required to have an environmental monitoring program that matches your hazard risk. This vagueness is because there are thousands of food product types, and the ingredients you use and how you make the product can be different, even in similar products. On top of that, even if you make the exact same product using the same ingredients, your people, facilities, equipment, and traffic patterns are different and can introduce different risks. Because there are so many moving parts to developing an environmental monitoring program, it’s difficult and risky for regulatory groups to provide a specific process without knowing your facility.
As a consultant, I find that, most of the time, companies struggle just to get started. My first piece of advice is to just dive in. An environmental monitoring program isn’t set in stone and, in fact, should grow and be flexible so you can adjust it as needed based on collected data. The main goal of any environmental monitoring program is to search and destroy: Find the bacteria niches in your facility and address them. Getting into the details of how to do that and what practices are going to work best is where complication come in. In addition, running a hazard analysis can be complicated and time consuming.
Here are steps you can take to build an effective EMP from the ground up that’s specific to your product and company.
DETERMINE YOUR PRODUCT PROCESS
The first piece of information you need to figure out is what you do with your product after you make it. It’s in your best interest to test all areas of contact, both food and non-food, so you have a better idea of the risk level and cleanliness of your facility. You must be careful because presumptive positive environmental monitoring results can indicate that a product could also be contaminated. Do you hold your product for a few days and have the time to wait for results from your environmental monitoring program to come back? Or are your products made, packaged, and out the door in just a few hours?
If you’re able to hold the product, then you can complete pathogen testing in the highest-risk, food contact sites. If something comes back positive for Salmonella, Listeria, or pathogenic E. coli, then you can catch the implicated product before it leaves the facility. However, if your product is out the door as fast as you can make it, then a presumptive positive sponge/swab on a contact surface can cause you to pull back the product or issue a recall, which is a can of worms you want to avoid.
ZONE YOUR FACILITY
Next, select where you’re going to test, so you should define what the high-hygiene area is. For RTE products, this area starts where the raw product exits the cooking step as fully cooked, and extends to the point in the process where the product is fully enclosed in a sealed package. Everything prior to the cook step would be considered the raw area and the post cook hygiene area must be strictly off limits to personnel and equipment from the raw side. Personnel access to the high-hygiene area must be controlled and monitored to ensure the strict procedures for entering and leaving this area are followed.
Once the hygiene area is defined, you can determine the zones of your facility. The first zone is easy to identify—does it directly touch your product? Is it directly over exposed product after cooking or is it touched by hand-held utensils, or even the inside of the product packaging? If it’s around these areas or closely adjacent to any zone one and could easily be touched and transferred to your zone one, it’s going to likely fall into zone two.
If it’s in your production/manufacturing high-hygiene area but not zone one or zone two, it’s likely going to be zone three, which includes floors, walls, drains, and parts of equipment outside the scope of zone two in the hygiene zone. It can also include surfaces subject to backsplash from zone two.
Finally, if it’s part of the facility accessible to RTE and raw personnel but not part of the production/manufacturing area, then it’s probably going to fall into zone four. These include shared employee welfare areas, locker rooms, and common traffic routes. In some cases, this can also include office areas.
It’s not always that easy, however, to determine hygiene areas and sampling zones when looking at a facility. You must be aware of the entire area before and after the lethality step, or even after your product is sealed in its package. Zone one can be difficult to test if your machinery is complicated or not open to the environment. Some equipment, tools, and personnel can move between areas causing added risks. Don’t stress; not everything is set in stone, so depending on results or observations you might start with a site being classified as a zone three, but as you learn more you can easily move it to a zone two. You should use your data to change and improve your EMP. Spend time observing the process with a team to look for these changes.
Next, companies must determine what to test for. Usually, this is Listeria but can include other pathogens such as Salmonella, pathogenic E. coli, or indicator organisms such as aerobic plate count, Enterobacteriaceae, coliform, or generic E. coli. Sometimes you can even look for contaminates of high concern such as yeast and mold or S. aureus.
You should monitor the organisms that are high risk for the environment and the products that you make. For example, if your product contains meat or dairy, it doesn’t make sense to only monitor for Listeria, since Salmonella and E. coli could also be concerns for your product. If you can’t monitor for pathogens for zone one you can use indicator organisms mentioned above. This won’t directly implicate your product but can give you an idea of how high the bacteria counts are and, thus, the risk for contamination. For example, just because you have a high Enterobacteriaceae count does not mean you have a Salmonella contamination, but it can give you a good indication that the environment can support the growth of Salmonella, and because you have not killed or removed the Enterobacteriaceae, there is a high contamination risk.
HOW OFTEN TO TEST
Now that you have worked through the questions of where to test and what to test for, you’ll need to determine when and how often to test.
These changes are based on the secondary goals of your environmental monitoring program. Are you aiming to verify effective cleaning and sanitation? Or, are you looking to see how the day is progressing and how your facility is staying clean? If you have raw product/production that is naturally going to have bacteria and be cooked at home, your EMP is most likely going to be focused on making sure your sanitation process is effective at killing harmful bacteria spread during production. In this case, you’re going to want to take samples after cleaning and once sanitizer is dried, or before production to ensure surfaces are starting off in the best condition.
If your product is ready to eat and includes a bacteria-killing step during production, then your EMP should focus on ensuring that your production is not getting contaminated during day-to-day processing. When it comes to determining the best times to test, it is best to take samples during the production day, approximately two hours after the start of operations.
How frequently you carry out this testing is based on your product’s risk rate. If you have a high-risk product and are making a lot of it using very fast processing, you’ll want to monitor it more frequently. Some clients take samples every day, every week, once a month, or even once a quarter. I do not ever recommend doing less than that. It is always easier to test more frequently and then dial back. Each time you monitor, you cover the time between sampling. If you wait too long and have a problem, you potentially run into a gap where you’re not sure how clean your conditions were.
If you produce an RTE product and you test zone one samples, your plan must define what happens when a positive result is reported, or a quantitative indicator organism test is out of spec. The investigative sampling procedure must be outlined, in addition to the conditions that must be met to return to routine sampling.
If you test more frequently and discover you don’t have an issue, however, it’s much easier to justify to your team and your auditor why you should test less frequently. You do not want to run into a situation where you go three to four months with no results and then suddenly find a facility with several Salmonella or Listeria positives and have no idea how long it’s been a problem.
Finally, don’t forget other items you might have to monitor in your facility, such as water, wastewater, and passive and compressed air. You typically don’t need to monitor these as frequently, but they can contribute to contamination in your products.
FINDING THE RIGHT PARTNER
These are the basic elements that I use to help a facility start its program. Break it down, follow these steps, and document what your decisions are. From there, you can pick an accredited laboratory partner and get the supplies to start your testing.
Your EMP doesn’t have to be perfect, and getting one started is the first step in making it better. Safe and high quality products are critical to a company’s growth and to protecting public health. If you need more help or just expert advice, there are professionals available who focus on partnering with companies to set up EMPs.