Environmental Monitoring for SQF Edition 10 Readiness

Tammie Van Buren: All right, by my clock we are right at 1:00 Eastern time. So, we're going to get started. Again, welcome to everyone who's joining us live today and to everyone that's going to get this recording in their email within the next day or so. And yeah, we're going to talk about environmental monitoring today and what it looks like under Edition 10. So let's go to the next slide that has our antitrust statement in it. So if we could get that up on the screen. Yeah. So FMI SQFI we follow the antitrust laws. So, anytime we have people gathered together, we just always like to remind that there are some sensitive topics that we're not going to talk about that would create antitrust issues. So, price fixing, allocating of markets, boycotts, anything like that, we're just going to stay away from. But today, we're going to be talking about food safety as it relates to environmental monitoring. So, that's a topic we can all talk about. And, as always, if you have questions, feel free.

You can put them in the chat or you can use the Q&A button. we will try to get all of your questions answered or as many as we have time for today. and with that, I'm going to let us go on to the next slide and I'm going to introduce our speaker, Doug Marshall. he is one that we have used before to talk about environmental monitoring because Doug really does know what he's doing when it comes to that topic. So Doug, I'm going to hand it off to you. Talk to us a little bit about Eurofins and yeah, what do you want to say to us about your organization?

Douglas Marshall: Well, thank you Tammie. good morning, good afternoon, good evening to everyone watching the webinar. Really appreciate your investment in time with me today. And I'm just scrolling through a few slides just so those of you unfamiliar with the Eurofins brand have an appreciation that not only are we a large testing body globally, but we're also an SQF certification body. So those of you who do business with us, I thank you for your patronage. Those of you interested in us, please contact your local representative. So, in the amount of time we have today, I'm going to be covering a lot of content. And so, the slide decks are content-rich. I'm not going to read all the bullet points in the slides, but I'm going to bring out some important points for you to consider when you are looking at your current environmental monitoring program or you are in the beginning phase of building one so that you have an appreciation for what SQF has done with the current version related to pathogen environmental monitoring. And so that's what we're going to discuss today.

And we're going to go through some of the questions a lot of people have in terms of how do I make sure I'm compliant with an auditing scheme, but also how do I make sure that I have ownership over my plan and I do the risk-based assessment that allows me to justify why I'm doing what I'm doing when it comes to pathogen control and pathogen environmental monitoring. So, these are the sections we're going to cover today. And let's go ahead and proceed. I'm going to go over just the language in the code and have you think about what is important for you to put in your environmental monitoring plan. And just very briefly, the change has put a much greater emphasis on you need to have a documented risk-based environmental assessment and then from that then you can look at it as a risk-driven preventive system that allows you to measure whether or not your GMPs are working, your sanitation is working, your personal hygienic practices are working and so forth. But again, we're talking about risk based. So the pointers I'm going to make are some risk-based decisions you have to make in your program.

So the goals then we're going to talk about how your risk assessment and your hazard analysis then leads into your program decisions. while provide you with recommendations on how to how to build or refine a practical sampling program that's based on the risk of your products in your facility. And hopefully that gives you a better understanding on how to build a good environmental monitoring program that is fit for your risk. and then we'll finish up and provide some examples on how you can turn the data that you're getting from your environmental sampling program into actionable results. So, let's go on. What does a good environmental monitoring program look like? Well, first and foremost, you need a great sanitation program because that sanitation program allows you to number one control pathogens in your environment, but number two, it also allows you to have an effective root cause and effective corrective actions. So, if your sanitation program isn't working well, then everything else we do is just going to be telling us that's the case. Second thing you need is an environmental testing program that assess the effectiveness of your sanitation and sometimes your GMPs.

And then you need to evaluate the test results and do a root cause analysis when you have an out of specification sample. And then you need to take corrective actions based on a root cause analysis. So this really is the core of your environmental pathogen monitoring program. to give you an example of regulatory thinking. And again, those of you who are not under FDA scrutiny, you need to make sure that you follow your own regulatory requirements for your product and process types as well as for your region. But this is what FDA's put in the law for FSMA. And it basically says that we expect food manufacturers to have an environmental product test and a product testing program. And then there's a subp part here that you really need to do environmental monitoring to make sure you don't have pathogens in in your processing plant that can get access to food. and so just keep that in mind. All right, let's go over the core clause. So the first item here is a risk-based environmental assessment to determine the level or the depth or the scope of your environmental monitoring program.

And that should be in place for all food manufacturing processes in immediate surrounding areas that impact those manufacturing processes. And then the environmental monitoring program shall be evaluated annually or when trends or other changes affect the product safety. So one question that people have with environmental monitoring is do I have to do environmental monitoring? Well, let me walk you through some examples where maybe you do, maybe you don't. So if you have a validated microbiological kill step, so a process control that applies to the product inside a sealed container and the food in that container is not subsequently exposed to the manufacturing environment. Maybe environmental monitoring may not be required for pathogens because again the product inside the container gets a microbiological kill step to eliminate pathogens. The package isn't open until used. Pathogens can't recontaminate the product. Here's another example. Maybe the product itself is lethal to pathogens. And I use the example here of vinegar where the very low pH is toxic to survival and growth of pathogens.

The best example I can give you is a hermetically sealed product undergoing a minimum botulinum cook such as a canned food. Again, that process step and the package prevents contamination by environmental pathogens. An example that may or may not fit this model would be high pressure processed foods. So in this case the process may eliminate non-sporeforming pathogens such as Salmonella Listeria ecoli but it may not be fully sufficient to inactivate spore-formers. So if you've got your risk assessment that says four formers are a risk and the product is exposed to the environment, maybe you need to do environmental monitoring. Okay, so the bottom line is if you have a processed food that's exposed to the manufacturing environment after a microbiological kill step, pathogens can get back on the product. Therefore, you should do pathogen environmental monitoring to ensure your processing environment is free from pathogens.

Douglas Marshall: Tammie, is there a question?

Tammie Van Buren: We do have a couple of specific questions. So, I thought while we were on this screen, so we've got one that's saying, "What about ready-to-eat foods with intrinsic factors that would prevent microbial growth such as low water activity and high acid?" I think you've kind of touched on that, but is there anything to add there?

Douglas Marshall: Yeah, with low water activity that may be sufficient to prevent multiplication and growth of the pathogen, but something like Salmonella can persist on a dry low water activity food for days, weeks, months, even years. So if you have environmental cross-contamination of that food with something like Salmonella, then you would still need to do environmental monitoring.

Tammie Van Buren: Okay. So what if your process doesn't have a kill step but it's not ready-to-eat? So things like flour environmental monitoring required or expected?

Douglas Marshall: Oh, this is a good question. This is where your risk assessment will help you answer the question. So, you need to think about, we'll get into the risk assessment in a few minutes, but you really need to ask the question, what is the intended use of the product or the ingredients? And it might also just out of being a prudent brand owner ask the question, what is the unintended use of this food or this ingredient? And if it's going to be consumed without someone applying a kill step prior to consumption, even though it technically may be raw, I think you still have an environmental cross-contamination risk that merits an environmental monitoring program.

Tammie Van Buren: Yeah, our chat is blowing up with some very specific examples, so we're not going to go through each one. but one that we always get asked is food packaging. And I came from a food packager and we had an environmental monitoring program but even though we were low risk but I had data to support that we didn't need to do it very often. So what are your thoughts on having that program so that you do have some data to support or back up what you're doing as far as environmental monitoring goes.

Douglas Marshall: Yeah. I'm going to revert back to your risk assessment. So, if you're a packaging manufacturer and the material is going to be used to package a product that has a microbial kill step, then the package in and of itself material could be a cross-contamination risk. Yeah, that's a on the other hand, if it is a an a metal can that's going through a minimum botulinum cook then the metal can really I would argue probably doesn't need environmental monitoring to prove that yeah when it goes through a retort process the food is not possible to be contaminated. So again, you could go both ways depending on your risk.

Tammie Van Buren: Exactly. All right. Well, I'm going to let you go on.

Douglas Marshall: Very good. All right. Other sections of the code talk about responsibility and methods for the program. Needs to be documented. So again, if you don't document it, then you're probably not doing it. And if you don't have records, you definitely can't prove that you got a good program. All right? So, you need to have this program. So what should be in this this document? So you need to detail the applicable pathogens. That's what we're talking about today that you should test based on your hazard analysis. So again we have all kinds of variations with product and process. So, it's beyond the scope of a 1-hour webinar to give you really a ton of examples, but they're all out there, and I'm guessing, Tammie, they're in the chat. Second thing is you need to determine the number of samples you're going to be taking when you do an environmental monitoring event. You also need to determine the frequency of sampling and when you're going to take the samples. So, this is this bullet item here is the one that I get asked all of the time. Dr. Marshall, tell me how many samples I need to make, take, when I should do sampling, and where I should be sampling.

I cannot answer that question unless I work with you to do a hazard analysis and do develop a risk-based decision making program. So, we'll talk about how you can get to those answers. You should identify the locations where you're going to take the samples. It's recommended you do random selection, but I will tell you if you have a known hotspot, why would you want to not do that spot in your routine sampling? But just think about that. Again, it's a risk judgment call. identify your acceptance criteria. For most people with pathogen environmental monitoring, the acceptance criteria is not detected. Okay. And then describe the methods how you would deal with elevated trends or an undesirable test result. All right. Next items. You need to have these test results monitored, tracked, and trended. A lot of people when they get their data back from their laboratory, if it's in spec, they do nothing. That's a great day in the office, right? Well, not necessarily. You should be collecting those data and doing some sort of trend tracking so that when you do get an out-of-spec, you will have some understanding of what's going on in your process. It's like taking your pulse.

You're taking it every day. Hopefully, your heart is working. The end result of that is you're going to have a good day. If it's not working, you're dead. Don't be a dead food processor. When you get an out-of-spec, then you need to do root cause analysis, corrections, and corrective and preventive actions. Okay? And anytime when you have an unsatisfactory test result or when you see trends that your environment's getting out of control. All right. So back to the question is environmental monitoring required? You might ask required by who? your customer an auditing scheme like SQF or a regulatory environment in which you work under. I would argue it's required for you to be able to prove your processes are under control. So that would be number one on my list. So really you can use environmental monitoring to assess whether your sanitation and your GMP activities are working. Okay. So, when you do your risk assessment, one question we occasionally get is what should I test for? And I'll just use this picture as an example and the statement that all pathogens could potentially be in the environment and they need to be controlled. But how do you do that?

And how do you really want to test for all of these in your environment? And the answer is you may not necessarily have to. So in this particular picture one GMP that I think would be interesting from this is do you have a preventive control for foot direct product contact of a potentially ready-to-eat product. And again if you're a bird flying down this wind row of drying peppers, what a nice bombing run you might have with your feces. All right. So, we can simplify this thought process by thinking about what the risks are of environmental pathogens. And most of the scientific studies, most of the outbreaks demonstrate that Salmonella is the target pathogen for control when you have a dry low moisture product that's manufactured in a dry low moisture facility. So Salmonella as a pathogen has the ability to exist in a state of quiescent animation for a long period of time when it is dehydrated. Therefore, it typically is the most difficult pathogen to control in a facility like this. A related organism, Cronobacter, has similar ability to survive in a low moisture environment, but we're really focusing on trying to control this pathogen in one constellation of foods.

And these are foods destined for consumption by high-risk young infants. Okay, Listeria on the other hand is a target pathogen for control and for testing in high moisture foods and high moisture food manufacturing facilities because in a high moisture food both Listeria and Salmonella may be able to multiply and grow as well as the other pathogens. What we know, Listeria also has the ability to establish residence in a facility and be a persistent environmental contaminant in those facilities. Okay. So, I want to talk about the term verification because that is what we're really doing most often with our environmental monitoring program. And in this case, I'll give you an example definition. And that is once your sanitation program has been validated, meaning that it is capable of controlling pathogens and you have evidence supporting that, that evidence could be environmental monitoring. But when you use this validated program, you need to periodically test your environment to demonstrate that when you use this validated protocol, it is actually giving you the outcome you expect and that is no environmental pathogens in your facility and you verify that by testing for pathogens.

Next question that comes up is within my plan, I have to use a risk assessment to define what I'm doing, why I'm doing it, and why I believe I'm justified doing what I'm doing. So, let's work walk you through this. Number one, you need to identify sampling sites. We usually recommend that you use a facility grid. So you take your facility blueprint and you can grid out that area within your facility where the product is exposed to the environment either before or with with no kill step in the process. So that means the entire manufacturing room would need to be part of your grid or it could be a smaller location. If you have a kill step, you have final package closure and you've got product exposed between those two unit operations. Then your primary control area is going to be that area. So you build these grids. People ask, well, how big should the grid size be? That's your choice. If you have larger grids, you have fewer sampling sites.

I always advise that if you have a piece of equipment that is challenging to clean and therefore challenging to sanitize, that location, it could be that piece of equipment or could be a location on the equipment that could earn itself a grid in and of itself. The floors maybe under those circumstances a larger grid size. So the grids do not have to be the same size, but we recommend using facility gridding. And then when you do your testing, you randomly rotate amongst those grids. Be sure, however, that your random selection device, whatever that is, that you have adequate coverage of all these locations over whatever prescribed duration you want. I have heard of auditors writing up companies for doing this, but they missed a spot over the course of a year. So again, is that a critical mistake? That's between you and your auditor to have that conversation. All right. Again, routine sampling of those high-risk sites. Okay. Then we're going to talk about frequency, number of samples, sampling procedure, test method, and corrective actions in the next slides. Okay. you can probably go out and find a consultant who will give you a number.

Now, does that consultant do a risk assessment to come up with a number of samples to take? They might use some mathematical formula that says for a processing room this size you should take this number of samples but that has one element of risk meaning a larger footprint would merit a larger number of samples so that is risk based but it is it appropriate for the risk that you've identified for your facility and I would say probably not. Okay, so some questions you have to ask. What are the number of unit operations in the room? How many shifts do we run? how many different SKs do we run? again, all of this complexity helps you define your risk. So there is no one format that works for all facilities. Facility condition is critically important. So a modern facility built a proper sanitary design with no plant defects perhaps could do a risk assessment where they would reduce the number of samples that they believe is important to justify their program. Whereas an older, poorly kept facility using equipment that is no longer fit for use, I would argue you should do more sampling. And then you've got your pathogen risk assessment.

So, a facility that's a wet processor, has a large number of floor drains in close proximity to exposed product, I would say you would want to pay really good attention to those floor drains because we know those are potential harborage sites. And then for facilities that have been in operation and you've been collecting data for months, years, the trends that you have in that data set tells your story. It actually is a marvelous way to define your risk. So use that data to inform your answer to how many samples do we need to take? How often do we take samples? Again, look at your physical plant, look at your product and your process, look at the product flow. All of these things will also help you to determine frequency. But should you do it daily, weekly, monthly, quarterly, or not needed at all? You have to make that determination. So here's one way I advise people is the frequency that you do environmental monitoring can be used to define your recall scope by a regulatory agency.

So, if you're doing sanitation verification activities once a week and you have an out-of-spec between the verified sanitation runs, then potentially you would have to recall all of the product that was done between those bookends. So companies that want to reduce their recall risk may want to consider doing sampling more frequently than those who are willing to accept a larger recall risk. Here's another question we get frequently and that is I do end-product release testing for pathogens on every lot that we produce. Do I need to do frequent EMP testing? And my response to this question goes something like this. If you have an out-of-spec on your end product testing, what caused that out-of-spec? Was it an ingredient defect that you didn't catch in your supplier verification activities? Was it a GMP failure? Was it a process control failure? or was it a sanitation failure? So, think about if you get that out-of-spec when you do a root cause analysis, you are going over all of your processes to try and figure out why was this product contaminated. So, it may have nothing to do with a lack of environmental control.

So that's why I argue that this is not a get out of jail card to say my environment was under control because my end product test came back negative. That may be a good piece of data to share with your customer to be able to argue we did this with this lot. It was a requirement for our contract to do this test. It was in spec here. We're shipping you this lot. Okay. Back to sampling frequency. Anytime you have reason to doubt whether your environment is under control, you should consider doing increased investigative sampling. So, this is where you're going to deviate from your routine sampling and do more. Okay? I'll give you a couple of reasons why. Number one, if you're first starting in your environmental monitoring program, you're lacking that past his test history that tells your story. That's a big gap you need to fill. So, I argue when you're first starting out, make sure you have an adequate budget to be able to collect enough samples that tells your story because you're just guessing on your risk at this point. You need those data to help you define your risk. The second reason is when anything I would call it abnormal occurs in your facility.

When you have ingredient changes, leaky roof is a gigantic one. A lot of recalls have been associated with this. Drain backups. How do you get Listeria out of a drain? You have a drain backup. You broadcast it all over your floors. And then Johnny and Janie with their high-pressure hoses are blasting an aerosol of the Syria all throughout your facility. Construction events. Anytime you pull equipment away, you can expose harborage sites such as when an equipment leg is bolted to the floor, there is a sandwich point between the bed of that equipment leg and the floor. When you pull that apart, if you have a Listeria biofilm there, now you've released that into the environment. Vermin and pest intrusion events can bring pathogens into the facility and they don't recognize stop signs and yield signs. They're potentially running all over the place, including onto product-contact surfaces. And then lastly and more import most importantly is whenever you have an out-of-spec environmental test sample you need to do investigative monitoring to answer the question why did that out-of-spec occur? Time of sampling.

This one has been evolving over time and I want to make sure that we have some thought processes here to be able to answer when do I collect my samples. Okay? And I'll give you some examples of some recommendations out there. So first of all one of the most important reasons to do environmental monitoring for pathogens is to make sure you are verifying that your sanitation worked that day. And that is an important data point that goes into your verification program. Second reason would be verify that your equipment stays pathogenfree during processing. So in that case, maybe you would want to sample at the end of a production run before cleaning and sanitation. Now then, here's where this one gets tricky. What if you are a manufacturer of raw produce for examples? You're doing washing, dicing, and bagging of fresh produce. You are expected to get Listeria on the product coming into the facility. So, your washing step may or may not include an antimicrobial. Have you validated whether that washing step is capable of completely removing pathogens from the product prior to final package closure?

I would argue you're going to be hardressed to get a five log validated kill step with a wash, particularly produce wash. So if that's the case then occasionally Listeria would come in on the product. It may escape your wash step and it may be deposited on your product-contact surfaces. So if you're doing sampling at the end of production, are you really verifying whether or not your sanitation worked? And I would say no. But you are verifying that pathogens may be deposited on these product-contact surfaces. Maybe there's some additional intervention you could do to reduce that risk. Again, using a regulatory example, again, this is what FDA says. The caveat is make sure you are following the regulatory expectations of the jurisdiction and the region that you work in. as well as following what your customer expectations are. But what FDA argues is taking your Listeria samples 3 to four hours into production or before cleanup. And the logic here is that any embedded cells in your manufacturing equipment or in your environment when you're actually doing production you could release these pathogens from these harborage sites and they could get in your environment. Okay.

So, that's that's one recommendation as well and you can look at FDA's guidance document in that reference URL. Okay. Where to do your sampling? So, you've got a manufacturing site, you grided it out, you maybe establish that a piece of equipment, for example, in this picture, it's a conveyor belt, is its own grid. So, we know it's high risk. we want to make sure we sample that location on a regular basis. So, one way we can simplify our thinking about a facility room is we can designate high-risk locations and low risk locations. And the simplest way to think about this is your greatest risk location is likely going to be the belt on this conveyor system because it actually touches product. So we call those areas Zone 1. So we can define those as that. Zone 2 would be areas in close proximity and in this case on the conveyor belt maybe it's the siding on that conveyor or the guides on that conveyor system or maybe it's the motor or maybe it's the support leg. Okay. So this is non-product contact areas that are in close proximity to Zone 1 surfaces. Then as we get further away then we have non-product-contact areas that are further removed. So maybe it's maybe it's the floor here.

Maybe that floor you would consider Zone 1, but the floor over here might be further away from exposed product. and we would put that into the Zone 1 list. And then Zone 4 would be areas outside of the primary production area. So think about your offices, the employee welfare areas, the maintenance room, the warehouse, etc. So could you get pathogens in those areas and could they be transferred into higher risk areas? The answer is yes. But your control program should take care of this transient pathogen introduction. If it's on the floor, you should have good GMPs. You should have good sanitation. If your sanitation works, then that listeria that gets transferred there, you should be taking care of that with your sanitation routine. All right. So now you've got your grid, you've got all your sampling locations identified by zone. You put all these on your facility map. You're going to test these locations periodically. Periodically is a non-quantifiable term. You need to determine how frequently you do this.

And then again you could do a fixed rotation where you're always going to hit these locations because you these are greatest risk or randomly selecting locations within that facility to do your verification testing. So again, using a risk assessment, if you have known high-risk locations, particularly those that are Zone 1 and two, your sampling of that location or those locations should occur at a greater frequency and as we talked about probably using a greater number of samples than lower risk locations. I also mentioned and I want to repeat it any difficult difficult to control locations should be sampled at a greater frequency than locations that are always under control. Okay. So again think about when you're looking at your facility you should have a primary control area and that's usually the area after a kill step until final package closure if the product is exposed to the environment. So if you have a totally enclosed system where you do CIP, remember that if that enclosed system gets contaminated, that's all Zone 1 surface, all high-risk surface. You need to make sure that those surfaces are under control. Okay.

Now then, let's give you an example of an energy bar manufacturer where you're just collecting ready-to-eat ingredients. You are assembling them. You are pressing them on a plate. You're chopping them into bars and then the chop bars go immediately into a package. You are applying no kill step in your process. Therefore, environmental contamination in your facility could get onto the product. And there's nothing you are doing other than GMPs, personal hygienic practices, good air handling units, annual environmental monitoring to tell you whether that area is free from pathogens or has potential to contaminate this product that has no kill step in the process and your consumer is not going to cook it prior to consumption. So in that case maybe that whole processing room becomes your primary control area. So again two examples of how you might define that. Another question is Zone 1 testing. I can't tell you the number of companies that have a company policy that says we will not test for pathogens on the greatest risk Zone 1 surfaces. And one question they you their primary reason for that is because that's what everybody does in the industry.

Okay, argue that in your risk assessment. Just because everybody does a rolling stop through a stop sign doesn't make it the right thing to do. Second thing here is that if you find pathogen on your greatest risk Zone 1 surfaces, now you've created a potential recall situation. Because the argument is if the pathogen's on a product-contact surfaces and product touched that surface, why wouldn't the pathogen also be on the product? Here's the other argument I hear with this logic. Pathogens on Zone 1 surfaces would be washed down during sanitation and would be more likely to be found on non-Zone 1 surfaces. Okay. Well, I can sort of see how that might be true. How do you prove that? Okay. And then pathogen testing should focus on non-product-contact surfaces in the post-lethality area. And product-contact surfaces then on Zone 1 should be routinely monitored for something other than pathogens. So in this example I put in indicator microorganisms or some other indicator type test. If you do this last bullet item, do you have verification data or validation data that shows that your indicator of choice is actually correlated with pathogen prevalence?

That's usually pretty difficult to do. Let's switch now and talk about another school of thinking. Okay. So again FDA is a member of this school and their argument is do Zone 1 testing for Listeria species. So in this case it's an indicator that is usually highly correlated with the presence of Listeria monocytogenes. So it's a genus right. and FDA also gives companies the option to consider if you do get an out-of-spec for Listeria. We still don't know whether it's has pathogens on it. Okay. But it makes you do some sort of corrective action. All right. On the other hand, for Salmonella, the indicators that are often used really are poorly correlated, particularly for dry, ready-to-eat foods. You can get a correlation with raw meat for example, but for for many foods, the indicators that are considered aren't very well correlated. So in your product, in your process, do you have validation data that shows why you were doing what you're doing? And then does that verify and justify your risk assessment on on what you're doing? And then the last one here is if you're trying to ask the question, did my sanitation control pathogens?

Yes or no, you should always come to the conclusion that it worked because you are doing this testing. So what are you afraid of? If you don't believe your sanitation's working, testing Zone 1 surfaces is a much lower problem than trying to fix your sanitation. If you get an out-of-spec, we recommend doing vector swabbing. So in the image on the right, you can see that there's a red spot. So this is where we had an out-of-spec environmental sample. So we know that spot is out of control. What we don't know if we didn't do any testing adjacent to that location is how widespread is my out of control situation? Is it literally limited to that spot or is it more widespread? And we know that pathogens can travel great distances in a facility. So if you find it on a floor here, there's no guarantee it's not on the floor over there or on a Zone 1 surface nearby. So you need to sample around that hot spot to make sure that it is truly limited there. But you also may be able to find where it came from. So that might have just been a transit point, but the harborage site's somewhere nearby. And if you miss the harborage site, you haven't really done an effective corrective action.

All right, in the last few minutes we have left, I'm not going to spend a lot of time on this, but you're collecting these data. You need to have records that you collected the data. use these records to establish a baseline. In other words, that's how you determine what your specification is. You also should be doing trend tracking to follow whether or not your environment is trending out of control or continues to trend in control. If it starts trending out of control, you should act immediately rather than waiting until you had a definitive out-of-spec. So with pathogen testing, your u acceptance criteria is determined by the method that you're using. So we're doing detection or or not detected with our pathogen tests and different methods have different limits of detection. So is it one cell? Is it a 100 cell? Is it a thousand cells? If you're using a method that's not very good, you may infrequently find the pathogen even though your environment's out of control. So consider that. Here's an example where you could take this positive or negative detected not detected result and do some quantitative data tracking with qualitative data. And so you just assign a binomial to this.

A zero means the test result was in spec. You give that test result a one if it was out-of-spec. And in the table on the right, this is just a hypothetical example where you're doing weekly testing of eight locations. And down and you're recording how many out of specs that you had. And in this particular example, you can see that I've just circled a couple that week one you've got a 25% failure rate. That's not good. If you ignore that, the next week it's 38%. Your goal is to reduce that. And you can you can do this quantitative trend, Danny. All right, back to corrective actions. You need to make sure you've got corrective actions. If you have a persistent out-of-spec, that tells you that location probably needs something more than just pouring more sanitizer on the location. You might need to remove that equipment. You might need to redo the floors, the walls, the ceilings, the HVAC, etc. Here are recommendations on what to do with your response plan. these are questions you should ask in a root cause analysis. I'm not going to go through through these. You'll all get a copy of the PowerPoint deck. Important point here is if any of these are a root cause then why did they fail?

That last question is critically important for you to figure out. And then recommendations on corrective actions. Just simply going to that location recleaning, resanitizing and resampling may not be enough. Again talked previously about records. These are some records we recommend that you keep. And on behalf of Eurofins Assurance, who's the sponsor of this webinar, I appreciate their interest and support in this topic. And those are some contact URLs for Eurofins. And Tammie, I think we've got a bit of time for some questions. That's good. we had lots of questions coming in and I didn't want to interrupt your flow because you were really hitting on some important information. so I was trying to group the questions so we could kind of move through them in in groups. so the first question is about the hazard analysis and so in Edition 10 we said your risk assessment has to tie back to your hazard analysis in your food safety plan and not necessarily just what the industry is doing. So it's site-specific.

So the question came in is does everything that's listed in the hazard analysis in the food safety plan automatically have to carry over into the environmental monitoring program? do you have a thought on that, Doug, or

Douglas Marshall: Yeah. Well, when you're doing your hazard analysis, a question you should be asking is, how do I control this hazard if I've identified it as a potential hazard? number one. And then if it's reasonably foreseeable in your product or your process, then you need preventive controls. And some of those preventive controls could be GMPs, could be sanitation, could be maintenance, could be a lot of things. But if any of those are identified as something you need to control on your risk assessment, then environmental monitoring is a way that you can collect a verification data point that says your control is working.

Tammie Van Buren: Exactly. Significant hazard is the terminology that we use in Edition 10. So the next one is do you have some tools that you could recommend for people to use how do they get started on that risk assessment? So are there some assessment tools already out there? Is there something you could suggest to them? there are a lot of different ways to do a risk assessment. a lot of regulatory agencies have specific guidance on tools that they recommend. I know in here in the states FSIS and FDA have tools. FDA just released a new guidance document on risk assessments. So, Google is your friend and let those happen and see what tool is going to be best for you. Usually the one that most people reference in a talk like this is you identify the risk. What is the severity of risk? Not going to harm a consumer or going to kill a consumer and gradations in between. And then how likely is it to occur? Not going to occur at all or not very often all the way up to occurs all the time. And so if it's going to kill a consumer and it occurs frequently down in that corner, everything is red, meaning you need to control this hazard based on this risk assessment tool.

Tammie Van Buren: No, that's a great comment. Google is your friend. I love that because I use Google every day and I talk to it as if it were a person and I ask it questions and it typically gives me some pretty good answers. So the next few questions are about zones. Okay. So, is there a recommended percentage of how you divide your zone testing up? Zone 1 versus two versus three versus Good question. the answer it my answer is no. again you can read resources and someone might tell you and a consultant yeah I recommend you do 10% in zone 4 or 20% and so forth but those are they related to your risk assessment. So my answer is pretty simple. greater risk. Zone 1 and locations within Zone 1 that are hard to control should merit more frequent attention than something as zone 4. And if you want to make a point, this is a joke folks, not a recommendation, sample the production manager or the CEO's office chair when you're doing your annual or your quarterly zone 4 testing. just to prove a point and hope you keep your your job after that result comes back out-of-spec.

Tammie Van Buren: Love it. so, just briefly, somebody had asked the question, what zone would a raw area be? And can you elaborate on that? Yeah. it gets back to the definition of what is your primary microbiological control area? If it's the raw area, you've got a kill step in your process that eliminates the pathogens that are in the raw area. Again, your area of focus is between the kill step and your final package closure. Yeah. So, your management tools then and the question you should ask is I've got raw over here. How is it getting over here? And if you have transportation vehicles, I don't mean a truck, it could be the air, it could be water, it could be people that get the pathogen from the raw side to the RTE side, then sampling the raw side, you're probably always going to find the pathogen, right? Is that really helpful? But if you're testing ways in which it can transfer then maybe testing some raw site areas should be in your plan. So that's just an example. so the next question on zone is if you don't test Zone 1 because your finished product is low risk the product is tested for the same pathogens and you have like five years of data to prove that there's not an issue.

Do you still suggest adding some Zone 1 testing?

Douglas Marshall: Oh, wow. Great question. I would love to work in a company that had that history because you have the easiest job in the whole wide world as a food safety quality assurance manager. But to address the question, you still need to be able to verify whether your sanitation was effective. Yeah. Therefore, I would argue, you need to be doing that testing. Now, the number of samples, the frequency, that's your decision based on your history. Maybe you don't need to do a lot, but all it takes is one out-of-spec to totally mess you up and make it a day you actually have to go to work.

Tammie Van Buren: Exactly. Good comment. so you talked a little bit about indicator organisms. So is EBAC a good in indicator organism?

Douglas Marshall: It depends on your product and your process. So for example, we know that there are some studies that demonstrate that EBAC in raw ground beef for example, as that population increases in the raw ground beef, the prevalence rate of Salmonella increases in that raw ground beef. But this is something that is a real raw product doesn't have a kill step in in the process. Okay. So if you're talking about a kill step product where you've got great environmental control and the prevalence rate of Salmonella in the environment is really small then it's typically pretty hard to demonstrate that EBAC counts or prevalence rate is correlated with Salmonella. I'm not saying it's impossible. I'm just saying it's usually pretty challenging simply because your detection rate for Salmonella should be very low if everything's under control. But if in your product and in your process you can do that validation study right that shows that as EBAC counts increase in the environment salmonola prevalence rate increases then you've got the data that defines your risk and justifies your behavior for doing that type of indicator test.

Tammie Van Buren: Okay. So it depends depends on a lot of factors as a microbiologist. Unfortunately, that usually is the first answer to any question. Exactly. let's move into swabbing just a minute. So, somebody asked about how do you qualify someone to be able to perform environmental monitoring swabbing? I think for me it's just training, right? You just you show them how to do it and you, assess them and make sure they know how to do it correctly, right?

Douglas Marshall: Yeah. So you need an SOP on how to do this correctly. You need to validate that your SOP actually works. You need to train against your SOP and then you need to verify that after you've done that training that the employee is actually capable of following your directions.

Tammie Van Buren: Exactly. And have a record of that. Okay. So that's one way. there are a lot of training tools available for free on the web. and again, Google's your friend. You could use those to help build your training program to use it as as a tool, write your dates and your times and who attended and so forth? Yeah. do the samples collected need to document when they were taken during the process pre-op, during operations, post-op? Should we be documenting the time?

Douglas Marshall: I think that is a very important thing to do and I'll give you a reason for that. If you have an out-of-spec, you need to know what was going on in production at the time that sample was taken because oftentimes you can correlate the out-of-spec to other activities going on in the facility. Yeah, that piece of equipment we had a maintenance worker doing some work on it mid-production and then we took an environmental sample right after. It helps you with root cause to figure out why that out-of-spec occurred. In the absence of that, you're you have unanswerable questions.

Tammie Van Buren: Yeah, exactly. let's see. We've got one more minute. could you please elaborate on third-party suspect results and recommended actions? So, what happens if we have a presumptive? So, what are some recommended actions? Well, because I work for a third party testing lab, my recommendation is you always blame the lab. That's a joke, people. Yes, in case you didn't pick up on that. So much for my dry sense of humor. So, the point here is

Tammie Van Buren: I know Doug well.

Douglas Marshall: Most of the time when you do this pathogen testing, you're doing a test that doesn't directly detect a live cell. It detects the proteins on the outside of a cell. It detects the DNA or the RNA of a cell or it detects some metabolite that happens if the organism grows. So you're not actually looking at the microscope and say yeah that's Listeria that's salmon. So we call that at least in our vernacular a presumptive positive or a presumptive detection. What that tells me as a microbiologist is the organism was there at that location at one time. Does it really matter if it was alive or dead? And my answer is heck no, it doesn't matter because it got there at some point in a live state and that location is still out-of-spec. Now then, here's the difficult question. Some customers will ask the laboratory to do a confirmation test. That involves one of two ways and that's doing culture confirmation which is sloppy at best using imperfect methods to try and find the live organism on a Petri dish. Many times that fails and if it fails the customer gets a result that is presumptive detection not confirmed. Now what do you do?

You've been sitting there for two, three days twiddling your thumbs hoping that it comes back not confirmed because that means I don't have to do anything, right? I think that's risky behavior because you already have evidence that the pathogen was there. Whether it's alive or dead, at that point it really shouldn't matter. You should go attack that location immediately with that result.

Tammie Van Buren: Exactly. Treat it as if it were actual. Right. Okay. Well, those that's all the time we have for questions for Doug. I do know there were a couple questions that were on things like allergens and APC. I had to hold Doug back. He he wanted to talk about all those things. but SQF looks at those things independent of the environmental monitoring program. So, I asked Doug to focus on pathogens only. so look for additional webinars coming up over the next few months. you might see one on allergen management or cleaning and sanitation. That's where we would talk about APC testing, things like that. So, you just may see those topics come up. So, please join us for all of our webinar Wednesdays and hear all about the updates to Edition 10. Thank you, Doug. Thank you for everybody that joined and we'll hope to see you again on another webinar Wednesday with SQF.