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Tips for an Effective Environmental Monitoring Program

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In this recorded webinar, Dr. Douglas Marshall, Ph.D., Chief Scientific Officer of Eurofins Microbiology outlines his most valuable tips for how to assess your own environmental monitoring program, implement best practices, and improve the overall effectiveness of your program. This recorded webinar will equip listeners with an educational guide and useful strategies for executing and maintaining a strong environmental monitoring program.

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Sarah: [silence] Hi, hello, everyone. Thank you so much for tuning in for our live webinar today. Our presentation is called Tips for an Effective Environmental Monitoring Program. Doug Marshall will be our presenter today, but before we begin I'd like to introduce myself. My name is Sarah Kern. I'm a Marketing Communications Specialist with Eurofins marketing department. I will be here on this call to facilitate the webinar, to organize our presentation, and to help everyone utilize our question and answer period. Before we get started I wanna let everyone on the line know that this webinar is being recorded and that a copy of both the video recording and the PDF slide will be emailed to everyone who is both on the call, and those who registered but did not attend, in two business days. So we will send that out via email. It will also be available in our online resource center at eurofinsus.com/food.

 

There will be a question and answer session following the presentation. To ask questions on our webinar, please use the question box in your GoToWebinar dashboard. You can also tweet your questions @eurofins ... e-u-r-o-f-i-n-s. We will be live tweeting throughout the presentation. Before we get started, I'd like to take just a second to ask everybody if they can hear and see everything clearly. If you're having any troubles seeing the presentation or hearing our speakers today, please send me a message in the chat or in the question box and I'll try to help you resolve your viewing problems and speak a little clearer.

 

So a little background on Eurofins before we begin. Eurofins is driven by a mission to contribute to global health by offering the highest quality testing, training, auditing, and consulting services. We strive to listen to our customers and not just meet, but exceed your expectations. Our footprint is global with over 35,000 staff in 400 laboratories across 44 countries, and a portfolio of over 150,000 analytical methods. Eurofins provides a unique range of analytical testing services to the pharmaceutical, food, environmental and consumer product industries, and to governments. I'd like to introduce our speaker today. Dr. Doug Marshall is Chief Scientific Officer with Eurofins microbiology laboratories. Doug is an IAFP volunteer and consultant to the NIH, WHO, FAO, USDA, and other government agencies and private companies. He has over 255 publications, 180 presentations, and experience as both a speaker and an author. He focuses his research and outreach on improving microbiological quality and safety of food. And without further ado, I will hand the presentation over to Doug.

 

Doug: Thank you very much, Sarah. And I do want to express my sincere gratitude for everyone taking an hour's worth of time to be with us today to learn a little bit more about some best practices for conducting an environmental monitoring program. I'd like to start off by framing where environmental monitoring, hereafter referred to as EMP, gets into some other food safety programs that are required to be compliant with FSMA expectations. So the real backbone of food safety, the pillars that hold the table up, are current good manufacturing practices, sanitary operating procedures, HACCP based principles, so process controls, and then environmental monitoring to measure the effectiveness of these other control plants. Next, please.

 

Some additional preventative control programs ... again, these will be very familiar to you if you've gone down the path of being FSMA compliant. So training programs for managers or workers, written records to be able to ensure that your current process is under control, validating these control measures, in other words, making sure that when implemented they achieve the desired outcome, your written SOPs, food label review, and obviously I'm biased working for a testing lab, but the way you validate and verify is you get data points. You can do that by testing of your in-coming raw materials or supplier verification purposes, testing of in-process materials, testing of finished product, and testing the processing environment through your environmental monitoring. And then auditing programs are nice way to measure the effectiveness of all these other programs.

 

So to put this into context, one of the largest recalls happened due to contamination of the environment inside of a manufacturing plant. So some examples are a peanut corporation had a salmonella control problem and wound up having a severe economic and civil penalties related to that outbreak, as well as criminal charges that led to convictions. Salmonella in hydrolyzed vegetable protein lead to one of the largest recalls. Listeria in ready-to-eat meats lead to a change in how USDA regulates ready-to-eat meats. And then both pathogens have been a problem in a simple product like cantaloupe.

 

So I'm not going to read through the hydrolyzed vegetable protein recall, but I do want to point you to how the management was dealing with this recall. And if you go to the bottom bullet point, they're quoted way of dealing with this was they just wanted it to go away. So rather than have vigorous control over the potential for environmental salmonella contamination, they used the cross-the-fingers, lift their heads up and pray to the skies as their management plan. Next, please.

 

So what we don't want to do is to be in a situation like this where you just simply look at a situation in a processing plant and make a wild guess on whether or not you have pathogens in that processing plant. So instead, the remainder of this talk we'll talk about some of the best practices for environmental monitoring. Next. So why would you want to do testing for pathogens or allergens in the environment? These are some of the reasons. Some of these are economic reasons. So if you're trying to justify a budget to do environmental monitoring, remember this is part of the cost of doing business, and certainly there is a FSMA expectation you have to meet. So there's brand protection, liability reduction. FSMA compliance is important. You're doing environmental monitoring sometimes to help you validate other parts of your FSMA compliance programs besides just sanitation and you were using it to not only help you validate the purchase specification by you and your customers are going to use it on you before they purchase your products. And then, certainly for compliance and outbreak investigations.

 

If you decide that the cost of doing testing is beyond what your management is able to produce for you, then these are the risks you're going to carry. Obviously, injuring or killing your customers are not a long-term successful marketing campaign. There are the intrinsic and extrinsic costs associated with recalls. There's facility closure and loss of business, damaged brand reputation, and in the case of FSMA, if you're in charge of QC or your food safety program, you are personally liable for any damages that happen. And if you're doing no testing, imagine what your defense is when you're in the testimony box and the plaintiff's attorney ask you this question, "Why did you not do any testing?" And if your reply is, "Well, because company management thought that it was an expense not worth keeping," what have you just told the jury and the judge? That you don't care about your customer. So good luck trying to win that lawsuit. Next, please.

 

Sarah: All right. And I'm going to slide in here with polling question, really quickly, for our audience. We have a question to ask. It should be launching on your screen right now. The question is, how do you currently test your environmental samples? So we'll give everyone about one minute to respond to that question. As you can see the last option is “other” and if you do have another answer to this question, please give us an explanation in the question box. We want to know more so that we can tailor our content better to our audience. All right. Just a couple more seconds for everyone to get their vote in. Okay. And I'll close our poll. And hand it back over to Doug.

 

Doug: Thank you, Sarah. So some additional reasons ... again, this really summarizes why environmental monitoring may be important to your business. One is, there may be a regulatory perspective where you're producing some high-risk kinds of products and environmental monitoring is not voluntary, it becomes obligatory. And I'll give you the definition of why that would be. Certainly many of you are motivated to do environmental monitoring because your customers are expecting it, so it becomes the cost of doing business. But most importantly, I think, it's incredibly relevant for you to meet your expectations to be able to prove if your processing environment is fit for purpose of making food. So just to keep this in mind, environmental monitoring is an essential component for microbial control, but it is not a control measure in and of itself. It's an assessment tool to be able to measure the effectiveness of your other control programs. Next.

 

So again, I talked about it regulatory perspective, so there is language in the FSMA law that I highlighted in red, where under many circumstances, environmental and product testing are an appropriate way to be able to verify that you're control plans are working and that an environmental monitoring program to the effectiveness of your controls to prevent environmental contamination of food products is really, really important. Next.

 

So when is environmental monitoring required or strongly suggested? Or if you're not doing it, you could be in very severe hot water with an inspector, your customer, or an auditor. So the most important one to remember is if you are manufacturing a ready-to-eat food, and that food is exposed to the processing environment before final package closure, and that final package, after it's closed, does not have a kill step applied to minimize pathogen contamination, then you will need to do sanitation verification monitoring to ensure that you do not have pathogens in that environment that can get on that ready-to-eat product. So again, this is a critical definition for you to remember is, if it's ready-to-eat and environmental pathogens can gain access to the product before final package closure, then monitoring that environment for those pathogens of concern is going to be expected. Next.

 

So what are some components of an effective environmental monitoring program? Well, first of all, you need to have an impeccably well-run sanitation program that identifies and sanitizes potential harboring sites for pathogens and unwanted allergens. You use a testing program then to verify that your control plan for environmental sanitation is working. You evaluate the results of those tests data, and you conduct a root cause whenever you have a out of specification result. And then based on that root cause, you formulate proactive actions so that you don't have repeat occurrence of the same problem. Next.

 

So what are some of the goals of a good environmental monitoring program? Well, first and foremost, it's to find pathogens or allergens in the environment, before they can contaminate products. So this is a seek and destroy, a get rid of it kind of mission. Another reason would be to assess the effectiveness of your cleaning, sanitation, employee hygiene practices. Next question you might want to ask is, where do I test? We advocate a zone approach, a four zone approach. You could do a two zone or a three zone. It is at your discretion. But we'll talk about the four zone approach. And really, if you're doing a two zone approach you're going to be focusing on the difference between a direct product contact surface ... So this is where equipment and package materials come in direct contact with the products, versus non-product contact surfaces where the risk might be a little bit lower. Next.

 

Another question that we often get asked is, which pathogens are important to me? A really easy way to answer that ... This is a food processing example here where these are red peppers, undergoing a drying unit operation. And it doesn't take your imagination very long to discover there are many potential environmental contamination points in this unit operation. These peppers may be destined for further processing, or they may be considered ready-to-eat. So that's a question you have to ask is, what's the intended use of this product? So at any rate, all pathogens could potentially be found in any food or ingredient, or any food processing environment at any time. Does that mean I recommend that you test for everything? Well, that would be great for our business, but that's an unrealistic expectation. So, next, please.

 

We can simplify the thinking here based on what history tells us about the potential for environmental contamination of foodborne pathogens. And a general rule ... again, this is a general rule, this is not a Ten Commandment, this is a general rule. Salmonella is usually your target microbe for environmental monitoring on product contact and non-product contact surfaces where the production of the food and the environment is a low-moisture production environment. With that, with listeria monocytogenes is typically the target organism for control and for environmental testing in areas where there is a high-moisture food or a lot of water in the manufacturing environment. And the biological reason for this simplification is that salmonella is able to survive for long periods of time in a dry quiescent state of existence, meaning it's alive but it's not actively metabolizing. And when I mean a prolonged period of time I mean days and weeks of time it can exist in that environment.

 

Listeria on the other hand, thrives in a high-moisture environment. So you can get large population sizes on equipment and environmental surfaces if those surfaces have residual food and have residual moisture. Does that mean that other pathogens may not also be in that environment? And the answer is, yes, they potentially could. But if you are monitoring for these two bacteria in these respective production environments and you are controlling them, then you will do a very, very good job controlling all the other pathogens. Next, please.
Where do you control? What you're really looking at are trying to find areas within the production environment that are likely areas that can contaminate food as it's being manufactured. And so you are really looking to define those primary control areas. So you can do that by visual observation and best guesses, but you can also use investigational monitoring to gather data points that will really help you identify where these areas are. So if you are making a ready-to-eat product and you do not have a kill step in your process, guess what? Your entire manufacturing facility would be considered your primary control area. Next, please.

 

Don't forget that temperature and humidity monitoring may be important because both of these are important for survival and growth of pathogens. They also can be influential in your ability to remove soils from surfaces as well. So just try and set some specifications and routine monitoring there that help give you some environmental control of pathogen prevalence. Next.

 

What are some elements that should be in your written EMP plan if your risk assessment concludes that you need one? Well, first and foremost, you should identify your sampling sites. And I recommend using a facility grid and to do random selection of grids during routine monitoring. But don't forget, if you have identified hot spots, you should also do those hot spot testing every time you do an environmental monitoring. Because if that's the most likely area you'll find pathogens, why would you want to ignore them when you're doing a routine monitoring selection? You should specify when and otherwise how often are you going to do sampling, how many samples you will take, what procedure you will use to collect the samples, what test methods will be deployed on those specimens. You probably should put your spec limits; what you’re willing to accept and not accept, and then corrective actions based on excursion out of those spec limits. Next, please.

 

Sarah: All right. And I'm back with one more polling question. This one is, if you currently do, how often do you review and update your environmental monitoring program plan? Monthly, annually, as needed, other ... again, let us know in the questions or in the chat if you have another answer. We'll give everyone just a few seconds to give us their response. If you think this is a trick question, go ahead and let us know in the other section. And I'll give everyone just a few more seconds. We only have a couple people that have not answered. And with that, I will close our poll. This one I'll share our results so everyone can kind of see what the answers were. It's a tie between as needed and annually. Very interesting.

 

Doug: So that's a good one, Sarah, because if people are doing it as needed, I'm presuming the trigger point to that would be if they've got something that requires a corrective action, that might be a good time for you to look at your environmental control plan to see if that is up-to-date and is as vigorous where you want it, so great question. So back to the presentation. Where do you test is another question I frequently hear. Again, sampling priorities should be based on a zone approach, and don't forget risk. So if you have known hot spots then certainly, you would not want to ignore those spots. So you should focus on non-product contact surfaces for the pathogens in the post-lethality areas. And for product contact surfaces it's generally recommended that you should monitor only for indicator organisms. So with these two recommendations, I would ask, and this is not a polling question, this is just an Uncle Doug question, what this basically does it is ensures that the industry is taking a stupid pill, because you are basically ignoring direct product contact surfaces for the presence of your highest risk thing, and that would be allergens or pathogens.

 

So it may not be the best recommendation in the world because of that. But that seems to be where most people pursue their where to test questions. You should rotate them, your sampling sites, to ensure that you are accessing all areas of the production plant, and don't forget to access the difficult to find areas ... So under equipment, overhanging structures. If it's difficult for you to collect an environmental sample, it's also probably difficult for your sanitation crew to clean and sanitize those areas, which makes them a more reasonable site for pathogens to reside and allergen residue to be retained. You should not composite or cool your samples. And I'll tell you why I don't recommend that. Obviously I work for a testing lab, so we'd want to do more testing. But the problem becomes where you're trying to save a dollar on test costs, but if you have an out of spec sample, now you're going to be wasting $10 of remediation because you can't go back and pinpoint which sector the violation occurred in, so you have to remediate all the sectors that were part of that composite.

 

Okay. Allergen testing. Our recommendation is to focus really on your direct product contact surfaces. So unlike microbes, allergens aren't going to be able to multiply and grow and increase in dosage on surfaces. They're either there or they're not, the bubbles in which the residue supports. Next, please.
Your biggest concern is the formation of microbial biofilms in your production environment. Because these are going to be nooks and crannies where the microbes can have access to food, to moisture, and a protective physical environment that prevents access of cleaning and sanitation chemicals and makes it more difficult to physically remove. So anytime a biofilm gets disrupted then you are shedding potentially large numbers of microbes into that environment. Next, please. Next slide, please. Thank you.

 

Some other questions that you should ask yourself is why are you sampling? What's your motivation? And how you use the results. So a good example here is you're starting off an environmental monitoring program, I'd strongly recommend you don't target pathogens right off the bat, because if you find them then what are you going to do? So have your program well written, collect some investigational monitoring indicators that'll help you find hot spots before you open the pathogen Pandora's Box. So you should have your alert and action levels and have your corrective actions already figured out in case you do find an out of spec sample. Next, please.

 

Where to test? We've already gone through this, gridding or mapping. And make sure you, again, find the hot spots. This is really, really important. I also recommend that with the indicator bacteria accounts that you establish baseline counts that tell you something about your risk. And from that, that's how you're going to set your action or your alert levels, based on the indicator counts. So you can do some remediation without having to do a corrective action, because you're using indicator counts rather than just relying on a pathogen prevalence or absence. Next, please.

 

So here's how we define the zone approach. Zone 1 or any area in the plant where the food material, or other material such as packaging or equipment, comes in direct contact with the food. And this is ... You can simplify this area, because if you have a kill step in the process ... In other words, if you have a microbial reduction step, then you can focus on areas where that food is exposed to the production environment after the kill step and until final package closure. So again, your primary focus area might be relatively narrow in that scenario. If you don't have a kill step in the process and the food is ready-to-eat, then the entire facility could be considered to be a high-risk area for pathogen control, and many of those areas could be considered zone 1.

 

Zone 2 is a little bit lower risk area. This is going to be pieces of equipment and areas and surfaces that are in direct proximity to zone 1 areas, but generally do not have direct product contact implication. And so you have to use a judgment call on what's zone 1 and zone 2. Zone 3 are going to be non-product contact areas within the processing area that are further removed from direct product contact surfaces. So these would be things like floors, and walls, and ceilings, forklifts and so forth. Zone 4 are going be areas outside of the production area and might be things like employee welfare areas, offices, loading docks, warehouses, etc. Next, please.

 

So I want to give you some examples. Up here at the top, people are always asking me, about how often do I have to do testing? And my answer is, "Well, it's based on your risk. And if I don't know your risk I can't give you a recommendation." So there is some recommendation here that if you want to at least be able to address frequency from an inspector, and auditor, or a customer's perspective, you have to come up with a frequency. And so I'll list some of these here at the top of some of these slides. If you're a high-risk facility, maybe you need to be doing daily. So again, it is your discretion to decide what is correct for your product and process combination. Not one size fits all shapes.

 

So these, again, are going to be surfaces that have direct contact exposure. So I'm not going to read through these. You can look through these here as we go through them, or you can look at the slide back when you receive those. Next, please. So again, if you are not testing direct product contact surfaces for pathogens, you open yourself up for criticism from an inspector, an auditor, or a customer. How do you rebut that criticism? Because again, you are basically ignoring your highest risk surface against the highest risk food safety issue, that would be unwanted allergens or pathogens.

 

One way you can do that is if you're doing indicator testing. You could do indicator testing on non-zone 1 surfaces and do your pathogen testing on non-zone 1 surfaces, and build a correlation between indicator counts and pathogen prevalence. And then you make the argument that the same scenario should fit for my zone 1 surfaces. So if I find very low or no prevalence of pathogens at an active indicator count, I'd assume that the same thing happens on my zone 1. So that's one way you could do that. So you're trying to validate the use of indicators. Also understand that any product that's ready-to-eat that has gone across a zone 1 surface that subsequently tests positive for a pathogen, then it's reasonable to assume that a regulator would make the assumption that that product is also adulterated and contaminated. So you should hold that product prior to release until you get that test result back. Next, please.

 

Zone 2, again, a little bit lower risk because these are further removed from zone 1 surfaces. Here are some examples. So these could be equipment frames and legs. Control panels and buttons, Maintenance tools, etc. Next, please. Zone 3, again, these are surfaces that are far removed from direct contact surfaces. So floors, walls, ceilings, and so forth. But be very careful, because if pathogens are residing in those areas and you use a cleaning program that involved high-pressure sprays or high-pressure air hoses, or other cleaning devices that can transport or aerosolize those pathogens, then they can easily get onto direct product contact surfaces. Just because they may be lower risk doesn't mean they are zero risk. Next, please. And a few more examples of zone 3 surfaces. Next, please.

 

Zone 4, again, these are areas outside of the facility. I think because they're lowest risk generally, you could argue a fewer number of samples that could be required, and a lower frequency of testing. So I just put monthly here. I strongly advise people to do some zone 4 testing because this helps you ... the data points help you educate your employees on the importance of GMP and personal hygiene. So it's a great educational tool to be able to teach them that these organisms are everywhere and it's your job to prevent them from getting into food. Next, please.

 

I want to go through some high-risk areas for salmonella. So if you are intending to find hot spots at a manufacturing site, these are some good places to look. I don't want to dwell on these again, because you'll get the slides back later on. But just think about, in your own facility, do you have areas that are potential harboring sites, that could potentially harbor biofilms? And then once those biofilms are disrupted, can they can easily disseminated throughout your facility and ultimately contaminate food? A lot of these are controlled by GMPs. And so if you don't have a very good GMP plan, guess what your environmental monitoring data will show? It's going to show that your environment is out of control. Next, please.

 

Here are some additional areas. Again, some of these areas might be appropriate for dry harborage of salmonella, but a leaky roof is going to ... that water that comes off of the roof could have salmonella because you have birds roosting on the roof and the water becomes a vehicle to bring that salmonella into the facility. Next, please. Don't forget your maintenance employees and your maintenance tools. They are traveling all over the facility. And do you expect the same level of personal hygienic practices of your maintenance team as you do your line workers? If not, you probably have to readdress that management plan. Some of the devices that are used to clean and sanitize, also, I typically find salmonella in, and listeria. So if they're present on these cleaning devices guess where they're going? On that direct product contact surfaces. And then obviously, vermin control is important. Next, please.

 

And just a few additional ones here. Again, vermin control is another one, so birds, rodents, insects. These can serve as vehicles to bring salmonella in and move them around the facility. Next, please. Some high-risk areas from listeria, you'll see a lot of similar areas that we just saw with salmonella. Again, one of the key factors here is look for places where water is pooling. It could be large areas, it could be small areas. And the classic place to look for listeria to increase your odds of finding it are floor drains, because all the food goes down there, all the water goes down there. And if your sanitizer residue is diluted by all the water you're using, it might not kill listeria biofilms in those floor drains. Next, please.

 

Some additional ones. Some of the devices used to control personal hygiene, such as foot baths, can actually grow listeria in the biofilms in or underneath those foot baths. So make sure you do preventative maintenance on those devices so that those don't become more harmful than good. Next, please. So again, a question that we get asked all the time, and I cannot answer this to any one of our customers is, how frequently should I be testing? I gave you some general guidelines on frequency. If your product and process is extremely low risk, then I think you could argue my test frequency should be longer or less frequent than a facility that is manufacturing a high-risk food with known harbored sites of pathogens.

 

So it really depends on the history and trends, the features of the plant, the type of product and the size and volume that's being manufactured, and the complexity of that manufacturing and product quo. Next, please. And our government can't really do a good job answering that question, too. This is some language that the USDA Food Safety and Inspection Service gives for meat processing plants. And just look at the red. How frequently? Well, it really depends on the establishment features. Sample sites should be selected randomly and some sites may be designated for sampling on a more routine basis based on the risk. So again, it's up to you to make this determination. Next, please.

 

This is an old tool that was used by the pharmaceutical industry to do verification testing of the pharmaceutical manufacturing room before it was allowed to go into production. So they just simply took the square meters of the facility, took the square root of that, and you got a number. In this example you got 15 and so you would take 15 random environmental samples. If they all came back clean then that room was acceptable to begin production. So does this take into account any of the items I just mentioned? So, complexity of the product, risk of the product, size of the facility? A little bit there and so forth. So next, please. By the way, that's no longer used by the pharmaceutical industry because it doesn't have the kind of specificity they need. Next, please.

 

So if you're just getting started out with your environmental monitoring plan, I strongly advise you that you do investigational sampling to begin with. Front load your testing budget so that you can get data points that helps you answer all of the other questions you may have on what is my risk? So you should sample as many sites as you can afford. Use large surface areas to judge the degree of contamination and judge and identify your problem areas. So when would you do investigative sampling? Well, obviously when you get started. That's a great time to do it. And any time you have any kind of disruptive event in the facility. These disruptive events could be ingredient changes; so if you're bringing in larger populations of microbes, you'll have larger populations on your higher-risk surfaces. If you have some physical plant issues, such as leaky roof, drain backed up, construction events, equipment installation and so forth, then those disruptive activities in the facility can disrupt biofilms, they can allow access of vermin into the facility. You've got uncontrolled workers running around in the facility.

 

All of those you should do investigational monitoring to make sure that that manufacturing environment is back within your specifications before you restart production. And then, obviously, any time you find an out of spec situation, that's a great time to do some investigational monitoring to be able to determine how widespread is my problem? Next, please. What samples should you take? A lot of people make the argument that if I do an end product test, I don't need to do environment sampling. Well, that obviously is the ultimate arbiter of whether or not you're producing "clean/unclean" product. However, it doesn't give you an answer to, is my sanitation program working? Is my personal hygiene program working? Are my GMPs working? All that simply says is when I'm looking for a needle in a haystack and I don't find it, it doesn't necessarily mean that your control programs are working. So environmental sampling to verify those is the definitive way to do that. But product testing does give you a very useful data point.

 

Food contact surfaces, obviously, are your highest risk surfaces. That's where you should be doing the prevalence of your testing. Don't forget to test air and water because those can be vehicles to contribute some pathogens or unwanted allergens onto those surfaces. Next, please. I want to talk a little bit about method selection and data collection. And in terms of your methods, don't make it harder than it has to be. So the idea is to collect as many data points as you can afford and based on your risk. And so you don't want to over-complicate how you collect those data. Sample for the type of product in the room. So if you're manufacturing ready-to-eat product and non-ready-to-eat product, your ready-to-eat product is going to be your highest risk. That should be where you put the bulk of your efforts. Select appropriate sampling equipment recognized by the industry to perform said sampling. Don't go to the hardware store and try and come up with sampling devices, because those aren't necessarily fit for purpose.

 

So you have your choice of swabs or sponges. If you take a swab and you take a sponge and you swab the same surface area, the literature says you're going to get, basically, equivalent results. So think about the physical attributes of the sampling device. Swabs are good for nooks and crannies. So cracks, crevices, bolt holes. That's where you want to do a swab to get in there to make sure you are assessing whether you have biofilms or not. Sponges are better for larger surface areas because they're easier to use and access. Next, please.

 

So one thing you need to be careful with is make sure the employees collecting the samples have been adequately trained in aseptic sample collection. So we have some white papers that you could use as a sample collection SOP that kind of walk you through the steps to make sure that the sample collection devices aren't being contaminated by the person using them. Recommended that you chill the samples and get those to your execution lab within 24 hours. If you are unable to do that, then we recommend that you use dry swabs to collect a dry sample and then get those to the lab whenever you can. Absolutely do not freeze the samples. So in other words, if you want to collect samples over the course of a five day production run, you need to send those in every day, not put them in the freezer and send them in once a week, because freezing will kill microbes. Might be a good way for you to keep those in spec, but it's inappropriate from a scientific behavior perspective.

 

Again, reinforcement here. Find the hard to clean areas and use the results to educate your employees. Next, please. We recommend that you use sampling devices that are, again, are acceptable in the industry. We certainly provide those to our customers if asked. And then, if you are sampling sites where you know you have residual sanitizer, then that sanitizer's going to be active when you collect the specimen. So make sure you use sampling devices where the transport buffer has an activation agent that inactivate the sanitizer of interest. Again, we have a white paper that provides a guide for you. All you have to do is ask. If you are sampling food residue that has known antimicrobial activity, such as antimicrobial spices or if you have antimicrobials in the formulation, again, those are going to be active in a wet sampling device and can reduce your populations and kill off your pathogens.

 

If you're using sponges and swabs to do an allergen test, make sure that the transport buffer in there does not contain the allergenic protein you're testing for. So some microbial sampling devices have protein digests such as peptone, which are milk digests and soy digests. Both of which are considered to be allergens. And you'll get false positive results. Next, please. Data interpretation and management is important. So what do I do with the data that I get from the laboratory? What does it mean? So you should understand what kinds of data you're collecting. And there are many, many kinds you could use beyond just sponges and swabs.

 

What does the data mean? So how do you keep your records? How do you establish performance targets and baselines? Trend data over an environment that is getting out of control before it's out of control, you can do a process correction and not have to do a corrective action. Again, form a response team. An environmental monitoring plan that is managed by a man of one is not the best environment monitoring plan. Next, please.
So you can get lots of different data. I'm not going to dwell too much on this because sometimes it's complicated. But just remember that not all sampling devices and not all testing methods can give you equivalent results. So if you sample a larger surface area versus a smaller surface area, your numbers may be different. If you’re using two different kinds of methods, let's say ATP versus an APC count, those numbers are not necessarily equivalent. So make sure you understand the limit of detection of the method, and the limit of quantification of your accounting data. Next, please.

 

Okay. Your analytical result can be displayed in a number of different ways on the certificate of analysis from your performing laboratory, whether it's in-house or outsourced. Make sure you understand what those numbers mean before you start acting. And again, you should have a great relationship with your laboratory and they should be able to walk you through how to interpret what the data means. Next, please.
Record keeping. Again, in your environmental monitoring plan, you should have a section on how you're going to keep records and what records you're going to keep. So the date and time of sampling, who collected the samples, where the samples were taken, the date that they were sent to your laboratory, the analytical results. Put the action limits on this records chart, because the gives the person reviewing the records an easy decision point to make, having it right there on that form, and then also listing the corrective actions there, because again, if they have to go hunt for another record to find, what am I supposed to do if it's out of spec? You're making it unnecessarily difficult for that individual. Next, please.

 

So here's an example of where you could potentially build a correlation between an indicator count and pathogen prevalence rate. So on the left of this table would be a total enterobacteriaceae count, which is your indicator. And on the right column is the percent salmonella positive in that sample. And what clearly ... It is demonstrated here that as your indicator count increases, your pathogen prevalence rate increases. And if it were me and I wanted to set an action limit, I would probably set my action limit at something that is greater than or equal to 100. Because when I do, I know my prevalence rate goes from about 1%, by an order of magnitude, up to a little bit less than 10%. So that's a good way you could use data to help you decide what my action limit should be. Next, please.

 

Here's another set of tables here that also just kind of give you some examples of ways in which you could set performance targets. None of these data are specific for a single person on this phone call. So I want to caution you, if you just say, "Eurofins said we should do this," be aware that Eurofins is not telling you that this is what you should use for your action levels. These are just simply examples. Next, please. This is an example of how you could bring these data to life by doing an XY plot. So every data point here is a day you collected a specimen on a particular surface. And here I've got a target limit.

 

So anytime you are below the target limit you're good. But I set the unacceptable limit just a little bit above the target limit, because it gives you an opportunity to do an operational correction before you have to do a corrective action. So you can use that early warning that forces you to do some sort of intervention to get you back under control. And in this example, if you ignore that early warning, then you've got a completely out of control environment. You've got to go through investigational sampling, you've got to do corrective actions. It becomes a pain in your rear. Next, please.

 

Again, have a team put together. These are some recommended members of that team. Next, please. This is a good way to build an example of a corrective action response. So you do investigational sampling to find out how widespread or repeatable is the issue, and you continue that until you get three consecutive days of monitoring that are within spec, and then you can return that site back to your routine sampling frequency. Next, please. And here's some more examples of some corrective actions that you should use. And again, I don't want to keep us here all day, so I'm not going to go through each one of these.

 

I do want to say something about vector monitoring. And a vector monitoring is if you have your facility gridded and one of your grids comes back out of specs, then in your investigational monitoring you should not only do another sample of that out of spec grid, but you should also sample every single adjacent grid to that out of spec grid. Because again, the question you don't know is, how widespread is the contamination? All you know is that that grid is contaminated. You don't know how widespread it is. So doing the vector monitoring helps you define how much I need to remediate in the facility. Next, please.

Sarah: And I have one more polling question for our audience before we move into our Q&A. Now that you've been through Doug's whole presentation, you've learned our tips, how would you rate the effectiveness of your current environmental monitoring program? I'll give everyone a few more seconds to respond. All right. I'm going to close the poll. And with that, we'll move into Q&A. So a few different ways to submit your final questions. Again, you can utilize the question box in your GoToWebinar dashboard. You can also tweet @eurofins or tweet using #emptips. And Doug, I do have quite a few questions for you. So for everyone online still, if we don't have time to answer your question live, we will follow-up via email with a response. So you can look forward to that even if you don't hear your question today. One short one that came in during the presentation was, do they need to worry about standing water in a boiling room?

 

Doug: Boiling room?

 

Sarah: A boiler room.

 

Doug: Boiler room. Okay, got it. Yeah. Typically, you're looking for judging the risk. So a boiler room is going to be an area that is maybe zone 3, probably zone 4. So it's going to be far removed from direct product contact surfaces. So the water on that floor, although it certainly would be fair game for an auditor, inspector, or customer to write you up on it, you have to ask the question how risky is it? So if you routinely come in, open the door, and you have a high-pressure hose to clean that floor and you're aerosolizing all the material from that boiler room back into the production environment, then that would tell me that maybe the risk is relatively high. So again, I'm not saying it's low risk, but it probably is not a high risk.

 

Sarah: All right. Someone asked kind of a hypothetical. If a company takes thousands of samples and they almost never get a suspect result, how should the EMP be adjusted? Or-

 

Doug: Good question. Yeah, yeah. Great question. And again, I can tell you what best practices are, but they're not appropriate for anyone on this call, because you all have different products and processes. But if you had that history that tells you ... And that history really defines your risk and it's low risk, then I think you use that data to argue reducing your test volume and reducing your test frequency. Again, it's going to be your word against your critics, and you have to be able to justify the basis of your decision. And pointing to the data, looking at that trend risk, looking at any time you have an excursion, if you know exactly why you had an excursion, that helps you defend your decision on how risky your environment really is. So absolutely, that history helps you make a business decision on whether to reduce the number of samples and reduce frequency.

 

Sarah: All right, thank you. Kerri has asked ... She mentioned that SQF requires annual proficiency testing for those who conduct swabbing. How would you go about conducting a proficiency test for those individuals?

 

Doug: Okay. I'm gonna make the assumption that this is related to the laboratories doing the testing, rather than the individual doing the sample collection. So I have to make that assumption, first and foremost. There are what we call PT providers that will ... that you contract with if you're a laboratory that will send you samples on a periodic basis of known microbiology. And what you do is you perform the testing on those samples and compare your results with all the other participants of that PT program. And that gives the laboratory data points on how it's performing. So that certainly is the way Eurofins does it and the way most other third party laboratories would do it.

 

Sarah: Yeah, and I'll slide in here too. I do know that Eurofins training consulting does offer environmental monitoring program training courses. Doug, you are often personally involved in those training programs. We also have a swabbing guide that anyone can use as a resource for training individuals who are doing the swabbing, as well.

 

Doug: And we also offer a good laboratory practices workshop, as well.

 

Sarah: Yup. All right, I know we're at 2 o'clock, but I'll ask one final question since we still have you on the line, Doug. What about standing water in washrooms? What's the concern there?

 

Doug: Okay. Yeah, it's a similar answer to the boiler room. Anytime you have standing water you should be asking where is the best place for pathogens to multiply and grow? And if that's the case, what kind of traffic patterns have access to that standing water? So does equipment go across this? Do people walk across it? Your cleaning and sanitation, do you splatter this water elsewhere in the facility? So all those increase the risk of getting that water in a non-food production area, perhaps it could help you get access of pathogens on the direct product contact surfaces and increase the risk. So you need to define that risk for that particular area where you have standing water. The general rule is if I'm auditing a facility and I see standing water, that's automatically going to raise my eyebrows and I'm going to ask, what do you do to manage this standing water? And if the answer is nothing, then I would consider that to be accepting too much risk.

 

Sarah: All right. Thank you so much, Doug, for all of your responses. And thank you for giving our presentation today. A final thank you to everyone who attended our webinar today. Thank you guys all for tuning in. We will be sending a copy of the slides and recording of this presentation out to everyone. We'll also be following up on the questions that came in before we had time to respond. There are quite a few, so we'll follow-up on those with you directly. And with that, I will sign off. Thank you, everyone.