Almost every food manufacturer must manage a food safety program that includes an environmental monitoring program (EMP). Initially, it might sound straightforward—pick some testing sites, take some sponges/swabs, and run pathogen testing—but, as you build a program or start to analyze your data, you may realize that running an EMP is not as easy as it seems.

There is no one-size-fits-all approach to starting an environmental monitoring program. Most regulation or auditing bodies are not going to give the best testing details on how much, how often, when, or sometimes even what to test for. Most of the time you are only required to have an environmental monitoring program that matches your hazard risk. This vagueness is because there are thousands of food product types, and the ingredients you use and how you make the product can be different, even in similar products. On top of that, even if you make the exact same product using the same ingredients, your people, facilities, equipment, and traffic patterns are different and can introduce different risks. Because there are so many moving parts to developing an environmental monitoring program, it’s difficult and risky for regulatory groups to provide a specific process without knowing your facility.

As a consultant, I find that, most of the time, companies struggle just to get started. My first piece of advice is to just dive in. An environmental monitoring program isn’t set in stone and, in fact, should grow and be flexible so you can adjust it as needed based on collected data. The main goal of any environmental monitoring program is to search and destroy: Find the bacteria niches in your facility and address them. Getting into the details of how to do that and what practices are going to work best is where complication come in. In addition, running a hazard analysis can be complicated and time consuming.

Here are steps you can take to build an effective EMP from the ground up that’s specific to your product and company.

Determine Your Product Process

The first piece of information you need to figure out is what you do with your product after you make it. It’s in your best interest to test all areas of contact, both food and non-food, so you have a better idea of the risk level and cleanliness of your facility. You must be careful because presumptive positive environmental monitoring results can indicate that a product could also be contaminated. Do you hold your product for a few days and have the time to wait for results from your environmental monitoring program to come back? Or are your products made, packaged, and out the door in just a few hours?

If you’re able to hold the product, then you can complete pathogen testing in the highest-risk, food contact sites. If something comes back positive for Salmonella, Listeria, or pathogenic E. coli, then you can catch the implicated product before it leaves the facility. However, if your product is out the door as fast as you can make it, then a presumptive positive sponge/swab on a contact surface can cause you to pull back the product or issue a recall, which is a can of worms you want to avoid.

Zone Your Facility

Next, select where you’re going to test, so you should define what the high-hygiene area is. For RTE products, this area starts where the raw product exits the cooking step as fully cooked, and extends to the point in the process where the product is fully enclosed in a sealed package. Everything prior to the cook step would be considered the raw area and the post cook hygiene area must be strictly off limits to personnel and equipment from the raw side. Personnel access to the high-hygiene area must be controlled and monitored to ensure the strict procedures for entering and leaving this area are followed.

Once the hygiene area is defined, you can determine the zones of your facility. The first zone is easy to identify—does it directly touch your product? Is it directly over exposed product after cooking or is it touched by hand-held utensils, or even the inside of the product packaging? If it’s around these areas or closely adjacent to any zone one and could easily be touched and transferred to your zone one, it’s going to likely fall into zone two.

If it’s in your production/manufacturing high-hygiene area but not zone one or zone two, it’s likely going to be zone three, which includes floors, walls, drains, and parts of equipment outside the scope of zone two in the hygiene zone. It can also include surfaces subject to backsplash from zone two.

Finally, if it’s part of the facility accessible to RTE and raw personnel but not part of the production/manufacturing area, then it’s probably going to fall into zone four. These include shared employee welfare areas, locker rooms, and common traffic routes. In some cases, this can also include office areas.

It’s not always that easy, however, to determine hygiene areas and sampling zones when looking at a facility. You must be aware of the entire area before and after the lethality step, or even after your product is sealed in its package. Zone one can be difficult to test if your machinery is complicated or not open to the environment. Some equipment, tools, and personnel can move between areas causing added risks. Don’t stress; not everything is set in stone, so depending on results or observations you might start with a site being classified as a zone three, but as you learn more you can easily move it to a zone two. You should use your data to change and improve your EMP. Spend time observing the process with a team to look for these changes.

Next, companies must determine what to test for. Usually, this is Listeria but can include other pathogens such as Salmonella, pathogenic E. coli, or indicator organisms such as aerobic plate count, Enterobacteriaceae, coliform, or generic E. coli. Sometimes you can even look for contaminates of high concern such as yeast and mold or S. aureus.

You should monitor the organisms that are high risk for the environment and the products that you make. For example, if your product contains meat or dairy, it doesn’t make sense to only monitor for Listeria, since Salmonella and E. coli could also be concerns for your product. If you can’t monitor for pathogens for zone one you can use indicator organisms mentioned above. This won’t directly ­implicate your product but can give you an idea of how high the bacteria counts are and, thus, the risk for contamination. For example, just because you have a high Enterobacteriaceae count does not mean you have a Salmonella contamination, but it can give you a good indication that the environment can support the growth of Salmonella, and because you have not killed or removed the Enterobacteriaceae, there is a high contamination risk.

How Often to Test

Now that you have worked through the questions of where to test and what to test for, you’ll need to determine when and how often to test.

These changes are based on the secondary goals of your environmental monitoring program. Are you aiming to verify effective cleaning and sanitation? Or, are you looking to see how the day is progressing and how your facility is staying clean? If you have raw product/production that is naturally going to have bacteria and be cooked at home, your EMP is most likely going to be focused on making sure your sanitation process is effective at killing harmful bacteria spread during production. In this case, you’re going to want to take samples after cleaning and once sanitizer is dried, or before production to ensure surfaces are starting off in the best condition.

If your product is ready to eat and includes a bacteria-killing step during production, then your EMP should focus on ensuring that your production is not getting contaminated during day-to-day processing. When it comes to determining the best times to test, it is best to take samples during the production day, approximately two hours after the start of operations.

How frequently you carry out this testing is based on your product’s risk rate. If you have a high-risk product and are making a lot of it using very fast processing, you’ll want to monitor it more frequently. Some clients take samples every day, every week, once a month, or even once a quarter. I do not ever recommend doing less than that. It is always easier to test more frequently and then dial back. Each time you monitor, you cover the time between sampling. If you wait too long and have a problem, you potentially run into a gap where you’re not sure how clean your conditions were.

If you produce an RTE product and you test zone one samples, your plan must define what happens when a positive result is reported, or a quantitative indicator organism test is out of spec. The investigative sampling procedure must be outlined, in addition to the conditions that must be met to return to routine sampling.

If you test more frequently and discover you don’t have an issue, however, it’s much easier to justify to your team and your auditor why you should test less frequently. You do not want to run into a situation where you go three to four months with no results and then suddenly find a facility with several Salmonella or Listeria positives and have no idea how long it’s been a problem.

Finally, don’t forget other items you might have to monitor in your facility, such as water, wastewater, and passive and compressed air. You typically don’t need to monitor these as frequently, but they can contribute to contamination in your products.

Finding the Right Partner

These are the basic elements that I use to help a facility start its program. Break it down, follow these steps, and document what your decisions are. From there, you can pick an accredited laboratory partner and get the supplies to start your testing.

Your EMP doesn’t have to be perfect, and getting one started is the first step in making it better. Safe and high quality products are critical to a company’s growth and to protecting public health. If you need more help or just expert advice, there are professionals available who focus on partnering with companies to set up EMPs.

Craig is the corporate director of technical training and consulting at Microbac Laboratories. Reach him at trevor.craig@microbac.com.

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The COVID-19 pandemic has had far-reaching effects on all aspects of the food manufacturing industry, including environmental monitoring programs (EMPs), an essential element to any food safety and quality regimen.

According to Sedgwick’s 2021 Recall Index, during the second quarter of 2021, the U.S. saw 106 food recalls, which affected 7.9 million units and were attributed to undeclared allergens, product quality, lack of inspection, bacterial contamination, and foreign material contamination. As a result of the pandemic, consumers are more aware of food safety than ever before. Even though the overall number of recalls is still lower than pre-pandemic levels, there are numerous lessons the food industry can take away from the heightened expectations consumers have today for safe, quality food products. Each player within the industry has a role in ensuring food quality and safety, and establishing and maintaining an efficient and effective EMP can help increase the likelihood of delivering a safe finished product.

During the pandemic, labor shortages and the need for social distancing caused food processors and labs to adjust the way they operate. Weak points in processes and opportunities to improve facilities became apparent as manufacturers struggled to keep up with demand and experienced a lack of resources.

Here are four critical trends processors should embrace as they continue working to strengthen their EMPs.

1. Food Safety Education and Cross Training

QA technicians have had to take on new responsibilities due to the increased labor turnover industry wide and the challenges posed by COVID-19. With new responsibilities and the need for speedy onboarding, continuous education is instrumental in keeping up with testing needs. Manufacturers can meet demand without sacrificing product quality or safety by creating a continuous learning program and establishing a streamlined onboarding and training process.

Similarly, in the wake of pandemic turnover, it has become clear that the best EMPs are those that involve a cross-functional group from their organization. Not only does this allow organizations to use wider expertise on the product and process, but it also ensures that the whole team knows the value of environmental monitoring and preserves an institutional focus on safety, even in the face of high turnover. Many of the food safety controls in place at a plant rely on people, so ensuring that the whole team understands the goals and importance of the program can provide the “why” behind day-to-day tasks. Cross-functional teams can also define areas of potential failure so that when things go wrong, they can be corrected swiftly and efficiently.

2. Virtual Training

The need for virtual versus in-person training to help stop the spread of COVID-19 resulted in more comprehensive and technology-based virtual training programs in the industry. Where training used to be mainly in person and slide-based, the majority of programs now incorporate virtual reality to increase the level of detail and understanding among trainees.

3. Regularly Review EMPs and Historical Trends

One of the best ways to proactively approach environmental monitoring is to have those employees most familiar with the data and facility regularly analyze trends of quantitative data. It can be difficult to keep up with production needs and still find time to analyze data trends throughout the course of the year. As manufacturers strive to keep up with the short-term goal of releasing product or releasing zones, many only look at whether a point passes or fails rather than how it’s trending over time and what the long-term implications of those trends could be. By regularly analyzing the trending data, manufacturers can identify a problem in a caution zone and anticipate a failure before it happens, identify vulnerable areas of the plant, and work toward continuous improvement.

Another good practice is implementing caution zones. Rather than having pass or fail cutoffs for EMP test results, establishing caution zones can help alert the plant to a potential upcoming failure before it happens in the hygiene zone or on a product contact surface. This can help bring attention to problems such as the need for a additional training, a sanitizer changeover, replacement of out-of-date equipment, or a growth niche before they become bigger problems.

4. Creating a “Food Safety Culture”

As a result of the pandemic, some organizations have experienced a renewed sense of purpose; as a result, we have seen an increased emphasis on food safety culture and the creation of guidelines around what this entails. While not a direct result of COVID-19, one example of this renewed interest in food safety culture is the most recent update of the Safe Quality Food (SQF) Institute’s Food Safety Code. At the end of 2020, SQF shared a number of updates for its guidelines for food manufacturing, including adding the need to “establish and maintain a food safety culture within the site” and training requirements around “sampling and test methods, environmental monitoring and allergen management, food defense, and food fraud for all relevant staff.”

Management should work to create a culture in the plant that encourages finding a positive or identifying a vulnerable area of the plant. Testing programs should emphasize sampling locations most likely to find the target organism and require aggressive response to positive samples. Educational resources should be readily accessible, as well.

Though the pandemic has presented challenges in establishing and maintaining EMPs, it’s also helped shed light on the critical role of education, the usefulness of virtual training, the need to continually review EMPs and the importance of establishing a food safety culture.

Vieth is the U.S. technical services representative for 3M Food Safety. Reach her at mvieth@mmm.com.

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Editors’ note: This is part 3 of a three-part series on environmental monitoring. Part 1, which explored the first steps in implementing a cleaning/sanitation process, was published in the August/September 2020 issue of FQ&S, and part 2, which reviewed sanitation recommendations after receiving an out-of-specification microbiological result, was published in the December 2020/January 2021 issue.

This is part 3 of a three-part series discussing the link between environmental monitoring and sanitation. In part 2, we provided root cause investigation’s information on equipment and, in this part, we’ll continue to discuss root cause investigations, turning our attention to clean-in-place (CIP) systems.

CIP System Types

There are two basic types of CIP systems:

1. Single-use systems: Typically, this is one tank where the CIP solution is used and then replaced with a fresh solution. An example of a single-use system is a pasteurizer wherein solutions are used a single time to reduce the contamination risk.

2. Re-use systems: In this system, multiple tanks use the wash solution repeatedly to clean multiple circuits. Re-use systems have a higher initial capital cost but may allow for shorter CIP run times or they can be set up to wash two different circuits at the same time, using two supply pumps. Multiple tank re-use systems can lower water and energy cost by having the cleaning chemicals stored in one or two tanks and fresh water for final rinsing in another. A final tank, the reclaim tank, stores the spent post-rinse water after the alkaline wash and may be used as the prerinse water for the next CIP circuit.

CIP systems can be time-based or conductivity- based, which measures chemical concentrations. Time-based controls are simplified in that they receive a signal from the CIP controller and the pumps run for a specified time. The pumps deliver the same volume every cycle regardless of demand.

CIP: Less Is More. The objective of a CIP system is to clean the interior of an enclosed stand-alone vessel and its fittings (tanks, spiral freezers, mixers, blenders) or multiple closed-system vessels within processing line(s) and their connecting pipework. The substantive goal being, counterintuitively, less—less workforce, less water, less disassembly, less downtime, fewer chemical accidents, less chemical waste, and lower operating costs.

Mechanical Action (or, in the CIP World, “Flow”). In part 1 of this series, a “Sinner’s circle” was described that identified the four factors needed for cleaning/sanitation: mechanical action, temperature, time, and chemical concentration. As one factor is altered (decreased or increased), the others are adjusted to compensate. In manual cleaning, mechanical action is created through scrubbing, water sprays, and foaming. In CIP, mechanical action is produced by flowing liquids (flow) to create turbulence, which, in turn, generates convection (energy transfer by mass motion of molecules). Convective energy is more efficient at removing soils because the surface soil’s adhesive force is often less than the force of convective energy (flow plus temperature), leading to the soils being released from the surface more quickly and with a lower temperature and fewer chemicals than when exposed to conductive energy (energy transfer by direct exposure) or temperature and chemicals exposure via soaking. Or, said another way, the amount of time, temperature, and chemicals can be reduced (or their effect is amplified) when flow is present.

How Is Flow Rate Calculated? Flow rates are calculated by two factors:

• Pipe diameter and configuration: This is the largest pipe size diameter in the circuit and flow requirements for all spray devices in the line. Pipe diameters are a critical consideration because they must be completely filled and the solution velocity high enough to produce turbulent flow during both cleaning and sanitizing. While this may sound easy, piping can be a dizzying maze, causing missed diameter size changes.
• Spray balls: Each spray ball will have a gallon/minute rating. If there are four in a line each rated 40 gal/min, the pump for that line will need to deliver 160 gal/min.

What Are Minimum Flow Rates? The minimum flow rate necessary for effective turbulent flow is 5 feet/second. To put this into perspective, it is similar to wiping down a counter with a cloth, therefore highlighting the synergistic attributes when convective flow is applied. Nevertheless, even under the best circumstances, there are areas these flow rates are unlikely to reach—notably at dead ends, 90-degree corners, fissures, and cracks.

How Is Flow Generated? Pumps, valves, spray devices, and pipe diameter work together to create a flow rate.

• Valves create flow by pulsing (opening and closing). Flow is created when the pressure behind a closed valve is released. Often, valves are used to direct supply and clean the O-rings of the valves, which rotate when pulsed. Valve placement and pulse timing are also factors in restricting or routing flow.
• CIP systems must be designed with enough pump capacity to exceed soil build-up resistance, allow for valve back-flow pressure, meet spray ball capacity, completely fill pipe diameters, and maintain liquid velocity.

System Analysis and Root Cause Analysis. Poor cleaning is the No. 1 symptom of CIP failures. Other indicators include the creeping up of finished product indicator results (aerobic plate count, coliforms, E. coli, yeast/mold), pre-op allergen findings, a color bleed-through, or cleaning rinse water pH abnormalities. The CIP failures allow for incomplete soil or chemical removal. The longer that soils remain on the surface, the stronger they attach (think of dishes left in the sink overnight versus dishes cleaned shortly after use). Compounding the effect, sanitizers may be less effective because they do not have direct contact with microbial cell walls/ membranes, which is needed for microbial reduction/elimination.

On some CIP systems, software packages can be added that report system functionality, including flow rates, conductivity, temperatures, preventive maintenance prompts, or other sanitation verifications. These reports are valuable to detect system drift, unintended consequences of program changes, or equipment damage. Additionally, since day-to-day interior equipment/circuit inspection after cleaning and before sanitation is difficult or not conducted until preventive maintenance results in disassembling pipes or tanks, these metrics are tools to maintain system effectiveness.

Programming errors or changes can cause incorrect valve pulsing and sequencing, which may send cleaning solution down the wrong flow paths or release excessive amounts of heated solution to the drain. Additionally, incorrect valve pulsing may lead to decreased flow rates. Installation errors, such as incorrectly installed valves, process dead legs, and non-uniform pipe sizes, may result in unsanitary lines and bacterial contamination risk.

Temperatures of liquids that are above parameters for the soil can cause proteins to denature (unfold), exposing bonds that strongly adhere to surfaces. Liquids that don’t meet temperature requirements may not dissolve soils, as in the case of sugar removal. Thermocouples and resistance temperature detectors (RTD) can be used to measure the temperature in the system. As with any temperature measuring device, calibration must be conducted for accuracy.

Conductivity measurements indicate interfaces between ionic cleaning solutions and non-conductive water. Conductivity can be an indication of chemical concentrations and its removal from the system. The meter calibration must be maintained on a routine basis or drift can occur. If chemical concentration is in doubt, test kits provided by the chemical supplier can be used. Ensure that the reagents in the kit are not expired and that kit instructions are followed accurately. As a fast test, pH paper can be used to confirm acid or alkali presence, but should be followed up with a test kit for confirmation. Further, water hardness (calcium carbonate) and any mineral deposit build up will impact the effectiveness of the sanitizers used. Testing the parts-per-million (ppm), mg/L, or grains per gallon of calcium carbonate in the facility water will point chemical suppliers to the needed chemicals and temperatures for maintaining effective and efficient CIP functions (See Table 1, below).

Table 1. Water hardness classification measured as parts-per-million (ppm) or grains-per-gallon calcium carbonate.

In conclusion, a CIP system can deliver cleaning and sanitizing functionality with reduced operating costs. When issues arise, it is often due to system drift, minor operator adjustments that compound over time, not setting up, or trending metrics. While cleaning performance is a main CIP issue, the root causes are most often caused by reduced flow rate, a main component of temperature and chemical synergistic effect, followed by disparate temperature or conductivity values. Conducting consistent system analysis by measuring key metrics will drive CIP efficiencies and effectiveness.

Dr. Deibel, a Food Quality & Safety Editorial Advisory Panel member, is the chief scientific officer at Deibel Laboratories, where she is responsible for leading the technical staff in research, food safety, and regulatory issues. Reach her at virginiadeibel@deibellabs.com. Baldus is food safety program manager for Hydrite Chemical Co. Reach her at kara.baldus@hydrite.com or foodsafety@hydrite.com.

The authors would like to thank Joel Cook and Spencer Lightfield at Hydrite Chemical Co. for their assistance with this article

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Hazard analysis and critical control point (HACCP) guidelines are the primary preventive approach applied in the United States to keep food safe from biological, chemical, and physical hazards at every stage of the production process or food chain. HACCP guidelines were revised extensively in 1997 and promulgated. Much more recently, HACCP has added radioactivity to its list of hazards.

If your company is required to comply with HACCP guidelines—and they are applicable in food manufacturing to preparation processes such as packaging and distribution, as well as to retail sales and food serving—your steps are laid out in the seven principles of HACCP. The overriding goal of these principles is to prevent harm to customers (and also to mitigate damage to the reputation of your brand and customer loyalty). The plan’s methodology emphasizes a systematic approach to the entire process, and the result is a HACCP plan and food safety system for your business. The fundamentals of HACCP have been applied successfully to growing, harvesting, processing, manufacturing, distributing, merchandising, and preparing food for consumption. The details for each stage, industry, and business will be different, of course. (Prerequisite quality assurance, such as good manufacturing practices, is viewed as a foundation for HACCP success.)

Systematic Planning, Implementation, and Monitoring

Because the essence of HACCP is systematic planning and vigilance, its implementation at a company requires an across-the-board effort. This means that the plan must have complete buy-in by top management and the company must adopt a commitment to making food safety and quality an enduring priority. It means the kind of leadership that catalyzes the interest and commitment of employees at all levels. One tool of management is regular training in key concepts, control points, standards, and best practices in monitoring different kinds of processes and stages in production (see “Employee Roles in a HACCP Program,” below).

The HACCP Team

All of these and other roles are defined by the HACCP team you form to create and launch the plan. Special knowledge and expertise, representation from various departments, and other considerations go into choosing your team. Depending on your industry, size, and any special issues, your plan might include production, sanitation, quality assurance, food safety, manufacturing, and operations. In addition, you probably will need to involve consultants with specific technical expertise. When creating your team, you’ll want to think about the following elements.

Products and processes to cover: Get clear about your final food product—ingredients, recipes, and final product standards, for example—and how it is prepared, including materials, equipment, and processes.

Food product use and users: This element could be considered the public at large, but also, more specifically, babies and children, hospital patients, or members of the armed services.

Distribution and storage methods: A key variable, for instance, will be at what temperature the food is distributed (room temperature, chilled, frozen).

The procedure: How does the food move through the parts of the system that your firm controls? What are the stages where the HACCP process is vital, and what are the checkpoints?

Check your flow diagram on site: Whether your core team or an outside inspector handles this component, you must check the accuracy of the flow diagram “on the ground” and modify it as needed to both perfect and, if possible, streamline it. Usually, the more attention you bring to these “setup” steps, the better you will be prepared to apply the seven principles of HACCP.

Implementing HACCP Principles

FDA guidelines offer comprehensive guidance for the entire HACCP process, including instructions for each guideline, a glossary of key terms, diagrams, tables, and appendices. It is not the goal of this article to repeat that information, but to offer an overview of the seven principles—the essentials—and how they progress.

1. Conduct a Hazard Analysis

The HACCP system is built on the identification of hazards. In this context, a “hazard” is a “biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” The standard is “reasonably likely,” and the preventive measures (control responses) are required to reasonably control the hazards. In other words, no complex, continuous process is perfect. The focus is on hazards that are reasonably likely to occur. Although your company is focused on quality, and safety is an aspect of quality, the HACCP process should focus resolutely on hazards and not quality.

An effective, comprehensive hazard analysis that follows the guidelines but zeroes in on your facility or retail location is of the essence, because each facility is different. If potential hazards are overlooked, no amount of adherence to a food safety system will protect you. In the same vein, the severity of the hazard, not in general but in your particular case, should correlate with the amount of effort devoted to it.

2. Determine Critical Control Points (CCPs)

A CCP is a step in your process—whether it is manufacturing or food preparation—where the right procedure makes the difference between controlling a potential health hazard or failing to do so. Attention to CCPs in conducting your business reduces the risk of harm to the public. FDA guidelines illustrate a CCP decision tree useful in diagramming each CCP.

3. Establish Critical Limits

No operating conditions at every point are immutable. When your planning team has identified CCPs, the next step is to establish the range within which your process can vary at a given CCP without tipping over from a safe to an unsafe operation. These limits must be referrable to scientific factors, guidelines, regulatory standards, experts, or experimental results. When challenged, the range you have set must refer to one of these justifications. A few examples might help you to concretize the kinds of factors to consider as you establish the range of allowable variation: humidity, pH, physical dimensions, salt concentration, sensory information (visual appearance, smell), temperature, time, viscosity, or water activity.

4. Establish CCP Monitoring Procedures

Once you’ve identified the CCPs that are relevant to your business and established safe ranges within which the process may vary, the challenge become monitoring them. Continuous monitoring that is accomplished electronically is ideal. The alternative is periodic or intermittent monitoring, which is often performed manually. When you automate, you increase the accuracy, control, and visibility of the process. By monitoring a specific point in the process, you will know if the trend is toward loss of control, and you can act to remedy the problem. You also record when a deviation occurs. Employees trained to conduct monitoring have to have accountability and, for this reason, must schedule their work and documentation outcomes.

5. Establish Corrective Actions

Deviations can occur in any process, so your corrective actions must be available to implement immediately. Determine the cause of noncompliance and correct the situation so that the CCP is back under your control. At the same time, you must decide on the appropriate way to dispose of the non-compliant product, and document what you discovered and how you have managed the process. Your HACCP planning will identify the people responsible for these steps and where you will store the documentation of the steps taken.

6. Establish Verification Procedures

The HACCP process must not only perform its protective function; its performance at any given moment must be verifiable. You may verify your monitoring, but, more broadly, you will need to verify the successful operation of the HACCP system as a whole at your specific location and facility This is not only product testing, as important as that may be. It is a direct, regular review of the HACCP plan itself. Initially, the goals will be to validate the plan’s technical and scientific aspects, which can be done through scientific studies, observations on location, measurements on location, or evaluations on location.

7. Establish Record-Keeping and Documentation Procedures

The systematic approach of HACCP requires objectivity, which makes it crucial to maintain records for all aspects of the HACCP and be prepared to be audited. The FDA guidelines give this enumeration of aspects of the system to be documented: core team, assigned roles and responsibilities, description of the product, intended use and consumer, flow diagram, CCPs, hazards likely to occur, critical limits, monitoring, corrective actions, verification procedure, verification schedule, and documentation procedures.

Applying an effective HACCP plan will ensure the safety and loyalty of your customers, your brand’s reputation, and the long-term success of your business.

Hansen is the VP of Technical Solutions at SafetyChain Software.

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Editors’ note: This is part 2 of a three-part series on environmental monitoring. Part 1, which explored the first steps in implementing a cleaning/sanitation process, was published in the August/September 2020 issue of FQ&S, and part 3, which will cover procedures for use during extenuating circumstances, will publish in the February/March 2021 issue.

In Part 1 of this three-part series, we discussed the basics of sanitation, soil, and chemical identification, in addition to basic procedures and applications for routine cleaning and sanitation. In this article, we will discuss root cause analysis and intensified cleaning and sanitation activities to perform after receiving an out-of-specification (OOS) microbiological result during routine environmental monitoring.

Let’s begin by stating that OOS results are an expected, albeit perhaps not welcome, outcome of a robust microbiological environmental monitoring program (EMP). Usually, we find that cleaning and sanitation procedures are a common scapegoat, if you will, for an OOS. While this may be part of the story, we have found that OOS results signify that the EMP is working as intended, meaning that the results will detect whether there is a gap or drift between procedures as they are written versus what is occurring on the plant floor; if the written procedures do not address circumstances that lead to cross-contamination; or if there is a situation festering that, if not addressed, could lead to a major production disturbance. Taken together, OOS results are a shot over the bow and encourage bridging the food safety and sanitation departments in performing augmented procedures.

So, what do we mean when we say augmented? Let’s start by giving an example. A company is enjoying an increase in sales and the plant is producing 30% more product, which undergoes a thermal lethality step. To meet the production demands, the second shift is running late and encroaching into nightly sanitation time. Months into this schedule, trending of the coliform counts shows the quality team increasing counts on equipment during the second shift. Two weeks later the increased counts are then noted during first shift and then at pre-op, where <10 cfu/sponge is the specification. Microbial analysis on retained product identifies swelling packages before the end of shelf life, and coliform counts are well above specification.

The quality manager takes five 360° vector sponges surrounding each of the equipment sites with OOS coliform counts and identifies three pieces of equipment where the vector sponge counts are high. The HACCP team determines that, on the next down day, maintenance will disassemble the equipment to the frame. During disassembly, sponges are taken, and there are copious amounts of accumulated product residue tucked deep inside numerous crevices, all with a rank odor. Sanitation performs an intensified cleaning of the area. After sanitation, verification samples are taken and sanitation is determined to be effective. The equipment is then reassembled by maintenance and the equipment sanitized again.

While waiting for results, the sanitation records are reviewed. Records indicated that due to second shift time overruns, the sanitation team does not disassemble the equipment or sanitize all equipment in order to save time. As preventive actions, the sanitation manager shift is changed to overlap with production so she can verbally report activities or issues to the HACCP team in morning meetings. Further, checklists are devised to capture each step in the sanitation standard operating procedures (SSOP), including equipment disassembly, chemical concentrations, and applications on each piece of equipment. Additional sanitation personnel are hired to allow for SSOP adherence.

Let’s unpack this scenario. What went right?

1. We’ll assume that a risk assessment identified coliforms as a risk for product spoilage.
2. Organisms identified in the risk assessment were added to the EMP, which, as one of its purposes, is a tool to identify gaps in sanitation (or other food safety) programs.

• Suggestion: Sampling frequency, timing (first, second, or pre-op shift), sampling sites, zones, and organism selection should be predetermined and based on risk assessment of the facility and product.

3. EMP specifications were set and samples were taken during pre-op, first, and second shift of operations.

• Suggestion: Specifications are based on collection of baseline data, which are accumulated over an extended period (i.e., at least six months to account for seasonality) and trended to understand the normal concentrations of microorganisms in that specific manufacturing facility and during each shift (accounting for building age, equipment condition, products, number of employees). After specifications are set, exceeding their limits results in investigation and corrective actions.

4. The results were trended and noted to increase.
5. Retains were saved and tested for the organism found to be OOS.
6. Vector samples were taken to assess origination and scope of OOS results.

• Suggestion: Root-cause analysis should include additional sampling to determine the location of the source, or harborage site, which is often different from the sample site. This is called vector sampling, which includes sampling beyond the OOS point to other locations in the vicinity. Vector samples are those taken in a 360° radius, up to 30 feet from the original OOS site, including the ceiling, walls, and floors. Water droplets from cleaning, air currents, cross-contamination from tools, hoses, utensils, and people are all means of translocation from a harborage site to external locations. Harborage sites are those locations that are difficult to inspect, reach, or clean. In this regard, they are usually not product contact areas (Zone 1); rather, they are areas further removed (Zone 3). They usually have access to water and a food source, typically product build-up. Harborages can allow bacteria to accumulate, grow, and then excrete back out into the environment. Harborages can be present for weeks, months, or even years. Eventually, the bacterial concentrations will build to a point high enough that they will be detected on nearby equipment or product.

7. The HACCP team met to discuss the EMP results and determine next steps.
8. Maintenance disassembled the equipment to the frame and, before any cleaning of the equipment, coliform samples were taken and a visual inspection conducted.
9. Sanitation was present during the disassembly process and conducted an intensified sanitation procedure. They were able to witness where in the equipment the soils were accumulating. An intensified cleaning procedure (deep clean) includes a number of steps that are expanded from routine cleaning. These include:

• Equipment disassembly: Do this to the framework or as close as possible.
• Manual scrubbing: Although this is the hardest method to control and monitor, this may be the most effective way to clean in areas that are difficult to access. Two rounds of detergent application, which involves the use of alternative chemicals (i.e., apply chlorinated alkaline first, rinse, then apply alkaline) or the same cleaning chemicals but in higher concentrations than used in the routine process, should be conducted. These stronger chemistries should be used with caution and only on an intermittent basis due to potential damage to the equipment or environment and strict enforcement of personal protection equipment. Consultation with a chemical supplier is suggested prior to conducting any type of change. The best practice for small parts removed during disassembly is using two buckets: one bucket with detergent and one with sanitizing solution. Small parts may then be left in the sanitizing solution until retrieval for reassembly. Use non-scouring pads, single time only.
• Sanitizer application: After rinsing detergent, apply an environmental strength (the high end of a chemical supplier’s recommended parts-per million) sanitizer. Rinse and apply a second round of sanitizer, which may be a different compound than the first. Rinse food contact surfaces. At this juncture, swab equipment, assemble, and apply a third round of sanitizer (food contact concentrations for Zone 1 and 2 and environmental concentrations for Zone 3). Although sanitizers are effective across a broad spectrum of microorganisms and have proven efficacy per EPA standards, certain sanitizers have greater efficacy against specific types of organisms than others. For example, chlorine dioxide is extremely effective against Gram-negative and Gram-positive bacteria, but weak against yeasts. A facility applying chlorine dioxide may experience yeast contamination in the environment, meriting a switch to peroxyacetic acid, which has efficacy against yeasts. Chemical substitution should not be implemented without a risk assessment and a discussion with a chemical provider.

10. After sanitation, verification sponges were taken to verify that the sanitation procedures were effective. There are times when the harborage is longstanding. One intensive cleaning and sanitation event may not be effective and another is needed. After maintenance reassembled the equipment, it was sanitized again to avoid contamination during assembly process.
11. Preventive actions were identified and implemented. Cleaning records provide an additional awareness of breaches in protocol. For example, insufficient concentrations of cleaning compounds lead to product build-up and potential biofilm formation. Records give indication of trends in microbiological creep data. If equipment is not being cleaned according to the SSOP, bacteria counts tend to increase over time. Equipment that may not have been fully disassembled in the past will now be put on a disassembly schedule and dismantled to the framework (or as close to this state as possible). By removing parts, hollow areas and or damages are exposed that would otherwise be impossible to reach, see, or sample. During disassembly, use a designated mat with specific top and bottom identified or a dedicated rack to contain parts. Do not place parts directly onto the floor. Always clean mats after use and hang up in a designated location to allow drying.

While a one-size EMP or cleaning and sanitation regimen does not fit all, there are baseline tasks that can be incorporated into all programs to set up your integrated food safety program for success, regardless of changes that will inevitably occur. Incorporating predetermined steps into an EMP program when there are OOS results, and using the strength of the entire HACCP team will aid in a successful approach for bacterial management.

Dr. Deibel, a Food Quality & Safety Editorial Advisory Panel member, is the chief scientific officer at Deibel Laboratories, where she is responsible for leading clients through food safety and regulatory issues. Reach her at virginiadeibel@deibellabs.com. Baldus is food safety program manager for Hydrite Chemical Co. Reach her at foodsafety@hydrite.com.

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Food safety programs have depended on hazard analysis and critical control points (HACCP) programs to ensure the safety and quality of food products. Processors start by conducting an analysis of potential hazards, whether that be contamination by pathogens, allergens, or other contaminants that could compromise the integrity of the product, and then work to identify a specific critical control point (CCP) for any given hazard of concern. The specific parameters that allow for effective control of the target hazard at the given CCP are firmly and clearly established and then are monitored on a defined timeline.

As most food safety professionals are well aware, HACCP has long required “prerequisite programs” be in place to ensure that the food safety and quality systems being implemented are working correctly. These prerequisite programs can include anything from proper sanitation procedures to good employee hygiene practices to pest control. If even one of those prerequisite programs relied on to keep food safe isn’t applied correctly, however, or if the system of prerequisite programs in a processing facility is not designed comprehensively or verified to be effective, this leaves a window open for food contamination.

The food industry and consumers have become increasingly concerned with food safety and quality. As a result, the food industry and its regulators have more recently heightened their emphasis on environmental monitoring programs (EMPs). Conceptually, environmental monitoring may serve as either validation or verification of specific prerequisite programs or may be more generally seen as a strategy to monitor the environment for unhygienic conditions.

The increasing importance of EMPs is particularly well illustrated by recent changes to regulatory approaches to food safety. The U.S. FDA Food Safety Modernization Act (FSMA) and similar regulations in other countries have elevated the importance of prerequisite programs. For example, in the FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (PC Rule), many of the specified “preventive controls” represent programs that would have previously been classified as prerequisite programs. However, FSMA preventive controls include a requirement for verification of the preventive controls, which was not in place for prerequisite programs.

Additionally, the FSMA PC Rule includes a specific recognition of environmental monitoring as a key verification strategy for certain nonprocess preventive controls such as sanitation. The rule states: “Environmental monitoring, for an environmental pathogen or for an appropriate indicator organism, if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples.” This provision demonstrates the growing consensus on the importance of environmental monitoring programs as an essential part of food safety and quality systems.

Effective Environmental Monitoring Programs

Exactly how EMPs should be designed and executed—from the frequency and process of sampling to which test method or technology is fit for the purpose to how results are reported and acted upon—is highly variable depending on each facility, the prerequisite programs used, the product(s) produced, and other factors. Regardless of the specifics of the program, the effectiveness of any environmental monitoring program and, by extension, a total food safety program, is most often determined by a company’s willingness, engagement, and commitment to taking a preventive mindset toward food safety.

John Butts, PhD, a member of the FQ&S editorial advisory panel, president of FoodSafetyByDesign. and advisor to the CEO of Land O’Frost, has described a model for control of Listeria monocytogenes in meat processing called “seek and destroy” and an overarching concept of microbiological or environmental process control. Environmental process control contains three steps: elimination of the resident organisms of concern from the processing environment, management of the vectors and pathways within that environment, and use of process control methodology to measure and predict loss of control.

Environmental process control uses environmental monitoring as a key tool. Environmental monitoring measures the risk present in the processing environment and also assesses the hurdles established to control entry of pathogens. This requires multiple sites in the processing environment to be sampled individually and in conjunction with one another. These results indicate the level of control in the facility and help identify when failures occur or when interventions or additional actions are required to bring the process back with control parameters.

However, achieving a high level of environmental process control is not an easy task and requires full cooperation throughout the organization. The relationship between effective EMPs and an organization’s culture is more significant than most food safety practitioners and business leaders realize.

As such, concern can spread quickly throughout a food company when positives are detected through verification activities, especially in cultures where food safety activities are largely completed by food safety professionals. Food safety in these stages is crisis management driven, with leaders stressing the importance of “doing things right” while conducting investigations that fail to get to the root cause.

The development of such effect-driven behaviors that wait for a crisis to engage operations professionals is harmful to consumers, brands, and overall company financial performance. No matter the industry, for an EMP to be as successful as possible, organizational alignment from the food safety experts all the way to the C-suite should ensure that the primary goal of any monitoring program is to proactively and transparently find, correct, and verify problems before they happen, and positive tests are a necessary part of that process. Linking EMPs to organizational and food safety culture can create a “line of sight” to the corporate vision and values, down to individual behaviors, enabling a preventive mindset to help protect consumers, brands, and financial performance.

Effective EMPs, particularly those linked to specific goals such as sanitation validation and verification, can significantly reduce the risk of contamination and associated recalls. For example, good environmental monitoring data are often essential to allow companies to limit recalls to a single lot, production day, or production week. Without appropriate validation and verification data, it is challenging to sufficiently prove that finished product contamination on a given day could not have been transferred to subsequent lots. In addition to food safety hazards, spoilage issues (including problems caused by organisms introduced from the environment in processing plants) represent a growing business risk for food companies. Consumers often use social media platforms to communicate food spoilage issues and pressure companies into action.

Therefore, the business needs for EMPs represent another benefit to food companies. It’s widely known that recalls are extremely costly for companies; despite this given, quantification of the benefits of EMPs is still often considered challenging. As foodborne disease surveillance systems continue to improve, companies are being placed at an increased risk of being identified as the source of an outbreak.

However, food companies have also seen that effective EMPs can facilitate extended run times, thereby improving production efficiency. For example, environmental monitoring may identify difficult-to-clean areas that can be eliminated through equipment redesign, which will subsequently allow for longer production runs.

With renewed industry focus on the programs underpinning HACCP and a greater understanding of the important role environmental monitoring plays in delivering safe products to consumers, it is imperative that food manufacturers regard EMPs as critical and invest the resources necessary to ensure effective execution. Once implemented, it is also vital that the programs evolve with the organization to continuously improve and to foster an effective and positive company culture surrounding food safety.

For more detailed guidance, Cornell University and 3M recently partnered to develop the first comprehensive Environmental Monitoring Handbook for the Food and Beverage Industries, a free resource to guide any processor on how to create a rigorous environmental monitoring program that’s mindful of employees, regulators, and consumers in this safety-conscious time.

David is the global scientific affairs leader for 3M Food Safety. Reach him at jmdavid@mmm.com.

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The hazard analysis and critical control points (HACCP) system was established in 1959 by NASA to protect food for astronauts in space. It is a science-based systematic approach and risk assessment tool designed to identify and assess specific hazards, including chemical, microbiological, physical, and, now, often radiological hazards. Its focus is on control and prevention throughout the food production process, instead of reliance on finished product testing only.

As a result of its initial success, the process was soon adapted to include not only “space food,” but also traditional food production. Given the fact that HACCP was first developed more than 60 years ago, is this method now an outdated risk assessment tool?

Over the years, the approach to HACCP use has changed slightly. In the past, a large number of critical control points (CCPs) were often identified and defined in food facilities. Now, the tendency is to limit these CCPs and ensure that they are each continuously under control.

To conduct a HACCP assessment, the Codex Alimentarius suggests 12 steps:

1. Assemble a multidisciplinary team;
2. Describe the product;
3. Identify the indented use, including consumer groups and vulnerable groups such as infants;
4. Construct a flow diagram;
5. Perform an on-site verification of the flow diagram;
6. Conduct a hazard analysis;
7. Determine the CCPs;
8. Establish critical limits;
9. Establish a system to monitor and control the CCPs;
10. Establish corrective action for any case in which the CCP is not under control;
11. Establish a verification procedure to confirm that the system is working effectively; and
12. Establish documentation concerning all procedures and records appropriate to these steps.

Based on the questions most often asked by manufacturers, a number of these steps warrant additional consideration and clarification in the development of your HACCP plan.

How do I conduct the hazard analysis? As defined by the Codex Alimentarius, the analysis needs to be conducted by a multi-disciplinary team. The team approach is important to bring different experiences, knowledge, and backgrounds to the process. Involving a technical manager will provide different experience and areas of focus than that of a production manager. A quality manager can then include points from literature and scientific information, which are necessary in a HACCP study to demonstrate that more than just site knowledge is used to inform the process. This diverse team approach supports completion of a well-rounded analysis.

To ensure a good understanding of the basics of the HACCP philosophy, training is also key. The first group in need of training is the core HACCP team, as they will need a detailed understanding of the hazard analysis process and each step of the assessment. The next training group will be those responsible for conducting CCP controls, as they need to know why they are conducting the check and how to best do so. They will also need to know the consequences of improperly completing the check, which may lead to severe health issues for consumers. It is also crucial for this group to understand that if there is any problem or issue related to a CCP, they may need to withhold or recall products from distribution and also then work with their teams to adequately address the problem. To fully implement your HACCP plan, all production employees will need to have completed basic HACCP training so that they understand why such a risk assessment is done and the consequences if it is not properly executed.

Is it sufficient to check only for the intended use of the product? While the intended use should be the focus of your plan, unintended uses should also be taken into consideration. This does not mean that you’ll need to check every bizarre idea about the potential use or misuse of the product. You will, however, need to consider those that are likely to occur. A good example of a likely unintended use is marshmallows. These fluffy treats are not only directly consumed; they can also be heated by microwave or grill, and recipes are published regarding this use. The hazard analysis process should take this unintended use into consideration. If there could be a risk from this heating process, the formula may need to be changed or a warning will need to be published on the product label, stating that the product is not intended for heat treatment.

How do I identify a CCP? The determination of CCPs can be done with the help of a decision tree. This process will guide the HACCP team through a series of questions to help define whether the step is a CCP or not and whether there is a further process step that can prevent, eliminate, or reduce the risk to an acceptable level. This important question helps focus the process on the critical production steps.

Are there rules for the monitoring of CCPs? For the monitoring and control system, a continuous control is often requested. This could involve a process such as permanent temperature control, including pasteurisation and sterilisation. However, controls such as strainers can also be regarded as permanently controlled units if they are checked prior to production and are also in good condition after the production run. This means that, throughout the duration of the production shift, the strainer was in place and all product was properly strained. However, to properly manage it as a CCP, the controls of that strainer need to be completed during the shift, before the product is released, and while it is still the responsibility of the facility. If the product is released automatically 24 hours after production, but the strainer is only checked at the end of the week, it is not an adequate and allowed control of a CCP. In this case, it would be required for the strainer to be checked following each shift, or daily, before the product is released.

Do corrective actions need to be predefined? Prior to any incident, it is mandatory for the HACCP team to clearly define the corrective actions that would be taken in case of a non-compliant CCP. The team will need to discuss and define the possibilities for either the retreatment or destruction of the product in question. For example, milk that isn’t properly pasteurized could be sent back through the process to be pasteurized again, but only after the equipment is cleaned and working properly. Other products, such as one that passes through a free-fall metal detector and is packed in a metallized packaging material and cannot be unpacked and repacked again, will have to be destroyed, as there is no retreatment possible for that product. In a case where a rework is possible and not too costly, the control frequency of the metal detector should be much more frequent, as it should ultimately save product and resources. The advantage of defining these corrective actions prior to an incident is that it can be done in a calm environment, rather than the “panic” mode of an incident or crisis situation. Making senior management aware of this process will gain their support for the consequences of a failed CCP and the defined corrective actions.

What do the verification procedures include? The first verification check is the responsibility of a supervisor or other trained and identified individual or individuals on the team. These controls need to be completed as defined in the HACCP plan. This includes verification by set timelines, whether hourly, by shift, or otherwise as predetermined in your plan. The next level of verification is the control that the calibration of the equipment used is done in the defined frequency, such as the temperature probe calibration for a pasteurizer or the proper calibration of test probes for the metal detector.

The last level of verification/validation is the analysis of complaints that should have been eliminated by the defined CCP controls. For example, if the company has defined 2.5 mm as the critical limit for the metal detector check and there are no metal complaints larger than 2.5 mm, that means the system is working properly. However, if there are several complaints of metal parts between 1.0 and 2.5 mm, the HACCP team should further analyze whether the critical limit of 2.5 mm is an adequate limit to control the risk. For many companies, this verification/validation step is completed, but not necessarily to the required level to control the risk. This step is crucial to finish the cycle of the risk assessment and adequately define further control steps or other limits as needed.

Even though the HACCP method was first established more than 60 years ago, this science-based, systematic approach and risk assessment tool continues to provide a valuable process for manufacturers. By effectively identifying and controlling risks through the production process, the method can help ensure that food is safe. It also helps companies reduce the risk of product recalls and damage to their brands, saving them those costs and ensuring consumer trust in today’s food supply chain.

Auer is food safety professional, EMEA, operations, for AIB International. Reach him at tauer@aibinternational.com.

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Large food producers are testing for Listeria monocytogenes in their frozen food manufacturing facilities, at least to some degree, according to a new study from the University of Georgia in Athens. Researchers used an anonymous survey to collect information from more 46 frozen food production facilities to better understand existing environmental monitoring. The results were published in the January 24, 2020 issue of the Journal of Food Protection.

Although frozen foods do not support the growth of L. monocytogenes, the moist and cold conditions in frozen food production environments are favorable for its growth. The purpose of the study was to determine the current state of awareness and practices applied across a variety of frozen food facilities related to environmental monitoring for Listeria.

The survey indicated that facilities are more likely to test for Listeria spp. in environmental monitoring zones 2 to 4 (nonfood contact areas) on a weekly basis. The major areas of concern in facilities for finding Listeria-positive results are floors, walls, and drains. The survey showed that few facilities incorporated active raw material and finished product testing for Listeria; instead, programs emphasized the need to identify presence of Listeria in the processing environment and mitigate potential for product contamination.

The researchers concluded that recognition of environmental monitoring as a key component of a comprehensive food safety plan was evident among the facilities surveyed, along with an industry focus to further improve and develop verification programs to reduce prevalence of L. monocytogenes in frozen food processing environments.

“Over the last few years, the FDA has started putting more emphasis on Listeria monocytogenes,” says Mark Harrison, PhD, lead author of the study and a professor in the university’s department of food science and technology, referring to the revised environmental monitoring guidelines to industry for ready-to-eat foods issued by the FDA in 2017.

While there are at least half a dozen species of Listeria, only L. monocytogenes is dangerous to humans, he says. Listeria is prevalent in nature and in production facilities, some of which test for multiple types of Listeria and some only for L. monocytogenes. An estimated 1,600 people in the U.S. each year develop listeriosis, a serious infection typically caused by eating food contaminated with the Listeria monocytogenes bacterium, and approximately 260 people die, according to the CDC. The infection is most likely to sicken pregnant women and their newborns, adults aged 65 or older, and people with weakened immune systems.

Dr. Harrison adds that frozen food producers need to review their sampling strategy for L. monocytogenes, including the frequency and timing of sampling. Although there are no guidelines with precise recommendations for sampling, he says regular testing can identify problem areas. “Facilities should focus on looking for Listeria monocytogenes at times and in places where they are most likely to find the pathogen for a realistic assessment,” he adds.

Listeria monocytogenes is ubiquitous in the environment and can be brought into facilities on clothing and shoes, he says. It also can survive freezing temperatures. Floors and walls tend to be places where the pathogen is frequently found. The study found that facilities generally tested non-contact areas weekly.

“This survey demonstrates there is a pretty high awareness in the industry of the risks of Listeria monocytogenes,” says Sanjay Gummalla, PhD, senior vice president of scientific affairs at the American Frozen Food Institute in Arlington, Va. The institute funded the University of Georgia study and several other related studies.

Dr. Harrison is working on another study funded by the institute that relies more heavily on data to help answer questions about whether to sample a certain area of a production facility, and how often. “[With the current study] we got a snapshot of the industry now,” he says. “We found it is aware of Listeria and the need for additional training and resources.”

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Recently, I had the opportunity to sit down with Cliff Coles, president for over 20 years of Clifford M. Coles Food Safety Consulting, Inc., to discuss the topic of what makes an effective environmental program. Here’s how the conversation went:

Richard Stier: Should every company put together a hygiene monitoring program? Why or why not?

Cliff Coles: A hygiene monitoring program should reflect the risk assessment on the product being made. Certainly, a ready-to-eat product such as a salad or a cold-cut sandwich should and would have a more in-depth significance, whereas a beverage facility producing shelf-stable juices would be concerned with economic spoilage organisms, such as yeast, molds, and perhaps Lactobacillus or Alicyclobacillus. Whatever the case, it becomes the report card that justifies the efforts and dollars being spent by a company to remain in the marketplace. With respect to food safety, keep in mind that regulatory officials do not need to prove that a product is contaminated. They simply need to show that the product is being manufactured in an environment whereby it may become contaminated. This is a big difference, and if a company fails to monitor and control the environment, it could fail the test.

RS: Do you have a preference for the type of tests used?

CC: A company needs to decide how it will set up an environmental swab program. Will the program include Zone 1 swabs (direct food contact surfaces) or Zone 2, Zone 3, and Zone 4 only? Those who choose to include Zone 1 areas may opt for testing for “indicator” organisms, such as coliforms, as their choice over the other options. Several companies have chosen non-specific genetic testing (performance testing) to gauge the effectiveness of the sanitation on Zone 1 and Zone 2 environmental areas.

The options for monitoring an environment are plentiful, each has its own pros and cons, and each can be used to support the other. While plate counts and other counting methods require incubation time and can be cumbersome, counts can be used to determine levels of a specific organism and identify indicator organisms. Adenosine triphosphate (ATP) is a longstanding technique that is sometimes misunderstood. ATP results do not equate to the microbial load on a surface being sampled but do reflect the presence of organic material that can be the source of bacterial contamination, or at least be a food source for bacteria. A word of caution however: If the sanitation chemicals contain phosphates (the “p” being “phosphate” in ATP) and the chemicals are not sufficiently rinsed off of equipment surfaces, then the ATP swab results will naturally be consistently over the action limits that a company has deemed as acceptable.

Allergen swabbing is not a measure of microbial sanitation, but again, if the cleaning for microbial contamination is insufficient it’s pretty much a guarantee that the allergen proteins, if present, will remain. Environmental monitoring has to include the presence of allergens within the facility if allergenic ingredients are used. If gluten is the allergen of concern for example, the monitoring program needs to include ancillary areas of the production zones like walls, overhead structures, air ducts and air filters, and other product contact surfaces on adjacent equipment and in Zones 1 and Zone 2.

RS: If a company gets positives in its hygiene monitoring, what do you suggest as a corrective action?

CC: How a company reacts to a positive should be dictated by where the positive is found. Unless the company is doing ATP swabs, non-specific genetic performance testing, indicator organism swabs, or protein swabs on Zone 1 sites, finding a positive swab implicates finished products, while a Zone 2 or Zone 3 positive may not have a direct impact on the finished product. A Zone 1 positive for a pathogen should at a minimum indicate that the finished products manufactured since the last break-and-clean should be placed on hold.

This also assumes that the company has a hold-and-release program in place. The dilemma some industries face (produce for example), is the shelf life of the product dictates that almost immediately after packaging the product is into distribution—often before results are available. The response to that situation is the company should have a well-founded, extensive sanitation program, environmental monitoring program (EMP), and one heck of a Work in Process testing program with rapid methods that are: 1) reliable, 2) recognized reliable and applicable to your matrix, and 3) being used effectively to provide the warnings before the product gets out of the control of the company.

FDA has always taken the following approach: You cannot test enough samples to prove the product is not contaminated or test your way out of a problem. This is basically why most companies do not test for the pathogen but rather test for an indicator that does not incriminate the product. Keep in mind that by not testing Zone 1 sites, it doesn’t mean the product does not represent a potential health hazard in the marketplace. Should that product be associated with an illness outbreak, there are severe consequences to:

• Failing to keep the product safe;
• Having a paper trail that indicates you knew, or should have known, there were potential issues associated with the finished product based on the Zone 1 swab result, or lack thereof; and
• Testing the product, finding nothing in the few samples you tested, and assuming that the rest of the “untested” production was acceptable.

Finding a positive environmental swab result, regardless of the Zone, still requires the offending area be cleaned and that subsequent swabs are negative. I will also add that if the remedial actions and result aren’t documented, then you didn’t do them.

The Food Safety Modernization Act (FSMA) has expanded the swab zone to be a 12-inch-by-12-inch area. The increase in size represents an increased potential of finding a positive, and that is exactly the point of any well-designed environmental program. John Butts, PhD, one of the foremost authorities on Listeria and environmental sampling, preaches the Seek and Destroy mission, which is the fundamental foundation of every environmental swab program. Seek out the niche places that harbor the offending microorganisms and adjust the sanitation programs and environmental surveillance to destroy that harborage. FDA expects:

• A positive environmental swab to be attacked and eliminated;
• Negative results for a minimum of three consecutive swabs be conducted on separate dates;
• That the once-positive site be monitored and continually swabbed for at least six months; and
• Documentation, documentation, documentation!

Positive environmental swab results are telling you something, and you need to listen. A positive result in a drain that is cross connected to other drains tells you all the drains are potentially positive, and cleaning that one single positive in no way ensures you’ve eliminated the source of the problem. Establish the fact that you have a drain cleaning program and use things like quaternary-containing socks or appropriate biocides throughout the production day to minimize the chances that aerosolization of the drain water is not allowing pathogens to become airborne. Having a intermittently positive drain may also indicate that your cast iron drain pipe is harboring a biofilm and continuing to put chlorine and other harsh chemicals down the drain in an attempt to eliminate the problem is actually making it worse.

The corrective action to consider is to isolate the entire drain area with floor-to-ceiling polyethylene and sandblast the corrosion off the inside of the drain. Once the drain is again smooth, a metal epoxy coat should be applied to the inside of the drain to prevent further rust development and/or pitting. Consider inserting a cleanable, stainless steel insert that extends significantly down into the drains.

Many companies will expand the swab site following a positive environmental sample. This vectoring-out concept will keep reaching further away from the initial positive until the positive detections are no longer found. In many cases, this can be several feet to several yards from that original finding, but this is the definition of Seek and Destroy.

One effective tool in eliminating pathogens is the use of silver ion-containing compounds. I find PURE Bioscience is helpful in eliminating Listeria and Salmonella from environmental niches.

RS: Should companies routinely do air testing of any sort? Do you have suggestions for the best means to do so?

CC: Air testing should be an integral part of an effective environmental program. All air sampling programs should include a sample of the environmental air outside the facility as a baseline. Granted, it will vary day to day and season to season, but when it is done in conjunction with the samples being taken in the production area, it will give a perspective as to how effective the air filtration system is.

Similar to the swab results, air sampling is telling you something. If you investigate, you might find the excessive counts in the facility in comparison to outside air indicate that the PM for changing filters is not occurring at the frequency the plan requires. Maybe there is a tear in the filters or there are no filters; I encountered both situations during plant visits to determine the high rate of mold contamination of finished products. The air sample program also indicated that access doors directly across from the filling lines were left open far too long or too often, and the dust and debris from a neighboring non-food manufacturer were infiltrating into the food plant’s production areas.

The very best method for air sampling is to purchase equipment that actually pulls definable volumes of air into the unit and impinges the targeted microorganisms onto differential growth media. The results can be expressed as count per “X” liters of air or converted to counts per cubic foot.

Many companies continue to rely on air exposure plates. While it can be a reasonable indicator of air quality, realize the downside to the method is that results are obtained only when a random spore or microbe happens to settle on the open plate of growth media. Not very scientific, but if the plates are exposed in areas of high pedestrian or vehicular traffic, or directly under an air exhaust vent, the data can still be valuable and indicative of a need to initiate corrective actions.

RS: What steps should companies take to develop an EMP? Should they do it in-house or go outside?

CC: The steps companies need to take before designing the EMP start with a comprehensive risk assessment of the process, the raw materials being used, the product being manufactured, and an assessment as to whether the “category” of the product has been recalled or implicated in a foodborne outbreak. The entire management team needs to be on board with the program, the implications, the responsibilities of each department, and the fact that FSMA requires the environment be monitored. This is not just another “Oh there goes QC again!” program. A proactive environmental program requires every level of management from the very top down to be engaged in the goals and execution of a sound EMP. It is also not a bad time to engage the corporate or outside legal counsel with the intent of the program and how Zone 1 swabs are handled or not conducted at all.

Does the process have a kill step? Should it and could it have a kill step? Does it have something that could be or should be a kill step? Blanching might be considered a reduction step or in some corners a kill step. If you are applying a heat step to the product and the product still contains pathogens, there’s a problem. You have re-contaminated the product through the environment, unclean equipment, handling practices, or whatever. If the product is manufactured under conditions whereby it may become contaminated, FDA and other regulatory agencies will hold you accountable.

Getting a qualified consultant in to provide onsite assistance in evaluating the program and suggesting improvements or even deletions to a program can be a valuable tool. It has always been my opinion that the program belongs to the company and the company must be responsible for executing the EMP. It is not something to pass off to a third party. It is imperative the company understands and completely owns the program.

Stier, industry editor for Food Quality & Safety, is a consulting food scientist with international experience in HACCP, plant sanitation, quality systems, process optimization, GMP compliance, and food microbiology. Reach him at rickstier4@aol.com.

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“If you cannot define what you are doing as a process, you do not understand what you are doing.” — W. Edwards Deming

The purpose of this article is to share over 30 years of best practices developed in the area of environmental pathogen control. The focus is Listeria, but the practices and principles apply broadly to organisms harbored in our environment.

Many of these best practices were learned at some expense, many failures, and just plain tenacity. There are no silver bullets, but experience has shown that microbiological control of food processing environments can be attained. Every plant is different because the inherent microbiological risks are different even though equipment, procedures, processes, and products may be the same.

A Basis for Process Control

The theory of food safety process control has its basis in risk identification, science, and management. The challenges of environmental microbiological process control are daunting because there is no kill step to intervene. Root cause analysis produces three primary results:

Pillars of Control

1. Eliminate harborage sites in exposed product areas.
2. Control transfer of the organism.
3. Deploy process management techniques to control the environment.

Persistent resident pathogen strains must be removed from the exposed product production process even if there is not a kill step in the product production process. The Seek and Destroy Process started as an investigative method to assess the sanitation of and locate harborage sites in equipment. Today, it represents the totality of establishments’ overall microbiological sanitation process control efforts. This includes verification of control as well as measurements of process control. Most companies producing ready-to-eat (RTE) products deploy a pathogen environmental monitoring (PEM) program. Typically, sampling occurs during production with the intent to verify the absence of the organism. The PEM is an effect measure and trailing indicator of risk.

Verification monitoring program. This is a routine program to verify the effectiveness of the sanitation process control program that includes sampling of Zone 1, 2, and 3 environmental sites in the RTE area. This program is used for regulatory compliance.

Monitoring of verification sites detects the organism as it is being moved from its harborage location to a contact surface or the product. Verification sites are surfaces that are exposed during the normal operating conditions and are likely to serve as transfer points (i.e., they are located in transfer pathways). If an exposed surface is suspected to be a harborage site, then preoperative sampling should be used to measure the effectiveness of the sanitation process. Sanitation effectiveness of exposed surfaces needs to be validated with preoperative sampling then monitoring (APC) to verify effectiveness. Verification type sampling is used by USDA Food Safety Inspection Service in its RLm events as well as FDA in its “Swabathons” sampling events.

The S&D Process is a method for not only verifying the effectiveness of the sanitation process control program, but also sampling to measure preventive controls such as investigative (not-for-cause) sampling to define levels of disassembly, identification of indicator sites, qualification of new equipment, measure effectiveness of hurdles and barriers, and measurement of potential risk from Zone 4 areas.

Engage Your Employees

Figure 1. Classical Pathogen Environmental Monitoring
Image credit: FoodSafetyByDesign, LLC

The development and sustained deployment of best practices requires employee engagement—teamwork is the pathway to success. I strongly encourage the development of a team to be the responsible and accountable force to implement and deploy environmental control best practices at each plant site (see Figure 1).

Our team is called the “Seek & Destroy” Team. Below are our model team charters using the elements of purpose, methods, and the results expected.

Team meetings. These meetings are not committee meetings to discuss why GMPs are not working. Lengthy notes are not expected nor wanted. Instead the focus is on action taken to accomplish the results expected.

Task team leaders report progress and identify any roadblocks to success, which become key issues for resolution. These may be solvable within the team (vested authority to make change is a critical component of each team member’s responsibility); those that cannot must be addressed by team leadership, or plant and/or corporate management.

Action taken on roadblocks is reported in the team’s action log or action register. Transparency and communication of solutions to roadblocks and best practices implemented are needed to reinforce the preventive mindset of the organization.
Management, quality, and maintenance must all hold one another accountable for timely action on roadblocks, and each has a specific role to fill.

Figure 2. Seek and Destroy Mission
Image credit: FoodSafetyByDesign, LLC & Land O’ Frost

1. Management’s role: Management must support team training and provide facilitation when needed. Team members’ time must be allocated appropriately—this is another reason to keep the scope very narrow and address the most significant risks. The management systems of SOP, SSOP, operational procedures, and work instructions must support the documentation, training, and implementation of changes made by the team. In addition, management must not let the team “boil the ocean”—focus and execution are keys to success.
2. Quality’s role: Audits are designed by quality management to recognize changes made and to hold gains.
3. Maintenance’s role: The maintenance PM system is most often the ideal way of managing simple changes. The team leader and maintenance/engineering members can input and create work orders to address the types of problems that are encountered. Periodic infrastructure cleaning (PIC) and periodic equipment cleaning (PEC) are often best managed with the maintenance PM system.

Teams and teamwork best practices. It’s a good idea to rotate team leader and team members to create greater buy-in within the workforce. Take pictures and tell stories to onboard and engage new team members. They will spread and be used as a basis for the normal and accepted behavior.

Be sure to keep the team charter simple—two pages maximum. The charter should identify the team as the accountable body within the facility to define and implement process control measures. Management must support this concept and approach, and provide resources.

The determination of results expected is broken into smaller tasks. Assigned task teams are typically led by an S&D Team member. Task teams are small but employ key affected parties for solutions and implementations. The implementation of recognized best practices eliminates needless research and firefighting.

Teamwork enables the plant organization as a whole to have a much deeper understanding of “why” certain procedures exist as well as how to follow data and to use it to hold gains. “Why” is a driver of the process—a key to sustainability.

Eliminate Harborage

Hollow rollers have been and continue to be one of the greater nemeses of the food industry. The conveyor picture is from Bruce Tompkin, PhD (retired from ConAgra Foods).

A growth niche is defined as a location that supports microbiological growth and is protected from the sanitation process; it is characterized by high microbial counts after normal cleaning and sanitation. A harborage site is defined as a growth niche that contains the pathogen or its indicator. (For a complete list of Environmental Monitoring Operational Definitions see the 3M Environmental Monitoring Handbook 1st Edition.)

The slide image has been used in the (North) American Meat Institute’s Listeria Intervention and Control workshop for almost two decades. The conveyor picture is from Bruce Tompkin, PhD (retired from ConAgra Foods). This is classic because hollow rollers have been and continue to be one of the greater nemeses of the food industry. A classic mode of contamination and recontamination occurs during every cleaning cycle during the initial rinse. The rinse down and removal of product debris unfortunately enables food, water, and microorganisms to penetrate the hollow member, making the bacteria protected from the cleaning and sanitizing chemicals. Further rinsing only provides more water for growth. Land O’ Frost and I found the depth and degree of penetration is directly correlated to the force of the rinse water. High pressure used during sanitation is a major cause of sanitary design issues becoming growth niches and harborage sites.

No Niches. According to (North) American Meat Institute’s (N)AMI’s Equipment Design Task Force, “All parts of the equipment shall be free of niches such as pits, cracks, corrosion, recesses, open seams, gaps, lap seams, protruding ledges, inside threads, bolt rivets and dead ends. All welds must be continuous and fully penetrating.”

The method to identify growth niches and harborage sites is the Seek and Destroy investigation, which is used to find pathogenic growth niches, find potential growth niches requiring monitoring and control, define normal level of disassembly, define periodic deep levels of disassembly, define the frequency of periodic deep levels of disassembly, qualify a new piece of equipment (usually, run for 90 days then conduct Seek and Destroy Investigation); validate effectiveness of equipment cleaning protocol; and validate effectiveness of intervention applied to a piece of equipment (heat treatment or other method).

The sanitary design of the equipment during disassembly may be evaluated using the (North) American Meat Institute Equipment Design Task Force Checklist or another method.

In a Seek and Destroy Investigation:

1. Pre-number or pre-code sample collection bags.
2. Take a picture of the bag to indicate the next sample site to be taken.
   1. Get a distance picture to locate the site within the plant area. Take several more pictures up to a closeup of the site itself.
   2. Document the name of the site. Typically a maintenance person is the best resource for properly naming sites.
3. Repeat step 2 with each consecutive site

Understanding Movement

The movement of people, equipment, product, and materials during production operations provides motility for organisms—they move along a pathway by vectors from transfer point to transfer point. Movement from a harborage site also occurs deep within equipment or facility to the exposed processing environment. Sampling during production finds the organism moving from its preoperational state to a contact surface, the product, or a drain. The process flow of the vectors dictates the direction of movement.

Disruptive events such as rinse down at breaks even with sanitizer may physically remove many organisms from equipment. However, this activity does not eliminate the organism from the environment. Rinsing does relocate the organism, however, providing more pathways of movement.

Verification sampling during production of Z1, Z2 and Z3 pathways verifies the ability of the sanitation process control to minimize the transfer and movement of the organism.

To prevent or minimize movement, create a torturous pathway that maintains a high concentration of sanitizer on the floor and includes hurdles such as sole scrubbers between hygienic zones. Also consider captive footware, separation and segregation of transport equipment, and keeping floors dry.

Implement a Process Control for Environmental Pathogens

Figure 3. Seek and Destroy Process
Image credit: FoodSafetyByDesign, LLC

The final pillar of environmental pathogen control defines how the gains are being held while continuing the risk reduction process. The cost of pathogen sampling has and continues to drop. Pathogen sampling of verification and indicator sites are composited. History and data analysis have identified those most optimal and risky areas to sample on a regular basis. Not-for-cause investigations continue ensuring any process changes are done without increasing microbial risk. APC testing is fine tuned to recognize any shifts in the environment. Shifts that are found lead to the application of interventions and aggressive sampling.

The visual of the S&D Process as a whole is presented in the Figure 3 flow chart.

S&D Process best practices—process control (not-for-cause) investigation. The S&D Process can be conducted in situations where food safety has not been compromised. Examples include when samples are taken to find a new growth niche, find a new transfer vector/pathway, establish or qualify a hurdle or barrier system, establish a monitoring procedure or process, and assess or characterize risk of a control procedure, part of facility or process change.

Investigations can also be triggered by an indicator site positive. This becomes part of the aggressive sampling following an indicator out of control observation. These indicator sites are strategically located in close proximity to a known growth niche, barrier or hurdle. Movement of the organism from the indicator site through a verification site or area would be required before violation of food safety. These indicator sites over time measure the strength of the barrier or hurdle or the effectiveness of the management of growth niches.

In addition, a Seek and Destroy Investigation can be conducted on a new piece of equipment to develop sanitation methods and identify potential areas of risk and on a piece of equipment to define the normal and periodic deep level of disassembly.
Investigative sampling to identify optimal locations for placement of indicator sites in either Z3 or Z4, and measurement of risk in Z4 area are also acceptable.

Indicator sites. Indicator sites are the measurement system for a microbiological process control. They are “risk-based” indicators of special causes or process shifts in the environment.

Ideal indicator sites include locations close to the growth niche that can identify an active growth niche, locations that can identify suspect organisms before they become attached to or imbedded within the equipment, Z4 to Z3 Transfer areas, and Sanitary Facility & Equipment Design issues.

Post rinse. Post-rinse sampling is an indicator for potential risk. Positive post-rinse sampling is not an indicator of a food safety hazard, however. Typical sites are below the product line and in areas that tend to collect spatter from the rinsing process (e.g., machine sides, legs, support structure, floor wall juncture). Detection of the organism does not mean there is a harborage site within the scope of the sampled area. Positive post-rinse samples will typically trigger aggressive sampling or not-for-cause investigative sampling. Post rinse 10 days in a row.

Sample large areas that collect “spatter.” Composite sampling is acceptable. Positive results will direct investigation team to a line, pair of lines, or section on a line.

The S&D Process quick tips.

• Measurement system
  • APC to manage growth niches
  • APC at Preop to measure effectiveness of sanitation
    • Expect 99 percent large area swabs (Plant KPI) to be < 100 cfu (total area)
• Continuously seek indicator sites
• Increase percentage of indicator sites to verification sites by adding indicator sites as the process evolves and data is collected
• Reward finding positives
• Seek and Destroy Investigation on a piece of equipment that has been in operation without any linked verification positives to measure the effectiveness of sanitation methods below the normal level of disassembly

Maturity Models

Maturity models are used in the S&D Process to define the stages or levels of control attained. The stages include Awareness, Enlightenment, Preventive, and Predictive.

Awareness & Enlightenment are characterized by repeated positives in the same general areas: firefighting and a failure to find and eliminate or manage the harborage site(s). Failure to effectively use or deploy preventative practices keeps the establishment in a “firefighting state.” In this state, management promotes not getting to the root cause and rewards solving the same problem over and over again.

The S&D Process moves the establishment along the journey from the Awareness Stage to the Predictive Stage. The establishment transcends to the Preventive Stage when harborage sites are eliminated through redesign or managed with an intervention capable of eliminating the pathogen from the harborage site. The Predictive Stage evolves as data is used to predict when to apply interventions and other more aggressive preventive controls.

I see the elements of our maturity models changing as technological advances occur in metagenomics, rapid methods, and broader application of whole genome sequencing. These technologies are reducing the time for identification of outbreaks as well as detecting smaller events. Time compression is and will continue to occur at the processor level to identify, eliminate, or manage harborages.

Dr. Butts, a member of Food Quality & Safety’s Editorial Advisory Panel, is founder and president of FoodSafetyByDesign, LLC, and advisor to CEO Land O’ Frost. Reach him foodsafetybydesign@gmail.com.

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