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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Editors’ note: This is part 1 of a three-part series on environmental monitoring. Parts 2 and 3 will publish in the October/November and December/January issues of FQ&S.

It’s business as usual in the sanitation department during routine operations. Procedures change when there are out-of-specification (OOS) results from environmental sponge tests—or do they?

Reclean, resanitize, and retrain are three common approaches for corrective actions. During this time, it could be argued that the same sanitation procedures may be conducted, regardless of the circumstances—just more often.

This will be a three-part series. Part 1 will explore the first steps involved in implementing a cleaning/sanitation process: the selection of chemicals and developing a master sanitation plan. Part 2 will discuss differences in cleaning/sanitation procedures when normal conditions are not occurring, such as when there is an OOS, maintenance, or construction event. In Part 3, we’ll cover procedures for use during extenuating circumstances such as complex maintenance procedures, construction, and pathogen investigations.

During the recent coronavirus outbreak, food companies have augmented sanitation activities, focusing on the well-being of employees. While dealing with these unprecedented times, manufacturers should not lose sight of the sanitation procedures important to the maintenance of sanitary conditions in the production of products.

A solid program starts with the development of two main components: sanitation standard operating procedures (SSOPs), based on four cleaning dynamics, and a master sanitation schedule outlining what is cleaned or sanitized, and how often.

Sanitation Standard Operating Procedures

The goal is to define the activities encompassing cleaning and sanitation. This is a multi-stage process, and the documents will evolve over time. First, consider developing general cleaning instructions to efficiently capture company policies. Second, identify soil components for detergent selection,

General cleaning instructions. For efficiency, combine common/recurring SSOP practices (training, storage, responsible parties, chemicals and concentration, and personal protective equipment [PPE]) into general cleaning instructions that are performed prior to or during all circumstances (routine operations, OOS, extenuating circumstances) where cleaning and sanitizing occur.

Identify soil components. Detergent selection is driven by functionality, which is driven by the physical attributes of the soil (products/ingredients) and water. Specifically, identifying the pH, mineral content, and type of organic soil will lead to the identification of the best detergent for their removal.

The pH of water is typically between 7 and 8, which usually does not negatively affect the detergent activity, but it could affect sanitizer selection. The greater deviation of pH from neutrality (pH 7), the greater the potential exists for detrimental chemical effects. Product pH will have similar repercussions. Acid soils, such as citrus, will react with alkaline chemical products, reducing their effectiveness, and vice versa.

Water chemistry should be taken into consideration at the facility. Water hardness may affect the ability of the chemistry to perform by reducing detergent foam formation or forming scale in clean-in-place (CIP) systems. Sometimes, minerals are embedded in a complex matrix of minerals, fats, and proteins and are termed milkstone, beerstone, and waterstone.

A film on a piece of equipment can be identified as mineral by applying an acid to the surface. If the film is removed, the soil is a mineral. Mineral deposits and film can usually be prevented using alkaline detergents that contain sequestering or chelating agents, or an agent that binds to the mineral, keeping it in solution so it is easily washed away during a rinse step. Alternatively, mineral deposits may also be removed by periodic applications of an acid, if the water does not have a high silica content. When hot water is used, if the water is hard (>4 grains per gram of calcium carbonate), there is a greater opportunity for it to precipitate (fall out) from the water and adhere to surfaces, causing a film. This film can serve as a base onto which bacteria can adhere and act as a protectant. This increases the difficulty of their removal and shields them from sanitizers.

Organic soils (carbohydrates, fats, oils, proteins) require different methodologies for cleaning. For best results, all matrices should be identified prior to chemical selection and cleaning dynamics to SOP development.

• Carbohydrates. Some carbohydrates, such as sugars, may only require water for removal, while others, such as starch, may need a detergent. A cold water pre-rinse is best for starchy soils because a hot rinse can cause the soil to stick to the surface, making it difficult to remove.
• Oils and fats. Oils and fats may necessitate the additional chemical reactions of saponification or emulsification for removal. Saponification, conversion of fat/oils to soap and alcohol, occurs by the addition of alkaline (caustic) and hot water. Emulsification is the suspension of a typically immiscible liquid in another liquid. The process breaks down the surface tension of fat/oils, allowing for mixing of water. Once suspended, the fats/oils are further broken into small fat globules, allowing more mixing into water and permitting easier elimination through rinsing.
• Proteins. Proteins are generally the most difficult soils to remove. Routine cleaning of protein processing equipment is best achieved through the addition of chlorine to an alkaline solution. The chlorine peptizes (breaks down) proteins into smaller amino acids, facilitating removal from the system. Although effective, it is not recommended in all applications, such as RO membrane systems or evaporators. Additionally, when proteins are heated, they unfold (denature) and will adhere to a surface. In this state, they can be difficult to remove. Cold residues are easier to purge.

Once the pH, mineral content, and organic content of the soils are identified, the chemistry of the cleaning detergents may be determined and the best-fit product selected. In choosing the chemistry, compatibility with surfaces must be considered. While soil identification might lead to a strong acid product, the equipment may not be compatible with that selection, although some products may have choices within their lineups (e.g., soft metal safe).

Cleaning Dynamics

Once detergents are chosen, the procedures for their use will depend on three additional components: application time, water temperature, and mechanical action. Together, the four components are cleaning dynamics devised by Herbert Sinner in the 1950s and dubbed the “Sinner’s Circle” (See Figure 1). A balanced cleaning process requires a percentage of the components totaling 100 percent. If one component is changed, the others must increase or decrease to balance.

Product labels indicate typical time, temperature, and concentrations, but adjustments may be needed for time constraints or lack of available mechanical action (Figure 2). Increased CIP turbulent action increases solubility of most materials, rendering them easier to remove. Generally, the temperature range of cleaning is between 90°F and 185°F. Temperatures above 185°F may induce reactions that bind proteins more tightly to a surface, and in those below 90°F, (butter) fat remains a solid. If cleaning fats, the minimum effective cleaning temperature is 5°F higher than the fat melting point. A general rule of thumb is that cleaning temperatures should be 5°F to 10°F higher than the processing temperatures.

Mechanical action will be dependent on the type of action performed. Hand or manual cleaning may require an extended time period to ensure the removal of all matrices. CIP fluid flow applies the force or turbulence as the mechanical action. A fluid velocity of five feet/second for 1.5- to 2.5-inch pipes gives the minimum result for effective cleaning. For three-inch lines or larger, eight feet/second is recommended. This velocity results in the amount of flow necessary to achieve turbulent flow instead of laminar flow in pipes.

Time is a valuable cleaning process resource. Limiting the time needed for cleaning will only lead to later implications, such as ineffective sanitizer action, because without removal of soils, the sanitizer will not reach the microbial cell surface, causing its destruction.

While increased detergent concentration may give the appearance of improved soil removal, there is a minimum amount for effectiveness and an economical amount. Too much detergent may not be rinsed effectively, leaving a residue.

Sanitation

Only after the complete removal of soils can sanitizers be effective for microbial elimination. Selection of sanitizers depends on the nature of the processing environment and biological hazards identified through the Hazard analysis and critical control points (HACCP) risk assessment. Sanitizers follow the same dynamic wheel as cleaning, except soil removal is substituted for mechanical action. Sanitizer application must be conducted at the strength and time listed on the product label, especially for food contact surfaces, as the EPA administers the registration of chemical sanitizers and antimicrobial agents for use on these surfaces.

Sanitizers include chlorine, alcohol, quaternary ammonium, and peroxyacetic acid-based compounds. Each sanitizer has proven efficacy against a broad spectrum of microorganisms and has a different mode of action, which leads some manufacturers to rotate sanitizers. For example, chlorine dioxide is effective against Gram-positive and Gram-negative bacteria but not as effective against yeasts. An oxidation mode of action (chlorine) may be counteracted by cell lysis (quaternary ammonia).

Master Sanitation Schedule

Within each area, items cleaned and sanitized are noted on a master schedule serving as a checklist or accounting of when items are cleaned and by whom. You can view a sample schedule on our website at foodqualityandsafety.com.

A cleaning and sanitation program involves a chemical analysis of the soils to select the best chemical(s) for cleaning. Sanitizer selection includes the HACCP risk assessment and adds equipment composition to safeguard against damage. Under normal operations, the master cleaning and sanitation can be followed as it is written. In Part 2 of this series, we will address necessary alterations in the cleaning and sanitation regime when a plant experiences OOS results, equipment maintenance, and/or construction.

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 post Bridging Environmental Monitoring Program Results with Sanitation Practices appeared first on Food Quality & Safety.

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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No evidence so far shows that SARS-Cov-2 can spread through food. While comforting, that fact has not prevented major changes in food supply chains, customer demands, and safety strategies since the COVID-19 outbreak.

In March 2020, the European Food Safety Authority (EFSA) declared that “experiences from previous outbreaks of coronaviruses … show that transmission through food consumption did not occur. At the moment, there is no evidence to suggest that coronavirus is any different in this respect.”

Fast forward from that statement to today, and there’s still no evidence of foodborne transmission. However, consumers have been barraged by news and social media messages about how they could contract the virus, and many now distrust any supply chain, including food. As the world looks toward returning to a more normal, working, and economically thriving society, monitoring processes for cleanliness have never been more important.

Consumer Contamination Fears on the Rise

A recent Nielsen Global Intelligence poll showed that a sizeable number of respondents did not trust the source of fresh produce, meats, and other foods. The consultancy Campden BRI group reported that retailers are getting more questions about the national origin of their ingredients and the length of time a virus can last on surfaces, and that there is a general lack of understanding of how viruses are transmitted and what basic food hygiene steps have been in place for years. A smaller but still worrisome number of people claim to have taken to washing their fresh food with soap and water, a practice that is strongly discouraged by the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), and other public health authorities.

At the same time, the food industry has faced major adjustments in response to the virus outbreak. Sales of shelf-stable foods and drinks have surged in the United States since March 2020, including an 84% increase in powdered milk during one week in February, according to Nielsen. At the same time, plant based, shelf-stable milk sales shot up 323 percent. Sales of bread, eggs, rice, beans, and frozen foods have also increased, while interest in fresh produce has dropped or has remained steady. In addition, since most restaurants are closed to sit-in dining, foods normally shipped to them have been diverted to grocery stores and consumer markets, creating new supply relationships and, with them, new challenges in maintaining safety. USDA has had to relax package labelling requirements to ensure a supply of food to grocery stores.

Start—but Don’t End—with Handwashing

Standard hygiene practices such as washing hands, cooking meat thoroughly, and avoiding potential cross-contamination between cooked and uncooked foods are still the mainstay of food safety. But processors, retailers, and restaurants alike will have to do much more to prove to a suspicious (and potentially fearful) public that they can safely buy products.

“Consumers will be seeking greater assurance that the products they buy are free of risk and of the highest quality when it comes to safety standards and efficacy, particularly with respect to cleaning products, antiseptics, and food items,” wrote Regan Leggett, executive director of Nielsen, in a March 2020 report. “In the short term, this intensified demand from consumers will require manufacturers, retailers, and other related industry players to clearly communicate why their products and supply chains should be trusted. In the longer term, and dependent on the eventual scale and impact that COVID-19 has on consumer markets, it may speed up a re-think on how shoppers evaluate purchases and the benefits that they see as the key factors to consider.”

Regardless of the viral outbreak and its impact on food supply management, risks from bacterial, fungal, and other contamination have not disappeared. One in six Americans get sick from eating contaminated food every year, and FDA and USDA continue to report recalls and alerts about microbial outbreaks. Approximately 3,000 Americans die from food contamination each year, and illnesses cost businesses more than $15 billion a year.

ATP Maintains Current Safety, Helps Build Consumer Trust

Many methods help detect and remove the threat of foodborne infection, including visual inspections, cell culture, and whole genome sequencing. But these all come with disadvantages, ranging from the incompleteness of visual inspection, the expertise (and expense) needed to perform sequencing, and the time necessary to retrieve cell culture results.

One method of hygiene monitoring—detecting adenosine triphosphate (ATP), the energy-delivering molecule in every living cell—is a proven, simple, cost-effective, and rapid first line of defense in food safety monitoring and hazard detection.

Because viruses do not contain ATP—instead they hijack other cells’ metabolic structure and reproduce using the host cell—ATP monitoring systems cannot detect viruses; however, reducing the possibility of bacteria and other host cells from surfaces reduces the risk of contamination, including viruses. In addition, because SARS-Cov2, like other coronaviruses, is susceptible to strong disinfectant chemicals, a rigorous and thorough cleaning plan can help defend against COVID-19. In fact, CDC and WHO have advised businesses specializing in food, as well as airlines, hospitality companies, and offices, to adopt a more aggressive cleaning and disinfecting program. The EPA, along with providing a list of disinfectants approved for use against SARS-Cov2, has also advised a three-fold reduction in contamination levels on all surfaces that contact products or members of the public.

Ideal Monitoring Systems

For food safety professionals, ATP monitoring delivers on several areas that they have prioritized—faster time to results, accurate readings, reproducibility, actionable data, simplicity of use, lower cost per test, and reliable equipment. Instruments like the Hygiena EnSURE Touch Monitoring System deliver ATP results, expressed in relative light units (RLUs), in 10 seconds.

ATP monitoring instruments are invaluable for their ability to fulfill these needs, and they generate reports, graphs, and charts that help management make cleaning improvements, train personnel, and clearly illustrate performance. Once testing has begun, results can be immediately analyzed to give feedback on cleaning performance and areas for improvement. This is crucial for adjusting methods to meet new supply chains and customer demands. A good ATP system should be easy to use and should include:

• Wi-Fi capabilities and wireless sync technology for secure data transfer to analysis software.
• Ample collection and storage of important testing data such as sample location, line name, cleaner used, date and time stamped, secured access, and surface type.
• Built-in screen sharing to train remote teams; ATP has been shown to be a valuable tool for education of staff and a powerful way to reinforce a facility’s cleanliness and safety culture.
• A responsive shatter-proof touch screen that works while wearing gloves; this ruggedness expands the range in which it can be used.

Just as important as the measuring instrument are the test devices used to collect samples. These need to be convenient to use, have a low risk of cross-contamination, and be able to effectively collect residues. Test devices should be integrated, should be all-in-one and ready to use, and should contain liquid-stable reagents. Test devices should be available for solid surfaces and for liquid samples such as CIP rinses and other water samples. They should have a simple activation step and tolerate ambient temperature abuse.

Government and Public Expectations

USDA and FDA do not endorse a specific technology or brand-name product under the implementation of FSMA, but, like nearly all government agencies, they do mention in certain guidance documents the array of sanitation/cleaning monitoring technologies available, including visual inspection, bioluminescence tags, and ATP detection.

The agencies want to see actions taken when data is out of specification and documentation of efforts to prevent contamination, adulteration, allergen exposure, and other aspects of food safety. How efforts are carried out will vary with each food manufacturer, distributor, farmer, or other part of the supply chain (including import/export).

It’s important to emphasize that ATP does not directly measure any specific microorganism (like bacteria, fungus, or molds) any more than it can detect a virus. Nor is a “zero” RLU reading particularly helpful by itself, because machines and surfaces are different and baseline values need to be set. However, as consumers become more selective in what food they purchase, quantifying and validating your cleaning efforts will be essential to maintaining a healthy supply line and, ultimately, to your brand’s success.

Mora is western sales manager for Hygiena. Reach him at fernando@hygiena.com.

The post ATP Monitoring Can Help Adjust to Food Safety’s New Future appeared first on Food Quality & Safety.

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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The significance of environmental monitoring to verify effectiveness of sanitation programs and minimize or prevent pathogen food contamination is well recognized. Foods, especially ready-to-eat (RTE) foods, can be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes through cross-contamination with the plant environment, including contact surfaces, unclean equipment, floor, drains, air, and water. The FDA and USDA expect the industry to have a hygienic zoning and effective environmental monitoring program designed to reduce the potential for contamination.

Many novel rapid and automated methods for microbiological testing of the food plant environment are available commercially and new methods are being introduced regularly. Their acceptance by the industry, however, depends on several factors, including speed (time to result), specificity, selectivity, accuracy and reproducibility. Other things to consider are ease of use, cost, reagents, consumables, need for training, the availability of technical support, and regulatory acceptance.

Microbiological tests designed for detection or enumeration of indicator organisms or environmental pathogens using swabs or sponges and plating are used to obtain quantitative verification of the effectiveness of sanitation procedures. These tests, however, can take days to yield results. Indirect methods like adenosine triphosphate (ATP) testing are a popular option for hygiene monitoring and verification of cleaning and sanitation.

Unlike other methods, ATP testing provides results in seconds and is sensitive, quantitative, effective, and simple. Microbes and product residue contain ATP, an indicator of biological residues that can be easily detected to measure cleanliness because effective cleaning and sanitation remove all ATP from the food plant environment and food contact surfaces. A positive ATP test is indicative of unclean or not adequately clean surfaces.

Many food processors who found hygiene and environment monitoring by swabbing and microbial counts tedious, time consuming, and expensive are considering the ATP bioluminescence system for hygiene monitoring. The proliferation of new kits and luminometers has provided several options for the food processing industry but can cause confusion about the capability and proper application of the technology. The following are some of the main criteria and considerations to keep in mind when selecting an ATP bioluminescence system:

1. Intended Purpose: ATP systems are designed to provide a quick idea about the cleanliness of food contact surfaces such as equipment, conveyors, pipelines, pumps and valves, or drains. They are NOT intended for determining a level of residual microorganisms (e.g. < 100/in² ) on a food contact surface.
2. Speed (time to result): All ATP systems currently available on the market provide “rapid” results—the reading time may vary, but a reading is obtained in a few seconds. It is also important to consider the time required for an activated swab to be read in the luminometer. Other factors, such as the number of sampling sites per shift, or per day, the location of sampling sites, and operator-related factors will influence the overall speed in obtaining results.
3. Reagents and Swabs: The ATP bioluminescence systems employee swab devices already containing rinsing buffer and luciferin-luciferase reagent. The convenience of the swabs is obvious. However, reagent stability, shelf-life expectancy, and storage temperature requirements are important considerations. Also, consider if you have to “read” the test immediately after swabbing or can allow some time lapse before reading. You should also look at the quality control of swabs in terms of background reading (if any) and the batch-to-batch variation.
4. Instrument: ATP hygiene monitoring systems are based on one of the two photodetection technologies: photomultipliers and photodiodes. The sensitivity, robustness, accuracy, and precision of the rapid hygiene monitoring device are influenced by these technologies. All ATP bioluminescence systems offer portability, computerized data logging, and visual readout of ATP levels in terms of the RLUs (relative light units) or “zones” of cleanliness. The ruggedness of the instrument, battery life, computer interface with other computers in the plant, and availability of a “hard copy” of the data are other important considerations when selecting a system. For a multiproduct plant, the system’s versatility would also be something to look into. Its ease of operations and user friendliness are also important.
5. Training and Technical Service: When you consider adding an ATP bioluminescence system to your plant, keep in mind the training and technical service required for transition from conventional methods. All major vendors of the instruments and kits provide some training for proper operation and maintenance, but you should try to obtain training specific to your plant and situation. Contact colleagues in other companies who may have experience with a particular ATP system to discuss their experiences. Also, technical service and responsiveness should be available following the purchase. In this regard, you may also want to access training opportunities available through professional organizations and universities as well as keep current with professional reading in pertinent scientific journals and trade magazines.
6. Cost: I would list cost as the last consideration, although it may be the first thing you ask about. The cost of instruments, reagents, swabs, etc. is definitely a factor to be considered, but many variables influence the true cost. Most luminometers and swab devices are priced competitively and may be compared easily on a cost/test or cost/swab basis, and there may be incentives provided by vendors based on the testing volume or leasing versus purchasing the hardware. You may also consider return on investment or the time it will take to pay for the instrument. Savings resulting from improvements in cleaning and sanitation of plant equipment and environment may reflect in improved quality and shelf life and less time spent managing and monitoring the cleaning process and crew.

The above criteria and considerations are, by no means, a complete list of dos and don’ts when selecting an ATP bioluminescence system. Current ATP bioluminescence methods can be very useful in verifying effectiveness of plant cleaning and sanitation, becoming a valuable part of your food safety management program and sanitation preventive controls implementation.

Remember, though: The results from ATP surface hygiene monitoring are different from those of microbial enumeration methods and are not directly correlated to microbial counts or detection of Listeria or Salmonella. ATP tests are not intended to replace environmental microbial testing, but they can be an excellent way to obtain indication of hygiene efficacy in seconds versus days.

Dr. Vasavada is professor emeritus of food science at the University of Wisconsin-River Falls and a co-editor of Food Quality & Safety. Reach him at Purnendu.C.Vasavada@uwrf.edu.

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