Pesticides are used extensively on a global scale to protect crops, ensuring they can be successfully grown, stored, and transported to meet consumer demands. The type of pesticide used varies widely depending on the produce in question, with insecticides, herbicides, rodenticides, and fungicides being the most common. A recent review by the Pesticide Action Network showed that there are more than 17,000 pesticide products currently on the market.

Solvent-based pesticides have traditionally been the pesticide of choice, but in light of growing health concerns, less toxic ionic pesticides are being more widely adopted. For example, glyphosate—an anionic pesticide—is now the most widely used pesticide in the world on GMO-engineered glyphosate-resistant crops. Recently, though, there has been growing public concern that any pesticide contamination in food could be a potential health risk, especially as pesticides can often remain in food at trace levels. This has resulted in increased attention from regulatory agencies and health researchers, who are seeking to better understand and monitor these residues.

To ensure that only minimal levels of pesticides are present in food, accurate quantification is required. Many methods exist for determination of pesticides, but gas chromatography (GC) and liquid chromatography (LC) combined with mass spectrometry (MS) are the standard techniques in regulatory test methods; however, these traditional analytical methods aren’t as effective for determining ionic pesticides, as the compounds are too polar to be retained and separated. In addition, it is difficult to maintain low baselines when analyzing ionic pesticides, making them an analytical headache. These challenges in current analytical approaches have been driving the need for more effective analytical techniques to continue protecting public health.

Taking Charge with IC-MS/MS

Ion chromatography coupled with tandem mass spectrometry (IC-MS/MS) can be used to effectively overcome the challenges faced by existing methods when it comes to anionic pesticide determination (see figure 1). Crucially, the technique is ideal for separating polar compounds and has been used to determine anionic polar pesticides such as glyphosate and glufosinate.

IC-MS/MS has a number of benefits that make it ideally suited for this application. The technique offers high selectivity and sensitivity, as tandem MS detection using selected reaction monitoring (SRM) eliminates sample matrix interference by only scanning for ions of interest. The method also provides low chemical noise, overcoming the baseline issue of GC-MS and LC-MS. With this technique, analytes are also provided in their ionic form, meaning electrospray can be used and the molecular ion retained. Further improvements in pesticide determination are enabled by the electrolytic suppressor, which neutralizes eluent and lowers the background while offering increased sensitivity for conductivity detection and improving the compatibility for MS.

Anionic samples are typically prepared for IC-MS/MS using the quick polar pesticides method (QuPPE) developed by the European Union Reference Laboratory for Pesticide Residues in Fruits and Vegetables (EURL-FV). This acidified methanol-based extraction method has been widely used and accepted for extraction of polar pesticides, according to a 2012 review published in the journal Analytical and Bioanalytical Chemistry, giving excellent results. IC-MS/MS used with QuPPE extraction provides a highly useful and sensitive approach for anionic pesticide determination, ultimately helping analytical scientists to better protect public health.

The Rise of Cationic Pesticides

Cationic quaternary amines, or quats, are a new class of ionic pesticide now gaining popularity. Unlike glyphosate, quats are permanently charged species, regardless of pH. Of these, paraquat, diquat, mepiquat, and chlormequat (see figure 2) are among the most important and commonly used.

Although ionic pesticides are generally less toxic than solvent-based ones, compounds such as paraquat and diquat are still highly toxic. Often, these pesticides are used late in the plant’s life as desiccants to kill the plant before the harvest. By doing this, farmers can bring the crops in earlier, before they are contaminated with mold during the rainy season. While this practice helps to guarantee the food supply, the late addition of these pesticides to the crop can cause problems as they can bind to the plant, creating a higher risk of food supply contamination.

The use of these cationic pesticides, and the risk of contamination, varies globally. Paraquat, for example, is a restricted-use pesticide in the U.S., and neither paraquat nor diquat are approved in the EU, but chlormequat and mepiquat are allowed. Alongside country-by-country restrictions on usage of different pesticides, the permissible quantities of these pesticides vary too. For chlormequat and mepiquat, the EU’s Maximum Residue Levels (MRLs) generally range from 0.01 – 0.05 mg/kg. These differences in approvals and MRLs mean that for products to meet the individual requirements of different countries, it is essential to be able to chromatographically resolve different ionic pesticides from each other to allow separate quantitation.

But to date, cationic polar pesticide analysis has lagged behind analysis of anionic pesticides, even by IC-MS/MS. Most notably, analysis is hindered by poor chromatographic resolution and high costs. While the permanent charge of quats makes them highly effective as pesticides, this feature also makes them highly impractical to derivatize for detection. Second, it also means they adhere, often irreversibly, to glass, metal surfaces, and particles such as clay. This leads to tricky sample preparation, and means chromatographic separation is not reproducible.

IC-MS/MS: A Powerful Quat ­Pesticide Determination Approach

With recent improvements in column stationary phases, IC-MS/MS can now be used to tackle challenging separations of cationic polar pesticides, including paraquat and diquat, which has been exceptionally difficult due to their similar structures and close m/z values for molecular and fragment ions (a difference of less than 2 a.m.u) (see figure 3).

Thanks to these advances, IC-MS/MS has been used to analyze quat pesticide levels in a range of some of the most widely consumed foods, showing promising results.

Here, we highlight two such studies: one examining cereals, and the other investigating wheat flour, baby food, and tea. In these experiments, the samples were prepared for analysis using QuPPE or adaptations of it. Overall, the IC-MS/MS method provided adequate resolution of the analytes of interest from the rest of the complex food matrix, giving more accurate results.

Cereals

Cereals are a principal component of many diets, yet the EU’s MRLs are much higher for pesticides in oat cereals. This is primarily because more pesticides are expected to be present in the produce due to higher levels used in cereal crop production. Matrix interference from complex samples makes it challenging to obtain accurate values, too, so this is factored into the MRL. With more analytical labs now using IC-MS/MS, these MRLs could be lowered in line with other produce, as matrix interference is reduced with IC-MS/MS.

Table 1. Summary of measured results and recoveries of added standard in cereal samples.

The study in question demonstrated that quaternary amine pesticides can be accurately and sensitively determined in oat cereals within 15 minutes using IC-MS/MS. Here, the sample extraction followed QuPPE and was passed through a Thermo Scientific Dionex IonPac CS21-Fast-4μm ion exchange column paired with a triple quadrupole mass detector. For determination of paraquat, diquat, mepiquat, and chlormequat, recoveries of 86% to 118% were obtained, and limits of detection (LODs) <0.1 μg/L or 0.5 μg/kg (see table 1).

Wheat Flour

Wheat flour is another dietary staple across the globe, and USDA estimates that 131.1 pounds of wheat flour was consumed in the U.S. per capita in 2019. Grain and grain products have particularly complex matrices, making samples challenging to prepare for determination. A simplified version of the QuPPE method has been used for the extraction of anionic polar pesticides, and this approach was also used for extracting cationic polar pesticides from wheat flour in the second study. Using IC-MS/MS here delivered excellent results, with apparent recoveries in QuPPE extracted wheat flour ranging from 97% to 113% (see table 2).

Table 2. Instrument apparent recoveries for four quaternary amine polar pesticides in wheat flour over a period of seven days.

Baby Food

MRLs in the EU for specific prohibited pesticides in baby food were previously set between 3–8 μg/kg; however, the European Food Safety Authority (EFSA) believes this may not be sufficiently protective for infants younger than 16 weeks of age. Yet, to date, there have been no further reductions to MRLs, as suitable analytical methods for detection with improved sensitivity are scarcely used.

IC-MS/MS can be used for effective determination of quaternary pesticides in baby food, though. Following the approach used with wheat flour (in the same study), the simplified QuPPE method can be used to prepare samples and extract pesticides from carrot baby food. The IC-MS/MS method, using the Dionex IonPac CS21-Fast-4μm ion exchange column paired with a triple quadrupole mass detector, worked extremely well, giving apparent recoveries of the pesticides ranging from 96% to 103% (see table 3).

Table 3. Instrument apparent recoveries for four quaternary amine polar pesticides in carrot food over a period of seven days.

Tea

Testing and regulation of beverages have also greatly increased over recent years. One of the most widely consumed beverages—tea—can suffer from pesticide contamination; that is, pesticides that remain in tea leaves can leach into the drink when hot water is added. Determination of these compounds is therefore essential.

To show the versatility of the IC-MS/MS method, tea infusions from both green tea and white tea were prepared as part of the second study and filtered for analysis by IC-MS/MS. The method effectively separated the four common quat pesticides, and corrected apparent recoveries were 94% to 102% for green tea and 92% to 106% for white tea (see table 4).

Table 4. Instrument apparent recoveries for four quaternary amine polar pesticides in green tea and white tea over a period of seven days.

Paving the Way for Food Safety

Quaternary ionic pesticide use is growing, which is bringing many advantages to food production and distribution. While cationic compounds have typically proved difficult to analyze, advances in ion chromatography column technology are now enabling IC-MS/MS methods that can accurately and sensitively determine them while significantly simplifying analysis.

Eventually, as such IC-MS/MS approaches continue to gain traction for the analysis of quats, the possibility opens for MRLs to be lowered. These lower MRLs will drive improved agricultural practices, alleviating concerns for consumers and regulators and ultimately improving the protection of human health.

Man is product marketing manager specializing in ion chromatography at Thermo Fisher Scientific. Reach her at wai-chi.man@thermofisher.com.

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With the constant influx of new flavors, new ingredients, new sizes, and new shapes, the food and beverage industry is constantly adapting. From changing consumer trends to sourcing and supply chain disruptions, the demand for flexibility is real. Navigating demand fluctuations and ever-changing products are not the only priorities for food manufacturers today, however—consistency and quality are also top of mind. Without these key areas, profitability can plummet.

From the onset of product ideation, food manufacturing teams must plan how to implement any new equipment and new lines needed and modify existing production to accommodate them. As with any implementation or modification, risks can arise—specifically, risks in reduced quality, reduced output, and breakdowns in safety. In a pivotal industry with a small margin for error, food producers must employ new ways to maximize their yield without risking their operations.

Reactive to Proactive

If you are implementing a new system or process at your facility and are waiting for physical testing to determine equipment readiness or discover errors, you are already too late. When design and controls meet for the first time, rework is almost inevitable. Working backward to replicate, repair, and retest results is lost time and money. Unlike some fortunate industries, the food and beverage sector must also navigate the challenge of working with time-sensitive ingredients. From the moment an error is discovered, the race is on to diagnose and repair before you encounter major product loss and break promises to your customer.

Designing and commissioning new machinery or processes entails a significant investment. Manufacturers must think proactively and leverage technology to help protect their investment. What if there was a way to virtually commission new machines, new lines, or new automation technology for faster time to market, or a way to identify potential breakdowns or inefficiencies before they occur? There is, and the answer lies in emulation.

Why Emulation?

The consumer packaged goods industry, from food production to goods manufacturing to fulfilment, is realizing substantial savings by using emulation software to optimize configurations based on digitally recreated environments that account for business needs. With advancements in visualization and training, emulation is even easier to employ and can quickly become a competitive advantage.

Specifically, emulation software can help you:

• Dive deeper with digital twins: Create a virtual model of your equipment and system to simulate your manufacturing environment for scenario testing;
• Model integrations: Predict and solve complex integration challenges before they occur;
• Demonstrate value early on: Reduce the need for physical demonstrations and the risks associated with them by performing virtual testing; and
• Build quickly: Access a resource library of standard equipment to help design a digital twin of your operations.

Risk Reduction Using Emulation

Changes in the food and beverage industry are pushing manufacturers to employ new technology and rapidly adapt automation. Each change to your operations, whether you are introducing a new product or updating outdated machinery, opens the door to additional training requirements, unexpected downtime, and/or safety breakdowns. While embracing new technology and innovation can be an overwhelming undertaking, using emulation software can support deployments and help reduce risks associated with them.

Additionally, quality and output are highly dependent on one another and are equally vital to producers. Without visibility into machine behavior, when a line changeover is needed, questions start to surface, such as:

• “Will changing the product size require new equipment?”
• “How can we ensure that the new packaging process will be successful?”
• “What impact will adding a new product to the mix have on system throughput?”

With strategic planning and the right technology, these questions can be answered before existing operations are disturbed. Simulating changeovers allows you to test and validate in a virtual space before making any adjustments. Additional efficiencies and speed can be realized by using an emulation software’s resource library to build your virtual factory floor and tailor the simulation to your unique operations. The insight gained from employing emulation helps maximize output while meeting stringent quality expectations.

Once a bottleneck is discovered or a malfunction occurs during control integration, the time to make the necessary changes to the system has passed. Unfortunately, many manufacturers find themselves in these situations, in which the changes must be made against the clock. Additionally, with supply chain disruptions and longer lead times on replacement parts, unplanned downtime can come with excess costs.

Frozen food line simulation featuring independent cart technology.

In addition to time and cost, anytime a change or reroute is needed, an opportunity for a safety issue is introduced as well. When production must abruptly stop and an operator must dislodge an unruly package, or cross contamination occurs on a line, safety is compromised. Testing your changeover in a virtual environment before implementing it could help prevent package mishandling or eliminate the need for manual intervention and associated cross contamination risks. Leveraging technology to limit intervention helps reduce risks that could impact your quality and output, and compromise safety— all of which impact the bottom line.

Engage Stakeholders in a New Way

Manufacturers across the country are feeling the effects of workforce challenges, and food and beverage producers are no exception. Between retirees leaving the organization and taking their knowledge with them and the next generation being more technology savvy from the start, there is an added benefit to introducing emulation into your operations.

For those exploring emulation options or currently using the technology, having a dynamic representation of your factory floor can help your workforce gain a comprehensive view of your operations. Being able to showcase your entire footprint, combined with the power of augmented/virtual reality, you can help get new workers up to speed more quickly. Emulation software can also be used when introducing machine changes to current employees or training an employee on a piece of equipment they are not familiar with. When a problem occurs, simulations can be created to provide a high-fidelity virtual environment with troubleshooting options so that a solution can be applied with unparalleled speed.

Why Now?

Emulation software solutions are not new, but with advancements in technology and robust 3D simulation, companies are quicker to adapt and realize their potential. Workers are also ready for innovation. Introducing emulation tools is no longer a daunting task when now, more than ever, workers are trained to work with advanced technology. In fact, many workers have come to expect it. While companies make changes to embrace more innovative and enhanced cultures, employees are also seeking better and safer workplaces. With all of the technology available at our fingertips outside the workplace, employees are not interested in struggling to use outdated technology when they come to work. Workers are ready to embrace new technology such as emulation. Are you and your operations ready?

Additionally, consumer demands are constantly fluctuating, and companies must be prepared to implement new lines, change what their technology looks like, and incorporate different machines in different ways. Applying emulation can support these changes and assist your teams in producing the high-quality goods your customers count on. Not only does the application help maintain quality and output, but it also helps mitigate unnecessary risk by reducing the manual intervention needed when scenarios are run digitally in advance.

In today’s competitive environment, companies can’t afford lack of visibility and costly changeovers. It’s time to move the needle from reactive to proactive and explore what emulation can do for your bottom line. 

Phillips is global Emulate3D business development manager at Rockwell Automation, based in Milwaukee, Wisc. Reach him at tyler.phillips@rockwellautomation.com.

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For grocers and their food distribution divisions, food shrink is a continuing issue that cuts into profits and contributes to food waste. “Food shrinkage” refers to spoiled or wasted products from distribution to a grocery store. Consumers today are also concerned about sustainability efforts, placing additional pressure on grocers and distributors to make improvements in their overall operational strategies.

In the U.S., food spoilage and waste are estimated to be between 30% and 40% of the overall food supply, according to USDA. For their part, grocers have traditionally relied primarily on inventory management solutions to reduce fresh food waste; however, new solutions are needed because, in addition to a greater focus on sustainability by consumers, the continued problem of food shrink is costing food retailers more than $52 billion annually.

Industry players are having a difficult time reducing this cost. Reducing shrink can lower operating costs by 15% to 20%, or more, Martin Gooch, PhD, chief executive officer of Value Chain Management International, told Produce Business. In retail, a 1% reduction in shrink helps improve the financial bottom line equivalent to a 4% or higher increase in revenue, simply because organizations reduce the subsidies of ineffective operations.

Food shrink also adds financial pressure as grocers must restock their shelves. More than 60% of grocers say they have had to significantly increase fresh inventory to keep up with demand, according to a whitepaper by Shelf Engine, a ­Seattle-based technology firm focused on food waste.

Improving On-Time Deliveries to Reduce Spoilage

There may be other ways to reduce food shrink, and a closer focus on improving on-time deliveries among food distributors may help. Many grocers leverage private trucking fleets for their grocery delivery and, according to the 2021 National Private Truck Council’s Benchmarking Survey Report, 68% of fleets measured on-time performance for 2021, versus 82% in the prior year.

Improving on-time delivery rates alone could have a profound impact on saving food from spoilage. In many cases, trucks arrive late to a store due to weather or traffic delays; however, when older trucks remain in a distributor’s fleet, maintenance and repair (M&R) problems, and other mechanical breakdowns can cause more serious delays, further damaging delicate produce that needs to arrive at the store on time.

When isolated down to an aging truck fleet, organizations aren’t just losing billions because of food shrink. These older trucks can further erode a grocer’s or food distributor’s bottom line when M&R costs and lease structures are factored in.

Older Truck Fleet Means More Spoilage and Additional Expenses

Distributors and transportation fleets have had their eye on improving truck M&R in their operations for years, especially since operational expenditures can significantly add up over time on aging and older trucks. These companies believe it’s such a big problem that M&R was the largest reason why fleets renewed, replaced, or upgraded their trucks according to the most recent industry benchmark report from Fleet Advantage.

M&R costs on a 2016 sleeper model-year for grocer distributors total $25,392, compared with $2,244 on a 2023 model-year truck, which provides a savings of $23,148. Across a fleet of 100 tractors, this amounts to $2.3 million.

These cost savings become even more significant when you look beyond the typical M&R expenses, including tires, tubes, liners, and valves, and include preventive maintenance measures, brakes, expendable items, exhaust systems, fuel systems, and more. The older the truck, the costlier the repairs become. What’s more, technician time becomes more expensive, too, because fleets end up requiring more technician time for service.

Lease Agreements for Your Truck Fleet

Aside from the specific costs involved with M&R on older trucks, distributors are also paying closer attention to the type of lease agreement they have (full service versus unbundled lease [UBL]), which can also dramatically impact the expenses involved with maintaining their fleet of trucks.

Distributors must realize that in long-term lease or ownership of the vehicles, they are locked into a higher “fixed” cost for M&R. In contrast, a shorter lease life cycle of two trucks using a UBL agreement equates to a sliding scale of M&R costs. At about 48 months, the costs reset to newer truck cents per mile (CPM). This means M&R costs are much lower over time and can help improve margins toward the bottom line.

Furthermore, M&R is “front loaded” in a full-service lease agreement. As an example, companies will pay a minimum of .07 CPM in year one versus .02 CPM when unbundling (national average for year one). All trucks come with a bumper-to-bumper two-year warranty that can be extended to four years. Expenses for year one include wearable items (tires, brakes) plus preventive maintenance. A shorter truck life cycle produces long-term savings beyond the first year. In a UBL, the CPM average equals 5.675 cents over five years. However, in a full-service lease agreement, fleets pay up to 9 CPM.

Innovative Programs Deliver Cash Infusions

Strategic fleet partners today can help offset financial losses from food shrink in other ways. Innovative programs are now available to help distributors with an infusion of cash while also upgrading trucks for future growth. These “sale-leaseback programs” allow distributors to select the assets from their fleet that are older models so that flexible lease partners can purchase those assets and lease them back to the distributor for an interim period until they place an order and transition to new equipment when available. Using a sale-leaseback program can help provide a cash infusion to offset food shrink losses and position a company for future growth.

Food shrink is an industry issue that has been around for years and will continue to be a challenge going forward; however, grocers and food distributors should expand solutions beyond inventory control and rethink their truck fleet life cycle strategies to improve on-time deliveries and reduce other operating expenses that can add up in costs.

Antonellis is senior vice president of fleet operations at Fleet Advantage.

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The rise of COVID-19 in February and March 2020 changed the world, and that included the food processing industry.

The pandemic, which now seems to have evolved into an endemic, caused many changes in how the industry carried on their business: Regulatory inspections ground to a halt, supply chain issues at many levels caused numerous companies to rethink where and how they purchased ingredients; staffing issues, which remain to this day, were abundant; and food companies scrambled to enact programs to protect their workers from the virus. And, there were many more effects.

Unlike some businesses, food processing could not take a break during the worst of the pandemic; billions of people around the world had to eat. The industry had to operate short-handed in many cases, however, and many of those who were out sick were those responsible for food safety. The food industry as a whole was somewhat fortunate from a food safety perspective; while there have been recalls and outbreaks over the past two and a half years, until the recent issue with infant formula, there was really nothing that was exceptionally high profile. The food industry may well have dodged a bullet from a food safety standpoint; however, there were other issues, one of which was the inability to conduct regular audits of facilities by certifying bodies and buyers. Travel and visits were curtailed for months, and, in addition, many companies established “no visitor” policies that lasted for a year or more—so, no auditors were allowed.

Elements of an Audit

Audits have become an integral part of conducting business in the food industry, and the smart companies view them as an important element in their continuous improvement program. A fresh set of eyes often sees things that company people take for granted.

Audits generally incorporate several different elements, including:

1. A review of documented procedures;
2. A record review;
3. Inspection of the plant and grounds; and
4. Determination of whether procedures are being followed.

In short, an auditor should review and understand the programs and procedures included in the food safety plan and then confirm their implementation and effectiveness at controlling hazards through observation of operations and assessment of the facility and grounds.

The first two elements are often referred to as desk audits. There has been a push among many audit firms to place a greater emphasis on the time spent in a plant so that the focus of the audit is more on what’s going on rather than on the review of documents and records. While it’s not uncommon to find perfect records, it’s rare to find perfect plant practices or pristine facilities.

As an example of the importance of observing what goes on in a plant, here is a story from a long-time auditor I spoke with. The auditor was asked to conduct a GMP/food safety audit of a plant. He met with plant management who basically gave him free access to the whole facility. The auditor found a niche in a balcony overlooking the production floor and made himself comfortable. The plant manager, who was a very hands-on person, came by several times over the next few hours and observed the auditor sitting up on the balcony. He finally waved the fellow down and wanted to know why he had planted himself in one place—he was paying for an audit. The auditor then proceeded to show the plant manager several pages of adverse observations that he had made just sitting. This underscores the importance of observing the process.

So, if one cannot visit a facility and conduct this observation in person, what is the alternative? Enter the remote or virtual audit, an audit conducted via a web-enabled remote system.

The Virtual Audit

Many companies mandate that their suppliers successfully pass one of the Global Food Safety Initiative (GFSI) certification schemes and these programs all require an annual on-site audit. Early in the pandemic, GFSI provided a six-month extension on audit requirements while continuing certification. When the pandemic showed no sign of abating quickly, GFSI allowed the use of virtual or remote audits in lieu of further extension of certification without any audit at all. Proponents of remote auditing saw this as a move forward; however, there are those who opposed their use even in such extenuating circumstances. Let’s look at the pros and cons of the virtual or remote audit.

I spoke with Warren Edde, manager of supply chain for the J.R. Simplot Company, a potato and French fry producer based in Boise, Idaho. As part of his job duties, Edde manages and conducts audits directly for Simplot:

“About June of 2020, when I realized travel would be off the docket for quite some time, I began to conduct virtual audits. At that time, though, it was only put on as a bridge and was not intended to be a long-term program. Two years later, the virtual audit program has continued to be an integral part of my supply chain verification activities, especially with foreign suppliers and new suppliers.

The virtual audits I perform are conducted over video conferencing tools. These platforms provide the ability to review programs, ask clarification questions, and review implementation records to ensure the food safety programs are being followed. This gave me confidence that the hazards had been properly assessed, the preventive controls necessary were in place, and that the facility was performing essential monitoring, verification, and corrective actions according to the written programs. The virtual audits are an essential component during no-travel times and, quite honestly, are a useful tool for assessment of programs for new and existing vendors. The downside [is that] they do not allow for conducting operator interviews, facility observations, assessing hygiene controls, [or for] adherence to cGMPs, which are essential components of the on-site audit.

That said, the virtual audit will remain in my toolbox and will continue to be incorporated into future auditing, not replacing the on-site audit, but acting as an extension to the onsite audit. This approach will allow for review of programs and records prior to the onsite review and allows me to better schedule my time. I can conduct multiple virtual audits in a week, and in many cases I can then travel to a process location and perform multiple onsite inspections at a future time. I can honestly say that I prefer conducting the program and record review at my desk where I have plenty of room and plenty of monitors.”

So, there are pros and cons to a virtual audit program in Edde’s mind, but he is very clear that on-site audits are not going away. One point that should be underscored is that having access to documents and records before going into a plant is important; reviewing these materials beforehand can considerably reduce the time spend in the plant.

John Surak, PhD, professor emeritus of food science at Clemson University in Clemson, S.C., and past chair of the United States delegation that helped develop the ISO 22000 for safety standard told me that he has similar thoughts on virtual audits:

“I do not support virtual audits when the auditor is in the production part of a site. For example, [when] auditing PRPs. I also believe that virtual audits are not effective when auditing the lab. The auditor has a limited view of what is happening. In addition, the auditor is at the mercy of the person holding the camera. You do not have the ability to smell or clearly hear what is happening in the manufacturing part of the facility.

However, there is some value in the virtual audit. I was working with a plant in the pre-COVID days. The manufacturing plant was located in the U.S., and corporate was located in Germany. Two individuals on the plant’s organizational chart were located in Germany. The question was, do these individuals need to travel from Germany to the U.S. for a one-to-two-hour interview as part of the audit? There was substantial interaction between the managers located in Germany and the United States. To eliminate needless waste, the audit interview of the German managers was conducted via video conference. I observed the interview, and I did not see any problems. The auditor was able to access any needed documents electronically.

I can see the use of video conferences as a useful tool for auditors. It can increase efficiency in the audit process when the auditor is auditing a portion of the food safety management system that is carried out by professionals at remote locations such as at the corporate location. When this is done, the auditor should assess the effectiveness of the communication between the two different sites. This process could be useful in the days of unannounced audits. It would allow the interviewing of the management team that may be away from the facility because of travel.”

In chatting with other food industry professionals, I found that they echoed similar thoughts. One individual stated that she participated in a virtual audit, but when travel opened up and she was able to actually visit the plant, she found much in the plant itself that the camera did not show. This same person acknowledged that the desk audit could be done virtually, however.

The Value in the Virtual Audit

Dr. Surak’s comments about utilizing all the senses when doing an audit are absolutely correct. There are those who say that one way to evaluate cleanliness is to ensure that the equipment looks clean, smells clean, and feels clean, and that test results verify this. You really can’t do any of these activities virtually; even looking through a camera lens isn’t always as effective as the human eye.

So, while virtual audits do have a role in managing food safety, auditors, certifying bodies, and the companies under audit need to understand the potential concerns and the commitments that are required for this remote inspection to be successful. The company has to be willing to share information via hard copy or electronically with the auditor. This means that signing a nondisclosure agreement may be an essential first step in the audit process; however, there needs to be a culture of nondisclosure for all participants involved in the audit process. If documents are shared, the auditor may be asked to return them at the end of the audit or erase them from their computer, a procedure to be avoided since the documents form the completed audit record. With programs such as Zoom, completed records may be shared in real time, but such a session may not give the auditor enough time for a proper review.

On the upside, virtual audits can drastically reduce travel costs, which could increase audit frequency. In many cases, travel costs can account for as much as 60% to 75% of the total audit. More importantly, it reduces wear and tear on auditors, a significant concern in a field that is chronically understaffed; auditor burnout is common

Another upside is the value of training new auditors using virtual audits. Sending a trainee to accompany an auditor can add as much as $5,000 to travel costs, which can severely limit the amount of training new auditors receive before going out alone.

Still, the on-site audit should never be ignored. The time in plant allows the auditor to verify that what they saw in the documents and records is accurate and true. Remember, there are places with great records that are imperfect when the records or procedures are viewed against actual practices. Even though cameras and cell phones will provide access to a plant, they only provide an incomplete snapshot of what is actually going on. Auditors need to use all their senses, including hearing. A well-run plant may be compared with one’s own car; the owner can usually detect issues by how the car sounds. The same is true with a food plant that is up and running well—it has its own sound.

As virtual audits increase in use, procedures and practices will improve, as will the auditor’s skills in detecting hidden problems. Technology improvements will also contribute to improved results as demand increases. The ultimate answer to the question of on-site versus virtual audits likely lies somewhere in the middle. A hybrid using local third-party staff guided remotely by a seasoned auditor seems like the best of both worlds.

Stier is a consultant food scientist and a member of the Food Quality & Safety Editorial Advisory Board. Reach him at rickstier4@aol.com.

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In June 2022, Tom Vilsack, USDA’s Secretary of Agriculture, unveiled a $2 billion plan to “transform” the food system in the United States.

The efforts are expected to increase competition, capacity, and supply, and—ultimately—ease inflation. More than that, the plan is designed to improve the supply chain, make things fairer for smaller producers, improve the affordability of nutritious food, and boost underserved communities.

“As the pandemic has evolved and Russia’s war in Ukraine has caused supply chain disruptions, it has become clear we cannot go back to the food system we had before,” a spokesperson with USDA tells Food Quality & Safety. “The Biden–Harris Administration and USDA recognize we must build back better and strengthen the food system across the supply chain, from how our food is produced to how it is purchased, and all the steps in between.”

For that reason, USDA announced this framework to transform the food system with a goal to build a more resilient food supply chain that provides more and better market options for consumers and producers while reducing carbon pollution, combating market dominance, and helping producers and consumers gain more power in the marketplace by creating new, more, and better local market options.

Gary Iles, senior vice president for marketing and business development at TraceGains, a Westminster, Colo.-based technology company that helps global suppliers manage their food supply, product development, safety, and compliance issues, says a plan like this is welcome—and long overdue. “We need to upgrade the department when regulators across the board are struggling to keep up with the markets they’re regulating,” he says. “It also recognizes that today’s supply chain is broken and that fixing it requires just two things: technology and diversity. Technology is essential for supply chain transparency and, by extension, supply chain security.”

The impact of the pandemic over the last two years has painfully revealed how critical it is to diversify the next generation of the supply chain, with Iles noting that it’s naïve to think anyone can rely on a single supplier or region.

What to Expect

The funding is targeted at food production, processing, distribution, and consumers, including up to $300 million to help transition farmers to organic production methods and up to $75 million to support urban agriculture. “Overall, the administration clearly wants to make a significant push in leveling the playing field in the meat and poultry markets, whether it’s investment help for startups, a renewed commitment to organic and urban operations, or pulling financial levers to rein in rising costs,” Iles says. “But it also looks like the best chance for success here are the efforts at diversifying the supply chain, with a straightforward push at supporting local and regional suppliers. This is where we’ll see a real difference in the supply chain that will benefit everyone, from the rancher to the consumer.”

Catie Beauchamp, PhD, vice president of food science, quality, and safety at ButcherBox, a direct-to-consumer meat brand in the U.S., says that responding to the opportunities that were highlighted over the last two-and-a-half years is critical, and there are opportunities within this plan for food safety professionals to take advantage of. “I believe the funding opportunities directly related to supporting [the] private sector’s ability to adapt or respond to needs identified during the pandemic have the most opportunity to be successful in the longer term,” she says. “It may not be directly related to food safety, but I also believe that funding and development within the urban agriculture sector has much potential for success as well.”

Bryan Quoc Le, PhD, a food scientist and consultant based in Puyallup, Wash., believes that the plan is moderate and does not address some serious systemic issues in the food industry. “I’d be curious to see, for example, how point one on building a more resilient food supply chain that’s more regional will be implemented in practice,” Dr. Le says. “I’m also curious to know how the organic and urban agriculture elements in the plan will be implemented. Will that be sufficient to curb the impact of transporting produce and other agricultural goods, or should investments be placed into more sustainable infrastructure for existing manufacturers, such as solar panel installation, advanced wastewater treatment systems, and electric transportation vehicles?”

However, Dr. Le feels the investments spent on processing will likely be successful, as many manufacturers have aging or un-updated equipment. “As we are moving toward more automated and digital systems, these investments will help support processors in designing state-of-the-art facilities with more robust monitoring of food safety hazards,” he adds. “I believe having a response to the current way the food system is operating is important, especially as we’ve seen its weaknesses during the pandemic.”

How Is Food Safety Represented?

However, while the transformation is geared toward the resiliency of the food chain, Vilsack’s announcement said very little about food safety.

Iles notes that the plan isn’t as heavily focused on food safety, but that’s not to say it ignores it either. In theory, food safety professionals can expect better support from regulators in terms of training and technical assistance, especially at smaller operations, which is a big focus of this initiative. “As it stands right now, the USDA appears to be earmarking $100 million to help develop a more reliable pipeline of well-trained workers and investments in safer workplaces,” he says. “Also, it looks like Vilsack wants to establish a ‘robust technical network’ by investing $25 million in technical assistance for meat and poultry processing plants, including a focus on compliance.”

Plus, the $200 million the plan sets aside for Food Safety Certification for Specialty Crops will be a boon for those operations. Additionally, one of the largest impacts on food safety will be the $600 million investment in cold storage, refrigerated trucks, and processing facilities as well as food safety certifications.

When it comes to food safety, Dr. Beauchamp notes that the plan covers technical assistance network development related to start-up or expanded processing facilities, access to lending and education related to lending opportunities, funding to support workforce training, and, most obviously aligned with food safety, the financial support for food safety certifications for on-farm operations. “I believe all of the aforementioned areas impact food safety, as individuals in the food safety arena often play key roles in new plant start-ups, expansions, the challenges of staff turnover, burnout and generally effective training, and in creating and maintaining successful food safety programs,” she says. “This strategy is consistent with the areas that Secretary Vilsack has identified as important, and highlights several of the critical gaps in supply chain infrastructure or food access that arose during the pandemic.”

Dr. Le feels that more money will be available for food safety professionals to upgrade their equipment and facilities, as well as receive advanced training. “The cost of testing has also always been out of reach, and sometimes smaller players do not have the capital to put money into food safety testing,” he adds. “Hopefully, this investment will help provide that needed funding.”

Challenges to the Food System Plan

Any time you have regulators trying to “motivate” banks and lenders to help, it can be tricky, Iles notes, citing the Food Supply Chain Guaranteed Loan Program, which will back private lenders that invest in independently owned food processing, distribution, and aggregation infrastructure, along with other projects along the middle of the supply chain.

USDA has deployed $100 million to make more than $1 billion in guaranteed loans available immediately. “The ideas, especially the loan guarantee program, are undoubtedly exciting, but things like that are much easier said than done,” Dr. Loc says. “Whether you care about food safety, food equity, or you’re ambitious enough to want to remake the entire supply chain, there’s a lot here to work with. But it’s just as important to remember that the federal government moves at its own pace.”

Extensive funding of federal programs has potential to benefit the broader industry, Dr. Beauchamp says, warning that it’s imperative that the relationships between federal agencies and the food production industry are strengthened, versus creating silos of information that are difficult to understand or access. “Collaboration with industry, related to the support needed to strengthen industry outcomes as aided by federal agencies is essential,” she adds. “Solutions designed by any party without the input from professionals with intimate knowledge of the nuanced issues at hand make implementing those solutions difficult for all parties involved.”

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One of the outcomes of the COVID-19 pandemic has been an increased awareness of and sensitivity to food safety issues by the general public. As government regulators, food testing laboratories, and food producers have become better at conducting outbreak tracing, companies are realizing the necessity of having a robust pathogen testing program in place to avoid the risk of an outbreak.

As a result of the increased awareness, food testing labs faced some challenges early in the pandemic while trying to meet demand for pathogen testing and detection. At the same time, some new trends and ideas have come about, demonstrating how the understanding of food pathogens and food safety is always advancing.

The Current State of Food Safety Pathogen Testing

Generally speaking, the U.S. public is well aware, either through personal experiences or conversation, of the ongoing labor shortages caused in part by the pandemic. The food manufacturing industry has also felt the effects of these shortages—from lab technician turnover and struggling to find new technicians to replace those who are leaving, and issues with working in person in a laboratory setting where social distancing requirements are enforced. Meanwhile, as restaurants, schools, and other food service venues closed, food production in retail spiked, sending demand for retail food testing to new heights.

On top of this elevated retail demand, consumers have become more invested in the safety of the food they are purchasing, and more demanding of food safety testing information. As a result, food manufacturing labs have had to keep up with increased customer demands, such as those calling for robust validations, including different sample sizes than typically used, requesting quicker turnaround times, and requiring novel matrices.

To keep pace with these increased demands among ongoing labor shortages, labs have relied more heavily on implementing the most efficient testing solutions. Automation in the lab can provide a solution that allows for time savings, while also taking out the subjectivity of the test method and results interpretation.

Where Pathogen Testing Is Heading

One rising solution to labor shortages is the use of automation in food testing laboratories. As labs struggled to source employees during the pandemic, there was a major shift toward using contract labs to help keep up with testing demands; however, contract labs have faced the same worker shortage struggles and are leaning heavily on automation technologies as a result. In fact, some contract labs are now leading a shift to testing automation because these technologies help food testing labs increase efficiency by reducing technician time when testing for pathogens. Additionally, the learning curve when hiring new technicians to replace lost workers is significantly shorter with automated testing, as the technician does not need to manually count.

Customer demand influences the future of pathogen testing and detection. Historically, pathogen testing has been a qualitative result—looking to see whether there is a presence or an absence of the target pathogen. However, a new concept of pathogen testing has emerged due, in part, to increased knowledge and sensitivity around food safety. Customers are increasingly demanding quantitative testing. With quantitative testing, labs are now looking for the number of a target pathogen that is present in food. This method is of major interest to the poultry industry, which is currently the leading industry seeking advancement for quantitative testing. Quantitative results are especially important for Salmonella testing in the poultry industry, as the pathogen is widely present, and knowing the qualitative result of Salmonella testing is not as valuable as knowing how much of it is present.

Another concept at the forefront of pathogen testing is the idea of serotyping. Serotypes are groups within a single species of microorganism that have distinctive surface features that may make them more of a food safety risk. For example, certain Salmonella serotypes have a higher propensity to cause foodborne illness, so if food manufacturers can concentrate on limiting the levels of these Salmonella serotypes, they will produce a safer food for their consumers. As the industry continues researching pathogens, scientists can further understand the different strains of each pathogen, allowing pathogen testing and detection methods to continue advancing.

Our knowledge of pathogen testing is ever-changing as we continue to research prevalent and emerging food pathogens and continue to make advancements in testing technologies and detection methods. As we try to recover from the lasting effects of the pandemic, automation technology and new testing methods will help shape the industry moving forward.

Thevenet is a U.S. and Canada technical sales manager and pathogen manager for 3M Food Safety.

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The serial monotony of the pandemic period kept many otherwise frequent travelers grounded. Certainly, many continued to travel, and others have already returned to routine, but my situation kept me pretty much grounded until now. So, as I’m writing this column, I’m also dusting off a suitcase and preparing to head to the airport in a few days.

This year’s IAFP marks yet another milestone in the return to normal, at least for me. The emails to colleagues are sent, the meetings arranged, and the countdown clock to departure day is running. The anticipation of seeing familiar faces again is tinged with a slight anxiety, too. The return to normal isn’t quite complete, is it? Let’s see: There’s another coronavirus variant brewing, extreme flight delays, and last—but not least—recent WHO headlines about monkeypox to consider. Believe me, that’s one I didn’t have on my traveling risks bingo card and is not even close to normal.

I have to connect through Atlanta to get anywhere, so interrupted travel is more routine for me than most—way more routine. So, I can comfortably put that in the return-to-normal bucket. We have a new puppy that loves to chew things so much we named him Chewy. So, have I hidden all of my shoes? (He’s gotten six pairs so far.) What about the TV remotes? (We lost one.) Are all the power tools in a place he can’t get to? (Yes, he’s even chewed up a power drill.) Are all the power cords tucked away? Check.

As for the rest? Packing is like riding a bike: Once you learn how to do it, you never really forget. Device chargers? Check. Comfy shoes? Check. But even this is a little different now. Will most people be wearing masks? Will masks be enough protection for traveling? How many do I need to bring? Disposable or fabric? Comical statement or designer fabric? These questions mark new ground to consider. Black disposable masks? Check.

On a more serious note, I’m looking forward to sharing my new role at Food Quality & Safety with colleagues I haven’t seen for a while. It will be interesting to reengage on the pre-pandemic issues facing the food safety sector and learning about new ideas by attending as many sessions as possible. I’m excited to learn more about what others have been doing and can’t wait to apply that knowledge to future issues of FQ&S.

As always, send me your thoughts at fqseditor@pawesta.com.

The post From the Editor: A Return to (Nearly) Normal appeared first on Food Quality & Safety.

To some degree, food products with “free from” claims, especially those with gluten-free and dairy-free claims, have been on the market for years. In recent years, however, the number and diversity of products with claims relating to allergen-free status has grown much larger. With the passage of an FDA regulation defining gluten-free claims at <20 ppm gluten, the gluten-free market niche has been very active in recent years. Dairy-free products have been available for some time, but the terminology can differ now, with labels that include dairy-free, milk-free, lactose-free, and non-dairy phrasing.

Additional free-from claims have started to appear in the marketplace, including nut-free, peanut-free, egg-free, soy-free, and even allergen-free terminology that goes beyond the required labeling. Compared with gluten-free claims, the number of products available in the market with other free-from claims is smaller and less diverse. Food products with “free” claims definitely appeal to the segment of the market representing consumers with allergies and related illnesses to specific foods. Additionally, some consumers are also known to select products with gluten-free labels based more on their personal lifestyle choice rather than a clinical need for avoidance of gluten. Presumably, the same behavior also occurs when it comes to products with other free-from claims.

While market opportunities exist for food products with free-from claims, potential risks also exist and must be avoided when using these claims. Let’s examine both sides of this issue, with the goal of identifying the safest and most transparent strategy to use for such product claims.

Market Appeal and Challenges

Of course, products with free-from claims appeal to consumers with allergies or intolerances to those specific foods; in fact, they rely solely on ingredients labeling to choose foods safely. Specific food allergies have a prevalence of 1% or less among the U.S. population, however, so the size of the market would be rather small if these products only appealed to consumers who actually had specific food allergies or intolerances. In such situations, marketing of products to the affected and most interested consumers can be quite challenging and may involve specialized approaches, such as online sales and other forms of direct-to-consumer marketing.

Beyond the allergic consumers themselves, however, products with free-from claims can also appeal to consumers who interact with and purchase food for periodic occasions that include food-allergic individuals, such as nuclear and extended family members and organizers of school events and extracurricular activities such as team sports. As companies consider these specialized market niches, the possibility that the specific niche might have broader appeal should be examined on a case-by-case basis.

Dairy-free, milk-free, lactose-free, non-dairy claims: The universe of dairy-free foods has evolved over the decades, but the use of multiple terminologies for these claims can be confusing. Part of the confusion stems from the fact that dairy-free foods can appeal to several categories of consumers: milk-allergic individuals, lactose-intolerant individuals, vegans, and those following certain types of kosher restrictions.

Originally, many dairy-free products were simply intended for lactose-intolerant consumers. Lactose intolerance affects a very large segment of the consuming public because it is a genetically acquired condition that worsens with advancing age and affects many older children and adults, primarily in certain ethnic groups. Affected consumers experience mild intestinal discomfort (flatulence, bloating, cramping, diarrhea) after eating dairy products containing the milk sugar lactose. Lactose-intolerant consumers can often tolerate small doses of lactose in their diets without experiencing symptoms. Some dairy-free products are essentially free of lactose but still contain other milk-derived ingredients, especially milk protein fractions such as caseinates or whey protein concentrates. Some products are specifically labeled “lactose free,” which is the appropriate terminology if the product is free of lactose but contains other milk-derived ingredients.

Lactose-free or dairy-free products containing milk protein would be unsuitable and even hazardous for milk-allergic consumers who must diligently avoid ingestion of any levels of milk protein. Even very small amounts of milk protein are sufficient to provoke adverse reactions in such individuals. The symptoms are variable and can involve the skin (hives, itching, swelling), the intestinal tract (vomiting, diarrhea), and/or the respiratory tract (asthma, rhinitis); very severe anaphylactic reactions and even deaths can occur in some milk-allergic consumers upon inadvertent ingestion of milk proteins. The percentage of consumers with milk allergy is rather small. Up to 2% of infants younger than 3 years of age have a milk allergy, but most of them outgrow that condition to the point where milk allergy is much rarer in adults, although an accurate prevalence estimate is not available for adults.

Few foods in the marketplace are labeled as milk free, but producers are required to include the common name in the ingredients list for products containing caseins and other milk-derived proteins. Dairy-free products are more widely available, but some dairy-free products are not suitable for milk-allergic consumers because these products still contain milk proteins. It could be argued that dairy-free products would ideally contain no detectable lactose or milk proteins so that they are well suited for both types of consumers.

“Non-dairy,” another term encountered in the U.S. marketplace, is usually applied to coffee creamers. Curiously, non-dairy products are required to contain caseinates. Since casein is a major allergenic protein in cow’s milk, non-dairy products pose a serious risk to milk-allergic consumers if these consumers neglect to read the ingredient declaration. The presence of casein is typically identified in the ingredient list, and non-dairy products may even have a “contains milk” statement, but the prominent labeling of the product as non-dairy can cause consumer confusion. Non-dairy coffee creamers may be safe for consumers with lactose intolerance.

The market for dairy-free products has wider appeal beyond those with milk allergy or lactose intolerance. Dairy-free products appeal to vegan consumers and others who do not consume dairy products as a matter of choice. Additionally, some Jewish consumers follow kosher pareve diets, which prohibit the ingestion of milk or meat. Kosher pareve foods cannot contain any milk-derived ingredients and are typically certified by various rabbinical organizations that then allow the application of their symbols on the labels. Kosher pareve foods should be dairy-free but are not always also labeled as dairy-free. It is also important to recognize that as Kosher pareve certification is not focused on food allergen risks and does not use analytical methods for verification of its absence, so it is possible for products labeled as Kosher pareve to contain detectable levels of milk protein, and sometimes at sufficient levels to provoke allergic reactions in milk-allergic consumers.

Egg-free claims: Egg-free products obviously appeal to consumers with egg allergy, although the number of consumers with egg allergy is actually quite small. As with allergies to milk, egg allergy mostly affects young infants and children, with a prevalence of about 2%. Most egg-allergic children outgrow this condition, so egg allergy is not common among older children and adults. The symptoms of egg allergy are similar to those noted for milk, and reactions can be triggered by exposure to very small amounts of egg protein. Egg-free products likely exist in the marketplace because they appeal to vegan consumers and are often available as replacements for products that would otherwise typically contain egg. Examples would include egg-free mayonnaise and egg-free noodles. While the vegan market niche is growing, any egg-free product must be formulated and produced to contain no detectable egg protein so that it is also safe for egg-allergic consumers.

Nut-free and peanut-free claims: The phrase “nut free” on food products can be confusing because it is unclear if this term also means peanut free in all cases. Peanuts are, of course, legumes that are different from the various tree nuts except for their form and texture. “Peanut free” is a labeling term that is much clearer. For consumers, “nut free” should be construed to mean free of the various tree nuts, but not necessarily peanuts. As always, review of the ingredients statement is recommended for clarity Tree nuts as a group are not defined similarly in all countries of the world. A recent expert panel assembled by the Food and Agricultural Organization of the United Nations and the World Health Organization identified walnuts, pecans, cashews, pistachios, hazelnuts, and almonds as the most important tree nuts from an allergy perspective on an international basis. Brazil nuts, macadamia nuts, chestnuts, and pine nuts are identified as tree nuts for labeling purposes in two or more countries, which perhaps reflects regional differences in the allergenicity of tree nuts. The U.S. has an even longer list of tree nuts considered allergens that includes coconut and lychee, even though these examples are not truly nuts by botanical definition.

Peanut- and nut-free products are primarily targeted to peanut- and tree nut-allergic consumers. Peanut allergy affects 1% to 2% of U.S. consumers, while tree nut allergies affect about 0.6%, although some tree nut-allergic individuals can tolerate some of the nuts. About one-third of peanut-allergic individuals are also allergic to tree nuts, so some consumers must avoid both. Allergic reactions to peanuts and tree nuts can on occasion be quite severe and are among the leading causes of deaths due to food anaphylaxis. The doses needed to elicit reactions are very low in some susceptible individuals. Thus, peanut-free and nut-free products should not contain any detectable protein from any of those sources. The market for these specialty free-from products is likely restricted to the allergic segment of the population.

Soy-free claims: Soy-free products appeal to the soy-allergic segment of the population; however, the prevalence of soy allergy is very low, affecting less than 0.1% of the population. At one time, soy allergy was more common among infants due to the popularity of soy-based infant formula, a frequent substitute for milk-based formula for infants who develop cow’s milk allergy; however, the popularity of soy formula for infants has declined and fewer infants are now identified as soy allergic. Like milk and egg allergy, soy allergy is often outgrown, so its prevalence among older children and adults is rather small.

Achieving soy-free status for a food product is challenging due to the ubiquity of soy-based ingredients and the frequency of agricultural comingling of soy with other commodity crops such as wheat, oats, corn, and other legumes. The doses of soy protein needed to provoke allergic reactions are not as low as those needed for peanut, milk, tree nuts, or eggs. The use of the term “soy free” indicates that the products should not contain any detectable soy protein. The suitability of analytical methods for the detection of soy residues is more challenging due to the use of soy-based ingredients, which may contain isolated fractions of the soy proteins, some ingredients with altered structure, chemical modifications, and solubility, and others with varying degrees of hydrolysis. The clinical reactivity of susceptible individuals to these soy-based ingredients is uncertain, leading to the assumption that such ingredients may be hazardous to soy-allergic consumers even if residues cannot be detected.

Allergen-free claims: In the U.S., “allergen free” typically means that the product is free of all of the priority allergenic foods identified in the Food Allergen Labeling & Consumer Protection Act: peanut, tree nuts, milk, eggs, fish, crustacean shellfish, soybeans, and wheat (sesame seeds are soon to be added to this list). Rather obviously, these foods are targeted toward that segment of the consuming public with food allergies. The overall prevalence of food allergies in the U.S. is a matter of some debate but likely falls between 4% and 11% of the U.S. population. Affected individuals can suffer from any or several of a range of symptoms. In some cases, allergic reactions can be triggered by low provoking doses.

The formulation of allergen-free foods can be challenging because it can be hard to find suitable replacement ingredients for some types of food products. Because of the low provoking doses, these foods must not contain any detectable protein from any of these commonly allergenic sources. Most food-allergic consumers would  need to avoid the specific food they’re allergic to, but may not wish to avoid all commonly allergenic foods. Thus, the appeal of allergen-free products is likely far less than the overall prevalence of food allergies in the population; however, the prevalence of consumers with multiple food allergies (three to five foods) is increasing for unknown reasons, which could create a market for such products. Additionally, some of these products may also be vegan depending upon other components of the formulation. While analytical methods with reasonable sensitivity and specificity exist for many of the priority allergenic foods, good methods don’t exist for the detection of all tree nuts or for fish.

Vegan claims: Just as dairy-free and egg-free products can appeal to vegan consumers, vegan product labeling may imply to some consumers that the product is dairy free and egg free. Vegan labeling is often applied primarily as a lifestyle or consumer preference claim, rather than for consumers with medically necessary dietary restrictions, but it would be prudent for food-allergic consumers to interpret these label claims with caution. Food manufacturers should also recognize that vegan-labeled products may appeal to milk- and egg-allergic consumers and evaluate allergen risks accordingly. Other pseudo-free-from claims, such as “school safe” or “classroom safe,” are even more ambiguous and challenging for consumers to interpret.

Regulatory Limitations

Gluten free is the only one of these free-from claims that has a regulatory definition: less than 20 ppm gluten in most countries in the world. The use of other free-from statements on packaged foods is voluntary and is not specifically defined or restricted but must be truthful and not misleading. The use of the word “free” suggests that the food should contain no detectable protein residues, but the availability, specificity, and sensitivity of detection methods to support such claims can vary. The selection of test methods will affect the veracity of these free-from claims.

Recommended Strategy

While “free from” products may appeal to wider audiences of consumers, the food industry must be vigilant about potential risks to that subset of consumers with allergies or intolerances to the specific food(s). For gluten-free claims, the existence of a regulatory definition establishes the manufacturing objective. Gluten-free ingredients must be sourced, and the potential for cross contact from the use of facilities or equipment used for the manufacturing of gluten-containing foods must be carefully managed. A suitable method for the detection of gluten residues must be selected.

No regulatory definition exists for use of these terms other than the free-from claims mentioned herein. As noted, the claim must not be false or misleading. The Food Allergy Research and Resource Program (FARRP) recommends that food manufacturers establish their own definition for a claim and post it in publicly accessible locations such as product websites. The definition should identify and specify the nature of the claim and carefully distinguish among possible variations, e.g., milk free versus dairy free versus lactose free. The definition should identify the allowable levels of allergen residues and the analytical methods used for compliance, e.g., peanut-free products contain less than 5 ppm peanut protein as measured using XX method (specific for peanut protein residues).

With the other free-from claims, food manufacturers need to source ingredients that are reliably and consistently free of detectable residues of the relevant allergenic food(s). As mentioned earlier, sourcing can be quite difficult for ingredients that are sourced from agricultural commodities subject to comingling, particularly with respect to soy and wheat (gluten) residues. FARRP recommends analysis of individual lots of ingredients for use in products with free-from claims and the retention of samples of all such ingredients to use in investigating any potential problems.

The selection of suitable analytical methods to support free-from claims can be challenging. Enzyme-linked immunosorbent assays (ELISAs) specific for proteins from the allergenic source are the most frequently used. For support of free-from claims specifically, FARRP recommends the use of the quantitative, well-based ELISA methods as opposed to lateral flow devices (LFDs). If a company does utilize LFDs for qualification of ingredients or analysis of finished products, it is highly recommended that an evaluation of the LFD in the ingredient or food matrix is conducted to ensure that the matrix does not affect the sensitivity and reliability of the LFD.

For some allergenic foods such as peanut and gluten, several excellent ELISA methods are commercially available; however, the availability of robust ELISA methods requires more care as methods may not have equivalent sensitivity, utility in specific matrixes, or reliability in detecting processed versions of the proteins from the allergenic source.

Food products free of specific allergens or groups of allergens can have market appeal beyond the segment of consumers with food allergies and intolerances. Market opportunities may exist but would not be expected to generate the magnitude of the gluten-free market unless they also become market trends generating their own inertia. The size and profitability of these “free” markets is uncertain, however. The degree of difficulty involved in making products for such markets is variable, and great care must be taken to protect those consumers who are truly sensitive to small amounts of these allergenic foods, because they will be among the consumers attracted to such products.

The authors are with the Food Allergy Research and Resource Program in the Department of Food Science and Technology at the University of Nebraska-Lincoln. Reach Dr. Taylor at staylor2@unl.edu, Dr. Downs at mdowns2@unl.edu, and Dr. Baumert at jbaumert2@unl.edu.

The post How Food Producers Should Approach Allergen-Free Claims on Food Labels appeared first on Food Quality & Safety.

When aiming to achieve pre-harvest agricultural soil safety, the key is to maintain the level of beneficial soil microorganisms while minimizing the potential contamination of foodborne pathogens and plant disease from agricultural inputs used to produce crops, says Achyut Adhikari, PhD, associate professor and extension food safety specialist in the School of Nutrition and Food Sciences at Louisiana State University AgCenter in Baton Rouge.

Soils are often enriched with biological soil amendments of animal origin (BSAAO) to increase nutrient values, enhance water-holding capacity, and support crop growth and yield, says Kali Kniel, PhD, professor in the department of animal and food sciences at the University of Delaware in Newark. Soil amendments can be delivered to soils as raw animal manure, treated or composted manures, and compost teas.

Using animal manure as a fertilizer on agricultural farms is a common practice in the United States because it’s a good source of macro- and micronutrients required for crop production, Dr. Adhikari says. In addition, organic matter present in manure helps improve physical, chemical, and biological properties of soils. It also improves water infiltration, enhances nutrient retention, reduces wind and water erosion, and promotes the growth of beneficial organisms.

According to the Food and Agriculture Organization (FAO) of the United Nations, livestock contributes 40% of the global value of agricultural output and supports the livelihoods and food and nutrition security of almost 1.3 billion people. But, despite their benefits, BSAAOs can also contribute to food safety risks. They can be contaminated with zoonotic pathogens or enhance the growth of zoonotic pathogens in and around the growth of raw agricultural commodities, says Dr. Kniel. “It’s important that growers use soil amendments appropriately to grow healthy, efficient crops, as well as avoid the excessive use of soil amendments that could affect agricultural water if contamination occurs by runoff into produce fields,” she adds.

Potential Pre-Harvest Problems

Poor soil health can cause plants to become diseased, contaminate fruits and vegetables, and ultimately lower food production, says Dr. Adhikari. In addition to the indigenous microflora of soil, pathogens and other microorganisms can be introduced into soil from different inputs such as contaminated irrigation water, runoff water, and unfinished or improperly treated compost or raw manure application, as well as both domestic or wild grazing animals.

The persistence of bacterial and viral pathogens in raw animal manure is based on the manure type, how it’s applied and incorporated into soils, soil type, storage of manure before application onto soils, and the microbial diversity present and nutrient ratios in manure-amended soils, says Dr. Kniel. Persistence and survival of bacterial pathogens in manure-amended soils depend on geographical and environmental factors.

According to Michael Mahovic, PhD, branch chief of the division of produce safety within FDA’s Center for Food Safety and Applied Nutrition in College Park, Md., among the most commonly occurring foodborne pathogens are:

1. Salmonella spp., which can come from domesticated and wild animals and their feces as well as humans and their feces. Some strains have become resident in the environment.
2. Shiga toxin-producing Escherichia coli, which can come from domesticated and wild animals, particularly ruminant animals (e.g., cattle, sheep, goats, and deer), and their feces.
3. Listeria monocytogenes, which can be found in soil, decaying vegetation, water, and domesticated and wild animals and their feces.
4. Cyclospora cayetanensis, which can come from humans and their feces.

Using untreated or partially treated animal manure as a fertilizer in crop production may result in contaminating fresh produce with enteric pathogens, Dr. Adhikari says. Once contamination occurs, it is difficult to remove pathogens completely from fresh produce, even with chemical and physical decontamination treatments. As plants uptake water, soil-borne pathogens can enter the fruit, making it impossible to wash away, leaving heat as the only means of rendering the produce safe.

Furthermore, human exposure to untreated animal manure or insect vectors may put workers at risk of pathogen infection, says Dr. Adhikari. Therefore, it’s essential to adequately treat or compost animal manure before application, and to use proper strategies during application and storage of raw manure to ensure reduced risk of contamination.

Agricultural water can be another vehicle for produce contamination pre-harvest. It can easily become contaminated with rainwater, surface runoffs, wildlife access, animal fecal deposits, and many other things. Surface water that is open to the environment is the most prone to microbial contamination, says Manreet Bhullar, PhD, research assistant professor in the department of horticulture and natural resources at Kansas State University in Olathe. Water can carry pathogens from soil to a plant’s surface through splashing, sprinkling, or other modes of irrigation or crop management practices. Excessive rainfall that causes runoff that can also be a source of contamination from seemingly distant locations. In addition, using contaminated water for irrigation may deposit pathogens that can survive and persist in soil for longer periods of time, depending on several factors.

Water quality is crucial for fresh produce that is consumed raw, says Dr. Adhikari. Water used for irrigation should be routinely tested to ensure its safe to use. Once contaminated, pathogens are difficult or even impossible to remove from fresh produce even after vigorous washing with sanitizers. Municipal waters are potable and safe for agricultural purposes but are not always available. Due to the limited supply and access growers must depend on surface water or well water to meet production requirements.

Mitigating Potential Issues Pre-Harvest

The Food Safety Modernization Act (FSMA) shifted the focus from reacting to problems after they occurred to preventing food safety problems, Dr. Adhikari says. When using BSAAOs per the FSMA Produce Safety Rule (PSR), Dr. Bhullar says the following criteria should be applied:

• To minimize the risk of contamination, soil amendments must be treated to destroy pathogens.
• Aerated compost should be treated at 131°F or 55°C for three days, followed by curing; turned composting should be treated at 131°F or 55°C for 15 days, followed by curing.
• Use a thermometer to check the temperature of the compost pile.

When using and applying soil amendments of animal origin:

• Maximize the time interval between application and harvest.
• Minimize runoff and access by animals.
• Separate raw and finished manure to prevent cross-contamination.
• Designate special tools for treated soil amendments and clean them after use.
• Do not allow manure to contact the edible portion of the plant.

Growers can also mitigate pathogen survival in soils by following guidance from the USDA National Organic Program (NOP) and the California Leafy Greens Handler Marketing Agreement. The NOP recommends that raw (untreated) manure be applied at least 120 days before harvest for crops that are likely to contact the soil and 90 days for crops less likely to contact soils. “This is to provide sufficient time for pathogens to die off in soil and minimize their likelihood of transfer,” says Manan Sharma, PhD, a research microbiologist in the Environmental Microbial and Food Safety Laboratory of USDA’s Agricultural Research Service (ARS) in Beltsville, Md. “Currently, the FDA has ‘no objection’ to the NOP interval for the application of manure and harvest of fruit and vegetable crops, but is evaluating data to determine if the NOP interval is appropriate for produce.”

Research published in 2019 in the journal Applied Environment Microbiology indicated that weather and regionality drive survival of pathogens in soils, more than soil type or manure amendment type, says Dr. Sharma. Rainfall and soil moisture affect pathogen survival duration. Specific amendment types, such as those based on poultry litter, have supported longer survival durations than dairy cattle manure or horse manure in previous studies conducted collaboratively by USDA ARS, the University of Maryland Eastern Shore, and FDA.

A collaboration among USDA ARS, the University of Delaware, and FDA, led by Drs. Kniel and Sharma and published in 2021 in Applied and Environmental Microbiology, showed that the transfer of pathogens to cucumbers from soils occurred at higher levels in seasons with greater rainfall, says Dr. Sharma. Pathogen survival in soils also increased in seasons with more rainfall. Studies are currently underway in different states (e.g., California, Georgia) that examine the survival of pathogens in soils and transfer to specific commodities (e.g., onions, leafy greens), for both untreated (raw) manure amendments and heat-treated amendments. These studies are part of a USDA SCRI-funded grant called CONTACT, a multi-institution produce safety research project.

Despite its benefits, the major concern about using raw manure is that it’s a significant source of human pathogens, says Dr. Adhikari. In fact, growers must avoid using raw manure if they’re growing crops that are consumed raw. Developing practices of using properly composted materials on produce farms will reduce the risks associated with microbial contamination.

Using Good Agricultural Practices

The best way to reduce risks associated with contamination of raw agricultural commodities is to promote the use of USDA’s good agricultural practices (GAPs), says Dr. Kniel. GAPs include good handling practices of soil amendments, which may reduce risks of contamination with zoonotic pathogens (i.e., bacteria, viruses, and protozoa that can cause illness in animals and humans). “Growers should use color-coded tools to reduce the risk of contamination of treated and untreated soil amendments,” Dr. Kniel says. For example, “use tools with ‘green’ handles for untreated soil amendments and don’t use those tools with other soil amendments. Be sure that those tools don’t come into contact with crops at or near harvest time.”

It’s also important for growers to know if the soil amendments they’re using are properly composted, Dr. Kniel says. This requires certification by the retailer or proper monitoring of time and temperatures if a grower does their own composting.

Managing soil amendments can reduce food safety risks. This includes assessing risks from the soil amendment being used, selecting low-risk crops for application (e.g., agronomic), and reviewing the application method (e.g., incorporated, injected, or surface applied) and timing (e.g., days to harvest, season of application) to reduce risks, says Dr. Kniel. For this reason, raw manures are more often applied to agronomic crops rather than to raw agriculture commodities.

Another GAP, according to Amanda Deering, PhD, associate professor in the department of food science at Purdue University in West Lafayette, Ind., is limiting the amount of time that fresh produce touches the soil when possible; however, this is not possible for crops such as cantaloupe, which grow on the ground. Also, fresh produce items that are dropped and touch the ground after harvest should never be sold because they can become damaged when hitting the ground. Cuts and bruises on fruits and vegetables can release nutrients (sugars) from a plant and may be a source of food for any bacteria that are present, which will allow them to grow to high numbers and cause illness in those consuming the fruit or vegetable.

Going Forward

Managing risks in produce production includes addressing potential sources and routes of contamination, such as those described in FSMA. Additionally, if farms aren’t covered by this ruling or face additional distinctive challenges due to their local conditions or practices, they should consider implementing appropriate GAPs, Dr. Mahovic says.

Understanding one’s farming operations is critical to establishing microbially safe practices for safe, fresh produce production. “FSMA’s PSR guidelines don’t fit all farms and only provide scientific recommendations on the common routes of contamination in order to minimize risks,” Dr. Bhullar says. “It’s important to identify all potential concerns of contamination on a farm and to consider them when developing a farm food safety plan.”

Risk-based preventive controls will continue to help minimize risks of contamination; however, there is no such thing as a one-size-fits-all plan. “Microbial food safety risk depends upon pre- and post-harvest practices, agricultural inputs, commodities grown, and environmental factors,” says Dr. Adhikari. “Conducting a risk assessment that is geared toward a particular farm and developing practices to minimize the risk of contamination will help to mitigate specific risks.”

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The bad news began to leak just as the 2008 Summer Olympics in Beijing were starting: Adulterated infant formula was sickening babies in China. After testing, the formula was found to contain melamine, a chemical that is used to produce plastics and coatings and that can cause kidney damage when ingested. It also can be used to increase the nitrogen content in diluted milk, making it look as though the milk has more protein when it is tested for quality. That is what happened in China, where the adulterated milk ultimately caused illnesses in more than 50,000 infants and killed six.

Melamine was found in other products, including eggs and dry milk, sold by the company that produced the infant formula, and some of the products found their way around the world in candies and other foods and drinks. The incident stands as one of the most poignant impacts on the beverage industry and underscores the importance of testing these products for quality and safety.

Adulteration remains a threat today, with supply chain disruptions and baby formula shortages raising product vulnerability issues. Some products may contain substituted ingredients because there are shortages of the original ingredients. Other switches are made for economic gain, to swap out a more costly ingredient with a cheaper one. Any switched ingredients need to be tested because there can be health consequences to consumers.

“Any time there is a shortage, that brings up potential vulnerabilities in the supply chain as far as adulteration,” says Daniel Berg, analytical services manager for Eurofins Food Chemistry Testing in Madison, Wisc. “There’s a lot of need to further verify that the product being produced is safe and formulated with the same quality.”

Testing for adulteration is a growing area in beverage testing, says Tarun Anumol, PhD, director of global food and environment markets at Agilent Technologies in Wilmington, Del. The company sells equipment such as mass spectrometers and gas chromatographs that can detect molecular mass to four decimal places of accuracy. “You typically see this [testing] in higher value, economically upscale items such as alcoholic beverages like spirits, distills, and some beers,” he says. “But the onus falls more on the manufacturer than on regulations because they need to protect their brand identity.” Substitutions can include taking out one flavor and adding another that costs less. Agilent’s equipment can differentiate specific molecules and fraudulent chemicals or flavors, he says.

What to Test

Aside from adulteration tests, beverages and their ingredients are checked for nutritional content, contaminants, allergens, pathogens, and taste, among other factors. The testing can be conducted at various stages in the product’s lifecycle, starting with ingredient testing, tests at a co-packer, and tests at the manufacturer or even at the retailer. Tests can be done either in house or at independent testing laboratories. Some manufacturers may want to outsource pathogen culture tests to an independent laboratory, for example, to avoid possible contamination of their product at the factory, says Berg.

A beverage must contain what its label claims it does. This is especially true if they are “functional” beverages with added vitamins or protein. It is important to have the correct amounts of ingredients in a drink, as more or less protein, for example, could negatively affect a consumer’s health. That includes the amount of sugar, especially if there is a “sugar-free” claim, and the alcohol content, says Dr. Anumol. Approximately 100 parameters are tested in basic nutrition, safety, and quality checks, although producers can choose to test for more.

Another large class of chemicals that are tested are pesticides. A 2008 study in the journal Analytical Chemistry heightened concern about pesticides in fruit-based soft drinks, although drinks sampled from the United States had relatively low levels compared with those in the United Kingdom and Spain. The study still raised concerns globally about what pesticides are used on fruit that ends up in beverages and water sources used in manufacturing that might contain chemicals from runoff.

Chemical and microbiological analyses are key measures taken to ensure the safety and quality of a product and help determine its shelf life once it has entered the market. Chemical testing for beverages could include measurements for pH, titratable acidity, turbidity, or relative clarity and contaminants such as nitrates and nutrients.

FDA guides most of the testing parameters, although companies may choose to conduct broader tests. Changes to the FDA Nutrition and Supplement Facts panel on packaged foods, including labels on beverages, went into effect on January 1, 2021 for larger companies. The updated nutrition panel now includes potassium and vitamin D, because people do not always get the recommended amounts, says Gayle Gleichauf, applications lab manager at Thermo Fisher Scientific, a test equipment manufacturer based in Chelmsford, Mass.

Gleichauf says the trends toward automation and speedier results are pushing demand for equipment such as automatic titrators for testing titratable acidity, vitamin C, and sulfites, as well as qPCR instruments for microbiological testing.

Spoilage organisms pose a risk for producers and have the potential to influence the end product. Beverage companies may test for the presence of specific strains of wild yeast used in fermentation that need to be closely monitored.

Traditionally, this type of microbiological testing has been conducted by culturing and incubating samples overnight or longer, but the use of qPCR can make testing faster and more cost effective for bacteria and yeast assays, she says.

Testing Trendy Drinks

Fermented and functional drinks are two trendy parts of the beverage industry that present their own testing challenges. Fermented drinks, which use yeast and other ingredients to create a specific taste, need to be monitored closely, because they can form undesired byproducts during processing.

Ethyl carbamate, for example, is a naturally occurring component of all fermented foods and beverages, but FDA issued an advisory based on its potential for carcinogenity in high doses in animal tests. The wine industry, for one, is interested in reducing ethyl carbamate levels in its products. FDA also established a level of concern for inorganic arsenic in apple juice.

But fermented drinks are touted by their makers as having health benefits, especially for good digestion and gut health. Beverages including kombucha, kefir, and yogurt drinks can be monitored during fermentation for pH, titratable acidity, sugar, microorganisms (beneficial and otherwise), and other parameters to ensure safety, consistent quality, and shelf life, says Gleichauf.

The pH affects the microorganisms that will be found in the beverage, as well as enzyme reactions, color, shelf-life stability, flavor, and clarity. Titratable acidity is generally considered to be more closely tied to flavor than pH, says Gleichauf, so a low titratable acidity can make a beverage taste flat or soapy, while high titratable acidity results in a tart or sour beverage.

She says the market for other fermented beverages, including craft beer, cider, and wine, is expanding rapidly as well, so similar testing is needed for those products.

Plant-based drinks, which are functional drinks with alternative proteins and claims of being more sustainably produced, also are becoming popular. While manufacturers claim they can control the entire production process in a lab without introducing environmental contaminants, the factory must be kept very clean, says Dr. Anumol.

Sensory testing, especially for new beverages in R&D, is another key part of a beverage’s success. Jerald O’Kennard, executive director of the Beverage Testing Institute in Chicago, says that now is a creative time for new beverages with lower alcohol or more exotic flavors. But producers need to test new products to try to ensure they’ll be a success, he adds.

The institute uses blind taste testing to rank mostly adult beverages by structure, aroma, acidity, balance, flavor, and their intended use. It also looks for flaws and determines whether a wine, for example, is sellable and whether its taste meets a standard of identity for the product category.

“You only get one chance, because the market is very competitive,” says O’Kennard. “If you mess it up, you might not only hurt your brand, but possibly the whole category of the drink for everyone.”

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