Food safety training has traditionally focused on foundational topics such as Hazard Analysis Critical Control Points (HACCP) and Good Manufacturing Practices (GMPs). While these topics are essential in defining and implementing Food Safety Prerequisite Programs, they define the What and How, but not the Why of Food Safety. In order to address the Why of Food Safety, training programs need to address food safety culture, and the role of a food safety management system in establishing that culture.
A session during the 2015 Food Safety Consortium Conference will discuss advancing food safety and harmonization through educating employees. | November 17-20, Schaumburg, IL| REGISTER NOWCreating a food safety culture needs to start at the top. It must be known that food safety is a top priority to upper management. In order for training programs to support a food safety culture, they need to be delivered in a format that enables employees to contribute to the organization’s business strategy and food safety objectives while simultaneously reinforcing employee skills, attitudes and behaviors. Studies have shown that during training, one should consider manufacturing as a whole—not bits and pieces—and that the correct and most effective approach to training should look at collective knowledge requirements rather than any single requirement. A good starting point is to understand how a well-planned management system can help bring focus on a holistic approach that transforms the culture. A company’s ability to adopt a culture of food safety is dependent on its ability to take a holistic approach to manage food safety risk and incorporate all components of a food safety culture.
The second area of focus is having an effective FSMS in place. The International Organization for Standardization (ISO) defines a system as “a set of interrelated or interactive elements” and a management system as “a system to establish policy and objectives and to achieve these objectives.” In order for the FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the whole organization. A food management system is most effective when it benchmarked against a proven standard and independently verified. Having an effective FSMS in place provides a vote of confidence in your organization—a statement that your organization takes safety and quality seriously and has made the right moves to help protect your brand reputation and consumers by addressing the complexity of risks, up and down your supply chain, and assuring food safety and sustainability.
By following these pragmatic guidelines your organization can raise the level of food safety around the world by creating more effective food safety solutions not only for today, but also tomorrow.
To understand why an integrated informatics solution is important to manufacturers in the food and beverage industry, it helps to first consider the unique challenges this industry faces. Simply put, food production has scaled into a global business so rapidly that oversight has hardly kept pace. Even the stricter regulatory stances taken by the FDA and the European Union in the past decade are effectively catch-up efforts.
The broader food industry, which for purposes of this article will also comprise the beverage industry, has globalized quickly and, many would argue, haphazardly. It actually wasn’t that long ago that the products we purchased in our local food store were produced locally or regionally. Seasons determined selections as well—if you wanted a tomato in November, you would pay a premium for that indulgence.
Seasons and geography no longer constrain what we can buy and when. By far the world’s largest industry—with a combined revenue of more than $4 trillion, the food industry has used its massive scale to overcome historical limitations. We now take for granted that our grocery carts can be filled with fresh products that may come from thousands of miles away. And those products may have been grown, processed and shipped in multiple countries before they reach our local grocer.
The complexity and scale of this modern food supply chain is the industry’s greatest challenge and regulators’ greatest worry (on consumers’ behalf). How can growers, producers, processors, packagers, shippers and others in the global supply chain secure a food chain that’s so distributed? How can regulators ensure safety without restricting choice or inflating prices?
The Bits and “Bytes” of Food Safety
The food industry—and its regulators—would likely agree on one thing: A system this massive cannot operate on trust alone, as it once did. The grower with generations of experience on the land, for example, is now too far removed from end consumers. A finished product may contain one farmer’s product and those from five others, all from different regions worldwide.
Integrated informatics may seem like an unlikely fix for modernizing a highly distributed food chain, but it’s actually perfectly suited. An integrated informatics platform provides access to massive amounts of information in a timely fashion, dramatically improving decision-making. It does this by making information rapidly available to many stakeholders and by ensuring that it’s reliable.
Consider this example. A hypothetical lab uses an analytical instrument to detect pesticides in barley, and regulation dictates that this data be compared to allowable maximum residue limits (MRLs). If the barley sample exceeds allowable MRLs, the manufacturer must identify everywhere that ingredient is being used, quarantine it and determine who produced it. All this must happen quickly and according to strict procedures.
Procedures are critical. Not only must the lab have a process for checking against current limits for a pesticide, for example, but also that analytical information must be carefully tracked with the appropriate sample, and the method used to deliver the result must be consistent between different samples and users. Without an integrated informatics solution, adhering to these procedures, defending the quality of the data, and making it usable would be nearly impossible.
The Role of Informatics in Compliance
Gathering the bits and bytes of data, following procedures and making the data useful enterprise-wide is important, but regulatory compliance is where most industry attention is focused today. This is another area where integrated informatics provides significant benefits.
As mentioned above, food industry growth significantly outpaced regulatory oversight in the past decade. Globalization was rapid and inevitable, but so too were food safety breaches, and with progress came stories of tainted fruits, vegetables, meats, cereals, nut butters and much more. Suddenly we had a trust issue. With a food chain that’s distributed across many borders and jurisdictions, how is the public’s trust best protected and by whom?
From the Food Safety Modernization Act (FSMA) to EU Regulation No. 178/2002, we’ve seen a heightened regulatory focus, and the most common themes are traceability, authenticity and risk-based approaches. The common denominator here is food chain security.
So what does all of this mean for multinational food and beverage producers? It means having to conform to multiple regulatory requirements for each distribution market, and there are often many. And this is a data management and reporting headache. Fortunately, however, common standards such as ISO 22000 exist that enable companies to standardize their processes enterprise-wide, achieving levels of operational rigor and quality that satisfy multiple regulatory authorities at once.
So where do informatics fit into this regulatory compliance landscape? In a typical multinational food producer, a significant amount of the quality data is delivered by the laboratory. Raw materials are analysed for pesticides, herbicides, nutritional content and so on. Packaged products are monitored for shelf-life compliance. Plant hygiene is monitored using microbiological samples taken from across the facility. Records from all of these distinct, but interrelated activities are critical for demonstrating compliance.
Defending Data
The shift in recent years has been toward prevention instead of crisis response. Regulators now focus on auditing food and beverage producers to assess their practices prior to any adverse event. For companies with good systems in place, time-consuming audits will be less frequent, so it pays to have systems in place that demonstrate that data is reliable and defensible.
Audits can be daunting. The producer must prove that activities were carried out correctly, that records are properly collected and that supporting information is accurate. Auditors typically pick a starting point in a process and follow the trail. They may start by looking at the data associated with a released batch of product; perhaps quality assurance samples; follow the trail to cleaning validation, and then review individual laboratory results, including entire methods, instrument calibration, user training, etc. At each point of the audit, producers must show evidence of compliance—even the smallest details.
With an integrated informatics solution, all evidence resides in a single platform. Hierarchies and relationships within the data records are automatically recorded and retained. Everything—from relationships between lots or batches of material; the connection between methods, specifications and results; the history of an instrument configuration, maintenance and calibration; and user training records—is in one place for easy retrieval and reporting.
Having one system of record not only codifies data capture, it also helps labs create standard operating procedures (SOPs). Establishing SOPs does several important things:
It ensures that all lab users are following the same process—no personal preferences for carrying out a specific test.
It makes sure that all necessary data is collected—by enforcing a series of data entry steps, labs can prevent a method from being marked complete until everything has been entered.
Labs can roll out updates to their processes by updating the method for all users at the same time.
Managing lab execution activities in this way means that data is more consistent; it is being collected in the same way for all users. It is also prone to fewer errors because users move stepwise through each stage of the measurement process, and they can stop a test whenever they encounter a problem.
Achieving Traceability
Traceability, the ability to verify the history, location or application of an item using documented information, has become increasingly more important for the food industry. And traceability is closely linked to compliance and data defensibility. Fortunately, traceability is another strength of an integrated informatics solution.
In practical terms, to demonstrate traceability we must be able to go either backwards or forwards within a set of process items and understand the complicated relationships. An integrated informatics solution lets us map relationships between “child” and “parent” batches, information that can also come from integrating ERP or process or production information management (PIMS) systems. By integrating all this information, manufacturers can trace a product back through intermediate products and raw materials and then forward again to any resultant batches that may be contaminated. In other words, with an integrated informatics solution, traceability is built in.
Brand Protection
Because of its size and fragmentation, the global food and beverage industry is a target for adulteration and counterfeiting. The Grocery Manufacturers Association estimates that these activities cost the industry $10–15 billion each year.
While the risk to consumers of adulteration can be deadly, as in the case of milk solids adulterated with melamine in China, much of the impact comes in the form of trust erosion and fraud. An example is Manuka honey, a premium product with purported health benefits that commands a high price. The entry of fraudulent producers into the market affects legitimate producers by creating uncertainly about all products, depressing sales and lowering prices.
Having access to data from all critical points in the food production chain is the most important safeguard against product recalls and loss of revenue for food manufacturers. Having an integrated informatics solution in place provides data when it is needed for quality checks in the production process, for management metrics reporting or to adhere to regulatory requirements. (Click to enlarge)
This is only one example, but it illustrates the larger problem: Once consumer trust erodes, it’s hard to regain. As it happens, however, honey has unique chemical markers that can be used to determine whether it has been adulterated. But isolating these markers involves complex analysis, including ultra- high-performance liquid chromatography (UHPLC), and methods that are highly specific, consistent and defensible.
Consistency and defensibility are hallmarks of an integrated informatics solution. For the honey producers, an informatics solutions, such a LIMS, can automate processes so that no non-conforming product is missed, establish compliance rules and checks for instrument calibration so that results are defensible, and standardize methods through built-in laboratory execution system (LES) capability.
Conclusion
An integrated informatics solutions is designed to address multiple business needs in the food and beverage industry, from compliance and data defensibility to traceability and brand protection. The complexity and scale of the modern food supply chain demands it.
Growers, producers, processers, packagers, shippers and others in the global supply chain are now interdependent, but not necessarily integrated. The only way to protect consumers, however, is to achieve this integration through a combination of voluntary and imposed compliance. And to achieve this compliance without undue burden on the industry and imposing higher costs on consumers, we need technology that is built for integration at scale—and informatics solutions have proven they are more than capable.
The upcoming implementation of FSMA will likely result in increased scrutiny of contaminants in food products. If the foreign matter can be identified, steps can be taken to eliminate the source of contamination and avoid future losses of product. Small foreign particles are sometimes observed in drums of bulk granular or powdered raw materials. While these foreign particles may be seen as dark specks in the product, they are often too small for standard QA/QC methods of analysis. Microanalytical techniques, however, can be used to isolate and identify the specks. This article describes a case study of dark particles in a granulated sugar sample.
Microscope Exam
Ideally, when conducting contaminant analysis, all sample manipulations take place in a cleanroom to eliminate the chance for contamination by extraneous environmental debris. This is especially important when working with small contaminant particles, which may consist of environmental debris such as metal particles, fibers and other types of dirt. If the unknown particles are identified as common environmental debris, the analyst must be certain that he or she did not introduce any debris while handling the unknown sample.
Figure 1. Granulated sugar with dark foreign particles, 13X (Click to enlarge)
The first step in the identification process involves examination of the sample under a stereomicroscope. Figure 1 is a photomicrograph of dark brown particles, less than 1 mm in size, in the sugar sample. Particles of this size must be isolated from the bulk product prior to analysis in order to correctly identify them.
Since all of the dark particles are visually similar, only a few representative particles need to be isolated. The contaminants can be isolated by removing a small glob of tacky adhesive (50 µm or smaller) from a piece of tape with the pointed tip of a fine tungsten needle. The adhesive-coated needle tip is gently touched to the surface of one of the dark particles, causing the particle to adhere to the needle, and the particle is transferred to a glass slide or other substrate for further examination.
Figure 2. Isolated dark foreign particles, 63X. (Click to enlarge)
Figure 2 is a photomicrograph of three dark particles, isolated from the sugar granulation. The dark brown particles have a smooth, shiny appearance with conchoidal (shell-shaped) fracture surfaces, and are visually consistent with glass. However, when probed with the tungsten needle, the particles are found to be brittle and fragile, and this texture is not consistent with glass. Therefore, chemical analysis is needed to identify the brown particles.
Micro-FTIR Analysis to Identify Organic Components
Most organic compounds (and some inorganic materials) can be identified by Fourier transform infrared (FTIR) spectroscopy. For the analysis of small particles, a microscope is coupled with a standard FTIR system; this method of analysis is known as micro-FTIR analysis. The micro-FTIR system passes a beam of infrared radiation through the sample and records the different frequencies at which the sample absorbs the light, producing a unique infrared spectrum, which is a chemical fingerprint of the material. By comparing the spectrum of the sample with spectra of known compounds from a reference library through an automated computer search, the sample can often be identified.
In order for the FTIR analysis to work, the sample must be transparent, or thin enough to transmit light. In the case of the particles from this case study, this is achieved by applying pressure to a ~50 µm portion of the sample until it forms a thin transparent film. This film is placed on a salt crystal for micro-FTIR analysis.
An FTIR spectrum of crystalline sugar is shown in Figure 3, and a spectrum of a brown particle is shown in Figure 4. The spectrum of the brown particle has some similarities to sugar, but there are fewer peaks, and the remaining peaks are rounded, consistent with a loss of crystallinity. The loss of crystallinity, coupled with the brown color of the particles, suggests charred sugar.
Figure 3. FTIR spectrum of granulated sugar. (Click to enlarge)
Figure 4. FTIR spectrum of a dark foreign particle. (Click to enlarge)
SEM/EDS to Identify Inorganic Compounds
The FTIR method does not provide complete information about the presence or absence of inorganic materials in the contaminant. To complete the analysis of the brown particles, scanning electron microscopy (SEM) combined with an energy dispersive X-ray spectrometer (EDS) detector is needed. Using the SEM/EDS method, two types of information are obtained: SEM provides images of the sample, and the EDS identifies the elements that are present.
Figure 5. SEM/EDS analysis of a dark foreign particle
A brown particle was mounted on a beryllium stub with a small amount of adhesive, and submitted for SEM/EDS analysis. Figure 5 includes an SEM image of the particle, and a table of EDS data. The SEM image provides some information about the composition of the particle. This image was acquired using backscattered electron mode, in which heavier elements appear lighter in color. The image displays light colored specks scattered across the surface of the particle, indicating that more than one type of material is present. The light-colored circle on the SEM image shows the area that was included in the EDS analysis (the entire particle was analyzed). Looking at the column in the table for weight percent (Wt%), the particle consists primarily of carbon and oxygen, with small amounts of chlorine and iron. Carbon and oxygen are chemical constituents of sugar, but chlorine and iron are not.
Figure 6. SEM/EDS analysis of specks on a dark foreign particle
The EDS system can also be used to focus on individual small areas on the particle. Figure 6 includes EDS data from five specific light-colored specks on the surface of the brown particle. The specks contain major amounts of iron with small amounts of chlorine, and sometimes chromium and silicon, plus contributions from carbon and oxygen from the surrounding sugar matrix. The composition of the specks indicates steel corrosion, likely from low alloy steel. The presence of chlorine suggests that a chlorinated substance was the initiator for the corrosion process.
In some cases, steel corrosion can be the sole cause of brown or dark discoloration of small particles. In the case of this brown particle, the SEM image shows that the iron-rich particles are not evenly distributed throughout the particle, but are only scattered on the surface. Charring is the most likely cause of the overall brown color of the particle.
Conclusion
When examined under the microscope, the dark particles in the sugar sample had the visual appearance of glass. However, chemical microanalysis of the particles revealed that they were not glass at all, highlighting the importance of microanalytical methods in determining the identity of the foreign matter. The brown particles were ultimately identified as charred sugar particles with scattered specks of steel corrosion (likely from low alloy steel) on the surface. This information can be used to narrow down the search for possible sources of the brown particles in the bulk sugar sample. As part of a root cause investigation, samples of dark particles from various locations in the manufacturing and packaging processes can be studied by the same techniques to look for a match.
For consumers and manufacturers, product quality and cleanliness are a preeminent priority. Product recalls resulting from manufacturing errors in sanitation often warrant national headlines and cause widespread mistrust and panic among consumers.
After a tumultuous spring and summer, Blue Bell Creameries, a Texas-based ice cream manufacturer, will be restocking its products in select grocery store freezers in five phases. The popular brand was forced to recall its products due to Listeria contamination, which has been blamed for the deaths of three people.
Learning from these instances can greatly reduce the number of sanitation-related issues in the future. Investing in sanitation not only increases safety but does wonders for performance and efficiency.
How can sanitation be a competitive advantage and not a troublesome necessity? It’s all about OEE.
Investing in sanitation efficiency now will pay off later. Image courtesy of Myrtle Consulting Group
While not investing in sanitation may save you a little money in the short-run, neglecting it can cause exponentially larger costs down the road, including elevated food scrap, equipment reliability failures, excessive non-value adding to production time, expensive recalls, remediation costs, potential legal liability, and destroyed consumer trust.
A focus on Overall Equipment Effectiveness (OEE) will increase capacity without investment or additional resources, and it does not need to be overly difficult or expensive. However, OEE management does require detailed process analysis, process rethinking, reconstructing of resource assignments, and installation of management control and reporting systems. When equipment is scheduled to run, it’s running at the correct rate, using the right number of resources and at the right level of quality. This will not only boost the efficiency of your operation, but the safety and quality of it as well.
An Important Piece of the Puzzle
Adopting lean techniques into your sanitation plan is an effective and efficient way to improve process time. With this approach, you can determine:
Using LEAN will allow you focus in on three essential areas: the elimination of waste, reduction in variability and reduction of inflexibility. When these factors come together, work can be completed in a standardized, efficient and sanitary manner.
Study. Streamline. Standardize.
Product recalls due to manufacturing errors in sanitation cause mistrust among consumers. Image courtesy of Myrtle Consulting Group
Study. To incorporate, improve or ensure sanitation, the first step is to evaluate what you’re working with. Take the time to examine existing protocols and contracts. Conducting a detailed study of the current processes can help you define the areas that need work, which may include equipment effectiveness, supervisory staff and materials used.
Streamline. Once you obtain the initial result of the study, goals and plans can be determined to streamline the process and make everything run more efficiently. It is not unusual to discover at least 30% of non-valued time within the existing process, mainly due to poor planning, poor coordination or the use of overly cumbersome methods.
Standardize. After creating a plan to improve effectiveness and sanitation, swift and certain implementation of these ideas are critical to maintain commitment and realize results. With a detailed plan, sanitation of machines and other supplies can be executed in an exact, timely fashion.
Placing Sanitation Operation First
One of the biggest mistakes that can be made in manufacturing is viewing sanitation operations as secondary in importance. This attitude can lead to all kinds of oversight and carelessness, which can cause costly mistakes. Clear expectations, clear roles and responsibilities, and measured performance are the hallmarks of well-executed operations and an effective way to make sanitation a priority.
Dramatic Improvements, Significant Savings
Making these changes to increase efficiency and sanitation have yielded dramatic improvements for manufacturers. A large U.S. food manufacturer installed this system in five of their plants and quickly cut costs while boosting productivity. One of the plants was able to repatriate production outsourced to a co-manufacturer at a savings of approximately $500,000. Another replaced its entire 50+ person sanitation crew with a subcontract cleaning crew, reducing its labor cost from $22 to $11.47 an hour, while at the same time increasing the work effectiveness of the crew and performing 15% more sanitation work within the same time frame.
Manufacturing isn’t only about quantity; it involves ensuring a level of quality that builds consumer loyalty and efficiency. When your product potentially poses risk for the consumer, it also poses a danger to your business and its success. Remember, you don’t have to risk using unsanitary methods for the sake of saving money or increasing efficiency. In fact, sanitation and efficiency are easily attainable when they are brought together in a strategic plan. Putting in the time and dedication to create an effective sanitation plan will help you avoid negative consequences and bring you to the top of your game. Stay clean.
Research and development (R&D) is an essential starting point toward the creation or modification of new and exciting food products, processes and packaging. To ensure that a product is safe for consumption, food safety should be considered during the initial stages of a product’s lifecycle. Incorporating food safety into R&D can be tricky, as safety considerations may change the initial idea or concept of a new food product. For example, the idea of a freshly squeezed orange juice in every supermarket shelf is appealing; however, without pasteurization, that juice will not be safe for consumption, nor will it have the desired shelf life. Adding raw chopped garlic to a hummus product makes it taste great, but will it be safe for consumption after being on the shelf for a month?
To better understand how safety of new products is assured from concept to launch, I spoke with two R&D scientists about food safety considerations during new product development. The interviewees, Maria and Laura, work for the same large food manufacturer, which is located in the Midwest, in the snack foods and breakfast cereals categories, respectively. They both confirm that the R&D team follows a specific procedure during the product concept phase—one that places food safety at the forefront. The team starts by determining how the new product compares to food safety regimens already in place with other products that the company manufactures. If the product is a line extension with only a few changes to an existing formulation, the food safety concerns are likely to be low, and the food safety program already in place is adapted to meet the safety needs of the new product. However, if the product being developed is highly differentiated from other products manufactured by the company, food safety moves into a more central role throughout the development cycle.
According to Maria and Laura, the first step in ensuring food safety for a new product is for the development scientists to have in-depth discussions about the product’s formulation, ingredients and supply sources. These three aspects, along with the planned manufacturing process, are then evaluated through a hazard assessment. The hazard assessment is comprised of microbiological, quality, regulatory, stability and physical hazard assessments. Ingredients that pose food safety concerns without prior controls and process conditions are identified. The quality team determines controls for these ingredients and subsequently involves process engineers to verify that process conditions are attainable and will provide proper control for the hazards identified. A complete HAACP plan is put in place for the new product production, taking into consideration equipment cleanability and location, traffic control for ingredients and operators, and air handling systems. The hazard assessment is documented in detail and must be approved by the quality manager before production runs can begin and development can resume. Although the entire process is led by R&D, multiple other functions are involved and consulted throughout the process.
Manufacturing processes, formulation and market availability of ingredients drive the food safety of a new product, with manufacturing processes and formulation usually being the key drivers. “However, in cases like the recent shortage of eggs due to the avian flu crisis, finding substitutions for ingredients in shortage becomes an important driver for food safety,” says Maria. Laura says that at times, product formulations can change due the integrity of the ingredient or its source. In such cases, a similar ingredient from a credible source is chosen and the safety of the product is re-assessed. There are critical quality and food safety elements that must be considered in the product design phase to prevent issues later in development. When R&D professionals keep these elements top-of-mind when considering formulation and ingredient sourcing, everyone benefits—from the company to consumers.
Although consumer confidence in the safety of the U.S. food supply is slipping (11% said they were “very confident” in the safety of the food supply, down from 15% in 2013; 50% said they were “somewhat confident”, down from 55% in 2013, according to the International Food Information Council’s 2015 Food and Health Survey), the interview with Maria and Laura shows that manufacturers are putting significant effort into developing safe food products. It is equally as important for suppliers and vendors to have robust food safety programs to build strong relationships with manufacturers. Food companies have a lot to lose if a product they develop is, or becomes, unsafe for consumption. Not only can the average cost of a recall add up to $10 million in direct costs to a food company, lost sales and the impact to the company’s market value, brand reputation, and business relationships is major. Some companies never recover from the punch. Through taking the time to audit suppliers, screen new ingredients, and make robust prototypes, food companies can be more confident in the safety of their innovative new products as they go through the development process.
Donald Bowersox, a long-time business professor at Michigan State University and one of the progenitors of modern supply chain management, once said, “The job of supply chain is clearly a senior management challenge, and it’s one that sits right alongside the other C-level jobs in the corporation. We may call it something different going forward, but basically it will remain the stewardship of moving products from the material origin points all the way through the process of conversion to the end consumers efficiently, effectively, and relevantly. That challenge is a big one and will continue to be for a long time. So I don’t see a next organizational evolution. Instead, I see the supply chain manager becoming more deeply involved in the corporate strategic initiatives and being part of the C-team management.”
Applying this approach to food safety in the supply chain has become more critical during the last few years as a result of regulatory, market and consumer pressures. At the start of this century, only 15 years ago, the food safety director rarely, if ever, interacted with the CEO. Many retailers didn’t even have such a position, or it was combined with quality control or loss prevention.
Now, not only does the top food safety manager have the ear of the CEO, he or she is engaged with all senior executives. Part of this is the result of the Food Safety Modernization Act, which holds those officers personally liable for a wide variety of preventable incidents. Likely bigger causes for the shift are the changing market and the changing consumer, which both relate directly to the company’s brand reputation. And in the food business, everything starts and stops with the supply chain.
Why? Because the supply chain is ground zero for the failures that are responsible for causing food safety problems. And the supply chain is where food safety problems are prevented. It is the choke point or series of choke points that allow or prevent spoiled and tainted product from getting to the consumer. It is also the process by which that unsaleable product is reclaimed so as to ensure it never enters the marketplace.
It is critical for the food safety manager to work closely with the merchandisers and the store operations teams, as they have the relationships with suppliers and work to ensure that standards for everything from ingredients to production are met with every shipment. But it’s even more critical for those professionals to work closely with the supply chain team to determine weak links in the system and address those pressure points before they cause real damage. Without food safety-supply chain collaboration, the risks to a company’s reputation multiply. With it, the likelihood of a food safety incident reaching consumers diminishes tremendously.
It’s becoming clearer every day—if you don’t button up your supply chain, somebody else, namely the government or the consumer, will and the results won’t be pleasant.
By Gina R. Nicholson-Kramer, Jeff Mitchell No Comments
Listeria: It has been in the news and in our food throughout the past year. It has cost companies millions of dollars in recalls, shutdowns and mitigation; it has cost the government thousands of dollars in outbreak investigation, inspection and follow-up; and it has cost millions of dollars in medical bills for victims and for some, it has cost their lives.
I have asked Jeff Mitchell, vice president of food safety at Chemstar, to share his knowledge about Listeria mitigation and control, and to talk about the research that supports the innovative program that Chemstar uses with its customers.
Listeria Mitigation & Control Program
By Jeff Mitchell
Jeff Mitchell, Vice President of Food Safety, Chemstar
Thus far this year there have been several recalls of ready-to-eat (RTE) foods due to contamination with Listeria monocytogenes. Efforts to prevent contamination of food products with Listeria monocytogenes must be conducted at all levels of production. This is a difficult task given the fact that the bacteria is so widespread in the environment. Focusing efforts in your process where contamination risk is of greatest concern to the consumer is important. There is solid evidence that commercially prepared foods that have been contaminated with Listeria monocytogenes has occurred after the food product has been subjected to an initial lethality treatment. The product may be exposed in this area as a result of slicing, peeling, packing, re-bagging, cooling, or other procedures that may expose the product to potential contamination.
Listeria monocytogenes survives extremely well in food processing and retail food preparation environments. It may be introduced into your facility through a variety of routes, including:
Raw materials
Employees’ shoes or clothes
Equipment (boxes, crates, carts)
Controlling traffic flow into critical areas of the process can help reduce the chances of introducing and spreading the organism.
Once Listeria is introduced into the nonsterile environment, retail and factory conditions that promote its growth increase the risk of post-processing contamination. Several factors, including moisture, nutrients, temperature, competitive microflora and pH, affect the growth of Listeria in the food preparation and processing environment. Moisture is the most crucial factor, as it is essential for microbial growth and is the most easily controlled of the factors.
Listeria tends to form a biofilm to enhance its survival when resident populations become established in the food prep/processing environment. The resident populations that are referred to as “persistent” are not easily eliminated by general cleaning and sanitizing procedures. Biofilm penetration is necessary for removal and inactivation of Listeria. The correct blend of chemical, contact time and agitation will aid in the removal. This combination dissolves the biofilm and the organic material to which it adheres, allowing the sanitizer to inactivate the released, sensitive cells.
To learn more about Listeria from Gina and Jeff, check out their archived webinar with Food Safety Tech, Preventing Listeria Contamination: A Practical Guide to Food Safety ControlsBiofilm removal is important, because persistent L. monocytogenes can be dispersed from a biofilm into the environment and onto food processing equipment, and non-food contact and food-contact surfaces. Passive dispersal of Listeria can occur by aerosolization from high-pressure hoses or brushing; once aerosolized, Listeria can contaminate other growth niches in the food handling/processing area, eventually contaminating food contact surfaces and food. Another form of passive dispersal is the movement of processing equipment. If a biofilm is present, cells can be released by the movement or vibration of the equipment.
Inactivation of L. monocytogenes in biofilms is an important part of a Listeria control program. Understanding this face prompted our team to perform research with the University of Georgia using a mixed culture biofilm formed by Pseudomonas putida and L. monocytogenes to evaluate the ability of Chemstar’s foaming sanitizer to inactivate L. monocytogenes present in biofilms under realistic use conditions. The results revealed that it provides for a greater than four-log reduction.1
Identifying Listeria in the environment and eliminating the resident populations can reduce the risk of secondary contamination. Once these procedures are established, employee training and environmental monitoring are vital. An effective Listeria control program requires that employees understand their role in mitigating the spread of Listeria, and management must relay those expectations. Control strategies are not likely to be effective if employees won’t cooperate, or don’t understand what they are expected to do, or why it is important, and that expected procedures or behavior will be monitored.
Reference
Frank, J. and Mitchell, J. (December 3, 2010). Evaluation of Chemstar foaming sanitizer for inactivating Listeria monocytogene in floor drain biofilms.
Join us for the Listeria Mitigation and Control Workshop at the Food Safety Consortium in Schaumburg, IL on November 17, 2015. Learn about the Five Key Elements in building an effective Listeria Control Program:
Specific Sanitation Controls for Listeria
Training of Personnel (they need to understand their role in the program)
Traffic Control
Targeted Environmental Monitoring and Testing
Control Water Introduced into the Process Environment
The workshop will be a hands-on approach to learning about Listeria and practical solutions to take back and implement into your company’s sanitation program.
We’ve said this already: 50 different methods for labeling U.S. food products just aren’t realistic from both a practical as well as a cost standpoint. Thus, it is not surprising that we continue to see activity in this space from Congress.
The latest round from Congress would pre-empt state efforts and put the responsibility on federal food agencies. The move is a result of the voice-vote passage of The Safe and Accurate Food Labeling Act of 2015 (H.R. 1599) by the House Agriculture Committee. This bill would stop state GMO-regulatory efforts and ban mandatory GMO labeling. FDA would also develop a non-GMO labeling standard, similar to that of USDA’s organic labeling.
The bill, which is a substitute amendment of the original bill, will go to the House (which is expected to pass it) and then to the Senate (where passage is less certain).
If approved by Congress and signed by President Obama, H.R. 1599 would:
Pre-empt state-level efforts to enact mandatory GMO labeling laws, overturning the state GMO-labeling laws recently passed and prohibiting local regulation of GMO crops.
Create a voluntary, consistent federal process of certifying and labeling food products as non-GMO, while prohibiting the mandating of labeling for all GMO foods.
Allow the Secretary to require labeling of a GMO food if “(A) there is a material difference in the functional, nutritional, or compositional characteristics, allergenicity, or other attributes between the food so produced and its comparable food; and (B) the disclosure of such material difference is necessary to protect public health and safety or to prevent the label or labeling of the food so produced from being false or misleading in any particular.”
Require that manufacturers have written FDA certification that a GMO product is safe.
While “right-to-know” activists are pushing GMO labeling, some on the other side are saying that this bill recognizes that right to know about a food’s origin and production is similar to the current labeling of organic foods. Rather than requiring that food manufacturers label their products as non-organic, the USDA National Organic Program allows approved products—and only NOP-approved products—to be labeled as organic. Similarly, as proposed in the bill, a standard to be developed by FDA would allow food manufacturers to label approved products—and only approved products—as GMO-free. Thus, like organic, those concerned with GMOs could purchase products fitting their needs.
This is an important difference, especially regarding the perceived safety of food products. Research conducted by the PEW Research Center reveals that although 88% of scientists from the American Association for the Advancement of Science say GMO foods are safe to consume, 57% of the general public believe these foods are unsafe. If more than half of your potential consumers mistakenly believe your product is unsafe, that would certainly have significant effect on your company’s business. Again, it is a similar argument as that of organic, where supporters often promote the food as healthier, despite USDA’s repeated assertion that “organic” simply means organic, not better or healthier.
In addition to the pro- and anti-labeling sides, the controversy has long been about who should have the authority. As we’ve said before, establishing state laws (i.e., those already passed by Vermont, Connecticut and Maine) would create a patchwork of rules, and food manufacturers would have to adapt to 50 different sets of laws.
Fundamentally, the consumers right to know what they are eating is not only understandable but, to me, totally appropriate. Where this goes off the rails is when it comes to complex labeling requirements and a push to require food companies to put information on labels that is nice to know but not critical to know. Regulations should be about protecting the consumer, and until (or unless) we have solid science indicating GMO foods are a problem that requires a warning, let’s keep mandatory labels where they belong and information for curious consumers in places where they can access it easily using modern technology.
Scientists have been challenged by the capability limits of gas chromatography high- resolution mass spectroscopy (GC-HRMS) systems for years. There has been interest in a high-resolution accurate mass (HRAM) system with applications in food safety, and a new GC-HRMS technology for pesticide analysis indicates a step forward in GC-MS analysis.
Mass Accuracy Benefits
At the recent 1st International Symposium on Recent Developments in Pesticides Analysis in Prague, Hans Mol, Ph.D., of the RIKILT Research Institute and Jana Hajslova, Ph.D., a professor at the Institute of Chemical Technology, Prague, presented new data obtained using a technology called the Q Exactive GC system based on GC separation, electron ionization (EI) and detection using a hybrid quadrupole-Orbitrap mass spectrometer. Mol described the system as a promising and complementary method to LC-Orbitrap that together enable new comprehensive workflows for quantitative analysis of targeted compounds and qualitative screening of non-targeted compounds for both GC and LC amenable pesticides. He also discussed the advantages of excellent mass accuracy (<1 ppm) for each scan across a peak in a complex matrix, at a resolving power (RP) of 60,000, and the simplicity of one acquisition event to obtain multiple accurate mass ions that can make use of existing EI-MS libraries.View videos of the symposium
Resolving Power
As sample types increase in complexity, the resolving power of the mass spectrometer becomes a key factor in reliable pesticide detection. A study that examines high-efficiency broad scope screening of pesticides using GC-HRAM details the mass accuracy, acquisition rate, linearity, detectability, accuracy, precision and identification capability observed at high resolving power. The experiment revealed that 60K RP (m/z 200, full width half maxima, FWHM) was needed to discriminate analytes of interest from matrix components and thus achieve reliable results for pesticides spiked into animal feed. The results indicate that the new system, when used with specific screening software, is an effective tool for routine screening of pesticides in food and feed samples.
Similar experiments for the analysis of pesticides in baby food again demonstrated that full scan acquisition at high resolving power (60,000 FWHM at m/z 200) provided a sufficient number of scans across individual chromatographic peaks to obtain excellent measurement precision over a wide linear dynamic range. Based on retention time (±0.1 min window), accurate mass information (±2 ppm window), ion ratios, isotopic pattern similarity (measured versus theoretical), and library search hit (NIST14 all 132 pesticides spiked at 10 ng/g were detected and identified in acetonitrile extracts of baby food. Overall the Q Exactive GC system provided selectivity at least if not better than, and quantitative performance comparable to, GC triple quadrupole MS.
Different Pesticides Screening Methods
Hajslova also discussed the use of the Orbitrap technology in two different pesticide screening methods. The first approach focused on the targeted screen for pesticides from a customized HRAM database and a review of data using software. The second method involved non-targeted screening using deconvolution of accurate mass data and spectral library matching with identification using accurate mass fragments. When analyzing pesticides in whiskey samples, Hajslova commented that she was surprised that many compounds where automatically identified. Since a non-targeted method involves full scan data, it allows the identification of compounds that would go undetected in a targeted method.
Screening using high-resolution mass spectrometry is an effective way to increase the scope of analysis. Routine resolving power of 60,000 FWHM eliminates matrix interferences, increasing confidence in results when screening pesticides in complex matrices. Consistent sub-ppm mass accuracy ensures confident compound identification.
Laboratory testing is an integral part of the cannabis industry for the same reasons it is important in the food industry. To ensure the consumer is ingesting a safe product, accurate testing should be required for microbials, pathogens, pesticides, heavy metals, and perhaps most importantly dosage. Unfortunately, however, the problem is that testing requirements are not quite there yet in the handful of states that have legalized marijuana for recreational or medical purposes. This creates a degree of uncertainty in the marketplace, which is detrimental to the growth of the industry as a whole.
Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.
Lauren Finesilver, Executive Chef at Sweet Grass Kitchen, sits on a counsel for compliance with C4 (Colorado Cannabis Chamber of Commerce). Finesilver believes “We are a food manufacturer first and foremost so we need to ensure we sell a final product that is safe for the public and [one] that consumers know is coming from a responsible manufacturer.” Ahead of marijuana rule changes that are soon to come, Colorado’s Marijuana Enforcement Division (MED) announced five new rulemaking working groups, one of which will address testing, packaging, and labeling.
Some states, including Colorado and Nevada, have made impressive strides in implementing proper testing regulations.
“Nevada has done a really good job from the start in designing a program where they have at least addressed some of the issues with product quality including testing, labeling, and potency requirements,” says Tobias Paquet, Chief Scientific Officer of C3 Labs, LLC (Cannabis Chemistry Consulting).
Paquet, who previously worked at Waters Corporation as a field chemistry specialist, cites potential contamination at almost every step of the cannabis supply chain from seed to sale. “Some of the biggest concerns with contamination during cultivation or extraction are pesticides, heavy metals, and microbial contamination,” he says, adding that he is most concerned about two microbial carcinogens—mycotoxin and aflatoxins.
“We aim to provide reliable and consistent labeling that is accurate and reflects the contents of that product,” says Paquet. “This comes with a validated method on qualified instruments and laboratory accreditation.”
Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.
Much like the food industry, accurate testing across the board is needed for consumers to feel safe ingesting edibles containing marijuana. Laboratories that operate in states where marijuana is already legal need to utilize good laboratory practices and standards to ensure consistency.
“We have been working to create an accreditation process that is accepted on a national level,” says Roger Brauninger, biosafety program manager at the American Association for Laboratory Accreditation (A2LA). “Without firm state laboratory accreditation regulatory requirements in place, the possibility exists that people may shop laboratories to get the results they want. So if applied across the board, ISO 17025 accreditation would help reduce that, thereby helping to create greater consistency of tests results between laboratories, ultimately helping to reduce marketplace confusion.”
The cannabis industry has the momentum to become a safe and regulated marketplace as state reforms continue, with testing and analytics acting as the wind behind its sails.
Matt Karnes, founder and managing partner of GreenWave Advisors, LLC, suggests that by 2020, assuming full legalization occurs in all 50 states and D.C., the lab testing industry could easily reach $850 million (this figure includes testing, data analytics and consulting services). The firm provides an analysis of each state’s potential market size which is predicated on its U.S. retail marijuana forecast of $35 billion (again, assuming full legalization by 2020). Karnes was recently cited in a Forbes article suggesting that cannabis testing is one of a handful of top new technology investment opportunities.
Karnes’ predictions echo that of many when discussing the cannabis analytics space. “More states are becoming focused on standardized laboratory testing requirements,” he says. “There is really no consistency, which is something that needs to be worked out.”
While a handful of states work toward achieving good laboratory standards, players in the cannabis industry, including laboratories, dispensaries, and cultivators, continue to self-regulate when it comes to safety and quality.
CannabisIndustryJournal.com, our newest publication, will be launched in late September. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!
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