Tag Archives: FSMA

FDA

FDA Says Routine Intentional Adulteration Inspections Will Start March 2020

By Food Safety Tech Staff
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FDA

Learn more about how to mitigate the risks of food fraud and intentional adulteration at the Food Safety Supply Chain Conference | May 29–30, 2019 | Rockville, MD or attend virtuallyThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.

The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.

FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.

Todd Fabec, Rfxcel
FST Soapbox

Why the Modern Food Supply Chain Needs Real-Time Environmental Monitoring

By Todd Fabec
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Todd Fabec, Rfxcel

Food supply chains are becoming more complex, as food companies are increasingly faced with blind spots such as deviations from required environmental conditions, theft, fraud and poor handling. Supply chains are global; transit routes that involve road, rail, sea and air create many potential points of failure in food safety or product integrity protocol that, until recently, were largely outside a company’s control.

Learn more about how to address risks in your supply chain at the Food Safety Supply Chain Conference | May 29–30, 2019 | Rockville, MD (or attend virtually)To maintain product quality and safety, companies should implement an environmental monitoring (EM) solution that paints a complete picture of their food products as they move through the supply chain. EM solutions that utilize devices powered by the Internet of Things (IoT) allow real-time tracking of cargo and provide actionable data that can mitigate common problems, change outcomes, and protect brands and consumer health.

Let’s take a deeper look into the problems that food manufacturers and distributors are facing how EM solutions can minimize or eliminate them altogether.

Current Hurdles for Food Supply Chains

As the global network of food trade expands, the diverse challenges facing suppliers, manufacturers, distributors and logistics companies present even more of a threat to supply chains and revenue.

According to PwC agribusiness advisory partner, Greg Quinn, worldwide food fraud results in losses of at least $65 billion a year. Luxury products such as Japanese Wagyu beef and Italian olive oil are regularly counterfeited and incorrectly labeled, and buyers often have no way to trace the origins of what they are purchasing.

Companies in the food and beverage industry also face diversion and theft, which can happen at any of the many blind spots along the supply chain. In fact, food and beverages were among the top commodities targeted by thieves in North America last year, accounting for 34% of all cargo theft, according to a report by BSI Supply Chain Services and Solutions.

Food product quality and safety are also seriously compromised when cargo is poorly handled while in transit, with hazards such as exposure to water, heat and cold, or substance contamination. These types of damages can be particularly acute in the cold chain, where perishable products must be moved quickly under specific environmental conditions, including temperature, humidity and light.

Furthermore, inefficiencies in routing—from not adhering to transport regulations to more basic oversights such as not monitoring traffic or not utilizing GPS location tracking—delay shipments, can result in product spoilage and/or shortened shelf life, and cost companies money. Routing and EM have become more important in light of FSMA, which FDA designed to better protect consumers by strengthening food safety systems for foodborne illnesses.

In short, businesses that manage food supply chains need to be on top of their game to guarantee product quality and safety and care for their brand.

How Does Product Tracking Technology Work?

Real-time EM solutions are proving to be an invaluable asset for companies seeking to combat supply chain challenges. Such product tracking capabilities give companies a vibrant and detailed picture of where their products are and what is happening to them. With EM in the supply chain, IoT technology is the crucial link to continuity, visibility and productivity.

So, how does integrated EM work? Sensors on pallets, cases or containers send data over communication networks at regular intervals. The data is made available via a software platform, where users can set parameters (e.g., minimum and maximum temperature) to alert the system of irregularities or generate reports for analysis. This data is associated with the traceability data and becomes part of a product’s pedigree, making it a powerful tool for supply chain visibility.

EM Combats Supply Chain Stumbling Blocks

EM allows companies to monitor their supply chain, protect consumers and realize considerable return on investment. The technology can show companies how to maximize route efficiencies, change shippers, or detect theft or diversion in real time. Tracking solutions transmit alerts, empowering manufacturers and suppliers to use data to halt shipments that may have been adulterated, redirect shipments to extend shelf life, and manage food recalls—or avoid them altogether. Recalls are a particularly important consideration: One 2012 study concluded that the average direct cost of a recall in the United States was $10 million.

The IoT-enabled technology provides real-time information about how long an item has been in transit, if the vehicle transporting it adhered to the approved route, and, if the shipment stopped, where and for how long. This is crucial information, especially for highly perishable goods. For example, leafy greens can be ruined if a truck’s engine and cooling system are turned off for hours at a border crossing. With EM and tracking, businesses are able to understand and act upon specific risks using detailed, unit-level data.

For example, a company can find out if pallets have dislodged, fallen, or have been compromised in other ways while in transit. They can receive alerts if the doors of a truck are opened at an unscheduled time or location, which could indicate theft. Thieves target food cargo more often than other products because it’s valuable, easy to sell and perishable, and evidence of the theft does not last very long. In fact, the U.S. Federal Bureau of Investigation estimates that cargo theft costs U.S. businesses $30 billion each year, with food and beverage being one of the primary targets. Businesses need to get smart about preventative actions.

All of this actionable data is available in real time, allowing businesses to make decisions immediately, not after the fact when it’s too late. When necessary, they can divert or reroute shipments or take actions to remedy temperature excursions and other environmental concerns. This saves money and protects their reputation. Furthermore, third-party logistics firms and contracted delivery companies can be held accountable for incidents and inefficiencies.

Conclusion

As the benefits of global supply chains have grown, so have the risks. With the FSMA shifting responsibility for safety to food companies, real-time EM is a vital step to ensure cargo is maintained in the correct conditions, remains on track to its destination, and is safeguarded from theft and fraud. With the advent of IoT-enabled tracking and EM technologies, supply chain operations can be streamlined and companies can prevent waste and financial losses, protect their investments and brand identity, and gain an advantage in the marketplace.

2019 Food Safety Supply Chain Conference

FDA to Provide FSMA Update at 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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2019 Food Safety Supply Chain Conference

EDGARTOWN, MA, April 8, 2019 – Innovative Publishing Co., publisher of Food Safety Tech, has announced three speakers from FDA will kick off the 5th Annual Food Safety Supply Chain Conference on May 29–30. Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN; Andrew J. Seaborn, Supervisory Consumer Safety Officer, Division of Import Operations, ORA; and Lisa L. Ross, Consumer Safety Officer, CFSAN (Office of Food Safety, Multi-Commodity Foods, Refrigerated and Frozen Foods Team) will provide the opening presentations on Wednesday, May 29. An interactive Town Hall with attendees will follow.

Lisa Ross, CFSAN, FDA
Lisa L. Ross, Consumer Safety Officer, CFSAN

Seaborn, Rathnam and Ross will provide FDA perspective on FSVP inspection updates, including outcomes and compliance, the voluntary qualified importer program (VQIP) and where the agency is headed with enforcement activities. They will also take a deeper dive into supply chain requirements as per subpart G of part 117.

“As FDA continues its ‘educate while regulate’ strategy, having FDA officials present to inform attendees of the agency’s latest activities, available resources for industry, and how industry can work together with FDA in achieving compliance provides a crucial benefit,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Supply Chain Conference. “Andrew and Priya added tremendous insights to the conference last year, and I am thrilled to welcome them back, along with the addition of Lisa this year.”

The Food Safety Supply Chain conference takes place May 29–30 in Rockville, MD. Registration is open with a virtual attendee option as well.

Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew J. Seaborn,Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA at the 2018 Food Safety Supply Chain Conference

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

FDA

FDA Announces Enforcement Discretion Related to Produce Safety Rule

By Food Safety Tech Staff
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FDA

FDA has announced it will exercise enforcement discretion for Produce Safety Rule requirements that apply to entities that grow, harvest, pack and hold wine grapes, hops, pulse crops and almonds. The agency added that it will “consider pursuing rulemaking to address the unique circumstances” that the above-mentioned products present. It also issued the guidance document, “Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds”.

How ERP Can Help Ensure Food Safety in the Cannabis Edibles Market

By Daniel Erickson
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The popularity of cannabis edibles and infused beverages as a socially accepted and convenient method of marijuana consumption has grown exponentially for consumers in states with a legalized market for both recreational and medicinal cannabis. The edibles industry’s success has been met with many challenges however, as the absence of federal regulation has provided little guidance regarding food safety practices. With consumers generally expecting these products to have the same safety expectations as they do with other food and beverages they consume, many manufacturers have elected to follow FSMA best practices to ensure cannabis edibles’ integrity in the marketplace. Proactive cannabis growers, processors and dispensaries are seeking out ERP software solutions in greater numbers to utilize the technological tools and vendor experience in the food and beverage market to establish greater accountability and plan for current and future compliance requirements.

This year the Cannabis Quality Conference & Expo is co-located with the Food Safety Consortium | October 1–3 | Schaumburg, ILCannabis Edibles Defined

Cannabis-derived edibles are food or beverage products that are made with cannabis or infused with cannabis extract—either consumed recreationally or to manage or alleviate health concerns. Cannabis extractions used in edibles include tetrahydrocannabinol (THC), which is psychoactive, and cannabidiol (CBD), which is not, as well as many derivatives when speaking of “whole plant” benefits. While there are a variety of edibles including gummies, candies, cookies, energy drinks, teas and chocolates, the defining characteristic of these products is that they are meant for human consumption. Public perception is that these products are held to the same safety and quality considerations as mainstream food and beverage products available in the market. With these expectations and lack of oversight, the responsibility falls on the manufacturer to meet those expectations and ensure a safe, consistent, quality edible product.

Safety and Quality Concerns

An unregulated industry at the federal level has resulted in a lack of consistency, predictability and safety in the edibles market. Frequently, it has been found that edibles don’t always produce the same experience from one consumption to the next, resulting from inconsistent appearance, taste, texture and potency. These variances pose a problem from a marketing perspective, as it impacts brand recognition, loyalty and returning customers. Similar to the food and beverage industry, foodborne illnesses, outbreaks, undeclared ingredients and inaccurate labeling provide further concern in an unregulated manufacturing environment. Specific safety issues of the cannabis industry include extraction processes, mold and bacteria growth, chemical exposure, pest and pesticide contamination, employee handling of products and the unintentional ingestion of cannabis edibles. With the high risks associated with this market, it is necessary for proactive growers, processors and dispensaries to adequately address quality and safety concerns that mitigate risk until the eventuality of regulatory oversight.

How ERP Can Help

Implementing an industry-specific ERP software solution that provides security and standardizes and automates business functions helps support cannabis manufacturers by providing the proper tools to track operations from seed-to-sale. With support for best practices and streamlined and documented processes, companies can incorporate safety and quality initiatives from cultivation to the sale of edible products and beyond. Utilizing the expertise of ERP vendors in the area of food safety management, edible manufacturers are provided with the same benefits that food and beverage companies have experienced for decades with ERP solutions. Cannabis ERP software allows your company to track all aspects of growing, manufacturing, packaging, distribution and sales—providing functionality that manages inventory, traceability, recipes and labeling to support quality initiatives.

The following areas supported by ERP can lead cannabis edible manufacturers to succeed in the realm of food safety:

Inventory Control. ERP’s automatic recording and tracking of inventory attributes, including balances, expiration dates, plant tag ID’s, serial and lot numbers and end-to-end traceability, allows cannabis edible manufacturers to maintain appropriate raw material and product levels, reduce waste, evaluate inventory flow, facilitate rotation methods and avoid overproduction. It provides accurate ingredient and cost tracking throughout the greenhouse operations and supply chain by use of barcode scanning that links product information to batch tickets, shipping documents and labels. Maintaining real-time and integrated information facilitates the ability to locate items in the event of contamination or recall. This detailed level of continuous monitoring mitigates the risk of unsafe consumables entering the market.

Labeling. Accurate product labeling is essential for food safety in the cannabis edibles industry, and its importance cannot be understated. Proper labeling and transparency ensure that consumers are provided a consistent experience and also help to mitigate unintentional consumption of cannabis-infused products. Certain states have enacted labeling requirements to increase accountability and mitigate the misrepresentation of cannabis edibles on the label with unverified, misleading or inaccurate information. Employing an automated ERP system assists with label creation that includes nutrient analysis, ingredient and allergen statements, testing notification for bio-contaminants and pathogens and expiration dates to ensure quality—providing a faster and more efficient method for labeling. Accurate labeling is also an imperative component of product recall planning, as traceability and labeling history documented in ERP software helps to identify and locate items quickly in the event of a recall.

Recipe and Formulation Management. To achieve consistency of products in taste, texture, appearance, potency and intended results, complex recipe and formula management are maintained with a real-time ERP solution that delivers tightly managed control. Raw material data, version and revision information and production notes are documented for each batch. The monitoring of key quality specifications such as THC and CBD percentage, containment and impurities testing, etc. are readily handled within the system and allows for the scalability of recipes as needed. Direct access to the calculation of specific nutritional values, which includes ingredient and allergen information, provides accurate labeling and consumer information for product packaging—a valuable asset in the cannabis edibles market. R&D functionality supports the creation of new and innovative edibles and marijuana-infused beverages in a sandbox environment to meet the demands of this consumer-driven market.

Approved Supplier Relationships. Assurance of cannabis edible safety is enhanced through the acquisition of quality raw materials from trusted vendors. An ERP solution plays an essential role in the process as it maintains a supplier list by documenting detailed supplier information and test results to assure in-house qualifications and potency standards are met. A fully-integrated ERP system regulates quality control testing to ensure consistent and approved materials are being used and undeclared substances, harmful chemicals and impure ingredients are unable to infiltrate the supply chain. Failure to meet quality control standards results in ingredients being quarantined, removed from production and disposed of safely, and indicates that a search for alternate vendors is needed. This detailed level of documentation is a best practice for maintaining current and accurate supplier information in the event of a product recall.

Current Good Manufacturing Practices (cGMPs). As the bedrock for the food and beverage industries, following cGMPs establishes an important foundation for the edibles market. An ERP efficiently documents processes to ensure safe and sanitary manufacturing, storage and packaging of food for human consumption. This includes monitoring equipment status, establishing cleaning and hygienic procedures, training employees, reporting illnesses, maintaining food and cannabis handling certifications and eliminating allergen cross-contact risks. Validating procedures within an ERP solution automates documentation of an audit trail and addresses food safety concerns more efficiently than manual methods.

Hazard Analysis Critical Control Points (HACCP) Requirements. Establishing a food safety team that develops a HACCP plan to enact procedures that protect consumers from the biological, chemical and physical dangers of edibles is a recommended best practice for quality assurance, despite the current lack of federal regulations. Critical control points recorded within an ERP solution prevent and control hazards before food safety is compromised. Parameters within the ERP system can be utilized to identify potential hazards before further contamination can occur. Applying these best practices historically used by food and beverage manufacturers can provide an enhanced level of food safety protocols to ensure quality, consistent and safe consumables.

Food Safety Plan. As a requirement of FSMA, a food safety plan provides a systematic approach of identifying and addressing food safety hazards by implementing preventative food safety procedures throughout the manufacturing, processing, packing and storage of products. With a trained Preventative Control Qualified Individual (PCQI) at the helm to coordinate the company-specific plan, an ERP solution automates and records preventative controls, full forward and backward lot traceability, recall plans and employee training records within an integrated system to ensure that food safety policies and procedures are being followed.

With the growth of the edibles and infused beverage market expected to skyrocket over the next four years, the success of growers, processors and manufacturers will continue to thrive off of technological tools and established best practices. Employing the industry experience of ERP software providers that have implemented food safety and quality control procedures will follow suit of the market and be a sought-after resource when federal regulations are imposed. Proactive cannabis businesses are already experiencing a return on investment in their ability to provide quality, consistent products that meet cannabis enthusiasts’ high expectations and keep them ahead of this trending market.

Hand

ImEpik and Food Safety Tech Partner on Agreement for PCQI Online Training

By Food Safety Tech Staff
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Hand

EDGARTOWN, MA, Feb. 27, 2019 – Innovative Publishing Co., Inc., publisher of Food Safety Tech, has entered into a reseller agreement with ImEpik, an online training company that serves food manufacturers globally. Food Safety Tech will serve as a reseller of ImEpik’s PCQI online training course as per training that is required under FSMA.

“I’m pleased to announce our partnership with ImEpik, as it allows us to expand our efforts in giving the industry access to resources that are critical to food safety education and training,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference and Expo.

“Our ten-module online training program ensures that Preventive Control Qualified Individuals are proficient in the standards that are required under FSMA,” said Laura Lombard, CEO of ImEpik. “Providing compliance training in an online capacity also saves our ‘students’ time and money, as they can take the course any time and anywhere, without having to travel away from their job.”

As part of the partnership, the training will be offered at a reduced rate for professionals who also register to attend the Food Safety Consortium Conference & Expo, an annual industry event held October 1–3 in Schaumburg, IL. Full conference registration that includes PCQI training starts at $845 with the early bird discount. After September 13, the cost of the full conference registration with PCQI training is $995.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.

About IMEPIK

IMEPIK is a market-driven, and research-based online training company, facilitates food safety training for food manufacturers around the world. With an emphasis on accessible and innovative training, ImEpik offers a unique advantage in providing effective training for you, your employees, your association members, or your clients to ensure food safety compliance and best practices. We offer Preventive Controls courses that include the “standardized curriculum” recognized by the FDA.

FDA

Routine Produce Inspections to Start in Spring, FDA Offering Compliance Support

By Food Safety Tech Staff
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FDA

After FDA delayed product inspections under FSMA to further prepare industry and ensure there was enough training and education, the agency is reminding farmers and other stakeholders in the produce industry that there are resources available to help them in preparing for the routine inspections—for large farms, these will start in the spring. The inspections will be conducted to verify compliance with the Produce Safety rule.

Resources include the FDA’s produce safety inspections page on its website to serve as a central resource for industry and state partners during the inspection preparation process and the draft guidance, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”.

An FDA Voices blog by FDA Commissioner Scott Gottlieb, M.D., Deputy Commissioner for Food Policy and Response Frank Yiannas and Associate Commissioner of Regulatory Affairs Melinda Plaisier also discussed how the agency has been supporting industry work to comply with the rule, including:

  • Granting 46 states and one territory with more than $85 million through the State Produce Implementation Cooperative Agreement Program to aid in the development of state produce safety systems that offer education, outreach and technical assistance
  • With partners, supporting the training of more than 31,000 produce farmers globally on the Produce Safety rule requirements
  • The sharing of expertise via the FDA’s Produce Safety Network
  • With partners, the creation of a new inspection form that gives farms feedback and observations that occurred during the inspection, regardless of whether non-compliance issues were found, in an effort to help explain what they’re looking at and how observations apply to the produce rule
Maria Fontanazza, Douglas Marshall, Food Safety Consortium, Eurofins

Top Questions Food Companies Should Ask Prospective Suppliers

By Food Safety Tech Staff
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Maria Fontanazza, Douglas Marshall, Food Safety Consortium, Eurofins

Building a supply chain verification program can be a complicated task. In the following exclusive video with Doug Marshall, Ph.D., chief scientific officer at Eurofins, we learn the top questions that should be asking their suppliers during the process. Marshall also gives his perspective on the integration of data into the supply chain and how it can mitigate risk, along with where he’s sees the future of food safety testing headed.

Video shot at the 2018 Food Safety Consortium.

Emily Kaufman, Emport, Allergens
Allergen Alley

Matrix Matters: Why Allergen Test Kits Are Only Half the Story

By Emily Kaufman
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Emily Kaufman, Emport, Allergens

On-site rapid tests for allergens are an important part of any manufacturing facility’s allergen control plan. Several companies offer allergen test kits for day-to-day use, and it can be hard to tell the differences between them or determine which is the best fit for a given facility. What’s a busy QA professional to do?

One of the most overlooked factors when choosing an allergen test kit actually has almost nothing to do with the test kit itself. Instead, it’s much closer to home: The matrices being tested are just as—if not more—important to consider than the test kit itself.

Before you commit to any allergen test kit, you should talk to someone extensively about the types of products you plan to test. There are a variety of surprising and counterintuitive ways that your matrices can impact the functionality of a test, and you’ll save time and money by understanding information BEFORE you start testing. Below, we’ll review some of the most common matrix challenges.

High Fat Matrices

fruit pops, allergensLet’s imagine a facility that makes ice cream and sorbet. Let’s assume they make a gourmet strawberry ice cream and a fat-free strawberry sorbet, both of which ought to be peanut-free—but since some of the ingredients come from a supplier who also works with peanuts, the QA team decides to run a rapid peanut test on the strawberry products.

Much to the team’s surprise, the sorbet tests positive for peanut but the ice cream does not. What could be happening? Of course, the simplest explanation is possible: The sorbet has peanut residue in it and the ice cream does not. However, there’s another, trickier possibility: They could have the same amount of peanut residue, but the full-fat ice cream could inhibit the test kit’s ability to detect the allergen.

In general, the higher the fat content of your matrices, the higher the detection limit on your test kit. It’s an imprecise spectrum: Using rapid tests to find traces of allergenic protein on an oil is nearly impossible, on fat-rich items like ice cream or cream-based soups it’s a challenge, on items with little or no fat it shouldn’t be an issue. That isn’t to say there couldn’t be other issues with low-fat items, as we’ll review below.

Matrices Processed with High Heat

peanuts, allergensLet’s say our ice cream facility starts making a peanut-butter-swirl flavor. Perhaps they will begin testing their rinsewater for peanut residue after running that flavor, to ensure satisfactory cleaning. The kit they use says it can detect peanut allergen to 5 ppm, and rinsewater is not a high-fat matrix, so they should be good, right?

In this exact example, it’s probably just fine. However, it’s important for the QA team to consider the temperature at which peanuts were roasted. While raw peanut might be detectable at 5 ppm, roasted peanuts could have a detection limit that is much higher. In fact, very strongly roasted peanuts could only be detectable at levels of 500 ppm or more. This doesn’t mean there is no reason to test—but it’s important to know that many antibody-based tests will respond differently to an allergen processed with high heat than one that is raw. The same detection challenge can sometimes be seen with canned or tinned items that are subjected to high heat in processing.

Fermented or Hydrolyzed Matrices

Two of the trickiest items when it comes to allergen detection are soy sauce and fish sauce. In both of these condiments—and many other common ingredients subjected to these types of processing—the allergenic material is subjected to heavy modification. As proteins get folded and broken in unpredictable ways, they become more challenging for antibody-based test kits to detect. In fact, soy sauce and fish sauce are nearly undetectable by most kits.

When validating a cleaning process after using one of these ingredients, often the safest thing to do is to test for a different allergen—formulated in a simpler way—that is also present. Sufficient cleaning after a product made with fish sauce and breadcrumbs, for example, could be proven with a gluten kit; that second allergen will be unaffected by the fermented allergens in the recipe.

Matrices without Multiple Proteins

Some kits look for a variety of proteins commonly found within one allergen. Other times, though, each test kit will be looking for one specific protein. It’s important to confirm that the allergenic protein your facility works with is in fact an allergenic protein that your test kit is trained to recognize.

Perhaps the most common FALCPA allergen where this plays a role is milk. While there are a number of proteins in milk, casein is the most common and accounts for approximately 80% of the protein in milk, making it a common target for allergen test kits (both rapid and ELISA). The remaining 20% of protein is comprised of various whey proteins, most commonly beta-lactoglobulin.

In the case of our ice cream and sorbet facility mentioned above, a kit that detects casein OR beta-lactoglobulin OR both proteins together could be suitable for confirming that the sorbet is truly milk-free. However, there are other types of product that contain only whey proteins, which are a popular way to increase protein content in a variety of foods and beverages. If a facility that works exclusively with whey proteins uses a kit that only detects casein, they will never have a true understanding of their allergen contamination risk.

Another challenging FALCPA allergen is fish, as there are many different species of fish with quite divergent protein structures. If you are testing for fish contamination, it’s important to understand which species of fish the test you are considering can detect, and which species may pose a problem. If there is a mismatch between kit and matrix, then you’ll need to find a different way to ensure safety.

How to Troubleshoot Your Matrices

If you are beginning an allergen testing program, find time to talk with the manufacturers of any allergen kits you are considering. You may also want to talk with the representatives of any labs that are doing third party testing for you. Some questions to ask include:

  • What matrices have you validated your tests for?
  • Do you anticipate any issues with my matrices?
  • How should I validate your tests for my products?
  • What factors impact the sensitivity of this kit?
  • Does the detection limit change based on the matrix?

Your kit manufacturer (or third-party testing lab) should make you feel confident that they understand the quirks of your specific matrices—and they should have ideas for how to troubleshoot any challenges that they foresee. If a supplier tells you that their kit will work equally well across all matrices and declines to offer proof that corresponds to your needs, beware (or at least be prepared to conduct rigorous validation on your own). Allergen detection is complicated, and as with so much of life: If it sounds too good to be true, it probably is.

Laura Lombard, IMEPIK
FST Soapbox

The Business Case for PCQI Training

By Laura Lombard
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Laura Lombard, IMEPIK

Beyond reducing liability or checking a regulatory box, investing in robust training can reap measurable business impact. The FSMA regulation requires that Preventive Control Qualified Individuals (PCQIs) “have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system,” as per Subpart C Section 117.180 (c) (1). Even if the person serving in the role of PCQI is qualified through job experience, FDA investigators will expect adherence to development and application of risk-based controls as contained in the standardized PCQI curriculum material or the alternative training allowed in the regulation.

Let’s face it: Our employees serving in the role of PCQI come from a spectrum of food safety plan experience. In addition, many are mentoring new members as Qualified Individuals on the food safety team. Others are building a whole new team from scratch. Team members may be specialized department heads or hold several titles and job duties within a manufacturing facility. Your PCQI is charged with overseeing the development and analysis of the food safety plan. The PCQI needs a team that has had consistent training in the language of the new rules and how to comply to support the PCQI’s charge.

Beyond meeting the regulation, companies should train at the PCQI level to safeguard a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more you save in costly recalls, loss of current or potential customers, and your brand’s reputation. A company with a robust safety culture has a competitive advantage over competitors who are more lax in their food safety and may suffer financially and reputationally from recalls and customer quality assurance complaints. In an era when customers are seeking more information about the food they consume, being a trusted food safety brand can make your company stand above the crowd.

In addition, consistent training can help with internal culture change and worker productivity. Working on hazard analysis and defining preventive controls requires that employees show critical thinking and problem-solving skills. Team members taking a curriculum with standardized material and consistent learning objectives can reflect together to identify and document gaps and corrections to practices or processes. They can quickly apply their learning for more accurate analysis of the components of the food safety plan. This is the true impact from investment in high quality instruction—motivating employees to learn updated food safety practices, change their behavior, and make more efficient and effective decisions to keep the quality and safety of your products. Well-trained food safety employees are a key factor in the protection of your customers, your company’s brand and the prevention of costly food recalls. The investment in training at the PCQI level is strategic on all fronts.