Tag Archives: allergens

Production line, NiceLabel

Farm-to-Fork Transparency: How Digitized Labeling Can Prevent a Major Allergen Recall

By Lee Patty
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Production line, NiceLabel

For consumers and brands alike, the damaging impact of mislabeling or neglecting to clearly outline an allergen can be colossal. Therefore, to prevent a health and business disaster, best practices around allergen labeling must be top of mind. Luckily, technology can help, and the farm-to-fork transparency provided by a centralized and digitized modern label management system can ensure organizations improve responsiveness and accuracy while reducing costs beyond those saved by mitigating recalls.

No one wants to face a recall, but have you done enough to prevent one from happening to you? More than 650 food products were recalled last year in the United States alone. And one of the leading causes might just be the easiest to prevent: Undeclared allergens.

According to the Q2 2019 Stericycle Recall Index, undeclared allergens are the leading cause of U.S. food recalls, accounting for 48.4% of food recalls from the FDA and 62.9% of food pounds recalled by the USDA. This statistic becomes more alarming considering that roughly 11% of US adults have a food allergy, according to JAMA.

Enacted in 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) stipulates that all packaged food regulated under the Federal Food Drug and Cosmetic Act (FFD&C) comply by listing major food allergens. “Major allergens” refers to milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans, and for nuts and shellfish, the species must be declared.

For brands, the damaging impact of mislabeling or neglecting to clearly outline an allergen can be colossal, resulting in costly recalls or litigation. However, the impact to consumers can be even greater when one small mistake can cause serious illness, or worse, death. To prevent a health and business nightmare, best practices around allergen labeling must be top of mind.

However, with constantly changing legislation, this can be easier said than done. For instance, in a move that outpaced the FDA, Illinois issued a state law requiring sesame labeling. And in the UK, Natasha’s Law was recently introduced, requiring companies to label all food ingredients on fresh pre-packaged food after 15-year-old Natasha Ednan-Laperouse died of a sesame allergy from a sandwich that didn’t list all the ingredients.

The need for optimal allergen labeling is clear, so how can organizations ensure allergens are clearly labeled on their products and meet existing standards while preparing for future requirements?

Though the underlying principle behind a clear label is simple, the process of designing such labels can be multifaceted and difficult to streamline—especially if labels are designed, printed and managed by separate users across a franchise or store network. And this challenge is multiplied further when products reach across international boundaries. But technology can help, and the farm-to-fork transparency provided by a centralized and digitized modern label management system can ensure organizations improve responsiveness and accuracy while reducing costs beyond those saved by mitigating recalls.

Disorganized Sprawl: A Major Hurdle to Effective Labeling

When implemented properly, modern label management can cost-effectively centralize labeling, reducing inefficiencies and human error. However, before this can happen, there are a few common roadblocks that may make standardizing the labeling process challenging.

One issue may be a sprawl of legacy equipment that is not integrated into a cohesive network. For instance, a legacy labeling system may only support certain label printers while certain manufacturers of direct marking equipment may only support their own propriety brand of printers. In another sense, a lack of standardization can also make it difficult to efficiently integrate labeling with other business solutions like manufacturing execution systems (MES) and enterprise resource planning (ERP) systems.

A damaging impact of sprawl is adoption of a wide range of different labeling applications across various facilities. This will result in inconsistent label formatting, the need to create the same label multiple times, and the need to accommodate different systems and printers. Consequences of this may be a lack of centralized storage when everything is saved locally, complex user training encompassing many software programs, an increased burden on IT, and a great deal of extra administration and human intervention to maintain and update labels.

Another problem with a disorganized ecosystem for labeling is that quality assurance inevitably suffers because tracing a label’s history or implementing standardized approval processes can be difficult or impossible. To accurately track labeling, it’s necessary to have a production log stating where and when labels were produced and who produced them. Having such a log and using it effectively requires centralization or else it can become difficult to track different versions or enforce universal approval processes for altering templates.

Implementing Modernized Labeling to Improve QA

Modern label management systems can help suppliers and manufacturers standardize and control marking packaging or label production across an entire organizational ecosystem. These solutions feature a central, web-based document management system and provide a reliable storage space for label templates and label history. This will enable changes and updates to be tracked centrally, so local facilities can access uniform and accurate templates to produce labels.

An ideal label management system can also interface with a multitude of direct marking and labeling printers, even if they are from different manufacturers, and it can integrate labeling and direct marking with a business system’s master data, which eliminates manual data entry errors. This decreases upfront capital expenditures in more costly efforts to standardize equipment, provides a system that is easy to integrate with partners, saves costs generated from having to discard product or rework labels, and increases a company’s ability to implement unified, organization-wide labeling processes.

Centralized Labeling is Easily Delivered Through Cloud

To many, the thought of migrating legacy labeling to a centralized system or investing a large sum of resources into centralizing labeling may seem inordinate or daunting. However, cloud technology makes migrating to a modern label management system feasible for organizations of all sizes.

With the cloud, designing labels and ensuring quality assurance becomes far more accessible. Additionally, the software-as-a-service (SaaS) model doesn’t require the capital investments or operations and maintenance upkeep associated with costly IT infrastructure and is easily scalable depending on business needs. This is a game changer for small to medium sized businesses who can now benefit from a centralized labeling system because of the cloud.

The Benefits of a “Single-source-of-truth”

In addition to other benefits, integrating a modern label management solution with other business systems allows users to access a “single-source-of-truth.” This allows for enforceable, specific user roles with logins for each user as well as traceability and transparency across all factories that produce products. The traceability from being able to monitor a “single-source-of-truth” is a critical component to farm-to-fork transparency because it can provide an accurate production log overviewing label versions and changes, so companies can pinpoint the locations and causes of labeling inaccuracies and fix them instantly.

A modern label management system also enables organizations to nimbly respond to new regulatory requirements because alterations only need to be made in one location, new templates can be previewed before going to production, and nutrition and allergen functionality can be easily formatted so that it is clear and stands out to the consumer. This increases labeling consistency and accuracy, and saves time when rules change and when new products need to be incorporated during a merger or acquisition.

Futureproofing and Ensuring Consumer Safety with Allergen Labeling

In today’s world, food and beverage manufacturers must rise to the challenge of changing regulations while meeting the call of shifting customer demands and integrating themselves within greater business ecosystems and extended supply chains. In the case of allergen labeling, this may mean preparing labels for different countries, which have varying standards for labeling allergens like sesame, royal jelly, bee pollen, buckwheat and latex, or ensuring labels can be altered quickly when new products are rolled out or when bodies like the FDA revamp standards.

Companies that implement modern label management solutions position themselves to adapt to competition and regulations quickly, implement solutions that can easily be integrated with partners in a supply chain, and streamline quality control. This can help improve productivity, reduce labeling errors, increase collaboration, and prevent product recalls. But most importantly, it helps ensure the safety of consumers everywhere.

Recall

Undeclared Allergens Top Cause of FDA and USDA Food Recalls

By Food Safety Tech Staff
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Recall

Stericycle released its Q3 2019 Recall Index last month. The following are the key takeaways:

FDA Food Recalls

  • Recalled food units increased 319.5% to 8.8 million
  • 21.5% had nationwide distribution
  • Top food categories
  • Prepared foods: 24
    • Produce: 19
    • Flavoring: 14
    • Seafood: 12
  • Undeclared allergens were the top cause at 35.5%
  • Foreign material were top cause of units impacted at 47%

USDA Recalls

  • Decreased 25% to 24
  • Affected 537,000 pounds
  • Top Categories
    • Poultry: 33%
    • Beef: 21%
    • Pork: 12.5%
    • Seafood: 4.2%
  • However, this category came out on top for recalls by pound, at 22.6% of recalled pounds
  • Top Reasons
    • Undeclared allergen: 37.5%
    • Bacterial contamination: 21%
    • Foreign material: 17%
Susanne Kuehne, Decernis
Food Fraud Quick Bites

Careful, Don’t Go Nuts

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food fraud, allergens, peanuts
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne.

Food items containing peanuts can cause severe allergic reactions and even allergic shock to sufferers from a peanut allergy. The Czech Agriculture and Food Inspection Agency (CAFIA) did not allow a biscuit product with chocolate and hazelnut to be sold in retail because the peanut content was 3,500 times higher than the limit. While the product was labeled “May contain peanuts”, the amount of peanut was significantly over the limit for unintentional cross-contamination during manufacturing

Resource
Mgr. Pavel Kopřiva – CAFIA Spokesperson (August 26, 2019). “Warning for Consumers: CAFIA found chocolate biscuits with c. 3,500 times higher content of peanuts than indicated on the labelling”. Retrieved from Czech Agriculture and Food Inspection Authority.

Home food delivery, food safety

Home Food Delivery: “It’s Kind of a Wild West Out There”

By Maria Fontanazza
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Home food delivery, food safety

As the popularity of home delivery services for food (i.e., online grocery shopping, prepared meals from restaurants, meal kits) continues to gain traction, the industry has been grappling with clear-cut guidance on how to ensure food safety during what is known as the “last mile” of delivery to the consumer. For example, how do third-party delivery services address concerns such as maintaining the right temperature of food during transit? How are allergen risks controlled? Do the people who deliver the food undergo any food safety training?

“It’s kind of a wild west out there,” said Donald Schaffner, Ph.D., professor at Rutgers University during a panel discussion on the topic of home food delivery at the IAFP annual meeting last week in Louisville, Kentucky.

In April, Acting FDA Commissioner Ned Sharpless, M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas acknowledged that there are food safety challenges presented by “evolving business models” such as e-commerce, and stated that the agency will be looking at ways to work with federal, state and local stakeholders to address the issues. During the IAFP panel, food safety professionals from Amazon, Uber Eats, The Kroger Company and FSIS shed some light on how their respective organizations are handling the food safety risks associated with home delivery.

Home food delivery, food safetyTraining the People Who Deliver Your Food

The overarching consensus among panelists was that there is not a one-size-fits all approach to training the people who deliver food to the consumer, because there are so many different business models out there. The key to developing successful training will be to first understand the risks associated with each of those different models.

“Everyone needs training, but we don’t want to over-engineering it—not everyone needs ServeSafe training,” said Schaffner. For example, training the person who is simply putting food in the car and delivering it to an address should be different from the training necessary for an employee selecting food in the grocery store versus the warehouse employee packing food. “Figuring out the right-size training and what kind is currently available is one of the things that we’re trying to figure out on the [Conference for Food Protection] committee.” (Note, the Conference for Food Protection committee is developing guidance that addresses home food delivery.) Schaffner indicated that training surrounding time and temperature, allergens and product tampering are important considerations.

Howard Popoola, vice president, corporate food technology and regulatory compliance at The Kroger Company provided the retailer perspective. “Our challenge is multiple in nature,” he said, emphasizing that stores try to keep labor at a minimum. Designing training for workers who are getting a $.25-per-hour raise presents a different hurdle. “What we’re doing in the store today is something we’ve never done before, and [we’re] asking individuals to do things they’ve never done before,” said Popoola. “The training we’ve done before is slowly becoming obsolete.” He said that The Kroger Company is evaluating its current basic food safety training and is looking at building on the segments of its stores that are involved in picking, packing and preparing food—especially the fresh items that are more susceptible to potential microbial contamination.

The Allergen Risk

A question was raised about whether delivery services use the same bags over and over, introducing the potential for cross-contamination. As part of its restaurant community guidelines, UberEats encourages restaurants to put food in tamper-resistant packaging. According to Joseph Navin, senior manager of global safety at the company, in order to reduce the possibility of cross contamination, all food should be placed in a bag before it is put in the insulated bag for transport. UberEats also has guidelines for how those bags should be cleaned. Further addressing the allergen risk: “How do we optimize the way that consumers can disclose that they have a food allergy? We don’t want to have food allergies going in the same free form text [box] that says ‘send extra napkins’,” said Navin. He added that UberEats is developing ways in which dealing with allergens is more conspicuous for restaurants when their employees are preparing food.

Allison Jennings, director food safety and compliance North America at Amazon, said the company has experimented with multiple types of packaging, but there isn’t one perfect set of variables and inputs. Amazon currently uses single-use bags for delivery to mitigate risks with re-cleaning, she said.

Consumer Complaints

As a best practice, integrating relevant information from consumer complaints should become part of a company’s food safety program, said Schaffner. An important role of technology will be its ability to collect feedback that allows companies to generate actionable insights related to food safety, identify any gaps, strengthen controls and be able to develop ways to mitigate risks, said Navin. Amazon currently monitors customer feedback using automatic detection for keywords related to food safety and quality that arrives via the phone, online chats with customer service and social media outlets. When necessary, the method can prompt an investigation, look for trends or help engage in continuous improvement processes. “We are constantly looking for any potential blind spots with our processes,” said Jennings. “We also mystery shop ourselves and make sure we’re meeting our requirements.”

The most common consumer complaints reported among the panelists were not related to food safety, but rather food quality—the product was crushed, didn’t look appealing, etc. “Since we rely on third party partners, we’ve walked through with them on those processes…[and are] challenging our third party partners on who they hire to deliver food, training, etc. and taking caution on delivering food,” said Popoola.

Schaffner said common complaints noted during a study conducted by Rutgers University and Tennessee State University were the following: The product was received out of temperature control; there was evidence of packages leaking (meat, poultry, and fish); a lack of cooking directions; and no mechanism to provide feedback to the company if you have a complaint.

According to Navin, among the top complaints that UberEats receives is missing food or a replacement for items that might be out of stock.

Recalls

In general, recalls in the home delivery segment would apply to products that are received via online grocery shopping services. Since consumers must sign up for these services by providing either an email or phone number, companies can contact customers in the event of a recall. For example, Amazon requires an email account, so it directly emails customers when there is recall or known safety risk associated with a product purchased. Similarly, when a customer uses a loyalty card at a grocery store such as Kroger, the retailer can use its robocall system to notify customers if they purchased an item that is subject to a recall or is associated with an outbreak.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

The Meat of the Matter

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food fraud, sausage
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

Use of sulphites in food is tightly regulated in the Netherlands. “Vleesfraude” or meat fraud was committed by Dutch meat processors and butchers by adding large amounts of sulphites to ground beef, sausages and other processed meats in order to achieve the perfect “meaty” red color. Sulphites are classified as an allergen with mandatory labeling requirements, however, their use in meat is illegal in the first place. The affected products were pulled from the market and the companies were fined for fraud.

  1. Resource
    Fortune, A. (June 21, 2019). “Illegal sulphite use found in Dutch meat”. Global Meat News. Retrieved from https://www.globalmeatnews.com/Article/2019/06/21/Illegal-sulphite-use-found-in-Dutch-meat
Third party certification program, FDA, audits, Food Safety Supply Chain Conference

Your Supply Chain in 2019: Top Considerations

By Maria Fontanazza
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Third party certification program, FDA, audits, Food Safety Supply Chain Conference

Last week industry gathered for the Food Safety Supply Chain conference at USP in Rockville, MD. The following are some quick highlights of insights they shared.

Most Common Form 483 Observations

Following FSVP inspections, the most common Form 483 observation was a company’s failure to develop an FSVP. From FY 2017 to present, the observation was cited 552 times, outweighing any other observation and underscoring the need for an educational component. – AJ Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA

FDA, Food Safety Supply Chain Conference
(left to right) AJ Seaborn, Lisa Ross and Priya Rathnam of FDA share an update on FSMA implementation at the 2019 Food Safety Supply Chain Conference

Top Citations for FY 2018

  • Hazard analysis (when a facility is not identifying a hazard that requires a preventive control)
  • Lack of a food safety plan. “There’s still work to be done on the education and outreach on this one.”
  • Equipment and utensils (GMP deficiency)
  • Allergen controls monitoring
  • Sanitation control verification procedures
  • Personnel (usually, this is related to a repeated issue)
    – Priya Rathnam, supervisory consumer safety officer, CFSAN, FDA

Critical Supplier Questions Must Be Asked

  • How do you choose and approve your suppliers?
  • What must be done to ensure that we aren’t receiving hazards from suppliers?
  • What requirements must be defined?
  • Does every supplier need to be audited?
  • Should we treat all suppliers equally? (No, it depends on their risk profile)
  • How do we ensure that our program is effective?
  • When working with suppliers, it’s important that your decisions are reproducible and that you apply the same risk methodology across the board. – Erika Miller, food safety specialist, D.L. Newslow & Associates, Inc.

“Before you can do anything to transform your business, you have to have visibility in your supply chain.” – George Dyche, senior director, innovations & solutions, Avery Dennison

“’Compliance’ should be replaced in industry with ‘commitment’…when you’re committed, compliance will follow.” – Felix Amiri, food sector chair, Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP)

Putting the “P” in CAPA = Getting out in front of issues before they happen. “Don’t wait for the consumer to get sick… if you have a recall, it means you haven’t done your work on the CAPA side.” – Andrew Kennedy, director, Global Traceability Center, IFT

Food Safety Supply Chain Conference
(left to right) Felix Amiri, Lucy Angarita and Andy Kennedy discusss supply chain vulnerabilities and solutions.

On critical success factors to establish a traceability program: Technology will never fix a company’s data quality or process issues. If you don’t already have it defined, you won’t get there. And after you understand the KPIs and goals, don’t give up. This doesn’t happen overnight. Engage your leadership, because the vision has to be from the top for others to also allocate the time and effort. “It’s a journey, not a destination. If you take your eyes off data quality, data quality goes down.” – Lucy Angarita, director, supply chain traceability, IPC/Subway

In 2018, 47% of recalls were allergen related, and this rate has increased. “People still don’t get [allergen labeling]”.  – Barry Parsons, senior consultant, PTI Consulting Group (Division of Paster Training)

On the significance of teaching truck drivers the importance of food safety risks: “They are part of our supply chain, and we need to incorporate them. It shouldn’t be out of sight, out of mind.” – Holly Mockus, senior industry analyst, Alchemy

Third party certification program, FDA, audits, Food Safety Supply Chain Conference
Trish Wester, chair of The Association of Food Safety Auditing Professionals, leads an FDA panel discussion about the Third-Party Certification Program. (left to right) Doriliz De Leon, program coordinator, accredited third-party certification program, FDA; Marla Keller, biologist, FDA; Marianne Fatica, policy analyst, Office of Compliance, FDA; Clinton Priestley, consumer safety officer, audit staff, human and animal food operations, ORA, FDA
Emily Kaufman, Emport, Allergens
Allergen Alley

Skip Validation, You’re Asking for Problems

By Emily Kaufman
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Emily Kaufman, Emport, Allergens

Running an unvalidated program or product is like betting your life’s savings on a horse because you overheard a “surefire tip” outside the racetrack, or driving around without any mirrors.

To put it less dramatically: Skipping validation is asking for problems. But what does validation mean, how much is necessary, and what’s the best way to include it in your plans?

In order to start understanding validation, we must first break it down into two main categories: Product validation and process validation. From there, it’s important to look at whether something has been broadly validated for general use, and whether it has been narrowly validated for use in your specific situation. That last question is where people often struggle: How can we ensure this product or process is validated for use in the way that we plan to use it?

Validating an on-site allergen test kit requires a few different layers of research and testing. Taking the time to carefully design and vet a validation process may seem tedious, and it may require some additional up-front costs—but in the long run, it’s the only way to ensure you are spending your money on a test kit that works. And if you’re using an allergen test kit that doesn’t actually detect allergens in your facility—best-case scenario, you’re wasting money and time. Worst-case scenario, you’re headed straight for a recall and you won’t see it coming until your customers get sick.

If you are buying a test to determine the absence or presence of allergens in your facility (specific or general), you’ll likely ask the kit manufacturer if the test kit has been validated. This validation can come in many forms, most commonly:

  • Third party validation (eg., AOAC)
  • Internally produced validation documents or whitepapers
  • Published studies

A product with more validation (third-party certifications, studies, whitepapers) isn’t necessarily better than a product with less. It may have simply been on the market longer or be produced by a company that allocates its funding differently. However, validation documents can be very comforting when reviewing a product, as they provide a starting point for your own research. When you are reviewing validation data, ask yourself a few questions:

  • Does this data cover products like mine?
    • Are the ingredients similar (raw meat, ice cream, spices, etc.)?
    • Are the preparation processes similar (heat, fermentation, etc.)?
  • Does this data cover an environment like mine?
    • Will the tests be run the same way in my facility as in the data?
    • Is the contamination being introduced in a way and amount that feels realistic to the risk factors I know about in my facility?
  • Does the data mention any complicating factors (and do I need to care about them)?
    • Are there ingredients known to cross-react or cause false negatives?
    • Are there processes known to change the LOD or cause false negatives?
  • If I am aware of limitations with other similar test kits, are those limitations addressed in the data for this test kit as well?

To give an example, let’s imagine you make premium ice cream and are reviewing allergen test kits that look for peanuts and almonds in product, in rinsewater and on surfaces. You’ll want to ask questions like:

  • How does the kit perform in a high-fat environment?
  • Does the validation data cover product, rinsewater and surfaces?
  • Are there ingredients in our facility that are called out as cross-reactive (or otherwise troublesome)?
  • Do our ingredients get exposed to temperatures, pH levels, or other processes that impact the LOD?

You might learn, for example, that one of the matrices tested in validation was ice cream. If so: Wonderful! That’s a vote of confidence and a great starting point. Or maybe you learn that the kit in question isn’t recommended for matrices that include an ingredient in your formulation. If so: That’s equally wonderful! Now you know you need a different solution. Or maybe the instructions on your current peanut test kit indicate that heavily roasted peanuts have a higher detection limit than raw peanuts, but this new test kit only has data for raw peanuts. If so: OK! You have more research to do, and that’s fine too.

In short: Pre-existing product validation data is a helpful starting point for determining whether or not an allergen test kit MIGHT work well in your facility—but it doesn’t eliminate the need for you to run your own internal validation study.

Once you’ve identified an allergen test kit that you want to use in your facility, you’ll want to prove that it can work to identify contamination in your specific environment. This is where a more narrowly tailored validation comes into play. Your test kit provider may have resources available to help you design an internal validation. Don’t be afraid to ask for help! A reputable test kit provider should care not just about making the sale, but also about making your food safer.

Before you even order a new test kit, you should have a good idea of how your validation process is going to work. It’s important to have both the study design and study outcome on file. Here are some possible additions for your internal validation study:

Validating that an allergen test kit can reliably prove your surfaces are clean of said allergen:

  • Test the surface prior to cleaning, after the allergen in question has been run. Do you see positive results? If not, then a negative result after cleaning is essentially meaningless.
  • Test the surface after cleaning. Do you see negative results? If not, it could mean a problem with your cleaning process—or a strange interference. Both require further research.
  • If your products encounter multiple surfaces (eg., stainless steel and also ceramic), test them all with before and after testing.

Validating that an allergen test kit can reliably prove your rinsewater is free of said allergen:

  • Test water from the beginning of the cleaning cycle as well as the end. Do you see a change in results, from positive to negative?
  • If you don’t ever see the allergen present in your rinsewater, you may want to “spike” a sample by adding a small amount of the product that contains the allergen into the rinsewater you’ve collected. Could it be that something in your cleaning protocol or some aspect of your matrix is affecting the detection limit?

Validating that an allergen test kit can reliably prove your ingredients or finished products are free of said allergen:

  • Test a product that you know contains the allergen but is otherwise similar. Keep in mind that some allergen test kits can be overloaded and can show false negatives if too much allergen is present in the sample—if you aren’t sure whether the test kit you are trialing has this limitation, ask your supplier. Do you see a positive?
  • Have you encountered batches of your product with accidental cross-contamination from the allergen in question? If so, and you have some of that batch archived, run a test on it. Would this kit have identified the problem?
  • Do you have a batch or lot of product that has been analyzed by a third-party lab? If so, do your results in-house match the lab’s results?
  • Run—or ask a lab to run—a spiked recovery. This is especially important if there is no pre-existing data on how the test kit works against your specific matrices.
    • Some test kit manufacturers can provide this service for you—you would simply need to send them the product, and they can add various amounts of allergen into the product and confirm that the test kit shows positive results.
    • Some kit manufacturers or other suppliers can send you standards that have known quantities of allergen in them. You can mix these into your product and run tests, and confirm that you get positive results when expected.
    • You may want to simply do this on your own, by adding small quantities of the allergen into the sample and running tests. However, take care to be especially careful with your documentation in case questions arise down the line.
  • No matter how the spiked recovery is being run, consider these two factors:
    • Be sure you’re including what could be a realistic amount of contamination—if you’re concerned about catching 25ppm of allergen, loading up your sample with 2000ppm won’t necessarily help you prove anything.
    • The matrix of your allergen-containing foods is just as important as the matrix of your allergen-free foods. If your allergen has been fermented, roasted, pressurized, etc. —your spike needs to be processed in the same way. If you aren’t sure how to think about your matrices, this previous Allergen Alley post is a good starting place.

Once you’ve proven that the test kit in question can in fact show positive results when traces of allergen are present, you can confidently and comfortably incorporate it into your larger allergen control plan. If your matrices change, you’ll want to re-validate whatever’s new.

While it can be tempting to rely on a kit’s general validation, taking the extra step to validate your unique matrices is an essential part of a truly robust food safety plan. If you’re stumped for how to begin, contact your kit provider—after all, you share the same goals: Safe, allergen-free food for consumers who rely on you to keep themselves and their families healthy and well fed.

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.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Method Acting: Comparing Different Analytical Methods for Allergen Testing and Verification

By Gabriela Lopez-Velasco, Ph.D.
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Gabriela Lopez, 3M Food Safety

Every day, food industries around the world work to comply with the food labeling directives and regulations in place to inform consumers about specific ingredients added to finished products. Of course, special attention has been placed on ensuring that product packaging clearly declares the presence of food allergens including milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy, sesame and mustard. (Additional food allergens may also be included in other regions.)

But labeling only covers the ingredients deliberately added to foods and beverages. In reality, food manufacturers have two jobs when it comes to serving the needs of their allergic consumers:

  1. Fully understand and clearly declare the intentional presence of allergenic foods
  2. Prevent the unintended presence of allergenic foods into their product

Almost half of food recalls are the result of undeclared allergens, and often these at-fault allergens were not only undeclared but unintended. Given such, the unintended presence of allergenic foods is something that must be carefully considered when establishing an allergen control plan for a food processing facility.

How? It starts with a risk assessment process that evaluates the likelihood of unintentionally present allergens that could originate from raw materials, cross-contact contamination in equipment or tools, transport and more. Once the risks are identified, risk management strategies should then be established to control allergens in the processing plant environment.
It is necessary to validate these risk management strategies or procedures in order to demonstrate their effectiveness. After validation, those strategies or procedures should then be periodically verified to show that the allergen control plan in place is continually effective.

In several of these verification procedures it may be necessary to utilize an analytical test to determine the presence or absence of an allergenic food or to quantify its level, if present. Indeed, selecting an appropriate method to assess the presence or the level of an allergenic food is vitally important, as the information provided by the selected method will inform crucial decisions about the safety of an ingredient, equipment or product that is to be released for commercialization.

A cursory review of available methods can be daunting. There are several emerging methods and technologies for this application, including mass spectroscopy, surface plasmon resonance, biosensors and polymerase chain reaction (PCR). Each of these methods have made advancements, and some of them are already commercialized for food testing applications. However, for practical means, we will discuss those methods that are most commonly used in the food industry.

In general, there are two types of analytical methods used to determine the presence of allergenic foods: Specific and non-specific methods.

Specific tests

Specific methods can detect target proteins in foods that contain the allergenic portion of the food sample. These include immunoassays, in which specific antibodies can recognize and bind to target proteins. The format of these assays can be quantitative, such as an enzyme-linked immunosorbent assay (ELISA) that may help determine the concentration of target proteins in a food sample. Or they can be qualitative, such as a lateral flow device, which within a few minutes and with minimum sample preparation can display whether a target protein is or is not present. (Note: Some commercial formats of ELISA are also designed to obtain a qualitative result.)

To date, ELISA assays have become a method of choice for detection and quantification of proteins from food allergens by regulatory entities and inspection agencies. For the food industry, ELISA can also be used to test raw ingredients and final food products. In addition, ELISA is a valuable analytical tool to determine the concentration of proteins from allergenic foods during a cleaning validation process, as some commercial assay suppliers offer methods to determine the concentration of target proteins from swabs utilized to collect environmental samples, clean-in-place (CIP) final rinse water or purge materials utilized during dry cleaning.

ELISA methods often require the use of laboratory equipment and technical skills to be implemented. Rapid-specific methods such as immunoassays with a lateral flow format also allow detection of target specific proteins. Given their minimal sample preparation and short time-to-result, they are valuable tools for cleaning validation and routine cleaning verification, with the advantage of having a similar sensitivity to the lowest limit of quantification of an ELISA assay.

The use of a specific rapid immunoassay provides a presence/absence result that determines whether equipment, surfaces or utensils have been cleaned to a point where proteins from allergenic foods are indiscernible at a certain limit of detection. Thus, equipment can be used to process a product that should not contain a food allergen. Some commercial rapid immunoassays offer protocols to use this type of test in raw materials and final product. This allows food producers to analyze foods and ingredients for the absence of a food allergen with minimum laboratory infrastructure and enables in-house testing of this type of sample. This feature may be a useful rapid verification tool to analyze final product that has been processed shortly after the first production run following an equipment cleaning.

Non-Specific Tests

While non-specific testing isn’t typically the best option for a cleaning validation study, these tests may be used for routine cleaning verification. Examples of non-specific tests include total protein or ATP tests.

Tests that determine total protein are often based on a colorimetric reaction. For example, commercial products utilize a swab format that, after being used to survey a defined area, is placed in a solution that will result in a color change if protein is detected. The rationale is that if protein is not detected, it may be assumed that proteins from allergenic foods were removed during cleaning. However, when total protein is utilized for routine verification, it is important to consider that the sensitivity of protein swabs may differ from the sensitivity of specific immunoassays. Consequently, highly sensitive protein swabs should be selected when feasible.

ATP swab tests are also commonly utilized by the food industry as a non-specific tool for hygiene monitoring and cleaning verification. However, the correlation between ATP and protein is not always consistent. Because the ATP present in living somatic cells varies with the food type, ATP should not be considered as a direct marker to assess the removal of allergenic food residues after cleaning. Instead, an analytical test designed for the detection of proteins should be used alongside ATP swabs to assess hygiene and to assess removal of allergenic foods.

Factors for Using One Test Versus Another

For routine testing, the choice of using a specific or a non-specific analytical method will depend on various factors including the type of product, the number of allergenic ingredients utilized for one production line, whether a quantitative result is required for a particular sample or final product, and, possibly, the budget that is available for testing. In any case, it is important that when performing a cleaning validation study, the method used for routine testing also be included to demonstrate that it will effectively reflect the presence of an allergenic food residue.

Specific rapid methods for verification are preferable because they enable direct monitoring of the undesirable presence of allergenic foods. For example, they can be utilized in conjunction with a non-specific protein swab and, based on the sampling plan, specific tests can then be used periodically (weekly) for sites identified as high-risk because they may be harder to clean than other surfaces. In addition, non-specific protein swabs can be used after every production changeover for all sites previously defined in a sampling plan. These and any other scenarios should be discussed while developing an allergen control plan, and the advantages and risks of selecting any method(s) should be evaluated.

As with all analytical methods, commercial suppliers will perform validation of the methods they offer to ensure the method is suitable for testing a particular analyte. However, given the great diversity of food products, different sanitizers and chemicals used in the food industry, and the various processes to which a food is subjected during manufacturing, it is unlikely that commercial methods have been exhaustively tested. Thus, it is always important to ensure that the method is fit-for-purpose and to verify that it will recover or detect the allergen residues of interest at a defined level.

Gabriela Lopez, 3M Food Safety
Allergen Alley

Five Steps to Creating a Successful Validation Study

By Gabriela Lopez-Velasco, Ph.D.
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Gabriela Lopez, 3M Food Safety

Manufacturing large volumes of food product that must be safe for human consumption with finite resources is, simply put, a demanding responsibility. For many food brands, having dedicated production lines is not always an option, so lines are often shared amongst a variety of food products. A potential problem arises when products containing allergenic foods are manufactured on the same equipment as other products, and those allergenic foods are not meant to be declared in the product label. As a result, residues of the first product manufactured may move to the next product. Known as direct cross-contact contamination, this issue can have a severe adverse impact on allergic consumers.

Cross-contact contamination can occur at various stages of production, but it’s direct food cross-contact in shared production lines that is often found as a particularly significant food safety hazard. Addressing cross-contact through effective cleaning procedures is one of the most critical allergen management activities in establishing preventive controls and minimizing the potential of unintentional presence of food allergens. Allergen cleaning validation enables food manufacturers to evaluate that their cleaning procedure is adequate when it comes to removing ingredients from direct food contact surfaces.

Cleaning validation consists of generating data to demonstrate that allergenic foods are removed from direct food contact areas to a pre-defined acceptable level. A basic cleaning validation design consists of determining the residual level or presence of allergenic food before cleaning (baseline), and then assessing the level of the allergenic food after cleaning.

If the cleaning procedure exists in several steps (i.e., more than one rinse or purge, as with dry cleaning) additional testing to assess the level of allergens between cleaning stages and in the final product can also be incorporated. It is important to remember that a single validation study may not be applicable for an entire site operation. Different production lines within a food production site may require an individualized validation analysis. This determination will depend on the cleaning process as well as the formulation of the products being manufactured.

There are five important considerations for establishing a successful validation study:

  1. Set up a team and assign a leader to carry out the design of the validation. Involving relevant personnel with knowledge in the product formulation, manufacturing process, equipment design and cleaning and sanitation regimes may provide valuable insight to identify processes that should be included in the validation. It may also bring to light critical sampling points in the equipment that should be considered.
  2. Determine the scope of the study. This is where you describe and justify which equipment, utensils, cleaning regime and production processes will be validated. It may be wise to group different processes or select the worst-case scenario. For example, you might choose to focus on food production equipment regarded as hard to clean or equipment that contains the highest concentration of the allergenic food.
  3. Design a sampling plan. This is a critical prerequisite before starting a validation study. The plan should be clearly defined, with critical sampling points and locations prescribed to challenge the effectiveness of the cleaning regime and to find evidence of allergenic food presence. In both open equipment and equipment that will be dismantled as part of the cleaning regime, it is important to select sites where food can get trapped, as well as other sites that are hard to clean. Also consider other surfaces that can be a source of direct cross-contact like protective clothing and utensils. For clean-in-place (CIP) systems, wash water should be collected from the onset of cleaning and then at intervals leading up to the final rinse water. This helps to demonstrate that allergen food levels are diminishing, thereby validating the use of CIP analysis as a verification method. Note that it is important to consider that the sampling plan for the validation should also reflect the sampling plan that will be used during routine verification. Support from a statistician may facilitate the decision to define how many samples and type of samples (swabs, CIP or final product) should be collected for the validation and how many cleaning runs should be performed to demonstrate validity.
  4. Select a method of analysis. Validation and verification involve the use of a specific method to detect allergenic foods. The selected method should be validated as well, an undertaking most often done by the commercial supplier. Then it should be verified by the food processor that the method is fit for purpose, such that the allergenic food will be recovered and detected under the conditions in which samples are routinely collected. This ensures there will not be interference due to the food itself or due to cleaning chemicals. There are a variety of different analytical methods; most are based in technologies designed to detect proteins. Enzyme-linked immunosorbent assays (ELISA) and immune-based lateral flow devices (LFDs) offer detection of specific protein targets (i.e., egg proteins, milk proteins, peanut proteins) and are ideal for a validation study. ELISA can provide quantitative data from pre-cleaning, at various intervals during the cleaning process, at post-cleaning and at final product, offering a measurable level of the allergenic food during the cleaning process. Rapid detection through LFDs also allows food processors to assess the presence or absence of a specific protein or group of proteins, but different from ELISA, the result is only qualitative. In either case, these rapid tests may be used for both validation and routine verification. In addition, there are non-specific tests that can detect total protein that may be selected for a cleaning validation study. These tests do not provide specific information about the allergen to be managed, and thus may be more suitable for routine verification. During a cleaning validation study, it is important to include the test that will be utilized for verification and ensure it is also fit for purpose and detects the allergenic food to an appropriate pre-defined sensitivity. This is particularly important if the test is different from the analytical method chosen for cleaning validation.
  5. Establish acceptance criteria. Proteins from allergenic foods may cause an adverse reaction at very low levels. To date, there are very few regions in the world in which threshold or permitted levels for allergens in food are established. Each individual food manufacturer should define a criterion to establish when a surface is clean from allergens after routine cleaning. The limits that are set up should be practical but also measurable and verifiable, thus it is important to define a level with knowledge of the sampling and analytical method selected. The sensitivity of the analytical methods currently available may be used as a criterion to verify that levels of an allergen are under control if they fall below the limit of detection of the analytical method.

Once a cleaning regime has been validated and documented, routine allergen cleaning verification should be performed as part of a monitoring program to demonstrate that the cleaning process in place is effective and that the risk of direct cross-contact is consequently being controlled. The validation should be repeated at defined intervals, often once a year. However, it is expected that a cleaning verification will be performed after each production run and cleaning procedure in order to reflect that the validated cleaning process is still effective. Cleaning verification, along with other allergen management activities, strengthens implemented food safety programs and helps to protect consumers.