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.

Bob Pudlock, Gulf Stream Search
FST Soapbox

Architect the Perfect Food Safety Team: Does Your Next Food Safety or Quality Team Member Even Exist?

By Bob Pudlock
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Bob Pudlock, Gulf Stream Search

As a food safety leader, you’re accountable for keeping the company in line with regulations and ensuring consumer trust, yet you’re constantly asked to “do more with less”.

In an environment with such a thin margin for error, it’s imperative to have a seamless, friction free, fast but effective recruitment process.

As a food safety leader, you want to move the needle towards more proactive measures to optimize systems, develop more robust risk management systems and above all else get everyone in the company singing the same song when it comes to a food safety “culture”.

Bob Pudlock will be moderating the panel discussion, “Food Safety Leadership: Earning Respect”, at the 2019 Food Safety Consortium | October 1–3 | Schaumburg, ILOur three-part series on architecting the perfect food safety team will show you the components of a hiring and recruitment methodology that you can champion to your internal recruitment team, a third-party recruiter you trust, or you yourself.

Our first of three articles will focus on the IDENTIFICATION step, where, based on your job description, your compensation plan and your skill set requirements, you’ll be able to quantify the size of your candidate pool locally, regionally and nationally fast. This is really important.

Most companies don’t do this.

Internal recruitment teams aren’t optimized to do a deep dive on each job profile, whether it’s a Food Safety Specialist or a VP of Food Safety. The gap is exacerbated in food safety and quality due to the significant uptick in expertise required to execute on all the requirements that today’s food safety climate requires. Many roles that historically required only “attention to detail” and “Microsoft Excel skills” now require a microbiology or chemistry degree as well as subject matter expertise with quality management and ERP systems.

Unfortunately, your internal talent acquisition team will find it next to impossible to tell you how many SQF-certified QA managers with experience in a manufacturing setting with a Bachelors degree that reside within 30 miles of each plant in your network, much less be in a position to effectively contact and recruit them quickly.

You have to know where your future team members are today—either through internal means (your talent acquisition team) or externally(a recruitment firm)….and you can’t wait until you’ve had an unexpected resignation.

It’s like burying a fire extinguisher in your closet and not remembering where it is–if everyone in the house doesn’t know where it is, it hasn’t been tested, and it’s not located in the optimal place, it will serve no purpose when it’s an emergency.

At a recruitment firm approaching the food safety talent ecosystem and executing a search is done in much the same manner as how you develop your company’s HACCP plan.

Your HACCP plan addresses:

  1. What threats and hazards are we trying to avoid?
  2. What are we trying to achieve with our plan?
  3. What does a fully executed plan entail? Safe food and…..

Similarly, we start a search with a role’s “intent” fully defined.

The “intent” of the role rarely exists in a job description—this is fleshed out when having a conversation with a client. It starts with a series of questions such as:

  1. What is the first area of focus this person will tackle?
  2. What problem(s) will they be tasked with solving?
  3. What will this person’s area of focus look like after a year(best case)?

It’s an oft-overlooked step because most of our hiring managers are so busy they end up using the same cut-and-paste job description that’s been used for the last 10 years.

An example our clients have used for searches we’ve completed for them include:

  1. “In 12 months, the new hire will have fulfilled our company’s initiative to attain SQF Certification Level III for Plant X.”
  2. “Within 12 months, the new hire will have participated in the installation and led internal training of plant personnel; each plant team member will have been trained and passed internal testing requirements of the new system.”
  3. “The new hire will lead improvement initiatives that dramatically improve our KPI indicators around hazardous materials and foreign objects within 6 months of hire.”

With the end result in mind, you now have a clearer picture of what you’re looking for in your new hire rather than a stale, generic job description which, oh by the way, every other company is looking for.

With a clear picture of who you’re looking for and the end results you’re looking for, the next crucial step in the IDENTIFY stage is determining to what degree that candidate exists and is available in the market.

If you create a “wish list” in a vacuum without determining how many people actually have those criteria, it’s equivalent to developing a HACCP plan without validating it.

How do you validate a HACCP plan? You test it. You challenge the thresholds. That takes time, sure, but at the end of the testing, you know where the Critical Control Points are( room for improvement), you know better what absolutely needs to be changed (Corrective Action).

How you validate your HACCP plan is similar to how we provide our clients with data that reflects the feasibility their expectations – from there, we chip around the edges of the requirements until we have a large enough candidate pool from which we can effectively execute a recruitment strategy.

For example, we’re often asked to help clients with a search that has the following particulars:

  1. Plant QA Manager with three years of management experience
  2. QA Manager with management experience in a food, beverage, ingredient or flavor manufacturing/processing environment
  3. Bachelor degree in Chemistry and/or Biology
  4. Local candidates only

Each of the four-above criteria is a “limiter” of some sort—as you work through the list and add a requirement or a “must have”, the candidate pool decreases.

In the example above, the limiter that impacts the candidate pool the most will be the last one: “Local candidates only.”

That limiter might be forced on food safety or the quality department because of budget restrictions or it may be your choice altogether. Regardless, you’ve set the parameter and now it needs to be tested. Weeks and months can be lost if the search is executed without first knowing how many candidates actually have these skills locally.

You know how it feels when Marketing calls you in to test a new innovation for a product launch, three months into the gig? How within minutes of showing up at the trial you realize that production and quality will be compromised? How you wish they would have involved you from the start so you could have saved them, the company and your team all the headaches, time and money by offering an alternative? If only they would have asked you sooner?!?!

It’s the same with a search for a candidate with a particular set of skills and/or experience that doesn’t actually exist.

So, what’s the answer?

Well, the optimal strategy is to know every single food safety / quality candidate in the local market and/or nationally (especially if your category has more stringent needs like Dairy, Brewing, etc.) and to nurture them on an ongoing basis. You’ve done the work up front to assess and determine the caliber of the local candidate pool – since you’re already in rapport with the target candidate base, the turn-around time when you’re in a pinch is significantly shorter.

When a client asks us for the requirement we outlined above, we deliver an audit of that expectation within 48 hours, letting them know if that person actually exists and how many of them.

No time is lost. We have countless examples in the last year of alerting our client that two, yes two QA director candidates have the “must have” skills locally they are requesting, and neither is interested. We get clients to that point of discovery within hours, with tangible real-live data(not opinions), where they can then reassess their requirements and expand their candidate pool.

It’s a healthy conversation when it’s done early and up front— it results in less spinning of wheels and more productive dialogue around working within capabilities and restraints.

So do that—get your talent acquisition partner and talk to them specifically about your wish list, and have them come back to you with tangible numbers that validate whether or not what you’re asking for is reasonable.

Once you’ve done that and have a large enough pool of candidates to whom you can market the opportunity, you’ll be operating from a position of strength when it comes time to ASSESS the candidates who are brought forward. We’ll dive into more about the ASSESS step in Part two of our three-part series.

Megan Nichols
Retail Food Safety Forum

How Can We Make Food Labeling More Consistent?

By Megan Ray Nichols
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Megan Nichols

Consistent Inconsistencies

Current food labels may seem to possess a wealth of information, but they’re often challenging to read even if you know what you’re looking for. Additionally, studies have shown that even accurate food labels don’t work —they lead to no significant dietary changes. Even posting the calorie counts on fast food menus did little to change people’s eating habits.

It might sound as simple as telling consumers to read the ingredients labels on the items that they’re purchasing. The problem with this—aside from the fact that ingredients are often printed in a painfully small font—is that you almost need a degree in chemistry to understand the components. This confusion is a big issue with processed foods that contain a variety of chemicals to protect the flavor of the food and preserve it during storage.

When it comes down to it, choosing healthy foods isn’t the problem—or at least, not the only problem. Picking a healthy option isn’t as complicated as doing your taxes or choosing a mortgage when you purchase a home. We as consumers have plenty of information available to us when it comes to eating healthy. The problem is the fact that it’s easier and usually cheaper to choose the unhealthy option. You can buy a can of soda for $0.50, while a bottle of water often costs more than $1 at a soda machine or convenience store.

No One Reads Them Anymore

Another big issue with nutrition labels is that no one bothers to read them anymore. One survey found that two-thirds of young adults in the Minneapolis-St. Paul area don’t bother reading nutrition labels or worry about the nutrition content of what they’re eating.

While the survey didn’t explore why adults were no longer utilizing nutrition labeling, it’s likely due to a combination of consumer distrust and confusion. People either don’t trust that the labels contain accurate information, or they’re merely confused by the information presented in that format.

The Healthwashing Dilemma

How many times have you walked into the grocery store and chosen a brand based on whether or not it had “All-Natural” or “Organic” labels? Even if these phrases are written on the label, that doesn’t necessarily mean that the food contained within falls under either of those categories. That’s where the problem of healthwashing occurs.

Food packages will slap these labels on their product even if it doesn’t apply—a company can claim that their product is “all natural” and still use pesticides on it. Some businesses use products like pyrethrins, which are potentially dangerous pesticides derived from natural sources—specifically, the chrysanthemum flower.

Food companies don’t typically like to advertise this information because it might discourage potential consumers from choosing their brand, especially if the user is concerned about their health and is trying to remove all chemicals and pesticides from their food chain.

Fixing the Labeling Problem

What can we do to encourage consumers to pay attention to nutrition labels? The biggest challenge lies in making these labels more consistent and transparent. That task is more complicated than it sounds since there is no regulation or standardization in nutrition labeling. Clean labeling could be the solution.

Five key facets define clean labels — Simple ingredients lists, transparency in ingredients and packaging, no flowery language, accurate images and fresh food—are top priorities for consumers, with transparency being in the highest demand. However, these labels face the same problems as current nutrition labels—a lack of standardization. When asking more than 27,000 people in 31 countries what they thought clean labeling meant, more than a third had no idea, according to a report from Packaged Facts.

Many companies have started to transition to clean labels, but no law currently requires businesses to do so.

The Need for Change in Food Labeling Consistency

Food labeling could potentially help consumers make healthier choices if they were more accurate and easier to understand. Eliminating the flowery language that currently defines food labeling is one step in the right direction. The federal government— or, more specifically, the FDA— may need to step in as well to create standards that each company can be held to so that consumers know what exactly is in their food, no matter the brand.

Food labels are on nearly everything that we buy, except for fresh meat and produce. It’s time to create a standard and transparent label that everyone can understand.

Erika Miller
FST Soapbox

Does the Sanitary Transportation Regulation Require Seals for LTL Shipments?

By Erika Miller
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Erika Miller

This question has come up frequently in our FSMA Sanitary Transportation workshop. Just as with all the parts of FSMA, the focus of the Sanitary Transportation of Human and Animal Food regulation is on addressing hazards that may be present throughout the food chain and assigning responsibility (liability) for preventing those hazards. There are very few specific requirements—most of it is couched in very general language, for flexibility on both sides (FDA’s and industry’s).

While the regulation does not specifically address locks or seals on trailers, the FDA has stated publicly that they intend to enforce the adherence of industry to generally accepted best practices. Sometimes, as in the case of certain animal food applications, the FDA has stated they will accept mild steel transports instead of stainless (as would typically be required for hauling food) because it’s all about the risk, and mild steel is not a risk in those applications. What is the risk of an unlocked load to the food being hauled, and to the business being conducted? Maybe a seal or lock on an LTL can protect a significant investment from an identified hazard.

Generally, in most food hauling operations, seals or locks are required on trailers by businesses in order to protect their investments. They are also expected under GFSI-approved food safety management systems, used by most food manufacturers (which are private, voluntary standards, not regulatory). They are definitely required if you want to haul 100% juice under Juice HACCP and the JPA guidelines.

There are so few straightforward answers with FSMA. You must always look at your operation, your risks, and decide if controls are necessary. Document the basis for your decision, ensuring it is based on facts. If the FDA inquires, you must make your case for your decision. Do you feel comfortable defending it, all the way to a court of law if need be? If so, then stand by it.

If there are potential risks to food that is being hauled (don’t forget about defense-type risks as well, like the truck being stolen or misrepresented) then you must take reasonable, industry-standard precautions to prevent those hazards from occurring.

Of course, you want to do this anyway because it is smart business.

Karen Everstine, Decernis
Food Fraud Quick Bites

Media Sources for Food Fraud Intelligence

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

A recently published paper advocates the inclusion of media reports as a source of information for assessing food fraud vulnerability.1 Those of us who maintain the Food Fraud Database could not agree more. We have been monitoring media reports for years and they are an important source of information in the database (accounting for 45% of all primary source references).

As I mentioned in last month’s post, there are challenges with using media reports to inform food fraud vulnerability. Many media reports are general discussions of the issue of food fraud and are not necessarily reporting new information. It may be difficult to filter out these types of reports without manual review. There may also be concerns about the validity of media reports on food fraud. This is the reason we implemented a classification for “weight of evidence” for incident records in the database. Overall, approximately 30% of the incident records in our database are classified as a “low” weight of evidence due to unverifiable data or a lack of corroborating reports. Some of our users choose to filter these out of their searches.

We have received requests for information about how the data in the Food Fraud Database compares with numbers reported in the paper. Table 11 in the paper described the top product categories, countries and type of fraud as reported in four food safety tracking systems.1 We have adapted that table below to data from the Food Fraud Database.

Product Category % Country of Origin % Type %
Meat/Poultry 18 India 26 Dilution/substitution (misrepresentation of animal origin) 26
Seafood 16 China 9 Dilution/substitution (“other”) 19
Dairy Products 14 United States 9 Dilution/substitution with a non-food substance 14
Alcoholic Beverages 6 Columbia 6 Dilution/substitution (misrepresentation of botanical origin) 12
The most common food fraud records (“cases”) in the Food Fraud Database (2014-2015)

As shown in Table 11 in the paper, the top four products by number of articles in the media monitoring system (in 2014-2015) were meat, seafood, milk and alcohol. As shown above, when looking at data in the Food Fraud Database from 2014 and 2015, the top ingredient categories are very similar: Meat/Poultry, Seafood, Dairy Products, and Alcoholic Beverages. However, there was little agreement in the country of origin of the reported cases among any of the systems. For the Food Fraud Database (shown above), the top countries of origin in 2014–2015 were India, China, the United States and Colombia. According to the paper, the top countries of origin reported by the food fraud media monitoring system were Egypt, the United States, the U.K. and Saudi Arabia. The top country of origin reported by RASFF was China and by HorizonScan was the Czech Republic.

Table 4 reported the “types” of food fraud (which correspond to what we call “reasons for adulteration”) and the corresponding number of articles collected, which we have also adapted to the data in the Food Fraud Database below.

Types of Food Fraud in Records in the Food Fraud Database (2014–2015)
Type of Food Fraud Number of Records %
Dilution/substitution – misrepresentation of animal origin 212 26
Dilution/substitution (other) 159 19
Dilution/substitution with a substance not approved for use in foods 118 14
Dilution/substitution – misrepresentation of botanical origin 101 12
Unknown 87 11
Fraudulent labeling 64 8
Artificial enhancement of apparent protein content 58 7
Artificial enhancement with color additives 57 7
Other 41 5
Dilution/substitution – misrepresentation of geographic origin 40 5
Dilution/substitution – misrepresentation of varietal origin 28 3
Use of unapproved biocides (antibiotics, anti-fungal agents, preservatives, etc.) 21 3
Artificial enhancement (other) 7 1
Formulation of an entirely fraudulent product using multiple techniques and adulterants 2 0
TOTAL 828 *
* Greater than 100% because one record can have multiple types of associated fraud

It is not possible to make meaningful comparisons among the reported fraud “types” without harmonized definitions and standardization of data collection processes, as noted in the paper. A glance at Table 1 from the paper illustrates the variety of food fraud categorizations in use among the various systems.1 Generally, it is a challenge to directly compare any of the information coming from various sources such as RASFF, HorizonScan, the Food Fraud Database and others, due to the differences in the way data is collected, standardized and reported.

In contrast with foodborne illnesses, which are generally required to be reported to public health agencies, food fraud typically does not result in acute illness and is difficult to track. The nature of food fraud combined with differences in data tracking systems make it almost impossible to reconcile the data among the various systems. Regardless of which system is reporting, the reports are likely just a fraction of the true occurrence of food fraud; however, each can provide valuable perspective on risks to food safety (including those from food fraud). A holistic assessment of food fraud vulnerability should take into account a wide variety of information sources, including media reports.

Reference

  1. Bouzembrak, Y., et al. (November 2018). Development of food fraud media monitoring system based on text mining. Food Control. Vol. 93. Retrieved from https://doi.org/10.1016/j.foodcont.2018.06.003
Steve Ardagh, Eagle Protect
FST Soapbox

Glove Polymers: The Unregulated Food Safety Threat

By Steve Ardagh
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Steve Ardagh, Eagle Protect

Various polymers are used in food contact applications that include food packaging and disposable gloves. More than 30 different types are used in packaging and up to six in disposables gloves. In terms of safeguards for the U.S. food supply as well as user safety, it is worth noting that 87% of the production of packaging polymers is based in the United States and subject to FDA regulation and monitoring. On the other hand, all (100%) of the 100 or more glove factories supplying the United States are based in Southeast Asia, according to a report by the British Medical Association and are not subjected to the same FDA monitoring or scrutiny.1

Packaging production is carefully overseen by the FDA, is included in FSMA, and covered in the HACCP process. Toxicology of food packaging is carefully prescribed and subject to strict enforcement action from production to storage.

Glove factories, however, are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. A clear opportunity exists for accidental contamination within the glove-making process. More significantly, because of the geographic and economic implications in workforce and workplace conditions, intentional contamination potential is greatly increased. Polymer gloves utilized in food processing and service have been implicated in 15–18% of foodborne illness outbreaks in the United States.2

There is a striking difference in the requirements for these two different types of food contact polymers. Food packaging is extensively regulated, gets tested within the context of completed food product and has production primarily in the United States under close supervision. Disposable gloves, on the other hand, rely on self certification, often with testing results only on glove constituents, and little or no oversight of factory process and conditions. It seems as though this is a glaringly obvious but little accounted for risk to the U.S. food sector.

As a result, based on the root cause analysis of food cross contamination, a selection of tests and certifications, some of which are unique to the glove industry, are being implemented by one particular glove supplier. These tests ensure that their gloves coming into the United States are made in clean, well-run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove fingerprint testing program consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS, surface free energy determination, in vitro cytotoxicity analysis, and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, I believe these tests are essential to further reduce the food safety risks associated with them. Objective…Zero surprises!

References

  1. Bhutta, M. and Santhakumar, A. (March 2016). In Good Hands. Tackling labor rights concerns in the manufacture of medical gloves. British Medical Association. Retrieved from https://www.bma.org.uk/collective-voice/influence/international/global-justice/fair-medical-trade/medical-gloves-report.
  2. Michaels, B. (2018). Determination of the % of Foodborne Illness Outbreaks Attributed to Glove-Related Cross-Contamination. Unpublished report

The author would like to acknowledge Barry Michaels, an international scientific consultant on food safety, infectious disease transmission and glove use, who has assisted in the fingerprint testing program discussed in this column.

Gisli Herjolfsson, Controlant
FST Soapbox

How Supply Chain Digitalization and Data Helps Prevent Costly Recalls

By Gisli Herjolfsson
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Gisli Herjolfsson, Controlant

Recalls are something that food brands plan for but hope to never experience. They are an important public safety issue, but they also have a significant economic impact as well. At best, a product recall is a benign mistake that causes little more than aggravation and inconvenience for a few angry customers. At worst, the consequences can be tragic, both in terms of human and financial impact.

Industry research conducted by the Food Marketing Institute and Grocery Manufacturers Association places the average cost of a single recall at $10 million. That calculation includes only the direct costs of a recall. For the full, long-term costs, including direct and indirect liabilities, you’d need to further account for the immediate loss in sales, litigation costs, as well as any long-term damage caused from a loss in consumer confidence in your brand.

Consumers’ relationship with food is ever changing. They demand transparency about its contents, origin and safety, and for good reason. The World Health Organization estimates that nearly 1 in 10 people are sickened yearly from eating contaminated food, leading to 420,000 deaths. Consumers have long memories for businesses that poison them. The larger the size of your company and the more attention it receives, the potentially greater impact on your long-term business prospects. With the recent E. coli outbreaks tied to romaine lettuce, food safety is top of mind for consumers, and it is impacting entire market segments.

One of the easiest ways to prevent recalls associated with perishable foods is to ensure that food and beverage products are safely produced and continually kept at the right temperatures. Sounds easy, right? In reality, it is far from it.
Gaining end-to-end supply chain visibility can help you prevent costly recalls altogether. Data that today’s technology provides will be important for mitigating risk and protecting a brand’s reputation.

Get Proactive

The idea of prevention is paramount to FSMA. It’s clear that the FDA expects that once a producer or supplier discovers that something has gone wrong, they go back and figure out exactly what happened so that they can put measures in place to prevent it from happening again.

While current FDA guidelines and various EU safety regulations generally require that food can be tracked one step up and one step down the supply chain, this remains a very siloed approach to traceability and is open to risks—risks that producers, food retailers and restaurant brands cannot afford to take.

For USDA-regulated products, HACCP employs a similar process. Prevention is key, and if your monitoring measures miss an issue that could compromise food safety, you’ll need to go back and determine the root cause of the problem.
A cold food manufacturer can do a lot to control risks under its own roof, but how do you avoid costly recalls with ingredients or with temperature abuse after a product leaves the facility? Regulations or not, knowing where your ingredients and food products come from and being assured of their safety is critical in protecting your brand and company from the financial and reputational damage caused by a food recall.

Looking forward in the supply chain, maintaining the cold chain is necessary for many products, including fresh produce, frozen and deep frozen foods, and also those that must be kept at room temperature but still require temperature control. Even if you and your suppliers are incredibly careful and practice prudent safety measures, you may not have full visibility over who else is handling your products. If temperature mishandling by someone else necessitates a food recall or results in a food safety incident, it is still associated with your brand, even if you weren’t the direct culprit.

For many food retailer and restaurant chains, it is common practice for them to share their internal food safety guidelines with their suppliers and partners, and require that they prove a product’s source of origin, lifespan, how those products are stored and transported from point A to point B, as well as the environmental conditions in which foods are kept. Allowing suppliers and logistics partners to self-manage their supply chain does nothing to proactively ensure that they and a food brand aren’t in the headlines due to a food safety incident.

Digitally Connect the Supply Chain

This is where technology and data can play a critical role in managing your temperature-controlled food and beverage products. More and more food enterprises are utilizing Internet of Things (IoT) technologies that talk to the internet so they can collect supply chain data into dashboards and access it on demand.

IoT can be considered as a central nervous system for the supply chain. Through IoT, you can track shipments or trace temperature, moisture or other factors that can have an impact on food quality. Not only can you discover problems more rapidly with this technology, you can narrow the scope of recall. For businesses transporting temperature-sensitive products, this means they can manage product movement data in real-time and respond to issues before they lead to a food safety incident or product waste.

From a food production standpoint, IoT solutions can substantially reduce recalls from issues like labeling, processing and contamination. One of the primary causes of a food recall is microbiological in nature, with the majority of cases involving fruits and produce. IoT data can help detect issues further upstream in the supply chain and, since products will change hands several times before they reach a consumer, it can give you a complete picture of the product’s lifecycle—something that cannot be done with clipboards and ad hoc or periodic inspections.

Through cloud technology, food businesses can connect their end-to-end supply chain, analyze data, discover trends, illuminate weak points and directly respond to them to improve their overall processes.

Track and Trace Everything

Continuous and consistent tracking and tracing through technology not only simplifies recalls, it helps prevent them altogether. The only thing worse than being faced with a food recall is not knowing which products are affected or where exactly they are located.

Real-time temperature monitoring and product movement traceability technology can give you the confidence that foods are continuously kept at their required temperatures and remain safe for consumption. When you need to track and trace an ingredient or product, time is often of the essence. Delays may mean more resources and efforts are spent in producing something that may be rejected, or worse, recalled, or that the potentially impacted product isn’t isolated in time.

The digital integration of suppliers and other partners is vital if a food enterprise wants to have more control over its cold chain. Consumer demand for social responsibility and ethical business operations means that businesses need to provide greater visibility and transparency into the origins of their products. With today’s supply chains, having data—essentially, a horizontal IT layer that lets people share and access data—removes the barriers of communication among stakeholders.
IoT serves as a tool to remove the barriers to collaboration between food manufacturers, food logistics businesses, restaurant and food retail chains, regulatory agencies, and the end consumer. It increases the transparency of information and helps to deliver better products throughout the food supply chain.

Get Started

Acknowledging that most food companies have limited resources, food brands can still face their efforts only on the suppliers and customers that are of the greatest concern. Often this means looking at the combination of “high-risk product” with “high-risk supplier/partner” and prioritizing that part of the supply chain. This prioritization will help food brands allocate their resources and focus their time and money on the highest risks to their customers and brand. Once they’re able to reap the benefits of a preventive food safety program, they’re better able to justify allocating additional resources to other parts of the cold chain.

While IoT, cloud monitoring and traceability technology has been around for some time, real-time data is now becoming standard. Traditionally, the cost of IoT technology and data infrastructure could be quite expensive. However, different business models like subscription are on the rise, which lower the cost of entry for new prospects and can connect a broader range of products, not only high-value goods.

Although many food brands already have some proactive food safety programs in place, it only takes one incident to lead to a major food recall—even if it isn’t your company’s product—and it can negatively impact your business.
As an industry, food brands need to continue raising the bar in terms of what is considered standard and “best practice” when building an effective, proactive food safety strategy. Utilizing best-in-class technology can ensure the delivery of safe foods to the market, prevent recalls, protect business interests, and most importantly, protect consumers.

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.

Chelle Hartzer, Orkin
Bug Bytes

Filthy Flies Can Put Your Operations at Risk

By Chelle Hartzer
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Chelle Hartzer, Orkin

When we think about dirty pests, cockroaches are usually the first to come to mind. But while the conditions they thrive in are disgusting, flies breed and feed in the filthiest areas. Their lifestyle means their bodies can be covered in dangerous, potentially disease-inducing pathogens, which can be spread anytime they land on a surface or their body comes into contact with something.

House flies are born as maggots, emerging into their larval stage from tiny eggs laid anywhere decaying organic matter can be found. After splashing about in the grime and decay and consuming just about anything they can find, the larvae leave their food source and crawl around seeking out cool, dry, protected places. A shell forms around the pupae, where they remain for a brief time before turning into adults. This entire process takes less than two weeks from egg to breeding adult. Once they’re adults, house flies take off in search of more decaying organic matter and moisture to lay their eggs in and continue the processes.

Essentially, a house fly spends its entire life cycle either crawling around in filth or flying around to find new sources of filth. Add in the fact that they reproduce rapidly, and it’s easy to see why they’re a food safety threat. But they’re not the only species of fly that plagues food processing facilities, as fruit flies and moth flies are two other incredibly common fly species that love to make food processing facilities a new home.

To prevent flies, the first step is to take a close look at your current integrated pest management (IPM) program and ensure your program focuses on taking a proactive approach to mitigating pest issues. But before discussing the specifics of how to protect a facility from these fly invaders, it is important to know how and why they get into a facility in the first place. Each species has slightly different locations where they’re likely to be found, which should be monitored closely to ensure they don’t become hot spots.

Let’s look at the three most common fly species most likely to plague a food processing facility:

House Flies

House flies are persistent and active. Each time they pause to rest on floors, walls or ceilings, remember they’re potentially dropping off disease-causing pathogens. House flies are known to transfer more than 100 pathogens resulting in ailments like typhoid, tuberculosis, cholera and dysentery. They’ll feed on any moist human food, animal food, garbage, carcasses and just about any other wet or damp organic material. Flies detect a food source and hone in on it, which is why they’ll be looking for a chance to invade your food processing facility.

Moth Flies

Although moth flies feed on organic matter and sewage, they’re found in moist areas coated with nutrient-laden organic material. They are sometimes called drain flies because (you guessed it) they are often found in drains. They love the buildup that sticks around the pipes, and once they start reproducing, they can be a nuisance to eliminate. Usually, you’ll never see drain fly eggs and larvae because they drop irregular masses of egg sacs that hatch into larvae, which then live in the gelatinous film inside drains. From there, they mature into pupae and then flying adults, which is when you’ll start to notice them. This is why regular drain cleaning, with a foaming cleaner, is important in controlling these fly issues.

Fruit Flies

Like drain flies, fruit flies are named aptly. They’re most attracted to rotting or decaying fruit and vegetables, but they also enjoy fermented items like beer, liquor and wine. Aside from the products themselves, fruit flies may also breed and develop in drains, garbage disposals, trash cans and even mop buckets. Fruit flies are also known for being a major risk to contaminate food with bacteria and other pathogens. If there is food waste present, fruit flies want to be there. Finding their source and eliminating it is especially important for successful control.

Now, the most important strategy for preventing flies—and most pests in general—is to implement a robust sanitation plan. Flies are looking for food and water to survive, so any source of organic matter or moisture is going to be likely to attract them. And once they’re inside, flies are likely to stay there. Most won’t travel more than a few hundred feet from the spot they were born in their entire lifetime. While small flies are more likely to be found breeding inside facilities, large flies are likely to be breeding outside and flying inside structures.

Consider these tips, as they can help you keep flies and other pest threats away:

  • Make sanitation a priority. Sanitation is one of the most important ways to help reduce pests. Flies love any damp organic matter they can find, so clean up messes as soon as they occur. And don’t forget to take out the trash on a regular basis. That means at least daily. Don’t miss cleaning the insides of trash bins, liners often leak and a buildup of material can be present underneath them.
  • Swap outdoor lighting. Use outdoor sodium-vapor lights, especially near entrances/exits to the inside of your facility. Lights can be placed away from the building to draw flies away and reduce populations at the same time. Ensure that inside lights don’t shine out at night and attract night flying insects and flies in.
  • Install automatic doors. Automatic doors give flying pests a smaller window of opportunity to get indoors by reducing the amount of time that doors remain open. For greater effectiveness, install two sets of automatic doors that only open once the other is closed to create a vestibule. Installing air curtains behind these doors can also help block pests from finding a way inside. Air curtains alone aren’t perfect, but they can help some.
  • Inspect loading and unloading areas. Shipment areas are a prime location for flying pests to wander in. Make sure all doors form a tight seal when shut and are not allowed to stay open for extended periods of time.
  • Seal cracks and crevices. Just about any gap, no matter how small, can be big enough for flies to find a way inside. Door sweeps and weather stripping can be installed to minimize these gaps. You can also use weather-resistant caulk to seal gaps on the exterior of your building, although this will likely take some time and a team effort at larger facilities.
  • Clean drains on a regular basis. Even if you don’t have a lot of “wet” processing, all drains, including break room, restroom, and locker room drains need to be cleaned. Small flies can develop in as little as seven days, so weekly cleaning is a must.

Implement these sanitation and exclusion efforts as part of your ongoing IPM program. With flies, sanitation cannot be stressed enough. They are living and breeding in conditions that need to be cleaned up, inside and outside. As with any pest issues, it is important to contact a pest management professional if it seems things are getting out of hand. If you’re seeing flies daily inside the building, that’s probably a good sign that your products may be at risk!