Food Adulteration Archives - Food Quality & Safety https://www.foodqualityandsafety.com/tag/food-adulteration/ Farm to Fork Safety Thu, 20 Oct 2022 00:37:26 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.1 180523520 Food Fraud: A Global Perspective https://www.foodqualityandsafety.com/article/food-fraud-a-global-perspective/ https://www.foodqualityandsafety.com/article/food-fraud-a-global-perspective/#respond Thu, 20 Oct 2022 00:36:12 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=37475 Preventing food fraud is critical, but understanding and identifying the risky hot spots is not that easy.

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Food fraud is nothing new. It has been a problem for many years and remains essentially unsolved. It is recognized as one of four different challenges to food integrity and is almost always motivated by economic gain. The European Commission defines food fraud as “any suspected intentional action by businesses or individuals for the purpose of deceiving purchasers and gaining undue advantage therefrom.”

The other three challenges are:

  • Food defense, which is primarily aimed at preventing intentional harm and may even occur when disgruntled employees sabotage food products;
  • Food quality, which usually results from unintentional actions but may involve food fraud; and
  • Food safety, which is mostly unintentional, with causes such as contamination and failure to control critical processes, but can also be malicious or fraudulent.

The phrase “food fraud” covers a variety of different types of fraud, among which are dilution, substitution, unapproved enhancement, concealment, counterfeit, mislabeling, and gray market. It is continually an issue because of the increasing length and complexity of supply chains. Moreover, supplier vulnerabilities are driven by the need to shift from one supply chain to another. Aside from the economic impacts of food fraud, there is always an inherent safety risk when ingredients are substituted, whether intentional or not. Traceability is lost, increasing the chances of additional undetected substitutions.

An example of an unintentional action with a big impact is the melamine scandal in China in 2008. This started as a food fraud case when someone used melamine, a non-food nitrogen source that was misidentified as “protein” by substituting routine total nitrogen testing methods for testing that would have indicated digestible nitrogen in baby and pet foods. This resulted in fatalities and hospitalizations, followed by the establishment of new regulations to address the potential for economically motivated fraud that results in a food safety hazard. There have been other cases over the years of fake ingredients being used in many products driven by people who basically don’t know what they’re doing.

A Growing Global Problem

Each month, the Joint Research Centre of the European Commission publishes a summary of food fraud and adulteration cases brought to its attention. This summary is by no means an exhaustive list, comprising only the cases reported in press articles around the globe.

The March 2022 monthly summary of articles on food fraud and adulteration had instances from 22 countries, including four countries inside the EU and the U.K. The size of some is quite staggering. One from China involved a criminal network smuggling more than 180,000 tons of seafood. Another resulted in the closing of a factory in Cameroon that was producing fake honey by mixing water, powdered sugar, and other ingredients.

While these examples represent significant economic fraud, others such as ingredient substitutions that introduce unlabeled allergens pose a huge risk to those with food allergies.

Food fraud is clearly a significant threat to food safety, impacting consumer health, industry operations, and brand reputation. Preventing food fraud is critical, but understanding and identifying the risky hot spots is not that easy. Sound food safety systems will always be an essential foundation, and developing these is a key challenge if food fraud is to be defeated. Current mitigation measures based on sampling and testing are useful in the short term but do not necessarily solve the problem. Detecting food fraud does not prevent it; it just postpones the issue until the fraudster has found another means of avoiding detection.

As mentioned, food fraud is very often a criminal activity driven by economic gain. The high value of the ingredient or material in saffron, honey, or beef, for example, is one motivator. Substituting or adulterating a high value item with something of a lesser value creates more profit. But even some traditionally lower-value items can make a profit for food criminals because of climate or disease impacting crop yields, such as hot weather affecting olive oil harvests, driving up the price of virgin olive oil. This makes adulteration or mislabeling even more appealing. Geopolitical tensions, such as the impact of war on availability of ingredients in the supply chain, create similar pressures.

The latter point is particularly relevant today, given the situation in Ukraine. Both Ukraine and Russia are major grain exporters. In 2019, the combined export of these two countries provided more than a quarter of the world’s wheat. Despite sanctions, Russia will likely be able to export a considerable quantity, but the harvest in Ukraine will inevitably be impacted, and its seaports are effectively rendered unusable.

According to the UN’s FAO Food Price Monitoring and Analysis, world wheat prices soared by 19.7% during March 2022. Maize prices posted a 19.1% month-on-month increase, hitting a record high along with those of barley and sorghum. Vegetable oils (Ukraine is a major producer) also rocketed in price, and a world shortage is predicted. We are already seeing a shortage in the stores and “rationing” by some retailers. Sunflower oil is also a major ingredient in processed food, so the risks of fraud among these items are already on the horizon.

Supply Chain Vulnerability

Longer and more complex supply chains create more opportunities for food fraudsters to infiltrate. The more often a material is transferred from one operator to the next, the more chances criminals have to make a profit. Multi-ingredient processed products, with components sourced from many regions or countries, have increased supply chain length and complexity. Ingredients may pass through many buyers and sellers from farm to fork and be transported as bulk ingredients or smaller units by road, rail, or air in frozen, concentrated, or dried forms for reconstitution at later stage. All these steps invite the opportunity for fraudsters to make money.

In the past, when the food industry was made up of mainly smaller organizations and individuals, food fraud would have been perpetrated by the organizations themselves; however, it is clear that, as the scale of food production has increased, criminal organizations have become involved.

The horsemeat scandal of 2013, when horse DNA was discovered in products mainly sold as beef, was a shock to the industry. It became clear to the industry and the general public that there was money to be made in food, and if there was money to be made, criminals would be active. Generally, these criminals have no desire to make customers ill or worse. This would only call attention to their activities. But, when monetary gain is the driving factor, there will be times when greed overrides safety concerns, especially if the consequences of food adulterations are not fully understood.

Europol became involved in coordinating investigations among national authorities, raiding premises and making arrests. Following an independent review, national Food Crime Units were created, and the industry started to take the risks seriously. Food safety standards used by the various bodies and organizations involved in certifying food safety management systems were reviewed to include risk assessments linked to food fraud, in addition to those linked to food safety, using a similar methodology to hazard analysis and critical control points (HACCP).

A New Way of Fighting Food Fraud

Essentially, the new method involves testing and there is a risk assessment process. There is a place for testing, but obviously there are downsides. For example, are you testing for the right thing? Do you wait for the result before you use that ingredient? Can you trust the testing and are the methods to test available? Are the analysis certificates fraudulent or counterfeit? It is all about using a risk assessment approach to try to identify where those risks are and to effectively manage them. Although similar to HACCP, but it’s called vulnerability assessment critical control points (VACCP).

Many of the leading global standard organizations now include VACCP as part of the auditing process for food safety systems; others require a food safety plan that includes an ingredient hazard assessment to address known cases of fraud that pose a food safety threat, as well as the more common food safety hazards. This will mean a control plan incorporating mitigation strategies and corrective procedures, which could involve audits of the entire supply chain, supplier assessment, and extensive quality control checks of ingredients and processes.

The secret of any successful food safety plan is setting up a team that is familiar with what is happening in the industry—a team that can consider every part of the process and identify vulnerable points in the supply chain, determine where the risk factors are, and decide how best to control them. It is not possible to completely eliminate the risks, but what organizations should be trying to do is control all that have been identified in order to minimize food fraud.

Steps to Minimize the Risks

A typical food fraud management system would begin with creating the team needed to operate the system, after which all the materials or groups of materials would need to be listed and studied. This would allow identification of potential fraud issues, fraud issues that pose a food safety risk, and evaluation of the degree of risk under current procedures. The next step would be to evaluate any need for further controls or processes and thereafter record and implement all additional measures. The final step is common to all successful management systems: regularly reviewing and verifying activity and resolving any non-conformities and carefully documenting the outcomes.

Organizations need to adopt a unique management system for several reasons:

  • There is no single, prescribed method of conducting a vulnerability assessment; any structured approach to identifying the risks can be used.
  • The choice of methodology may therefore be a matter of personal preference, of company policy, or of the complexity of the situation.
  • The vulnerability assessment is a specialized form of risk assessment, and it is therefore logical to consider similar tools and methods.
  • Some organizations have found tools such as threat assessment and critical control points (TACCP) and VACCP useful.

Knowledge of the supply chain, mapping, and monitoring are the key items needed for developing a consistent strategy to prevent food fraud, together with adequate auditing programs focusing not only on food safety and quality but extending their scope to counter fraud elements including traceability. The traceability element is also important because it is part of standards like ISO 22000:2005. This enables companies to test the vulnerability of their chain and check on their ­robustness.


McCarthy is the global food and beverage manager for DNV Business Assurance, a UK-based food certification body. Reach her at amanda.mccarthy@dnv.com.

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Testing Methods for Determining Honey Authenticity https://www.foodqualityandsafety.com/article/testing-methods-for-determining-honey-authenticity/ Tue, 01 Feb 2022 01:08:52 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=36706 Honey is a natural food product loved by the global population. However, its limited production, relatively high price, and complex composition make it vulnerable to adulteration. In fact, it ranks... [Read More]

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Honey is a natural food product loved by the global population. However, its limited production, relatively high price, and complex composition make it vulnerable to adulteration. In fact, it ranks in the top 10 most adulterated food products worldwide.

Honey adulteration is a form of food fraud, which is the deliberate and intentional substitution, addition, tampering, or misrepresentation of food, and it’s a major trend impacting the honey industry today.

Wiley has partnered with Agilent Technologies to bring together a special collection of articles detailing the advanced technologies available to detect adulteration and determine the authenticity of honey products. This important compendium features content from Agilent Technologies and Wiley publications, including Food Quality & Safety. In this collection, you’ll read about:

  • Detection and estimation of rice syrup in honey;
  • Food authenticity testing best practices;
  • Preventive measures you can take against food fraud;
  • Major honey authentication issues, such as production and origin; and
  • Pollen composition, physicochemical parameters, and phenolic and mineral contents of honey samples from Portugal.

We think this series of essential articles will help you combat food fraud in your operations and ensure that your customers are getting a quality product.

Discover this important compendium of content from Agilent Technologies, Food Quality & Safety and Wiley publications. Download the application note to learn more, courtesy of Agilent.

  • Application note: Detection and estimation of special marker for rice syrup (SMR) in honey
  • Fire up your next food authenticity project
  • Food fraud: A criminal activity. Implementing preventative measures that increase difficulty in carrying out the crime
  • A comprehensive review on the main honey authentication issues: Production and origin
  • Authentication of honeys from Caramulo region (Portugal): Pollen spectrum, physicochemical characteristics, mineral content, and phenolic profile

Download this whitepaper today!

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Detecting Food Adulteration with Benchtop NMR https://www.foodqualityandsafety.com/article/detecting-food-adulteration-with-benchtop-nmr/ https://www.foodqualityandsafety.com/article/detecting-food-adulteration-with-benchtop-nmr/#respond Fri, 06 Nov 2020 20:03:39 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=35023 NMR analysis can rapidly create a molecular “fingerprint” of a product, identify any adulterants, and establish the true country of origin.

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Food authenticity is not a new concept, but it remains a ubiquitous issue across the globe. While it is difficult to quantify how prevalent food fraud is throughout the entire supply chain, experts estimate its impact on the food industry to be in excess of $50 billion each year. Incidences of food fraud over the past decade have increased media attention on the issue of food authenticity, which has, subsequently, made it a hot topic in the food industry and regulatory agencies.

Over the last few years, nuclear magnetic resonance (NMR) technology has become an increasingly accessible technique for food safety laboratories, particularly for verifying food and beverage authenticity. NMR analysis can rapidly create a molecular “fingerprint” of a product, identify any adulterants, and establish the true country of origin—a frequent target for fraud.

The Demand for Accurate and Rapid Quality Control in Food Safety Labs

Traditionally, the food safety industry has utilized gas chromatography (GC) and polymerase chain reaction (PCR) testing to determine the chemical composition of products. However, these methods require large quantities of expensive reagents to operate effectively and can take hours, even days, to produce results.

Since its discovery in 1946, NMR spectroscopy has continued to grow as an indispensable analytical tool across a range of applications. NMR is an information rich, non-destructive analytical technique that provides detailed information about molecular structure and dynamic processes. It is also a primary quantitative method that can determine the concentration of molecules, even in complex mixtures.

NMR is utilized in the food industry for a variety of applications, including the determination of the chemical composition of foods and the quantitative analysis of changes induced by processing, storage, and spoilage. NMR has become a particularly popular technique in the food safety sector over the last decade, primarily used for verifying the authenticity of food and beverages and detecting counterfeit products.

In NMR analysis, food or beverage samples are analyzed and compared to large databases of genuine products, generating a “fingerprint” that users can compare with the test sample in order to check for compliance. Information that can be gathered not only includes what components the sample contains, but also details such as geographical origin to confirm if the product is from the source claimed.

The Shift Toward Benchtop NMR

The past 50 years of NMR spectroscopy innovation have, until recently, centered around steadily increasing the magnetic field strength of instruments. Now, new benchtop NMR spectrometers offer the reproducibility and stability of NMR technology in a more accessible, smaller instrument that can be installed on the lab bench.

A benchtop NMR spectrometer is significantly more compact and portable than the conventional NMR instrument. It does not require dedicated infrastructure or an extensive installation process. Benchtop spectrometers offer improved workflow, even for novice users, as they are intuitive in use and do not require extensive user training.

Low-field benchtop NMR can provide a high value solution for the food sector by delivering the same answer as high-field NMR to an array of analytical questions. The advantages of benchtop NMR systems are paving the way for the introduction of this technology:

  • No specialist NMR expertise required;
  • Same direct quantification and deep structural information as high-field NMR;
  • Compact benchtop size;
  • No additional infrastructure needed;
  • Cryogen-free permanent magnets—no need to refill liquid helium;
  • Operates from a single standard power socket; and
  • Easy maintenance and minimal cost of ownership.

The significantly reduced costs, low maintenance requirements, and simplicity of benchtop NMR spectrometers are leading this technology. Their advanced electronics and methodology make them ideally suited to high-throughput quality control.

Supporting Food Quality and Authenticity

Olive oil is one of the top-10 most adulterated food products, so detecting its dilution with a lower quality substitute, such as sunflower oil, is critical to the industry. The edible oil industry is a prime target for adulteration, with high quality oil, such as olive oil, often adulterated with significant levels of other edible oils that have a lower market price or are of a lower quality, such as hazelnut oil, sunflower oil, soybean oil, rapeseed oil, or corn oil. The olive oil industry has been petitioning FDA for years for a standard.

Benchtop NMR can differentiate among saturated, mono-unsaturated, and poly-unsaturated fats (Figure 1) and, based on this, can differentiate among different types of oil (Figure 2).

Figure 3 shows a gradual increase of one of the signals by adulteration with increasing concentrations of sunflower oil. NMR as a benchtop tool allows manufacturers and food safety officials to rapidly test the authenticity of foods such as olive oil, to protect brand reputation and ensure consumer confidence in the product’s authenticity.

Other features often analyzed with NMR that are now benefiting from benchtop systems are fat content of milk and species of coffee bean. The determination of the origin of these foods in the supply chain is vital to preserve the integrity of the manufacturer’s product and protect the consumer.

Mitigating the Risk of Food Fraud in the Future
Food fraud dents consumer confidence in the supply chain and causes distortions in markets that can lead to unfair competition, with legitimate producers undercut and potentially forced out of the market. If the whole supply chain is acting in accordance with a single standard, consumers can be confident in the seal of approval.

Benchtop NMR has a wide variety of potential applications in the fight against food fraud. Benchtop NMR systems can slot into any laboratory environment and begin providing accurate results quickly, without the need for expensive reagents or extensive user training.

For more information about how benchtop NMR is tackling food fraud, please visit bruker.com/products/mr/nmr/benchtop-nmr.html.


Dr. Decker is product manager for compact NMR (TD/FT) for Bruker BioSpin.

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Food Adulteration: History of Food Safety Laws and What It Means Today https://www.foodqualityandsafety.com/article/food-adulteration-history-of-food-safety-laws-and-what-it-means-today/ https://www.foodqualityandsafety.com/article/food-adulteration-history-of-food-safety-laws-and-what-it-means-today/#respond Thu, 18 Jul 2019 11:14:03 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=31371 What does food adulteration mean? From a legal standpoint, the answer is surprisingly complex.

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What does it mean for a food to be “adulterated”? From a lay standpoint, it is a simple question. But from a legal standpoint, the answer is surprisingly complex.

The section of the U.S. Code (21 U.S. Code § 342) that governs adulterated food begins innocuously, with the words “A food shall be deemed to be adulterated…” That simple directive, however, is followed by more than 1,200 words of dense legalese, an extraordinary amount of information to define something as seemingly straightforward as whether a food is adulterated.

By contrast, the First Amendment to the Constitution, which grants freedom of speech, freedom of religion, freedom of the press, and the right of the people to peaceably assemble is 45 words in length. The entire Bill of Rights is fewer than 500 words. Likewise, Merriam Webster’s definition of “adulterate” is only 17 words. Why then, does the statute need an additional 1,200 words?

In short, the statute is exhaustive because it must be. To serve its intended purpose, the federal adulteration statute must address a complicated nexus of enormously important (and often competing) societal concerns. Broadly speaking, food safety brings into play social, political, demographic, and economic interests. Effective adulteration laws, in turn, must anticipate and address all possible risks—microbiological, manufacturing, and, perhaps most difficult, risks associated with human greed and ingenuity. That is to say, adulteration standards must simultaneously cast a wide enough net to capture all foreseeable risks while avoiding loopholes that would defeat the purpose of the law.

The safety and plentitude of food in the U.S. is truly extraordinary. In fact, never in human history has any society had access to such a wide variety of safe and wholesome products. On the contrary, historically most people have lacked access to safe and healthy food. Even today, an estimated 800 million people are going hungry globally. Most Americans, however, take for granted that the food they eat is safe. We trust, for the most part, that our food is free of contamination (microbiological, chemical, or otherwise), that ingredient statements are accurate, and that the food we consume will not be injurious to ourselves or our loved ones. That is a truly remarkable, albeit largely overlooked, reality.

The History of U.S. Food Safety Laws

Currently, there are 15 federal agencies responsible for administering dozens of federal food safety laws. This may seem excessive but given the importance of safe and wholesome food to our collective national health, security, economy, etc., it is in fact unremarkable. Put differently, food touches every aspect of our society, and as a result, the laws pertaining to its safety must necessarily do so as well.

Congress enacted the first food adulteration laws in the 1880s, but most experts regard the early 1900s, when Congress enacted sweeping food safety laws, as the de facto advent of American food safety regulation. The timing was due to a confluence of factors, including the emergence of transnational food shipments (made possible by the rapid expansion of railroads), the application of electricity, the invention of refrigeration (which allowed perishable food to be shipped nationally) and, most importantly, a series of scandals that shocked and enraged the nation.

One scandal, which appeared on the cover of The New York Times, involved Chicago meat producers who shipped chemically and economically adulterated beef—so-called “embalmed meat”—to American soldiers fighting in the Spanish-American War. The contaminated meat is believed to have caused thousands of illnesses and deaths among American soldiers. At the time, most Americans were unaware of the widespread economic and chemical adulteration practices being employed by American food manufacturers.

The tipping point came six years later, in 1905, with the publication of The Jungle by Upton Sinclair. The novel, which detailed the atrocious and insanitary meatpacking practices in the Chicago Stockyards—enraged Americans and led to the 1906 enactment of the Federal Meat Inspection Act (FMIA) and the Pure Food and Drug Act.

The FMIA created sanitary standards applicable to the meatpacking industry and mandated the first continuous governmental inspection oversight of food production. Perhaps most importantly, the FMIA granted USDA enforcement authority over food safety regulatory violations. The FMIA also bifurcated oversight responsibilities between meat products and other types of food. That regulatory fragmentation has continued ever since.

The next piece of landmark food safety legislation was the 1938 Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA granted FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics. When the FDCA was enacted, FDA and USDA’s Food Safety and Inspection Service were both part of USDA. In 1940, however, President Roosevelt reassigned FDA to the Federal Security Agency (currently HHS) due to concerns about perceived conflicts between USDA’s and FDA’s respective missions.

For 70 years after the passage of the FDCA, food safety regulations remained largely unchanged. Then, in 2011, Congress passed the Food Safety Modernization Act (FSMA), vastly expanding FDA’s food safety oversight authority and ushering in the modern era of food safety.

Food Adulteration Today

For all that has changed in the century since the FMIA became law, it is surprising how much has remained the same.

Although the definition of adulteration has undergone many revisions and is now more comprehensive, it remains materially the same. Generally, a food is adulterated if it contains any poisonous or deleterious substances that may render it injurious to health. This could include chemicals, drugs, pesticides, and certain pathogens. Likewise, food that has been prepared, packed, or held under insanitary conditions such that it may have been rendered injurious to health or otherwise contaminated is adulterated. So are foods comprised in whole or in part of any filthy, putrid, or decomposed substance, or are otherwise unfit for food. Any food derived from an animal that has died by means other than slaughter, such as from disease, is deemed adulterated.

These are all relatively straightforward examples that ostensibly capture the ambit of adulteration. Yet, they collectively cover less than the first paragraph of the statute. In addition to the foregoing, products that have been intentionally subjected to radiation are adulterated. That’s pragmatic, but what about products unintentionally exposed to radiation? Shouldn’t any product exposed to radiation be adulterated? Perhaps. But then, sunlight is a form of radiation. Does that mean all sundried tomatoes are adulterated? Presumably not. This intellectual exercise, and countless others like it, illustrate how difficult it can be to define a seemingly simple concept, like adulteration.

There is also economic adulteration. Economic adulteration—also referred to as food fraud—refers to the practice of intentionally adulterating food for economic gain. Food fraud is among the most intractable problems facing the food industry. It isn’t a new problem, either. Evidence of food fraud dates back thousands of years, and has afflicted manufacturers, importers, retailers, and consumers alike. Nobody, as the old adage goes, is immune from human greed.

In some respects, food fraud presents a more formidable challenge than any other type of adulteration, including pathogens. This is because food fraud involves deliberate concealment. Moreover, successful perpetrators of food fraud seek to avoid inflicting discernible harm, meaning their crimes often go undetected—in fact, experts almost unanimously agree that most instances of food fraud go undetected.

That does not mean, however, that food fraud is a harmless crime. It is not. Food fraud causes profound economic and physical harm. For example, the Grocery Manufacturers Association estimates that food fraud results in $10- to $15 billion of direct losses annually. Further, food fraud impedes competition, rendering responsible, honest purveyors of food products unable to compete against fraudsters.

As noted, 21 U.S.C. § 342 is comprehensive. Food fraud features prominently. The statute prohibits the undeclared omission or abstraction of any valuable constituent. Recall the embalmed meat scandal of the early 1900s: One manufacturing practice involved extracting all the nutritional components from the beef and selling it as beef extract. After the nutrients were extracted, the pulp was treated with chemical preservatives, canned, labeled as roast beef, and shipped to unwitting soldiers. Of course, we have come a long way since 1900. Today, Americans enjoy the safest and most plentiful food in the world. Yet, acts of food fraud still abound.

As the food industry continues to globalize, food fraud will likely become more widespread. This is due to lack of oversight in other nations as well as diminishing resources. Consequently, oversight of suppliers will become both increasingly important and difficult. Given the intrinsic difficulties associated with detecting food fraud, and the substantial losses that companies and consumers suffer because of it, it will be increasingly important for companies to address the threat directly and unilaterally.

It may be that future technologies will effectively eradicate foodborne pathogens and better prevent contamination that, today, would otherwise render food adulterated. However, it is less likely that technology will be able to eradicate food fraud because doing so would require technology capable of outsmarting human beings.

Consequently, companies should develop and implement comprehensive multi-faceted strategies that incorporate testing, auditing, and oversight of suppliers, including certification by trustworthy organizations. Already, genetic testing, where applicable to prevent food fraud, is both economical and effective. Other testing methodologies are effective in identifying food fraud in situations where DNA testing is not feasible.

Employing a comprehensive and proactive approach to prevent all types of adulteration will help to minimize the risk to food businesses and their customers. Put another way, sometimes it is better to use 1,200 words to describe something, even if others use only 17.


Chappelle is a food industry lawyer and consultant at Food Industry Counsel, LLC. Reach him at chappelle@foodindustrycounsel.com. Stevens, also a food industry attorney, is a founding member of Food Industry Counsel, LLC. Reach him at stevens@foodindustrycounsel.com.

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A Food Defense Plan Is Good for Business https://www.foodqualityandsafety.com/article/food-defense-plan-good-business/ https://www.foodqualityandsafety.com/article/food-defense-plan-good-business/#respond Fri, 18 Jan 2019 12:13:43 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=29494 Having a food defense plan that addresses compliance qualifications and responsibilities under the Intentional Adulteration rule reinforces effective communication between all stakeholders.

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I am grateful to Food Quality & Safety magazine for the opportunity to share my professional viewpoints and personal experiences on the subject of food defense and its critical importance to overall product security. As a new column, I hope Food Defense will provide subject matter knowledge, insight, and thought-provoking conversation regarding experiences, challenges, and opportunities that confront us in managing food defense responsibilities.

In case food defense-related news has escaped your attention lately, a continuing pattern of intentional adulteration and economic fraud incidents have been reported by both private and government media sources around the globe in 2018. Examples of recent intentional adulteration—economic and otherwise—includes:

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  • Australian-sourced fresh strawberries, intentionally adulterated with sewing needles, with subsequent copycat metal contamination incidents, were discovered in New Zealand and Singapore, causing consumer injury and significantly disrupting global trade;
  • The seizure of 45 tons of quality-expired, chemically-treated tuna from three seafood processing businesses in Spain that marketed and sold the seafood as “fresh;”
  • Two Missouri-based U.S. pet food ingredient companies and several individuals were convicted on a misdemeanor count of selling misbranded pet food ingredients for economic gain (i.e. they substituted inferior ingredients)—the company was ordered to pay $7 million;
  • A man from Belmont, Miss., plead guilty in a U.S. District Court to diverting a possible 180 truckloads of packaged food and beverage products from 10 companies that were destined for destruction or use in animal feed, reselling these same goods for human consumption on the open market and also falsifying records on the purported “destruction” of these goods;
  • A seafood business owner in Newport News, Va., was charged with committing Lacey Act (as amended) and the Food, Drug, and Cosmetic Act (FD&CA) (as amended) violations for blending foreign-sourced crab meat with Atlantic blue crab and mislabeling the crabmeat as “Product of USA;” and
  • In December 2018, after a long State food fraud investigation, the New York Attorney General reported the “common practice” of seafood fraud as verified by “rampant” high levels of species mislabeling found in genomically-tested seafood samples taken from New York State supermarket chains.

These examples are what new FDA Food Safety Modernization Act (FSMA) intentional adulteration regulations, soon to be implemented, address. Regardless of the perpetrator’s motive (e.g., terrorism, sabotage, extortion, counterfeiting, theft, or economically motivated adulteration), intentional or unintentional food tampering can cause serious harm to humans and animals.

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The arrival of FDA “Mitigation Strategies to Protect Food Against Intentional Adulteration” (or as it’s perhaps better known, “Intentional Adulteration (IA) Rule”), originally published as a Final Rule in the Federal Register on May 27, 2016 (81 FR 34166), will soon usher in new regulatory requirements for large food businesses that must follow this rule. This requires certain businesses that manufacture, process/pack, or hold food must not only be already registered with FDA as a Food Facility, but now must meet provisions of Section 415 of the FD&CA, conduct a formal Vulnerability Assessment, and develop and implement a Food Defense Plan. One of seven FSMA rules, the implementation of the IA Rule has not come too soon. An upcoming implementation and compliance date of July 26, 2019, is nearly upon us. If you must comply and haven’t already addressed required facility tasks that underpin the rule, the time to act is now!

IA Rule Basics

Acts of intentional adulteration may take several forms: acts intended to cause wide-scale public health harm, such as acts of terrorism focused on safety of the food supply, and acts of disgruntled employees, consumers, or competitors and their economically motivated adulteration for financial gain. Acts intended to cause wide-scale public health harm are associated with intent to cause significant human morbidity and mortality. Other forms of adulteration are typically not intended to cause wide-scale public health harm, although public harm results from unintended adulteration consequences that are unknown to the perpetrator prior to an attack. Attacks intended to cause public health harm to both humans and animals are appropriately ranked as the highest risk.

Food defense experts Capt. Jon Woody, Ryan Newkirk, and Colin Barthel of the FDA Center for Food Safety and Applied Nutrition Food Defense and Emergency Coordination Staff have made every effort to make all stakeholders aware and inform and educate the global food industry and regulating bodies, writ large, on agency expectations in how to comply with the new FSMA IA Rule. In addition, these agency “owners” have also been instrumental in developing “Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry” (published in June 2018 with the public comment period closed in December 2018), on how to best comply with agency IA Rule expectations prior to the publication of its final guidance document.

The IA Rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the U.S and is required to register under section 415 of the FD&CA, unless one of the exemptions provided in 21 CFR 121.5 applies. (21 CFR 121.1)

Let me briefly review the key FDA-directed food defense facility compliance qualifications and responsibilities as contained within the IA Rule. In regards to the qualifications:

  • Are you the owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food for consumption in the U.S and is required to register with FDA? (21 CFR 121.1)
  • Does your business (including any subsidiaries and affiliates) average less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee)? If so, your facility is exempt, except that you are required to provide for official review, upon request, documents sufficient to show your status as a very small business. (21 CFR 121.5(a))
  • Does your facility hold food, except the holding of food in liquid storage tanks? (21 CFR 121.5(b))
  • Does your facility pack, re-pack, label, or re-label food where the container that directly contacts the food remains intact? (21 CFR 121.5(c))
  • Is your facility a farm mixed-type facility that conducts activities that fall within FDA’s “farm” definition? (21 CFR 121.5(d))
  • Does your facility produce alcoholic beverages? (21 CFR 121.5(e))
  • Does your facility manufacture, process, pack, or hold food for animals? (21 CFR 121.5(f))
  • Is your facility a farm mixed-type facility whose only activities that would be subject to section 418 of the FD&CA are on-farm manufacturing, processing, packing, or holding of eggs (in-shell, other than raw agricultural commodities) and certain game meats? (Note that this is limited to small and very small businesses. (21 CFR 121.5(g)) If applicable, your business is exempt from compliance with the IA Rule.

If you must comply with the IA Rule, the following are the principal tasks your food-related business must formally address:

  1. Develop and implement a written Food Defense Plan that includes (21 CFR 121.126):
    • A vulnerability assessment, including required explanations, to identify significant vulnerabilities and actionable process steps (21 CFR 121.130(c));
    • Mitigation strategies, including required explanations (21 CFR 121.135(b));
    • Food defense monitoring procedures (21 CFR 121.140(a));
    • Food defense corrective actions procedures (21 CFR 121.145(a)(1)); and
    • Food defense verification procedures (21 CFR 121.150(b)).
  2. Food defense training and qualifications of supervisors and personnel working at actionable process steps. (21 CFR 121.4)

IA Rule records that must be prepared and kept include:

  • The vulnerability assessment—for each point, step, or procedure in the facility’s operation, it must evaluate the severity and scale of the potential impact on public health if a contaminant were to be added, and the degree of physical access to the product;
  • The ability of an attacker (from outside or inside the facility) to successfully contaminate the product (21 CFR 121.130);
  • The mitigation strategies applied at each actionable process step to significantly minimize vulnerabilities—the facility must include a written explanation of how each strategy minimizes the vulnerability (21 CFR 121.135);
  • Food defense monitoring of the mitigation strategies with adequate frequency to provide assurances that they are being consistently performed (21 CFR 121.140);
  • Records of food defense corrective actions to be taken if mitigation strategies are not properly implemented (21 CFR 121.145); and
  • Food defense verification that monitoring is being conducted, that appropriate decisions about corrective actions are being made, that mitigation strategies are being properly implemented, and that a reanalysis of the food defense plan has been conducted, as appropriate, according to 21 CFR 121.157. (21 CFR 121.150).

Maintaining Trustworthiness

So, why is food defense good for business?

As a food-related facility covered under the requirements of the IA Rule, trustworthiness must be earned by partnering with others occupying space in the global supply chain by making a management commitment and resource investment to ensure cooperative understanding and sharing of responsibility to mitigate international product security risks. Even if a food-related facility is not covered by regulatory statute under applicable FSMA rules, including the IA Rule, commercial agreements between supply chain parties may still contain language that requires FSMA compliance to specific FSMA rules and their provisions prior to engaging in the purchasing, manufacturing, and sale of goods. A relationship in food defense requires honest and effective communication of clear expectations among all stakeholders.

With the exception of an opportunistic intentional terrorist attack using toxic agents, most perpetrators, in their deceit, have no intent of harming life. Sadly, akin to a food safety incident that occasionally escapes detection and control, supply chain food defense breaches that the IA Rule now addresses can have serious adverse health consequences or death for human or animals. Everything possible must be done to intercept these product security issues before they become public health concerns. The chain of food protection and product security custody and trustworthiness, once broken, has already been proven to be both difficult and costly to regain.


Park is the principal for Food-Defense, LLC. He has practiced food protection technical and management consulting for 46 years, is an FDA-recognized international processing authority, and an FSPCA PCQI Lead instructor. Reach him at dkpark72@aol.com.

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Beefing Up Defense Against Food Adulteration https://www.foodqualityandsafety.com/article/beefing-up-defense-against-food-adulteration/ https://www.foodqualityandsafety.com/article/beefing-up-defense-against-food-adulteration/#respond Wed, 11 Apr 2018 10:16:58 +0000 http://www.foodqualityandsafety.com/?post_type=article&p=25862 The need behind FDA’s strong security measures for food adulteration prevention.

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Criminal and terror attacks on food and drugs don’t happen often, but when they do the public doesn’t forget them. Most Americans born before the mid-1970s remember the Chicago Tylenol poisonings of 1982 and the terror that followed them. Two years later, in Oregon, followers of cult-leader Bhagwan Shree Rajneesh launched the largest bioterror attack seen to date on U.S. soil when they inoculated salad bars in 10 restaurants with Salmonella in an effort to prevent their political opponents from voting in large numbers, sickening over 700 people. Japanese consumers faced the same terror when, in late 2013, an employee at a Aqlifoods Co. manufacturing plant deliberately contaminated frozen food with the pesticide malathion, leading to as many as 2,800 cases of reported illness.

Such attacks can cast a shadow of anxiety on the everyday routine of buying and eating meals, and it’s with the goal of reducing that anxiety that the Food Safety Modernization Act’s (FSMA) Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration will begin coming into effect next year.

This final rule is designed to deal specifically with the threat of malicious actors attempting to taint food with the goal of hurting consumers.

Rod Wheeler, founder and CEO of the Global Food Defense Institute, says that in most cases of tampering he encounters from year to year, the actor has been a disgruntled employee or other internal figure. However, he notes, groups like ISIS have encouraged their followers to kill Westerners by poisoning their food supplies.

“Obviously, [terrorists] are talking about this,” he says. “Every year, you’ll hear a little bit of something come through the wire, whether it’s through the government agencies or through some other agency in another country.”

An Old Problem with New Solutions

Earl Arnold, global manager for food defense and FSMA at AIB International, notes that intentional adulteration as a means of waging war on a civilian population has a long history.

“It was first recorded in the Roman times using deceased cattle to contaminate water supplies,” he says.

With that history in mind—and with an eye toward future risks—the Intentional Adulteration rule demands production facilities conduct a vulnerability assessment that considers the public health impact of an adulterant being introduced at each process step, the extent to which the product is accessible at each step, and the ease by which the product could be deliberately contaminated.

“When evaluating all of this,” Arnold says, “you must consider these things could be done by someone welcomed into the facility. If a processing step has a significant vulnerability identified—one that could cause wide scale public health impact—then a facility must develop mitigation to reduce the risk.”

One of the important changes in the Intentional Adulteration rule is the expansion of the idea of what constitutes production security. Arnold notes that until recently, production security has largely been considered a matter of fences, CCTV cameras, and passkey doors—the goal was to keep “bad people” from doing “bad things.”

Amy Kircher, DrPH, director of the University of Minnesota’s Food Protection and Defense Institute, says that FSMA will force a greater depth of understanding about what producers have to do to keep food safe.

“There is a significant culture change happening now,” Dr. Kircher says, “where companies are now having to come into compliance in a way that will be enforced, and so many companies are starting to think about, ‘How do we do vulnerability assessments for our entire company? How do we put mitigation steps in place that are beyond guns, gates, and guards?’”

Novel Vulnerabilities

The FSMA rule prescribes attention to four key activities: 1) bulk liquid receiving and unloading, 2) bulk liquid storage, secondary ingredient handling, 3) and mixing and blending activities.

Wheeler notes that traditionally, production facilities have not paid much attention to security of shipping and receiving facilities, chemical laboratories, and chemical storage areas.

“But guess what? In 2018, now we do,” he says, noting that the present-day adversary is likely an Internet-radicalized lone-wolf actor. He tries to imagine what the Boston-bomber Tsarnaev brothers would do if their goal was to attack the food supply, he says, because they are the model of the kind of adversary against which legislation is attempting to protect. “They’re smart, Internet savvy, and they did their research before they set those bombs off,” he says. As well, they had the appearance of law-abiding citizens—meaning they could easily find themselves employed in positions with access to food production facilities.

In food factories and packaging centers, Wheeler says, “you have open product and we have so many people coming and going out of our facilities each and every day that we, historically, have not vetted these people properly. You could gain access inside a facility as, let’s say, an HVAC contractor or plumbing contractor. Really, you could be the bad guy in disguise. My philosophy has always been, which is right along with the FDA’s, is just keep the bad guys out and those that we let in to these critical facilities, we vet them as best we can.”

Dr. Kircher says that fortunately, food producers have already been conscious and active in the preservation of food safety, so a move to adopting food defense measures is simply a matter of evolution. However, with each stage of evolution, the complexity of the process becomes more significant.

“We have to get beyond this sort of physical protection of our food,” she says, “because very easily, we could have something come into an ingredient. We could have our cyber controls hacked. How else do we think about our food being intentionally adulterated beyond someone just trying to break into the manufacturing plant? If we’re worried about cyberattacks, we should understand our technology and put safeguards in place so that nobody can, for example, hack the thermal processing controls that make sure pasteurization happens.”

But the range of possible vulnerabilities extends well beyond any one company’s production facility, as Dr. Kircher notes with reference to the problem of the ingredient supply chain.

“With Worcestershire sauce, for instance, to get from spices or paprika to the actual sauce, that might be 11 steps, and companies don’t always know the entire sequence of steps,” she says. “They know who they bought from and who they sold to, but really to make these things, there are brokers and sellers and growers. When you get to a final product that we the consumer are buying on the shelf, it has taken many steps. If you think about a basic recipe for a cheeseburger, that’s 84 different components to make all the products that make up your cheeseburger. To me, that’s 84 supply chains.”

In conjunction with the Foreign Supplier Verification rule and the Transport rule, Dr. Kircher says, the Intentional Adulteration rule provides for robust preventive controls that create a more defensible food system even when it involves buying from vendors outside the U.S.

“This is not an overnight thing,” she says. “It’s a different philosophy. Companies focus on making good food that we want to buy. They don’t think about somebody intentionally trying to harm their product, and so it is a mind shift, it is a culture shift, and we, I think, collectively recognize that we need to do it. But it will take time.”

Training Employees

At the plant level, meanwhile, Wheeler stresses that beyond all other measures, the most important factor in mitigation is well-trained employees. Cameras have no power to perceive potentially threatening behavior and stop it, while card-access systems may only serve to slow down potential threat-actors.

“If someone is going to harm the product, they have to come through the door in order to get to the products in our processing areas,” he says. “It’s going to be that frontline worker that sees something and says something about it to someone and then can maybe stop what could, potentially, be a huge event.”

The Intentional Adulteration rule mandates monitoring, corrective actions, and verification as components of a mitigation strategy. This is, Dr. Kircher notes, not necessarily an expensive process, however, it is a process that requires effort and organization and a plan for deployment. At the same time, she agrees with Wheeler that employee training is essential.

“There are different levels of food defense training or awareness training that have to happen for employees that are what they call actionable process steps, or steps we know that could be a vulnerability in a system,” Dr. Kircher says. “It might be an open vat. It might be bulk liquid receiving—those places that we think are at higher risk of adulteration than others. That means people working on the line, all the way up to your food defense program manager, have to have some level of training in food defense, and really, that is increasing the awareness of those that are working and making our food, which actually will create a lot of defense in and of itself, just to have more eyes and understanding of how to protect our food systems.”

She notes that FSMA requires companies to protect against “reasonably foreseeable threats,” including weapons of mass destruction. “Reasonably foreseeable” is a difficult phrase to define.

“The way it was defined in FDA rules was, if it’s happened in the past, you have to show that you can mitigate against it,” Dr. Kircher explains. “If there’s been some adulteration in the past in this particular product, or for this particular method, or this particular agent, that’s something that is a foreseeable risk.”

She offers the example of a bunch of bananas versus a can of chicken noodle soup: While the products are each sold in the same stores, their producers and supply chains chart wildly different courses—one of which offers far more opportunity for intentional adulteration. Accordingly, threats that may be “reasonably foreseeable” for one producer are not at all applicable to the other, and vice versa. For that reason, food defense must take into account the peculiarities of each individual mode of production. Preparing to do that, Dr. Kircher says, is going to involve the food production industries acting together as a business community with a shared interest in customers’ health and well-being.

“To do this comprehensively, we have to figure out a way to share information between companies and between governments, so there can’t just be a single company that leads it,” she says. “No one will be successful, so we have to figure out how to be more transparent about our global supply chain in a way that we’ve never been before. I would argue we can do it and still maintain those proprietary aspects that have to be maintained.”

A Brighter Future

Among all parties, there is an air of confidence that FSMA’s Intentional Adulteration rule will contribute to an increase in safety and trust in food-production processes, which will hopefully translate into an increase in consumer confidence.

“Since this is a preventive measure-driven program which allows facilities to identify their significant vulnerabilities and develop mitigation strategies that they know will work for their facility, I feel the food industry in the U.S. and globally will vastly improve,” says Arnold.

Wheeler agrees, saying that while there’s still a good stretch of road ahead, it’s nothing compared with how far we’ve come on food defense.

“I’m very proud of the food industry and the leadership at a lot of these companies,” he says. “Not just the major companies, but the midsize to small companies too because they’re doing the best they can. As long as we can train frontline workers as to what to do, and get them involved, that’s half the battle.”

Over his 15 years in food defense, Wheeler says the change has been dramatic, in part because the most successful companies have been adopting goal-based defense: Rather than simply meeting the demands of regulation, they are envisioning the security of their product and facilities and implementing programs to serve that need.

“Companies need to understand why FSMA exists and not place so much emphasis on complying with the law,” he says. “You’re going to have to comply with the regulation anyway but place your emphasis on what is it that we’re trying to achieve.”

Reading Material on Authentication

Published by Wiley, the Food Authentication: Management, Analysis, and Regulation book covers the most advanced analytical techniques used for authenticating a vast number of products around the world. An introductory section presents the concepts of food authentication while the second examines the analytical techniques for the detection of fraud relating to geographical, botanical, species, and processing origin and production methods of food materials and ingredients. Finally, the third section looks at consumer attitudes towards food authenticity, applying bioinformatics, and future outlook. For
more information, go to https://bit.ly/2IMi7oT. —FQ&S

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Food Defense: It’s Everyone’s Job https://www.foodqualityandsafety.com/article/food-defense-protect-against-fraud-adulteration/ https://www.foodqualityandsafety.com/article/food-defense-protect-against-fraud-adulteration/#comments Fri, 16 Mar 2018 10:22:39 +0000 http://www.foodqualityandsafety.com/?post_type=article&p=25461 Identifying common gaps in current food defense plans and the key components that can strengthen compliance for the Intentional Adulteration rule.

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Back in the 1980s in Wasco County, Ore., an extremist group sought to sway election results by poisoning people. They did so by contaminating 10 restaurant salad bars with Salmonella, and 751 people got sick.

In 2014, thousands in Japan became ill after eating food laced with 2.6 million times the allowable level of the pesticide malathion. This was the work of a disgruntled employee from a frozen food company. Before it was over, 6.4 million bags of frozen food were recalled.

This past December, two boys, aged 12 and 13, broke into a Sioux City, Iowa, honey farm and knocked over all of the hives. No bees survived the winter temperatures and the business was devastated.

Political gain. Revenge. Plain old vandalism. The motives and the methods are different, but these three stories have several things in common: the companies were completely unprepared for these actions; and the business and the brand were harmed.

There are many more stories, and with the increasing globalization of the food supply chain, there will be many more opportunities for the intentional contamination of food. No one in our industry is exempt from the threat.

Food Defense in a Global Supply Chain

We live in a country where food from everywhere in the world enters our food supply chain every day. We are truly fortunate to have such choice. But we must also ask ourselves how many steps are in place to protect those products on their journey?

A classic illustration is milk. It is stored at individual dairy farms, transported from farm to farm via tanker truck, moved to a co-op, transferred to a dairy milk processor and moved through storage tanks, mix tanks, homogenizers, and fillers, and finally into a carton destined for a state-wide school system. The possible points of entry for an attack are numerous, and the impact both emotional and physical in loss of life and suffering would be devastating.

These very real threats have been recognized by the U.S. government and the voluntary Global Food Safety Initiative (GFSI) benchmarked standards, which contain criteria for food defense. With the passage of the Food Safety Modernization Act (FSMA), the Intentional Adulteration rules and regulations have been put in place. These state that you must develop and implement a food defense plan that includes: a vulnerability assessment; mitigation strategies; monitoring, corrective actions, and verification procedures; and training and recordkeeping.

At a minimum, the food defense plan must be reanalyzed every three years. Records of all activities must be maintained for two years.

If a vulnerability assessment is an evaluation of each point, step, or procedure in your food operation to identify significant vulnerabilities and actionable process steps, the parallels to Hazard Analysis and Critical Control Points (HACCP) are unmistakable. Any company that has a food safety management system in place understands the framework within which the food defense plan must be developed.

But it would be wrong to simply add food defense to your HACCP team’s list of duties. Food defense requires a different mindset and a different set of skills. And just as you train your workforce in food safety best practice, you must train them in food defense awareness and mitigation strategies.

Building Your Food Defense Training Plan

What to train and how much to train will depend on the specific responsibilities of your workers. The baseline is awareness training: What is intentional adulteration? How does it differ from food safety and food fraud? And what can each individual do to protect the company?

The FDA has developed resources to help you build awareness in your workforce, and I encourage you to take advantage of them.

A series of webinars on the Intentional Adulteration rule can be found on the Food Safety Preventive Controls Alliance (FSPCA) website.

In these webinars FDA presents expectations and methods for achieving compliance to the rule. Present them to your food defense team and employees, customize the message to your situation, and, above all, get the conversation started.

There’s also a tool for identifying appropriate mitigation strategies. This tool is built on a mitigation strategies database, which is broad reaching and practical.

The FDA also provides helpful posters, called Employees First. These can be printed off and used to educate frontline food employees as to what they can do to promote food defense.

Beyond awareness training, the topics and level of complexity in your education programs will be dictated by the responsibilities of the individual. The following table provides a breakdown of topic categories based on job role.

The Qualified Individual

The Intentional Adulteration rule clearly states that the food defense plan must be prepared by a qualified individual. The plan must also include a written explanation stating how each strategy significantly minimizes or prevents the significant vulnerability at the actionable process step.

One of the ways to gain this expertise is by taking the FSPCA intentional adulteration training that will be available in both a face-to-face version and an online option.

The qualified individual, with support from senior management, will be best positioned to determine a training plan that will address all individuals in the facility including seasonal and temporary employees.

The Food Defense Team

The food defense team is at the heart of your defense plan. Who is on that team and how they are trained is critical. Most will never have been involved in a food defense event, and this will be new territory for them.

Following best practices for risk assessment and building a multi-disciplinary team will be particularly helpful in this situation. In addition to a trained and knowledgeable team leader, consider other plant roles, such as human resources, health and safety, security, and IT, as team members. They can bring insight into potential vulnerabilities that need to be understood and addressed.

The risk assessment team must think outside the box and challenge themselves to consider vulnerabilities that are unique to the process and the particular facility. For example, have they considered the threat of a cyberattack? How easy would it be for the refrigeration systems to be hacked? Could hackers break into your PLC or refrigeration systems, bypass the alarm, and turn a cooler up for five hours and then back down on a weekend?

If some of your team members are new to risk assessment in general, they will require training on the topic. The same is true for procedure writing skills, conducting a gap analysis, understanding cybersecurity threats, and recognizing signs of employee dissatisfaction.

The type of vulnerability assessment training that you select will depend on the two methodologies outlined by the FDA: the three elements from Carver + Shock or the four key activity areas. It is up to you to select the one that you feel your team can best manage.

The results of the vulnerability assessment will highlight the food defense practices required to maintain the production processes and environment, and these may function much like food safety prerequisite programs. Once again, training will help focus efforts and prioritize implementation of prevention strategies. Most of us understand the need to keep doors closed and locked, but how significant is that threat when compared to protecting an isolated area of the facility where product is exposed and multiple ingredients are blended?

Here again, the FDA has provided a useful tool in its Food Defense Plan Builder. This user-friendly software program helps you tailor a food defense plan to your facility. It harnesses existing FDA tools, guidance, and resources into a single application. By asking you a series of questions about your production process, it calculates a vulnerability score for each step in the process that will help you prioritize your efforts.

Training to Support a Food Defense Culture

The ultimate goal of any training program is behavior change. You want people to do things differently. In this case, you want them to understand how intentional adulteration can occur, recognize threats to your food products, and take ownership of the part they play in preventing threats from becoming realities.

There are three key areas in training:

  1. Knowledge—how well your employees know the topic, both the fundamentals of food defense and the requirements of your plan;
  2. Skill—how well they can perform specific tasks as itemized in your food defense plan; and
  3. Attitude—how they approach their role in food defense.

Once you have classified these areas, you can customize your training program to address specific gaps. Assessing attitude is by far the most difficult task, as is training for attitude change. And yet, it is the most important. Just because someone has been trained on a topic, or has passed an exam, it’s no guarantee of success.

When people choose to do something because they believe it is the right thing to do—even though it might take longer and even though it might interfere with their other duties—then you know you are building a strong food defense culture.


Onett is the technical manager for training and education services at NSF International. Reach her at konett@nsf.org.

The FSMA Intentional Adulteration Rule

The purpose of the Intentional Adulteration rule is to prevent intentional acts of adulteration of the food supply that would cause wide-scale harm to the public. Since 2004, the FDA has been conducting vulnerability assessments on a wide range of products and processes as per the Homeland Security Presidential Directive #9.

Using the Carver + Shock prioritization tool, it identified three of the seven elements that contributed most consistently and significantly to the threat of intentional adulteration of food:

  • Criticality—measure of public health and economic impact;
  • Accessibility—degree of physical access to the facility and the product; and
  • Vulnerability—ease of accomplishing the attack (including the possibility of an inside attacker).

These form the basis for the step-by-step vulnerability assessment of the process and contributed to the FDA’s identification of four key activity types: 1) bulk liquid receiving and loading; 2) liquid storage and handling; 3) secondary ingredient handling; and 4) mixing and similar activities.

A food defense vulnerability assessment must at a minimum assess the process against the key activity types. This assessment must also include the possibility of an inside attacker.

The guidance document released by FDA in August 2017 describes the rule in detail and includes the following training requirements.

  • The vulnerability assessment and the resulting food defense plan must be conducted by a qualified individual, with the education, training, and experience to conduct the assessment and the reanalysis. This includes the written explanation of the chosen mitigation strategies.
  • The individuals responsible for implementing the mitigation strategy at the actionable process steps must be trained in those activities and must receive food defense training.
  • Supervisors of those responsible for implementing the mitigation strategy at actionable process steps must receive training to ensure they can carry out supervisory activities and receive food defense training. Records of training must include the type of training, date, and names of the persons trained and must be maintained for two years.—K.O.

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A Meaty Proposition for Fighting Food Fraud https://www.foodqualityandsafety.com/article/meaty-proposition-fighting-food-fraud/ https://www.foodqualityandsafety.com/article/meaty-proposition-fighting-food-fraud/#respond Fri, 08 Dec 2017 11:30:01 +0000 http://www.foodqualityandsafety.com/?post_type=article&p=24558 A new way of screening ground beef could help combat the problem of additional unwanted animal products

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Researchers at the University of British Columbia have revealed a new technique that can detect impurities in ground beef within minutes.

In the study, headed by professor Xiaonan Lu, food science students used a laser-equipped spectrometer and statistical analysis to learn this better way to identify unwanted animal products in ground beef.

“We developed a rapid, cost-effective, and user-friendly technique for screening ground beef to determine if it has been adulterated with offal (i.e. internal organs),” Lu says. “Our spectroscopic-based method, combined with appropriate statistical analysis, can achieve 100 percent accuracy in differentiating authentic ground beef from meat adulterated with offal, and can identify and quantify the adulterants within five minutes.”

Over the past few years, high-profile scandals in the U.K., Ireland, and Russia have seen lamb, chicken, and rat meat substituted for higher-quality meat products.

Reliable detection techniques to differentiate authentic food from misrepresented food are the last barrier preventing consumers and industries from successfully fighting food fraud. Lu says that this method is ideal for adoption by governmental laboratories and inspection agencies who need to perform regular and frequent analysis of food authenticity.

She explains the method was established by aiming the spectrometer at meat samples they had prepared by grinding together beef and offal from local supermarkets at various concentrations. Since animal products all have different chemical compositions, their molecules absorb and scatter energy from the spectrometer’s laser in different ways. The spectrometer captures these signals to produce an image of each substance, which can then act as a library for comparison with other samples.

“The good thing is that this method doesn’t require highly trained personnel,” Lu says. “It is time-efficient and cost-effective, so less manpower would be needed to frequently test the authenticity of food products. Consumers, industries, and government would be able to minimize the chances of food fraud.”

Not that there aren’t some challenges. While the instrument utilized in the research is commercially available, the part that takes more time to complete is the establishment of a robust database.

“To take full advantage of the method, you need a comprehensive database that stores spectra of authentic products and potential adulterants,” Lu says. “Establishing that database is the major challenge ahead in bringing this method to more widespread use for combating food fraud.”

A Growing Problem

Food fraud is not a new issue, but due to rapid globalization, the traceability of food products and ingredients is becoming more and more difficult.

According to recent estimates by PricewaterhouseCoopers, food fraud has risen to be a $40 billion a year problem. And the NFU Mutual Food Fraud Report 2017 revealed one in three people are less trusting of products and retailers than they were just five years ago.

“The importance of the topic centers on trust,” says Adele Adams, director at Adele Adams Associates Ltd. “Primarily it is the consumers trust in the retailer or manufacture’s brand that these efforts are trying to protect. We have seen that shaken to its core by the events around horsemeat.”

Lu notes that having rapid and simple methods for fast, frequent analysis of food authenticity to prevent all parties from suffering the damages that could be brought on by food fraud is therefore vital for combating the problem.

To help prevent food fraud, Adams says there is a definite trend towards more structured and documented risk assessments both in the raw material supply chains and at an onsite level.

“Understanding and mapping the raw material supply chain is the key starting point, as until all the touch points within supply chains are known and mapped they cannot be interrogated for potential threats,” she says. “Obviously, the increased surveillance through established techniques such as DNA testing provides a significant deterrent to the substitution of species, however, claims such as breed and provenance are not as straight forward to prove.”

Jackie Healing, director of consulting and technical services at NSF International, notes that while there haven’t been significant cases of fraud recently—as was the case with horsemeat a few years ago—there is still concern about food fraud globally.

“We know that low-level substitution or cross-contamination continues to happen particularly in the case of comminuted meat products,” she says. “In the majority of cases, this occurs due to poor manufacturing practices such as inadequate clean downs, poor segregation, or labeling in processing plants, not deliberate ‘food fraud’ necessarily.”

However, the NSF does see examples in the meat industry where butchery disciplines are poorly adhered. An example might involve a fillet steak being cut from too broad an area on the carcass and is not entirely as stated. If deliberate, this is usually done so the plant can improve yields on the more expensive cuts.

“The best way to mitigate risk is to get to know your supply base, including the factories and farms, and understand the cultures of each operation,” Healing says. “When done well this may reveal increased risk and provide an opportunity to take action.”

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Intro to Food Recalls https://www.foodqualityandsafety.com/article/intro-food-recalls/ https://www.foodqualityandsafety.com/article/intro-food-recalls/#respond Tue, 13 Jun 2017 10:30:54 +0000 http://www.foodqualityandsafety.com/?post_type=article&p=22298 Fundamentals for new food professionals on how to handle recalls

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While most food manufacturers and resellers do everything they can to keep all products 100 percent safe for consumers, unfortunately issues do crop up more often than anyone would like. In fact, the FDA recalls close to 100 million units of food every quarter.

When you’re new to working in the food industry, it is important to be aware of how food recalls come about, and why, and what steps need to be taken if items are found to be harmful.

How Recalls Come About

In the U.S., the FDA is the department responsible for regulating and imposing safety standards on the majority of the nation’s food supply (around 80 percent), for both domestic and imported foods.

The government office also oversees the safety of pet foods. The remaining percentage of food items, in particular meat, poultry, and some egg products, are overseen by the Food Safety and Inspection Service (FSIS), a branch of the USDA.

These two agencies typically find out about an issue with the food supply because a manufacturer or distributor becomes aware of a safety issue and contacts them directly; or because an inspection of a manufacturing facility or importing business by one of the departments reveals a cause for concern.

In addition, the FDA or FSIS tend to conduct various sampling programs, and one of these can result in a particular food item or manufacturer failing a test. Alternatively, an individual state health department (or multiple offices around the country) could contact the CDC about illnesses caused by specific food products. If this happens, the FDA or FSIS would be alerted to the problem by the CDC.

Recalls can be classified in three different ways, according to the potential seriousness of the case. The FDA and FSIS use the same classifications, namely:

  • Class I recalls—for situations in which there is a reasonable probability that eating the affected food will cause health issues or death;
  • Class II recalls— for situations in which there is a remote possibility of adverse health consequences if the food is eaten; and
  • Class III recalls—for situations in which eating the affected food won’t cause any adverse health problems.

For most food recall cases, the recalls are voluntary and initiated by the particular manufacturer or distributor involved. Other times, when one of the government agencies asks for a recall, the firm that manufactures the item will be responsible for taking action to get the product off shelves. If this business does not respond to requests from the FDA or FSIS to instigate a recall, legal action can be taken.

In accordance to the Food Safety Modernization Act (FSMA), the FDA has the authority to shut down operations at food production facilities if the department believes there is a serious threat to public health involved. In September 2012, the agency exercised this authority for the first time by shutting down a peanut-processing factory owned by Sunland Inc. This came about because a Salmonella contamination was discovered.

How Recalls Work

When a food manufacturer or distributor voluntarily initiates a recall, the FDA or FSIS will be called upon to evaluate the potential severity of the recall. The relevant agency will need to ensure that the company involved makes reasonable efforts to correct the issue and/or removes the affected products from shelves.

Furthermore, when the situation requires widespread public awareness, in a short amount of time, the regulatory bodies will seek publicity about the case via the media. Most of the time, recalls are simply listed online on the agency websites so that consumers, resellers, and other interested parties can read the information as needed.

When a recall is initiated, the company involved will need to submit its strategy for handling the process to the FDA or FSIS for review. The plan will need to cover things like the depth of the recall (for instance, if it will affect just wholesalers and/or retailers, or consumers too); what the proposed checks are to ensure effectiveness of the recall; and the type of press release that the company wishes to issue.

Businesses do not need to wait for strategies to be approved for them to be executed; plans can be followed out straight away, even if they’re under review. However, if the agency involved in the matter feels that corrections are required to the strategy, this can prompt the manufacturer or distributor to make necessary changes.

To terminate a recall, food manufacturers or distributors can request permission to do so in writing to the relevant regulatory body, or simply wait for the agency to determine when the appropriate time is. Products are typically classified as safe again once a decent amount of the offending product has been recovered or corrected.

Common Causes of Recalls

There is a wide variety of reasons why food recalls can be initiated. Some of the major contributing factors in recent years, though, have been contaminations, adulterations, and misbranding of food stuffs that have needed to be addressed.

For example, products can be contaminated with pathogens like Salmonella, E. coli, and Listeria monocytogenes; undeclared sulphites, or allergens like soy, peanuts, eggs, tree nuts, milk, or shellfish; uneviscerated fish; or foreign objects such as metal, plastic, or glass fragments. A nutrient imbalance (generally found in pet food recalls) also occurs quite often.

Other reasons for recalls include a company’s non-compliance with their own Standard Operating Procedures; a failure to properly maintain processing facilities and equipment used for food; deficiencies in the monitoring and production processes for food (e.g., non-compliance with the current Good Manufacturing Practices or cGMPs, or incorrect food labeling); a firm’s inability to track products through their supply chain; and weaknesses identified in the producer’s Hazard Analysis and Critical Control Points (HACCP).

If Food Recalls Are Initiated…

There are numerous consequences faced by businesses if food recalls are initiated. Apart from the obvious public health issue and brand damage, there is obviously a significant financial cost to be factored in. Companies can lose a lot of sales and market value, plus have to pay for costs associated with notifying regulatory bodies, the supply chain, and consumers; product retrieval, storage, and destruction; additional labor costs; and investigations of the root cause of the safety issue.

Another large financial burden that needs to be considered is the potential litigation cost. Consumers who are affected by a food recall, particularly those who are seriously injured or who have faced a death in their family, often hire specialists in the area of recalls to submit a legal claim for compensation.

To prevent recalls in the first place, firms need to ensure that the best business practices are put in place and carefully followed at all times. GMP and HACCP plans should be put in place to ensure optimum quality and safety levels during the manufacturing process; and regular audits, training, and testing should be carried out. Companies that achieve certifications in world-class standards, such as ISO 22000, BRC, and SQF, particularly show their commitment to food safety principles.

If a recall is deemed necessary, companies must alert government bodies as quickly as possible, coordinate closely with the relevant department, and remove all affected products from the market in a fast and efficient manner to limit the amount of harm caused. Businesses should have contingency plans and crisis-management strategies in place in advance too, so that if recalls are put in place, they can be quickly facilitated.


Zavala, a content coordinator for Seek Visibility, has built up relationships over the years within various blogging communities. Reach her at cherz@seekvisibility.com.

 

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Securing the Global Food Supply Chain https://www.foodqualityandsafety.com/article/securing-global-food-supply-chain/ https://www.foodqualityandsafety.com/article/securing-global-food-supply-chain/#respond Fri, 19 Aug 2016 10:30:01 +0000 http://www.foodqualityandsafety.com/?post_type=article&p=18106 Adopting preventative approaches to food security before goods reach American shores

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Many of the foods and drinks we consume every day are not as safe as we think. Despite increasingly stringent safety regulations, food fraud, adulterated products, and ingredients containing harmful chemicals or pathogens continue to slip through the global safety net to sicken an estimated 600 million people every year.

Why do these incidents continue to occur? Try three words: demand, globalization, and money. The demand for imported foods and ingredients into the U.S. has more than tripled in the past few years. Imported food now totals over $120 billion dollars per year. Americans’ appetite for foods from around the world is so insatiable it is fueling a gold rush among importers and producers who are casting their supply nets ever wider to meet the growing demand. The result is a global supply chain that is stretched to its very limits.

The story is not new. Fraud, adulteration, and tainted ingredients are as old as civilization itself. The ancient Romans even created a now-famous term to forewarn consumers that they should be cautious about what they buy: caveat emptor. Considering that 15 percent of the U.S. food supply is now imported—including 50 percent of fresh fruit, 20 percent of fresh vegetables, and up to 90 percent of its seafood—government officials, importers, food manufacturers, and consumers would all do well to heed the Roman warning when it comes to food safety.

Inspection: An Enormous Task
Prompted by a series of food-related safety incidents such as the melamine in milk tragedy in China, the U.S. government introduced a number of sweeping laws, including the Food Safety Modernization Act. While such legislation has done much to help protect the U.S. food supply, officials are struggling to move the food safety needle away from a response level to one of proactive prevention.

One reason for that slow slog is the sheer size of the global task. More than 8,000 FDA inspectors need to inspect thousands of food processing and import facilities around the globe. They monitor everything from meat inspections and sanitation to food imports at the border that could pose potential threats to homeland security. Despite the increased regulatory muscle, officials struggle to keep pace with the growing number of food imports. Last year, for example, they inspected over 2,000 foreign food and feed facilities. Still, that represents less than 0.5 percent of the more than 285,000 such facilities around the globe that are registered with the FDA. The result raises the specter for all kinds of health and safety issues that could simply elude detection.

A Helping Hand
In an effort to improve the global safety inspection process, the FDA is now actively working with its global counterparts to devise new ways to ensure food safety. One such initiative is a recent FDA ruling to accredit third party foreign certification bodies. This process will allow approved organizations, including foreign government agencies, to conduct food safety audits and issue certifications to demonstrate that ISO 17021 standards are being followed to prevent harmful produce from entering the U.S. Scheduled for implementation in January of 2018, the new initiative is part of the FDA’s Voluntary Qualified Importer Program (VQIP). When placed into operation, VQIP will allow for the expedited FDA review, lab analysis, and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their global supply chains. The initiative is expected to alleviate the backlog of companies wishing to import food products into the U.S and to provide globally sanctioned entities to finally adopt a preventative approach to food security even before goods ever reach American shores.

An International Approach to Food Safety
In the aftermath of the 2013 horsemeat scandal in Europe, investigators found that there have been very few prosecutions over time for food fraud. Chief investigator Chris Elliott, director of food safety and microbiology at Queens University in Belfast, Ireland, went so far as to say that there continues to be a “huge incentive for the criminal to pursue food crime.” Globalization, it seems, has its seamier side.

To turn the tide against unsafe food and food fraud, the EU is doing more than just enforcement. Member states recently agreed to launch four global initiatives to address the nagging issues of hunger, malnutrition, education, and the lack of proper agricultural funding in some 45 countries around the world in an effort to confront the root causes of dangerous food and fraud.

Meanwhile, the UN and Global Food Safety Initiative also recently agreed to actively collaborate on building “a roadmap for scaling up” food safety and agricultural programs for local food enterprises in a number of key regions in the global food supply network, including China, Southeast Asia, and Africa.

The Power of Science
When all is said and done, food safety is about effective risk management. Yes, the task is daunting. Even the simplest of today’s food products often contain dozens of ingredients sourced from around the world. Nations, companies, and importers all along the global food supply chain are increasingly turning to science for answers in detecting risks to human and animal health. For example, PerkinElmer’s Perten and Delta Instruments solutions focus specifically on the agricultural and dairy industries. And PerkinElmer’s NexION 350 Inductively Coupled Plasma Mass Spectrometer, Spectrum Two Mid Infrared Spectrometer, and Altus Liquid Chromatography system are additional examples of solutions that can help identify known and unknown ingredients and adulterants so that scientists, food suppliers, and the global farming community can rapidly and easily detect toxins, heavy metals, and pesticides in the things we eat and drink every day.


Dr. Packer is senior manager of food safety for PerkinElmer. Reach him at robert.packer@perkinelmer.com

 

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