FDA has confirmed that lead and chromium detected in the cinnamon in applesauce pouches imported from Ecuador are from lead chromate. Three brands of applesauce pouches, manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands, were recalled last November due to lead contamination.

Historically, lead chromate has been illegally added to certain spices increase to their weight and enhance their color, which increases the monetary value of the adulterated spices, the agency said in a February 29 statement. FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.

FDA has limited authority over foreign ingredient suppliers who do not directly ship product to the U.S. This is because their food undergoes further manufacturing/processing prior to export. Therefore, FDA has limited ability to take direct action with Negasmart, the supplier of cinnamon to Austrofoods, or Carlos Aguilera, the processor of the cinnamon sticks.

Ecuadorian officials in Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) have reported that Carlos Aguilera of Ecuador, is the likely source of contamination and is not in operation at this time.

The CDC has identified 468 total cases of contamination in 44 states. The investigation is ongoing.  

The post FDA Says Applesauce Contamination May Have Been Deliberate appeared first on Food Quality & Safety.

Virgin and extra virgin olive oils are sometimes adulterated with cheaper vegetable oils and lower-grade olive oils due to the high demand and price of high-grade olive oil. Not only is it important to authenticate olive oil to prevent fraud, it is also necessary to determine purity for the health and safety of consumers.

Read this case study to discover a simple way to tackle the adulteration of extra virgin olive oil. You’ll learn:

• Why there is research on olive oil adulteration;
• The mission of the first center in North America dedicated to olive oil research;
• How to authenticate olive oil quicker and easier; and
• The future of olive oil production.

Download this resource today!

The post Fighting Food Fraud: A Unique Approach to Tackle Extra Virgin Olive Oil Adulteration appeared first on Food Quality & Safety.

The bad news began to leak just as the 2008 Summer Olympics in Beijing were starting: Adulterated infant formula was sickening babies in China. After testing, the formula was found to contain melamine, a chemical that is used to produce plastics and coatings and that can cause kidney damage when ingested. It also can be used to increase the nitrogen content in diluted milk, making it look as though the milk has more protein when it is tested for quality. That is what happened in China, where the adulterated milk ultimately caused illnesses in more than 50,000 infants and killed six.

Melamine was found in other products, including eggs and dry milk, sold by the company that produced the infant formula, and some of the products found their way around the world in candies and other foods and drinks. The incident stands as one of the most poignant impacts on the beverage industry and underscores the importance of testing these products for quality and safety.

Adulteration remains a threat today, with supply chain disruptions and baby formula shortages raising product vulnerability issues. Some products may contain substituted ingredients because there are shortages of the original ingredients. Other switches are made for economic gain, to swap out a more costly ingredient with a cheaper one. Any switched ingredients need to be tested because there can be health consequences to consumers.

“Any time there is a shortage, that brings up potential vulnerabilities in the supply chain as far as adulteration,” says Daniel Berg, analytical services manager for Eurofins Food Chemistry Testing in Madison, Wisc. “There’s a lot of need to further verify that the product being produced is safe and formulated with the same quality.”

Testing for adulteration is a growing area in beverage testing, says Tarun Anumol, PhD, director of global food and environment markets at Agilent Technologies in Wilmington, Del. The company sells equipment such as mass spectrometers and gas chromatographs that can detect molecular mass to four decimal places of accuracy. “You typically see this [testing] in higher value, economically upscale items such as alcoholic beverages like spirits, distills, and some beers,” he says. “But the onus falls more on the manufacturer than on regulations because they need to protect their brand identity.” Substitutions can include taking out one flavor and adding another that costs less. Agilent’s equipment can differentiate specific molecules and fraudulent chemicals or flavors, he says.

What to Test

Aside from adulteration tests, beverages and their ingredients are checked for nutritional content, contaminants, allergens, pathogens, and taste, among other factors. The testing can be conducted at various stages in the product’s lifecycle, starting with ingredient testing, tests at a co-packer, and tests at the manufacturer or even at the retailer. Tests can be done either in house or at independent testing laboratories. Some manufacturers may want to outsource pathogen culture tests to an independent laboratory, for example, to avoid possible contamination of their product at the factory, says Berg.

A beverage must contain what its label claims it does. This is especially true if they are “functional” beverages with added vitamins or protein. It is important to have the correct amounts of ingredients in a drink, as more or less protein, for example, could negatively affect a consumer’s health. That includes the amount of sugar, especially if there is a “sugar-free” claim, and the alcohol content, says Dr. Anumol. Approximately 100 parameters are tested in basic nutrition, safety, and quality checks, although producers can choose to test for more.

Another large class of chemicals that are tested are pesticides. A 2008 study in the journal Analytical Chemistry heightened concern about pesticides in fruit-based soft drinks, although drinks sampled from the United States had relatively low levels compared with those in the United Kingdom and Spain. The study still raised concerns globally about what pesticides are used on fruit that ends up in beverages and water sources used in manufacturing that might contain chemicals from runoff.

Chemical and microbiological analyses are key measures taken to ensure the safety and quality of a product and help determine its shelf life once it has entered the market. Chemical testing for beverages could include measurements for pH, titratable acidity, turbidity, or relative clarity and contaminants such as nitrates and nutrients.

FDA guides most of the testing parameters, although companies may choose to conduct broader tests. Changes to the FDA Nutrition and Supplement Facts panel on packaged foods, including labels on beverages, went into effect on January 1, 2021 for larger companies. The updated nutrition panel now includes potassium and vitamin D, because people do not always get the recommended amounts, says Gayle Gleichauf, applications lab manager at Thermo Fisher Scientific, a test equipment manufacturer based in Chelmsford, Mass.

Gleichauf says the trends toward automation and speedier results are pushing demand for equipment such as automatic titrators for testing titratable acidity, vitamin C, and sulfites, as well as qPCR instruments for microbiological testing.

Spoilage organisms pose a risk for producers and have the potential to influence the end product. Beverage companies may test for the presence of specific strains of wild yeast used in fermentation that need to be closely monitored.

Traditionally, this type of microbiological testing has been conducted by culturing and incubating samples overnight or longer, but the use of qPCR can make testing faster and more cost effective for bacteria and yeast assays, she says.

Testing Trendy Drinks

Fermented and functional drinks are two trendy parts of the beverage industry that present their own testing challenges. Fermented drinks, which use yeast and other ingredients to create a specific taste, need to be monitored closely, because they can form undesired byproducts during processing.

Ethyl carbamate, for example, is a naturally occurring component of all fermented foods and beverages, but FDA issued an advisory based on its potential for carcinogenity in high doses in animal tests. The wine industry, for one, is interested in reducing ethyl carbamate levels in its products. FDA also established a level of concern for inorganic arsenic in apple juice.

But fermented drinks are touted by their makers as having health benefits, especially for good digestion and gut health. Beverages including kombucha, kefir, and yogurt drinks can be monitored during fermentation for pH, titratable acidity, sugar, microorganisms (beneficial and otherwise), and other parameters to ensure safety, consistent quality, and shelf life, says Gleichauf.

The pH affects the microorganisms that will be found in the beverage, as well as enzyme reactions, color, shelf-life stability, flavor, and clarity. Titratable acidity is generally considered to be more closely tied to flavor than pH, says Gleichauf, so a low titratable acidity can make a beverage taste flat or soapy, while high titratable acidity results in a tart or sour beverage.

She says the market for other fermented beverages, including craft beer, cider, and wine, is expanding rapidly as well, so similar testing is needed for those products.

Plant-based drinks, which are functional drinks with alternative proteins and claims of being more sustainably produced, also are becoming popular. While manufacturers claim they can control the entire production process in a lab without introducing environmental contaminants, the factory must be kept very clean, says Dr. Anumol.

Sensory testing, especially for new beverages in R&D, is another key part of a beverage’s success. Jerald O’Kennard, executive director of the Beverage Testing Institute in Chicago, says that now is a creative time for new beverages with lower alcohol or more exotic flavors. But producers need to test new products to try to ensure they’ll be a success, he adds.

The institute uses blind taste testing to rank mostly adult beverages by structure, aroma, acidity, balance, flavor, and their intended use. It also looks for flaws and determines whether a wine, for example, is sellable and whether its taste meets a standard of identity for the product category.

“You only get one chance, because the market is very competitive,” says O’Kennard. “If you mess it up, you might not only hurt your brand, but possibly the whole category of the drink for everyone.”

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Variety is the spice of life, and spices add so much variety to life. Treasured as trade goods for thousands of years, spices are used not only to season and preserve food, they have been embraced as medicines, dyes and perfumes dating back to ancient times. The word spice comes from the Latin species, which means “wares.”

In the culinary world, spices are aromatic flavorings originating from seeds (fennel, mustard, nutmeg, and black pepper, for example), fruits (cayenne pepper), bark (cinnamon), flower buds (cloves), stigmas (saffron), roots (turmeric and ginger), and other plant parts.

Spices were a primary driver for early maritime and land trade routes developed between Europe and Asia, and remain a significant focus of international trade. In 2018, more than 22,000 metric tons of spices valued at $111 million were exported from the U.S, while imports of nearly 412,000 metric tons were valued at $1.76 billion, according to the USDA Foreign Agricultural Service’s Global Agricultural Trade System. (A metric ton equals 2,204.6 pounds.) As with other food products, especially ones that are exchanged globally, spices are subject to food safety and quality concerns.

Microbial Hazard Concerns

The most important food safety issue that the spice industry deals with today is the need to manage the potential for contamination by microbial hazards, according to Laura Shumow, MHS, executive director of the American Spice Trade Association (ASTA).

Founded in 1907, the Washington, D.C.-based ASTA bills itself as “the voice of the U.S. spice industry in the global market.” “ASTA represents the interests of approximately 200 members including companies that grow, dehydrate, and process spices,” Shumow relates.

ASTA’s members include U.S.-based agents, brokers, and importers. There are also member companies based outside of the U.S. that grow spices and ship them to the U.S. and other companies associated with the U.S. spice industry. “ASTA members manufacture and market the majority of spices sold in the U.S. for industrial, food service, and consumer use,” Shumow elaborates.

Shumow points out that most spices require tropical or subtropical conditions to grow. “That means spices are typically grown in developing countries where sanitation and food handling practices may not always be adequate,” she says. “Like all agricultural products, spices are commonly exposed to dust, dirt, insects, and animal waste before they are harvested. Then there are additional opportunities for contamination during primary processing, storage, and transportation. Much of the spices imported in the United States are essentially a raw agricultural commodity that will undergo extensive cleaning, processing, and treatment for pathogens once they enter the U.S. to ensure it is clean and free of microbial contamination.”

Salmonella Control Is Essential

Foodborne illness attributed to spices is rare. But relative to potential microbial hazards that can affect spices, Shumow says that Salmonella, in particular, is a pathogen that must be controlled by treatment. “Spice companies use a variety of treatment methods to control for Salmonella, including ethylene oxide, propylene oxide, steam, and irradiation,” Shumow notes. “This treatment is an essential food safety step in the spice supply chain. Spice companies must comply with the Preventive Controls for Human Food rule under the Food Safety Modernization Act.”

The FDA basically defaults to a 5-log reduction of pathogens, Shumow says. “However, the FDA has advised ASTA it would accept a different approach if scientific evidence demonstrated the process would adequately control the hazard, and conversely could require a 6-log reduction if it would be reasonably foreseeable that the food could be contaminated with more than 100 colony-forming units per gram,” she explains.

Quality issues related to spices include the potential to contain foreign material, as well as low levels of environmental contaminants, Shumow says. “These issues do not usually present a food safety issue, but are managed to ensure products meet quality and regulatory standards,” she explains. “Spice companies may rely on supply chain controls such as sampling and testing, specifications, and supplier audits to mitigate these types of quality issues. The spice industry also employs a variety of equipment to physically clean spices, including air separators, sifters, and spiral gravity separators that separate sticks, stones, hair, insects, and other debris from the spice. These techniques are designed to ensure finished product complies with industry and regulatory specifications.

“The highest priority of ASTA is ensuring clean, safe spice for American consumers,” Shumow emphasizes. “The association facilitates food safety in a number of ways, including the development of technical guidance, white papers, research, analytical detection methods, and education.”

To this point, another ASTA offering is its Check Sample Program, which is proficiency testing designed to evaluate spice laboratories for a common range of analyses that are significant to the spice trade, Shumow explains. “Proficiency testing is the analysis of samples in conjunction with other laboratories testing the same sample type at the same time,” she elaborates. “The program allows individual laboratories to evaluate their performance and set goals for improvement and consistency in analyses.”

Guidance for Industry

ASTA publishes Clean, Safe Spice Guidance, which includes references to FSMA and information related to the FDA’s Reportable Food Registry, Shumow says. “ASTA has worked and continues to work with companies and other associations to disseminate this guidance throughout the supply chain,” she relates. “ASTA also collaborates with organizations in spice-producing regions of the world to provide education and resources on food safety and good agricultural practices for spice farmers and processors.”

Publicly available resources include ASTA’s Identification and Prevention of Adulteration Guidance Document, Good Manufacturing Practice Guide for Spices, Good Agricultural Practices Guide, and HACCP Guide for Spices and Seasonings. “Likewise, ASTA offers several resources for non-member purchase, including an analytical methods manual and recorded webinar series,” Shumow adds.

Educational and training resources for member companies are another offering in the ASTA toolbox, Shumow adds. “Webinars and workshops are regularly offered for the industry,” she relates. “Recent topics covered by expert speakers have included whole-genome sequencing, new research on allergens, traceability/blockchain technology, and validation of spice process controls.”

Changing Concerns with Spice Safety

Issues with spices have changed over the years, says Martin Mitchell, chairman emeritus of Certified Laboratories, Inc. “Prior to the 2000s, 90 percent of spice industry concerns focused on product quality parameters, like cleanliness, color values, and volatile oil content,” he relates. “Today, as Laura Shumow points out, bacterial contamination, particularly with Salmonella, is the major concern.

Based in Melville, N.Y., Certified Laboratories is an independent laboratory specializing in microbiological and chemical analyses of numerous foods and beverages, including spices. The firm also maintains operations in Aurora, Ill., Turlock, Calif., and Buena Park, Calif. Certified participates in the ASTA Check Sample Program, Mitchell notes.

Mitchell says Certified does the majority of the independent testing of spices in the U.S. “We test for most all of the ASTA members, as well as spice companies throughout the world,” he relates.

A long-time ASTA member, Mitchell has served on the board of directors, and is a member and former chair of the Food Safety Committee. He was also a member of the ASTA Methods sub-committee that developed and approved the official ASTA testing methods for spices.

“In the early 2000s, there was some talk in the industry about Salmonella, but it was not universally accepted as a concern, especially since Salmonella does not proliferate on dry spices,” Mitchell says. “But it has evolved to a major effort to control bacterial contamination, since by the mid-2000s Salmonella and other pathogens were traced to spices. At that time most spices came into the country untreated and any bacteria present were not necessarily treated upon arrival.”

Most imported spices are now cleaned and subjected to a kill step by the U.S. processors when they take possession, Mitchell continues. “And there are now industry expectations for a validated kill step, documented sanitation controls, and pathogen testing for all spices, so they are sold to food manufacturers, food service customers, and consumers pathogen free,” he emphasizes.

Adulteration Issues

Mitchell concurs with Shumow that adulteration is another major concern in the spice industry. “Some imported ground spices from Third-World countries are coming in adulterated,” he elaborates. “For example, lead and lead chromate have been found in cumin and turmeric, and Sudan dyes have been identified in red pepper. Herbs such as sumac have been added to ground oregano.”

Industry deals with the problem by requiring certificates of analysis for all imported spices, and also by testing imported product, Mitchell says. “The standard is zero tolerance for chemicals and foreign botanical matter mixed in with pure spices,” he points out. “Adulteration is not a problem with spices originating in the U.S. But some countries with less oversight are selling ground spices, so the risk of adulteration has become both a food safety and quality issue.”

New Proficiency Test

Fapas, the proficiency testing arm of Fera Science Ltd., Sand Hutton, York, UK, introduced on Sept. 1, 2019, a proficiency test for contamination of cumin with the allergens sesame and gluten.

The process begins when a customer orders proficiency testing materials online from the Fapas website, according to Mark Sykes, MS, Fera’s lead senior scientist for proficiency testing. “The testing materials are shipped to the laboratory on the advertised date,” Sykes relates. “The laboratory then analyzes the test materials using their own method—for allergens this is typically an enzyme-linked immunosorbent assay (ELISA)—and submits its results to Fapas online, before the closing date.”

For this new Fapas offering, there is just one test, but two test materials are provided to each participant and the results are grouped and assessed according to the brand of ELISA kit they used, Sykes explains. “The Fapas online site for entry of results has a list of commonly available commercial ELISA test kits and participants select the one they have used,” he elaborates.

“The results receive rigorous statistical analysis by Fapas’ proficiency testing experts,” Sykes says. “A confidential report is published online for the customer, typically within 15 days of test results submission. Fapas can also provide interlaboratory reports for multiple connected laboratories that show an overview of global performance.”

This new sesame and gluten proficiency test for cumin adds to Fapas’s current portfolio of proficiency tests that address the potential for contamination of spices. “The Fapas portfolio also includes black pepper, chili powder, ginger, paprika, turmeric, and garlic powder,” Sykes notes.

The post Spice Industry Professionals Committed to Safety Throughout the Supply Chain appeared first on Food Quality & Safety.

Combating food fraud has different meanings depending on whom you ask along the supply chain. For growers, it refers to protecting the integrity of the ingredients they introduce into the supply chain. For the regulatory community, it means helping to reinforce and establish the authenticity of the food market so consumers don’t have to worry about the safety of the food that they eat. For food retailers or manufacturers, it’s about maintaining their brands’ integrity and value with consumers and the industry. For everyone involved—from farm to fork—it’s about ensuring there is a continued supply of safe food around the globe.

In order to battle food fraud, it is vital to provide a host of robust analytical and informatics solutions that can detect and analyze adulterants throughout the supply chain. Techniques such as infrared (IR) spectroscopy, liquid chromatography tandem mass spectrometry (LC-MS/MS), and inductively coupled plasma mass spectrometry (ICP-MS) address food quality and safety and help consumers be more confident in the integrity of the food they eat.

First Line of Defense: UV-Vis and IR Spectroscopy

There are a number of different methods and technologies used to detect adulterants in food. The chosen method will depend on the type of food fraud that is being detected.

For example, a UV-visible light (UV-vis) spectrometer is considered a useful and simple instrument that detects adulterants in extra virgin olive oil. With olive oil consumption increasing, this high-value product has become particularly susceptible to fraud.

One example of olive oil fraud is the addition of lower grade, refined olive oils to extra virgin olive oil. These lower-quality oils contain unsaturated hydrocarbons that absorb UV light in the 200 nm-300 nm spectral range. Therefore, a high absorption within this wavelength range points to a lower quality olive oil, meaning UV-vis spectroscopy can be used to differentiate between oils in a sample.

Extra virgin olive oil can also often contain significant levels of other edible oils that have a lower market price or are of a lower quality. Some examples of common adulterants include hazelnut oil, sunflower oil, soybean oil, rapeseed oil, or corn oil. UV-vis spectroscopy offers a simple method for checking whether an analysis result is above a specific limit, and therefore whether other oils have potentially been added to a sample of extra virgin olive oil.

In situations where there is uncertainty about the type of adulteration that may have taken place, IR spectroscopy is the preferred method for rapid, onsite analysis of samples in other commonly adulterated foods like honey and orange juice. As IR spectroscopy requires little sample preparation, it is also an easy-to-implement method that is useful in providing a rapid pass/fail analysis of adulteration. This, along with the fact that it does not require significant training to be operated, means IR spectroscopy can be used for testing at any point during the supply chain.

For example, herb and spice adulteration—such as replacing oregano with olive or myrtle leaves, the addition of dyes to chili powders, or adding peanut and almond material to ground cumin powder—is rapidly becoming more commonplace in the food industry and is a prime fit for IR spectroscopy. One issue with herb and spice samples, as with most food samples, is that they typically contain many sources of natural variation and are therefore difficult to analyze. Near-IR (NIR) spectroscopy can overcome this issue, enabling deeper penetration into samples in comparison to mid-IR or far-IR. NIR can therefore produce stronger spectra, making it easier to detect adulterants in these complex samples.

By combining this instrumentation with advanced analysis technology, it is possible to compare the spectra of a specific food sample with a database of known “pure” samples. These algorithms and chemometric techniques then enable users to classify complex samples, determine authenticity, and estimate the level of a certain adulterant without the need to run a further test.

After the 2008 melamine scandal in China, detecting adulteration in milk has also become a critical application for IR analysis. Typically, milk with a higher protein content will in turn attract a higher price in the market. Unfortunately, the typical methods for testing the protein content of a milk product are based around measuring nitrogen levels. This led to the nitrogen-rich, but highly toxic compound melamine being added to milk products in order to raise their apparent protein content. IR analysis is crucial in determining the concentration of this adulterant in milk, as well as identifying any other adulterants such as sugars or urea.

Next Level: LC-MS/MS and ICP-MS

In instances of food fraud where adulterants are at too low a concentration to be picked up by IR, or where stricter regulations demand more precise determination of adulterant levels, LC-MS/MS comes into play.

In the case of milk, for example, mass spectrometry offers an alternative method for the detection of adulterants. Aside from melamine and the addition of other small molecules, large molecules can also be added to milk for the purpose of fraud—for example, diluting more expensive milks such as buffalo, camel, goat, or sheep, with cow’s milk. By using LC-MS/MS, it is possible to measure the addition of bovine milk to these pricier milks by detecting the presence of β-lactoglobulin A. (See Figure 1.) This species-specific marker protein is found only in cow’s milk, enabling users to detect the presence of this cheaper alternative in other more expensive types of milk.

A similar method can be used to detect the presence of pork in certain foods, which is crucial for consumers whose culture or religion prohibits the consumption of this meat. Pork meat, like milk, contains certain peptides that can be used as biomarkers for detection in food samples. LC-MS/MS enables the detection of these biomarkers, offering a rapid, selective, and sensitive method for analyzing raw, cooked, and processed meat products for the presence of pork.

LC-MS/MS is also crucial for the detection of synthetic azo and non-azo dyes down to 10-100 ppb concentrations. Although once used in the industry as food colorings, these dyes have now been widely banned due to their potentially genotoxic or carcinogenic properties. However, they are still being detected in the food supply chain—particularly in spices—making it crucial that sensitive methods are available for the detection of even minuscule amounts of these banned substances. First, a simple dye extraction is performed using an organic solvent, with the filtrate then injected into the liquid chromatography column. Using certain methods, LC-MS/MS can achieve exceptional chromatographic repeatability and peak resolution in under four minutes.

Additionally, LC-MS/MS can be used to detect both adulterants and contaminants in wine. As with other food products such as olive oil, additives might be introduced into wine to improve its flavor or color. There is also a high chance pesticides or fungicides could end up in the final product if the grapevines have been sprayed with these compounds during growth. Both of these additives, whether intentional or unintentional, can cause significant harm to humans if ingested. It is therefore imperative that they are detected as quickly and reliably as possible. LC-MS/MS can simultaneously determine the concentrations of both pesticides and pigments in a single analytical run, providing users with a quick and easy method for monitoring these compounds in their products.

ICP-MS can also be used to combat fraud in wine by helping to determine the geographical origin of grapes—an important factor in driving product price and consumer expectations.

Using ICP-MS, it is possible to identify the unique and varying levels of trace elements present in the wine. After an elemental profile is created by ICP-MS, informatics solutions can then deliver a visualization of the data correlating the levels of trace elements in certain wines to that in different, geographically situated soils. (See Figure 2.)

Future of Combating Food Fraud

Although food fraud is certainly not a new concept, the increasing cost of food ingredients is making it more common. This is combined with ever-stricter regulations and the fact that those committing food fraud are also becoming more creative and intelligent in finding new ways to adulterate food. It’s therefore clear that the more in-depth information available on fraudulent activity, the more effectively fraud can be reduced and controlled.

Advanced yet intuitive testing innovations will continue to play a big role in helping to combat these challenges at all points of the food chain. Informatics will also continue to emerge as an ever-critical component in the fight against food fraud. With informatics, labs, scientists, organizations, and companies have easier and more intelligent ways to visualize their data. Data can be shared more easily and securely via the cloud, and actionable insights can be drawn more quickly and easily. The food industry and solutions providers must therefore continue to work closely together to ensure optimal and advancing instrumentation and tools are being leveraged to help uphold the integrity of the food supply chain.

Sears is vice president and general manager of food, chromatography, and mass spectrometry at PerkinElmer. Reach him at Greg.Sears@perkinelmer.com. Tordenmalm is market manager for processed foods at PerkinElmer. Reach him at Stefan.Tordenmalm@perkinelmer.

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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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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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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.”

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With the alcoholic beverage market booming in the U.S., the safety and quality of both domestic and imported products must be assured. A disposable sensor that detects adulteration of liquor has been developed by researchers at the University of Illinois at Urbana-Champaign. The device is handheld and can be used quickly in the field to identify tampered or watered down spirits.

The colorimetric sensor array with 36 dyes can quickly categorize 14 liquors by alcoholic content and brand name, with an accuracy rate higher than 99 percent, according to the research published online ahead of print in ACS Sensors. These optoelectronic noses are designed to probe a broad range of chemical interactions by using a set of chemo-responsive dyes immobilized in relatively hydrophobic matrices. The sensor changes color when exposed to particular components in liquor, and it can detect liquor that has been watered down by as little as 1 percent.

“The device is a digital, multidimensional extension of litmus paper,” says researcher Kenneth S. Suslick, PhD, Marvin T. Schmidt Research Professor of Chemistry at University of Illinois at Urbana-Champaign. ”We use an array of chemically responsive dyes (like the dyes in litmus or pH paper or even black tea when lemon is added), and it is the pattern of their color changes after exposure to a vapor that tells the identity of the vapor being sniffed.”

The portable and self-contained device developed by Dr. Suslick and colleagues could potentially be used “in rick houses where barrels are aged or even in local bars to keep the barkeep honest,” Dr. Suslick said. The technology should be marketable within a year, with the technology being commercialized by iSense LLC, Mountain View, Calif.

The same device with a slightly different array has also been used to monitor meat freshness. In the research published about the device in 2016 in ACS Sensors, it is described as a portable handheld, self-contained optoelectronic nose that allows for in situ and real-time collection of data related to meat spoilage.

Several techniques are being used to detect adulterated whisky and spirits, but these most commonly are used in a lab setting. Another method designed for use in the field is a portable gas chromatography/mass spectrometry device from PerkinElmer that can detect the presence of denatured alcohol that has been added to spirit drinks.

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The U.S. FDA kept itself busy in August. Here is an update on the agency’s actions.

Exemptions from FSMA
FDA has published three guidances to help producers of food commodities covered by FDA’s regulations for low-acid canned foods (LACF), juice HACCP, and seafood HACCP understand which parts of the Food Safety Modernization Act (FSMA) rules apply to them and how the FSMA rules may affect their operations.

FSMA recognizes that FDA has previously-established regulations that are specific to seafood, juice, and LACF and so some exemptions have been made in the FSMA rules for these products. However, there are still some requirements in the FSMA regulations that apply to these processors.

The new guidances aim to help industry identify these exemptions and understand the juice, seafood, and LACF regulations in connection with some of the new FSMA requirements.

Major Sampling Study of Sprouts
In response to recent foodborne illness outbreaks linked to various types of sprouts, the FDA has completed a large-scale sampling study as part of its efforts to learn more about potential contamination in these products. The testing program was designed to estimate the prevalence of Salmonella, Listeria monocytogenes, and E. coli O157:H7 in sprouts, and to identify patterns in hopes of preventing these pathogens from contaminating sprouts.

The FDA collected 825 samples from 37 states, Puerto Rico, and the District of Columbia, and found that most of the positive samples came from a small number of sprouting operations: A total of 14 positive samples were found at eight of the 94 growers, and 10 of these samples came from just four growers. For complete summary report, click here.

Intentional Adulteration Rule Compliance Guide for Small Businesses
The FDA’s new Small Entity Compliance Guides (SECG) help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA. It was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. SECG provides nonbinding recommendations on such topics as developing a food defense plan and records management.

The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.

6th Chapter of Guidance for PC-Human Food Rule
FDA recently released guidance for food facilities that explains how to establish and implement a heat treatment, such as baking or cooking, to prevent contamination by disease-causing bacteria. This is the sixth chapter of the draft guidance, entitled “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food,” designed to help food facilities comply with FSMA’s preventive controls for human food rule.

The final rule, entitled “Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” published on Sept. 17, 2015, builds on previous food safety requirements and introduces others that together establish a more modern, preventive, and risk-based approach to food safety.

This draft guidance is intended to help food facilities comply with specific requirements of the rule, such as developing a written food safety plan, establishing preventive controls, and taking corrective actions. The FDA intends to publish at least 14 chapters of the guidance and will continue to announce the availability of each chapter as it becomes available.

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