Preventing economically motivated adulteration
Unfortunately, people and pets sometimes get hurt by consuming contaminated food and beverage products passed off as the real things.
Economic adulteration and counterfeiting of global food and consumer products are estimated to cost the industry $10 to $15 billion per year, according to a 2010 A.T. Kearney study conducted for the Grocery Manufacturers Association (GMA). The expense of one adulteration incident averages between 2 and 15 percent of a company’s yearly revenues. This translates into a $400 million loss for a $10 billion company or as much as $60 million for a $500 million company.
According to Europe’s FoodProductiondaily.com, the recent European horse meat scandal is expected to cost contract manufacturers tens of millions of euros as brand owners pass costs up the supply chain. Of course, some of this cost will be passed on to European consumers. Even so, the amount of product affected was relatively small. According to the UK House of Commons’ Environment, Food and Rural Affairs Committee, Food Contamination report (Fifth Report of Session 2013-14), horse meat contamination was limited to a relatively small number of products, with more that 99 percent of those tested free of horse DNA. Tests across EU member states found 4.66 percent of products tested contained more than 1 percent horse DNA. The report also expresses concern about the decline in the number of public analysts who carry out tests and the public laboratories in which they work.
How to report an incident to USP’s Food Fraud Database
Any person who has knowledge about an actual food fraud should immediately report this to the relevant authorities. USP’s Food Fraud Database is a tool that makes reports from science and media on food fraud available to everyone. Anyone with knowledge about scientific publications and/or detailed media reports regarding food frauds that are not yet captured in USP’s Food Fraud Database is encouraged to share them with USP; the website www.foodfraud.org makes the necessary tools for easy reporting available. FDA has very effective ways of informing the industry and consumers of threats to food safety and public health. USP’s Food Fraud Database is designed to make literature regarding food fraud available to everyone in the food supply chain, including regulators and the industry. USP believes this information is one piece of the food safety network that is designed to stimulate discussions and help all parties involved make informed decisions.
Typically, intentional adulteration is done to increase profit margins and is usually meant to be harmless to purchasers—whether a food processor or end-consumer. Conversely, unintentional—or incidental—adulteration is usually caused by bungling or carelessness in the process, e.g., not having and following a HACCP plan. Sometimes intentional and unintentional adulteration converge, and when they do, people—and pets—get hurt, as was the case with the Chinese melamine scandal in 2007. (For more details and definitions of economically motivated adulteration (EMA), see “Food Fraud: You purchased what?")
The melamine was added to Chinese gluten, grain and dairy products so analytical instrumentation would determine the products had more protein (based on nitrogen measurement) than they really did. The results of consuming these products depended on your species. For ruminants with multiple stomachs, there was no problem. However, for pets and humans—with mono-gastric stomachs that are unable to process melamine—the results ranged from severe sickness to death, according to John Surak, principal of Surak and Associates.
Another example where unintentional and intentional adulteration converged is the Peanut Corporation of America Salmonella outbreak. What started out as potentially accidental contamination, which wasn’t discovered until a couple of tests revealed a positive Salmonella count in the product, turned out intentional adulteration as company senior-level officers gave orders to ship contaminated product anyway, and failed to fix the issues that caused the contamination.
You bought what?
“Food safety requires quality systems and manufacturing approaches designed to put quality and safety into the very processes applied,” says Markus Lipp, senior director of food standards for US Pharmacopeial Convention (USP). “It also requires a risk-based approach for testing that these systems are indeed performing as they were intended and all the assumptions regarding the identity and purity of purchased ingredients are in fact still holding up, i.e., the ingredient is really what it is purported to be.”
Supplier qualification programs should always include a risk-based approach of testing and verifying specifications as well as COAs (certificates of authenticity/analysis). Neither testing alone nor the reliance or quality systems are sufficient to guarantee food safety and public health, adds Lipp. “However, the combination of both provides a formidable protection against food fraud and will help ensure a safe food supply.”
Up until a few years ago, the operating philosophy in the food industry regarding suppliers was, for the most part, “trust, but verify,” according to Mahipal Kunduru, Deloitte, senior advisor, food safety. “But now, with some of the events that have transpired, the mantra seems to be more like ‘verify, and then trust.’ How do you know what you’re getting is true and what you paid for?”
“This is a very difficult issue,” says Craig Henry, Deloitte ERS director—business risk, food and product safety. “Trying to identify whom or what products are most susceptible is the real challenge any company has. It’s a question of how accurate the information is and how it is coordinated with procurement.” The fraud issue is very real, and while testing is readily available, it is expensive and very difficult, with complex food matrices. Consequently, trying to figure out what the true product is can be elusive, says Henry.
“EMA of food products represents a huge gamut of things that folks who intend to manipulate the food supply can do,” adds Faye Feldstein, Deloitte Consulting senior advisor. The USP has a food fraud database that lists several forms of food fraud, including the mislabeling of fish products—such as substituting tuna sushi with escolar, a cheap fish that can make people sick—which is a violation of federal law. From a health perspective, much of the food fraud hadn’t really had a public health impact—until the melamine incident occurred, making animals and humans sick, and killing babies in China whose formula had melamine added to it, according to Feldstein.
When it was originally compiled, the USP database included 1,300 cases of food fraud occurring between 1980 and 2010. The database was just updated this year, and 800 new instances were added for the years 2011 and 2012. The top categories in which food fraud is practiced include milk, vegetable oils and spices—followed by seafood and clouding agents.
What goes in the USP database? “USP’s database did not attempt to track down US-specific or unique incidents,” says Lipp. Of course, once a major food scandal is discovered, numerous reports are published. But in the cases where widespread usage of adulterated materials are observed (e.g., melamine in milk powder and wheat gluten in China and phthalates [clouding agents] in Taiwan), it is likely impossible for anyone to count the number of independent instances of food adulteration, adds Lipp.
Considered the 2011 equivalent to the melamine scandal, numerous database records document the plasticizer Di-(2-ethylhexyl) phthalate (DEHP) and other related phthalates that were fraudulently added as clouding agents in place of the more expensive palm oil or other allowed food ingredients in fruit juices, jams and other products. The scope of this fraud involved 877 food products from 315 companies, according to Lipp. DEHP may be used in food contact materials, but its migration should not exceed 1.5 ppm; safety concerns concerning DEHP include cancer and improper reproductive organ development in children. Some products were found to have DEHP levels in excess of 25 ppm in a single serving.
“Once this scandal became known, FDA and other US agencies immediately deployed a risk-based inspection of all potentially affected imports and effectively prevented any further exposure of US consumers to these products,” says Lipp. “Currently, one may safely assume these tainted products are not a concern to the public health in the US.
“Food safety is high in the US and other developed countries, thanks to the ongoing vigilance of government, industry and informed consumers,” says Lipp. However, food fraud does occur. (Extra virgin olive oil, fish, maple syrup, honey and paprika are only some of the examples.) Some of these adulterated materials were effectively caught by FDA (and USDA) before reaching consumers, while others reportedly have reached the public. These incidents demonstrate the need for constant vigilance. Food safety, and ultimately public health, can only be protected and improved through the continued efforts and cooperation of all stakeholders—government, industry, consumers and standard-setting organizations such as USP.
Setting an action plan
According to Don Hsieh, Tyco Integrated Securities director, commercial and industrial marketing, FDA had done some vulnerability testing and identified four critical areas in which EMA can be lessened. Some of these also apply to food defense, where intentional adulteration may be attempted by, for example, disgruntled employees or terrorists. Tyco has implemented these four “A’s”:
- Assess: Conduct an assessment of the total food supply chain to identify areas of vulnerability to minimize theft of legitimate product that can be used as a source for EMA (counterfeit, diversion, dilution)
- Access: Ensure access to critical areas, e.g., product labels or packaging, are given only to authorized personnel to prevent use for EMA
- Alert: Receive real-time alerts of intrusion into secure areas, or when cargo shipments have gone off route, to protect the supply of authentic goods
- Audit: Systematically conduct random audits to detect divergence from standard operating procedures that may detect fraudulent activity.
In some cases, it may pay to “think like a criminal,” says Hsieh. One of the ways to protect against EMA is to raise the hurdle for criminal activity. Criminals tend to go for the easiest path first since they don’t want to be caught, adds Hsieh, so make it harder for them to succeed.
Taking a look at supplier audits also is a necessity. According to Surak, that means having someone who is fluent in the culture and language visit foreign suppliers to be sure that wants and needs are clearly translated to eliminate any misunderstandings. In addition, Surak recommends having backup suppliers and letting them know what is expected of them. A little competition can encourage continuous improvement as no primary supplier wants to be dropped to a level of secondary supplier. Contracts also must be written clearly and fully explain what is expected of the supplier in terms of performance and product quality and safety. Contracts must also include an escape clause in case a supplier does not live up to COA expectations.
“You can’t assume a foreign company understands US regulations,” adds Surak. “When we work with companies outside the US, we have a certain amount of responsibility in helping them understand what those regulations mean. We have an obligation to say, ‘This is what the word fraud means.’ Don’t assume they know it.”
In looking at supply chain issues, unauthorized people getting into the plant and stealing labels or ingredients may be a possibility, but the biggest problem is outside the plant. “Unfortunately, food and beverage has experienced the most cargo theft of any industry in the last three years,” says Hsieh, with 90 percent of cargo theft happening on trucks.
Whether the activity involves incoming product labels or outgoing product, stealing can be a major loss for processors—and potentially cause brand damage as well—either through the counterfeit production or reselling of product. Fortunately, new technologies are already available to make cargo theft much more difficult. For example, truck location, time and a key can be tied together so the truck trailer can’t be opened if any of these are incorrect. Plus, processors can have real-time verification the truck is where it’s supposed to be.
Working with copackers also can be problematic, according to Hsieh. To alleviate copacker-related issues, processors should have a good inventory control system that keeps track of labels and product going out the door. The more timely the information in the supply chain, the quicker the processor can find and resolve a problem.
Finally, processors with internal problems can use video auditing to detect issues in the plant, for example, shortcuts in equipment washing or failure to add the correct amount of critical ingredients (which might be going out the door instead). The videos can also aid in employee training.
Testing—anything but routine
With melamine, no one was aware there was a problem until pets and people got sick, and then babies in China died from drinking tampered formula. As in many cases, this wasn’t about diluting a product; the real issue was what had been substituted in its place to maintain the phenotypic characteristics of the food, says John Lee, Agilent Technologies global food segment manager. The fact is, the bad guys are getting better and better at manipulating food and drink without anyone’s knowledge.
Assuming the bad guys show up at food safety conferences, as MSU’s John Spink warned the audience at this year’s Food Safety Summit, it’s reasonable to assume they’re reading this article, too. To keep up their tricks, they need to stay one step ahead of the testing community, always finding ways around analytical instrumentation test results.
“Adulterating food ingredients for financial gain takes many guises, from crude substitution to sophisticated replication,” says Sharon Palmer, PerkinElmer food director for analytical sciences and laboratory services. “You may use physical, elemental, chemical, protein or DNA characteristics of foods to identify authentic versus counterfeit products, and a wide range of technologies within each of these methods can be used to make the measurements.” However, the fraudsters have a high level of knowledge of regulated test methods, as highlighted in the melamine scandal, so the industry’s aim now is to employ multiple techniques to ensure supply chain integrity.
But fraudsters get lots of help from the sheer complexity of food products. “First, [food] matrices are highly complex and can be extremely variable even within the same commodity group,” says Dr. Sara Stead, Waters Corp. business development manager—food and environment. “For example, the composition of an apple will vary depending on the country in which it was grown and the variety it belongs to. Foods produced all year ‘round like meat and milk may have seasonal variations depending on livestock feeding regimes. LC-MS/MS testing data shows a sample may contain tens of thousands of endogenous chemical components of varying abundance.
“Second, there is the ever-present threat of unknown or unexpected contaminant as was the case of the melamine scandal,” Stead adds. One approach to address the challenge posed by unknown adulterants is to generate specific analytical profiles based on full-scan, high-resolution mass spectrometry data for each commodity type, which can be used to reference the native or unadulterated form of the commodity. Unknown samples can then be compared against the known, good samples using statistical tools to identify significant differences. This allows the chemist to focus on specific regions in the data set, determine the elemental composition of the unknown compounds and subsequently elucidate the chemical structure and identity of the compounds, adds Stead.
“This testing of exceptions is possible, but requires building an extensive library of ‘normal’ samples,” says Michal Godula, food safety and environment marketing manager, Thermo Fisher Scientific chromatography and mass spectrometery division. “As such, it can be applied for a limited array of samples of the same kind. Usually, this would be used by processors manufacturing the same type of food. Another approach is to search on a semi-targeted basis, for example, using large databases of potential contaminants built on previous experience. However, even this does not eliminate the risk of encountering new contaminants.
“Current software tools can help identify the differences between sets of samples, good versus bad, for example,” adds Godula. “This is not a routine process. It requires extensive knowledge and sophisticated equipment.” Godula recommends processors and producers develop protocols for dealing with unexpected results.
Genomic testing and beyond
While the chemometric modeling methods described above can uncover many frauds, what about the scallops you purchased for dinner? Are they real? “Biological methods are often the method of choice in species determination for fish or meat species and grain [wheat, barley, rice] variant determination,” says Lee. But they can also be used for fruit preparations and juices and certain adulterations of milk products (cow’s milk or soy milk in sheep, goat or buffalo milk). Biological methods usually rely on the detection of proteins or DNA.
However, genomic testing is not without its issues. For example, when considering genomic-based testing for olive oil, it is important to consider potential obstacles such as the extraction of fragile DNA from an oily matrix and the selection of appropriate molecular markers that can provide reliable results, according to Stead. “If the DNA is damaged, it will not be fully accessible for the DNA polymerase. In other words, DNA of low quality would potentially lead to inconsistent and consequently inconclusive results. However, successful PCR amplification probably depends on the ability of the DNA extraction method and correct selection of molecular markers.”
Beyond genomic testing, a broad portfolio of techniques can used to detect counterfeit ingredients used to adulterate food products, says Thermo Fisher’s Godula. Stable isotope ration mass spectrometry (IRMS) is an important tool for assessing the declared geographical origin and the addition of adulterants like sugars in honey. Chromatography coupled with various detection systems is typically used to identify adulterated or mislabeled samples. Detectors include mass spectrometers, trace elemental analysis systems and molecular spectroscopy techniques such as FT-NIR. These are all information-rich techniques; statistical chemometric tools can simplify and classify the data for interpretation.
Beyond analytical testing, most analytical instrumentation suppliers have formed liaisons with universities and governmental agencies. So, plenty of help is available to the food and beverage industry.
For More Information
John Surak, Surak and Associates, 864-506-2190, email@example.com
Mahipal Kunduru, PhD, Deloitte, 408-510-4820, firstname.lastname@example.org
Craig Henry, PhD, Deloitte, 443-676-7463, email@example.com
Faye Feldstein, Deloitte, 410-562-9398, firstname.lastname@example.org
Don Hsieh, Tyco IS, 561-988-3600, email@example.com
John Lee, Agilent Technologies, 800-227-9770, firstname.lastname@example.org
Sharon Palmer, PerkinElmer, +44 (0) 1494 679020, email@example.com
Sara Stead, Waters Corporation, +44 (0) 161 4354194, firstname.lastname@example.org
Michal Godula, Thermo Fisher, 408-965-6408, email@example.com