Public Health Implications of Economically Motivated Adulteration
By The Food Protection and Defense Institute
The U.S. Food and Drug Administration (FDA) has defined economically motivated adulteration (EMA) as the “fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.” Common types of EMA include substitution or dilution of an authentic ingredient with a different and cheaper product; flavor or color enhancement using illicit or unapproved substances; and mislabeling of a product. An EMA incident results in brand damage; significant economic loss for industry; costs to government from public health, regulatory agency and law enforcement response activities; and consumer mistrust in the food system. The Grocery Manufacturers Association (GMA) estimates a single EMA incident results in an annual revenue reduction of 2–15%, depending upon the company’s size. Likewise, GMA also estimates EMA costs the global food industry $10 to 15 billion annually. Overall, EMA results in unfair market competition, complicates supply chain control and oversight, and impairs transparency initiatives to improve consumer trust.
Perspective on EMA
EMA generates considerable concern from multiple perspectives: company brand protection, criminality, public health and consumer fraud. Ongoing EMA-related research at the Food Protection and Defense Institute (FPDI) focuses on the vulnerabilities in the food system, drivers that create an opportunity for EMA and the impact of EMA with an emphasis on public health consequences. While EMA perpetrators do not intend to cause illness or death, as that will reveal the adulteration, EMA may still result in public health harm. Illnesses in both human and animals have occurred due to fraudulent adulteration, typically when the adulterant is toxic or allergenic. This results in EMA not only being an economic crime but also a public health threat.
EMA and Impacts on Public Health
EMA presents a potential public health threat because adulterants may be unconventional, unexpected, and uncontrolled when they’re added to food. In many cases, the adulterant may be a benign substance–possibly another food ingredient–used to substitute for more expensive ingredients. An adulterant may also be used to dilute an authentic product or mask the identity of substituted ingredient. Benign adulterants include ingredients such as cheaper spices, plant fibers, oils, juices and even fish species. There are times, however, when adulterants are not benign, and perpetrators substitute an ingredient without considering health consequences. For example, this includes inserting an ingredient unfit for consumption, an unapproved additive or a known allergen. While the perpetrator doesn’t intend to cause harm, as they are focused on economic gain, the extent of the consequences may not be known until it’s too late.
To assist in identifying potential public health threats from EMA, FPDI categorizes EMA into eight adulteration methods: dilution, substitution, artificial enhancement, mislabeling, trans-shipment and origin masking, counterfeiting, theft and resale, and intentional distribution of contaminated product. Dilution, substitution and artificial enhancement involve altering the food itself. The other five methods involve altering the exterior appearance, misrepresentation and/or violating commercial regulations. The scope of EMA public health impacts may be illustrated through understanding each adulteration method with an associated public health impact example. The examples are drawn from FPDI’s Food Adulteration Incidents Registry, which is available at incidents.foodprotection.io/.
Dilution. Dilution is achieved through the addition of a cheaper ingredient to increase the overall weight or volume of a product. For example, in the UK, curry sauces were found to contain peanuts, despite their claims of being peanut-free. Tests confirmed that more expensive almond powder, used as an ingredient in these sauces, was diluted with up to 50% of less expensive peanut powder. Three deaths linked to peanut allergies triggered the investigation.
Substitution. Substitution is the replacement of an authentic product with a fraudulent one. A common example is the substitution of lower quality fish for a premium species. Public health concerns come into play if a toxic fish species is surreptitiously substituted for another ingredient or a different fish. Two examples highlight the public health threat of substitution: 1) cheaper escolar, which can cause keriorrhea, a form of fish poisoning that causes oily diarrhea, has fraudulently been sold as tuna in restaurants in the United States; and 2) in the U.S., puffer fish has been substituted and labeled as monkfish, despite strict importation and sale restrictions. Improperly prepared puffer fish contains tetrodotoxin, which is potentially lethal at ingestion levels of less than 2 mg.
Artificial Enhancement. Artificial Enhancement enhances a product’s attributes by use of an unapproved additive. The most notorious case occurred in 2008 melamine was used to fraudulently boost the protein levels in diluted milk. Because melamine is high in nitrogen, adding it to milk makes it appear higher in protein and increases its value. The melamine adulteration of infant formula sickened thousands of infants in China and caused six deaths. Adulterated milk was also added to many different foods including baked products, chocolate and confections, and resulted in a massive recall spanning 47 countries. A more recent example occurred in 2015 when FDA India recovered 90 kg of rice granules, bran, lead chromate and Sudan dyes intended to be mixed with turmeric powder to increase the quantity and the color. Sudan dyes are known carcinogens and often used in industrial dyes and shoe polish. They are banned from being added to food products around the world. Lead chromate is also a carcinogen and known hazardous substance which can cause headaches, anemia, muscle cramps and brain damage. The factory where FDA India seized the products had been operating for 25 years without a license. As a result, it is unknown how long adulteration occurred.
Mislabeling. Mislabeling occurs when quality, harvesting, or processing techniques of a food product are misrepresented. Examples include selling a product as Kosher or Halal, organic or cage-free when it is not. Although these examples may not lead to public health harm, mislabeling involving food safety issues also occurs. For example, altering package expiration dates and reselling expired, mislabeled food creates public health risk. In 2010, a mislabeling EMA incident occurred when a shipment of imported, unpasteurized cheese was mislabeled as pasteurized. Because it had not been pasteurized, the cheese was contaminated with Staphylococcus aureus, which if ingested, can result in severe illness and even death. The mislabeling was detected and the importing company was ordered to destroy the cheese or send it back to its origin. However, the company tried to further defraud authorities by making a fake shipment of packages filled with waste water to imitate the weight of the cheese being returned.
Trans-shipment. Transshipment moves goods through an intermediary country before shipping to its final destination thereby masking its true origin. Motivations that include differences in regulatory oversight, consumer perception and avoidance of tariffs lead to transshipment. Transshipment can be an in-country issue as well. For example, a food company specializing in shell eggs misled consumers into thinking its eggs originated from California, even though they came from other states. This misrepresentation could have caused significant public health harm, as consumers, believing their eggs were from California, would not have worried about a Salmonella outbreak in Idaho. Honey is often transshipped to avoid both tariffs and to mask the use of hive treatments allowed in the producing country but not allowed for public health reasons in the destination country.
Counterfeiting. Counterfeiting refers to the mimicking of one food by replicating it out of different ingredients. Counterfeiting can be committed by fraudulently using a brand-name label on an inauthentic product, thus selling one product as a different—often more valuable—product. In 2005, for example, Turkish officials recalled millions of counterfeit raki bottles, a traditional anise-flavored distilled alcohol, after 23 deaths and numerous illnesses were reported. The counterfeit bottles contained over 200 times the legal limit of methyl alcohol. Approximately 500,000 genuine “Yeni Raki” brand labels, including the tax hologram, had been stolen from a bottling facility and then used to place counterfeit raki on the market.
Theft and Resale. This method comprises theft of food products and their resale through unapproved channels. In 2011 and 2012, approximately 6 million pounds of maple syrup, worth approximately $18 million, was stolen from the Global Strategic Maple Syrup Reserve in Quebec, Canada to be sold on the black market. The missing syrup was discovered as a result of a routine inventory check in July 2012. Only a quarter of the maple syrup was recovered. Public health concerns arise from theft and resale for a variety of reasons, as it is a loss of supply chain control. The perpetrator may insert a harmful adulterant, resell spoiled product with altered sell-by or expiration dates, or fail to maintain temperature control thus allowing microbial growth and toxin production.
Intentional Distribution of Contaminated Product. Intentionally distributing a contaminated product is another form of EMA. The deliberate distribution of Salmonella-contaminated peanut products in 2008 and 2009 by the Peanut Corporation of America (PCA) is the prominent example. PCA shipped product before microbiological testing results had been received, and then did not notify customers or recall the products when these tests came back positive for Salmonella. In addition, many of the products were shipped with fake certificates of analysis. The incident resulted in Salmonella Typhimurium infections in 46 states and nine deaths. The U.S. Centers for Disease Control and Prevention estimated that as many as 20,000 people may have been sickened by the contaminated peanut products.
EMA and the Preventive Controls and Foreign Supplier Verification Rules
The Food Safety Modernization Act (FSMA), passed in 2011, addresses EMA in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF) rule and the Foreign Supplier Verification Programs (FSVP) rule. EMA is included in these rules, because EMA is considered a hazard with potential public health consequences that may be reduced with proper preventive controls. The PCHF rule focuses on improving overall food safety processes by outlining and instituting policies that anticipate problems before they occur. Moreover, the PCHF rule requires food companies to identify hazards and implement and document preventive controls for EMA risks that might result in illness or injury to the consumer. The FSVP rule requires a facility that imports food into the United States to verify that foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls regulations.
EMA and Preventive Control Implementation
Companies should implement preventive controls to mitigate EMA hazards, protect the health of their consumers, preserve brand reputation and comply with FSMA. EMA hazards that pose a reasonably foreseeable and significant public health risk should be identified through an assessment process. This includes identification of vulnerabilities in the food system where EMA can be introduced and evaluation of the severity and probability of a potential EMA incident. Past history of EMA incidents should be used in the assessment. Preventive controls to control the EMA hazard should be documented in the production facility’s food safety plan.
Although the PCHF rule cites various types of preventive controls that may be used to control food safety hazards within a facility, preventive controls for EMA are likely addressed through a supplier program that includes written, risk-based supply chain controls to prevent or minimize EMA hazards. The receiving facility—for both domestic and foreign suppliers—is the party responsible for establishing and implementing supplier approval and verification procedures.
EMA and Hazard Assessment and Supply Chain Preventive Controls
Several tools are available to aid facilities with their EMA Hazard Assessment. FPDI actively monitors intentional adulteration incidents including those arising from EMA, sabotage, and terrorism. These are compiled in a Food Adulteration Incidents Registry that may be surveyed and monitored to understand the probability and risk of public health harm by food, food category and geography of origin. FPDI also developed a facility-based educational tool, the Food Defense Readiness Assessment (FDRA), which presents key food defense components of the FSMA regulations and allows assessment of a facility’s compliance readiness. Based on readiness scores, recommendations and resources are provided in the areas of EMA, intentional adulteration mitigation strategies, management and operation, and industry/government cooperation. The following excerpt from FDRA provides examples of how a facility might assess their EMA hazards and supply chain preventive controls.
EMA is intentional adulteration of food by intelligent perpetrators actively trying to deceive consumers, defraud customers and avoid detection by quality assurance and regulatory systems. Its potential repercussions—through recalls, brand damage,and public health harm—affect the entire food system, from farm-to-fork. Farms, production and processing facilities, and storage and distribution channels are all at risk from direct and indirect consequences of an EMA incident. A reactive approach is not sufficient to protect against EMA. Proactive identification of increased vulnerability will involve multiple factors including product EMA history, supply chain characteristics, analytical methodologies used for quality assurance, and the economic environment. It is in the interest of all stakeholders across the food system to take steps to prevent EMA, including:
• Developing and implementing preventive control programs specifically addressing EMA
• Sharing information about known EMA incidents
• Reporting incidents to FPDI via the FAIR website
• Aligning with professional groups focused on EMA like the Food Fraud Professional Development Group within the International Association for Food Protection
• Conducting preparedness exercises to test your organization’s resiliency, response and recovery plans
The Food Protection and Defense Institute (FPDI), formerly known as the National Center for Food Protection and Defense, was officially launched as a Homeland Security Center of Excellence in July 2004 at the University of Minnesota. Developed as a multidisciplinary and action-oriented research consortium, FPDI addresses the vulnerability of the nation’s food system. FPDI takes a comprehensive, farm-to-table view of the food system, encompassing all aspects from primary production through transportation and food processing to retail and foodservice.
4. Everstine, K et al. 2013. “Economically Motivated Adulteration (EMA) of food: Common Characteristics of EMA Incidents.” J Food Prot 76(4):723–735. doi.org/10.4315/0362-028X.JFP-12-399.
7. Ling, KH et al. 2009. “Fish-Induced Keriorrhea.” Adv Food Nutr Res 57:1–52. doi.org/10.1016/S1043-4526(09)57001-5.
9. Evershed, R and N Temple. Sorting the Beef from the Bull: The Science of Food Fraud Forensics (New York: Bloomsbury, 2016).
11. Gossner, CM-E et al. 2009. “The Melamine Incident: Implications for International Food and Feed Safety.” Environ Health Perspect 117(12):1803–1808. doi.org/10.1289/ehp.0900949.
21. 21 CFR § 117 Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food.
Categories: Management: Food Defense