Uncovering Product Vulnerability

The food supply is becoming increasingly globalized and U.S. consumers eat imported foods or ingredients on a daily basis. More than 15 percent of the foods we eat in the U.S. are imported, with as much as 80 percent of seafood products coming from other countries. Many food ingredients, such as spices, are sourced almost exclusively from other countries. The FDA estimates that importation of regulated products next year will be triple that from 2007. Globalization of the food supply increases the length and complexity of supply chains, and arguably increases the opportunity for both foodborne illness and economically-motivated adulteration (EMA). Of the more than 450,000 food and feed facilities registered with FDA, more than 285,000 are foreign facilities. There is a large gap in inspection coverage among foreign facilities and domestic facilities. Between 2001 and 2007, only 1 percent of foreign food firms were inspected by FDA. The agency has proposed a number of programs aimed at addressing the challenges posed by imported food products and ingredients. However, there is still some debate about how to approach the problem of EMA.

Types of EMA

Various groups have defined EMA, or food fraud, including the Global Food Safety Initiative (GFSI), the U.S. Pharmacopeial Convention (USP), and the Grocery Manufacturers Association, or GMA. The bottom line is that EMA involves misrepresentation of the true nature of a food product or ingredient, with the goal of the economic gain of the seller. The National Center for Food Protection and Defense at the University of Minnesota has identified the following eight types of EMA.

Substitution involves complete replacement of a food product or ingredient with an alternate product or ingredient. Examples include fish species fraud or selling olive pomace oil as extra virgin olive oil.

Dilution involves partial replacement of a food product or ingredient with an alternate ingredient. Examples include dilution of honey with sugar syrups and the addition of horse meat to ground beef.

Transshipment or origin masking refers to misrepresentation of the geographic origin of a product to avoid import duties, regulatory oversight, or to benefit from consumer demand. Examples include routing Chinese honey shipments through Vietnam to avoid U.S. import duties and mislabeling imported shrimp as U.S. Gulf coast shrimp.

Artificial enhancement is the addition of unapproved chemical additives to enhance the perceived quality of a product. Examples include the addition of Sudan dyes to chili powder and the addition of melamine to milk.

Mislabeling refers to misrepresentation with respect to harvesting or processing information. Examples include falsification of label information for organic produce, cage-free eggs, kosher foods, halal foods, and date-markings.

Theft and resale refers to situations where a food product has been stolen and re-enters into commerce through unapproved channels. Examples include retail theft of infant formula and cargo thefts.

Counterfeit is fraudulent labeling of a product by an unauthorized party as a brand-name product. Examples include counterfeit infant formula and counterfeit Heinz ketchup bottles.

Intentional distribution of a contaminated product is the intentional sale of a product despite knowledge of foodborne contamination. Examples include the intentional sale of Salmonella-contaminated peanut products and the intentional export of dioxin-contaminated fish.

EMA has occurred in many food products (see Figure 1). EMA incidents typically do not result in consumer illnesses or deaths since the goal of the perpetrators is to not be detected. However, perpetrators do make mistakes and are not always knowledgeable enough about the safety of the adulterants being used. Adulteration of milk supplies in China with the nitrogen-rich chemical melamine is the most recent example of EMA resulting in widespread illnesses and deaths. In 1981, thousands of people in Spain became ill and hundreds died after consuming fraudulent olive oil that was actually industrial-grade rapeseed oil.

In 1985, sweet white dessert wines imported from Austria were recalled in the U.S. and other countries due to adulteration with the chemical diethylene glycol (DEG). The addition of small quantities of DEG allowed the continuous production of desirable wines of a consistently high quality without causing short-term health effects in consumers. Ultimately, the adulteration was discovered by a tax inspector who investigated the tax records of a winery. This incident illustrates two of the biggest challenges of preventing EMA. The first is that perpetrators—in this case, a chemist—are intelligent adversaries that may have the technical expertise to effectively evade quality assurance and regulatory testing programs. The second challenge illustrated by this incident is that the most successful adulterant is the unexpected adulterant. At the time of the Austrian wine incident, there was no reason to expect the presence of DEG in wine and no testing was being done for this adulterant.

Vulnerability Assessments

For all these reasons, food companies that want to proactively address the risk of EMA in food ingredients that they source need to go above and beyond what is currently outlined in the proposed rule on preventive controls in the recently-released update to the Food Safety Modernization Act (FSMA). In the “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” proposed rule, FDA indicated that additional requirements surrounding EMA would best be addressed as part of preventive controls efforts. The regulations as proposed would focus on “circumstances where there has been a pattern of adulteration in the past” and adulterants that are most likely to cause illness. Relying only on these factors would likely not have prevented the tragic melamine incident of 2008 given the lack of historical information about melamine adulteration of dairy products that was available at the time. There is general consensus among many organizations that effective mitigation of EMA requires a vulnerability assessment type of approach that holistically considers several contributing factors that underlie the opportunity and incentive for perpetrating EMA instead of just focusing on historical incidents. The GFSI Food Fraud Think Tank recommends the food industry conduct vulnerability assessments and subsequently put in place appropriate control measures.

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Table 1: Framework for conducting an EMA vulnerability assessment. Each contributing factor to EMA vulnerability should be evaluated separately in terms of its contribution to overall vulnerability of a food ingredient.

On Nov. 17, 2014, USP, a scientific standards-setting organization that develops quality standards for medicines, food ingredients, and dietary supplements, issued the first publicly-available draft guidance on conducting EMA vulnerability assessments. The draft guidance for mitigating EMA risk was designed to be generally applicable to any food ingredient, and any food fraud management system that can be developed from this framework should be viewed as a dynamic and continuous process. The guidance includes an assessment of the contributing factors to EMA vulnerability, which can then be ranked on a low-to-high scale for vulnerability (see Table 1). Each of these contributing factors is discussed briefly below.

EMA/Food Fraud History. One of the most basic indicators of EMA vulnerability in a particular food product or ingredient is its EMA history and pattern. Information about EMA incidents and issues can be found in the NCFPD EMA Incidents Database and USP’s Food Fraud Database.

Supply Chain Structure. Visibility and control along supply chains can mitigate EMA vulnerability. The degree of vertical integration, oversight, and traceability should all be considered as part of a vulnerability assessment.

Supplier Relationships and History of Quality/Safety Issues. In addition to the structure of supply chains, the degree to which an established and trusted relationship has been formed with ingredient suppliers and the history of food quality and safety issues among those suppliers can provide insight into the potential for EMA vulnerability.

Susceptibility of QA Methods and Specifications. EMA perpetrators are often very familiar with industry standard QA methods and specifications. Therefore, it is important to consider how effectively the suite of methods and specifications that are incorporated into a QA program can characterize an ingredient and detect inauthentic ingredients.

Audit Strategy. The rigorousness of the audit strategy and the inclusion of anti-fraud measures in audits are an important consideration when assessing the vulnerability of a food ingredient to EMA.

Testing Frequency. The frequency used to test raw materials entering a food processing facility is an important factor in EMA vulnerability. Evidence-based testing reduces EMA vulnerability by increasing confidence in the integrity of raw materials and helps to establish trust in suppliers.

Geopolitical Considerations. U.S.-based food companies and consumers are reliant upon the food safety and regulatory systems in other countries when importing food products. Therefore, it is recommended to include a consideration of the level of development of the food safety and regulatory system and other relevant factors such as system disruptions and corruption indices for the geographical source of the ingredient, as well as geographic locations through which it is transported.

Economic Anomalies. Since EMA is motivated by the potential for economic gain, monitoring of various forms of economic data may help provide insight into increased vulnerability to EMA in a particular food commodity or ingredient. This may be either macro-level or micro-level data, depending on what is accessible to the organization conducting the vulnerability assessment. One example is the sharp increase in global vanilla prices beginning in 2000, and corresponding evidence of vanilla fraud during the same time period.

The horse meat adulteration incident resulted in a 1 percent drop in sales for one U.K.-based grocery chain, followed by a 5 percent drop in shares. In addition to the cost to companies, EMA threatens the health of consumers, has negative effects on markets, and causes brand damage. Food companies that have a vested interest in protecting their brand will need to adopt proactive programs to address EMA that go beyond traditional food safety measures.

Dr. Everstine is a research associate at the National Center for Food Protection and Defense at the University of Minnesota where she manages multiple federally-funded EMA projects. Reach her at [email protected]. Dr. Moore is a senior scientific liaison at USP. He manages EMA projects and develops standards and reference materials for verifying the integrity of food ingredients published in USP’s Food Chemicals Codex. Reach him at [email protected]. Claudia Costabile, M.A. from USP is also a contributor to this article.

References Furnished Upon Request