The food industry is no stranger to risk management. In the battle for consumer dollars, product recalls caused by contamination or adulteration can be catastrophic. Business, legal and moral repercussions resulting from lapses in food safety and quality are top-of-mind issues for all manufacturers. Significant resources are dedicated to minimizing these risks, generally through a variety of industry (and additionally, manufacturer- or retailer-specific) quality assurance (QA) systems. As global food sourcing and international manufacturing sites have skyrocketed, risk management is an increasingly complex proposition, and quality and safety systems are challenged to keep pace.

Contamination and adulteration are distinct threats. While both involve the presence of something that should not be in a food product, contamination is unintentional and generally predictable (manufacturers are aware of potential risks that need to be controlled, though clearly a quality lapse has occurred in a contamination event). Economically motivated adulteration, however, involves purposeful and intentional replacement of the expected food substance with a cheaper one, including simply diluting the expected substance with a solvent such as water. An important element is that such replacement or dilution occurs without the knowledge of the seller. Consequently, this creates a singularity in the food safety system, insofar as nobody (aside from the perpetrator) is able to evaluate any consequences for the safety of consumers due to the exposure to the said cheaper adulterant. Furthermore, to ensure repeat business, economically motivated adulteration is often designed to avoid detection by standard QA testing.

Adulteration, however, has yet to catch the public’s attention as a food safety issue. Contamination—especially microbial—tends to generate the majority of the headlines and does, in fact, present potentially serious health consequences to consumers. On the other hand, intentional adulteration can be an equally critical issue. Though it has been around for hundreds (perhaps thousands) of years, intentional adulteration has recently been spotlighted with the release of a report by the U.S. Government Accountability Office in November 2011, evaluating the U.S. Food and Drug Administration’s (FDA) capacity to detect adulteration in food and drugs, the challenges the agency faces (largely arising from globalization) and potential options for preventing this threat. The report indicates just how far we still need to go in addressing this issue. Of course, governments and industry have taken other actions in the past few years, particularly in light of some high-profile adulteration episodes. FDA held its first public meeting on economically motivated adulteration in 2009. In 2010, the Grocery Manufacturers Association released a report it commissioned on the subject. Among other findings, the report stated that the cost of one incident of product adulteration runs between 2 and 15 percent of yearly revenues for a company, which could translate to a $400 million impact for a $10 billion company. The report also laid out a host of deterrence strategies, including developing food ingredient specifications.

Adulteration: A Long History, Modern Urgency
Adulteration is not a new threat. Notorious examples include episodes where industrial oil has been sold as cooking oil, with devastating results. Such was the case in Morocco in 1959, when olive oil was adulterated with lubricating oil used in jet engines, and in Spain in 1981, when hundreds of people died from toxic oil syndrome that resulted from the sale of denatured rapeseed oil labeled as olive oil. More recent episodes of adulteration have included melamine in pet food in 2007 (originating from China but causing serious illness and deaths of pets worldwide) and milk products in 2008 (serious illness and deaths largely in China of infants and others), dioxins in animal feed in 2011 (Germany and throughout Europe) and waste (gutter) oil recycled and sold as cooking oil in 2010–2011 (China).

Although it has been written about extensively, melamine presents an interesting example in that the chemical, by itself, is relatively nontoxic. In fact, it has been used widely as a feed additive to boost the diet of calves. In the 2007 and 2008 incidents, the melamine used was likely scrap melamine containing cyanuric acid. When combined, the two compounds can form a stable and insoluble complex crystal that can block renal tubules, which was the route of harm for thousands of consumers. Had nonscrap melamine alone been used, it likely would have gone undetected. Herein lies the ultimate risk of adulteration. In cases of economically motivated adulteration (as opposed to bioterrorism), the incentive is purely profit; there is no intent to harm. When people (or animals) are sickened or die, that reveals evidence of tampering, increasing the likelihood of getting caught and preventing further profits—an undesirable outcome to economic adulterers. But the perpetrators in the melamine incidents were not aware of the serious consequences of using a mixture of melamine and cyanuric acid, illustrating a central point. Adulteration puts everyone (industry, regulators, consumers—society as a whole) at the mercy of the adulterer’s scientific knowledge (or lack thereof). As only that party knows what has been added, adulteration introduces new and a priori unknown risks into the food supply without any oversight by anyone, including industry and regulators. Through adulteration, the identity of the food is altered and food safety collapses into that single element: the adulterer’s knowledge.

It is important to note that most (if not all) of the egregious examples above were revealed only by adverse reactions in consumers and pets (i.e., illness or death), as routine QA checks were unable to detect the adulteration in these cases. And it is likely that adulteration will continue to slip through routine QA checks as the adulterer aims to remain undetected. Hence, the central danger of economically motivated adulteration is that standard systems such as Hazard Analysis and Critical Control Points, Good Manufacturing Practices, ISO 22000, the Global Food Safety Initiative, British Retail Consortium and similar food safety plans and safety nets dangle empty and will not catch unexpected risks unless the authenticity of the food ingredient can be established and confirmed.

Establishing Authenticity: The Role of Standards
Of course, the critical nature of existing quality systems should not be discounted; they are indispensable to ensuring the safety and quality of our food. However, as we cannot test products into safety (production processes have to be designed for safety), we also cannot rely only on quality systems and safety nets built on the assumption of predictable threats and risks. In an increasingly complex and global food supply chain, the collective response of industry, government and others must evolve to incorporate new, undefined threats. An essential supplement to quality and safety systems that anchors them in reality is periodic testing to verify the authenticity of food ingredients—proof that food ingredients are what they say they are. Knowledge of food ingredients’ authenticity—their identity, quality and purity—should be considered fundamental, yet it is often taken for granted. This is where public quality standards can serve both industry and consumers.

The Food Chemicals Codex (FCC), published by the U.S. Pharmacopeial Convention (USP), is a compendium of internationally recognized standards designating the identity, quality and purity of more than 1,100 food ingredients. Its scope is broad—any food ingredient legally marketed anywhere in the world is eligible to be included in the compendium. In addition to quality specifications, FCC provides test methods suitable for the verification of these standards and, in numerous cases, reference materials as well, which allow manufacturers or regulators to verify the appropriate execution of the test method. These standards are developed in collaboration with industry, under a public review process that invites comments from all stakeholders to arrive at the best possible specifications. Such food ingredient standards are useful in a variety of ways, including maintaining regulatory compliance and conducting day-to-day business transactions as part of contracts between food manufacturers and ingredient suppliers. Overall, they can help keep parties honest and ensure everyone is speaking the same language on the same level playing field and maintaining the same expectations regarding quality. In a globalized food industry where suppliers of varying sizes and sophistication are relied upon for needed food ingredients, public standards provide real benefit and could be one of the cornerstones for industry’s self-regulation.

Enhancing Standards: Testing for Modern-Day Realities
One of the most powerful uses of quality standards is in testing for identity. To keep pace with the threat of adulteration, the development of more specific identity testing for food ingredients is a central focus in USP’s efforts regarding food ingredient standards. The rationale for this approach is as follows: Rather than adding tests for each potential adulterant for a food ingredient, a more efficient (and effective) approach is to better define what something is (as opposed to what it isn’t). Chasing whatever the next food adulterant will be always puts industry, regulators and others one step behind unscrupulous food adulterers, who are constantly engaged in finding new ways to gain illicit profit. USP’s efforts to combat adulteration include modernizing existing FCC monographs with better identity tests, particularly for those food ingredients deemed to be at higher risk of adulteration, and incorporating more specific tests when developing new monographs. Particular categories of food ingredients may be at greater risk, based on such considerations as consumer demand, economic value and the existence of scientific/analytical testing weaknesses that may be exploited.

USP formed a Food Ingredients Intentional Adulterants Expert Panel in 2009 to examine, among other critical issues, food ingredients that are more vulnerable to adulteration and to develop work plans to address these threats. At-risk food ingredients identified by the panel include novel sweeteners such as rebaudioside A (stevia), infant formula ingredients, spices, cocoa powder, meat powder, rice protein isolate and others. In many of these categories, USP has proposed new food ingredient standards since the expert panel began its work. The latest edition of the food ingredient compendium, FCC 8, will be released in March 2012 and incorporates much of this work. The expert panel has also commissioned some exciting larger-scale projects, including a Food Fraud Database compiling published instances of food adulteration over the past 30 years, which will be used to guide USP’s future work in this area and as a resource to industry’s risk management efforts.

The Bottom Line: What We Don’t Know Can Hurt Us
Economically motivated adulteration poses a host of risks—from business, legal and public health perspectives. The sobering reality is that every safeguard in place in our global multibillion-dollar food industry is null and void if one cannot confirm the authenticity of the food ingredients that make up a product. Once an unknown substance enters the food supply chain, everything we do to manage risk goes out the window, and we can only hope for the best. In an industry that touches us all, with so much to lose, that simply cannot suffice.

Markus Lipp, Ph.D., is the director, food standards, at USP.