REGULATORY REPORT“...the critical natureof existing qualitysystems should not bediscounted; they areindispensable toindustrial oil has been sold as cookingoil, with devastating results. Such wasthe case in Morocco in 1959, when oliveoil was adulterated with lubricating oilused in jet engines, and in Spain in 1981,when hundreds of people died fromtoxic oil syndrome that resulted fromthe sale of denatured rapeseed“oil labeledas olive oil. More recentepisodes of adulterationhave includedmelamine in pet foodin 2007 (originatingfrom China but causingserious illness anddeaths of pets worldwide)and milk productsin 2008 (seriousillness and deathslargely in China of infantsand others), dioxinsin animal feed in2011 (Germany andthroughout Europe)and waste (gutter) oilrecycled and sold ascooking oil in 2010–2011 (China).Although it hasbeen written about extensively,melamine presents an interesting examplein that the chemical, by itself, is relativelynontoxic. In fact, it has been usedwidely as a feed additive to boost thediet of calves. In the 2007 and 2008 incidents,the melamine used was likelyscrap melamine containing cyanuricacid. When combined, the two compoundscan form a stable and insolublecomplex crystal that can block renaltubules, which was the route of harm forthousands of consumers. Had nonscrapmelamine alone been used, it likelywould have gone undetected. Herein liesthe ultimate risk of adulteration. In casesof economically motivated adulteration(as opposed to bioterrorism), the incentiveis purely profit; there is no intent toharm. When people (or animals) are sickenedor die, that reveals evidence of tampering,increasing the likelihood ofgetting caught and preventing furtherprofits—an undesirable outcome to economicadulterers. But the perpetrators inthe melamine incidents were not awareof the serious consequences of using amixture of melamine and cyanuric acid,illustrating a central point. Adulterationputs everyone (industry, regulators, consumers—societyas a whole) at the mercyof the adulterer’s scientific knowledge (orlack thereof). As onlythat party knows whathas been added, adulterationintroducesnew and a priori unknownrisks into thefood supply withoutany oversight by anyone,including industryand regulators.Through adulteration,the identity of the foodis altered and foodsafety collapses intothat single element: theadulterer’s knowledge.It is important to notethat most (if not all) ofthe egregious examplesabove were revealedonly by adverse reactionsin consumers and pets (i.e., illnessor death), as routine QA checks were unableto detect the adulteration in thesecases. And it is likely that adulterationwill continue to slip through routine QAchecks as the adulterer aims to remainundetected. Hence, the central danger ofeconomically motivated adulteration isthat standard systems such as HazardAnalysis and Critical Control Points,Good Manufacturing Practices, ISO22000, the Global <strong>Food</strong> <strong>Safety</strong> Initiative,British Retail Consortium and similarfood safety plans and safety nets dangleempty and will not catch unexpectedrisks unless the authenticity of the foodingredient can be established andconfirmed.ensuring the safety”and quality ofour food.”Establishing Authenticity:The Role of StandardsOf course, the critical nature of existingquality systems should not be discounted;they are indispensable toensuring the safety and quality of ourfood. However, as we cannot test productsinto safety (production processeshave to be designed for safety), we alsocannot rely only on quality systems andsafety nets built on the assumption ofpredictable threats and risks. In an increasinglycomplex and global food supplychain, the collective response ofindustry, government and others mustevolve to incorporate new, undefinedthreats. An essential supplement to qualityand safety systems that anchors themin reality is periodic testing to verify theauthenticity of food ingredients—proofthat food ingredients are what they saythey are. Knowledge of food ingredients’authenticity—their identity, quality andpurity—should be considered fundamental,yet it is often taken for granted. Thisis where public quality standards canserve both industry and consumers.The <strong>Food</strong> Chemicals Codex (FCC),published by the U.S. PharmacopeialConvention (USP), is a compendium ofinternationally recognized standards designatingthe identity, quality and purityof more than 1,100 food ingredients. Itsscope is broad—any food ingredientlegally marketed anywhere in the worldis eligible to be included in the compendium.In addition to quality specifications,FCC provides test methodssuitable for the verification of these standardsand, in numerous cases, referencematerials as well, which allow manufacturersor regulators to verify the appropriateexecution of the test method.These standards are developed in collaborationwith industry, under a public reviewprocess that invites comments fromall stakeholders to arrive at the best possiblespecifications. Such food ingredientstandards are useful in a variety of ways,including maintaining regulatory complianceand conducting day-to-day businesstransactions as part of contractsbetween food manufacturers and ingredientsuppliers. Overall, they can helpkeep parties honest and ensure everyoneis speaking the same language on thesame level playing field and maintainingthe same expectations regarding quality.18 F O O D S A F E T Y M A G A Z I N E
REGULATORY REPORTIn a globalized food industry where suppliersof varying sizes and sophisticationare relied upon forneeded food ingredients,public standardsprovide real benefitand could be one ofthe cornerstones for industry’sself-regulation.EnhancingStandards: Testingfor Modern-DayRealitiesOne of the mostpowerful uses of qualitystandards is in testingfor identity. Tokeep pace with thethreat of adulteration,the development of more specific identitytesting for food ingredients is a centralfocus in USP’s efforts regarding foodingredient standards. The rationale forthis approach is as follows: Rather thanadding tests for each potential adulterantfor a food ingredient, a more efficient(and effective) approach is to better definewhat something is (as opposed towhat it isn’t). Chasing whatever the nextfood adulterant will be always puts industry,regulators and others one step behindunscrupulous food adulterers, whoare constantly engaged in finding newways to gain illicit profit. USP’s efforts tocombat adulteration include modernizingexisting FCC monographs with betteridentity tests, particularly for thosefood ingredients deemed to be at higherrisk of adulteration, and incorporatingmore specific tests when developing newmonographs. Particular categories offood ingredients may be at greater risk,based on such considerations as consumerdemand, economic value and theexistence of scientific/analytical testingweaknesses that may be exploited.USP formed a <strong>Food</strong> Ingredients IntentionalAdulterants Expert Panel in2009 to examine, among other criticalissues, food ingredients that are morevulnerable to adulteration and to developwork plans to address these““An essential supple-”ment to quality andsafety systems thatanchors them in realityis periodic testing toverify the authenticityof food ingredients...”threats. At-risk food ingredients identifiedby the panel include novel sweetenerssuch asrebaudioside A (stevia),infant formula ingredients,spices, cocoapowder, meat powder,rice protein isolate andothers. In many ofthese categories, USPhas proposed newfood ingredient standardssince the expertpanel began its work.The latest edition ofthe food ingredientcompendium, FCC 8,will be released in<strong>March</strong> <strong>2012</strong> and incorporatesmuch of thiswork. The expert panel has also commissionedsome exciting larger-scale projects,including a <strong>Food</strong> Fraud Databasecompiling published instances of foodadulteration over the past 30 years,which will be used to guide USP’s futurework in this area and as a resource to industry’srisk management efforts.The Bottom Line: What We Don’tKnow Can Hurt UsEconomically motivated adulterationposes a host of risks—from business, legaland public health perspectives. Thesobering reality is that every safeguard inplace in our global multibillion-dollarfood industry is null and void if one cannotconfirm the authenticity of the foodingredients that make up a product.Once an unknown substance enters thefood supply chain, everything we do tomanage risk goes out the window, andwe can only hope for the best. In an industrythat touches us all, with so muchto lose, that simply cannot suffice. nMarkus Lipp, Ph.D., is the director, food standards,at USP.F E B R U A R Y n M A R C H 2 0 1 2 19
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