Food Safety Magazine, February/March 2013

MANAGEMENTBy Peter Overbosch, Ph.D.Food Safety Management:Hazard- or Risk-Based?A variety of approaches tofood safety managementexists: Which is right for you?Hazard Analysis and Critical Control Points(HACCP) principles require identified andrealistic food safety hazards to be prevented,eliminated or reduced to acceptable levels.The first two options are straightforward,from a conceptual perspective. The result in both casesis—again conceptually—a complete absence of the hazard,which should be acceptable to everyone. Things get morecomplicated with the last option: “reduced to acceptablelevels,” because acceptability is a multifaceted concept.Risk-Based ApproachesTraditionally, acceptable levels of food contaminantshave been defined on the basis of scientific dose-responseinsights—leading to, for example, the establishment of“allowable daily intake” (ADI) limits for substances oftoxicological concern or of infectious dose for microbiologicalpathogens.This approach leads then to the adoption of (legal)limits, such as “absence in 25 g,” which is a more stringentrequirement than “absence in 10 g,” indicatingthat the relative risk of a negative outcome (illness) isdeemed lower. For our current purposes, we will term thisapproach “risk-based.” It is important to note that “riskbased”always implies that a certain level of risk, not zero,is deemed acceptable.Allergenicity has long been a special problem in thecontext of this approach, especially in “may contain”cases. The distinguishing factor in allergenicity is theextreme variability of individuals’ sensitivityto the material in question. Mostpeople are not sensitive at all, a fewpercent are and some may be extremelysensitive. Furthermore, in products that“may contain” a certain allergen, the ideais that the actual content may also varysignificantly. The situation therefore getsincreasingly complex. One approachthat individual food processors havetaken is to label their products as “maycontain everything that could be presenton the manufacturing site (or sitesif the same product is manufactured atmultiple sites).” In response, consumerssensitive to specific allergens have beenknown to “calibrate themselves againstthe market,” trying little bites of “maycontain” products to see if they have animmediate reaction. If not, they wouldconclude that this product could safelybe consumed now and in the future,counting on allergen levels to be effectivelyconstant in subsequent productionlots. Where existing products have beentransferred from one manufacturing siteto another, resulting in different actualallergen residue levels, this has sometimesproven to be an unreliable strategywith severe consequences. Simple “maycontain” labeling is therefore not a realrisk-based strategy, because it does notconsider the actual level of allergens inthe product, invites risky behavior on theside of consumers and makes no attemptto link dose to effect. Fortunately, moresystematic approaches like VITAL (VoluntaryIncidental Trace Allergen Labeling)1 make a thorough attempt to bringallergen labeling back into the fold ofscientifically valid, risk-based approaches.Hazard-Based ApproachesIncreasingly, however, very differentconsiderations are being included in theconcept of acceptability. The Sudan Redcase in the UK in 2004 is an example. 2In this case, the nonfood dye Sudan Redhad been found as a contaminant in28 F o o d S a f e t y M a g a z i n e