MANAGEMENTBy Peter Overbosch, Ph.D.<strong>Food</strong> <strong>Safety</strong> 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
MANAGEMENTcertain spices. As no acceptable level hadbeen determined, all products containingSudan Red at any level were recalled.This included products that could belinked, through traceability, to the issue,even if no Sudan Red could be detectedin them anymore. It is questionablewhether homeopathic dilutions of asuspected hazard continue to pose anactual risk, but the case was handled onan absolute zero-tolerance basis. For ourcurrent purposes, we will term this approach“hazard based.”Whereas the Sudan Red case had conventionaltoxicological considerations(based on very little available evidence,which was where most of the problemoriginated) as the main driver, a fewother cases seem to go well beyond that.Imports of American long-grain ricecame to a halt in 2006, when traces ofgenetically modified LL601 were detected.3 “The protein found in LLRice 601is approved for use in other products.It has been repeatedly and thoroughlyscientifically reviewed and used safely infood and feed, cultivation, import andbreeding in the U.S. as well as nearly adozen countries around the world,” arguedU.S. Secretary of Agriculture MikeJohanns, but Japan and the EuropeanUnion (EU) stopped import immediately.As ships with rice were still underwaywhen the issue became known, tests hadto be developed to analyze cargoes uponarrival. The proposed sampling and testingregime was significantly more likelyto pick up LL601 than a very sensitiveroutine Salmonella test in case of suspectedSalmonella contamination, althoughnobody would suggest that LL601 wasmore hazardous than Salmonella. Furthermore,EU Member States would notagree on point-of-entry acceptance testing,but continued to test once-clearedbatches when they arrived within theirborders. Adopting a hazard-based approachin the absence of an actual hazardis, in this case, explained by the EUpublic’s strong aversion to geneticallymodified organism (GMO) technology,which in turn guided authorities’ actions.The case of azo dyes in food—whichmust now be labeled by EU law so parentscan choose to avoid the product fortheir children—illustrates how public andpolitical perception may designate anadditive as a hazard in a case where theEuropean <strong>Food</strong> <strong>Safety</strong> Authority clearlywas very reluctant to go that far. Thelabeling obligation then effectively actsas a hazard-based preventive measure,and the hazard status of these additivesReduce cost and save time!LaMotte introduces a new breakthroughin microbiological testing. BioPaddlesare flexible dual-sided agar paddles eachcontaining microbe-specific mediaenclosed in a sterile vial. Identify andquantify microbes in air, water, soil or onany surface. BioPaddles don’t require anyother testing equipment—only a magnifierand warm place to incubate!• Free App! Helps identify colonies• Ready to use• Longer shelf-life thantraditional Petri dishes• No refrigeration needed• Simple incubation requirements• Unique design enhances colonymorphology characterizationFor more informationcheck out our website!See us at PittCon • Booth 1327PO Box 329 • Chestertown, MD 21620 • 800.344.3100www.lamotte.com/biopaddles.htmlhas become a self-fulfilling prophecy andis now a well-accepted “fact” in publicmedia. Much the same applies to the “Enumber”ingredients (chemicals permissibleas food additives in the EU). Thesystem was originally designed to assureconsumers about the safety of these ingredients,but public opinion has movedin the opposite direction and producersF e b r u a r y • M a r c h 2 0 1 3 29
- Page 4 and 5: February/March 2013Vol. 19, No. 1FE
- Page 6: Editor’s LetterWe at Food Safety
- Page 10 and 11: USDA Seeks Comments on ProposedFroz
- Page 12: TestingBy Katerina Mastovska, Ph.D.
- Page 15 and 16: Testingheat treatment, the toxins c
- Page 17 and 18: staying connectedto your data hasne
- Page 19 and 20: PROCESS CONTROL1. Scope2. Normative
- Page 21 and 22: SANITATIONapproach, 1, 2 while effe
- Page 23 and 24: SANITATIONis a matter of legal liab
- Page 25 and 26: Accreditationment undertaken by the
- Page 27: AccreditationFood Microbiological L
- Page 31 and 32: MANAGEMENTtook so long to be resolv
- Page 33 and 34: Choose ConfidenceChoose Confidence
- Page 35 and 36: Special advertising supplement pres
- Page 37 and 38: AccuracyQualitySafetyHACCP Monitori
- Page 39 and 40: THE SANITARY CHOICEFOR FOOD SAFETYT
- Page 41 and 42: Specialists in Food & BeverageSampl
- Page 44 and 45: PACKAGING(continued from page 34)fo
- Page 46 and 47: Animal Welfareand Food SafetyBy F.
- Page 48 and 49: Animals versus PlantsBefore discuss
- Page 50 and 51: Percent (between 0 to 1) / $100 spe
- Page 52 and 53: Despite developments in traceabilit
- Page 54 and 55: INGREDIENTSBy Rupa Das, M.Sc.Qualit
- Page 56 and 57: SEAFOODBy Gary P. Richards, Ph.D.,
- Page 58 and 59: SEAFOODfoods is essential to reduci
- Page 60 and 61: SEAFOOD(infectious and noninfectiou
- Page 62 and 63: Product ShowcaseShelf-Life Extender
- Page 64 and 65: Coupler BrakeForce Control Industri
- Page 66 and 67: Advertisers IndexAdvanced Instrumen
- Page 68 and 69: Allergens LabeledSanitation Verifie
- Page 70 and 71: Solutions for Today,Planning for To
- Page 72 and 73: keynote theatre special events2013
- Page 74 and 75: WORKSHOPS • TUESDAY, APRIL 30WORK
- Page 76 and 77: Sessions • WednESDAY, May 1SESSIO
- Page 78 and 79:
Sessions • WednESDAY, May 1SESSIO
- Page 80 and 81:
Sessions • ThurSDAY, May 2SESSION
- Page 82 and 83:
Exhibit hall — where solutions ar
- Page 84:
155 N. Pfingsten Rd., Suite 205Deer