Food Safety Magazine, October/November 2012

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The Online ResourceConnectingYou with Food Safety SolutionsSearch a growing online databaseExplore products in categories like:• Analytical Instruments & Systems• Audits/Certifications/Training• Consultants• Detection Systems• Environmental Monitoring• Facilities• Inspection Systems• Laboratory Services• Pest Control• Sanitation & Hygiene• Software• Test Kits• Testing InstrumentsNew products added regularlyThe Online Marketplace for Food Safety SolutionsPowered by Food Safety Magazine

October/November 2012Vol. 18, No. 5FEATURES50 Cover StoryFrom Soup to Nuts: Regulatory,Legal and Communications IssuesInvolved in Food RecallsBy Marialuisa Gallozzi, Miriam Guggenheim,Suzan Charlton, Sally Squires and Christopher Pruitt58 Category: ProduceThe Leafy Greens Marketing Agreement:5 Years LaterBy April Ward62 Case StudyCostco Wholesale: Food Safetyfrom the Top DownBy Food Safety Magazine68 Spotlight: Meat and PoultryBacteriocin-Producing StarterCultures for SalamiBy Lone Andersen, M.Sc.74 Category: Dry IngredientsQuality Assurance and Food Safetyof Powdered IngredientsBy Herbert Weinstein, Ph.D.COLUMNS10 SanitationIntegrated Pest Management inFoodservice EstablishmentsBy Michael Swoyer, M.S.A.14 TestingForeign Object Detection:Integration in Food ProductionBy Karl Heinz Wilm18 InternationalRainforest Alliance CertificationBy Denis Twinamatsiko20 SanitationPersonal Hygiene: A Basic PrerequisiteProgram for Ensuring Food SafetyBy Richard F. Stier28 PackagingAttaining Clearances forFood-Packaging MaterialsBy George MiskoDEPARTMENTS6 Editor’s Letter8 News Bites79 Product Showcase83 Advertisers IndexEditorial Advisory BoardDaniel W. BenaPepsiCo Beverages InternationalReginald W. BennettCFSAN, U.S. FDARobert E. Brackett, Ph.D.National Center for Food Safetyand TechnologyJohn N. Butts, Ph.D.Land O’FrostBrian CampbellKroger ManufacturingLarry CohenSaputo Cheese U.S.A.Michael M. CramerWindsor FoodsBeth Ann Crozier-Dodson, Ph.D.Chestnut LabsJonathan W. DeVries, Ph.D.General Mills/Medallion LabsWilliam FisherInstitute of Food TechnologistsRussell Flowers, Ph.D.Silliker, Inc.Veny GapudFieldale FarmsKathy GombasCFSAN, U.S. FDAJim Gorny, Ph.D.CFSAN, U.S. FDADonald J. GrahamGraham Sanitary Design ConsultingPaul A. Hall, Ph.D.Flying Food GroupMargaret Hardin, Ph.D.IEH Laboratories & Consulting GroupLarry KeenerInternational Product Safety ConsultantsHuub L.M. LelieveldGlobal Harmonization InitiativeAnn Marie McNamara, Ph.D.Jack in the Box, Inc.Martin MitchellCertified Laboratories/Refrigerated Foods AssociationDoug PearisoContemporary Process Solutions LLCRobert Powitz, Ph.D., M.P.H., R.S.R.W. Powitz & AssociatesScott M. Russell, Ph.D.University of GeorgiaThomas M. SauerWells EnterprisesRichard F. StierConsulting Food ScientistDarryl SullivanCovance LaboratoriesJohn G. Surak, Ph.D.Surak and AssociatesAlexandra Veiga, Ph.D.ITQB-UNL and EFFoSTDon L. Zink, Ph.D.CFSAN, U.S. FDA4 F o o d S a f e t y M a g a z i n e

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News BitesFSIS ClarifiesSalmonellaTesting for PoultryThe U.S. Department ofAgriculture Food Safety andInspection Service (FSIS) haspublished a notice instructinginspectors on whichyoung-chickenproducts are eligiblefor carcasssamplingin its Salmonellaand Campylobacterverification testingprogram.All young chickens—includingCornish game hens,broilers, fryers and roastingchickens—are eligible, FSISsaid. However, capons, hens,fowl, baking chickens, stewingchickens, cocks or roosters arenot subject to Salmonella andCampylobacter verification testing.The notice can be read inits entirety at www.fsis.usda.gov/OPPDE/rdad/FSISNotices/57-12.pdf.Invisible Things—Essential Reading forFood Safety InspectorsInvisible Things by Yasmine Motarjemi, anexpert in food safety and food safety management,was written to implore food safety regulators tounderstand that globally harmonized food regulationsmust be based on science and not assumption.Currently, Invisible Things (Les Invisibles) is availableonly in French; to order a copy, go towww.elstir-editions.ch. For additional information,you can contact Yasmine atYasmine.motarjemi@bluewin.ch.Nominations Open for U.S. Dairy Sustainability AwardsThe Innovation Center for U.S. Dairy ® , established under the leadership of dairy farmers, isnow accepting nominations for the second year of the U.S. Dairy Sustainability Awards. Theaward program recognizes dairy farms, businesses andcollaborative partnerships for their contributions tohealthy people, healthy products and a healthy planet,and showcases the ways that sustainability makesgood business sense.Nominations are open through November 15, 2012,to all segments of the U.S. dairy value chain—from farm to table—for the following categories:• Outstanding Dairy Farm Sustainability• Outstanding Dairy Processing & Manufacturing Sustainability• Outstanding Achievement in Renewable Energy• Outstanding Achievement in Energy EfficiencyAn independent panel of judges will evaluate all nominations based on the program’s orproject’s results as measured by triple-bottom-line success—economic, environmental and social.Judges also will assess the potential for adoption of the practices by other dairy farms andbusinesses; demonstrated learning, innovation and improvement; and scalability.For more information or to nominate, go to USDairy.com/Sustainability/Awards.Food Protection Training ProgramEarns AccreditationThe International Food Protection Training Institute hasannounced that its signature training program, Applied Science,Law, and Policy: The Fellowship in Food Protection, hasreceived accreditation from the American National StandardsInstitute.The training institute, an initiative of the Battle Creek, MI–based Global Food Protection Institute, is a leader in deliveringcareer-spanning, standards-based food protection training. ItsFellowship in Food Protection program, established in 2010,is designed to provide experienced food regulatory professionals,from all areas of food protection, withcritical-thinking, problem-solving and decisionmakingskills within the framework of foodregulatory science, law and policy.Neogen’s Soleris ®TVC Test Now AOACApprovedNeogen Corporation has receivedapproval from the AOAC Research Institutefor its rapid and accurate test forthe total viable count (TVC) of microorganismsin a sample. The test detectsmicroorganisms in as little as 4 hours andtakes only 24 hours to register a negativeresult. Conventional methods can take up to2 days.Acrylamide-Preventing YeastReceives GRASStatus from FDAFunctional TechnologiesCorp. has reported that theU.S. Food and Drug Administration(FDA) has acceptedtheir generally recognizedas safe (GRAS) noticethat was submitted earlierthis year for its acrylamidepreventingyeast strains.In its GRAS submission,the company provided experimentaldata to supportits claim that their proprietaryacrylamide-preventingyeast should be GRAS. Thisyeast is now included onFDA’s list of GRAS substances,joining such productsas baker’s yeast and othercommercial yeasts.8 F o o d S a f e t y M a g a z i n e

Bringing Roka to your backyard.Roka Bioscience is taking to the road, showcasing the most advancedfood safety testing technology at locations across the country.Why a tour – Your time is valuable, sowe’re bringing the Atlas System to you.What the tour offers – A hands-onAtlas System demonstration plus aninteractive education on the advantagesof Roka’s unique molecular technology.Who should attend – Anyoneinvolved in food pathogen testing.What drives us – Our new 40-foot,custom-built conversion truck –featuring a demonstration room withthe Atlas System as well as a privatepresentation and meeting room.The journey starts now! Visit www.atlasontour.com for more details.We’re Roka. And we’ll help you get there.© 2012 Roka Bioscience, Inc.MAOTPUB07121.855.ROKABIO | www.rokabio.comThe Atlas System is manufactured by Gen-Probe Incorporated. Roka molecular technology is licensed from Gen-Probe Incorporated.

SANITATIONBy Michael Swoyer, M.S.A.Integrated Pest Managementin Foodservice EstablishmentsThe consequences of lax pestmanagement can bedevastatingFoodservice establishments typically dread thethought of pests, as well they should. Not onlycan pests give you low scores on inspections, theyalso can cost you money on contaminated foodsthat must be thrown away—and drive customersright out the door. It is easy to see why pest managementis a part of almost any foodservice establishment maintenance,but is it the right kind of pest management? Itis becoming increasingly clear that the most effective,healthiest and, in the long run, cheapest method of controllingpests is integrated pest management (IPM).IPM is the use of integrated techniques, such as exclusion,sanitation and baiting, to control pests, which areany creatures you don’t want inside your food establishment(rats, mice, cockroaches, flies, etc.), utilizing managementtools, such as reports on pest location, pest type,needed repairs and processes that get action when actionis needed. It utilizes the least toxic methods that will getthe job done. (There is no sense in poisoning ourselveswhen we’re trying to poison something else, is there?) It isknowing your pest so that you can use its own habits andbehaviors against it.Eliminating Vacancies at the Roach MotelFoodservice establishments attract pests. Food, waterand shelter, the three things any pest needs to survive,are all present. Traditionally, cockroaches, for example,are treated monthly by a “crack and crevice” type of application.This is where the exterminatorsprays any suspicious-looking areas witha pesticide to kill the cockroaches. Sincecockroaches like to hide in narrow areasthat touch their bodies both above andbelow, special attention is paid to cracksin the wall, gaps between shelving, etc.The two species of cockroaches that normallyinfest foodservice establishments,the German and the brown-banded, areboth colonizers. Once they find a placeto their liking, they have no reason toleave until you give them one. Othertypes of roaches, such as the Orientaland the American, are invaders, choosingto come inside only when conditionsoutside are unfavorable.One of the major problems withspraying is that sprays don’t just go intocracks and crevices. They can spreadand cover food, food contact surfacesand other areas. In addition, this typeof treatment kills only cockroaches nearthe surface, not those that have hiddendown deep. Flushing agents withinthe spray can cause the cockroaches tospread to previously uninfected areas.Additionally, spraying does not penetrateegg cases to kill eggs. When those eggshatch, the baby cockroaches eat anythingthey can, grow, reproduce and the cyclebegins all over again. You might say thatjust spraying is like farming cockroaches.You spray (harvesting) the cockroaches,emptying out the environment, whichleaves plenty of room and food to let allthe cockroaches you didn’t kill thrive.And the cycle starts up again.Let’s say you wanted to begin an IPMprogram. You might start by consultingwith your pest management professional(PMP, formerly “the exterminator”) anddoing a thorough cleaning. This helpsremove food sources for the cockroaches,dead cockroaches and egg cases (also afood, and an allergen, source) as wellas roach feces and body parts (“frass,”which looks a little like pepper sprinkledaround cracks and crevices and is also a10 F o o d S a f e t y M a g a z i n e

TestingBy Karl Heinz WilmForeign Object Detection:Integration in FoodProductionPhysical contaminationhazards can cause seriousfood safety issuesStones in lentils or beans may damage a tooth.Years ago, home cooks checked lentils for stonesto protect their family from any harm. The numberof occurrences of foreign materials in food isnow becoming less frequent, and consumers areless used to checking primary foodstuffs for stones, sharpmetal pieces or bones, as the food industry continuouslyimproves the safety and quality of their products.However, this trend also decreases public acceptancefor such occurrences to a level that approaches “zerotolerance.” Any incidence of foreign material harms theconsumer, undermines confidence in the brand andgenerates headlines. The name of the producer and thegrocery chain that sold the article are widely reported.Current Regulations around the WorldU.S. Food and Drug Administration (FDA) Regulations onAdulteration Involving Hard or Sharp Foreign ObjectsA physical hazard in food is any extraneous object orforeign matter that may cause illness or injury to the consumer.Consumers do not expect hard or sharp componentsin foods where kernels are normally removed, such ascherries or pitted olives. Hard or sharp pit fragments areunexpected and may cause serious harm if ingested.FDA considers a product adulterated if it containsa hard or sharp foreign object that measures 7 mm to25 mm in length, and is ready-to-eat or requires onlyminimal preparation steps that would not eliminate, invalidateor neutralize the hazard prior toconsumption. 1Foreign objects smaller than 7 mmrarely cause trauma or serious injury exceptin special high-risk groups, such asinfants, surgery patients and the elderly. 2Glass is the most frequently reportedforeign material in food to cause illnessor injury.In 1995, the U.S. Department of AgricultureFood Safety and Inspection Serviceconcluded that bone particles lessthan 1 cm are not a safety hazard; particles1–2 cm are low risk; and particlesgreater than 2 cm have the potential tobe a safety hazard and may cause injury. 3Foreign material other than bonemay pose a potential hazard, and eachinstance should be considered on a caseby-casebasis, irrespective of size.FDA Health Hazard EvaluationBoard conclusions in cases of foreignmaterials (1972–1997) found that 56percent of objects 1–6 mm in size mightpose a limited acute hazard. For objectsgreater than 6 mm, only 2.9 percent werejudged to present no hazard.Section 402(a)(3) of the Food, Drugand Cosmetic Act prohibits the distributionof foods that may contain repulsivematter, considered as filth, such as insects.Most consumers find the presenceof any visible filth contaminant, such ashair in a food product, nauseating. 4Canadian RegulationsCanadian regulations support theFDA concept based on the 7 mm to 25mm size criterion. 5 These limits are notfollowed by Europe in its regulations onthe hygiene of foodstuffs.EU Regulations on Physical Hazards inFoodsAll food products sold in the EUmust comply with regulations on thehygiene of foodstuffs, which demand,above all, that these products must besafe. 6 All potential biological, chemical14 F o o d S a f e t y M a g a z i n e

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Testingor physical hazards must be prevented,eliminated or brought down to an acceptablesafety level. To achieve such alevel of safety, food processors, packagersand distributors should use the HazardAnalysis and Critical Control Points(HACCP) concept, complemented witha quality control system, such as GoodManufacturing Practices (GMPs) or ISO9000. European regulations introducedthe HACCP concept, which obligesfood producers to install safety measuresto avoid physical hazards and maintaindocumentation of all events. 7–9Hard or sharp foreignobjects in foodsmay cause injury,including lacerationsof the mouth, throat,stomach and intestine.Safety concepts, suchas HACCP, are beingintroduced globally.They must cover allstages of the productionprocess, fromprimary production toretail sales.Types of PhysicalHazardsThe type of foreign objects in foodaffects the technology needed to detectit:Glass: Sharp glass contaminationoften occurs during filling processes inglass containers if a container is accidentallybroken. Another source, but lessfrequent, is light bulbs broken duringbuilding maintenance.Metal: Sharp metal objects may includescrews and equipment splinters,blades, broken veterinary needles, fragmentsand clippings of prior processingprocedures.Plastics: Soft and hard plastics maycome from packaging material of an intermediaryproduction phase.Wood: Wood splinters may have theirorigin at the farm or may come fromhandling wooden pallets.Stones: Small stones are common incrops like peas or beans contaminatedduring harvest.“A physical hazard infood is any extraneousobject or foreignmatter that may causeillness or injury to theconsumer.”Classification of Foreign Materialsin FoodEvery type of food processing hasits own specific and potential hazards.Evaluation of the type of product, theintended market for the product andother factors must be considered to determinethe risk category of a possiblephysical hazard.The Canadian Food Inspection Agencyrates the likelihood of occurrence ofphysical hazards based on the level ofcontrol a food processor can exercise to5, 10eliminate the risk:Low risk: If goodcontrol measures havebeen established, butminor infractionsoccur.Medium risk: Ifsome control measureswere established, butinconsistencies occur.High risk: If little orno control was established,major and criticalinfractions occur.Foreign materialmay occur naturally inraw materials and foodingredients, such as stones in lentils orbones in fish or meat.It may be added unintentionally duringprocessing due to poor equipment,as a result of maintenance work or constructionin the vicinity of an operatingproduction line. However, it may alsobe deliberately added to the food duringprocessing or at grocery retail as an act ofblackmail, revenge or mental disorder.Controlling Physical HazardsIt is necessary to implement GMPs,ISO 9000 and ingredient specifications,such as determining that containers areweld-sealed to exclude staples and plasticor twist ties. A vendor’s certificationfor raw materials must include physicalhazard controls. The use of foreign materialscreening equipment and employeetraining throughout the whole processingchain is strongly recommended.An effective physical hazard identificationprogram requires detailedinformation for every step of the foodprocessing line. To obtain such information,the production processes must beclosely observed during all phases oftheir operation. Procedures to controlphysical hazards can be determined withsuch observations, and a Control Pointcan be included in the HACCP plan.It is strongly recommended to bemore stringent than the required 7 mmto 25 mm rule of FDA. A customer willbe outraged if he finds a 30-mm plasticpiece in a jar of pasta sauce or 5-mmhard starch lumps in baby food. Fruitstones, flavor lumps, bone chips, metalfragments, broken injection needles,shotgun pellets, pieces of packaging,stones, glass, pit fragments, insects orother filth materials are serious problems.Such foreign materials representbadly maintained facilities and equipment,improper production proceduresand poorly conducted employee training.Any and all are a potentially lethalblow to consumer trust.Points of Origin and HACCPCorrective StepsControl methods include raw materialinspection and specification, vendor certificationand letters of guarantees, metaldetectors, X-ray technology, effective pestcontrol at the facility, preventive equipmentmaintenance and proper sanitationprocedures. Also important are propershipping, receiving and storage practicesas well as tamper-proof or tamper-evidentpackaging.The food categories, in decreasingorder of complaint frequency, are pastries,soft drinks, vegetables, infant foods,fruits, cereals, fish, chocolate and cocoaproducts. 11Of 10,564 cases of foreign object injuriesin children included in the Susy SafeProject Registry, 26 percent were due toa food item, resulting in complicationsand prolonged hospitalization. Boneswere the most commonly retrieved foodforeign object, while nuts were most frequentlyassociated with complications.The critical group ranging from 2 to 3years of age requires special food surveillance.1216 F o o d S a f e t y M a g a z i n e

TestingSpecific characteristics of foreignbodies associated with increased hazard,such as size, shape, hardness, pliabilityand elasticity, must be better defined toidentify risky foods for children up to 4years of age. Nuts and seeds are one ofthe most common food items leadingto injuries in children. Control of thehazard level of various foods should beimproved, and warning labels on highriskfoods are suggested. 13Medical reports on life-threateningincidents of physical hazards in foodare plentiful. Several medical reportsunderline the severity of swallowing foodcontaining sharp objects. Although mostpass harmlessly through the gastrointestinaltract and conservative managementis generally recommended, 10 to 20 percentrequire nonoperative interventionsand approximately 1 percent requiresurgery. An estimated 1,500 deaths occurannually from foreign object ingestion inthe U.S. 14Most upper gastrointestinal foreignobjects are related to food ingestion, andmeat products are most often found tobe the origin of such events. 15The removal of sharp foreign objectsfrom the esophagus can be dangerousand challenging. Hyun et al. 16 describeproper apparatus and appropriate techniquesthat should be employed to avoidlife-threatening complications. Theseauthors present a procedure for recoveringfish bones from the esophagus.The types of foreign-object swallowingincidences in children include coins(57%), button batteries (22%), sharpobjects (12%), chicken bones (2.3%) andothers (6.7%). 17Preventing Common PhysicalHazardsCare taken to protect the consumercovers bulk food production, portionedpackaged foods at grocery stores and fastfood. The complete production chainmust identify small particles of metal,glass, wood, plastic fragments, stones andother foreign objects, such as moths andbeetles, that hurt the consumer or causea nauseating reaction. Controls shouldinclude the following:• Inspection of raw materials and ingredients,looking for field contaminants• Provision of good storage facilities,usage of lamp covers to avoid bulbbreakage and maintenance ofeffective pest control• Development of specifications andcontrols for all ingredients andcomponents• Effective detection and eliminationsystems for physical hazards, such asmetal detectors or magnets to removemetal particles; use of X-ray and lowpowermicrowave systems to detectnonmetallic materials• Periodic training of employees engagedwith shipping, receiving, stor-(continued on page 81)O c t o b e r • N o v e m b e r 2 0 1 2 17

International Food SafetyBy Denis TwinamatsikoRainforest AllianceCertificationThis is one in a seriesof People, Planet,Prosperity and the FoodChain (P3FC) articles,essays and commentsfrom assorted authors.All articles in the seriesaddress the challenges ofproducing safe, nutritiousand affordable food ina profitable way withoutdamaging our planetor exploiting our fellowhumans. All participantsare volunteers and foodprofessionals, comingfrom diverse employmentsectors and from aroundthe globe. If you areinterested in contributingan article to the P3FCseries, please send ane-mail to the lead editor:katherine.flynn@safeconsortium.org.Ten principles for sustainabilityand safetyWith the current world population at 7billion, it is of paramount importancethat efforts geared toward satisfyingthe needs of society for sustainablefood quality, safety and securityshould be promoted. Sustainable agriculture is the wayto go if we are to produce sufficient food to match thegrowing population and, at the same time, mitigate theeffects of climate change.Rainforest Alliance (RA) certification is one of thecertifications that promote sustainable agriculture practices.The RA works to conserve biodiversity and ensuresustainable livelihoods by transforming land-use andbusiness practices, and consumer behavior. I have beeninvolved with RA certification through my work witha tea-growing and export company in Uganda (EastAfrica). The company is composed of six tea estates(with five processing factories) spread along the legendaryRwenzori mountain ranges. Having installed qualityand food safety management systems, we decided topursue RA certification to improve overall sustainabilityin the tea estates. We have been energized by arecent report released by the International Center forTropical Agriculture entitled “Future Climate Scenariosfor Uganda’s Tea Growing Areas,” which revealed thatclimatic suitability of much of Uganda’s tea-growingareas would decline significantly by 2050. This reportwas a wake-up call for everyone involved in Uganda’stea sector.RA certification hinges on the Sustainable AgricultureNetwork Standard represented by the following 10principles:1. Management System: Social andenvironmental management systems arein place so that auditors can confirmthat estates are operated in compliancewith the Sustainable Agriculture NetworkStandard and national legislations.2. Ecosystem Conservation: Weconserve existing ecosystems and aid inthe ecological restoration of critical areas.We protect waterways and wetlands fromerosion and contamination, prohibit loggingand other deforestation, maintainvegetation barriers and prevent negativeimpacts on natural areas outside estates.3. Wildlife Protection: Our estatesserve as refuges for wildlife. We alsoeducate our workers and neighboringcommunities about the importance ofwildlife protection.4. Water Conservation: We keeptrack of water sources and consumption.We hold proper permits for water use;we treat wastewater and monitor waterquality.5. Working Conditions: The companystrives to ensure good workingconditions for all employees, as definedby such international bodies as the InternationalLabour Organization. Forcedand child labor and all forms of discriminationand abuse are prohibited, andworkers are aware of their rights throughtheir membership in labor unions.6. Occupational Health: We haveoccupational health and safety programsto reduce the risk of accidents.Workers receive safety training, and thecompany provides necessary protectivegear and ensures that farm and factoryinfrastructure and equipment are in goodcondition and pose no danger to humanhealth.7. Community Relations: The companystrives to be a good neighbor andinform surrounding communities andlocal interest groups about its activities.8. Integrated Crop Management:There is no use of banned agrochemicalson estates. The company uses the safest18 F o o d S a f e t y M a g a z i n e

International Food Safetyproducts available and uses every possiblesafeguard to protect human healthand the environment.9. Soil Conservation: The companyuses measures aimed at long-term soilimprovements through prevention oferosion and fertilization based on croprequirements and soil characteristics.10. Integrated Waste Management:Each estate has an integrated wastemanagement program in place aimedat managing wastes through recycling,reducing consumption and reuse. Wasteis segregated, treated and disposed of inways that minimize environmental andhealth impacts. Workers are educatedabout properly managing waste on theestates and in their communities.We maintain patches of naturalforests within the tea estates. This hashelped us lower costs because we nowrely more on natural ecosystem processesfor crop care. We have also identifiedforest patches as one way to conservebiodiversity.With an internal control systemas part of our management system,documentation is helping us predictlong-term tea production patterns. Internationaltea buyers are also showinga preference for RA-certified teas, oneof them being Lipton (Unilever), whichis committed to sourcing all of their teafrom RA-certified estates by 2015.With our RA certification in additionto quality and food safety managementsystem certifications, we are doing ourpart in making sure that consumers ofour tea worldwide enjoy a safe cup oftea without compromising the needs offuture generations.Through RA certification, we haveadopted the eleventh commandment ofWalter Lowdermilk, one of the pioneersof resource conservation:“Thou shalt inherit the holy earth as afaithful steward, conserving its resources andproductivity from generation to generation.Thou shalt safeguard thy fields from soilerosion, thy living waters from drying up, thyforests from desolation and protect hills fromovergrazing by the herds, that thy descendantsmay have abundance forever.If any shall fail in this stewardship of theland, thy fruitful fields shall become sterilestony ground of wasting gullies, and thy descendantsshall decrease and live in poverty orperish from off the face of the earth.” WalterLowdermilk, Jerusalem, 1939 •P3FC Editorial Note: We urge other foodand beverage companies to consider meetingthe laudable goals of the Rainforest Alliance,in which economic viability is coupled toenvironmental protection and social equity.Denis Twinamatsiko, B.Sc., is astandards coordinator. He holdsa B.Sc. (Honors) in food science &technology from Makerere Universityin Kampala.The AIB Food ProtectionAdvantageGFSIAuditSchemesAIBInspectionAIBFoodProtectionEducationAIBLeverage the synergies of the best globalLet AIB provide theINTEGRATED single-source solutionto your Food Protection needs.Food Protection products and services to loweryour risk and protect your company’s brands800-633-5137 www.aibonline.orgO c t o b e r • N o v e m b e r 2 0 1 2 19

SANITATIONBy Richard F. StierPersonal Hygiene: A BasicPrerequisite Program forEnsuring Food SafetyManagement commitmentessential for employeehygiene successPersonal hygiene is (or should be) an integralpart of the food quality and safety for eachand every food processor. In the United States,Current Good Manufacturing Practices inManufacturing, Packing or Holding HumanFood (better known as cGMPs) found in 21 CFR Part110:10 includes a section entitled “Personnel.” The elementswithin this section may be found in “Personnel,”p. 22, and include disease control, cleanliness, trainingand supervision. The Codex Alimentarius Food Hygienedocument includes similar guidelines (see “Section 7— Establishment: Personal Hygiene,” p. 23). All thirdpartyaudits, both those approved by the Global FoodSafety Initiative (GFSI) and private audit schemes,also include personal hygiene requirements. One ofthe things that many food safety professionals likeabout the U.S. GMPs is that this is an interpretativeregulation—it allows the food processor leeway to meetthe spirit of the law. In other words, there are differentways to comply with the regulation. On the otherhand, there are those who feel that the GFSI-approvedaudit schemes, with the exception of FSSC 22000, aretoo prescriptive. The company must do it GFSI’s wayor they are in violation.Let’s take a look at what makes up a company’spersonal hygiene program using the GMPs as a guidelineand the steps that food processors should take toprotect their products. Operators must understandthat personal hygiene is more than justrules for the workers. Plant managementmust develop, document and implementthe necessary procedures, provide thenecessary tools and equipment, set anexample and provide the workforce withnecessary training so that they understandwhat is expected of them.Disease ControlThe object of this is clearly defined inthe GMPs. Food processors should notallow any worker who is sick or has openwounds in a food-handling environment,especially if “there is a reasonablepossibility of food, food-contact surfacesor food packaging materials becomingcontaminated; [that worker] shall be excludedfrom any operations that may beexpected to result in such contaminationuntil the condition is corrected.” In otherwords, food plant workers themselvesshould not pose a risk of contaminationof food. In the U.S., enforcement ofthis falls on both management and lineworkers. Training programs must addressthis issue. Workers should be instructedto notify management if they are sickor injured, and cannot handle foods.Managers should also have the trainingand observation skills to notice whethersomeone is injured or ill. This is one areawhere plant management can go fartoward ensuring enforcement. Manyfood plant workers are hourly wage earners,so being sick or injured could costhours and money. If plant managementcreates a program whereby someone whois ill can be assigned to a task where heor she is not handling food, they will bemore prone to notify management ratherthan try to hide their illness.Worker health is handled differentlyin other parts of the world. In manycountries, especially in Asia, foodhandlers are often given a battery oftests every year. These tests may include,but need not be limited to, blood tests,stool samples for intestinal parasites and20 F o o d S a f e t y M a g a z i n e

ELEVATECONFIDENCEIN FOOD SAFETYConfi dence means knowing your lab is delivering accurate, consistent,and timely results. We listen carefully to customers’ needs, both presentand future, engaging in lab-bench to lab-bench scientifi c collaborations toattack many of the food supply chain’s biggest challenges.Agilent’s comprehensive product and service solutions address thediscovery and measurement of both chemical and biological contaminantanalysis in current and emerging applications across the food spectrum.We’re confi dent that Agilent is uniquely equipped to support foodtesting– now and in the future.Access the new Food Safety Applications Compendium at:www.agilent.com/chem/foodFood Safety Summit:Scan with your smartphone to register now.© Agilent Technologies, Inc. 2012

SANITATIONMAXIMIZEFOOD ANALYSISPRODUCTIVITYConfi dence means maximizingyour food testing productivityno matter how challengingthe sample. With greaterprotection against cloggingand downtime, the AgilentPoroshell 120 family, includingnew Fast Guards for UHPLC,enables you to run moresamples without interruptionand still trust your results.Go further with Poroshell 120rugged performance.Visit www.agilent.com/chem/discoverporoshell forapplication notes, tips, andvideos about method transfer.© Agilent Technologies, Inc. 2012pathogenic bacteria, and chest X-rays fortuberculosis. Workers who fail the testsare not allowed to work until they testclean. Publicly available standard (PAS)220, published by the British StandardsInstitute, contains the following languagein Part 13.5:“Employees shall undergo a medicalexamination prior to employment inPersonnelfood contact operations (including sitecatering), unless documented hazard ormedical assessment indicates otherwise.“Additional medicals shall be carriedout at intervals defined by the organization,subject to legal restrictions in thecountry of operation.”PAS 220 is utilized with ISO 22000as part of the FSSC 22000 scheme.The plant management shall take all reasonable measures and precautions to ensure thefollowing:Disease control. Any person who, by medical examination or supervisory observation, isshown to have, or appears to have, an illness, open lesion including boils, sores or infectedwounds, or any other abnormal source of microbial contamination by which there is areasonable possibility of food, food-contact surfaces or food-packaging materials becomingcontaminated, shall be excluded from any operations that may be expected to result in suchcontamination until the condition is corrected. Personnel shall be instructed to report suchhealth conditions to their supervisors.Cleanliness. All persons working in direct contact with food, food-contact surfaces and foodpackagingmaterials shall conform to hygienic practices while on duty to the extent necessary toprotect against contamination of food. The methods for maintaining cleanliness include, but arenot limited to, the following:l. Wearing outer garments suitable to the operation in a manner that protects against thecontamination of food, food-contact surfaces or food-packaging materials.2. Maintaining adequate personal cleanliness.3. Washing hands thoroughly (and sanitizing if necessary to protect against contamination withundesirable microorganisms) in an adequate handwashing facility before starting work, aftereach absence from the workstation and at any other time when the hands may have becomesoiled or contaminated.4. Removing all unsecured jewelry and other objects that might fall into food, equipment orcontainers, and removing hand jewelry that cannot be adequately sanitized during periodsin which food is manipulated by hand. If such hand jewelry cannot be removed, it may becovered by material that can be maintained in an intact, clean and sanitary condition andthat effectively protects against the contamination by these objects of the food, food-contactsurfaces or food-packaging materials.5. Maintaining gloves, if they are used in food handling, in an intact, clean and sanitarycondition. The gloves should be of an impermeable material.6. Wearing, where appropriate, in an effective manner, hairnets, headbands, caps, beard coversor other effective hair restraints.7. Storing clothing or other personal belongings in areas other than where food is exposed orwhere equipment or utensils are washed.8. Confining the following to areas other than where food may be exposed or whereequipment or utensils are washed: eating food, chewing gum, drinking beverages or usingtobacco.9. Taking any other necessary precautions to protect against contamination of food, foodcontactsurfaces or food-packaging materials with microorganisms or foreign substancesincluding, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals and medicinesapplied to the skin.Education and training. Personnel responsible for identifying sanitation failures or foodcontamination should have a background of education or experience, or a combination thereof,to provide a level of competence necessary for production of clean and safe food. Food handlersand supervisors should receive appropriate training in proper food-handling techniques andfood-protection principles and should be informed of the danger of poor personal hygiene andunsanitary practices.Supervision. Responsibility for ensuring compliance by all personnel with all requirementsof this part shall be clearly assigned to competent supervisory personnel.22 F o o d S a f e t y M a g a z i n e

SANITATIONNote the language in paragraph 2, thatis, “subject to legal restrictions in thecountry of operation.” This kind of testingis not allowed in the U.S. and partsof Europe, as it is deemed a violation ofprivacy.ClothingOn the subject of clothing, theGMPs state that among the methods formaintaining cleanliness are the following:“Wearing outer garments suitable tothe operation in a manner that protectsagainst the contamination of food,Section 7 — Establishment: Personal HygienePersonal Hygiene ObjectivesTo ensure that those who come directly orindirectly into contact with food are not likelyto contaminate food by:• maintaining an appropriate degree ofpersonal cleanliness• behaving and operating in an appropriatemannerRationalePeople who do not maintain anappropriate degree of personal cleanliness,who have certain illnesses or conditions orwho behave inappropriately can contaminatefood and transmit illness to consumers.7.1 Health StatusPeople known, or suspected, to besuffering from, or to be a carrier of, a diseaseor illness likely to be transmitted throughfood should not be allowed to enter anyfood-handling area if there is a likelihoodof their contaminating food. Any person soaffected should immediately report illness orsymptoms of illness to the management.Medical examination of a food handlershould be carried out if clinically orepidemiologically indicated.7.2 Illness and InjuriesConditions that should be reported tomanagement so that any need for medicalexamination and/or possible exclusion fromfood handling can be considered, include thefollowing:• jaundice• diarrhea• vomiting• fever• sore throat with fever• visibly infected skin lesions (boils, cuts,food-contact surfaces or food-packagingmaterials” and “Wearing, where appropriate,in an effective manner, hairnets,headbands, caps, beard covers or othereffective hair restraints.”Suitable garments will depend uponthe type of processing operation andmanagement’s commitment not onlyto food safety and quality, but also toworker safety.Food plant workers should wear hairnetsthat contain and cover all the hairand ears. Many operations also mandatethat workers wear bump caps. Baseballetc.)• discharge from the ear, eye or nose7.3 Personal CleanlinessFood handlers should maintain a highdegree of personal cleanliness and, whereappropriate, wear suitable protectiveclothing, head covering and footwear. Cutsand wounds, where personnel are permittedto continue working, should be covered bysuitable waterproof dressings.Personnel should always wash theirhands when personal cleanliness may affectfood safety, for example:• at the start of food-handling activities• immediately after using the toilet• after handling raw food or anycontaminated material, where this couldresult in contamination of other fooditems; they should avoid handling readyto-eatfood, where appropriate7.4 Personal BehaviorPeople engaged in food-handling activitiesshould refrain from behavior that could resultin contamination of food, for example:• smoking• spitting• sneezing or coughing over unprotectedfoodPersonal effects such as jewelry, watches,pins or other items should not be worn orbrought into food-handling areas if they posea threat to the safety and suitability of food.7.5 VisitorsVisitors to food manufacturing, processingor handling areas should, where appropriate,wear protective clothing and adhere to theother personal hygiene provisions in theseareas.ASSUREACCURATESAMPLE PREPConfi dence means assuringyour results are accurate andreproducible, right from the start.Agilent’s comprehensive BondElut SPE & QuEChERS samplepreparation portfolio selectivelyremoves interferences fromcomplex food matrixes–effi cientlyand dependably.To learn more about Agilent sampleprep solutions for food safety visit:www.agilent.com/chem/assure© Agilent Technologies, Inc. 2012O c t o b e r • N o v e m b e r 2 0 1 2 23

SANITATIONAFFIRMFOOD SAFETYSTANDARDSConfi dence means affi rming yourinstruments are globally certifi edto maintain the strictest foodsafety standards. Affi rm yourproof-of-system maintenance andcalibration with Agilent’s FunctionalVerifi cation Services. Standardizemaintenance protocols and validatetesting methodology across all yourchromatography systems worldwide.To reduce regulatory risk andstreamline ISO 17025 documentation/certifi cation process, visit:www.agilent.com/chem/FVSfood© Agilent Technologies, Inc. 2012caps should be discouraged as they notonly do not properly contain a worker’shair, but they are often filthy. Workerswho have beards and/or mustachesshould ensure that they are fully covered.Some operations waive this requirementfor workers with neat mustaches and goon to define what constitutes a “neatmoustache.” It is much easier to definea requirement than to create a systemwhere something must be interpreted.Management should also consider thetype and color of hair restraints that theybuy. Workers often feel that hairnetswith wider mesh are more comfortable.Many operations also purchase hairnetsthat are white in color, which allowsthem to easily see whether workers arenot only wearing their hairnets but alsowearing them properly.The garments that food plant workerswear vary widely. Some plants allow theirworkers to wear street clothes, whereasothers provide complete uniforms. Streetclothes are not a good idea, as one cannever tell where employees were beforecoming to work. A description of thegarments to be worn in a food plantmight be as follows: Uniforms shall be tightfitting and be equipped with snaps or Velcroclosures. There shall be no pockets locatedabove the waist. Sleeves shall be manufacturedwith elastic bands at the wrist to protect thearms. When purchasing uniforms, plantmanagement should seriously considerthe materials from which they are manufactured.Ideally, the uniforms shouldnot “shed,” and they should be manufacturedfrom breathable materials, especiallyif a plant is located where thereare high temperatures or where workersmust work in a hot area.Many operations color-code uniforms,especially if the plant producessensitive products. In plants producingready-to-eat foods, workers on the rawside might wear white uniforms, whereasthose on the cooked or finished productside will wear blue. In operations such asthese, when moving between these areas,workers must not only change their uniformsbut also their shoes or boots.Shoes are an area that managementneeds to address. For safety purposes,shoes must be close toed and preferablyhave steel toes and shank. However,since food plant workers are on their feetfor a large part of each day, it behoovesmanagement to make a commitmentto identifying a supplier that producesa comfortable safety shoe. Many plantsbring the manufacturer of safety shoesinto the plant several times a year toallow their crews to select a shoe withwhich they are comfortable. When developinga policy for shoes, managementmust consider what they are manufacturing,their workforce and where theylive. For example, many food processingplants are located in a country with aworkforce that lives on farms or raiseslivestock or poultry. The last thing anoperation needs is to have them trackingchicken or turkey manure into a facilitythat produces a ready-to-eat product.This is why some facilities are designedin such a way to oblige workers tochange shoes immediately before goinginto the processing area or to utilize footbaths or boot washers.Jewelry and Other ObjectsAnyone entering a food processingarea must remove all jewelry, includingrings, brooches, watches, pins, earrings,necklaces and visible piercings.In addition, false nails, nail polish, falseeyelashes and any other object thatmay possibly contaminate food shouldnot be allowed in the plant. Piercingshave become an issue in recent years,which is why operators utilize the term“visible,” which, for most operations,includes tongue piercings. Another issuethat processors must look for if theydo not supply uniforms is clothing thathas spangles or rhinestones sewn into it.This can be an issue in Islamic countrieswhere women often wear decorativehead scarves.Only two types of jewelry are allowedin some plants. These are plain weddingbands and medical emergency braceletsor necklaces. The plain wedding bandsare allowed for two reasons; some simplycannot be removed and have nostone that can come loose. Notice thatthe term “some plants” was used. Some24 F o o d S a f e t y M a g a z i n e

SANITATIONoperations say no jewelry whatsoever. Ifan employee has an emergency braceletor necklace, it must be covered so it willnot pose a safety risk. There are operationsthat have addressed the emergencybracelet issue by having those employeeswear a special patch on their uniforms.The use of special patches is more commonthan many would suspect. Someoperations use patches to designate employeeswho are first responders, knowCPR or are safety committee members.Additionally, processors must developa cellphone policy. This should be quitesimple. No cellphones in the processingarea. Given that almost all phones havecameras, this makes it easier to establishsuch a policy.Employee Facilities and SupportServicesOne area where management playsa major role in employee hygiene isproviding funding for employee facilitiesand support services. These includelockers and locker rooms, toilets, handwashingfacilities, medical and first aidfacilities, lunchrooms and break areasand access points to the plant.Lockers and locker rooms are anoften-ignored area. Employees need aplace where they can change clothesand feel that their valuables are safe andsecure. Having safe and secure lockers isone means of discouraging employeesfrom bringing personal items into theplant. Ideally, the plant should provideemployees with lockers that are at leastsix inches off the ground to allow forcleaning. The tops of lockers should beslanted to preclude storing anything ontop. Employees should also be informedthat lockers may be inspected at any timeand that no food may be stored in thelockers.The plant must provide their employeeswith an adequate number of toiletsand handwashing facilities, and makesure these are kept both clean and wellsupplied. Having had the opportunity todo a great deal of work in Asia, I can personallytestify that clean facilities are anecessity. The rule of thumb is one toiletand handwash station for every 10 employees.Handwashing facilities shouldinclude hands-free sinks (knee or footoperated, or an electric eye), soap, a constantsupply of warm water and a meansto dry hands. Some operations use toweldispensers and others hot air blowers.More and more processors are adoptinghands-free towel dispensers. These notonly provide towels automatically whenthe user passes his or her hand in frontof an electric eye, many operators alsoreport a cost savings on towels.There is a need to create policies forhow people enter the processing areaand establish support facilities. Differentmethods can help ensure compliance.It is very common to set up a vestibulethat includes items such as hairnetsand snoods. Many companies also postpictures of both the proper way and thewrong way to wear garments. Applyingthe old adage “A picture is worth athousand words” is a great idea in foodplants, especially since many operationshave a multilingual workforce.All workers must wash their hands beforestarting work, after using the toilet,after eating or smoking or whenever theirhands become soiled. To ensure that allemployees wash before beginning work,management must install an adequatenumber of sinks to allow all employeesto wash without having to line up. Ifpeople have to wait, they may not dowhat is required.Management must make a decision asto whether they feel boot washers, bootbaths or sanitizing foams are needed atthe entrance to the plant. If the answeris yes, then programs to monitor concentrationsof sanitizer and/or foamerperformance are necessary. Some companieshave taken out their foamers,deeming them to be potential safety hazards.Other processors have determinedthat boot washers or baths can createpotential environmental problems. Onecompany removed their boot bath whenenvironmental monitoring indicated thatthe bath raised aerosol counts. Whateverdirection is taken, make sure that theprogram is effective and necessary. As anexample, boot baths may not be necessarywhen entering an aseptic processingFAST-TRACKPESTICIDE SCREENINGSTARTUPConfi dence means fasttrackingyour lab’s targetedpesticide screening startupto quickly and accurately gofrom instrument installationto method validation. Avoidfalse positives with AgilenttMRM LC/MS ApplicationKits, a complete solution ofanalytical standards, methods,comprehensive databases,libraries, and applicationsupport. Rapidly meet newregulations with Agilent triplequadrupole solutions.Take your fi rst step now, visitwww.agilent.com/chem/appkits© Agilent Technologies, Inc. 2012O c t o b e r • N o v e m b e r 2 0 1 2 25

SANITATIONand packaging area, given that the systemsare all closed.If a company provides their employeeswith uniforms, they need to eithercontract with a laundry service or installin-house laundry facilities. The laundryfacilities, whether they are contractedor done in-house, must be able to properlydocument their operations. In fact,the same procedures used for selectingvendors should be employed whenselecting a laundry service. Uniformsmust be inspected fordamage and washedat high temperatures.If the uniforms aredamaged, they mustbe fixed or taken outof service. As part ofthe laundry program,there should be facilitiesto place dirtylaundry and a meansof getting the cleaneduniforms back to theworkforce. Never relyon workers to properlywash their uniforms.There is simply noway to verify that it isbeing done properly.Lastly, the companymust establishpolicies and programs that address eating,drinking and smoking. There mustbe dedicated areas for these activities. Inmany states within the U.S. and in moreand more countries, employees are notallowed to smoke within the workplaceand, in fact, may only smoke out-ofdoorsand away from the building. Youcan always tell the dedicated smokersif you visit a plant in the dead of winterand see people outside in the cold.Remember, when people smoke, theymust wash their hands, so handwashsinks need to be provided near the smokingarea. Lunch or break rooms mustbe designed with food storage facilities.One element of the locker policy is thatfood may not be stored in lockers, sofood storage must be part of the lunch orbreak rooms. These must include cagesor some other place for storing food or“Managementcommitment andinvolvement areessential for successfulimplementation of allprerequisite programs,such as personalhygiene...”lunchboxes, plus refrigerated storage.Many companies also provide microwaveand/or conventional ovens to allowworkers to cook or warm their food.There are also processors that havelunch services or provide vendingmachines. When one travels to Asia,Central or South America, lunch is oftenprovided to the workforce for a minimalfee or free of charge. Another trend thatis seen in some plants is that they havebanned nuts and other allergens fromvending machinesand discourage theiremployees from bringingsuch items in theirown lunches. Somefeel this is overkill;others believe it to bea legitimate preventivecontrol.Management’s RoleOne commontheme that has runthrough this discussionhas been the roleof management. Witha standard like ISO22000 and the differentaudit schemes thathave been approved byGFSI, there is a considerableemphasis on the role of management.Management’s role is much,much more than signing and dating amission statement and a quality policy.ISO 22000 provides an excellent roadmap for management’s role in ensuringfood safety and quality. Perhaps themost important element is managementcommitment and leadership. Managersmust set an example and encourage communication.The standard includes thefollowing elements:• Management commitment• Development, communication andimplementation of the food safetypolicy• Management of the planning of thefood safety system• Clear responsibilities for managingthe food safety system• Assignment of leadership responsibilitiesfor managing the system thatensures that procedures are developed,implemented and maintained,and that persons responsible for thedifferent elements of the system areproperly trained• Monitoring and maintenance ofrecords that procedures are beingfollowed and verification that proceduresare not only being followed,but also are effective. This is wherethe internal audits come in.• Establishment and maintenance ofprotocols for internal and externalcommunication• Conducting management reviewsto evaluate all elements of the foodsafety management system on aregular basis• Use of the management reviews as atool for improvementManagement commitment andinvolvement are essential for successfulimplementation of all prerequisiteprograms, such as personal hygiene, andthe food safety management system. Thebest managers are those who are visible.They participate in training sessions, getto know their workforce and encouragecommunication. They are also notafraid of change and, in fact, understandthat acceptance of the status quo is asure road to long-term decay. There isa reason that ISO 22000 emphasizescontinual improvement and that part ofHazard Analysis and Critical ControlPoints includes regular reassessments ofthe program. Food safety, food qualityand sanitation should not be stagnant,but continually evolve to better ensuresafe, high-quality food. Good managementand leadership are what make thishappen.•Richard F. Stier is a consultingfood scientist with internationalexperience in food safety (HACCP),plant sanitation, quality systems,process optimization, GMP complianceand microbiology. Among hismany affiliations, he is a member of the Institute ofFood Technologists and an editorial adviser to FoodSafety Magazine. He can be reached atrickstier4@aol.com.26 F o o d S a f e t y M a g a z i n e

PACKAGINGBy George G. MiskoAttaining Clearances forFood-Packaging MaterialsA short review of regulatorysystems around the worldIn today’s global marketplace, an understandingof foreign laws and regulations, as well as internationalstandards, is necessary. Through Keller andHeckman’s “Ask an Attorney” feature on www.packaginglaw.com, we have received a numberof questions about how regulations governing foodcontactmaterials in one country compare with thosein another country. While similar scientific principlesform the bases of food-packaging regulations throughoutthe world, the approaches used and specific datarequirements can differ significantly from jurisdictionto jurisdiction.Systems for regulating food-contact materials caninclude one or a combination of the following: generalsafety requirements, mandatory positive lists, voluntarypositive lists, preclearance requirements, no-objectionletters and licensing and/or registration requirements.General safety requirements are intended to preservethe physical, chemical and sanitary integrity of thecontents of food packages. Overall, these requirementsprohibit the transfer of substances that may bedeleterious to human health or bring about an unacceptablechange in composition, taste or odor of food.Countries that regulate packaging materials for foodprimarily through general safety requirements includeMexico, South Africa, some South American countriesand some Asian countries.Jurisdictions that have mandatory “positive lists” ofsubstances permitted for use in food-contact articlesinclude the European Union (EU) and Mercosur(Mercado Común del Sur). These listsmay apply to specific categories of foodcontactmaterials, such as plastics orpaper products. Use of substances noton mandatory “positive lists” is generallyprohibited. Exceptions would includewhen there is a transitional period beforea “positive list” becomes mandatory orsubstances on a provisional list.There are also voluntary standardsthat include “positive lists.” For example,the German Federal Institute for RiskAssessment, or Bundesinstitut für Risikobewertung,has issued recommendationsfor food-contact paper and paperboardand other food-contact materials notcovered within the scope of mandatoryEU positive lists (see below). While notlegally binding, these recommendationsare widely respected by industry.Another example is voluntary standardsfor food-contact articles madeof polyolefins and certain polymers issuedby the Japan Hygienic Olefin andStyrene Plastics Association (JHOSPA).JHOSPA’s voluntary standards include“positive lists” of polymers, additives andcolorants.Data requirements—such as toxicologicalsafety assessments and migrationlevels—to support petitions to clear newfood-contact materials also vary betweenjurisdictions. Many of the differences inglobal regulatory systems governing foodpackaging are in the details. To illustratesome of these details, the remainder ofthis article will contrast and comparelaws and regulations governing foodcontactplastics in the U.S., EU, Chinaand Mercosur.U.S.: Clearance for Final PolymersIn the U.S., the Federal Food, Drugand Cosmetic Act (FDCA or the Act),21 U.S.C. Section 301, et seq., providesthat any substance that is intended tobecome a component of food (e.g., migratesfrom packaging into food) mustbe: generally recognized as safe, used in28 F o o d S a f e t y M a g a z i n e

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PACKAGINGaccordance with a sanction or approvalissued prior to 1958 by either the U.S.Food and Drug Administration (FDA) orthe U.S. Department of Agriculture, thesubject of a “Threshold of Regulation”exemption letter or cleared by a FoodContact Notification or a food additiveregulation.Polymers cleared for food-contact useby FDA are listed in Title 21 of the Codeof Federal Regulations(C.F.R.), Part 177,“Indirect Food Additives:Polymers.” Part177 is further dividedby types of polymers.For example, Section177.1520 lists clearedpolyolefin polymersand Section 177.1630lists cleared polyethylenephthalate polymers.For plastic packagingmaterials, FDAregulations clear thefinal polymer, not unreacted startingmaterials. There are, however, someinstances in which FDA does not clearthe polymer per se, but rather permitsany of a number of starting reactants tobe used to make a finished polymer. Forexample, in the case of adhesives, Part175.105 lists substances cleared by FDAthat may be used in adhesive formulationsintended for food contact.Another exception is found in Part175.300, “Resinous and polymeric coatings.”Since these substances are typicallycomplex and often cross-linked compounds,FDA lists cleared precursor materialsin this regulation. In either case,however, substances required to producea functional polymer, such as catalysts,chain regulators, chain transfer agentsand similar materials used at low levels(generally 1% or below), are typicallyconsidered part of the basic resin and donot require independent regulatory considerationby FDA.Food additive clearances may havequantitative limitations and end-testrequirements. More specifically, theymay limit the types of food that will be“Many of thedifferences in globalregulatory systemsgoverning foodpackaging are in thedetails.”contacted, the maximum temperature atwhich a material may be used or the typeof application (repeated-use versus singleuse).Any food-packaging material intendedto come in contact with food mustcomply with FDA’s Good ManufacturingPractices (GMP) regulation, found inTitle 21 C.F.R., Part 174.5. GMP requirementsapply to both the use level of anadditive as well as toits suitable purity. Thismeans that additivesmay only be used inan amount necessaryto achieve their functionor purpose, andmust also not containimpurities at levels sohigh as to result in theadulteration of food.In passing theFDCA, the U.S.Congress decided toexclude “housewares”from the need forFDA premarket clearance requirementsfor food additives. Housewares are finishedarticles sold without prepackagedfood and used by consumers in thehome to hold, prepare or serve food.Importantly, housewares are not exemptfrom the general safety requirements ofthe Act and, therefore, must be suitablefor use with food so as not to result in itsadulteration.Since the Food Contact Notification(FCN) program was implemented in2000, it has become the preferred methodto obtain FDA clearance for newfood-contact substances. Under the FCNprogram, a manufacturer or supplier ofa food-contact material may submit anFCN that includes the identity and intendeduse of the new food-contact substance,along with information supportingthe conclusion that the substance issafe for its intended use.In contrast to the traditional foodadditive petition process, which requiresa lengthy rulemaking process, FDA hasonly 120 days from the filing of an FCNto complete its review of the notification.Another difference from the oldpetitioning process is that FCNs areproprietary, that is, only the notifier/manufacturer and its customers can relyon them.EU: Positive List of Monomers andAdditivesPlastics Regulation (EU) No. 10/2011governs the use of plastic materials andarticles intended to contact food in theEU. It includes a positive list of permissiblemonomers and other startingsubstances, and additives (other thancolorants). It also includes some polymerproduction aids (PPAs); however, PPAsnot on the positive list can be used infood-contact plastics, subject to the nationallaws of individual Member States.The Plastics Regulation also establishesan overall migration limit (OML)of 10 mg/dm 2 for all plastics in contactwith food, unless the use is subject toan exemption. Specific migration limits(SMLs) and residual quantity in the material(QM) limits for certain substancesalso are specified. For substances notsubject to an SML (or similar limitation),a generic default SML of 60 mg/kg is applied.The Plastics Regulation introduceda separate testing scheme to verify compliancewith OMLs and set new timeand temperature parameters for SMLcompliance testing. These changes arebeing phased in.Unlike U.S. regulations, the EU PlasticsRegulation does not include limitson coreactants or use levels for startingmaterials, temperature restrictions, specificationof single versus repeated use andfood types for specific substances.Printing inks, adhesives and coatingsare not covered by the Plastics Regulationand, therefore, are subject to MemberState national laws. However, sincethe Plastics Regulation includes withinits scope printed plastic articles, componentsused in printing inks that are onthe Plastics Regulation’s positive list andhave SMLs or other restrictions mustcomply with those limitations whenused on plastic articles.Anyone can petition to add a newmonomer or additive to the PlasticsRegulation’s positive list. These petitions30 F o o d S a f e t y M a g a z i n e

PACKAGINGare first reviewed by the European FoodSafety Authority (EFSA), which will issuea formal opinion on the safety of thesubstance when intended for use withfood and any limitations that should beobserved.Once EFSA has issued an opinion,finding a proposed use of a substance tobe safe, the European Commission (EC),provided it concurs with the opinion,will add the substance to the list throughan amendment to the regulation.Finally, all food-contact materialsin the EU must comply with the safetycriteria requirements set forth in FrameworkRegulation (EC) No. 1935/2004,which covers basic requirements (e.g.,GMPs and the like) applicable to the useof all food-contact materials in the EU.China: Approval Required for AllFood-Packaging MaterialsChina’s Food Safety Law requiresapproval of all “food-related products,”including food-packaging materials. Additionally,it prohibits the importation,use or purchase of food-related productsthat do not comply with applicable Chinesestandards. China is in the processof “harmonizing” the GB (Guobiao, or“National”) Standards that were in placeprior to the effective date of the currentlaw (June 1, 2009) with its Food SafetyLaw and converting them to Food SafetyStandards. Until this process is complete,all packaging materials must complywith all existing GB Standards.One of China’s GB Standards, “HygienicStandards for Uses of Additives inFood Containers and Packaging Materials”(GB 9685), includes a positive listof additives permitted for use in foodpackagingmaterials and covers polymers,coatings and adhesives. Initially, the listconsisted of 959 additives despite thefact that there were numerous otherfood-contact substances in use in Chinaat the time. Accordingly, Chinese authoritiesestablished procedures for clearingthe use of additives and resins thatwere being marketed in China at thattime, but were not on the GB 9685-positive list. This resulted in the submissionof some 3,000 petitions under thoseprocedures, which were referred to as“cleanup” submissions or “grandfather”petitions.In response to these petitions, Chinahas cleared an additional 107 resinsand 301 additives for food-contact use,although additional specifications forthe resins and/or corresponding finishedarticle standards are still being consideredby the Chinese Ministry of Health(MOH). The MOH also is in the processof reviewing the remaining cleanuppetitions. The final list of approvals, inaddition to a negative list of substancesprohibited from use in food packaging,is expected to be published by the end of2012. Recently, China announced plansto revise GB 9685 by June 2013, but thatdeadline may be optimistic.Procedures for clearing new resinsand additives for use in food-packagingO c t o b e r • N o v e m b e r 2 0 1 2 31

PACKAGINGmaterials are included in China’s ManagementRules for the AdministrativeApproval of New Varieties of FoodRelated Products (the rules), which wereissued on June 1, 2011. Article 3 of therules sets out the requirements for petitionsintended to clear new food-relatedproducts, includingpackaging materials.Specifically, petitionsshould demonstratethat a substance: hasa clear scope of use; istechnically necessary;will not negativelyimpact human healthunder ordinary/reasonableuses or alterthe ingredients, structure,color or flavor ofthe food; and will beused at the lowest levelneeded to achievethe desired technicaleffect. In addition,an accompanyingguidance document(guidance) details datarequirements not specified in the rules.In this regard, toxicology data requirementsare set out based on projectedlevels of migration. Additionally,toxicological testing must be conductedin accordance with Good LaboratoryPractices. Although testing does nothave to be conducted in China, if it isdone there, the lab must be governmentaccredited.Mercosur: Recently RevisedPositive Lists of Monomers andPolymersMercosur, also referred to as the“Common Market of the South,” is thelargest trading bloc in South America.Current members include Argentina,Brazil, Paraguay, Uruguay and Venezuela.(As of July 31, 2012, Paraguay wassuspended but remains a full member.)Mecosur established general safety criteriaapplicable to all food-contact materialsin 1992 under GMC ResolutionNo. 3/92. Specifically, this resolutionrequires that all food-contact materials:“Data requirements—such as toxicologicalsafety assessmentsand migration levels—to support petitionsto clear new foodcontactmaterials...varybetween jurisdictions.”1) be manufactured in accordance withGMPs; 2) be of suitable purity; 3) nottransfer any harmful or toxic compoundsfrom the packaging to the food and 4)not cause any unacceptable changes infood composition, taste or odor. Mercosur’sgeneral standards for food-contactmaterials apply tohousewares and foodprocessingequipmentother than drinkingwater equipment.Mercosur also hasissued GMC resolutionsapplicable tosome specific categoriesof food-contactmaterials, includingplastics, elastomersand adhesives. GMCResolution No. 02/12,“Mercosur TechnicalRegulation on PositiveList of Monomers,Other Starting Substancesand PolymersAuthorized for theManufacture of PlasticPackaging and Equipment that Comeinto Contact with Food,” was recentlyadopted and must be incorporated intothe national legislation of member countriesby November 1, 2012.The resolution has five parts: 1) alist of monomers and other startingsubstances with usage restrictions, compositionlimits and SMLs; 2) a list ofproducts obtained by bacterial fermentation;3) general specifications; 4) notesrelated to “restrictions and/or specifications”and 5) a list of polymers obtainedfrom monomers listed in Part 1 and/orpolymers included in Part 2 and/or otherpolymers.The positive lists for additives (foundin GMC Res. 32/07) cover substancesadded to plastic to obtain a desired effect(e.g., antioxidants, foaming agents, lubricantsand plasticizers) and substancesused to produce an appropriate polymerizationmedium (e.g., wetting agents,surfactants and solvents). Separate resolutionsaddress test methods, includingone for determining overall migrationvalues (GMC Res. 32/10). Reusable plasticsare generally banned, with certainexceptions.The general requirements to add anew substance to a positive list are foundin GMC Res. 31/99. Petitions must besubmitted to either the Argentina NationalFood Commission (CONAL) orthe Brazil National Agency of SanitarySurveillance (ANVISA). Once eitherCONAL or ANVISA deem a petitionacceptable, it is forwarded to Mercosur.Generally, if a substance is cleared in theEU or U.S., the submitter can expect itto be adopted by Mercosur with similarlimitations (e.g., SMLs, QMs and typesof food).ConclusionsTo determine whether a food packagecan be legally marketed in jurisdictionsaround the globe, one has to considernumerous factors, beginning with thecomposition of the package, the food orbeverage intended to be packaged andthe conditions to which the package willbe subjected during manufacturing anduse.However, it is not a one-size-fits-allkind of world, as there are many subtledifferences from region to region in thedata requirements and in the manner inwhich these products are regulated. •George G. Misko is a partner in theWashington, D.C., office of Kellerand Heckman LLP. His practice focuseson food and drug matters andenvironmental concerns, includingpesticide regulation and chemicalcontrol regulations. He has extensive experience counselingclients on regulatory requirements relating tochemical substances, plastics and food products in theU.S. and other jurisdictions, including Canada, the EU,Latin America and the Pacific Rim. He also representstrade associations, including acting as general counselto the Silicones Environmental, Health and SafetyCouncil. Misko also has experience in civil trial andappellate matters. He can be reached atmisko@khlaw.com.For more information on packaging solutions,please visit www.foodsafetymagazine.com/signature.asp.32 F o o d S a f e t y M a g a z i n e

33 Special advertising supplement presented by Food Safety Magazine • October/November 2012 • www.foodsafetymagazine.comF o o d S a f e t y M a g a z i n e

Food Safety Insider: Rapid Micro SolutionsOutsourcing: Key Factorsto Consider In Choosing aQualified Testing Providerwww.silliker.comOutsourclng—converting corporate activities into serviceagreements managed by outside personnel—has becomea key part of operations for many food companies.Because consumer safety is a primary consideration amongfood manufacturers, many have opted to outsource their analyticaltesting with the goal of obtaining faster and more objectiveresults. But like the outsourcing of any function,this act of delegation requires companiesto address multiple interdependentbusiness and scientific variables in choosinga contract laboratory.Too Good To Be True?It is only second nature to focus on cost.Companies, however, should not give pricinginflated importance over other critical variablessuch as turnaround time and testing methodologies.Essentially, all contract laboratories face many of the sameoperational costs, provided they implement extensive quality systemsto ensure the accrual of quality data. If a laboratory placesan overabundant emphasis on price, bear in mind the old refrain:“If it sounds too good to be true, it probably is.”Request prospects to submit records detailing the scope oftheir internal quality systems. From participation in reputable proficiencytrials to the employment of statistical process controls,these records will provide you with an introductory snapshot oftheir quality systems.Deciding FactorISO 17025 provides the basis of laboratory accreditation. Dueto continuous expansion of the global food market, ISO accreditationhas become a major deciding factor for many companies.Due to the significant investment that is required to attain ISOapprovedstatus, accredited labs will readily share this informationwith you. If a candidate is not accredited, ascertain why.Responsive PartnerIn the unfortunate occurrence of a foodborne disease outbreakor product recall, your testing provider should be available to respondto crises. Determine if your prospects possess the technicalcapabilities to pinpoint problems in your food safety and qualitysystems, initiate environmental and testing programs, assistyou with regulators and devise practical, scientific solutions.Real-Time InformationState-of-the-art testing methodologies and technologies canmean considerable time and cost savings. Inquire about the analyticalmethodologies and testing equipment your prospects employ,and ask them to formulate a comprehensive testing programspecific to your product.Due to the importance of having realtimeinformation at your disposal, findout if your prospects have a LaboratoryInformation Management System.Lines of CommunicationProductive partnerships are built onsolid lines of communication. Learn ifyour prospects have a dedicated clientservices staff that will promptly appriseyou of problems and respond to yourspecial needs.Final CutSeek out the opinions of trusted colleagues.Odds are you will receive anearful of honest and open feedback onthe companies who make your initialcut. When two or three finalists remain,conduct on-site Good Laboratory Practices(GLP) audits. During a comprehensiveGLP audit, it is imperative forlabs to validate the existence of:• Written core standard operatingprocedures for the performance ofproperly documented methods• Written schedules for the regular calibrationof all laboratory equipment• Certification of routine participationin proficiency programs that are designedto verify testing results• Records verifying employee trainingand competencyGLP audits offer valuable opportunitiesfor you to interact with laboratorymanagement, view lab operationsfirsthand and ask far-ranging questionssuch as:• Do you use lab environmental testingto verify samples and tests arenot contaminated in the lab?• Is media sterility productivity andselectivity monitored for every lot ofmedia produced? How?• Do you use control checks (i.e., positiveand negative controls)? If so, atwhat frequency?• What type of daily checklist do youuse to verify methods are completedaccurately?• How often do your employees receiveupdated training and verificationof competency?• How do you notify clients if resultsare “suspect” or out of specification?Armed with this information, youcan find a contract laboratory that suitsyour organization.34 F o o d S a f e t y M a g a z i n e

Silliker Solution CenterTotal Confidence.Total Solutions.Silliker, the leading international network of accreditedfood testing and consulting laboratories, announces theopening of the Silliker Solution Center in Crete, IL.Incorporating the latest technologies and testing methods, this new71,000 square-foot facility – the largest in the Silliker global network –expands our industry-setting analytical portfolio to meet global testingdemands.Built for today with future growth in mind, the Silliker Solution Centeroffers a complete suite of expert services to meet your food safety,quality and nutrition needs, including:• Analytical Chemistry - Contaminant Analysis• Microbiology - Pathogen Detection• Nutrition Labeling• Contract Research & Innovation• Product and Process Validation StudiesThe Silliker Solution Center continues our 45 year record of deliveringaccurate, timely and cost-effective solutions. Nine out of 10 of theworld’s leading food companies trust Silliker to protect their brands.Partner with Silliker today to confidently protect your brand.E-mail info@silliker.com to request our new brochure, “ChooseConfidence. Choose Silliker.”Silliker Solution Center3600 Eagle Nest Dr.Crete, IL 60417 / USAemail. info@silliker.comwww.silliker.comSilliker, Inc.111 E. Wacker Drive, Suite 2300Chicago, IL 60601 / USAemail. info@silliker.comwww.silliker.com

Food Safety Insider: Rapid Micro SolutionsNext Generation ATPSystems: More thanSanitation Monitoringwww.hygiena.netSeveral industrial applications of adenosine triphosphate(ATP) bioluminescence have been developed since the late1970s. These largely non-specific applications have beenused for the direct objective assessment of cleaning verificationand gross monitoring of microbial biomass. Significant developmentshave been made over the past 10 years. Recent improvementsin reagents and instrumentation have led to the first specifictest application for the detection of low numbers of pathogenicand indicator organisms within a single working day.Traditional ATP bioluminescence is very rapid and very sensitive.However, ATP is a universal energy molecule that is abundantin most organic materials, and these tests cannot differentiate ATPfrom specific sources.The most widely used application of ATP bioluminescence issurface sanitation monitoring, which provides a direct objectivetest for cleaning verification. This application is a test for residualorganic matter and is not intended to replace bacterial culture tests.Facilities doing both ATP monitoring and bacterial testing can obtainreal-time readings of the general sanitation level and confirmresults within 24 to 72 hours with bacterial culture tests. The waittime between ATP and culture tests leaves room for improvement;food and beverage processors would like to have bacterial test resultssooner so that corrective actions can be taken earlier.Next Generation Rapid Microorganism TestsA novel reagent technology now bridges the time gap betweenATP results and bacterial culture tests, putting both tests in oneeasy-to-use system. Hygiena has created a new platform called MicroSnapthat can detect coliform, Escherichia coli and aerobic platecounts (APC) in less than 8 hours. By designing one system that cando both ATP sanitation monitoring and the most common environmentalindicator organism tests, food and beverage processors nowhave the ability to acquire an accurate status of plant hygiene duringthe same working day or shift. This allows for corrective actions totake place on the spot versus the following day.Easy-To-Use and Simplified For Any UserThe MicroSnap system consists of two easy-to-use components:device 1: a sample collection and enrichment device, anddevice 2: an end-detection device.Device 1 is fitted with a swab for testing surfaces, such as carcasses,but can also be used for product testing. After collectingor adding the sample, the device is activated to mix the samplewith the enrichment broth. The whole device is then incubated upto 7 hours at 37 °C, depending on the colony-forming unit (CFU)pass/fail thresholds. Higher CFU thresholds require less incubation,shortening the time to results. At the desired time points, 0.1mL enrichment culture is transferred to device 2, which is thenactivated and incubated for 10 minutes at 37 °C and then placedin the EnSURE luminometer, generating results in 15 seconds. Inpresence/absence testing (1–5 CFU), aresult greater than 10 relative light units(RLU) is considered positive. For differentCFU pass/fail thresholds, a chart isprovided that shows the correspondingRLU value to CFU level at 6 hours of incubation.This speeds time to results forfacilities with CFU thresholds of 40 CFUor greater. For example, a facility with a100 CFU coliform threshold would incubatefor 6 hours; a result of 30 RLU orhigher would indicate a fail.CFUEquivalent RLU(EnSURE)≤40≤10125 30300 100800 3002,000 1,0005,500 3,00015,000 10,000Better Performancethan Traditional BacterialCulture TestsMicroSnap has been independentlyverified by leading food safety and qualitylaboratories and shown to have asensitivity of 89% and a specificity of99%, which are better than traditionalculture methods. AOAC INTERNA-TIONAL approval is expected in thelatter part of 2012, but the product isbeing widely used by food and beverageprocessors today. For low numbersof organisms (1–5 CFU), the detectiontime was confirmed at 7 hours both inpure culture and inoculated foodstuffs.The traditional bacterial culture methoddetected 95% of samples, whereas MicroSnapdetected 99% of samples.The specification for coliforms andE. coli in many industrial applicationsis less than 10 CFU/g, which is effectivelya presence/absence test for a1:10 dilution of a solid sample (i.e.,

Tired of waiting 24 to 72 hours for traditional sample-ready plates?Detect Coliform, E. coli, and Total Aerobic PlateCount in 8 hours or less with Hygiena’s MicroSnap.Utilizing unique bioluminescence technology,MicroSnap is a quick, specific, and sensitivetest that delivers results on a plant’s microbialenvironment. MicroSnap provides results inthe same working day, enabling products tobe released sooner or corrective actions to betaken faster. Hygiena’s EnSURE measures thenew MicroSnap platform as well as ATP tests,quickly delivering a complete picture of dailyplant hygiene. To learn more about MicroSnapand EnSURE, contact us today.Free 30 Day TrialTry the EnSURE system with MicroSnap inyour facility for 30 days at no cost.Ask us how: 1.888.HYGIENAwww.hygiena.com 1.888.HYGIENA info@hygiena.comPromotion Code: FS30

Food Safety Insider: Rapid Micro SolutionsAdvanced Technology forRapid Pathogen Detectionwww.neogen.comAdvancements in technology have led to unprecedentedspeed and ease in the definitive detection of specificpathogens, such as Salmonella or Listeria, which are ofparticular concern to the food industry. These advancementshave brought DNA-based testing down to a level of simplicity andprice point that puts it in reach of many smaller processors.The latest foodborne pathogen technology uses an innovativeisothermal DNA amplification process to amplify DNA to detectablelevels, and fluorescent molecular beacon technology fordetection of the target pathogen. The new technology providesresults after as little as 10 minutes of reaction time. Other commerciallyavailable molecular amplification tests require up to 3hours of reaction time.The amplification mechanism involves binding of an oligonucleotide“template” to a specific sequence of target DNA or RNA.The template contains a recognition site for a specific endonuclease.The nicked strand is recognized as damaged and repaired bythe action of a thermostable DNA or RNA polymerase, displacingthe original strand with the newly synthesized repaired portion.This displaced DNA or RNA “product” then binds to a secondtemplate and the same reactions lead to formation of a secondproduct. The second product is homologous to the target sequenceand is detected using a specific molecular beacon probe.A fluorescent signal is generated in real time, with amplificationand detection complete within as little as 10 minutes. The entireassay is conducted at a constant temperature of 56 °C using atemperature-controlled fluorescence detection instrument. Assaysoftware analyzes the fluorescent signal over time; a datainterpretation algorithm interprets results as negative, positive orinvalid based on baseline, rate-of-change and other criteria.The new pathogen detection technology is currently availableunder the brand ANSR to detect Salmonella and Listeria in foodand environmental samples. ANSR stands for amplified nucleicsingle temperature reaction, and Neogen has received PerformanceTested Method sm Certification (Number 061203) from theAOAC Research Institute for its ANSR Salmonella assay, and asimilar certification is pending for its ANSR Listeria assay.In comparative testing for the AOACvalidation study, there were no statisticallysignificant differences in the numberof positive results for five differentfood samples obtained with the ANSRand USDA-FSIS reference culturemethods. In the testing of five differentenvironmental surfaces, there wereno statistically significant differencesin results by the ANSR and FDA/BAMreference methods.ANSR in ActionMichigan Turkey Producers hasbeen a longtime example of exceptionalfood safety. Michigan Turkey Producerswas awarded the 2009 Food QualityAward and the 2009 EnvironmentalSteward Award. Thus, when TinaConklin, quality assurance manager atMichigan Turkey Producers, was approachedby Neogen for another “easyto-use”rapid pathogen test, she wasskeptical that a new system would offersignificant advantages in pathogen detection.However, the simple three-stepworkflow, the 10-minute assay time forSalmonella spp. and the 18-minute assaytime for Listeria spp. changed hermind.Conklin agreed to perform rigorousevaluation of the ANSR system. Rapidresults allow Michigan Turkey Producersto implement interventions fasterand ship products hours ahead of anyother DNA-based assay. Using ANSR’sdefinitive DNA test, the samples correlated100% to traditional methods forMichigan Turkey Producers.The ANSR system was designed tocombine molecular-level accuracy witha scalable low-cost instrument and amethodology that can be easily incorporatedinto any testing laboratory’sexisting workflow. The system’s smallbench top footprint and extremelysimple procedure make it an easy fit inany laboratory setting.Combined with ANSR’s single enrichmentstep, Neogen’s new pathogendetection method for Salmonella canprovide definitive results in as little as10 hours from the time the sample istaken, and its method for Listeria canprovide definitive results in as little as16 hours. Additional tests for the ANSRplatform currently are in developmentand are expected to be launched in thecoming months.38 F o o d S a f e t y M a g a z i n e

PCR has gone the wayof the VCR.Simply the Fastest Rapid Pathogen Detection SystemANSR is a revolutionary new platform for rapid, DNAdefinitivepathogen detection that is simpler, better andfaster than PCR and ELISA-based methods.• DNA-definitive results in only minutes10 minutes for Salmonella; 18 minutes for Listeria spp.• Selective, sensitive, minimal matrix effects• Simple to learn, easy to useVisit www.NeogenANSR.com800/234-5333 or 517/372-9200foodsafety@neogen.com • www.neogen.com

Food Safety Insider: Rapid Micro SolutionsFood Diversity RequiresAdaptable Solutionswww.bio-rad.comThe global reaches of the food industry include every imaginabletype of food. With such diversity come unique andoften problematic challenges, especially with regard toanalyses of the diverse matrices of the food products produced.How does one prepare a sample for microbiological analyses, forexample, which can be screened for the presence of different microbiologicalspecies? Is therea one-size-fits-all solutionavailable?These are some of thequestions posed by ExactScientific Services, Inc., a fullservice,contract microbiologylaboratory established in 2006.Exact Scientific employs 14full-time staff professionalsand serves clientele rangingfrom dietary supplementmanufacturers, flax oil producers,berry producers, milk producers,meat facilities, herbalsupplement processors, providersof colostrum and wheyprotein powders, vegetable growers, fish processors and treenut farmers. The company analyzes a variety of food matrices forboth microbiological and chemical analysis. With the overwhelmingvariety of their customers’ products, Exact Scientific needed aworkable and flexible solution.Kent Oostra, co-owner of Exact Scientific with over 20 yearsof experience in this industry, explains why his company choseBio-Rad Laboratories as their solution provider: “The reasonswe chose Bio-Rad’s assays were the turnaround times, the functionalityand the adaptability to multiple matrices. With the broadrange of products we run, we needed a system that was adaptableto our schedule and work load.”Oostra is referring to Bio-Rad’s iQ-Check kits, which are optimizedfor fast, qualitative detection of major pathogens in foodand environmental samples. They function as a flexible and opensystem, allowing industrial microbiology laboratories rapid controlin their procedures. The kits utilize real-time PCR technology. Twoinstrument platforms are available to meet every user’s needs. A96-well instrument is suitable for high-throughput analysis, withthe ability to run four instruments from a single computer at thesame time. For lower-volume users, a 48-well instrument is available.Additionally, Bio-Rad offers enrichment media, real-timePCR detection systems and software for automated analysis.The iQ-Check kits available include the following: Cronobacterspp., Campylobacter, Escherichia coli O157:H7, Listeria spp.,Listeria monocytogenes, Salmonella II and STEC (Big Six serogroupsplus E. coli O157:H7). The AOAC Research Institute hasgranted Performance Tested Method status to this family of testkits. Since the reactions occur in closed PCR tubes, the chancefor cross-contamination is limited. Aninternal amplification control is performedin each well to verify the validityof the reaction and confirm a negativeresult. Due to the high sensitivity andspecificity of real-time PCR, a singleovernight enrichment is sufficient toobtain results equivalent or better thanreference methods, yielding resultswithin 12–24 hours.When asked what the advantagesare in choosing Bio-Rad’s kits, Oostraanswers, “The advantage of the assaysis the repeatability from assayto assay. Listeria, Salmonella, Cronobacterand E. coli O157:H7 are essentiallythe same assay with differentreagents. This repeatability allows forfewer mistakes and a more streamlinedprocess. Also, being able to run multipleassays on one system is a greatbenefit. Another great benefit is beingable to look at the graphs generatedfrom the RT-PCR assay and being allowedto interpret their meaning. Apositive/negative result isn’t goodenough for us and our clients. Bio-Rad’s system allows us to get into theheart of the run. We want the ability toanalyze the data and feel our clientsdeserve that. With Bio-Rad’s products,we can do that; with other systems, weonly saw a positive/negative result.”Bio-Rad’s assays allowed ExactScientific to arrange a work schedulethat gets data in their clients’ handsfaster with the confidence the companyrequires.“We are able to get our sample resultsout the next day by noon. Withthe automated emailing of results, Ican access data if I am in the field or athome,” he adds.“Bio-Rad’s system has given us theflexibility to handle more samples withoutadding more people. It allows us togive our clients the results needed in atimely fashion. The ability to meet clientneeds while allowing our employees tohave reproducible processes benefitsour company in both the work environmentand client relations.”When you have a mission statementthat reads, in part, “Exact ScientificServices, Inc. is committed to providingthe highest quality customer serviceand effective product testing services,”you need to rely on the best solutionpossible. Bio-Rad’s iQ-Check kits allowthem to do just that.40 F o o d S a f e t y M a g a z i n e

food science // iQ-CHECK REAl-TiME PATHOgEn DETECTiOnSafety.SPeeD.SuPPort.Bio-Rad Serves Up the Best Combo.Combine years of experience and the latest PCR technology for fast, accurate,and reliable results. How delicious is that?At Bio-Rad we have a proud 60 year history of serving the life scienceand diagnostic markets. Take advantage of our expertise in PCR and ourfive star service to get the answers you need from any type of sample.■■■■■■Perform rapid screening of samples with enrichment timesof 24 hours or less for all testsDetect even low levels of contaminants quickly and accuratelywith highly sensitive tests utilizing our patented technologyUse iQ-Check kits to identify Big 6 STEC, Campylobacter spp,Cronobacter, E. coli O157:H7, Listeria spp, Listeria monocytogenes,and Salmonella spp in food or environmental samplesTo learn more about real-time PCR and iQ-Check kits, visit us atwww.foodscience.bio-rad.com and request an in-lab demo.Bio-Rad delivers a comprehensive suite of tools forfood safety testing, including the latest PCR technology.To find To find your your local local sales sales office, office, visit visit www.bio-rad.com/contact.In the In the U.S., U.S., call call toll toll free free at 1-800-4BIORAD at (1-800-424-6723).Visit Visit us us at www.bio-rad.comat

Food Safety Insider: Rapid Micro SolutionsSetting the Standard with“Big Six” non-O157 STECReference Materialswww.atcc.orgThe United States Centers for Disease Control and Preventionestimates that non-O157 Shiga toxin-producingEscherichia coli (STEC) bacteria are responsible for 36,700illnesses, 1,100 hospitalizations and 30 deaths annually. The majorityof these infections have been associated with six specificserotypes: STEC 026, 045,0103, O111, O121 and O145.The strains, which are referredto as the “Big Six,” have beenlinked to a growing number offoodborne illnesses, promptingthe U.S. Department ofAgriculture (USDA) to addthem to their test regimen.USDA now requires routineverification testing for thepresence of STEC serogroupsO26, O45, O103, O111, O121and O145 in raw beef manufacturingtrimmings and otherraw ground beef componentsproduced domestically as wellas those imported. ATCC ispleased to now offer referencestrains and genomic DNAfrom each of the six non-O157STEC serotypes to the foodsafety community for qualitycontrol (QC) testing and assayvalidation.“The global community has been experiencing food-associatedoutbreaks of non-O157 Shiga toxin-producing E. coli foryears,” says Raymond H. Cypess, D.V.M., Ph.D., ATCC Presidentand CEO. “Our role is to equip food safety programs worldwidewith well-characterized standard materials for microbial testing,”he adds. Food microbiology laboratories look to the ATCC brandto provide the top-quality microbial reference materials neededto maintain outstanding programs. Since 1925, ATCC has set thestandard for authenticating and distributing biological materialsfor research and testing in the life sciences. ATCC’s mission is toacquire, authenticate, preserve and distribute biological materials,information, intellectual property and standards for the advancement,validation and application of scientific knowledge.Food producers, distributors and retailers understand theimportance of effective microbiological testing for assuring consumersafety and protecting their reputation and business performance.Microbial reference strains with confirmed identity, viabilityand purity, backed by meticulous laboratory procedures thatminimize subculturing, are importantfor effective product safety testing.Whether in QC testing, process validationor research and development,the microbial materials used should beconsidered vital factors in generatingvalid, accurate results. Therefore theselection of reference materials from asupplier that assures quality and reliabilityis critical. To identify microbialreference materials that are produced,tested, preserved and stored with theunparalleled expertise that comes fromover 85 years of experience, look toATCC. “As a global biological resourcecenter devoted to science and the publichealth, we take very seriously ourresponsibility to ensure the safety andquality of the reference materials providedby ATCC,” explains Liz Kerrigan,Director of Standards at ATCC. “QCmicrobiologists worldwide deserve toknow with certainty that any materialsthey obtain for QC testing of the foodsupply are authentic.”Authenticated reference materialsbring consistency to QC tests and allowresults to be meaningfully comparedamong a group of laboratories.They provide the consistency neededto standardize assay comparisons,interlaboratory comparisons of existingor new protocols and evaluation of factorsthat contribute to assay variability.ATCC now provides pre-selected MicrobialPanels containing either strainsor genomic DNA from each of the “BigSix” non-O157 STEC serogroups. Thepanels can be used to challenge assayperformance, validate or compare testmethods and to establish sensitivity,linearity and specificity during assayvalidation or implementation. They arean important tool for method validationand method-performance verification.ATCC reference strains and genomicDNA from each of the six non-O157STEC serotypes have been tested forShiga toxin (stx1 and stx2) and thegene that encodes for intimin (eae),an adherence protein. Non-toxigenicstrains are also available.Don’t take chances on the quality ofyour QC materials. Insist on productsthat meet ATCC’s high standards of fullcharacterization and low passage number.Look to the ATCC brand for “BigSix” non-O157 STEC QC referencematerials.42 F o o d S a f e t y M a g a z i n e

ATCC Food SafetyATCC is raising foodtesting to new heightswith the “Big Six”Know your microbes.Trust your controls.Protect your brand.Learn more at www.atcc.org/bigsixVerify your quality control assays for the “Big Six” non-O157 STEC serogroups classified asadulterants by the USDA. Choose high-quality ATCC® cultures tested for Shiga toxin (stx1 andstx2) and intimin (eae) genes from E. coli serogroups O26, O45, O103, O111, O121, and O145.Your trusted source for standards©2012 American Type Culture Collection. ATCC® is a registered trademark and the ATCC logo is a trademark of the American Type Culture Collection. ATCC productsare intended for laboratory research only. They are not intended for use in humans, animals, or diagnostics. E.coli image courtesy of Eric Erbe and Christopher Pooley,USDA ARS.

Food Safety Insider: Rapid Micro SolutionsThe Move TowardMolecular Methods forSalmonella Detectionwww.biocontrolsys.comRapid Salmonella detection technologies have continuedto evolve in an effort to provide food producers andtesting labs with the required improvements to specificity,sensitivity and speed. Many of these advancements utilizemolecular-based detection technologies suchas polymerase chain reaction (PCR) or otherenzyme-mediated nucleic acid amplificationtechniques. Molecular detection technologiesoffer distinct advantages over the older antibodybasedenzyme-linked immunosorbent assays,enzyme-linked fluorescent assays or lateral flowtechnologies. The latter generally requires longer,more complex enrichment schemes and are moreprone to false-positive results caused by crossreactingenterics, such as Citrobacter. The new molecular methodspossess their own set of unique challenges.The Challenges of Food SamplesMolecular methods typically provide superior sensitivity andspecificity compared to antibody methods and normally haveshortened enrichment procedures. Often times, the sample-tomediaratio is reduced below the traditional 1 part sample to 9parts media (i.e., 25 g in 225 mL) as well. These modificationsoffer cost and labor reductions but result in an increased potentialfor the sample matrix to interfere with the detection technology.Food and environmental surface samples often contain substancesthat can inhibit molecular detection in a variety of ways,including inactivation of the polymerase enzyme, degradation ofthe nucleic acids or interference with the optical signal. Examplesof common inhibitors include phenolic compounds found in chocolateand berries, certain polysaccharides found in plants, calciumions in milk, proteinase enzymes produced by microorganisms inthe sample, enrichment media components such as bile salts andacriflavine, colored samples such as spices or produce, and antimicrobialchemicals used as interventions during processing.Why Sample Preparation Is CriticalThe goal of an enrichment procedure is to ensure that Salmonella,if present, is grown to a detectable level. Equally importantis the sample preparation procedure used to prepare the enrichedsample for analysis. This step must ensure that inhibitorysubstances are removed from the sample in a way that does notreduce the level of the target pathogen. Many molecular detectiontechnologies rely on a dilution step in which a portion of theenriched sample is transferred to a buffer solution in preparationfor a heat or chemical lysis step that functions to release the targetednucleic acid material from the cells. However, this dilutionapproach counteracts the enrichment process, dilutes Salmonellaand reduces the method’s sensitivity. In contrast, AssuranceGDS ® Salmonella from BioControl incorporates a proprietary immunomagneticseparation technologythat utilizes antibody-coated magneticparticles to capture and concentrateany Salmonella in the enriched sample.These particles, with the captured Salmonella,are physically removed fromthe enrichment and transferred to thePCR tubes for analysis. This simple andeffective process takes less than 20minutes for 72 samples and helps ensurethat the reaction proceeds uninhibitedwithout compromising sensitivity.Negative or False Negative?Any molecular detection assayshould contain an internal control (IC)in each reaction. Because moleculartechnologies are susceptible to interferenceor inhibition, it is crucial that aSalmonella detection method can verifythat a negative test result is due to theabsence of Salmonella and not a failedreaction. As each sample represents itsown unique set of conditions, an assaycontrol that is separate from the sampledoes not provide sufficient informationto verify the negative result. EachAssurance GDS Salmonella AmplificationTube contains an IC that consistsof a unique sequence of DNA with itsown specific primers and probe. Amplificationof this IC must occur to ensurethat the PCR process has not beeninhibited in each tube in order for thecorresponding negative test result tobe determined valid by the AssuranceGDS Rotor-Gene ® Software. Withoutthe presence of an IC in each reaction,any negative test result could be theresult of a failed reaction and could, inreality, be a false-negative result.An Ideal Solution for RapidSalmonella DetectionA rapid Salmonella detectionmethod should also fit the lab’s workflowand produce results quickly andefficiently. The new 72 sample highthroughputoption for Assurance GDScan provide results for 400 samples ina single 8-hour shift, more than twicethe capacity of other molecular methods.Salmonella results are availablein just 20 hours for most samples andas fast as 10 hours for certain matriceswith a dual enrichment method for Salmonellaand E. coli O157:H7.For more information contactBioControl Systems at 800.245.0113 orvisit www.biocontrolsys.com.44 F o o d S a f e t y M a g a z i n e

Food SafetyAccuracySpeedAt BioControl we make accuracy our first priority.This is more important than ever when considering a testingstrategy for non-O157 STEC, given the complexities of testingfor the multiple virulence targets which define these organisms.Assurance GDS ® for Top STEC relies on an innovativeImmuno-magnetic separation technique in sample preparationto isolate the cells containing the top 7 O-groups of interestand introducing these to the PCR analysis for eae and shigatoxin genes. This technique reduces the potential for falsepositives, and allows for rapid, cost effective analysis of TopSTEC without the need for sequential testing with additionaltest kits.Find out what makes Assurance GDS the first choice for foodmanufacturers committed to quality.www.biocontrolsys.com | info@biocontrolsys.com

Food Safety Insider: Rapid Micro SolutionsSelf-Contained RapidSalmonella and ListeriaTest Kits:Protect Against Chances of Cross-Contamination in Your Plantwww.weberscientific.comListeria and Salmonella are two foodborne pathogens thatare of significant concern. According to the Centers forDisease Control and Prevention (CDC), nontyphoidal Salmonellaranks as number two in most illnesses (behind Norovirus)and as number one in illnesses requiring hospitalization aswell as illnesses resulting in death.Listeria monocytogenes ranks asnumber three in illnesses resulting indeath.Most food processing facilitieshave protocols for sampling environmentalsurfaces to ensure that theyare free of these pathogens. Manyfacilities then send the samples out toa commercial laboratory for testing. Aprimary reason that food laboratoriesdon’t perform the testing in their ownlaboratories is apprehension of potentiallyenriching and cultivating these dangerous bacteria withintheir facility and the fear of unintended contamination whenutilizing methodology, such as petri dishes and films that are nottightly sealed. An alternative method, using PDX media availablefrom Weber Scientific, addresses this concern because the entireenrichment takes place in a tightly sealed device.Both a Salmonella-indicator broth (PDX-SIB) and a Listeriaindicatorbroth (PDX-LIB) are intended to be used in the foodprocessing environment and on food contact surfaces, andgive rapid results, 24 hours and 30 hours, respectively. They areAOAC-RI Performance Tested SM for use as a presumptive positiveor a confirmed negative. AOAC studies were conducted at 4inch × 4 inch surface areas.PDX-SIB was subjected to a panel of more than 100 Salmonellaand non-Salmonella organisms. The test exhibited 99%sensitivity. The tests were conducted with inocula at both low[100 CFU per sample) levels.The applicability of PDX-LIB is limited for selected commonListeria spp. (L. monocytogenes, L. innocua, L. ivanovii andL.welshmeri) on selected common surface types (sealed concrete,ceramic tile, stainless steel and plastic). The test detectsas low as 1–10 CFU/mL. Results are comparable to U.S. Departmentof Agriculture (USDA) methods (2 percent false negativesand 1 percent false positives in real environmental samples).Positive viable Salmonella spp. will exhibit a color changefrom blue to yellow if Salmonella bacteria are growing. Theliquid medium contains selectiveagents to prevent the growth of competitivemicroflora while providingnutrients for the growth of resistantSalmonella. Salmonella are further differentiatedfrom any active backgroundmicroflora by metabolism of a specificenergy source metabolized primarilyby Salmonella. As the population ofSalmonella metabolizes the growthsubstrate, the compound is fermentedto an acidic byproduct, which turns thepH indicator in the broth from blue toyellow. A yellow color observable afterincubation at 37 ± 1 °C for 24–48 hoursis deemed presumptively positive.Any sample that is not presumptivelypositive at 24 hours must be incubatedfor a total of 48 hours to ensure thesample is a true negative.Listeria media contain a patentedformula of antibiotics, growth enhancersand color-changing compounds.The antibiotics function synergisticallyto inhibit most non-Listeria microorganisms.Growth enhancers providerecovery nutrients to support thegrowth of sublethally injured Listeria.Indicator compounds will turn thebroth from yellow to black by utilizingthe β-glucosidase enzyme producedby Listeria spp. A brown to black color30–48 hours at 37 °C indicates a presumptivepositive test for Listeria spp.Positive results can be read as early as30 hours. Results cannot be considerednegative until samples have beenincubated for 48 hours.Each bottle of media is availablewith the new EnviroMax Plus® foamtip swab system from Puritan Medical.The EnviroMax swab is sterile,pre-moistened and has a leak-proofcap for complete containment. Theentire procedure involves four steps: 1)Remove sponge swab from containerand swab a 4 inch × 4 inch surfacearea; 2) Return sponge swab to samecontainer and aseptically add one premeasured20 mL bottle of media; 3)Incubate at 37 °C for 24 or 30 hours;4) Read results. If a sample is positive,the sealed swab device can then besent to an outside laboratory for confirmation,if desired, utilizing a U.S. Foodand Drug Administration BacteriologicalAnalytical Manual or USDA procedure,such as XLD agar for Salmonellaor Modified Oxford media for Listeria.46 F o o d S a f e t y M a g a z i n e

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Food Safety Insider: Rapid Micro SolutionsLeading the Way in FoodSafety Scienceneeds. Our real-time test for E. coliO157:H7 detects all known E. coliO157:H7, including rough strains, withsame-day results. Additionally, ourreal-time STEC suite is closely alignedwith the FSIS method—providing ascreen to quickly clear stx/eae-negativesamples and panels to identify the “TopSix” pathogenic non-O157 serogroupsin potential positives.www.Qualicon.comFast, accurate testing results are critical for delivering saferfood products to consumers and more profitable growthfor food companies. That’s why at DuPont, our food safetyscience is focused on continually developing state-of-the-arttechnologies that are easy, effective and efficient. In fact, for morethan 16 years, we have been revolutionizing food safety.DuPont was the first company to apply PCR technology tocommercial food testing with rapid, DNA-based assays forSalmonella, Escherichia coli O157:H7 and Listeria monocytogenes.Our use of automated PCR processing with tableted rather thanliquid reagents created a dramatic increase in speed andconsistency—helping to usher in a new era of easy-to-use testingmethodology.Meeting a Global NeedLeading food companies and government testing labs aroundthe world have come to rely on the genetics-based BAX ® Systemto quickly and accurately detect pathogens such as Salmonella,E. coli O157:H7, L. monocytogenes,Campylobacter, Vibrio and more. TheU.S. Department of Agriculture FoodSafety and Inspection Service(USDA FSIS) has adopted theBAX ® System for meat andpoultry testing, and governmenttesting agencies in Brazil,Canada, China, Russia andother parts of the world havevalidated it as an approvedtesting method to help protecttheir food supply and theircitizens.The BAX ® System has beencertified by independent authoritiessuch as AOAC, NordVal and the FrenchAssociation of Normalization. What’smore, it has been included in the EmergencyResponse Validation program of the AOAC Research Institute,a program designed to respond immediately to foodcontamination crises.Delivering Innovations Year after YearWhile we’re proud to have been a part of food safety history,we’re always looking ahead to provide the next breakthrough withtechnological advances and new assays that make food safetytesting faster and more convenient without sacrificing accuracy.For example, as a result of collaborative research projects withthe USDA Agricultural Research Service, we have developed aportfolio of BAX ® System PCR assays to address E. coli testingMore Solutions Available fromDuPont Nutrition & HealthDuPont Nutrition & Health is abusiness dedicated to delivering awide range of sustainable, bio-basedingredients and advanced microbialdiagnostic solutions to the foodindustry. In addition to the qualityassurance products formerly availablefrom Qualicon, we offer Solae soyingredients to provide a healthier andmore sustainable source of proteins,and the DuPont Danisco ® range ofingredients to help provide enhancedbioprotection, an improved nutritionalprofile and better taste and texture.In the area of food safety, DuPontNutrition & Health provides advancedtechnologies for quality assurance,such as the BAX ® and RiboPrinter ®Systems, with all of the superiorspeed, accuracy, convenienceand world-class customersupport you’ve come to expectfrom DuPont. In addition, wecan now offer food companiesa multitude of premieringredients from the DuPont Danisco ® range that protectsfood from organisms such asListeria and yeast and mold.With this uniquecombination—which leveragesour capabilities in moleculardiagnostics and microbiology,innovative formulation science andadvanced manufacturing know-how—we can provide the food industrywith a new level of integrated DuPontsolutions. Through close collaborationwith customers, DuPont combinesknowledge and experience with apassion for innovation to deliverunparalleled customer value.For more information about theBAX ® System and other DuPontdiagnostic products, contact DuPontNutrition & Health at 800.863.6842 orvisit www.Qualicon.com.48 F o o d S a f e t y M a g a z i n e

THEY DON’T KNOW HOW TECHNOLOGY CANMAKE THEIR FOOD SAFER. BUT YOU DO.At DuPont, we believe that science—particularly biotechnology—offers the potential to help ensure thesafety and quality of our global food supply. Innovative science from DuPont Qualicon Diagnostics canhelp you perform fast, accurate food quality testing to address a broad range of challenges—so you can getproducts to market faster and help ensure the safety of the foods people enjoy every day.And, with the DuPont Danisco® range of food ingredients, we also offer food companies a multitude ofpremier formulation solutions, including natural ingredients that protect food from organisms such asListeria and Yeast & Mold.www.food.dupont.comCopyright © 2012 DuPont. All rights reserved. The DuPont Oval Logo, DuPont and Danisco ®are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates.

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By Marialuisa Gallozzi, Miriam Guggenheim, Suzan Charlton,Sally Squires and Christopher PruittIt seems that every week a food recall occurs somewhere. Thebig ones in recent years—some of which may have affectedyour own refrigerator or pantry—have involved cantaloupe,peanuts, ground beef, eggs and all kinds of vegetables, whetherbagged or not. At the same time, the regulatory, legal and communicationsissues involved in recalls are evolving rapidly. Morethan ever, food manufacturers need to understand the challengesinvolved in a recall and have both personnel and infrastructure inplace to respond.A Changing LandscapeLarge-scale recalls appear to be increasing in frequency andscope. As recent examples illustrate, these recalls can affect hundreds—ifnot thousands—of downstream products. The outcomecan be crippling, even for manufacturers that were not responsiblefor the contamination at issue.In 2009, the Salmonella contamination associated with PeanutCorporation of America products led to one of the largest recalls inU.S. history. It affected 1,790 separate downstream products, leadingto nine deaths and 691 reports of food poisoning. The company,which had manufactured roughly 2.5 percent of the nation’s peanuts,later filed for bankruptcy and liquidation.Before that, there were several ground beef recalls, including the Hallmark WestlandBeef recall in 2008 that involved 143 million pounds of beef. More recently, WrightCounty Egg of Galt, IA, initiated a massive shell egg recall, which again affected manydownstream manufacturers as well as retailers. All told, more than 500 million eggs wereinvolved in a nationwide recall.O51 c t o b e r • N o v e m b e r 2 0 1 2 F o o d S a f e t y M a g a z i n51e

In recent years, vegetables have also been recalled. These recalls can prove particularlychallenging, because in many instances it is hard to identify the source of the contaminant.A 2007 green onion recall caused Taco Bell to destroy its entire stock of green onions whilethe U.S. Food and Drug Administration (FDA) was trying to figure out where the contaminationoriginated. Ultimately, however, it was determined that the outbreak was caused bypackaged lettuce. Several years ago, a bagged spinach recall occurred. Again, a number ofcompanies suffered the problems associated with the recalls before the source was identified.Many products were pulled from shelves and consumers avoided bagged spinach longafter the threat of actual contamination had passed. Similarly, in 2008, FDA issued a warningabout Salmonella in tomatoes, but there was no actual recall. It was later determinedthat Salmonella associated with these vegetables did not come from the tomatoes at all; itcame from peppers. But the tomato industry suffered losses nonetheless. The lesson: Theimpact of a recall can be enormous, even if your product was not contaminated.Companies must therefore be prepared withsystems in place to help avoid recalls and minimizethe damage when they do occur.“More than ever, foodUnderstanding and Preparingfor Regulatory ChallengesOne of the most important aspects ofpreparing for a recall is understanding the regulatoryissues involved. For most food manufacturers outsidethe meat and poultry sectors, this will involvedealing with FDA.manufacturers needto understand thechallenges involvedin a recall and haveKey Regulatory IssuesThe food safety regulatory landscape underwentaa major overhaul in January of 2011 when PresidentBarack Obama signed the Food Safety ModernizationAct (FSMA) into law. The FSMA makesboth personnel anda number of important changes to existing law.Most significantly, when fully implemented, it willinfrastructure in placerequire most food manufacturers to utilize hazardanalysis and preventive controls plans—akin to theto respond.”more commonly known Hazard Analysis and CriticalControl Points (HACCP) plan—and to verifythe compliance systems of their foreign suppliers.The FSMA also vests FDA with mandatory recall authority and requires FDA to engage inrisk-based inspections (mandating that high-risk facilities be inspected every 3 years). FDAplans to fold the requirement for a hazard analysis and preventive controls plan into existingGood Manufacturing Practices (GMPs) regulations, along with preventive controls requirementsrelating to intentional adulteration, produce safety and sanitary transportation.Congress drafted these requirements to take effect for most manufacturers in July 2012.FDA failed to issue regulations needed to implement the section, however, and the agencyhas stated that it will not enforce the HACCP and preventive controls plan requirementsuntil these regulations are issued in final form and made effective—which might be yearsfrom now. Similarly, FDA will not enforce the requirements of FSMA’s foreign supplierverification section, which will require supplier verification activities for imported foods,until final rules are issued. Nevertheless, many sectors of the food industry are movingtoward implementing hazard analyses and preventive controls plans and foreign supplierstrategies.One aspect of the FSMA likely to drive more recalls is FDA’s inspection mandate.Owners of registered food facilities have probably noticed a marked increase in the frequencyand vigor of inspections. Even though FDA has delayed the implementation ofFSMA’s hazard analysis and preventive controls provision, inspectors are increasinglyofasking questions relating to HACCP concepts.The HACCP approach requires amanufacturer to qualify suppliers and havevalidated processes in place to controlidentified hazards. These activities must bemonitored and verified, including throughthe use of testing where appropriate. Importantly,everything must be documentedfor FDA to accept that it has indeedoccurred. Manufacturers have reportedinstances of inspectors asking questionsabout these issues during inspections underthe currently applicable GMP regulations.There have been a number of recalls followingsuch inspections, as well as an apparentincrease in warning letters regardingGMP violations over the last 6–12 months.Another key aspect of the FSMA isFDA’s new mandatory recall authority.Recalls under previous law were considered“voluntary,” but manufacturers thatdid not recall contaminated food riskedcriminal charges for adulteration, civil liabilityto consumers and adverse publicity.Due to these external pressures, companiesrarely refused FDA’s request to issue arecall. Thus, the new mandatory recallauthority is not likely to drive many newrecalls, although it might lead to disputesover timing and scope of such recalls.Although the FSMA is front and centerfor many in the industry, manufacturersshould not forget FDA’s pre-FSMAfood safety requirements, such as theReportable Food Registry, which requiresmanufacturers to report food that poses areasonable probability of “serious adversehealth consequences or death to humansor animals”—essentially the Class I recallstandard (classifications are defined below).These reports, coupled with the requirementthat manufacturers document theimmediate source and recipient of food,are intended to allow FDA to identify andtrace problem foods through the chainof commerce. An example of the registryin action was the hydrolyzed vegetableprotein Salmonella contamination in 2010,which was first identified through a registryreport and then traced to thousands ofaffected products.Taking Steps to Prevent RecallsUnderstanding the key regulatory issuesis essential, but preventing a recall in52 F o o d S a f e t y M a g a z i n e

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the first place is ideal. One important step to preventing recalls is having a top-notch foodsafety program. Again, the HACCP approach and supplier verification are increasinglybecoming standard practice for many sectors of the food industry, even though FDA willnot enforce these requirements of FSMA until final rules are issued. Among the benefits ofimplementing an HACCP plan is the use of validated control steps, such as a kill step, thatmay help prevent or limit the scope of recalls. For example, companies that had a validatedkill step for Salmonella were able to avoid a recall of products containing contaminated hydrolyzedvegetable protein. Likewise, implementing foreign supplier verification activities—such as auditing a supplier’s food safety systems—can go a long way to preventing recalls. Itis simply a fact that some ingredients from developing countries do not meet the standardsexpected for food sold in the U.S.The ability to trace ingredients through the supplychain is another important method of preventing“One of the mostrecalls. If a manufacturer knows it it has not receiveda certain ingredient involved in a a recall (e.g.,peanut products from the Peanut Corporation of important aspects ofAmerica), it can be confident in keeping its productson the shelf. In the future, greater traceability maybe mandated by law for certain products. The FSMA preparing for a recallrequires FDA to increase its capabilities for tracingoutbreaks and consider enhanced record-keepingis understanding therequirements for high-risk foods.regulatory issuesBeing Ready to ActOf course, some recalls are unavoidable—evenwith the most cutting-edge food safety system. As aresult, manufacturers should always be ready for the involved.”unexpected.One of the most important steps to prepare is tohave a recall team in place. This multidisciplinary team will be tasked with decision makingand communications with FDA, the media, customers and consumers. The team shouldcomprise regulatory, scientific, technical, legal, communications, business and brandpersonnel. Having the team lined up in advance will ensure that a manufacturer does notwaste precious time when a recall is necessary.The first order of business when dealing with a potential recall is to conduct a timelyand diligent investigation. In this context, “timely” means quick, but not at the expenseof quality. Many in the industry mistakenly believe that a report to the Reportable FoodRegistry is due within 24 hours of learning of a potential issue. In fact, the report mustbe made within 24 hours of determining that the food poses a reasonable probability ofcausing serious adverse health consequences or death. Thus, there is no hard deadline atthe outset. Rather, a food company is entitled to make a timely and diligent inquiry into aproblem, and only if it then determines that the reporting threshold has been met does the24-hour countdown begin.Of course, prolonging an investigation can exacerbate the risk to consumers and increasethe scope of the recall. Thus, a manufacturer should be ready to act on incompleteinformation. For example, a confirmed positive test for Salmonella in a consumer-readyhuman food product will typically mean a Class I recall is necessary. But a more difficultcall may arise when a company receives a presumptive positive test result. The generally acceptedthinking appears to be that a manufacturer should act on the presumptive positive,provided that the test is known to eventually confirm positive. Individual circumstancesmay vary, however, underscoring the need to have a recall team in place with the expertiseneeded to make a decision.Once the manufacturer understands the issue at hand, it should be prepared to classifythe recall. Ultimately, FDA will decide the formal recall classification, but manufacturersshould be ready to make a recommendation. FDA uses the following classification system:• Class I: a situation in which there is areasonable probability that the use ofor exposure to a violative product willcause serious adverse health consequencesor death.• Class II: a situation in which use of orexposure to a violative product maycause temporary or medically reversibleadverse health consequences or wherethe probability of serious adverse healthconsequences is remote.• Class III: a situation in which use of orexposure to a violative product is notlikely to cause adverse healthconsequences.• Market withdrawal: occurs when aproduct has a minor violation thatwould not be subject to FDA legal action.The firm removes the productfrom the market or corrects theviolation.For Class I recalls, FDA will expectthe risk to be rapidly communicated toconsumers. At a minimum, the companyusually is required to issue a press releaseto the Associated Press. Class II and IIIrecalls are not communicated directly toconsumers. Instead, they will be communicatedto customers, and the productshould be pulled from the warehouse andlikely retail shelves. For Class III, technically,only removal from the warehouselevel is required. As a practical matter,however, customers may not want to leavesuch products on the shelf. Thus, customersoften pull products from the shelves forClass II and III recalls. All recalls, regardlessof classification, are reported in FDA’sweekly Enforcement Reports.Market withdrawals are conductedwhen an issue does not constitute a violationof the Federal Food, Drug & CosmeticsAct or the issue is so minor that itwould not prompt an enforcement action.An example is a taste quality issue, suchas the lack of a flavoring ingredient. Typically,a manufacturer will pull its productback and communicate with customers,but there is generally no need to get FDAinvolved or to inform the public, and thewithdrawal can be done quietly.A final, but crucial, aspect of respondingto recalls is managing recall communications.Recalls involve communicationswith various stakeholders. Foremost,54 F o o d S a f e t y M a g a z i n e

manufacturers involved in a recall willneed to coordinate communications withFDA and foreign regulators, as appropriate.For example, a product sold in Canada andthe U.S. will often be the subject of a crossborderrecall, in which FDA and the CanadianFood Inspection Agency coordinate.It is important that communications areharmonized between regulatory agencies,customers and consumers.Of note, there has been an emergingtrend for manufacturers to use the term“allergy alert” rather than “recall” in pressreleases announcing undeclared majorfood allergens. Failing to declare one ofthe eight major food allergens is a Class Irecall situation, even where a small subsetof the population is at risk. For some time,however, there has been a discussion inthe regulatory community regarding themerits of using the term “allergy alert” andtreating these types of recalls differently.The rationale for this approach is to avoid“recall fatigue,” where consumers are soused to recall notices that they do not payattention. In the last year or so, FDA hasappeared to acquiesce in this approach, likely in recognition of the fact that these productsare not harmful to the majority of the population.Communicating MessagesDuring a recall, events can transpire quickly. Sometimes, a company makes all the rightmoves from a legal and regulatory perspective, but fails to explain what has happened tocustomers, to the media and to consumers. That failure can result in a hit to reputationand to the bottom line. For this reason, strategic communications need to be a key part ofthe recall response. It’s also a smart strategy to coordinate closely with the legal team.Of course, the best way to respond to a recall is to prevent it in the first place. Manycompanies do a regular review to identify potential issues that could develop into a recallproblem and harm the company’s financial status or negatively impact how customers,consumers and other key stakeholders view their reputation.Many companies also develop crisis plans that can be implemented quickly should arecall occur. It’s impossible to anticipate all crises, but companies that have a plan in placeare less likely to be caught flat-footed. That, in turn, can reduce their risk of having theirreputation damaged. To develop this plan, it’s important to think about the potential scenariosthat might emerge and to ask these questions:• Where are the possible risks?• How would the company respond if the worst scenario were to happen?• How will leadership communicate internally and externally?• What procedures can be put in place now to prepare?Ideally, the team that develops the plan should also implement it. It’s best if the teamincludes some top leadership with the authority to make decisions in a timely fashion—with counsel from key legal, regulatory and communications senior staff. Some companiesalso identify outside legal counsel or crisis communications staff to be part of this team.INMAR RECALL MANAGEMENTPROTECTING CONSUMERS. PROTECTING BRANDS.PROTECTING THE ENVIRONMENT SM .EVENT EXECUTION• Multi-Channel Solutions• End-to-End Management• International Field &Facilities Network• Brand Protection• Brand RecoveryCONSULTING• Strategy Development• Risk Mitigation• Readiness Assessmentwww.inmar.com • 866.440.6917 • solutions@inmar.comO c t o b e r • N o v e m b e r 2 0 1 2 55

Teams that know each other and have worked together previously can hit the groundrunning if a recall occurs, rather than meeting for the first time at the brink of a crisis.The ability to be nimble is essential. Media has changed enormously in the past decade.The Internet, smartphones and fast web connections, as well as popular social networks,from Facebook to Twitter, allow news to travel worldwide in seconds. As Mark Twain oncequipped, “A lie travels around the world while truth is still putting on her boots.”That’s why it’s important not only to have a plan, but also to take it for a dry run fromtime to time. Coordination is essential. One approach is to review recall plans at least oncea year, since job changes and reorganization occur frequently in many companies. It’salso wise to have the team meet regularly, either in person, by conference call or virtuallythrough teleconferencing.Crisis drills can help keep recall teams at peak “Understanding theperformance. These mock scenarios are designedto mimic the pace, the stress and the complexitiesof food recalls. Participants are ambushed by the key regulatory issuesmedia. They face onslaughts in social media thatthreaten to ruin their reputations. They must coordinatewith regulatory agencies and work with the FBI,is essential, butHomeland Security and FDA.They have to determine the facts as best as possiblein real time, take corrective action for the recallpreventing a recall inand craft messages for internal and external communications.They have to figure out if their CEO the first place isshould issue a statement or appear before cameras.They also must keep their customers, their consumersand their investors informed about next steps.ideal.”The exercise helps companies experience the realtimepressure of a food recall. They assess what went well and what needs improvement.They can see holes in their plans and procedures—before they have to put them into practicein the real world.Managing Risk and Recovering from Losses andLiabilitiesUltimately, a crisis will likely require a discussion of who bears the financial responsibility.As a result, manufacturers must think about how they will manage the risks associatedwith a recall. Methods of handling risk include:• Avoiding risk: A manufacturer can avoid certain risks by simply avoiding particularbusinesses or certain segments that it considers too risky. For example, a seafood processormay avoid sourcing from inexpensive foreign suppliers because it does not trusttheir food safety systems.• Reducing risk: Implementing strong food safety practices and effectively communicatingwith stakeholders may help prevent a recall or reduce the damage from a recall.• Assuming risk: Some companies are willing to absorb a certain amount of recall cost.• Transferring risk: Risk can be transferred to suppliers through indemnity agreements.In addition, as described below, diverse insurance options for recall-related losses arebecoming available. A hybrid of assuming and transferring risk is insuring oneself inthe form of a deductible or a self-insured retention (SIR). Depending on the size of thecompany, SIRs can be millions of dollars, with excess insurance intended to cover thesignificant losses.Insurance OptionsRecall-related losses can necessitate various kinds of insurance. Very often, when manufacturersapproach an insurance problem, they tend to look for the one insurance policythat responds to a particular circumstance. Sometimes the answer is more than one. As aresult, a company might need to look carefully at an entire insurance portfolio to piecetogether the complete coverage picture.Some basic categories of insurance relevantto recalls include:• First-party property insurance: This coversdamage to your own property andloss of business income that results or istied to that damaged property.• Third-party liability insurance: Thisis coverage that applies for liability tosomeone else, that is, to third parties.These can include parties like downstreampurchasers or consumers.• Specialty policies: These often arecalled “recall policies,” which is somethingof a misnomer because they typicallyare triggered by product contaminationrather than a recall itself. Thesepolicies often hybridize some aspectsof first- and third-party insurance. Theymay provide coverage for propertylosses as well as for liability losses thatcome from the recall. Additionally, theyoften provide certain kinds of add-oncoverage. For example, some specialtypolicies provide “crisis coverage” or“crisis management coverage” that istypically added by an endorsement andvery often is subject to a sublimit. Notinfrequently, the insurer dictates thepreferred vendor for such services.Although one or more such policiesmay cover a loss, they often haveexclusions and limitations. Limits can bedollar amounts or items that are carvedout entirely from coverage. For example,exclusions may apply to certain kinds ofingredients or certain kinds of suppliers,such as ingredients sourced from Chinesesuppliers. Depending on a manufacturer’sbusiness, such exclusions may create a substantialgap in coverage.Specialty Insurance PoliciesSpecialty policies are becoming increasinglypopular. These policies may providecoverage for items such as notifying customersof the recall, shipping, disposing,repairing, replacing or providing refundsfor recalled products, extra warehousing,extra personnel, crisis management servicesand customer lost profits. Small to midsizemanufacturers compose the main marketfor specialty policies, in part because thesecompanies may have concerns about bearinga substantial retention or absorbing the56 F o o d S a f e t y M a g a z i n e

isk rather than transferring it.Importantly, however, these policiesmight not be triggered by certain types ofrecalls and market corrections. Triggeringlanguage will not necessarily track relevantFDA regulations and policies, and certainrecalls deemed voluntary might be excluded.Contamination from accidents ortampering usually will trigger coverage. Ofcourse, the language of different policiesmay vary, and the terms agreed to by theinsurer and insured ultimately dictate thescope of coverage. Fortunately, in today’sinsurance market, where there is a great dealof variety among specialty coverages, someterms and conditions might be negotiable.The Key Lesson: CollaborationIs EssentialRecalls often occur at a rapid pace, requiringmanufacturers to quickly decipher,analyze and act upon an evolving fact pattern.The health of consumers, the reputationof the company and many millions ofdollars may be at stake. With so many concernslive at the same time, manufacturersshould expect to face regulatory, communicationand legal challenges during arecall. Accordingly, personnel experiencedin each of these fields should be involved,coordinated and aligned in their approach.Being aware of the diversity of potentialissues arising out of a recall, and being preparedto address them, tends to result in aseamless approach to a crisis.•This article is not intended as legal advice, nor does itnecessarily reflect the views of the clients of Covington& Burling LLP and Powell Tate. Readers should seekspecific legal advice before acting with regard to thesubjects mentioned herein.Suzan Charlton is a special counsel in Covington & Burling’s Washington office. She has represented policyholdersin insurance coverage disputes for more than 15 years.Sally Squires, senior vice president, leads the food, nutrition and wellness practice at Powell Tate communicationsagency in Washington, DC, which she joined in 2008 after spending years as an award-winning health journalistat The Washington Post.Christopher Pruitt is an associate in Covington & Burling’s Washington office. Pruitt has experience advisingmanufacturers of drugs, devices, food and other products on a range of regulatory issues involving FDA.For more information on recall solutions, please visitwww.foodsafetymagazine.com/signature.asp.Safety. Simplified.With Ready-to-Use Solutions & Standards.Our job is to make your job easier. We have the right BEVERAGEtesting chemical solutions and standards, ready when you needthem. Source with us to:• Save on manpower costs• Free up personnel for more productive activities• Avoid hazardous operations and the need to store/handlehazardous chemicals• Simplify purchasing• Eliminate the need to purchase multiple raw materialsto make one solution• Reduce paperwork and overheadMarialuisa Gallozzi is a partner in the Washington,DC, office of the law firm Covington & Burling. She has25 years of experience in providing settlement andstrategic advice on insurance coverage issues and hasrepresented and advised companies in recalls involvingfoods, drugs and medical devices, and assistscompanies in planning for crisis events and in crisiscommunications.Miriam Guggenheim is a partner in Covington &Burling’s Washington office. Her practice focuses primarilyon the food and dietary supplement industries.She counsels clients in all aspects of food developmentand marketing.Our dedicated team of technical serviceexperts will ensure that you receive theproducts you need to perform your jobin the lab or on the production floor.Contact us at:Phone - (888) GO-RICCA (467-4222)Email – customerservice@riccachemical.comWeb – riccachemical.comO c t o b e r • N o v e m b e r 2 0 1 2 57

PRODUCEBy April WardThe Leafy Greens Marketing Agreement:5 Years LaterIn 2006, a multistate outbreak of Escherichia coliO157:H7 sickened 202 people and resulted inthree deaths. The source was found to be spinachfrom California, and the cause is believed to becontamination from the farm. Understandably,consumer confidence in spinach, and other leafygreen vegetables, plummeted. Although the product came fromonly one company, the entire leafy greens industry was reelingfrom the impact of this tragic event. As a result, California farmerscame together to raise the bar for food safety and formed theCalifornia Leafy Green Products Handler Marketing Agreement(LGMA). Through this rigorous program, shippers and farmers areworking collaboratively to protect public health by reducing potentialsources of contamination in California-grown leafy greens.What Is the LGMA?The California LGMA is an unprecedented food safety program thatwas created to protect public health by establishing a culture of food safetyon leafy greens farms.At its inception, the LGMA was a unique program forging aAn entire industryunited to protectpublic healthnew path for produce food safety. Creating theprogram in response to the tragedy of the 2006spinach outbreak, the California leafy greensindustry vowed not to forget the victims. Overthe years, the industry has demonstrated a widespreadcommitment to protecting public healthby establishing a culture of food safety throughout their individualorganizations and farms. Today, 99% of the leafy greens producedin California come from 115 LGMA members, their growers andharvest crews. Arizona is another substantial leafy greens producerand has established a sister program—combined, approximately90% of U.S. leafy greens production is grown and harvested inaccordance with the LGMA program.The LGMA, operating with oversight from the California Departmentof Food and Agriculture, is a mechanism for verifyingthat growers follow science-based food safety practices for lettuce,spinach and other leafy greens. Each LGMA member is required tobe in compliance with all LGMA standards to achieve certification.Food safety audits, conducted by government inspectors, are mandatoryfor all LGMA member companies. Each member company58 F o o d S a f e t y M a g a z i n e

®SOLUTIONS FOR TODAY,PLANNING FOR TOMORROW ®Join thousands of your colleagues and like mindedprofessionals at the 15th Annual Food SafetySummit. You will learn from expert speakers andtrainers, exchange ideas and find solutions to yourcurrent job challenges.FROM FARM TO FORKENGAGE IN THE VALUABLE OPPORTUNITIESTHE SUMMIT HAS TO OFFER:• Extended Networking and Special Events• Top-Notch Suppliers Demonstrating the LatestTechnologies on the Exhibition Hall Floor• 8 hours of Uninterrupted Exhibition Hall Time• Specialized Training and Certification Courses• 3 Full Days of Education Covering Food Safetyfrom A to Z including:- The realities of implementing FSMA- Collaborating with local, state and federal regulators- Traceability and Farm to Fork accountability- Combating the most common pathogens in foodprocessing- Best practices in preparing for an audit or inspection- Import/brokers - foreign supplier validation programsAPRIL 30 – MAY 2, 2013 • BALTIMORE CONVENTION CENTERREGISTER TODAY AT: WWW.FOODSAFETYSUMMIT.COMSILVER SPONSORBRONZE SPONSORMEDIA PARTNER

PRODUCEis audited several times a year. Every leafy greens farm that suppliesproduct to an LGMA member is audited at least once per year. Theaudits are designed to determine whether a member of the LGMAis in compliance with the food safety practices that cover farming,harvesting and cooling operations.The LGMA service mark provides assurance for grocery stores,restaurants and other institutions that product bearing the markis already providing government audit and oversight of food safetyfor produce items with costs being borne by the industry itself.Doing so would allow the government to save approximately $1.2million per year in costs to inspect leafy greens in California aloneand would provide government inspection for approximately 80%of the leafy greens produced in the United States.“The California LGMA is an unprecedented food safety program thatwas created to protect public health by establishing a culture of foodsafety on leafy greens farms.”has been grown according to the LGMA food safety practices viamandatory government audits. Members are required to take correctiveaction on any and all findings cited during governmentaudits, and measures must be taken to prevent future infractionsfor any practice found to be out of compliance. The LGMA providesthe public with a list of certified member companies andposts names of any member who is decertified.Who Uses the LGMA?Leafy greens growers and shippers, North American produce buyersand U.S. regulators stand to benefit from this rigorous food safety verificationsystem.LGMA members are companies (also known as handlers) whoput California leafy green products into the marketplace. Theyare required to utilize the program’s food safety practices, whichare verified via mandatory audit every 2 months during production.Additionally, one unannounced audit is conducted annually.All members, their growers and harvesters are encouraged toparticipate in LGMA technical training seminars that are offeredthroughout the state and target areas of frequent audit citations.Only certified member companies are able to ship California leafygreens into Canada (a requirement of the Canadian Food InspectionAgency).Produce buyers, grocery stores, restaurants and other institutionshelp enforce the LGMA program by having policies in placeto buy only from certified members of the program. The programfocuses on continuous improvement by requiring corrective actionon all audit citations, which results in 100% compliance. LGMAmembers who fail to be in compliance with the program can bedecertified—notification of decertification is made public andshared immediately with the produce-buying community.The Food Safety Modernization Act (FSMA) is a new lawthat aims to protect the food supply by shifting the focus fromresponding to contamination to preventing it. The FSMA willdirectly affect the fresh produce industry when the U.S. Foodand Drug Administration (FDA) issues its pending Fresh ProduceSafety Rule. This rule will focus on the safe production, harvestingand packing of fresh produce. The LGMA is encouraging FDA toconsider adopting California’s comprehensive food safety programas a means of meeting requirements of new FSMA legislation as itA Model ProgramThe LGMA food safety program has been successfully implementedsince 2007 and provides a system that can be easily adapted for a widerange of farming operations and products. Similar to HACCP, theLGMA program has six principle elements.1. Assess RisksExperts have identified specific food safety hazards associatedwith the production of leafy greens for water, soil amendments,environmental conditions, worker practices and field operations.LGMA members must review their own operations for these potentialfood safety hazards.2. Apply ScienceThe food safety practices used every day by LGMA membersand their growers are designed to reduce potential sources of contaminationand give specific and science-based guidance for growingand harvesting leafy greens.3. Document PracticesLGMA members are required to document that all requiredfood safety practices have been implemented. Documentation isaudited by government inspectors.4. Verify ComplianceCompliance with food safety practices is verified throughmandatory audits of leafy greens farms by U.S. Department ofAgriculture-trained government inspectors. The audit covers farming,harvesting and cooling operations. Members are subject toseveral mandatory inspections annually, both scheduled and unannounced.5. Provide Corrective ActionsCorrective action is required on any and all findings citedduring government audits. Preventive actions are also requiredto further protect public health. Completion of corrective andpreventive actions is verified upon subsequent reinspection. EachLGMA member is required to be in compliance with all LGMAfood safety practices to achieve certification.60 F o o d S a f e t y M a g a z i n e

PRODUCE6. Promote TransparencyCertification status, including any decertification actions, ofLGMA member companies is listed on the LGMA website at alltimes. In addition, the LGMA website provides access to the foodsafety practices, the audit checklist and annual reports that provideinspection and citation data.What’s Happened Over the Past 5 Years?Since that first year (2007), the LGMA has conducted a total of 2,585audits and over 200 billion servings of leafy greens have been grown underthis system of mandatory government inspection.That is an average of more than 500 audits annually, with eachLGMA member being audited once every 2 months in productionand undergoing one unannounced audit annually.On average, approximately 1,000 audit citations have beenissued annually, all of which must be corrected for an LGMAmember to be certified. Minor infractions, which do not necessarilyincrease risk associated with the product, are corrected on-siteand account for 31% of all citations. Minor deviations, which areissued when practices on the farm don’t follow LGMA guidelines,but the risk to food safety is not necessarily higher, require thata corrective action plan be submitted in 5 days and account for64% of all citations. Major deviations account for about 5% of allcitations and are subject to reaudit in 3 days. Flagrant violationsaccount for less than 0.2% of all citations and can lead to decertification.Over the life of the program, six companies have beendecertified for noncompliance, and two companies that were notyet certified were declared ineligible for certification until the nextcalendar year.Over the years, assessment rates have dropped and inspectioncosts have decreased as the program becomes increasingly efficient.An impressive training program has been added to the LGMA offeringsto assist handlers and work crews to ensure everyone knowsand understands the importance of food safety on the farm.The LGMA program has continued to evolve, although its missionremains focused on ensuring safe products and confidencein leafy greens. During a recent strategic planning process, theLGMA board approved a set of priorities that include: attainingglobal food safety certification; engaging regulators on food safety;increasing industry education and working to establish the LGMAas a leading resource on leafy greens food safety. Yes, the LGMAhas come a long way in 5 years. While the program is continuallyworking to improve, the most important outcome of the LGMA isthat the industry has not repeated the tragic events of 2006.For more technical information on the CaliforniaLeafy Greens Marketing Agreement, visitwww.lgma.ca.gov.•April Ward is communications director of the California LeafyGreens Marketing Agreement.AOCS has the winning hand whenit comes to your laboratory needs.AOCS Technical Services provides the necessary resourcesfor your lab’s quality and reputation. A sure bet since 1909.● AOCS Methods● Laboratory Proficiency Program● Certified Reference Materials● Approved Chemist ProgramLearn more at www.aocs.org/LabServicesO c t o b e r • N o v e m b e r 2 0 1 2 61Tech-Cards-FoodSafety-Half.indd 15/10/12 9:42 AM

CASE STUDY: COSTCO WHOLESALEBy Food Safety MagazineCostco Wholesale:Food Safety from the Top DownWhen customers buy food products at Costco,they are assured of the company’s highest commitmentto food safety. This basic expectationis met every day for more than 56 millionCostco members shopping in 605 membershipwarehouse stores located in 40 U.S. states, PuertoRico, Canada, Mexico, the United Kingdom,Japan, South Korea, Taiwan and Australia. R. Craig Wilson,vice president, food safety and quality assurance, with CostcoWholesale, along with his international staff of 27 food safetyprofessionals, operates with the following mantra: Food safetyshould be absolutely invisible to Costco’s members.The primary reason that Costco’s food safety program issuccessful is that it is part of the corporate culture: Executiveand senior management understand how important food safetyis and are incredibly supportive of all food safety efforts, issuingthe group mission statement: Promote continuous improvementin product quality, and product safety systems, for thebenefit of our members and vendors.The Issaquah, WA–based wholesale club operator is the largestsuch company in the U.S., with sales of $87.05 billion in FYAn updated casestudy looking ata successful retailfood safety program2011. Costco offers between 3,700 and 4,000different brand-name products to its membersat any given time, with fresh food, groceriesand related items that constitute approximately50% of the company’s business. The warehousebuildings average 135,000 square feet,with ample space dedicated to the company’sin-building service deli, food court and fresh food and grocerydepartment operations. As part of its mission to provide clubmembers with high-quality products at substantially lowerprices than traditional wholesale or retail outlets, Costco alsomakes available the Kirkland Signature private-label productline, which includes food items such as coffee, juice and cookies.In addition, Costco Wholesale Industries, a division of thecompany, operates a food packaging manufacturing business inSan Diego, CA, and Monroe, NJ, and a meat processing facilityin Tracy, CA.Costco’s food safety program is composed of a four-pointplan: a company-wide food safety training; food safety operationsin the warehouse club buildings, which involve a uniqueuse of Sanitation Standard Operating Procedures (SSOPs) and62 F o o d S a f e t y M a g a z i n e

Food_Ad_NewFood_FoodSafety_twothirds.indd 15/16/12 3:34 PMHazard Analysis and Critical ControlPoints (HACCP) developed to work ina retail setting; knowledge-building foodsafety vendor audits; and quality assurance.Continuous Training andEducationTwo levels of food safety educationand training programs were developedin-house with the certifications and examinationsadministered by Costco staffin each building to maintain the company’scultural advantage. Educating allemployees, whether they work in foodor nonfood areas, about food safety isanother way in which Costco keeps foodsafety invisible to its members.All managers are required to take Level2 Food Safety Manager Training every3 years. This supports Costco’s commitmentto cross-training its employees.Says Wilson, “This is a dynamic company.We could have someone who’sworking in a nonfood-related area today,but tomorrow, he receives a promotionand is managing a foods area. Our foodsafety training and certification programenables employees to have the knowledgethey need to successfully move intodifferent departments during their career.”Costco’s Manager Certification isa nationally recognized training programthat is endorsed by the National EnvironmentalHealth Association and theAmerican National Standards Institute.All hourly employees who handle foodare required to take Costco U (in-housecomputer training system) Level 1 FoodSafety Training annually. Costco FoodSafety developed the hourly certificationtraining program in conjunction withMediaPro.Costco U provides a comprehensiveintroduction that covers SSOPs for allareas and advises employees on theirroles and responsibilities in ensuringsafe foods. Currently, Costco can offerthe training in English, Spanish,Cantonese, Japanese and French. Afterviewing Costco U’s food safety training,each employee is tested and awarded acompletion certificate that is recognizedby local health departments.waters.comServing fast, accurate resultswith innovative sample preparationand column solutions.With a wide range of food safety products, advanced applications,and dedicated technical support, we work with government andindustry partners around the world to ensure that you achievefast, accurate, and reproducible results.Browse our menu of laboratory solutions atwww.waters.com/ftPharmaceutical & Life Sciences | Food | Environmental | Clinical | Chemical Materials© 2012 Waters Corporation. Waters and The Science of What’s Possible are trademarks of Waters CorporationO c t o b e r • N o v e m b e r 2 0 1 2 63

CASE STUDY: COSTCO WHOLESALECostco has created easily understandable protocols and procedures available inboth print and electronic formats in all of its warehouse buildings and processing/packaging operations. The system encourages employees to proactively interact withcorporate food safety management, which further supports the emphasis on preventionand control found in HACCP plans and in the Costco culture. One measure ofthe program’s success is the fact that many organizations want to emulate it. Costcoshares program information with local health inspectors, food safety officials fromthe states of Washington, Oregon, Illinois and Michigan, among others, who use thecompany’s program as part of their training. “The satisfying part about having a programlike this is when health inspectors come into our buildings at locations aroundbuilding. The result was a set of specificHACCP plans for each food department—andfor each item, in some cases—all focusing on validated Critical ControlPoints, with specific updated FoodCode criteria included for the servicedelis and food courts, for example.To implement an HACCP plan thatworks, notes Wilson, a company musthave good SSOPs in place. “If you look“Costco has created easily understandable protocols and proceduresavailable in both print and electronic formats in all of its warehousebuildings and processing/packaging operations.”the world, not just in the U.S., and tell us that they are extremely impressed. We’revery open about sharing all of the information we have with these organizations,”says Wilson.Operations: An Ongoing ResourceFood safety operations serve as a daily resource for Costco buildings, buying offices,risk management, human resources and the call center/member services group,which deal with the following concerns:• Inspection issues• Environmental issues• Member issues• Employee issues• SSOP issues• HACCP issues• Depot issues• General building sanitation issuesEach Costco location is required to respond to every type of inspection [healthdepartment, credentialing opportunities online (COOL), U.S. Department of Agriculture(USDA), etc.] with a written letter, outlining findings of inspection and anycorrective actions taken. A copy of the letter is sent to the corporate regional vicepresident as well as to food safety operations, which tracks all inspections and responseletters, and issues a report each period outlining the findings, later using thesefindings to target training and update programs.This, says Wilson, is one of the distinguishing elements of Costco’s SSOP/HAC-CP program. “One of the biggest challenges for any food scientist or engineer is totake a concept that’s reasonably difficult and communicate it so that everybody understands.That’s our focus: Make it simple so it’s not a big deal. Our main goal wasto come up with a simplified, understandable process designed for and accessible tothat 18-year-old high school graduate who is actually doing the work in order to makethe program efficacious.”Costco began its retail SSOP/HACCP program approximately 12 years ago, usingthe government guidelines originally created for food processing operations. It thencustomized SSOP and HACCP-type criteria for each kind of food-related area in itsbuildings. The company’s goal included structuring its SSOP/HACCP program toexceed federal guidelines, whenever possible, and to incorporate related food safetyprotocols from sources such as the U.S. Food and Drug Administration (FDA) FoodCode and local health inspection agency rules into appropriate departments in eachat federal HACCP guidelines with regardto SSOPs for a meat, seafood or cerealfacility, you’ll find that they are verycomplicated and written in such a fashionthat perhaps only a sanitarian canunderstand. However, the person in thefacility who does the work may neversee the SSOP. Because we’re committedto making food safety procedures easyto understand for all employees, we’vetaken a completely different approach todeveloping the SSOP. We believe thata Sanitation Standard Operating Procedureshould be focused on the peoplewho are doing the work. This means giveemployees a tool that makes sense, atool that validates their work and then isreviewed by management.“As a result, these SSOPs have beendeveloped digitally with very limited textbecause those doing the work must beable to look at them and relate them towhat they’re doing. The employee cansee exactly what is expected from a foodsafety standpoint—how to set up andoperate a slicer or grinder, how to washit, how to reduce cross-contamination offood contact surfaces or food-handlingareas using appropriate hand washingand personal hygiene techniques, how tomonitor food product-specific temperatureand holding times and so on. Hecan also see what corrective actions mustbe taken and what documents or logsmust be completed.“Of course, there are SSOPs andHACCP criteria for each and every64 F o o d S a f e t y M a g a z i n e

CASE STUDY: COSTCO WHOLESALEdepartment, and every component of aHACCP plan that you would find in abig meat or seafood plant you will findin the manual here. The difference isthat this is simple and easy to follow,and is available on a computer in eachone of the buildings, so if there’s a questionabout an SSOP, the employee cango right to their department computer,pull up the SSOP and take a look at it.”Vendor Auditing for QualityAssuranceAnother element of Costco’s foodsafety program that has been imitated bymany others is its extensive vendor auditprogram. Twelve years ago, the companylooked at the large number of vendorsfrom which it purchased food productsand considered strategies to better assessthe safety and quality of the productssupplied. At the time, the Costco QualityAssurance Department conductedcursory checks of vendor products, Wilsonnotes, but the company decided todevelop a more interactive vendor auditprogram. The result is that Costco’ssystem is considered by many of its suppliersas the premier vendor operationauditing program in this sector of thefood industry. Additionally, Costco hasinvested in a documentation retentionand electronic storage service in whichall vendors supplying food to Costcomust be registered with and have audits(both food safety and animal welfare,see below) posted to the service’s site bythe auditing company. The site is alsoused to post other certifications relatedto products supplied to Costco. Wilsonnotes that it has been beneficial to haveall documents stored in a single location.Food SafetyIn FY 2010, 6,925 food safety auditswere completed by Costco-approvedthird-party auditing companies, focusedon sanitation, HACCP, vendor ingredientprograms, traceback, food defense/biosecurity and corrective actions. Ofthe completed audits, 39% of vendorsachieved an “excellent” rating (auditscore > 95%), 41% of vendors achieveda “good” rating (audit score between90% and 95%) and 14% of vendors achieved a “fair” rating (audit score between 85%and 90%). The audits are not punitive but are focused on improving the safety of theproducts supplied to Costco and were designed to meet the company’s requirementthat all food vendors have an annual food safety audit.Animal WelfareIn FY 2010, 304 animal welfare audits were performed and 100% of vendorsachieved an excellent rating. These audits were designed to ensure that all animalsconverted to food are treated in the most humane way possible on a consistent basisNationwideIndependent Sampling,Inspection and Testingof Imported FoodsCONTROL, MONITOR & VERIFYEnsure the safety and quality ofimported foods and ingredients:Inspect on entry into the USAToll Free: 888.387.5227Email: orders@ftslabs.comFOREIGN TRADE SERVICEIndependent Laboratory ServicesFDA Detention Specialistswww.ftslabs.comO c t o b e r • N o v e m b e r 2 0 1 2 65

CASE STUDY: COSTCO WHOLESALEand that vendors comply with standards set by both USDA/FDA as well as Costco.Wilson believes that this nod from manufacturers and vendors is due, in part, tothe fact that the audits make their own systems better. “Our vendors have embracedthe auditing program with open arms, because it’s making them better vendors andit’s ensuring that our members are getting exactly what our buyers want them to get:high-quality food items all the way through. We even negotiate the audit price for ourvendors so that they don’t have to pay a ton of money for the audits. It’s a real handin-hand,win-win situation with our vendors.”Wilson adds, “We spend a lot of time with our vendors, and if the audit shows thatthere are some unmet requirements, we’ll help that vendor do whatever they needto do to meet the criteria. For example, we provide resource lists to vendors to assistthem in finding industry consultants, trade association and academic experts, andup letter with even more details to helpanswer a member’s concerns. The systemis based on membership data collected atpoint of sale for each item sold.This recall approach is used as amodel by USDA, FDA, the ConsumerProduct Safety Commission and the EnvironmentalProtection Agency.The basis for the system is the “onestep back (supplier), one step forward(customer)” approach of recall traceback.The item affected is blocked and pulled“All areas of Costco’s food safety program are under constant review,change and improvement; nothing is allowed to remain static.”service providers such as pest control and testing companies. We do this to assist vendorswho want to begin to or continue to do business with us.” The buying staff, whoare all food-safety certified by Costco’s Food Safety Training program, schedule foodsafety audits with all new vendors, says Wilson, but the auditing program has a loftieraim. “Our goal is to audit every one of our vendors every year. We haven’t yet reachedthat goal because of the enormous number of vendors with whom we do business,but it is a goal that we continue to work toward achieving.”Quality Assurance Drives Food SafetyThe quality assurance (QA) department provides the science behind the foodsafety system, offering food safety and QA support to all of Costco’s warehouse,manufacturing, packaging and private-label operations.Food product samples are analyzed by the QA team against the specifications thathave been set by the buying staff. The department also works with third-party laboratoriesfor chemistry and microbiology in addition to the company’s own microbiologicallaboratories located in its ground beef processing plant and repackaging facilities.QA also coordinates sampling and testing of products scheduled for export and itemsto be tested in other countries in which Costco operates.“Having a strong technical arm gives us credibility in everything that we do,” statesWilson. “Not only do we have the programs, but we have the capability to get and usethe data to support the programs, which we feel is a very important element of oursuccess on many fronts.“The pathogen testing that we perform at the Tracy, California, meat plant, wherewe use polymerase chain reaction technology all the way through, is fully supportedup here by our QA department. Our ground beef operation produces about a half amillion pounds of ground beef a day, both raw and cooked, and we can effectivelycollect and analyze data on the microbiological quality of every single grind.”The data generated by the QA department is ultimately shared with vendor suppliersfor continuous improvement, feeding into the training and operations steps of thefood safety program.Unique Approach to Shopper ProtectionCostco has a unique approach when it comes to protecting their members and providingappropriate notification for a recalled food or nonfood item. The company canblock the sale of any item in the system within minutes of a recall notification.Costco can notify each member, who purchased an item that was included in aClass 1 recall by telephone within hours of an incident announcement, and a follow-from shelves quickly, even before anofficial regulatory announcement. Membersare notified, often at an average of870,000 calls per hour on the day of theincident (Class 1/Quality recalls). Costconever waits to protect their members: Itis part of the company culture and management’scommitment to food safety.Similac RecallPossible contamination of Similacbaby formula was noted in 2010 and252,631 members were contacted lessthan 24 hours from the notification.Danielle Salami ProductsA recall was issued in 2010 due toSalmonella contamination; 396,892 memberswere contacted, and the product waspulled from locations 8 days prior to anyissued press release.The Costco Way of FoodSafety“We have more than 164,000 employees,and when you look at making a programlike this work with so many peopleinvolved, it can sound daunting,” addsWilson. “But with our built-in culturethat supports food safety coupled withthe way that Costco is structured, we reallyhave a food safety staff that consistsof 164,000 employees, and so we’re successful.“I’m a firm believer that there’s notone person in our company who wantsto make somebody sick. It’s a matter ofhow we teach people to give them a clearunderstanding of their role in keeping66 F o o d S a f e t y M a g a z i n e

CASE STUDY: COSTCO WHOLESALEyfood safe and then giving them the righttools to do the right job.”While Costco’s four-point foodsafety plan is an established success, thecompany isn’t completely satisfied. “Wedon’t look at food safety as a competitiveadvantage,” states Wilson. “If thereis anything that we do that can be ofbenefit to the safety of the nation’s foodsupply, we’re more than willing to sharethat with the industry. Our food safetyprograms are under constant review, andwe continue to focus on how we canimprove them, simplify them for everybodyacross the board and still expectexcellent results.”Where Do We Go from Here?All areas of Costco’s food safety programare under constant review, changeand improvement; nothing is allowed toremain static.The company’s goal is to always beahead of and a contributor to the regulatoryagencies with which it works whilekeeping their members and buildings as a primary focus.With simplicity in mind, the following challenges have been identified for improvementin the coming year:• Food Safety TrainingExpand Level 1 Food Safety Training to all hourly employees in the locations.Improve warehouse adherence to Level 1 Food Safety Training requirement (currentlyat approximately 87% compliance).• Food Safety OperationsSOPs/SSOPs under constant review; change as necessary to accommodate newequipment, new procedures and best practices.Health department inspection follow-up, using information obtained from inspectionsto target training at the building level.Develop better ways to track follow-through with SSOPs.• Food Safety Vendor AuditsContinually increase expectations for vendors based on best practices.• Quality AssuranceEvaluate new food safety technologies for possible implementation.Finally, the biggest challenge but certainly an achievable goal moving forward is tocontinue to improve member communications and understand new communicationformats, including social media, for the ultimate protection of our members worldwide.•Many thanks to R. Craig Wilson, vice president of QA, food & product safety, merchandise services at CostcoWholesale, for his contributions to the article.New Dimensionsin Sample PreparationCYCLONE MILL TWISTER• Ideal for grinding feeds, grains, forage andsimilar products• 3 controlled speeds• Cyclone separator with 250 ml collecting bottlefor quick extraction of sample• No cross contamination thanks to easy cleaning• Convenient operating panel• Professional industrial design with long lifetimewww.retsch.com/twister74 Walker Lane | Newtown, PA 18940 | info@retsch-us.com1-866-4-RETSCHWWW.RETSCH.COMO c t o b e r • N o v e m b e r 2 0 1 2 67Food Safety-09Sep2012-TWISTER.indd 1 07.09.12 17:03

SPOTLIGHT: MEAT AND POULTRYBy Lone Andersen, M.Sc.Bacteriocin-Producing Starter Culturesfor SalamiMicroorganisms are a group of organismsthat are both treasured and despised. They arewell known and appreciated in, for example,production of dairy products and wine. Theyare detested because they cause a multitude ofdiseases, among them food poisoning, whichleads to deaths every year. Furthermore, theycause huge economic losses due to reduced shelf life and spoilageof food products. Nevertheless, not many contemplate thathuman beings carry approximately 2 kg of microorganismswith more than 10 14 CFU bacteria and a diversity of more than1,000 species, ranging from harmless to pathogenic bacteria, inour gut. All these microorganisms are necessary and performmany important functions for our existence and well-being.It is important to recognize that all not-sterile food containsmicroorganisms; nonetheless, only bacteria will be mentionedherein. The composition and level of bacteria are highly influencedby a variety of internal (e.g., bacteriological quality,food matrix, pH, water activity and fabrication) and external(e.g., humidity, packaging and temperature) features, in additionto synergistic and antagonistic interactions between thesefactors. For bacteria, the food matrix is important, as bacteriaDo good bacteriaexist for meatapplications?need nutrients and water to thrive, but thetype of packaging, availability of oxygen andtemperature during processing and storagehighly affect both the composition and levelof bacteria. Consequently, the bacterial biota isconnected with the food product and storageconditions, and it is important to rememberthat the bacterial population is extremely diverse: what is badfor one might be good for another, as protection might targeta limited group and, consequently, not be efficient. Evendormant bacteria might be of concern because, by either crosscontaminationor a change of environment, they might reacha food matrix or conditions that allow activation and therebytrigger food poisoning.For living bacteria, a certain level of pathogenic bacteriais needed to cause human food poisoning, but the amountrequired to cause illness depends highly on an individual’sphysical condition. Here, there are interactions between, forinstance, conditions of the immune system, use of medicinesor alcohol, pregnancy and age. For already-known pathogenicbacteria, it is difficult to provide specific limits; nevertheless,guidelines are available. Not only might bacteria cause prob-68 F o o d S a f e t y M a g a z i n e

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SPOTLIGHT: MEAT AND POULTRYlems in food products, but also toxins produced by certain bacteriamight be involved in food poisoning both before and afterthe pathogenic bacteria are eliminated. It appears to be a verycomplex and almost impossible task to contemplate bacteria infood products, and as mentioned, the presence of both spoilageand pathogenic bacteria results in huge economic losses dueto discharged food and food poisoning. Luckily, the majorityof bacteria are harmless, some even helpful, but why count onuncontrolled indigenous bacteria in food production whendominant and undamaging starter cultures might be an option?Starter CulturesTraditionally, lactic acid bacteria (LAB) have been used inthe production of food, in dairy products as well as in meatproducts and vegetables. For early applications, LAB werecharacterized by their presence that resulted in changes in, forexample, pH, texture and sensory characteristics of fermentedfood. More recently, LAB are applied as protective or probioticcultures that don’t influence the sensory properties of the foodproducts. LAB are generally recognized as safe (GRAS) organismsand well known for their ability to produce a number ofantimicrobial compounds. None of these compounds need, bythemselves, to elicit a complete inhibitory effect, but togetheror in the presence of other inhibiting factors, they can contributeto a hurdle effect. The understanding is that the sum ofthese protective factors results in the overall inhibiting effect.Protection of meat can be achieved by competitive exclusion,bacteriocin producers or a combination of both.Meat Starter CulturesCured meat products, such as cured, fermented and dry sausages/salamiand fresh sausages, are raw meat products; thus,there will always be an unknown amount and composition ofindigenous bacteria in the meat matrix.Salami was produced long before the outcome of microorganismson the process of producing salami was recognized.Before starter cultures were commercialized, the manufactureof salami relied on the existence of indigenous LAB in raw materials.That was possible due to smaller, handmade “home productions.”However, it was difficult to transfer this productionmethod to more industrial production. Problems such as long,variable production time, discoloration and off-flavor appeared.As a way to circumvent these problems, meat manufacturerscould presalt the meat to favor indigenous LAB to producesalami. Unfortunately, not all LAB are usable for this process.The “right” LAB are homofermentative, which produce lacticacid during fermentation. Unwanted LAB are heterofermentative,which also produce other organic acids and gas. Anotherway to overcome these problems is the usage of the back-sloppingmethod (using a prefermented meat mince addition earlyin the processing). The limitation of this method is that thebacteria present in this meat mince might be unwanted ones,such as pathogenic Escherichia coli O157:H7 and E. coli O111,which then are reinoculated and may survive the manufacturingprocess. In addition, this method could favor the survivalof indigenous antibiotic-resistant strains. Furthermore, if oldpieces of dry sausage are added, the bacteria present may not berepresentative or very active as fermenting and ripening bacteria,and therefore neither way of processing is reliable.Starter Cultures in Salami ProcessingAs a result, starter cultures were introduced about 40 yearsago to the salami industry and are now widely used and acceptedas a necessity to control processing and ensure qualityin salami production. The advantages of meat starter culturesare wide-ranging: They lead to standardization and safety of theproduction process, achieving enhanced development of aroma,flavor and stable color, depending on the processing. It ispossible to turn out product with a high degree of uniformity,and it might be possible to accelerate the processing time.In the manufacturing of meat products, starter cultures arestill primarily applied for technological reasons, such as addingLAB to enhance a controlled pH drop to ensure drying; nevertheless,they also are protective due to competitive exclusion,and they will inhibit some spoilage and pathogenic bacteriadue to the drop in pH. The right combination of the recipe,starter culture and fermentation conditions makes it possible tocontrol the composition and activity of the bacterial flora duringthe acidification and ripening of salami.Another group of bacteria beneficial in the production ofmeat products is nontoxic staphylococci. They are appliedto improve aroma formation, color development and colorstability. Staphylococci will not only improve these featuresduring the production of salami but likewise enhance theirdevelopment in whole muscles, such as coppa, pancetta, bresaolaand semidry ham products. The advantage of applyingstarter cultures in these categories of raw meat products is wellestablished, as it is recognized that it is necessary—and advanta-Bacteria Activity Action in meat AdvantageStaphylococci Nitrate reductase production Color formation Improves color formationCatalase activity Color stability Prevents discoloration and spoilageProteolytic activity Aroma formation Enhances aromaLipolytic activity Aroma formation Enhances aromaLAB Organic acid production Decline in pH Influences drying out, texture, safetyBacteriocin production Enhances safety SafetyDecrease in redox potential Inhibits aerobic bacteria Safety and color formationNutrient competition Inhibits indigenous bacteria Uniform productionTable 1: Activity of Meat Starter Cultures70 F o o d S a f e t y M a g a z i n e

SPOTLIGHT: MEAT AND POULTRYgeous—to control the indigenous biota with controlled andbeneficial bacteria.The activity of meat starter cultures is summarized in Table 1.When it comes to safety, LAB are most advantageous; therefore,only LAB will be further discussed.The antimicrobial properties of LAB consist of several activitiesthat most likely interact and possibly have synergisticeffects. Among the most powerful properties relevant for theproduction of salami are the following:• Production of organic acids lowers pH; organic acids havean antimicrobial effect, as many spoilage and pathogenicbacteria are inhibited by a lowering in pH.• Production of bacteriocins, heat-stable polypeptides producedby certain LAB, has an antimicrobial effect on other,mostly closely related bacterial species.• Lowering the redox potential by the growth of LAB inhibits, inparticular, indigenous, aerobic spoilage and pathogenic flora.• Nutrient competition occurs when a high number of LABare added. These bacteria quickly reduce the easily transformablenutrients, and consequently, indigenous bacteriaare inhibited.BacteriocinsAs mentioned, bacteriocins are antibacterial peptides, whichmay influence the growth of related bacteria in their nearenvironment. Nearly 300 types of bacteriocins have been discovered,of which the ones produced by LAB are used commercially.The genes encoding bacteriocins are located on eitherchromosomes or plasmids, and those produced by LAB have arelatively broad spectrum of action. The bacteriocin-producingstrains are protected against their own bacteriocin, as they possessgenetically determined immunity genes.There are different ways of classifying LAB bacteriocins; oneof them is division into three main classes, with a number ofsubclasses. The classification is predominantly based on similaritiesin structure, mode of action and common characteristics.For food applications, class I and II bacteriocins are prevalent,and most research has been conducted on these bacteriocins.Class I bacteriocins are called lantibiotics because they containthe amino acid lanthionine. They are small peptides synthesizedas prepeptides and are divided into types A and B. Type A areelongated peptides, which inhibit or kill susceptible bacteria byforming pores via electrostatic interactions in membranes of targetbacteria. Hence, the cell motive forces and equilibria are disrupted,and the bacteria inactivated. Nisin is the best-known classI type A bacteriocin. Type B are globular-shaped peptides that,by inhibiting enzymes in receptive bacteria, lead to destruction.Class II bacteriocins are small, heat-stable bacteriocins witha high content of small amino acids; their mode of action issimilar to class I type A bacteriocins with species-specific activ-TMREvolutionaRyPRotEctionProtect EQuipment, avoid recalls• Six NSF ® H1 aerosol lubricants• Metal Detectable Plastic Componentsreduce likelihood of contaminationand recalls• Printed labels eliminate torn paperlabel contamination• Highly visible “Food Grade H1”labeling ensures correct product usage• Ideal for foodmanufacturing,processing, andpackagingNEWTwo NSF ® K2 electronic cleanersLPS ® LABORATORIES • An Illinois Tool Works CompanyWebsite: www.lpslabs.comLPS ® and DETEX are registered trademarks of Illinois Tool WorksScan QR code to watch DETEX Demo Video orgo to www.lpslabs.com/LPS_ProductVideos.htmlFood Safety Horizontal Ad 9-12.indd 19/24/12 1:57 PMO c t o b e r • N o v e m b e r 2 0 2 71

SPOTLIGHT: MEAT AND POULTRYity that causes cell leakage by permeabilizing the target cell wall.They are divided into four subclasses: a—d. Class IIa bacteriocinsare produced by food-associated LAB isolated primarily fromdairy and meat products. They have different antimicrobialactivities but are commonly active against Listeria spp. Furthermore,they have the conserved amino acid sequence YGNGVand at least two cysteine residues that form S-S bridges, which“Another group of bacteria beneficial in the production of meatproducts is nontoxic staphylococci.”seem to be vital for their activity. Pediocin PA-1A is a wellknownclass IIa bacteriocin. The main characteristic of class IIbbacteriocins is that they require two different peptides for activity.To this group belong various plantaricins and lactococcins.Class III bacteriocins are large and heat labile; here, helveticinJ may be mentioned.As purified, commercially available bacteriocins, only nisinand pediocin are on the market. In purified form, they areconsidered food additives and therefore need regulatory approval.Within the EU today, only nisin, E234, is applicable toa limited range of food products, for example, types of cheese,puddings and canned food, but not to meat products.Bacteriocin-Producing Bacterial StrainsAs bacteriocins have a peptidic structure, the meat’s naturalproteolytic system might inactivate them if added directly toraw meat products. Therefore, active metabolizing bacterialstrains, which can produce bacteriocins during the fermentationprocess, are advantageous to achieve an inhibitory effect duringthe production of salami. Bacteriocin-producing salami cultureson the market consist of LAB strains, such as Pediococcus acidilactici,Lactobacillus sakei and Lactobacillus plantarum either aloneor in combination, to achieve production of bacteriocin acrossa broad temperature range such that differences in their temperaturegrowth optimums yield bacteriocin early and/or laterin the fermentation process.Generally, in properly fermented salami produced with acommercial starter culture, the built-in hurdles should controlpotential Listeria growth. Depending on processing, even aslight reduction in total Listeria might occur, but sufficientbacteria might survive to induce cross-contamination duringfurther handling, such as slicing. The good news here is thatListeria monocytogenes is vulnerable to bacteriocins, and consequently,by applying a bacteriocin-producing starter culture,not only are the technological demands accomplished, butenhanced safety also is achieved. In addition to controllingacidification, which enhances drying out, thus providing agood texture, their protective properties enhance the control ofListeria and the production of bacteriocins ensures improvedsafety of salami produced with such starter cultures.Listeria are very resistant to various physical and chemicalinfluences, and consequently, are widely spread in nature andpresent in all types of raw materials. Generally, Listeria resistboth high and low temperatures, and can resist freezing anddrying. Furthermore, Listeria are very tolerant to pH and havealso been known to aggregate as biofilms, being stubbornlyresistant to antimicrobial agents, which consequently results insecondary contamination of food products. A risk factor in theproduction of food products is that up to 10% of the populationare healthy carriers of L. monocytogenes, so without appropriateprecautions, this organism might contaminate productsduring the production process.Outbreaks of listeriosis from L. monocytogenes have beenlinked to cheese and raw materials as well as finished productsmanufactured from meat, poultry and fish. Symptoms canrange from ailments similar to influenza to blood poisoning,meningitis and encephalitis. Furthermore, the pathogenic bacteriacan cause abscesses or granulomas similar to those foundin tuberculosis of internal organs. The incubation period canrange from a few days up to several months. Afflictions occurparticularly in people with weakened resistance and cantherefore be fatal to people with compromised immune systems.Additionally, risk groups include the fetus, resulting inmiscarriage, small children, pregnant women and the elderly.Mortality is more than 50% for people in these groups, whereasit is only a few percent for individuals with healthy immunesystems. Therefore, although L. monocytogenes is widespread inthe environment and serious infections are rare, death rates dueto listeriosis are high with outbreaks.Protective Starter CulturesIn recent times, considerable focus has been directed to thefield of starter cultures for protection. “Protection with startercultures” is the term used when the sole purpose of a cultureis to suppress undesirable indigenous bacteria and thereby enhancethe quality and safety of the meat products.It has been found that most big food poisoning outbreakswere connected with “too bacteriologically clean” products, aswithout competitive and harmless flora, spoilage and pathogenicbacteria, such as Listeria, could develop rapidly. Protectivecultures should also be competitive at low temperatures,because at this point, the indigenous flora will develop in coldstoredmeat products. Furthermore, starter cultures should notconsiderably change the sensory properties of food products,but inhibit spoilage and pathogenic bacteria by competitiveexclusion and/or bacteriocin production to increase safety andquality. This means that by adding a controlled LAB culture toapplicable food products, it should be possible to suppress unwantedbacteria and thereby obtain a higher degree of productsafety. However, it is not so easy to persuade manufacturers toapply “good” protective cultures, because the beneficial evi-72 F o o d S a f e t y M a g a z i n e

SPOTLIGHT: MEAT AND POULTRYdence is not technologically apparent or easily measurable. Thestarter culture concept is used mainly in fresh sausages, spreadablemeat products and brine injected into whole muscles soldas fresh products. Protective cultures are also applied on thesurfaces of processed meat products to minimize cross-contaminationduring handling. With suitable starter cultures, thepotential for improved safety is extensive.Many hurdles are traditionally used during the processingof meat products: salting, addition of nitrite or organic acids,cold smoking and packaging using either modified atmosphereor vacuum. Still, lightly preserved food products are high-riskproducts, especially when consumed without heat treatment,when it comes to the growth of unwanted bacteria, as thehurdles are not usually sufficient to control the indigenousflora present from the raw materials, processing and postprocessing/handlingof the products. Nevertheless, it appears thatmost indigenous pathogenic bacteria in lightly preserved meatproducts may adequately be controlled by strictly respectingproduction hurdles, such as salt content, smoke and storageconditions. However, L. monocytogenes still remains a microbialrisk. The prevalence is usually low initially, but the expirationdate is often influenced by the risk of L. monocytogenes to exceed,for example, EU food safety criteria for ready-to-eat foodwithin the tolerated limit of 100 CFU/g (EC 1441/2007).Future ProspectsCommercially, the use of viable LAB as protective agents infood products is still viewed with skepticism, although researchers—obtainingpositive results—have worked with this technologyfor a long time. Starter cultures with protective properties in,for example, salami production, should be unproblematic withregard to both application and legislation. However, in practice,the application of protective cultures for other meat applications,such as fresh and cooked meat products, is not simple.Among other things, the cultures should not be considered preservativesor as stand-alone additives, but rather as extra built-insafety factors within a hurdle system. Furthermore, for severalproducts, it is a technical necessity to add an extra applicationstep after cooking to utilize the culture, which could be an obstaclefor some manufactures. It should also be mentioned thatthe application of protective cultures to meat products, such asbacon, smoked filet, emulsion products and other cooked meatproducts, is not part of general starter culture acceptance. Thismight be why supervisory authorities are not very understandingtowards the high initial level of LAB in such products. Yet,there is strong scientific opinion that consumers will considerprotective cultures a natural way to ensure the quality andsafety of food products in the future.•Lone Andersen, M.Sc., works with Sacco S.r.l. in Italy and is responsiblefor building up their nondairy application field, includingthe use of starter cultures for production of fermented meat,vegetables, bread and silage and the use of probiotic bacteria infood applications.O c t o b e r • N o v e m b e r 2 0 1 2 73

Category: DRY INGREDIENTSBy Herbert Weinstein, Ph.D.Quality Assurance and Food Safetyof Powdered IngredientsAlthough there is still much to learn about theprocess of mixing solid particles, designers ofindustrial plants often fail to take advantage ofavailable knowledge so that the best possibleresults can be achieved. The operation of amixer must be regarded as producing equilibriumbetween mixing and segregation; thosemixers being used can be classified as either segregating or nonsegregating.Components—or mix ingredients—to be used canbe similarly classified. In addition, the selection of the mixerfor a particular duty should be based on how materials tend tosegregate; those that do should not be put into a segregatingmixer. Further, care must be taken in the handling of a mixtureto avoid segregation. In regard to powdered foodstuffs, we candistinguish three main “actors”: ingredients, mixers and handlingor materials management.The Role of Quality AssuranceQuality assurance (QA) systems take a much wider view ofwhat is involved in satisfying customer and production needs,focusing on the prevention of problems, not simply on theirAchieving the bestpossible resultsfor powderedingredientscure. Curing problems is expensive; qualitycannot be “inspected into” a product.A QA approach, therefore, includes thewhole production and distribution system,from the suppliers of raw materials throughmanagement to the customer. QA systemsshould be documented in a simple way toshow who has responsibility for doing what and when. TheQA focus on prevention should mean that action is taken tomeet a specification and prevent failures from occurring a secondtime. This is done by planning, management action andagreements with key suppliers and other people in the distributionchain.QA requires that staff is well trained and motivated. Workersare normally well aware of the causes of most problems, andwhen QA is used properly, they can resolve most quality problemswithin their control. It is the responsibility of businessowners to ensure that the QA system together with any necessaryequipment and information are available to the workersto allow them to exercise this control. Then the importance ofQA becomes obvious when food safety is concerned.74 F o o d S a f e t y M a g a z i n e

Category: DRY INGREDIENTSWhy Use a Powder?The major reason for production in powdered form issimply to prolong the shelf life of the ingredients by reducingwater content; otherwise, the ingredient will be degraded. Thus,the major function of the powdered form is to maintain thestability of the ingredient’s functionality until it is required foruse, which is eventually in some sort of wet formulation.Food safety and QA must be concerned with those manufacturinghazards affecting foods (Table 1).HazardMicrobiologicalBiologicalChemicalPhysicalExampleYeast, mold, bacteria, virusesInsects, hair, fecesPesticides, toxins, cleaning liquidsBone, string, plastic, metalTable 1: Food Hazards of Concern to QA and Food SafetyWhen dealing with powdered beverages, in most cases, the hazards—ifthe raw materials have been handled properly—are primarilyphysical in nature because such ingredients, due to theirlow water activity coefficients, do not allow for microbiologicalhazards.The food industry still has processing problems and requiresfurther basic research to understand processes and handle powderedfoodstuffs, which means food safety and QA programsshould be integrated into research for such developments.For example, different product groups can be distinguishedin the following ways:Powdered products:• Powdered beverages (no fat)• Soups (powder and garnishes, low in fat)• Sauces and gravies (powder; sometimes garnishes; low in fatand often high in starch)• Recipe mixes (low in fat, spices)• Ready-to-serve dishes (cup products, pasta and rice preparations,big pieces)• Powdered bouillon (high in salt)• Seasonings (high in salt and glutamate)Agglomerated and granulated products:• Vending soups (agglomerated powder)• Foodservice sauces and gravies (agglomerated powder; highin starch)• Granulated or agglomerated seasonings• Instant bouillon (agglomerated or granulated powder, highin salt)Tabletted and compacted powders:• Bouillon tablets (hard and soft bouillon, high salt content,medium to high fat content)• Sauces (tabletted sauces; high in salt, fat and starch)Powdered beverages are a group within the powdered productscategory that have simpler formulations to control becausethey lack fat ingredients, similar to other powders like spices.This condition raises fewer concerns with regard to their manufacturingand distribution than those where fat is involved.Our technical and customer servicestaff averages over 20 years ofexperience, ensuring you: The right testing protocol,for your food and feed analysis The most cost-effective solution(only the tests you need) A personal commitment to workin partnership with youTrusted Testing Solutions Since 1916To put us to the test, visit our website atwww.npal.comor call us at 800-423-6832.O c t o b e r • N o v e m b e r 2 0 1 2 75

Category: DRY INGREDIENTSMixes containing powdered and coarse particles, which oftenhave different densities and shapes, tend to segregate duringproduction and transport; this phenomenon must be vieweddifferently if the powdered formulations include fat. In caseswhere no fatty ingredients are used, mixing time becomes animportant issue, such that the added mixing time and furtherhandling of the different dry components allow additional segregation,and very often the homogeneity of the mix decreases.Powder Components and CharacteristicsPowdered foods, including powder milks, dry-mix fruitdrinks and juices, gelatin dessert mixes, starch-based pudding,tapioca-based desserts, “energy” mixes and other sugar- andstick-slip flow, are often very dusty and stick to the containerwalls. Particle size is evidently an important determinant offlow type. If the mean particle size of a powder is greater thanabout 50 µm, it will tend to be free flowing, whereas below thatsize, it will tend to be cohesive. This boundary between flowtypes depends on more characteristics than just particle size, asit determines the philosophy of the processing of the powderand the type of mixer to be used. Particularly for large-tonnageindustries, the attractions of a free-flowing powder from bothprocessing and marketing points of view tend to outweigh thequality advantages of the cohesive powder. The attractionsof free flow are often so strong that significant process costswill be incurred to aggregate an otherwise cohesive powder to“The major reason for production in powdered form is simply toprolong the shelf life of the ingredients by reducing water content...”starch-based powdered formulations, tend to have diverse components,many of which with substantially different particlesizes and flowability characteristics. Please note that the aboveexamples are products that are essentially fat-free. The reasonfor this segregation is due to the different mobility of the particlesin the bulk state. However, there is no standardized andaccepted method to simulate this segregation behavior dependingon the real movement of the powder during productionand transportation, making any kind of measurement difficult.This situation creates a QA concern that must be approachedindividually in each product case, making the setting of qualitycontrol parameters—and testing methods—very difficult.Measuring uniformity of a mix requires experience andmust be specific to the product and manufacturing piece ofequipment. Furthermore, a clear rule or processing procedureis needed for how to design the product and its production toavoid this segregation.Experience has also demonstrated that external environmentalconditions in the manufacturing area have importanteffects on the characteristics desired in the finished product. Anexample typical of this effect is sugar-based, fruit-flavored powderedproducts. When the product is sugar-sweetened, this ingredientwill be the majority of the formulation, the rest beingacid, flavor and other minor ingredients (color, stabilizer, etc.).In a moist climate and processing area without climate control,the humidity level will dramatically affect the time and order ofaddition of ingredients—not to mention the design and effectivenessof the mixer. Additionally, the time of mixing and theflowability of the finished product will suffer. In this case, theshelf life of the product is affected as well as its ease of packing.When using visual examination for quality control and QApurposes, a variety of powders leads to a broad classificationof free-flowing and cohesive categories. Free-flowing powders,such as granulated sugar, exhibit a smooth flow, an attractivenondusty appearance and little adhesion to the container.Differently cohesive powders, such as flour, have an erraticachieve free flow. Only when product quality becomes dominantdoes the finer texture of the cohesive powder becomeattractive. This is often the case for high value-added applications,such as an intensely sweetened beverage, a mixture thatuses agglomerated stabilizers and flavors, sophisticated flavoredsauces that contain various types of chilies, etc., which, with asmall amount of added ingredients, can produce a higher-valueproduct that can command a higher price. A specific examplewould be a powdered beverage sweetened with aspartameinstead of sugar; in this case, substantial savings in packagingmaterials and distribution costs allow for a relatively cost-competitive,sugar-free product.Formulation InnovationsThe powdered drink category is undergoing rapid changes,driven by exciting product innovations; technology exists tohelp overcome challenges in formulating with functional ingredients,and encapsulation technology is available to protectvital flavor components from degradation. Whether the productsare powdered soft drinks or high-performance nutritionalpowders, they all must be hydrated prior to consumption andtheir presentation (to the consumer) must be taken into considerationin any QA program. It is easier if individual servingsare packaged for consumer use; the instructions on the packetwill indicate the need to use the total amount of powder in thepackage to prepare the drink. Thus, if actual segregation of theingredients does occur, this will not affect the finished drink.Yet, if the powdered beverage is being sold in a canister or jar,and in order to prepare a drink, water or milk must be added tox number of teaspoons (or other solid measurement) of powder,then the homogeneity of the product in the canister or jarbecomes paramount. These conditions require a much “tighter”QA program, which begins with tighter raw material specificationsand mixing times, and involves additional ingredients,climate control and mixer designs, as well as manufacturingand packaging specifications. Only in this way will the proper76 F o o d S a f e t y M a g a z i n e

Category: DRY INGREDIENTSratios of powder to liquid be assured when and if instructionsfor preparation of the drink are followed. One other examplethat often occurs, especially if a child is preparing his/her ownchocolate milk using a powdered mix: The excessive amount ofthe powder in a glass of milk can result in a lack of dissolutionof the powder, an oversweetened drink, an intensive chocolateflavored(or other flavor) drink, etc.Food ingredient companies can tailor their ingredients tobe used in powder formulations such that they can give a largevariety of functionality; however, such ingredients must beused exactly in the process for which they were designed, andmost applications have been developed empirically. This caveatalso tends to limit research and development, since suppliersregard it as an added cost, and their customers are reluctant tochange from established optimized processes even if they haveonly been developed empirically. Still, these prevalent issuesconcerning food safety and QA must be considered, even if itmeans more cost and time involvement with the supplier. Thesafety of the consumer is the responsibility of the manufacturer,not of the ingredient supplier.Food ingredient powders will eventually be utilized in somesort of wet formulation. For powdered beverages, that functionalitywill depend on the powder particle and its interaction withwater. Air is the cheapest food ingredient, followed by water,and many ingredients are applied to entrap more air and waterby utilizing their aeration and gelation properties. Such characteristicshave been appearing in new dry beverage powders toshow foam and/or similar characteristics upon the final preparationof the product.The use of complex mixtures of food products makes it difficultto establish optimal drying, flowability prediction, controlof dust, strength, etc. of the final products. Food powdersare not just powders. They have activity that can be microbial,enzymatic, flavor- and taste-enhancing, etc. This means thatthese aspects must be maintained as much as possible duringmanufacturing, creating extra problems during productdevelopment, production and distribution as well as a furtherneed for QA. As a result, sometimes the products may containactive ingredients that are potentially harmful. Thus, a properunderstanding of the responsible ingredients and a predictionof possible outcomes are needed, not only during productdevelopment, but also during manufacturing, quality control/QA and distribution. An example would be the distribution ofan orange-flavored powdered beverage in a tropical country.The product was developed with a natural orange extract and aflavor that was tested in the laboratory for stability, yet after 6months in the market, signs of rancidity appeared in the warmerand humid areas of the country, conditions that during testingwere simulated but not tested in situ. The orange-flavoredadditive in the flavoring mix had an unpredictable reactionwith the orange extract that caused the rancidity reaction.Another different, but similar example of looking at theresulting product during its development is a nutritional powderproduct to be used as a weaning food in low-income com-O c t o b e r • N o v e m b e r 2 0 1 2 77

Category: DRY INGREDIENTSmunities. In this case, the powder must be diluted in a certainamount of water to deliver the expected nutrition; also, theproduct must be prepared with potable water. The experiencewas that after market testing and diarrhea in some of the children,it was concluded that the instructions were unclear, establishingthe paramount need for proper training of the users.What about Powdered Food Safety?Food safety of dry powders is not given much attentionbecause of their characteristic low water activity, yet requiresmuch more attention, especially because of the sourcing of materialsand complexity of dry product handling.and development considerations. Expert powder manufacturersuse a host of technologies to meet the functional and sensoryexpectations of both clients and consumers. These technologiesinclude unique food safety and QA considerations to ensurethe uniformity of the finished product as it is consumed.“Consequently, inclusion and updating of food safety and QAprocedures in manufacturing must constantly be stressed.”Finally, because of the complexity of the total powderedfoodstuff manufacturing process and the lack of a formal educationfor practicing engineers and food scientists, college-levelcourses must be established. Meanwhile, some courses are available,conducted mainly by industry consultants and certainacademic institutions. The final question is: If there is a needfor more educational opportunities, when are the educationalinstitutions going to meet it? There is a potential for a worldwidedistance learning program dealing with aspects of powderscience and technology, which should include specific foodsafety and QA concerns.Establishing an adequate food safety and QA program forpowdered food products requires it to be specific to the product(formulation considering available specifications of theingredients), its manufacturing (handling, mixing and packagingequipment), its distribution and its ultimate use by the consumer.The needs and controls required cannot be generalized.The complexity of the overall processes of manufacturingand distributing powdered foods is not typically science- ortechnology-based, mainly because of a lack of formal educationalcourses. The process has been conducted more as an art,with experience and hands-on learning. There thus exists anopportunity for more research and development with the objectiveof technologically improving the process. Consequently,inclusion and updating of food safety and QA procedures inmanufacturing must constantly be stressed.Powders in the Food MarketThe powdered beverage market has grown beyond traditionalsugar-based drinks, basic protein shakes and sports energybeverages. Functional beverage and food marketers see powdersas a new opportunity to expand their delivery formats and offerconvenience, better value and an environmentally friendlysolution to ready-to-drink options. Supplement marketers offerincreased value by adding flavor, function and hydration components,creating delicious powdered drinks for consumers toenjoy. However, crossing over to powders has its unique designConclusionsPowdered food products and, specifically, powdered beveragesare mixtures of different ingredients that in all cases havedifferent characteristics and specifications. These mixes as foodproducts are rarely consumed as a powder, meaning that thoseingredients require mixing to produce the food product. Experiencehas shown that those mixing procedures, at an industriallevel, are tricky—homogeneity being the most important consideration—andin many instances require years of experience.In addition, in the development of the product as well as ofits manufacturing procedure, simple instructions often do notcontain sufficient detail to manufacture or use the product witha consistent quality result, resulting in a serious concern forQA and food safety. The recommendation is to be very awareof these conditions and product characteristics in order to havesuccess in the quality and consistent use of the finished, consumableproduct.•Herbert Weinstein, Ph.D., earned his chemical engineeringdegree from the Universidad Nacional Autonoma de Mexicoand his M.Sc. and Ph.D. in food science and technology from theMassachusetts Institute of Technology. He can be contacted atHERBWEIN@aol.com.Resources1. From proceedings of a workshop organized with the support of the EuropeanCommission, 5th Framework Program, Quality of Life and Managementof Living Resources, Key Action 1—Food, Nutrition and Health at DSMFood Specialties, 544-0150, PO Box 1, NL 2600 MA Delft, The Netherlands.Problems while handling and processing powdered convenience foodsby Dr. Ing. Stefan Palzer from Nestlé PTC Kemptthal, Zürich, Switzerland.Mixing of powders by N. Harnby from the University of Bradford, Bradford,West Yorkshire, UK.Functional properties of food powders and particulates by Peter Lillfordfrom the University of York, UK.Powder technology by DSM Food Specialties.Powders in applications by Gabrie M. H. Meesters.2. Food powder handling and processing: Industry problems, knowledgebarriers and research opportunities. Published in Chem Eng Process 2005;44:209–214 by John J. Fitzpatrick from the Department of Process Engineering,University College Cork, Cork, Ireland, and Lilia Ahrné from The SwedishInstitute for Food and Biotechnology, Gothenburg, Sweden.78 F o o d S a f e t y M a g a z i n e

Product ShowcaseAflatoxin TestRomer Labs has reported that it has the only test kiton the market that can provide quantitative aflatoxinresults from 1 to 5,000 parts per billion in less than 5minutes, a quantification range extended officially bythe U.S. Department of Agriculture. FluoroQuant ® Aflais an extremely robust method and contains all the disposablesneeded to run the test. Quantification is donewith the state-of-the-art FQ-Reader.Romer Labs, 636.583.8600 • www.romerlabs.comPackaging MachinerySpee-Dee ® PackagingMachinery Inc. hasannounced an all-servodrivenrotary filler thatis easy to operate andmaintain while providinglong-term productionflexibility for fillers ofdry products. Becauseof the system’s uniquedesign, users can cost-effectively address changes in packagingheight, diameter or shape by employing interchangeableplastic container adapters.Spee-Dee Packaging Machinery, 877.375.2121 • www.spee-dee.comCold Transport ControlControlling temperature-sensitive cargo is essential in allowingconsumers around the world to receive fresh produce, frozenfoods and other perishable chilled items at any time of year.Selco Products recently met the temperature control requirementsfor reefers (refrigerated containers) for truck transport.While specific to refrigerated trucks, the resulting refrigerationcontrol solution can be used in a variety of climate-controlledtransport applications, such as trailers, air and rail.Selco, 800.257.3526 • www.selcoproducts.comSample AnalysisLECO’s new TruMac CNS Macro Analyzer adds sulfuranalysis capabilities (perfect for soil and plant tissue analysis)to the instrument’s existing carbon/nitrogen configuration.Macro sample sizes (up to 3 g for nitrogen, 1.5 g for carbon/nitrogen and 0.3 g for carbon/nitrogen/sulfur) are quickly andsimultaneously analyzed with a low cost peranalysis. Large, reusable ceramic boats makethe sample-handling process easy to manageand allow for ash removal after every analysis.An autoloader provides unattended analysisof up to 50 samples.LECO, 800.292.6141 • www.leco.comCirculating BathPolyscience announces the availability of a largecapacitycirculating bath, designed to replicatethe temperature fluctuations associated withbeverage packaging, transportation and storage.Ideal for performing accelerated agingstudies, the 75-L Refrigerated Circulating Bathfeatures a –20 °C to 100 °C working temperaturerange, ±0.005 °C temperature stabilityand 1.8 cubic-foot reservoir. Its programmabletouch-screen temperature controller displaystemperature to 1/1000th of a degree andallows an endless array of thermal cyclingoptions and programs.Polyscience, 800.229.7569 • www.polyscience.comCell Culture AspirationBrandTech ® has proudly introduced a full lineof BVC biofluid aspiration systems fromVACUUBRAND ® for use in cell culture andother biology applications. Three designs areavailable, each with a choice of an autoclavablepolypropylene container or a safety-coatedglass bottle for bleach resistance for safe, sensitiveand efficient aspiration. Choose from theunpowered “Basic” version with automaticvalve to reduce demand on a central vacuumsystem, the powered “Control” versionwith touch-screen vacuum level control orthe “Professional” model, which adds anexternal liquid level sensor.BrandTech, 860.767.2562 • www.brandtech.comGet into the Product ShowcasePlease send your product or service press releases and images toBarbara VanRenterghem at barbara@foodsafetymagazine.comO c t o b e r • N o v e m b e r 2 0 1 2 79

Produced by CLFPFebruary 5 & 6, 2013Sacramento Convention Center(916) 640-8150 • www.clfp.com/expoCalifornia’s Largest Food Processing Tradeshow99th AnnualNW FOODPROCESSORS EXPOand ConferenceJanuary 14 -16, 2013Portland, OregonEXPONW Food ProcessorsEXPO and ConferenceJANUARY 14-16, 2013 PORTLAND, ORexpo@nwfpa.orgwww.nwfpa.orgEducateCollaborateInnovateQC Microorganism ProductMicrobiologics has launched a new quantitative qualitycontrol (QC) microorganism product that is classified as certifiedreference material (CRM). Epower CRM is designed tohelp laboratories maintain compliance with ISO/IEC 17025standards.Microbiologics, 800.599.2847 • www.microbiologics.comStainless Steel PalletsUltratainer has debutedtheir stainless steel pallets,which are designed for topperformance in the foodprocessing environment.The pallets are easy to sanitize,eliminate wood hazards(splinters and nails) in food, are corrosion-proof and rust-free,exceed corporate sustainability goals (100 percent recyclable)and have outstanding performance in hot or cold temperatures.Ultratainer, 800.665.3651 • www.ultratainer.comSample Prep for Pathogen TestingBased on HTI bio-X’s robotic workstations, BIOTECONDiagnostics will exclusively distribute worldwide their ownautomation solution for the food sector, the foodproof ® Robo-Prep X-Tract powered by HTI. Combined with magnetic preparationand real-time PCR-based pathogen detection kits (e.g.,for Salmonella), the foodproof RoboPrep X-Tract is the perfectsolution for automated food analytics. The system is ideal forlabs with low-to-medium sample throughput and is especiallyadapted for food monitoring.BIOTECON Diagnostics GmbH, 49 (0).331.2300.200www.bc-diagnostics.comConveyor Speed ControlThe new MA20 measuring wheel encoder from Baumerprovides simple, flexible and dependable position and speedfeedback for conveyor systems. The two-in-one device combinesa high-resolution optical incremental encoder and a highlyprecise measuring wheel. The encoder provides extremely exactmeasuring results, even at very low conveyor speeds.Baumer, 800.937.9336 • www.baumer.comEnvironmental Salmonella ScreenHardy Diagnostics has announced the new PDX-SIB test,which is both reliable and inexpensive with presumptive resultsavailable for the most common Salmonella spp. within24 to 48 hours. The test is AOAC-RI approved and is specificallydesigned as a Critical Control Point surveillance tool. TheSalmonella-selective enrichment medium contains a specificcolor change indicator that turns yellow when Salmonella spp.are present.Hardy Diagnostics, 805.346.2766 • www.hardydiagnostics.com80 F o o d S a f e t y M a g a z i n e

Testing(continued from page 17)Metal detectors: Metal detectors findsplinters from machinery, fractions ofbroken cutters and blades, needles,screws or fragments of clips.X-ray detectors: These respond tometal, stone, bone, hard plastics andTeflon. Both systems can screen theproduct after the filling procedure. X-raydetectors may find glass pieces that resultwhen a jar or bottle is crushed duringmalfunction of the packaging line.Near-field radar response: Foreign bodiesare detected in embedding materialby transmitting low-power microwavesthrough the material, as explained bythe Swedish Institute for Food and Biotechnologyand the Food Radar System(FRS). 18 The system uses a microwaveFigure 1: Transport Beltsing, handling and equipment maintenancethat encompasses the entirefood production chain, including:Agricultural ProductionThese include grains, vegetables, bigfarms and small organic businesses.Meat ProductionCare should be taken at farms, abattoirsand retail; knives, mincers, meatslicers, vacuum bowl cutters and brokeninjection needles must be scanned.TransportationSpecial care is needed for bulk transportation;recovery after road accidentsshould be observed.Food Processing FactoryThe daily maintenance of transportbelts must be assured (Figure 1). Wellsanitizedmachines that look very goodmay bear many hazards of foreign bodiesin food, like broken parts of defectivesystems. Audits should concentrate onthese problems and daily inspections ofpeeling machines and vegetable slicers.Grocery ChainsPersonnel should be trained to be attentiveto prevent packaging adulterationor criminal attempts of extortion.HospitalityRestaurants, hotels and fast foodchains should consider introducingGMPs and HACCP.Technology for Detection ofForeign ParticlesEvery product presents special technologicalchallenges. Translucent andopaque liquids filled in bottles, coloredopaque plastic packages, tin cans or milkcartons respond differently to availabledetection systems (Figure 2).O c t o b e r • N o v e m b e r 2 0 1 2 81

TestingFigure 2: Examples of Foreign Materialsensor designed for emulsions andpumpable products. It measures thedielectric properties of the food flow ofprocessing equipment. Foreign materialsproduce a deviation from the norm, activatinga pneumatic rejection unit. Thesystem not only detects denser foreignobjects but also is particularly suited toforeign objects such as wood, plastic,SAFELINEMetal Detection & X-ray InspectionHI-SPEEDCheckweighingCI-VISIONVision Inspectionbone, extraneous vegetable matter, contaminantssuch as fruit stones and nutkernels and process faults such as flavorand starch lumps in baby foods.FRS must be installed within the pipesystem, before packaging. Any deviationat the filling station is not covered.ConclusionsAmple technology exists for detectionof foreign material in foodstuffs. To ensurefood safety, this technology shouldbe complemented by quality controlpractices such as HACCP and GMPs,and by ongoing training of personnel.With proper implementation in the productionline, illness or injury to consumerscan be avoided.•Karl Heinz Wilm is a biochemist at the UniversityBelém do Pará, Brazil. He has 32 years of quality managementexperience in the German food industry.Food Safety RegulationCompliance ResourcesMETTLER TOLEDO has long been the product inspection industry leader in foodsafety education with our Safeline metal detection and x-ray inspection brand.We have launched a year-long initiative to provide you with the right training,educational materials and product solutions that will enable you to navigate the foodsafety regulatory environment with confidence.Visit www.mt.com/PINA-FoodSafetyResourcesto learn more!Contact us for more information at 800-221-2624or visit www.mt.com/piReferences1. www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074554.htm.2. www.ncbi.nlm.nih.gov/pubmed/10049789.3. www.fsis.usda.gov/OPPDE/rdad/FRPubs/02-033N/ThePhysicalHazardsofForeignMaterials.pdf.4. www.ncbi.nlm.nih.gov/pubmed/11029271.5. www.gov.mb.ca/agriculture/foodsafety/processor/cfs02s33.html.6. www.cbi.eu/?pag=85&doc=1109&typ=mid_document.7. eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:139:0001:0054:EN:PDF.8. eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:226:0083:0127:EN:PDF.9. eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:139:0206:0320:EN:PDF.10. laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html.11. foodsafety.unl.edu/haccp/start/physical.html.12. www.ncbi.nlm.nih.gov/pubmed/22376998.13. www.ncbi.nlm.nih.gov/pubmed/22365133.14. www.ncbi.nlm.nih.gov/pmc/articles/PMC3123183/?tool=pubmed.15. www.ncbi.nlm.nih.gov/pubmed/17131048.16. www.ncbi.nlm.nih.gov/pubmed/22318080.17. www.ncbi.nlm.nih.gov/pubmed/17766213.18. www.foodradar.com/assets/pdf/fruit_processing_0112.pdf.82 F o o d S a f e t y M a g a z i n eFSM11_MT_1111_HP.indd 111/25/2011 10:50:29 AM

Advertisers IndexAgilent Technologies • www.agilent.com/chem/food................21–25, 27AIB International • 800.633.5137 • www.aibonline.org...........................19Allied Blending and Ingredients.............................................................. 77800.758.4080 • www.alliedblending.comAmerican Oil Chemists’ Society (AOCS)..................................................61www.aocs.org/labservicesATCC • www.atcc.org/bigsix.......................................................................... 43Bia Diagnostics, LLC • 802.540.0148 • www.biadiagnostics.com.......... 84Bio-Rad Laboratories, Inc. • 800.4BIORAD • www.bio-rad.com...........41BioControl Systems, Inc. • 800.245.0113 • www.biocontrolsys.com.... 45CA League of Food Processors • www.clfp.com/expo........................... 80DuPont Qualicon • www.food.dupont.com.............................................. 49EMD Millipore • www.emdmillipore.com/foodsafety..............................15EtQ Management Consultants ................................................................... 5800.354.4476 • www.etq.com/foodsafetyFoodHACCP.com • www.foodhaccp.com.................................................. 73Food Safety Connect • www.foodsafetyconnect.com............................... 3Food Safety Summit • www.foodsafetysummit.com.............................. 59Foreign Trade Service Corp. (FTS)............................................................ 65888.387.5227 • www.ftslabs.comGlobal Food Safety Conference • www.tcgffoodsafety.com..................81Hygiena, LLC • 888.HYGIENA • www.hygiena.com.................................. 37Inmar Inc. • 866.440.6917 • www.inmar.com............................................ 55LPS Laboratories • www.lpslabs.com.........................................................71Marel Inc. • 888.888.9107 • www.marel.com/usa.....................................17Mettler-Toledo, Safeline, Inc. • 800.221.2624 • www.mt.com/pi......... 82Michelson Laboratories, Inc...................................................................... 77888.941.5050 • www.michelsonlab.comMicrobiology International • 800.EZ.MICRO • www.800ezmicro.com.31Midwest Food Processors Association.................................................... 80608.255.9946 • www.mwfpa.orgNelson-Jameson, Inc. • 800.826.8302 • www.nelsonjameson.com...... 73Neogen Corp. • 800.234.5333 • www.NeogenANSR.com....................... 38Northwest Food Processors Association................................................ 79503.327.2200 • www.nwfpa.orgNP Analytical Laboratories • 800.423.6832 • www.npal.com ............ 75Puritan Medical Products Co, LLC.............................................................. 2800.321.2313 • www.puritanmedproducts.comQ Laboratories, Inc. • 513.471.1300 • www.qlaboratories.com ..............13Refrigerated Foods Association................................................................ 69770.303.9905 • www.refrigeratedfoods.orgRetsch • 866.4.RETSCH • www.retsch.com................................................ 67RICCA Chemical Company • 800.467.4222 • www.riccachemical.com.57Roka Bioscience, Inc. • 855.ROKABIO • www.rokabio.com..............9, 53Romer Labs Inc. • 800.769.1380 • www.romerlabs.com/allergens....... 29Silliker, Inc. • www.silliker.com................................................................... 35Spartan Chemical Company, Inc.............................................................. 67800.537.8990 • www.spartanchemical.comThermo Fisher Scientific Inc. • www.thermoscientific.com..................1, 7Waters • www.xevotqs...................................................................................11Waters • www.waters.com/ft....................................................................... 63Weber Scientific • 800.328.8378 • www.weberscientific.com................ 47Join us for theMidwest Food Processors Association’s108th Annual Convention &85th Processing Crops ConferenceConsumer Concerns:Education & Advocacy ChallengesNovember 27-29, 2012Monona Terrace Convention Center, Madison, WIThe Midwest Food Processors annual convention and processingcrops conference is truly the place where industrymembers from the Upper Midwest and beyond come togetherto learn, network and gain valuable insights to improve theircompany's future. The association’s premier event attractsmore than 900 industry professionals in one location, showcasinginnovations and solutions to processors and suppliersto the food manufacturing industry. Don’t miss this opportunityto network, create successful business relationships andfind solutions to challenges facing the industry.Registration info is available at www.mwfpa.orgStatement of Ownership, Management andCirculation for Food Safety MagazineOctober/November 2012 (Required by U.S.C. 3685) Food Safety Magazineis published bi-monthly at 1945 W. Mountain St., Glendale, CA 91201. Thenames and addresses of the Publisher, Editor are: Publisher, Stacy Atchison,1945 W. Mountain St., Glendale, CA 91201; and Editor, BarbaraVanRenterghem, 1945 W. Mountain St., Glendale, CA 91201. Owner: TheTarget Group Inc., 1945 W. Mountain St., Glendale, CA 91201; stockholdersowning or holding 1% or more of the total amount of stock: Donald Meeker,1945 W. Mountain St., Glendale, CA 91201; Roberta Meeker, 1945 W.Mountain St., Glendale, CA 91201; Stacy Atchison, 1945 W. Mountain St.,Glendale, CA 91201.Average ActualNo. of Copies No. of CopiesEach issue of Single IssueDuring PublishedPreceding Nearest to12 Months Filing DateTotal no. of copies printed 17,300 17,239Paid and/or requested circulation 14,243 13,854Sales through dealers, carriers,street vendors and counter sales 0 0Other classes mailed through USPS 915 847Total Paid and/or requested Circulation 15,158 14,701Free distribution by mail 1,222 1,220Other classes mailed through USPS 16 17Free distribution outside mail 613 975Total free distribution 1,851 2,212Total distribution 17,009 16,913Copies not distributed 291 326Total 17,300 17,239% paid and/or requested circulation 89.1% 86.9%I certify that the statements made by me above are correct and complete.(Signed) Stacy AtchisonO c t o b e r • N o v e m b e r 2 0 1 2 83

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