Food Safety Magazine, December 2012/January 2013

SOLUTIONS FOR TODAY,PLANNING FOR TOMORROW ® ®Join thousands of your colleagues and like minded professionals April 30 – May 2, 2013 atthe 15th Annual Food Safety Summit. You will learn from expert speakers and trainers,exchange ideas and find solutions to your current job challenges.FSMA Workshop Tuesday, April 30, 2013Food Safety Modernization Act Implementation:A Global UpdateA forum slated to discuss how our US policy is impacting our trading partners and how they are changingfood safety regulations that will impact US suppliers. This session will help define what the White Houseadministration will do to enhance food safety in 2013 and beyond.Keynote Address Wednesday, May 1, 2013The Future of Food Safety:When Industry, Academia and Regulators Work TogetherKeynote speaker Will Daniels, Sr. Vice President, Operations and Organic Integrity, Earthbound Farm willaddress the need to have better collaboration between industry, academia and government with emphasison breaking old models and creating new ones that focus on transparency, understanding business modelsand a desire to truly protect public health.TOWN HALL Thursday, May 2, 2013Town Hall with FDA and USDAFDA’s Mike Taylor and USDA’s Elisabeth Hagen have been invited to join our Town Hall discussion to addressthe most pressing issues for today and tomorrow in regards to regulatory agencies and the private sector.APRIL 30 – MAY 2, 2013 • BALTIMORE CONVENTION CENTER, MDREGISTER TODAY AT: WWW.FOODSAFETYSUMMIT.COMGOLD SPONSORSILVER SPONSORBRONZE SPONSORMEDIA PARTNER

Editor’s LetterIsubscribe to numerous e-mail notices from our many governmentagencies, including those of food-related recalls, marketwithdrawals and safety alerts. It seems not a day goes by withoutsomething from FDA filtering through to my desk.When I first started to get these, I primarily took notice ofwhether I had purchased any of the foods in question, but themore these announcements came, I began tosee patterns. Most seemed to involve mislabelingof ingredients, particularly those involvingpotential allergens, whereas others warned ofpotential contamination. In fact, I just recentlyreturned a container of spinach for just such areason. (And I should have returned a packageof ready-to-eat sandwich meat that I had purchased for my son’slunch from the same store, as the inner plastic wrap had poppedthe lid off the outer package, reminding me of our recent article“Flavors Should Burst, Not Packages” by Kara Baldus, M.B.A.,and Virginia Deibel, Ph.D., from the June-July issue.)This barrage of notices does beg the all-important question:Are food companies prepared to weather such crises and survivethe negative publicity that stems from such events?We’ve made inroads to addressing these points through thepast year in Food Safety Magazine. We’ve tackled specific crises,such as carbendazim in orange juice (April-May), discussedthe management of food outbreak crises and the rebuilding ofconsumer trust (two different articles in June-July), defined theregulatory, legal and communications issues involved in foodrecalls (October-November), and in our pages here, we presentyet another perspective on dealing with food safety incidentsand recalls. Our cover story, “Incident Management: Food SafetyRequires Competence” by Bizhan Pourkomailian, Ph.D., is unpredictablytimely, given the recent weather disasters here in theU.S. Dr. Pourkomailian discusses the roles and responsibilities ofrisk management teams in responding to such events, includinghis example of the previous year’s tsunami that affected Japan.Recalls, whether prompted by reports of illness or suspectedcontamination, are facts of operation for the food industry.Mock recall training and preparedness by specialized teamswithin companies can help defuse the fallout from these events.If your company is still struggling to gain the upper hand in suchinstances, we’ve got your back. Our authors are experts in theseareas and their articles will help you succeed.Best Regards,Barbara VanRenterghem, Ph.D.Editorial DirectorCEO, The Target Group Inc. Don MeekerPublisher Stacy AtchisonVictim of “Fowl” Play Bobby MeekerEditorial Director Barbara VanRenterghem, Ph.D.Art Director/Production Craig Van WechelCirculation Manager Andrea KargesAdministrative Manager Allison Demmert-PolandPublishing Office 1945 W. Mountain St.Glendale, CA 91201Main (818) 842-4777Fax (818) 955-9504customerservice@foodsafetymagazine.comEditorial Office 2 Nick Alan Cir.Rutland, MA 01543Phone (508) 210-3149Fax (508) 210-3139barbara@foodsafetymagazine.comProduction Office 1113 Ellis StreetFt. Collins, CO 80524Phone (970) 484-4488craig@foodsafetymagazine.comAdvertising SalesBobby Meeker (818) 842-2829bobby@foodsafetymagazine.comAdam Haas (321) 804-4319adam@foodsafetymagazine.comFood Safety Magazine (ISSN 1084-5984) is published bimonthly byThe Target Group Inc., 1945 W. Mountain St., Glendale, CA 91201;(818) 842-4777; Fax (818) 769-2939; E-mail info@foodsafetymagazine.com.Periodicals Postage Rate paid at Glendale, CA, andadditional mailing offices. Subscriptions: Free to qualified subscribersas defined on the subscription card; $85.00 per year for nonqualifiedsubscribers. Back Issues: $10.00 per copy, prepaid. Change ofAddress: Notices should be sent promptly; provide old mailing labelas well as new address. Allow two months for change. EditorialContributions: Unsolicited manuscripts should be submitted to: FoodSafety Magazine, 1945 W. Mountain St., Glendale, CA 91201. Notice—Every precaution is taken to ensure accuracy of content; however, thepublishers cannot accept responsibility for the correctness of the informationsupplied or advertised or for any opinion expressed herein.Postmaster: Send address changes to Food Safety Magazine, 1945W. Mountain St., Glendale, CA 91201. ©2012 by The Target GroupInc. All rights reserved. Reproduction in whole or part without writtenpermission is strictly prohibited. The publishers do not warrant,either expressly or by implication, the factual accuracy of the articlesor descriptions herein, nor do they so warrant any views or opinionsoffered by the authors of said articles and descriptions.6 F o o d S a f e t y M a g a z i n e

Online & Of Notehttp://onfarmfoodsafety.org/The On-Farm Food Safety Project is acomprehensive national program thatoffers produce farmers, food safety professionalsand agricultural extension specialiststechnical assistance to utilize and teachbest practices in food safety. This websiteincludes the bulk of these resources,including a free online tool based on acomprehensive risk-based framework thatgenerates customized on-farm food safetyplans stemming from user input. The toolis designed for use by small to midscaleproduce growers and provides a full set ofrecord-keeping materials to documenttheir food safety program andprovide training to theiremployees.BizTracksSDIX Sells Food Safety and GMO Businesses to Romer LabsSDIX, a provider of biotechnology-based products and services, has sold the assets of itsfood safety and GMO businesses to Romer Labs, a global supplier of food safetydiagnostics, for $13.5 million. SDIX plans to concentrate on its life science businessand Advanced GAT technologies, which target monoclonal antibody discovery forbiotherapeutics and biomarker applications.Romer Labs acquired the intellectual property, current inventory and commercialcontracts, as well as the equipment for the two business units and will employthe current staff.PTI-Europe Establishes MOCON-Certified Testing LabPTI-Europe, a wholly owned subsidiary of Plastic Technologies Inc. (PTI), Holland,OH, has established a MOCON Inc.-certified permeation testing laboratoryat its facility in Yverdon, Switzerland.PTI has a global reputation as a thought leader in package development engineering.Its new MOCON certification will allow the company to offer expanded testingand analysis capabilities to the many major brand owners on its client list.With certification, PTI-Europe technicians, who already use state-of-the-art equipment, arenow recognized for having been trained on MOCON corporate test lab methods/protocolsand record keeping to ensure quality and equivalency. (News Bites continued on page 58)The Insights You Need to SucceedIn The Food Microbiology Testing MarketNow more than ever, accurate and in-depth information about food microtesting methods, trends and technologies is critical to success. At StrategicConsulting, we’ve been tracking this market for more than 15 years.Our market research reports can help.JUST PUBLISHED – NEW OVERVIEW• Food Micro, Seventh Edition:Comparison of the Food Microbiology Testing Markets in the U.S. and E.U.ALL NEW EDITIONS• Food Micro, Fifth Edition: Microbiology Testing in the U.S. Food Industry• Food Micro, Sixth Edition: Food Microbiology Testing in EuropeTo order or request a prospectus,call (802) 457-9933 or visit us online atStrategic-Consult.comEVERY STRATEGICCONSULTING REPORTCONTAINSExtensive Primary ResearchWe conduct detailedinterviews with foodprocessingplants, seniorquality officers, key opinionleaders, regulatory expertsand contract test labs.Detailed Data Summarizedin Clear Charts and GraphsTest volumes, market values,routine and pathogen testingby organism and methods,and more.The Information You Needto Make Sound BusinessDecisionsTrack key drivers and trends,and project future growth.Strategic Consulting, Inc. • www.Strategic-Consult.com • (802) 457-9933Follow Strategic Consulting’s President on Twitter @TomWeschlerD e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 9

Focus ON Food Safety RISKSBy Christian Mahr, Ph.D.Anticipating Food Safety RisksFigure 1: Predicting the Next Food Crisis EventYou don’t need a crystal ballto predict risks to food safetyNumerous food scares all around the world,including dioxin in Germany and Belgium,Salmonella in peanut butter in the U.S. andmelamine in China, have led to consumerslosing trust in their food supplies, despitethe fact that, as a general rule, food has never been aswell controlled and safe as it is today. Notwithstandingall the safety efforts in recent years, in 2011 wesaw some of the worst food scares ever, namely theEscherichia coli outbreak in cucumbers in Germany andthe Listeria outbreak in cantaloupes in the U.S., witha death toll of 35 and 13, respectively. In the absenceof a crystal ball that would allow us to predict the nextcrisis (Figure 1), there is clearly a need to better anticipatefood safety risks to prevent similar crises fromhappening at all, or at least be prepared to faceand manage them effectively, with a minimumimpact on consumers.Zero Risk vs. Appropriate Level ofProtectionTaking risks is part of our life ashuman beings, and our society is wellprepared to take risks in almost every domainof our daily life. We smoke, althoughwe are told with every pack of cigarettes that“smoking can kill.” We drive cars and acceptaccidents with severe injuries and even therisk of untimely death. We fly in airplanesin the full knowledge that one crashes nowand then. We build factories basedon certain standards and specifications,taking into account “foreseeable events,”but never really the “worst case scenario,”as the Fukushima nuclear crisisclearly demonstrated.Surprisingly, when it comes to food,consumers have come to expect “zerorisk.” Whether fresh produce, meat andcheese, or processed foods like canned oraseptically filled food products, consumersin many countries claim the right tohave safe, fresh and good-tasting enjoyableproducts with a long shelf life at alow cost. Only few are aware that thereis always some measure of risk involved.Contradictions must be managed tomeet all the paradoxical consumer expectations,and this has given birth tothe concept of an “appropriate level ofprotection” in the food industry.The concept can be illustrated byconsidering the risk management ofcarcinogenic genotoxic substances likeaflatoxins, for which the threshold ofno adverse effect cannot be calculatedor experimentally defined. Instead, athreshold has been defined measuringthe risk of hepatic cancer in the populationas more than 1 case for 10 6 people.As a consequence, authorities admit thattotal protection of the population is notachievable, and the actual limit gives anappropriate level of protection in theway that it will generate no more than 1hepatic cancer for 10 6 people due to aflatoxins.Industry, retailers, authorities andmedia need to work together to informand educate consumers about the appropriatenessof this level of protection.Hazard IdentificationA risk analysis starts with the identificationof a hazard. This could be microbiologicalcontamination with Salmonellaor E. coli, or chemical contaminationwith pesticides, mycotoxins or heavymetals. Hazards may be introduced infood through raw materials, processes10 F o o d S a f e t y M a g a z i n e

Colilert® and Colisure®Because your product is only aspure as your source waterrongRequest your FREE copytoday of our 265-pagebuyer’s guide!Call 800-328-8378 orvisit weberscientific.comBe certain your wateris coliform free Results for total coliformand E coli as fast as 18hours AOAC, EPA, APHA, PMOapprovedLegendary for great prices since 1959800-328-8378 • weberscientific.comLABORATORY SUPPLIERAWARD WINNING11 F o o d S a f e t y M a g a z i n e

Focus ON Food Safety RISKSFigure 2: The Risk Assessment/Risk Management Processand/or the environment. Primary packagingmaterials contain many chemicalsthat could migrate into the food andpose a risk for consumers. On top ofeverything, intentional contamination ormanipulation of food products cannotbe excluded and should also be takeninto consideration. Additionally, nutrientslike vitamins, minerals and traceelements could represent a hazard incase of over- or underdose.The Risk Assessment/RiskManagement ProcessAfter identification of the hazard, thereal job of risk assessment/risk managementbegins (Figure 2).Risk Assessment: Exploring Science andTechnologyHazard characterization: The startingpoint of the scientific and technologicalrisk assessment is the hazard characterization,in which the nature ofthe hazard and the potential adverseeffect are investigated. This requires athorough understanding of the toxicityof a contaminant or the virulence of aparticular microorganism, the ingesteddose thereof, the consumption patternof a food, the physiological condition ofthe target consumer group (e.g., infants),etc. Typically, the researcher starts with aliterature search to understand the scientificstatus quo on the particular subjectmatter. Depending on the availability,scientific depth and applicability of theinformation, further studies like chemicalor microbiological analyses, challengetests, scientific or medical experimentsor a field study may be required.Exposure assessment: With a fullunderstanding of the hazard, the nextstep investigates who may be exposedto a particular hazard and under whichcircumstances. The researcher evaluatesthe prevalence of certain conditions likeallergies, or vulnerability toward certainmicroorganisms (e.g., Cronobacter sakazakiifor infants) or ability to toleratecomponents like alcohol orenzymes, as well asconsumptionpatterns.Risk characterization: Using techniqueslike dose-response curves, the likelihoodand impact of the hazard are then investigated.This may lead to the definitionof performance objectives, food safetyobjectives, maximum residual levels orrecommended daily allowances relatedto specific consumer populations.The collected evidence of the riskassessment is used for the risk managementcycle, with the intention of mitigatingand managing the risk.Risk Management: From Understandingto Mitigation and ManagementRisk evaluation: As part of risk assessment,the likelihood and impact of ahazard on consumers in general are investigatedby scientific means. The nextstep is to evaluate this risk for a specificproduct and its application, a certaintarget group, a particular population, agegroup, country or region, etc. The outputof this risk evaluation is a food safetyobjective to be reached at consumption,which will give the appropriate level ofprotection for the population. This foodsafety objective could be broken downin several performance objectives to bereached at different steps of the foodchain and that will participate in fulfillingthe overall food safety objective.As an example, to have an appropriatelevel of protection of babies frombirth to 6 months, the food safety objectivefor C. sakazakii in infant formula hasbeen set to 0.06 CFU/gat consumption.As there is noreal step toreduce therisk betweenpackagingand con-Figure 3: Communication Partners for Risk Assessment/Risk Management12 F o o d S a f e t y M a g a z i n e

SANITATIONHygienic Design and ConstructionStandardsWorldwide, several organizations areinvolved in food equipment hygienicdesign. Despite variation between theseorganizations with regard to their standardsand/or recommendations, theyare in general harmony with food safetyintent and the importance of the applicationof sound principles of hygienicdesign and construction. Some of theseorganizations are generally describedbelow. More detailed discussion is providedfor 3A Sanitary Standards Inc.(3A SSI), with which I am most familiar,to provide more insight into the use ofequipment standards by regulatory andindustry personnel.European Hygienic Design Group(EHEDG). 5 A collaborative effort ofequipment manufacturers, food industries,research institutes and publichealth authorities, EHEDG is a recognizedauthority in hygienic designand engineering throughout the world.EHEDG promotes hygienic designthrough its guidelines, documents,training materials, education programsand laboratory testing methods forcleanability and related topics. TheCenter for Integrated Food Manufacturing6 at Purdue University is now partneringwith EHEDG to offer trainingworkshops and provide food equipmenttesting in the U.S.National Sanitation Foundation (NSF)International. 7 NSF International has highvisibility in the food industries worldwide,with a variety of certification andauditing programs, training programsand publications. The NSF mark is mostcommonly found on equipment used inthe retail foods and foodservice industriesand is recognized as an indicationthat such equipment meets NSF standards.Further, NSF/3-A/ANSI 14159-1Hygiene Requirements for the Design of Meatand Poultry Processing Equipment 7 hasbeen developed in collaboration with 3ASSI.3A Sanitary Standards Inc. 8 3A SSI isbest known for equipment standards inthe dairy industry. However, 3A is notjust for dairy. In recent years, other industrieshave recognized these standards,with more food processors specifying 3Astandards in equipment purchases. 3ASSI has been open to working with otherindustry groups and welcomes participationfrom other food industry sectorsinterested in the development of appropriatestandards for their equipment.A general 3A standard, which embodiesSanifan Technology Features Include:• Crevice Free PolishedStainless Fan• Ultra Sanitary Fanto Shaft Mounting• Integral SprayCleaning Endbell• Sanitary DoubleSeal Design• Multiple Port Optionsand Configurationsthe general principles of hygienic design,is also being developed that equipmentfabricators and food industry personnelmay use as a guideline. 3A SSI hasbeen very active in outreach training andknowledge transfer through its websiteand hygienic design workshops held atthe company’s annual meeting and atother venues.The Industry’s Only Clean-in-PlaceStainless Steel Sanitary MotorTHE NEW MEANING OF CLEANAvailable Exclusively From505.867.0224sanifan@stainlessmotors.comwww.stainlessmotors.comTMD e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 15

SANITATION3A SSI is organized into three interestgroups: fabricators (equipment manufacturers),users (processors) and sanitarians(state and federal regulatory sanitariansand academicians). This working modelis unique in that the standards developmentprocess requires representation andinput from regulatory sanitarians in additionto industry representatives.The 3A symbol provides assurancethat equipment meetsthe applicable 3ASanitary Standard.Obtaining this symbolrequires an on-siteevaluation (at the facilitywhere the equipmentis manufactured)of the equipment by acertified conformanceevaluator. A systemis also in place tofile reports of allegednoncompliance ifequipment bearing a3A symbol is observed(usually during a regulatoryinspection) anddeemed out of compliancewith the applicable 3A standard.General Principles of EquipmentHygienic Design and ConstructionImproved hygienic design enhancescleanability, decreasing the risk ofbiological (pathogens), physical andchemical (e.g., allergens) contamination.Furthermore, equipment that is designedand constructed to meet hygienic principlesis easier to maintain and reducesthe risks of physical hazards (e.g., metalfragments from food equipment) in foodprocessing.Surfaces of food equipment andrelated ancillary equipment are dividedinto food contact and nonfood productcontact surfaces. While most of thediscussion in this article relates to foodcontact surfaces, it should be recognizedthat nonfood product contact surfacesare very important and cannot be overlooked,as these surfaces have beenimplicated in environmentalcontamination.“Increased use ofcorrosive chemicalsin L. monocytogenescontrol programs hascreated new challengesfor food equipmentmanufacturers...”Under 3A Sanitary Standards, theaccepted definition of a food contactsurface is any surface that has direct contactwith food residue, or where food residue candrip, drain, diffuse or be drawn. All foodcontact surfaces must meet specifichygienic design and fabrication requirementsto ensure cleanability. Corrosionresistance and durability of the materialsused are also important to maintaincleanability. Where appropriate,equipmentshould also be constructedto allow accessibilityfor inspectionto observe whether it isadequately cleaned.Hygienic equipmentdesign encompassesthe following:Materials: Foodcontact surfaces offood equipment mustbe fabricated from materialsthat are smooth,impervious, nontoxic,nonabsorbent and corrosionresistant underconditions of intendeduse. 9 Each of these terms may be opento interpretation. It is only through wellwrittenequipment standards that eachbecomes defined.Primarily because of its corrosionresistance and durability compared withmost other materials available, stainlesssteel is by far the preferred material forfabricating food equipment. However,it should be noted that there are manytypes of stainless steel and that not allgrades are recommended for food contactsurfaces. 10, 11 3A Sanitary Standardsspecify AISI 300 series (excluding 301),with 304 and 316 stainless steel beingmost common. These nonmagneticstainless steel materials are composedof alloys in which chromium and ironpredominate. Chromium oxide thatforms on the surface (i.e., passive layer)protects the inner layer (i.e., active layer),containing iron, from corrosion. If thepassive layer is compromised, the surfaceis vulnerable to corrosion when exposedto chlorides (e.g., chlorine), other corrosivematerials or other environmentalstresses. Thus, it is generally recommendedthat a passivation treatment be done,following a recommended procedureand frequency. 123A Sanitary Standards allow for theuse of other metals for specific applications,provided that they are demonstratedto be at least as corrosion resistantas 300 series stainless steel. In addition,there has been an increased use of nonmetalmaterials (e.g., plastics, rubber,ceramic) in food contact applications.At the minimum, such materials mustbe safe and nontoxic through regulatoryapproval as an indirect additive or foodcontact substance. However, such approvaldoes not provide assurance thatthe material is durable and will maintaina cleanable surface under conditions ofintended use. When purchasing equipmentfabricated using these materials, itis recommended that such assurances beprovided by the manufacturer.Surface Finish and Modification: Eventhe most durable, corrosion-resistant materialis not recommended as a food contactsurface if the surface is rough or ifit has cracks and crevices. For food contact,stainless steel surfaces are usuallyfinished through polishing, grinding orother means to obtain a smooth finish. 13Most hygiene standards require that foodcontact surfaces have a roughness average(Ra) of 0.8 µm or less, determinedusing a profilometer, which corresponds8, 14, 15to a No. 4 finish on stainless steel.Stainless steel with a 2B or milled finishis acceptable, with limitations. The 2Bfinish is used for its superior fat-releaseproperties in equipment intended to processand handle higher-fat products (e.g.,butter, meats).Construction and Fabrication: Foodequipment must be constructed andfabricated to ensure that interior surfacesare free of cracks, crevices or sharpangles. 3A and other standards specifythat interior angles or corners (includinggasket grooves) be rounded to a specificradius. Fabricated equipment must alsobe constructed such that it is pitched toa drainable port and is self-draining (noholdup).16 F o o d S a f e t y M a g a z i n e

SANITATIONTo maintain appropriate fluid motionin cleaning and processing, all connectionsto equipment must be “closedcoupled” such that no dead ends or deadspaces exist. Dead spaces can be inadvertentlycreated when a connection pipe isused on a tank or line to attach ancillaryequipment (e.g., thermometers, gauges).To prevent a dead space, the length ofthe connecting pipe cannot exceed itsdiameter.A common error in equipment constructionand fabrication (and repair)is the use of inappropriate welds andwelding materials, and/or the use ofnoncleanable bolts and threads withinthe food contact zone. Hygienic designstandards generally specify the weldingmaterials allowed and that welds be ofbutt type (not overlapping) and groundto a smooth finish (Ra of 0.8 µm orless). 8, 16 Bolts and threads, if necessary,in the food contact zone must be of theacceptable hygienic type.Installation, Operation and Maintenance:In general, food equipment should beinstalled to allow 360-degree access forcleaning and housekeeping. If mountedto the wall or floor, it should be properlysealed. Depending upon its size andtype, food equipment should be elevatedeither on a pedestal or on legs at a heightthat meets recommendations 17 to allowcleaning under the equipment. All legs,levelers and related supports should bedesigned and constructed to have nohollow areas, penetrated framework orexposed threads that are not of cleanabledesign. Food equipment should be operatedin a way that ensures effective cleaningand does not allow cross-connectionsbetween product and other solutions(e.g., cleaning solutions, allergens, rawfood materials). The majority of the foodequipment is cleaned and sanitized usingmechanical or clean-in-place (CIP)systems. However, it should be notedthat not all food equipment is designedfor total automated CIP cleaning andshould be partially disassembled formanual cleaning as required.Regulatory Surveillance ProgramsThere is considerable variation in regulatoryinspection programs with regardto auditing and evaluating equipment.FDA inspections for most food industriesfollow current Good ManufacturingPractices. 18 The provisions for equipmentdesign and construction use general terminology(e.g., adequately cleanable, corrosionresistant, nontoxic)and do not explicitlymention specific hygienicdesign andconstruction criteriato further clarify theseterms. Thus, interpretationof the finerpoints of hygienicdesign is left to theindividual inspector orauditor. Under FDAregulatory HACCP forseafood 19 and fruit andvegetable juices, 20 itis required that facilitiesand food contactsurfaces be addressedthrough SanitationStandard OperatingProcedures (SSOPs).Interpretation of the adequacy of theseSSOPs and their implementation variesby individual facility and by regulatoryofficial.FSMA requires that all food facilitiesimplement a Hazard Analysis andrisk-based preventive controls plan. Theimplementation and enabling regulationshave not been finalized. However,it is likely that food contact surfaces willbe covered under prerequisite programssimilar to what’s been done in the FDAmandatedHACCP programs.Grade A milk and milk products areregulated under the National Conferenceon Interstate Milk Shipments(NCIMS), 21 a cooperative federal/stateprogram in which facilities are inspectedunder the Grade A Pasteurized MilkOrdinance (PMO). 18 Under the PMO,utensils and equipment shall be constructedof materials that are smooth,nonabsorbent, corrosion resistant andnontoxic, and constructed as to be easilycleaned. While these general termsare open to interpretation, the PMO“Improved hygienicdesign enhancescleanability, decreasingthe risk of biological(pathogens), physicaland chemical(e.g., allergens)contamination.”provides more definition by referencing3A Sanitary Standards as meeting thesePMO provisions. Under the NCIMSprogram, equipment is evaluated duringroutine inspections, state ratingsand FDA check ratings. In addition,FDA conducts state training programs,has issued M-I-00-2:“Milk and Milk ProductEquipment — AGuide for EvaluatingConstruction” 22 andparticipates in regionaldairy equipment reviewcommittees withparticipating states.The U.S. Departmentof Agriculture(USDA)/AgriculturalMarketing Service(AMS) provides voluntarygrading andinspection of dairyfacilities. This agencyroutinely performsequipment review onequipment before it isinstalled in a plant andduring plant inspections, and accepts3A Sanitary Standards as meeting theirrequirements. For equipment for whichstandards do not exist, the equipmentreview follows USDA Guidelines for theSanitary Design and Fabrication of DairyProcessing Equipment, 23 which follows 3Astandards.Under traditional meat and poultryregulations, the USDA/Food Safetyand Inspection Service maintained anapproved list of equipment allowedin facilities. However, the agency hasmoved away from this system in recentyears with the advent of HACCP regulations.The AMS is currently providingan equipment review as a service to themeat and poultry industry.Third-Party Auditing ProgramsA variety of third-party organizationsaudit food facilities. In recent years,auditing to meet standards under theGlobal Food Safety Initiative (GFSI), 24required by major retail foods outlets,(continued on page 52)D e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 17

TestingBy John T. ShapiroEnsuring Success of FoodCompany OutsourcingProper planning, carefulcontracting and ongoingoversight are criticalSubstantial and frequently changing hurdles standbetween food companies and success. A company’sbottom line often is subject to increasedcosts brought about by economic recession,natural disasters, fluctuating commodity prices,regulatory changes and changing consumer demands,among other obstacles. The Food Safety ModernizationAct (FSMA), for example, has imposed a host of foodsafety-related requirements on food companies thatmay be costly to fulfill, with more on the way come fullimplementation.In an effort to counter the costs of such hurdles and toprotect their bottom line, food companies of all sizes aremore often outsourcing business functions (human resources,information technology, etc.) and manufacturingoperations (research and development, testing, packaging,etc.). When well planned, outsourcing arrangements mayprove quite beneficial.But as with any supply relationship, changing circumstancesmay make an outsourcing arrangement unrewarding.Moreover, where an entire business function or manufacturingoperation is outsourced, the potential risks risefor business disruption and increased costs. A failure ina critical outsourced business process or manufacturingoperation may have a substantial, and potentially devastating,effect on the company’s business. (For more aboutthe benefits and risks of outsourcing food safety testing,see “Lab Outsourcing,” p. 54.)What can a food company do to adequately protectitself against risks that underlie outsourcing?In short, a food company shouldproperly plan for the life of the outsourcingrelationship. Proper planning comprisesat least four considerations:1. Thorough due diligence regarding,and preparation for, the outsourcedrelationship2. Thoughtful negotiation of the outsourcedrelationship3. Precise drafting of the agreement thatgoverns the outsourced relationship4. Vigilant management of the outsourcedrelationship and agreementEach aspect of planning is complex.Moreover, given the variety and complexityof outsourcing relationships andoutsourced processes and operations,unique due diligence and risk managementconsiderations may exist andshould be assessed in conjunction witha particular relationship. This article addressesoutsourcing relationships generally,highlighting key strategies, issuesand considerations that will help foodcompanies plan for such relationshipsand avoid outsourcing errors.Preparation for the OutsourcedRelationshipMismatched expectations between afood company and outsourcing partnermake it easy for the relationship to fail.Preparation for an outsourcing relationshipthus requires two assessments—oneinternal and the other external.First, a company must assess how theprocess or operation to be outsourcedfits within its overall business. It is essentialto consider any issues unique orcritical to that function that may be ofparticular concern in outsourcing. It alsois essential to consider the costs to transitionto an outsourced relationship andthe subsequent costs to manage it.If the internal assessment confirmsthat it is appropriate to outsource, thecompany should draft a plan that establishesits goals for the relationship.18 F o o d S a f e t y M a g a z i n e

[ XEVO TQ-S ][ ]You’re going to needa bigger graph.The Xevo ® TQ-S from Waters. Featuring high sensitivity with StepWave, ourrevolutionary off-axis ion-source technology lets you quantify compounds atlower levels than you ever thought possible. And its sensitivity, speedand selectivity will take your results to an entirely new level.Learn more at waters.com/xevotqs©2012 Waters Corporation. Waters, Xevo, StepWave, UPLC andThe Science of What's Possible are trademarks of Waters Corporation.

TestingAmong other things, an outsourcingplan should:• Specify the company’s objectives,both operational and financial• Define the scope of the function oroperation to be outsourced• Set forth any requirements and specificationsof the outsourced functionor operation• Explain operational, technical andfinancial metrics against which tomeasure potentialoutsourcingpartners• Describe expectedperformanceoutcomes• Assess how thecompany intendsto manage theoutsourced relationship,includingconsideration ofnecessary personnelThe plan alsoshould spell out anyessential criteria thatmight affect the successof the outsourcingrelationship, such asU.S. Food and DrugAdministration regulations,U.S. Departmentof Agricultureregulations, or industrybest practice standards governingthe particular operation. It may be morefruitful to select a supplier that understandsand has experience in the foodindustry. In addition, the plan shouldtake into consideration the personnelor consultants needed to assess whetherto outsource, to select an outsourcingpartner and subsequently to managethe outsourcing relationship. Withoutknowledgeable personnel or consultantsto form the plan, assess partnersand manage the relationship, it may bedoomed from the start.Second, a food company should useits outsourcing plan as the foundationfor the matters it examines when performingdue diligence on prospectiveoutsourcing partners. In addition to“A failure in acritical outsourcedbusiness processor manufacturingoperation may havea substantial, andpotentially devastating,effect on thecompany’s business.”assessing a potential supplier against operational,technical and financial metrics,careful due diligence also entails researchinto the potential supplier, includingsharing of information and review ofmaterial about the supplier that wouldimpact the efficacy of any relationship.This includes the potential supplier’sprocedures, culture, accreditation, certification,food industry experience, equipment,facilities, finances and financialstability. Where feasible,both high-levelbusinesspeople andtechnical personnelwho know the processor operation to beoutsourced shouldinterview the potentialsupplier in person todetermine whether thesupplier understandsthe company’s businessand industry, andto assess the potentialsupplier’s compatibilitywith the companyand its culture. If apotential outsourcingpartner is located outsidethe United States,additional considerationshould be givento conditions that maybe unique to that candidate’slocale, including environmentalfactors, accessibility, political unrest,labor pool, energy, telecommunicationsand transportation infrastructure, food,consumer and safety laws and pertinentother laws and regulations.A natural tension exists between afood company’s desire to cut costs byoutsourcing and its obligation to meetfood safety and consumer demands.Suppose, for example, that a company’smanufacture of its food product requiresmicrobiological testing subjectto regulatory parameters or marketplacedemand. Such testing may already be,or may soon become, so specialized thatthe company believes that purchasingor upgrading the necessary laboratoryequipment and retaining trained scientiststo perform the tests would be tooexpensive to do in-house. Nevertheless,the food company retains responsibilityfor compliance with the testing specificationsregardless of cost. Thus, the companymust perform sufficient internaland external due diligence to mitigatethe risk of the outsourcing partner’s noncomplianceto determine whether thecompany would benefit by outsourcingand whether those benefits outweigh therisks.Due diligence also plays a criticallegal function. Information gatheredduring due diligence will affect the contentof the outsourcing agreement. Thatis, unless a food company first identifiesits critical business needs and then assessespotential supply partners in lightof those needs, it may not have enoughinformation to perform an adequatecost-benefit analysis or to negotiate,reflect and protect those needs in an effectiveoutsourcing agreement.Thoughtful Negotiation and PreciseDrafting of the OutsourcingAgreementA well-negotiated, well-written outsourcingagreement is critical to forma productive outsourcing relationship.Boilerplate is almost unavoidable informal agreements, but relying on boilerplateincreases the chances of a companymisunderstanding the impact of contractualterms. Thus, a company shouldinstead carefully consider, negotiate andcontract for each aspect of the outsourcingrelationship. This is especially truefor food companies that are particularlysusceptible to the unpredictable natureof consumer perception. Even were aproblem caused by its supplier, consumersare unlikely to appreciate a distinctionbetween the food company and itsoutsourcing partners. A food companymay not be able to recover in the eye ofthe consumer even if the company didnot directly cause a problem.Given the complexities of an outsourcingrelationship, food companiesmust address a number of considerationsto make an outsourcing relationship successful.The particular considerations will20 F o o d S a f e t y M a g a z i n e

Testingvary, depending on the circumstancesand nature of the relationship. But generally,when effectively drafted, an outsourcingcontract should, among otherconsiderations:• Identify precisely who is the supplier• Specify the services, and the scope ofthose services, to be supplied• Detail the government regulationsand industry standards to which thesupplier is subject• Detail the business needs of the foodcompany that the supplier must meet• Specify the price for the supplier’sservices and account for price varianceswhere circumstances change• State the length of the agreement• Contain an appropriate warranty ofthe supplier’s performance• Define the metrics by which the supplier’sperformance will be measured• Specify the incentives and penaltiesfor the supplier complying with orbreaching the performance metrics• Provide for a clear and understandablemethod of declaring breach, cureand termination• Specify the manner and venue inwhich disputes will be resolved• Define the laws and regulations thatgovern the relationship• Eliminate, mitigate or otherwise anticipateand address potential risks tothe company that cannot be avoidedaltogether by limiting and definingthe supplier’s rights• Provide for the transparent, andif necessary, traceable steps in thecompany’s supply chain required byFSMAFurther examination of a few of thosekey considerations follows.Regulatory Compliance. If an outsourcedprocess or operation is subject togovernment regulation, the parties mustnegotiate who is responsible for compliance.Generally, a food company cannotoutsource compliance with the law. If acompany is obligated to comply with aregulation and fails to do so, outsourcingis no defense against government action.The company must identify the regulationsat issue, advise the supplier of theregulations and make compliance oneof the performance metrics to which thesupplier is subject.In addition, the parties should addresshow changes in regulations andlaws will affect their relationship. To thatend, the outsourcing agreement shouldspecify who will be responsible for determiningwhat precisely those changesrequire, how those changes apply to theprocesses or operationsoutsourced andhow the parties willallocate responsibilitiesfor incorporatingthose changes into theoutsourced activity.Further, the outsourcingagreement shouldspecify how the partieswill account for andaddress any increase ordecrease in costs attendantto changes in thelaw.Quality of Service. Toensure quality of service, an outsourcingagreement should:• Define rigorous quality assurance(and if applicable, regulatory compliance)standards with enforceable servicewarranties• Require regular compliance audits,conducted by both the supplier andthe food company• Provide a mechanism by which thecompany can participate in addressingand resolving problems identified• Provide for the right to reduce thescope of the services or operationsprovided, or for termination, if thesupplier does not meet the requirementsFlexibility. Business needs and strategiesaddressed at the outset of theoutsourcing relationship can change.Among other measures designed to ensureflexibility, the term of an outsourcingagreement should:• Be short in duration but provide thecompany the right to renew• Provide the company the right to reviewthe contract in light of changedbusiness needs or extraordinaryevents“Mismatchedexpectations betweena food company andoutsourcing partnermake it easy for therelationship to fail.”• Address service and quality in theevent of a force majeure event, eitherlimiting the supplier’s rights in responseto a true disaster or allowingthe outsourcing company to terminateif the supplier cannot performFurther, the terms used should bedefinite so that the parties know, withprecision, what conduct or quality deficienciesof the supplierwould run afoul of theparties’ agreement. Forexample, parties ofteninclude terms such as“material breach” and“generally acceptedstandards.” Absent amore specific definitionof those terms inthe context of the outsourcingrelationship,such terms may fostermisunderstanding andprolong resolution ofdisputes. The partiesshould be as specific as possible withtheir description of contractual standardsfor compliance.Exit Plan. Broad termination rightsalso are critical to an effective outsourcingagreement. To that end, an agreementshould provide a food companytermination rights tied to inadequateservices or changed circumstances thatmaterially affect the outsourcing relationship,including quality and economics.In addition, an agreement shouldinclude protections for the companydesigned to facilitate an effective transitionof the outsourced services to anothersupplier or back to the company.For example, certain suppliers may notbe able to comply with FSMA requirementswithout a significant increase incosts. In anticipation of such changes toregulatory circumstances, the companyshould leave itself an appropriate out sothat outsourcing remains cost effective.At the same time, to reduce the riskthat the supplier may prematurely terminatethe agreement and leave the companywithout a critical service or neededsupply, the agreement should allow(continued on page 54)D e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 21

PROCESS CONTROLBy Ted Snyder, B.C.E.Performing a Quality Auditon Your Supplier’s PestManagement ProgramImportance of pestmanagement system audits infood processing facilitiesThe majority of today’s food processing facilitiesoutsource only one component oftheir food safety system: pest management.Although it is good to have these servicesprovided by dedicated technicians trained inpest management rather than maintenance staff whosejob includes other duties, it does not mean your foodprocessing facility is not vulnerable to shortfalls in thepest management service provided.Just like any other system in a food processing facility,the pest management program must be auditedregularly. Use this guide to help determine whethersome common pieces of pest management equipmentare properly set up and working (see also “Stepping UpRodent Control,” p. 23).Multiple-catch traps, designed to capture severalmice in one setting, form the mainstay of your interiorrodent control program (Figure 1). These are typicallyfound around the interior perimeter of your facility.People often think these are designed to capture miceas they run along the walls. People also think mice areattracted to odors escaping through the holes in thetrap. Neither of these statements is true. Mice naturallyexplore new objects in their environment, looking fornew food sources and shelter. Before entering a multiple-catchtrap, they often investigate it, walking aroundit, sometimes even jumping on top of it.The trap placement should be along a wall asshown. However, having a trap pulled away from a wallFigure 1: Multiple-Catch Mouse Trapisn’t recommended if you are having athird-party auditor come through. Notall auditors understand how these trapsfunction in relation to mouse behavior,and you might find yourself scoring lowerin an audit if the traps are not locatedin the correct positions.Next, you should check the traps forproper function. The best way to checkthem is to simulate a mouse enteringthe trap, using your finger or a pen(Figure 2). The floor of the tunnel thatthe mouse travels through has a plasticpressure plate. If you push down on it,the tunnel should rotate, throwing themouse into the catch area inside.If the tunnel doesn’t rotate or rotatesslowly, the trap isn’t working properly.Figure 2: Checking the Multiple-CatchMouse Trap for Proper FunctionThe trap could be broken, it might havenot been set properly or, if you have ahigh-vibration environment, it mighthave unwound on its own.Now you need to remove the trapcover and look at its inner workings22 F o o d S a f e t y M a g a z i n e

PROCESS CONTROLFigure 3: Inner Workings of the Multiple-Catch Mouse Trap(Figure 3). The entire interior shouldbe free of any evidence of pests—spiderwebs, dead insects, mouse feces, fur andcarcasses. If it has been a couple of weekssince the pest management providerhas serviced the traps, you might findsome dead pests in them, so it is best toperform the audit immediately after yourregular service.Rodents living outdoors around thebuilding may try to get inside, lookingfor food and shelter. Exterior bait stations(Figure 4) are an important tool inpreventing this from happening.Exterior bait stations must be difficultfor a small child or wildlife to move.This can be accomplished by weightingdown the station. Some have the stationglued or bolted to a block. Other optionsinclude staking it to the ground or boltingit to the building.Exterior bait stations must require atool to open them. Modern stations havea key, although older stations might beclosed with a hex screw or even a zip tie.Figure 4: Exterior Bait StationsWith older stations, make sure that everystation is properly secured.When you open the exterior bait station(Figure 5), look for the following:1. First, look at the bait. Notice howit is threaded through a bar. This is importantto secure the bait within thestation.2. Next, make sure the bait still appearsfresh. What you don’t want to seeis bait that has melted from high heat,or moldy or otherwise discolored bait.In addition, if the service has just beenperformed, none of the bait should showany signs of rodent activity.Figure 5: Inner Workings of the Exterior BaitStationStepping Up Rodent Control3. Finally, the inside of the bait stationshould be reasonably clean. Plantmaterial, droppings, dead rodents, debrisfrom the bait and the like should beremoved.By taking these approaches duringa quality audit of your supplier’s pestmanagement equipment, you can ensurethat your supplier’s pest managementprogram is operating properly and thatthe equipment is correctly set up andworking. As for any other system in afood processing facility, these auditsmust be conducted regularly. I hope thisguide will help you keep your facilitiespest-free.•Ted Snyder, B.C.E., is a Milwaukee,WI-based entomologist who providesconsulting services to the pestmanagement and food processingindustries. He can be contacted atted.snyder.ltd@gmail.com.Automation has hit the pest control industry in a big way. Rodent stations can be checked viaportable scanners. All pertinent information can be entered in databases for historical reviews,and customers can view their data in real time over a secured database. This is convenientfor quality control directors with multiple locations. Documentation programs are essential toanalyze or review any trouble areas, service histories and records of all materials used on thepremises. Many times, this will be the most important information that third-party auditors willexamine.Rats and mice must be controlled in food plants and distribution centers because theydamage food containers, contaminating food with droppings and urine and consuming food.The mouse most often found in our industry is the house mouse; the two most common speciesof rats are the Norway rat and the roof rat. Most rodents are nocturnal and reproduce rapidly,having 20 to 35 offspring per year.Signs of rodent infestation include droppings, visual sightings, gnawing sounds, oil marksfrom their fur, tracks that can be seen in dusty areas with flour, gnawing of insulation and wiresand urine stains that are detectable under UV light.To effectively control rodents, you must eliminate their harborages, such as old pallets andretired equipment. Remove all junk and keep the exterior perimeter free of weeds and debris.The next step would be the elimination of food and water sources. Following that, rodent-proofyour facility to keep them from coming into the plant or warehouse.Rodent control should include a combination of tools such as outside baits in secure/tamperproof stations, inside traps such as professional-grade snap traps and large glueboards. Glue boards will catch rats, mice and the occasional invader such as grasshoppers orcrickets. Again, all traps and secure/tamperproof bait boxes should be regularly inspected andmaintained. Number them and map them out. The bait placement will probably have to beincreased during the winter months if activity increases. Inspecting the grounds for Norway ratburrows is very important. Burrows can be treated with rodenticides or toxic tracking powder,but this is a job for the professional.To preserve your company’s reputation, know your facility’s pest control program andalways keep track of the documentation.Adapted from “Effective Pest Control: The Essentials for Food Processing Plants andWarehouses” by Gary Hugé, Food Safety Magazine, December 2011/January 2012.D e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 23

By Bizhan Pourkomailian, Ph.D.ith food safety-related recalls becoming morecommonplace, it is essential for incident responseteams to understand and implement processesthat will help manage these events in the most transparentand effective ways possible. How your company choosesto function in the middle of a crisis, especially during theearly stages when communication is most critical, will undoubtedlyaffect your entire business going forward.Incident management may meandifferent things to different people.As with all discussion points, it isalways best to clarify the meaningof the subject under scrutiny. Therefore,before diving into this subject,here are definitions of the keywordsin this discussion:Risk — The potential that a chosenaction or activity (including thechoice of inaction) will lead to aloss (an undesirable outcome)24 F o o d S a f e t y M a g a z i n e

Incident — An occurrence of seemingly minor importance that can leadto serious consequencesCrisis — Any event that is, or is expected to lead to, an unstable anddangerous situation affecting an individual, group, community or wholesocietyManagement — The act of getting people together to accomplish desiredgoals and objectives using available resources efficiently and effectivelyThese words themselves are self-explanatory; however, their combinationwould define why different management practices would be requiredin different circumstances. To clarify which management practice suitswhich circumstance, one must consider the various management needs:Risk Management — In simple terms, this would relate to practices designedto prevent a situation fromoccurringIncident Management — The situationin this case has occurred and itis time to limit the damage by stoppingthe incident from becoming acrisisCrisis Management — At thispoint, the damage has occurred or iscontinuing and the response has tobe swift to clean it up and in somecases limit it (a heightened incident)D e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 25

One may look at this list and select a management practice based on the situationat hand. In reality, businesses need all three to function efficiently. Logically, the designof the program begins with risk management, followed by incident managementand ending with crisis management. However, since the processes of risk, incident andcrisis management are very similar, all may be prepared at the same time. In all three,the issues of concern and their management are the same; just the degree of urgencyand escalation differ.It must be understood that the implementation of a risk management programdoes not always prevent an incident or crisis. The value that a well-designed programbrings is in the preparedness of the organization for any inevitability. When an incidentdoes occur, success is evident when the organization prevents panic and chaos,and stops the incident from becoming a crisis. All too often,an organization is faced with an incident that occurredelsewhere but not due to failure in its own programs.Yet, the organization must respond and prevent theincident from becoming a crisis for its own business.Naturally, there also are cases where the “It must beincident is the direct result of action takenby the organization. In either case, understood that thewhether the organization is directlyor indirectly involved, the incidentmust be managed.implementation of a riskmanagement programCauses of IncidentsIncidents occur every single day, does not always prevent anand since they are often preventedfrom becoming crises, most are invisible incident or crisis.”to all but a few. In some cases, however, theylead to a crisis, and at that point, based on theseverity and scale, the news travels across the world.The types of incidents may be separated into twogroups, food related and non-food related. A few examplesare given below:Food Related• Contamination of raw food or feed• Consumer illness• Allergens• Chemical residues• Foreign objects• Packaging• Supply chain interruptionNon-Food Related• Natural disasters° Earthquake° Volcano° Flood° Storm° Famine• Man-made° Power plant accident° War° Political unrest° Resource depletionAlthough these are separated here, in reality, many are interrelated. The non-foodrelated incidents will eventually affectthe food supply chain and vice versa.Two examples demonstrate this interrelationship:The case of the tsunamiin Japan in 2011 and the 2011 Shigatoxin-producing Escherichia coli (STEC)outbreak in Germany.Japan Tsunami. The natural movementof the Pacific tectonic plates nearJapan caused a powerful earthquake witha magnitude of 9.0 that triggered a tsunami.Both the earthquake and tsunamihad devastating effects on the food supplychain—roads damaged, productionsites destroyed and people uprooted. Thecrisis further developed as the loss ofelectrical power and then a subsequentfailure of emergency systems at a nuclearpower plant caused a core meltdown,causing widespread radioactive contamination.Food manufacturers faced rawmaterial contamination as well as potentialcontamination of products due todamaged manufacturing sites.German STEC Outbreak. The STECoutbreak in Europe that began in Germanyin 2011 was responsible for over2,000 cases of foodborne illness and over20 deaths. The culprit was eventuallyidentified as freshly sprouted seed, yetoriginally, cucumbers from Spain wereidentified as the source. These mistakesled to supply chain interruption and politicalunrest between the countries.These examples illustrate the effectsof non-food related crises on food-relatedissues and vice versa. Nevertheless,preparedness comes by conducting a riskassessment and implementing managementprotocols to stop a potential incidentoccurrence.The Incident ManagementProcessFor a food manufacturer to be in asecure position, the organization wouldneed to assess all possible causes of apotential incident and its risk of occurrence.Generally, this would not be practical,so only reasonably possible causeswould be evaluated. However, beforethis information can be gathered, anincident management team would needto be formed. This team would look at26 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

the risks of potential incidents and how crises may be avoided. The formation andcomposition of the risk management team (RMT) is very similar to those of HazardAnalysis and Critical Control Points (HACCP) systems. The RMT must be multidisciplinary,comprising staff from key departments. In some circumstances, it may bedeemed necessary to include members external to the company. Membership shouldbe drawn from the following departments:• Supply chain• Quality assurance (QA)• Commercial• Legal• Communications• Operations• Human resources• Finance/Insurance• Information technologyThe core of the RMT is often drawn fromthe supply chain and QA departments. The “When anselection of team members would needincident does occur,to be determined by relevant skill sets.The group would have many taskssuccess is evident when theto perform but would need tobegin by establishing theorganization prevents panicground rules such as clarifyingvarious definitions:and chaos and stops theFood Safety Risk — The potentialfor food to be affected—or be perceivedto be affected—and leading to theincident from becomingpossibility of putting at risk the health and a crisis.”safety of customers, consumers or employees.This may be, for example, actual or perceived contaminationof raw product/feed (chemical, radiologicalor microbiological), customer illness, food allergens,animal/other residues in food or foreign bodies in food orpackaging.Legislation — Since January 1, 2005, EU Food Safety Law (Regulation 178/2002) hasbeen in effect. This regulation specifies EU-wide procedures in matters of food safetyand places a specific obligation on food business operators to immediately informregulatory authorities if food is assessed to be “injurious to human health” or “unfitfor human consumption.” European and/or local regulations may apply in the eventof product contamination and/or product recall. Any incidents are then reported inthe EU Rapid System Alert for Food and Feed.Risk Management Policy — The organization would need to have a policy in place todefine its priorities, which the RMT would look to safeguard through the process.Defining Roles and Responsibilities — The RMT has ultimate responsibility forcategorizing and managing the food safety risk, delegating to other company staff asappropriate. All communications, whether for notification, withdrawal or recall, mustbe approved by the RMT to ensure, among other things, that messages are consistent.Ownership — The RMT chair or a designated member would need to be responsiblefor the documentation that defines the program.Alert System — It is vital that a robust alert system is established to allow the RMTmembers to connect with each other in cases of incidents and/or crises.Training — As the RMT designed and put the program together, they would be theideal candidates to train or establish training programs for other company staff.Having established these basic requirements, the RMT would need to develop theprocess for managing any potential incident.As such, various logical steps maybe followed:1. Food Risk or Incident Identification. Aspreviously described, incidents havemany possible causes. In setting upthe program, the RMT would needto identify as many causes as it can.Items such as allergen contaminationor earthquake from the noncomprehensivelist presented earlier in thisdiscussion would need to be identified.2. Identification of Information Sources. Itis vital to know where informationabout an incident may come from.The information sources could bemany:• Suppliers• Customers• Government• Local authority• Police• Nongovernmental organizations• Internal3. Setup of Information-Gathering Protocol.Having identified where the informationmight come from, tools must bein place to efficiently capture it. Atthis point, it is necessary to ensurethat the protocol established is fast,accurate and from a reliable source.The information has to be confirmedand verified before any action istaken.4. Alert System. Once information hasbeen received, an alert system mustbe established that would notify therelevant personnel. The notificationwould need to cascade to the activationof the RMT.5. Initial Briefing. The RMT would needto meet/connect to evaluate the situationand identify resources needed.The composition of the team wouldbe based on the subject matter,personnel availability and expertiserequired. Key responsibilities need tobe assigned to gather the full team,schedule the next briefing and mostimportantly, to notify senior managementon the status quo.6. Full-Team Briefings. When the fullteam has been gathered, a strict, for-28 F o o d S a f e t y M a g a z i n e

malized approach is essential for clarityand efficiency. A possible formatwould entail:a. RMT leader (established in initialbriefing) self-introductionb. Roll callc. RMT checklist: Develop and usethe checklist to ensure capture of allrelevant information.i. Incident description• What has happened?• Is there a direct, indirect or nodirect link with the organization?• What is the external awarenesslevel?• What is the extent of customer/personnel effect?• Is there a short- or long-termduration?• Is any additional work in progressor needed?ii. Incident status• What are the RMT objectives?• What communication is needed?• What resources are needed?• Response timelines• Response effectiveness• How this could have happened?d. Administrator: Key information from the calls and meetings must be captured,approved and distributed after the calls/meeting. Creation of a central data informationfile would allow all members of the team to access relevant data duringand after the incident.e. Team actions: The team would need to discuss items on the team checklist aswell as further points:• Identifying additional resources and support• Identifying major stakeholders and potential issues• Identify communication strategies—select a good communicator who canrelate to the audience. Also, there is a need to set a strategy to ensure the appropriateinformation is communicated at the correct time in an appropriatemanner. The information presented should satisfy the following criteria:° Concern: There is genuine understanding of the situation of those affected° Control: Provide confidence that the situation is well in hand° Commitment: Show that the organization will not stop until the situationhas been resolved• Identify triggers that would assist in the proactive recognition of escalationtoward a worst-case scenariof. End of call/meeting: The discussions must be summarized, actions assigned tomembers and the next call or meeting time set up.7. Handover. Some issues will persist for a long time. This may require a change inteam makeup. In that case, a handover protocol would be needed. A logical andD e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 29

informative format would be the best option, which should involve:• The new member being presented to the administrator• The administrator introducing the new member to the RMT• For a short period, both new and outgoing members participating in the engagement.When all members of the RMT are satisfied with the handover, itwill be finalized.• Logging of the process8. Stand-Down Checklist. The RMT will need to decide at some point that stand-downis necessary. Before doing so, various agreements would be needed:• Do all members agree on the stand-down?• Does senior management agree on the stand-down?• Have relevant stakeholders acknowledged that normal activities may commence?When these points have been agreed on, these checkpoints should be followed:• RMT leader to lead team debrief on stand-down to establish key learning• RMT leader to ensure additional response teams (e.g., media) are informed ofstand-down if necessary• Administrator to ensure all log sheets, e-mails and notes are collected and filed• RMT to monitor situation to assess whether the issue could reoccur and,if required, discuss any necessary corrective actions• RMT leader/human resources to consider whether employees could besuffering from managing the issue and consider appropriate strategies• RMT to consider whether follow-up engagement is required with any of theidentified stakeholders and, if so, develop an engagement plan• The RMT should consider sending thank-you notes to those who haveprovided support both internally and externallyWith the process in place, a false sense of security will often arise. The documentencompassing the process may be a glossy corporate book, but few people in the organizationwould know of it. To make the process live, it needs to be communicated,acknowledged, trained and implemented.TrainingThe authors of the incident management process are often the most suited to designthe best training courses. However, external courses have advantages too. Externaltrainers with input from the authors of the incident management process would bethe ideal combination. Before the customized training courses could be establishedand deployed, the idea, reasons, content and governance of the incident managementprocess must be communicated to all employees. Employee education would be thefirst step in this area and it would take the shape of internal information transfer.A customized training course is best for deployment in every part of the organization.Where possible, every employee at some point should go through the training sothat when incidents occur, everyone will be involved.Course success is measured when incidents are managed with seamless efficiencyand calm. To achieve this goal, when an incident occurs, the scenario should not bea surprise. The avoidance of surprise can be managed by correct training scenariosaround applicable root causes of incidents. Therefore, when trainees know what incidentsmay occur, scenarios may be built to test the “what if” cases.Verification and ReviewAt a later date, the effectiveness of the training and the suitability of the scenariosshould be tested. Unannounced tests serve best to make the staff reaction and actionsin managing the incident more robust. Verification may be triggered internally or externally;both have their advantages and disadvantages. Whichever approach is taken,the more challenging the verification, the stronger the system over time.After a verification process or after anactual incident, which itself is a verificationof the system, a review is recommendedfor learning and improvement.Improvements may be in better trainingand communication, or perhaps intougher and more complex scenarios tochallenge the staff. Changes based on thereview should be logged to allow trackingand avoiding reversal to older versions ofthe verification process.ConclusionRisks of an incident will always exist,whether it is food or non-food related, orfrom a natural disaster or man-made one.It is the preparedness for incidents thatdefines the success of an organization inits incident management. To achieve success,the appropriate process would needto be developed and communicated, andtraining provided and verified. Gatheringthe correct team members and settingcorrect protocols is vital for clear, effectiveand efficient management. Thisteam would have a clear task to logicallyascertain the necessary information, alertall relevant stakeholders, analyze the dataand finally act upon the situation. Theactions would need to be designed tostop the incident from evolving into acrisis. Communication to the stakeholderswould need to be focused and directedto address concerns, show that thesituation is under control and demonstratethe commitment that the organizationhas to solving the issue. Everythingwould need to be documented to enablethe RMT to track and learn from actionstaken. From time to time, the systemwould need to be verified and reviewedfor continuous improvement. •The content of this article reflects the points ofview of the author and does not necessarilyrepresent those of McDonald’s.Bizhan Pourkomailian, Ph.D., is director, food safety& supplier workplace accountability, for McDonald’sEurope. He is responsible for providing direction anddeveloping management systems for food safety. Heholds a Ph.D. in biochemistry from Aberdeen Universityand an M.B.A. from Warwick University.30 F o o d S a f e t y M a g a z i n e

Go DigitalFood Safety Magazine offers a state-of-the-artgreen option for subscribers.When you choose our digital subscription,instead of receiving a printed magazine we willnotify you by email that your digital edition isready for viewing.• Speed • Immediacy • Global Accessibility• Intuitive User InterfacePreview the enhanced digital interface atwww.foodsafetymag -digital.com> Read the entire issue page-by-page> Go to any story from Table of Contents> Share with colleagues> Go directly to advertiser websites by clicking their links> Searchable archives> Download the magazine to your computer

MEAT AND POULTRYBy Margaret D. Hardin, Ph.D.Poultry Safety in an Ever-Changing WorldIn May 2012, the Food and Agriculture Organization(FAO) of the United Nations releasedits biannual publication, which focuses on thedevelopments affecting global food and feedmarkets. 1 The estimated output in poultry productionin 2012 is 103.5 million metric tons.This is only a slight increase (1.8 percent) overprevious years, and FAO attributes this restrainton production growth to three main factors:the current high price of feed, the resurgence of avian influenzaoutbreaks in Asia and ongoing trade disputes. While the resurgenceof avian flu is making itself felt in terms of trade barriersand bans, policy decisions related to both real and perceivedfood safety hazards continue to dominate import and exportof poultry worldwide. Avian influenza is not the only pathogenof concern for the poultry industry. On a day-to-day basis,Salmonella and Campylobacter continue to present the biggestchallenges and opportunities for the poultry industry and thepoultry “farm-to-fork” continuum.Salmonella and Campylobacter are two of the most commonfoodborne pathogens associated with human illness in theUnited States. Exposure to poultry meat has been identifiedMulti-hurdleapproach grows inimportance to meetrising expectationsas an important risk factor for illness fromboth of these pathogens. More recently, otherfoods, such as fresh produce, have also beenrecognized as significant vehicles of transmission.However, human foodborne diseaseinvolving Salmonella and Campylobacter is stilloften attributed to poultry. 2 While the poultryindustry has taken a very diligent approach tofood safety and continues to stay current onthe “latest and greatest” in intervention strategies and on-farmbest practices, outbreaks of foodborne illness associated withpoultry continue to occur. During the early discussions andpublic meetings surrounding the implementation of the federalPathogen Reduction: Hazard Analysis and Critical ControlPoints (HACCP) Systems Final Rule, the best managementpractices published by the National Turkey Federation werepraised in particular by the U.S. Department of AgricultureFood Safety and Inspection Service (USDA FSIS) as a modelfor on-farm food safety production practices. However, as outbreaksof foodborne illness associated with poultry continue tooccur and as government policy and regulations continue toutilize microbial performance standards, such as the pathogen32 F o o d S a f e t y M a g a z i n e

FREEMENTION THIS ADCALL: 1.888.494.4362www.hygiena.com• Coliform - Results in 7 hours or less• E. coli - Results in 7 hours or less• Total Viable Count - Results in 6 hours• ATP Monitoring - Results in 15 seconds• Alkaline Phosphatase - Results in 5 minutes• Acid Phosphatase - Results in 5 minutesSAVINGS CODE: 2012FS

MEAT AND POULTRYprevalence on poultry carcasses and finished products as anindication of safety, the poultry industry will have to continueto step up to the challenge of developing multi-hurdle strategiesto address these issues.chick to final processing; proper control of the environment(temperature, water and ammonia); wildlife; rodent and pestmanagement; biosecurity (including buildings, equipment,employees and visitors); cull-bird disposal; litter management;animal welfare, including transportation controls for the propertransfer and movement of eggs, chicks/poults and finishedbirds; and adequate maintenance and sanitation of the housebetween groups. These programs will often vary in their level ofdetail; however, they are best supported by proper training of“...human foodborne disease involving Salmonella and Campylobacteris still often attributed to poultry.”Common Contaminants of PoultryWhile the focus is often on biological hazards, a number ofcontaminants (or hazards) can appear in the food product atany stage during its production, processing, storage and preparation.Effective food safety practices that are implementedand managed throughout the “farm to fork” continuum willminimize the risk and opportunity for contamination of thefinal product as well as minimize or even eliminate the impactof contamination that has already occurred. This all begins onthe farm, where an in-depth understanding of the potentialfood safety hazards, often through an HACCP-based approach,is necessary to fully comprehend the interrelationshipsbetween animal health, biosecurity and food safety. Physicalhazards may include lead shot (often more prevalent duringhunting season), wire, wood chips (from litter), bones, metalscrews and glass from thermometers used during processing.Chemical hazards of concern may range from chemicals andpesticides used on the farm to mycotoxins in feed and veterinarydrug residues to cleaning solutions used in processing.To minimize the risk of contamination of poultry eggs andmeat for consumption, it is important to minimize the risk ofcontaminants reaching commercial poultry flocks. Good farmmanagement practices, such as hygienic practices and effectivebiosecurity procedures, will minimize the chance of contaminationand optimize bird health. The majority of on-farm productionpractices and controls are directed toward the health,welfare and economic performance of the animal and often arenot strictly for the control of human pathogens. In the morevertically integrated poultry production processes, these bestmanagement practices may begin with animal genetics and theselection of superior breeding stock for stress resistance, diseaseresistance and immune competence, thereby optimizing birdhealth and allowing the birds’ own immune systems to provideadditional safeguards against contamination. In addition, thedevelopment of scientifically formulated feed can promote andmaintain the health of the bird’s immune system throughoutthe grow-out period. Organic acids and probiotics may be incorporatedinto poultry feed as applicable to prevent the colonizationof Salmonella in the gut.Additional programs may focus on the sourcing, deliveryand monitoring of feed and water, as these can be significantsources of microorganisms, such as Salmonella, on the farm.Other on-farm programs may deal with bird health and diseasecontrol, including vaccination where appropriate, from egg toemployees and through the documentation and verification ofthe effectiveness of these programs in controlling the identifiedhazards of concern. Monitoring and verification activities mayinclude microbiological testing of samples ranging from feed,water and wastewater to environmental samples of litter, dragswabs, air plates and environmental sponge samples of surfacesto testing of poultry carcasses and of further processed raw andfully cooked products.Not all of these programs may directly impact the presenceor level of a specific pathogen on the birds; however,inattention to detail in implementing these best managementpractices may increase human pathogen loads in and on livebirds. 3 Salmonella and Campylobacter are often referred to as partof the resident microflora of many species of poultry, notablychickens, turkeys and ducks. While affected animals often presentno clinical symptoms of disease, these organisms are themain biological foodborne hazards of public health concernin poultry. Researchers at the University of Liverpool, UnitedKingdom, are studying the effects of stress on the prevalenceand levels of Campylobacter in the gut of the chicken and onthe spread of the organism, through subsequent shedding, toother birds in a house. 4 They are investigating the role thatcertain on-farm activities, such as those designed to addressanimal welfare, may have in controlling these organisms. Whilethe vaccination of poultry against viral and bacterial pathogensof veterinary health concern, including some serovars ofSalmonella, is a widespread and long-standing practice, the useof vaccination against pathogens of public health concern is amuch more recent development and has been limited largely toserovars of prevalence and concern to public health and regulatoryagencies. While specific activities such as vaccines targetingSalmonella spp. may have a direct impact on a specific foodsafety issue, the industry can’t control all the factors that mayinfluence the level or prevalence of these organisms on poultry,including humidity and the disease condition of the bird. Inaddition, the complexity and multitude of on-farm managementpractices present challenges in assessing the contributionof any single best practice in reducing the prevalence of humanpathogens on birds.34 F o o d S a f e t y M a g a z i n e

MEAT AND POULTRYContamination Control During PoultryProcessingOnce the bird enters the processing (slaughter) facility, it entersanother arena of food safety programs and HACCP whereinthe facility must consider the incoming hazards associatedwith all raw materials (i.e., birds) to minimize risk and meetcompany, regulatory, customer and public health expectationsof pathogens such as Salmonella, as excessive contaminationon incoming birds may cause the scalder water to become visiblyand microbiologically contaminated. This organic matter(feces, blood, feathers, dirt, etc.) and any associated pathogenicbacteria on the surface of one bird may then be transferredto the surfaces of other birds “sharing” the scalder. This mayfurther impact subsequent steps in the process, as the organic“In addressing microbial hazards..., most poultry processors employthe ‘hurdle approach’ to reduce the levels and prevalence of...pathogensduring processing and on final product.”for safety and quality. The food safety/HACCP team will identifyall the potential food safety hazards associated with eachstage of the production process, conduct a Hazard Analysis todetermine the likelihood of occurrence and potential severityand identify any associated control measures. In addressingmicrobial hazards (pathogens) in particular, most poultry processorsemploy the “hurdle approach” to reduce the levels andprevalence of these pathogens during processing and on finalproduct. This involves the use of multiple process control stepsand interventions (i.e., hurdles) located throughout the process.The premise is based on the fact that each hurdle reduces thelevels of the organism of concern, and after passing over manyhurdles, the organism is less likely to be present, such as in theend product. Although the primary target for the poultry industryis Salmonella, food safety systems should be built with bothSalmonella and Campylobacter in mind. However, most scientistsand regulators agree that interventions and technologies in aprocessing facility, proven effective in reducing or preventingSalmonella, will also reduce or prevent other pathogens of concern,such as Campylobacter.Several steps have been identified as being particularly effectivein controlling microbial hazards during slaughter and processing.These control measures actually begin prior to receiving,where a common practice to mitigate the risk of microbialcontamination on incoming live birds is the withdrawal of theanimals’ feed prior (8 to 12 hours) to catching and transportingbirds to the processing facility. Reducing gut contents prior totransport not only reduces cross-contamination during transport(reduced soiling) but may also reduce pathogen load andcross-contamination during processing if pathogens are present.The incidence and level of pathogens on poultry carcassesmay vary considerably and depend not only on the prevalenceand numbers of pathogens on the feathers and skin and in theintestinal tract, but also on the degree of cross-contaminationthat occurs from these sources during slaughter and processing.Once the bird enters the processing facility, limiting cross-contaminationduring the primary processing of the live animal,particularly during scalding, defeathering (picking) and evisceration,is extremely important. Scalding is one of the most importantprocessing steps with regard to controlling the prevalencematter and associated microorganisms can then be driven intofeather follicles during picking. Biomapping studies conductedby USDA FSIS at poultry plants throughout the U.S. foundthat in most plants, the prevalence of Salmonella increases as thecarcasses traverse the pickers. 5Effective Food Safety Programs for PoultryAs is true with on-farm production, effective food safetymanagement programs are necessary to reduce or eliminatethe risk and hazards associated with poultry processing. Theseprograms and best practices may include, but are not limitedto, the use of intervention technologies and maintaining properhygiene of employees and proper sanitation of equipment,surfaces and the environment during slaughter, fabrication andfurther processing of poultry and poultry products. The useof in-process sanitizers on belts and equipment, a myriad ofcarcass sprays and inside/outside bird washers can significantlyimpact the levels of bacteria on carcasses and further processedproducts. However, the overall effectiveness of these in-processsystems may vary from plant to plant, as incoming loads onbirds can vary tremendously. Therefore, the appropriate typeof sanitizer and system must be based on an individual plantsetup. Additionally, it is equally if not more important to properlyvalidate these antimicrobial intervention strategies and anyassociated equipment involved in their application. This beginswith reviewing the published literature and regulatory approvalsand performing any necessary in-plant validation steps. In addition,the proper identification of the critical factors involvedin the use and application of these antimicrobial interventionstrategies must be carefully monitored and verified. Critical factorsmay begin with the temperature, pH and hardness of thewater used, the size and shape of the spray nozzle used and thedwell time the product must be exposed to a particular chemicalintervention to ensure maximum effectiveness.Chilling is another opportunity to reduce and controlbacterial contamination. While immersion chilling is still thepredominant method used for broilers in the United States, airchilling is the method of choice for many broiler operationsand turkey-processing plants. The use of either air or immersionchill (or both) is based on pro-(continued on page 56)D e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 35

FSMABy Roger H. Gould, Ph.D.Food Safety Modernization Act:A View from ElsewhereAmerican authorities are attempting to bringtheir fundamental food law on product safetyinto the 21st century. They are not alone indoing this. Most developed countries are workingwith legislation that is decades old andregulations that have been amended so manytimes that no one can be quite certain of allthey contain. This article offers a view of the Food Safety ModernizationAct (FSMA) from those of us exporting into the U.S.In Canada, we have a somewhat similar initiative underwaywith the recently introduced Safe Food for Canadians Act(SFCA), which is intended to update, streamline and combinefour current statutes. In addition, according to the CanadianFood Inspection Agency, the SFCA “will be an important stepin aligning Canada’s food safety system with our trading partners,such as with the Food Safety Modernization Act in theUnited States.” We shall, no doubt, see.Challenges for All Food RegulatorsThere are many stimuli for all these efforts to improve foodsafety legislation, regulation and compliance, among whichThe impact ofthe Food SafetyModernization Actreaches worldwideinternational trade is only one consideration.They have been growing in significance in thelast 20–30 years and include the following:Foodborne Pathogens. In addition to old acquaintancessuch as Salmonella andClostridiumperfringens, we now have Listeria monocytogenes,which has gone from a laboratory curiosity toa major public health concern. The year 1985 was a banner yearfor bad bugs in food in the U.S., with the largest yet recordedoutbreak of salmonellosis (from milk) and the deadliest outbreakof food poisoning (from L. monocytogenes in soft cheese)since the U.S. Centers for Disease Control and Prevention(CDC) began keeping records. Since then, the incidence ofoutbreaks from most of the common bacteria, except Salmonellaand Vibrio, has actually fallen, but still CDC estimates thateach year roughly one in six Americans (or 48 million people)gets sick, 128,000 are hospitalized and 3,000 die of foodbornediseases. Somewhere someone, probably a young postgrad inmicrobiology, is looking at another laboratory curiosity thatwill become tomorrow’s major food poisoning agent. Will ourauthorities and industry be ready?36 F o o d S a f e t y M a g a z i n e

Allergens LabeledSanitation VerifiedResidues NoneMycotoxins NonePathogens NoneBuild a Better Burger.From crown to heel Neogen offers an integrated approach.Great foods are more than great ingredients. Science-based ingredient inspection and testing builds betterburgers, better quality, and better brands. Neogen has built its reputation by delivering superior productperformance and innovative products and services such as our new NeoSEEK STEC testing service andour new NeoCare customer support program.Increase your level of confidence with diagnostic testing solutions from Neogen – leading the way in foodsafety for more than 30 years.800/234-5333 or 517/372-9200foodsafety@neogen.com • www.neogen.com

FSMADemographics. Every other aspect of society has already experiencedthe population bulge, which is just beginning to entersenior citizenhood. Now it is the turn of all of us concernedwith food safety to deal with this surge in the proportion ofthe population usually described as elderly or immunocompromised.We have said for years that they are more susceptible tofoodborne illnesses, more likely to contract them and to havemore severe symptoms. However, now (certainly in my case)the they is us, and there are many more to come. Are our systemsready to minimize potential problems and accommodatesick seniors when necessary?countries trying different ways of implementing the program.Now everyone seems to have agreed on the approach endorsedby the Codex Alimentarius, which still leaves necessary flexibilityfor national-, company- and product-specific requirements.One remaining challenge is the full inclusion of HACCP inregulators’ routine activities.Budget. Last, but not least, in this limited list of challengesfacing regulatory authorities is the need imposed on them tocontrol their budgets. Other items on the list suggest that more,rather than less, activity will be required. This item makes thatimpossible. Instead they must look at doing different things“There are many stimuli for all these efforts to improve food safetylegislation, regulation and compliance, among which international tradeis only one consideration.”Food Variety. Despite the best efforts of locavores, the foodbusiness in North America is global. We have access to justabout any product from any source. It seems almost anyonethese days with a computer and Internet connection canbecome a food importer; this poses enormous problems forregulators. In their attempts to deal with these renegades as costeffectively as possible, regulators sometimes treat everyone asguilty until proven innocent, causing yet more problems forlegitimate operators. Effective control of importers and importsis a key part of FSMA as well as our SFCA.New and Novel Products and Processes. Our regulators haveprocedures established to deal with these innovations. Theymay require premarket approval, notification or nothing at all,depending on the perceived safety-related concern. A key questionis whether the regulatory agencies have sufficient capacityto deal with all the new ideas coming to fruition. No companywith a new ingredient, formulation or processing method wantsto spend years compiling data for governmental review andthen more years waiting for that review to be completed. Thisconcern only grows when coupled with the next issue.Demographics Again. It is not only the general populationthat is aging, but the staff of regulatory agencies as well. Asincreasing numbers of the general population reach retirementage, so too do increasing numbers of agency staff. We face animminent loss of a great wealth of experience and institutionalknowledge that even time will only partially replace.New Control Protocols. Principal among these is HazardAnalysis and Critical Control Points (HACCP), which is aproactive, predictive, preventive procedure to enable operatorsto preplan everything they need to do to produce safe food. Acomplete HACCP plan contains all that is needed, includingsteps to ensure it is properly carried out and that it is reviewedand updated regularly. The formal adoption of HACCP is regulatoryacknowledgement of what has always been true: Foodprocessors are responsible for the safety of what they produce.There were some hiccups in the 1980s and ‘90s with differentand doing them differently. This is a major challenge to whichFSMA may be part of the solution.Challenges for Exporters to the U.S.Companies hoping to establish a long-term export businessface a myriad of regulations and regulating agencies. There isCustoms and Border Protection of the Department of HomelandSecurity (DHS), the U.S. Food and Drug Administration(FDA; with or without FSMA), Food Safety Inspection Service(FSIS) and Animal and Plant Health Inspection Service(APHIS) of the U.S. Department of Agriculture and possiblyother acronymic spoonfuls of alphabet soup. This is probablysimilar to the companies’ home country except that the acronymsare new and the range of responsibility of each agencymay be different.In my former corporate life, I was fortunate to have experthelp. I worked for the Canadian arm of a European company.We had a sister organization in the U.S. with skilled staffknowledgeable in the minutiae of local requirements. Othercompanies with established cross-border business have built uplong-term relationships with brokers and customers who canadvise on new and changed regulatory requirements.There will always be fly-by-night operators whose primaryinterest is not regulatory compliance but enforcement avoidance.They will be unlikely to read this magazine or to understandit if they did. But they will continue to try to import theoccasional container of misbranded and possibly misconstitutedproducts and cause consternation among all the responsibleplayers in the market. FSMA requires FDA to collaborate withDHS on measures to combat these illicit imports.For those hoping to establish a successful and growing exportbusiness, there are rules to be followed and errors to beavoided. The errors may be classified broadly as those to dowith paperwork and those that are product safety related. Thelatter are, again, of two broad types, systemic and random.Paperwork errors, while not directly related to product38 F o o d S a f e t y M a g a z i n e

FSMAsafety, are a major cause of frustration for all involved andtake away resources that should be applied to more seriousconcerns. Everyone involved in the paperwork preparation,submission, review and decision-making process is a bureaucrat,and all should operate according to similar rules.Those preparing documents for submission need clear,concise requirements consistently applied. It should not matterwhere a shipment is presented for entry into the U.S.; properevaluation should give the same result in Washington State asin New England and everywhere in between. This also imposesa requirement on U.S. agencies to communicate fully andplant as described in the Codex Alimentarius General Principles ofFood Hygiene.HACCP is intended to be focused specifically on safetyrelatedhazards and their control. The same principles may beused, and may be useful, in controlling all other, nonsafetyaspects of product quality. However, these other aspects shouldbe documented separately from the HACCP program itself.In many countries, market sectors for which HACCP is notmandated are, nonetheless, implementing the program and enjoyingthe benefits of having done so. This is a good development,especially for those companies wishing to export to the“Companies hoping to establish a long-term export business face amyriad of regulations and regulating agencies.”promptly within and between themselves, so that all borderaccess points are working to the same rules.Those reviewing documents expect three things: that theyare 1) complete, with all questions answered, t’s dotted and i’scrossed; 2) correct, so there is not, for example, a Toronto officetelephone number given for the Winnipeg processing plantand, of course, it is the t’s that are crossed and the i’s dotted;3) compliant, such that the information provided meets all therelevant regulations.As a senior technical resource, I was sometimes referred toas Dr. No, usually while helping another new batch of juniormarketing persons design labels that included all the mandatoryelements while excluding the more creative, that is, false ormisleading, copy. The strategy not only helped develop compliantlabels but also built the understanding that “no” is the easiestword for a bureaucrat to say. Remove any justification for it,and that may speed the process to a favorable outcome.One specific requirement of FSMA is that prior-notice submissionswill be required to include, as an additional element,any country to which the food has been refused entry. “Anycountry” presumably includes the U.S., so that companies willno longer be able to go shopping for an easier crossing point afteran initial refusal. This confirms the need for excellent communicationon the U.S. side of the border to facilitate entry ofsatisfactory shipments and prevent unjustified refusals.Now, proceeding with confidence that the paperwork is allin order, what then of possible product problems? Most majorprocessors in most developed countries have implementedsome form of HACCP. In some jurisdictions, it is mandatoryfor some products. For example, here in Canada, it is requiredin all federally registered meat, poultry and fish processing establishments.Each country and commodity may have its own name forthe program, but all are based on the Codex HACCP principles.Importantly, too, those programs include the context, the backgroundthat HACCP requires to be effective. Whether calledprerequisite programs, as in Canada, or Good Hygiene Practices(GHPs), they establish the basic operating parameters for theU.S. Under FSMA, importers will be specifically required tohave a program to verify that the food products they are bringinginto the U.S. are safe. In FDA’s own words, “Among otherthings, importers will need to verify that their suppliers are incompliance with appropriate risk-based preventive controls thatprovide the same level of public health protection as those requiredunder FSMA.” (See “Cross-Border Shipping Goes BothWays,” p. 40.)This is a tremendous burden to place on importers who donot have in-house technical expertise to provide the requiredverification. Importers will, of course, turn to their suppliers forthe necessary information that will, eventually, be supported bycertification from accredited third-party auditors.However, HACCP implementation is not a guarantee thatsafety-related problems will all be either prevented or caughtand corrected. It is possible that a CCP may be missed, a controllimit may be set incorrectly or one or more of the GHPsmay be inadequately specified. Such systemic errors shouldbe caught as part of the regular review of the program’s implementation,but what of product made and shipped before thatregular review?There will always be random implementation errors. Somethingoverlooked in carrying out the GHPs, a critical checkmissed at just the wrong time, resulting in one batch, one lot,perhaps one day of suspect production. And just to compoundthe problem, the missed check itself might be missed in thefinal records review and the product released for shipment.Challenges for FDAAccording to the Codex General Principles of Food Hygiene,the roles of government include the adequate protection ofconsumers from illness or injury caused by food and the maintenanceof confidence in internationally traded food.Therefore, does, or will, FSMA help FDA fulfill these roles?The answer so far appears to be that it should indeed help. Atbest, it can do no more than that. Regulations and regulatorsdo not make food safe, only those involved in its production,processing, distribution and preparation for consumption canD e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 39

FSMAdo that. The North American food processing industry is wellaware of its responsibilities to produce and deliver safe food.The foodservice sector is equally well aware of its similar responsibilities,and consumers have every opportunity to makethemselves aware of their role in the safe-food chain.One main thrust of FSMA is protection through prevention,which extends the reach of FDA into foreign processingplants to the point of having accredited third parties certifythat plants and products comply with U.S. regulations beforeanything is shipped. FSMA specifically requires that FDA setup this accreditation program. A major concern for exportersis that other jurisdictions may follow FDA’s lead and try to setup similar programs. Then exporters with multiple markets willface multiple audits to verify compliance with multiple regulations.Better for us would be an intergovernmental agreementon basic food safety principles and practices. Isn’t that whatCodex is supposed to be?Fortunately, FSMA does require FDA to take into considerationexisting international standards and accreditation schemeswhen developing model standards under the third-party auditprogram. The intent here is to avoid unnecessary duplication ofefforts and costs. We trust that means avoiding duplication byindustry as well as by FDA.Once the criteria are establishedand third parties are actuallyaccredited by FDA, thenthey can embark on the voluntaryqualified importer program.Just as there are programs allowinglow-risk frequent travelersto cross the border more easilyand FAST lanes for prequalifiedtruckers, so now there will bespeedier access for shipmentsof low-risk foods from certifiedsuppliers. It is certain that accuracyof paperwork will be keyto participation but, undaunted,many Canadian exporters areclamoring to know: When?What are regulators to doabout industry-led efforts suchas the Global Food Safety Initiative(GFSI)? In Canada, thereis no formal method for theHACCP program in many foodsectors to be granted officialgovernment approval or evenrecognition. However, if, forexample, the International Cookie Alliance (ICA) develops itsown HACCP scheme, it can apply to have the scheme benchmarkedagainst the relevant GFSI guidance document. Let usassume that this effort succeeds. Then any cookie companywishing to export to the U.S. that passes its ICA certificationshould be acceptable to all American retailers who agree withthe GFSI approach of “once certified, accepted everywhere.”But will this be acceptable to FDA under FSMA? Can anindustry-led initiative ever be fully accepted by regulatory agencieswithout loss of credibility among their citizens?“FSMA requires FDA to take note of international activities—a moreactive approach will be more beneficial.”Cross-Border Shipping Goes Both WaysBorders are no longer barriers in either direction. Just as FDAis seeking assurance, before shipments leave, that products fromOutlandia destined for the U.S. actually meet all pertinent Americanrequirements, so the Outlandian Food Authority seeks similar assurancethat product from the U.S. (or anywhere else) meets all Outlandishrequirements before it is exported to them.The Outlandians consider their Food Code to be as good as anyof their international competitors’, indeed, at least the equivalent ofthe best of them. Therefore, from their point of view, they are beingonly reasonable in expecting a direct quid pro quo between their FoodAuthority and the U.S. FDA.If, say, We-B-Audits Inc. receives FDA accreditation to performcertification audits of would-be exporters to the U.S., then maybe theycould also receive Outlandish accreditation to perform the similarfunction in U.S. plants hoping to export to Outlandia.If this scenario comes to pass (as well it might), the next logical stepis that We-B-Audits Inc. and similar organizations, thoroughly vettedto the highest international standards, become accredited by FDA fordomestic inspection/audit activities.They then take over these responsibilities on behalf of FDA. Thiswill help reduce the size of government and leave FDA to manage theaccreditation process and monitor the certifying bodies in additionto their other food safety-related duties of administering regulations,reviewing submissions for new ingredients and processes, and lookingout for new food safety hazards.That would be different.The emphasis on prevention and introduction of certificationaudits is aimed at the potential systemic errors, at findingany faults in a processor’s program and its execution, and correctingthem at the source. While it all may seem somewhatonerous to the conscientious processor, another set of eyes canoften be helpful. The 1:10:100 rule applies: spend $1 to preventa problem, $10 to catch it before shipping or $100 to dealwith it after shipping. For exports, the third factor may be evenhigher as guilt by association can adversely affect other exportersin the same country.Systemic errors may be hard to find but random errors aremuch harder. They are, by definition, unpredictable. Canadianexporters have noted anincrease in FDA activities atborder crossings, leading todelays in shipments and increasedcosts. The hold-and-testprogram is proving particularlydifficult and costly.Governmental food inspectionoffers more comfort thanprotection. “Yes,” the typicalconsumer might say, “I knowmy food is safe because thegovernment inspects it”—a comfortingthought perhaps butrather naive. Some Americansmight say, as might some Canadians,“I know my food is safebecause I shot it myself,” whichsays more about the accuracy ofthe shot than of the statement.Some not-so-good news is thatfor imports into the U.S. infiscal 2011, FDA inspected only2.3% of food items. The betternews is that those inspectionswere supposedly targeted atcountries of origin, companies40 F o o d S a f e t y M a g a z i n e

FSMAand products with a higher level of food safety risk.If selection for inspection is risk based, then the programmight be useful. As the International Commission on MicrobiologicalSpecifications for Foods has noted (applicable to othercontaminants), when foods have been processed to reducemicrobiological levels significantly, or have very low prevalencefor other reasons, testing may not be the most effective meansto verify microbiological status. Trying to find a random errorby testing a random sample is a frustrating exercise.However, many Canadian exporters question whether riskis the determining factor in selecting shipments for inspection.Their experience is that lots for inspection seem to be identifiedrandomly rather than by a realistic risk evaluation, leading tounnecessary delays in clearing shipments and potentially seriouscustomer service difficulties.Other sectors have succeeded in making the border all butinvisible for component shipments and for delivery of finishedproducts. We hope that FSMA and other border-related initiativeswill allow the food sector to achieve similar efficiency.Where to Go from Here?All regulators must implement what their legislators givethem. No matter how much of their good advice is incorporatedinto a draft bill, regulators know that their particular legislativeblack box has its own peculiarities and that what is passedmay be rather different from the original.FSMA means that FDA cannot simply carry on doing moreand more of the same old business as usual. It will be a longprocess requiring much hard work, but the U.S. is not workingalone. There are agencies similar to FDA in many other countriesat different stages of the same process. They are facing allthose same challenges, from the apparent need to do more tothe budgetary constraints that make that impossible. Some ofthem are finding innovative ways to make improvements.Our own SFCA includes something new for us. It will allowfor the incorporation by reference, following full consultationwith all interested parties, of standards, protocols and proceduresfrom other jurisdictions and advisory bodies. Similarfood safety wheels already exist; they don’t need to be reinvented.FSMA requires FDA to take note of international activities—a more active approach will be more beneficial. This seems tobe an opportunity for FDA to consult, cooperate and collaborateto work toward a better system to deliver safe food to everyoneby doing different things and doing themdifferently.•Roger H. Gould, Ph.D., is a technical advisor to the Food Processorsof Canada. He can be contacted at fpc@foodprocessors.ca.D e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 41

SEAFOODBy Jacqueline KochakFSMA Era Opens withUncertainties for SeafoodThe question seems simple enough: How willthe Food Safety Modernization Act (FSMA)affect domestic fish producers and importers?Start asking people associated with the seafoodindustry, however, and they’re likely to respond,“Let me know when you find out.”President Barack Obama signed FSMA intolaw on January 4, 2011. Most food safety professionals areaware that the law is the most sweeping reform of food safetylaws in more than 70 years, shifting the focus of the U.S. Foodand Drug Administration (FDA) away from responding toproblems and toward preventing problems in the first place.The law deals with imported and domestically raised foods ofall sorts, including seafood.The increasing globalization of our food supply—food importshave more than tripled in the past decade—is one reasongiven for why FSMA is needed, and one of the law’s prioritiesis creating a new system of import oversight. According to TheNew York Times, FDA currently inspects less than one pound ina million of imported foods. This is especially pertinent to theseafood industry, because FDA estimates that some 80 percentUnansweredquestions cloudpicture for seafoodprocessorsof the seafood eagerly consumed by Americansis imported from faraway places such asNorway or Chile or Thailand. By contrast,some 15 percent of the total U.S. food supplyis imported from other countries.For that same reason, a good share of FDAattention is already focused on importedseafood. There is a real possibility that not much will changefor either domestic fish producers or seafood importers, thoseinterviewed say. In fact, many domestic food producers of alltypes supported FSMA’s passage in hopes that better oversightwould diminish the frequency and high cost of food recalls.Then again, there could be big changes. As noted, FSMAaims to shift the U.S. food safety system from primarily reactiveto proactive and prevention focused. The devil is in thedetails, however, and some of the confusion about the impactof the law results from the fact that specific FSMA regulationsor guidance documents have yet to be announced. The questionof what the new regulations will require is far more thanacademic, because while new guidelines will improve foodsafety in the U.S., adhering to more stringent requirements42 F o o d S a f e t y M a g a z i n e

Make food pathogen detectionSuper EfficientWith the Atlas System, you have the power.The Atlas System is the fully automated molecular pathogendetection system for food safety testing.AOAC-RI-certified assays:Listeria spp. and Salmonella **Additional assays in development.KKKKKKOver 300 samples processed in a single shiftNo secondary enrichment requiredMinimal hands-on timeContinuous access enables continuous fl ow to resultTrue walk-away automationMultiple assays can be run concurrentlySuperpower your lab!We’re Roka. And we’ll help you get there.© 2012 Roka Bioscience, Inc.MSEPUB02121.855.ROKABIO | www.rokabio.comThe Atlas System is manufactured by Gen-Probe Incorporated. Roka molecular technology is licensed from Gen-Probe Incorporated.

SEAFOODcould translate into dollars and cents for producers, suppliersand importers.“There are a lot of theories about why there is a hold-up,but FSMA could be costly for the industry,” says Lisa Weddig,director of regulatory and technical affairs for the NationalFisheries Institute (NFI), an industry organization dedicated toeducation about seafood safety, sustainability and nutrition.very small.”Unfortunately, there is a public perception—probably correct—thatnot all international seafood suppliers are followingthe rules, and not all importers are requiring the suppliers theywork with to follow the rules.“Where there has been some deficiency is that Hazard Analysisand the enforcement of the HACCP plan have not beengoing on with international and some domestic suppliers,” admitsClear Springs’ MacMillan. “This has always been a requirement,although it hasn’t been well publicized. With FSMA,that requirement is more explicit, and that is a good thing.”MacMillan says that a large part of the industry is alreadypolicing itself. At Clear Springs Foods, for example, one of“...a good share of FDA attention is...focused on imported seafood.”What to Do?Many producers and importers are already doing exactlywhat they should be doing to ensure food safety, but the goodapples might have to pay for the sins of the rotten ones. Thereis even discussion in some quarters about whether some importerscan survive. However, FDA doesn’t have any data aboutwhether a deficiency in seafood safety is caused by intentionalneglect by an importer or supplier or is due to other causes,says Sebastian Cianci, an FDA policy analyst/press officer andtrade press liaison.The consensus seems to be that domestic fish producersprobably will not see big changes, because they already havesystems in place to ensure safety, and neither the press nor thepublic has raised a hue and cry about domestic seafood safety.As part of its food safety program, FDA mandates that domesticfish producers have a Hazard Analysis and Critical ControlPoints (HACCP) plan in place. The HACCP system focuses onidentifying and preventing hazards that could cause foodborneillnesses, and one of the things FSMA does is extend HACCPto other kinds of food production and processing. FDA alreadymandates that domestic and international seafood processorshave HACCP plans, rather than rely on spot checks of finishedseafood products to ensure safety.“We have been under HACCP requirements and subjectto HACCP regulations for a long time, since the mid-1990s.Domestic fish farms are among the most highly regulated inthe world,” says Randy MacMillan, Ph.D., vice president forresearch, environmental affairs and quality assurance for ClearSprings Foods Inc., perhaps the world’s largest producer of rainbowtrout. Located in Idaho’s Magic Valley, Clear Springs alsoimports rainbow trout grown and processed in Chile.For Importers, the Outlook Is MurkyFor seafood importers, however, the outlook is a little lessclear. Like domestic fish processors, all processors of seafoodintended for the U.S. market are required to identify potentialhazards associated with the types of seafood they process andthen to develop and implement an HACCP plan to control forany likely and reasonable hazards, Cianci says.“This includes hazards that can occur before, during andafter harvest, both inside and outside of the processing plant,”he says. “With appropriate preventive controls in place, thelikelihood of there being a problem with the food should beMacMillan’s tasks is to verify that any seafood the companyimports from Chile or any other country comes from a supplierwith an HACCP plan in place. The company’s research anddevelopment division provides quality assurance services to thecompany’s farms as well as to Chilean partners, with HACCPcompliance verified by testing fish randomly.FDA is and always will be dependent on industry to playthis kind of active role in curtailing violations, because theagency will never have the personnel or the budget to inspectevery shipment of seafood that comes into the country. However,the truth is that no one really knows how well the industryis policing itself, because FDA inspectors currently inspect just1 percent of seafood imports as they come into the country.When student journalists for News21, part of the Carnegie-Knight Initiative on the Future of Journalism Education, investigatedseafood safety in 2011, they found that more than51 percent of the seafood that was inspected and turned awayfrom ports was spoiled or contained physical abnormalities,or was contaminated with a foodborne pathogen. About 20percent of those cases involved Salmonella, according to theiranalysis of FDA import refusal data. Nevertheless, it isn’t clearhow much of a food safety problem imported seafood reallyposes, and given its limited resources, FDA has been strugglingvaliantly to protect the nation’s food supply.“The information FDA gleans from country assessments,foreign inspections and importer inspections helps to target theproducts the agency chooses to examine more closely,” Ciancisays. “Products with a greater likelihood of posing a food safetyrisk are inspected at a greater frequency than those with lowerrisk.”MacMillan says that in his view, the FDA is already doing agood job.“If seafood was a real food safety problem, would there beillness associated with it the way there was with peanuts, spinachand cantaloupe?” he asks.The Foreign Supplier Verification ProgramOne of the things FSMA will do is create a foreign sup-44 F o o d S a f e t y M a g a z i n e

SEAFOODplier verification program. All food importers will be requiredto verify that their foreign suppliers have HACCP plans inplace—but facilities already in compliance with FDA’s seafoodproducts requirements are explicitly exempt. Nevertheless, sincethe specific regulations for this section of FSMA have not yetbeen released, there are questions about whether HACCP willagree that that’s a good thing. Another concern, however, isthat a more flexible standard for detaining products potentiallyin violation could sweep up innocent companies in a net fromwhich it might be very difficult and expensive to extricatethemselves. There is also a concern that FSMA will require additionalrecord keeping, with FDA having greater access to all“...FDA doesn’t have any data about whether a deficiency in seafoodsafety is caused by intentional neglect by an importer or supplier or isdue to other causes...”be enough, or if there will be a push for additional expensiverequirements for producers and importers who are currently incompliance and how compliance will be verified.“If seafood is exempt, it will be business as usual,” saysNFI’s Weddig. “But until we see the extent of the exemption, itis hard to know the impact.”“There is greater potential for enforcement,” MacMillanagrees. “Whether that means much to seafood is a good questionbecause we’re already under mandatory HACCP. The keywill be verification of compliance.”FSMA gives FDA greater authority to detain products inviolation of U.S. safety requirements, and those in the industryrecords—including food safety plans and other information thatcould be considered sensitive or private.“One way to look at this is whether the extra cost is worth itto ensure the U.S. food supply is safe,” MacMillan says. “If youlook at foodborne illness from all causes, seafood (except forshellfish eaten raw) is a very low risk. Fresh produce, peanutsand peanut butter and some cantaloupe have caused far morefoodborne disease.”At the same time and on the positive side, FSMA specifiesthat the process of importing safe seafood will be expeditedfor those who are already cooperating. The act states that 18months after FSMA enactment, a program will be establishedLaserONMIT 1000Introducing the MIT 1000 Microbial Identiication SystemFaster, More Accurate, Easier to Use, Lower Cost, More Compact.Non-biological, laser-basedNo gram stain requiredSimultaneous Identiiers TMVery low consumables costLow per-test costD e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 45

SEAFOODto “provide for the expedited review and importation of foodoffered for importation by importers who have voluntarilyagreed to participate in such program” and “establish a processfor the issuance of a facility certification to accompany food offeredfor importation by importers who have voluntarily agreedto participate in such program.”The act goes on to require a guidance document spelling outvarious aspects of the program, including eligibility. Eligiblepercent of an estimated 17,000 foreign processing facilities eachyear between fiscal 2005 and 2010.Because more seafood than any other kind of food is importedinto the U.S., the requirement for an increased numberof inspections likely will disproportionately impact foreignseafood producers and processors. Again, the mandate is unfunded,and it is not clear who will be doing the inspectionsand who will pay.“...FDA really has no idea how much seafood around the world wouldbe considered safe enough for the U.S. market, because the agency’semphasis is on protecting what actually gets into this country.”importers must have the required HACCP certifications, buteligibility also will depend on factors such as identified safetyrisks associated with the food, the compliance history of foreignsuppliers, the regulatory system of the country the foodis imported from, the importer’s practices having to do withrecord keeping, testing, inspections and audits of facilities, andfinally, traceability.That reference to traceability also has some importers concerned.They say a traceability system can be very expensive,and some importers already have sophisticated systems in placebecause of customer demand. They don’t want to see anothersystem mandated if one already exists. But for now, all theyknow is that FSMA requires the secretary of Health and HumanServices to establish pilot projects in coordination withthe food industry to “explore and evaluate methods to rapidlyand effectively identify recipients of food to prevent or mitigatea foodborne illness outbreak.”Foreign InspectionsFSMA also requires the FDA to significantly step up thenumber of inspections of all foreign food facilities exportingto the U.S. In the first year, FDA is expected to inspect at least600 foreign facilities, and in each of the following 5 years,the number is supposed to double. Which facilities will beinspected will depend on factors such as the known safety risksof the food, safety risks in the country of origin, importers’compliance history and whether an importer participates in thevoluntary qualified importer program.Although FSMA expands the effort, Cianci says the FDAalready conducts inspections of foreign processors to observetheir seafood HACCP programs, as well as inspecting domesticimporters to confirm they have verified foreign suppliers’ foodsafety measures.Nevertheless, the reality is that a minuscule number of inspectionsof foreign facilities are actually performed. To exportto the U.S., foreign processing companies simply register onlinewith the FDA, and most never see an inspector. According tothe News21 project (citing Government Accounting Officefigures), FDA inspected an average of less than one-half of 1“Again, what is the cost of a better food safety program?”asks MacMillan. “Should consumers bear the brunt of foodsafety problems or should suppliers?”FSMA does provide that FDA will be able to accredit qualifiedthird-party auditors to certify that foreign food facilities arecomplying with U.S. food safety standards, and products fromfacilities that refuse inspection can be banned from entering thecountry.FDA already utilizes a risk-based approach in conductingboth foreign inspections and wharf examinations, Ciancisays. Currently, if FDA finds food safety hazards in importedseafood, the foreign processor is placed on Import Alert. InSeptember 2012, for example, FDA’s website showed 148 fishery/seafoodproducts refused entry, from countries as diverse asIndia, Latvia, Nicaragua and Thailand.Future shipments of the problem product are prohibitedfrom entering the United States until the product is shownto be safe by a third-party verification lab. Samples have tobe pulled by a third-party sampler or an FDA agent has to bepresent to witness the pulling of samples, and the “chain ofcustody” has to be documented.“In certain situations, such as those requiring the impositionof an Import Alert, sampling and testing can go up to 100 percentfor those shipments subject to the alert,” Cianci says.How Much of a Hazard Are Antibiotics?One area of contamination in foreign food imports that hasgotten a lot of attention in recent years is the use of bannedantibiotics by foreign seafood producers. Cianci says that anyhazards associated with the use of animal drugs in aquaculturealready must be addressed in the processor’s HACCP program,and measures to control such hazards must be established,validated and monitored. An international supplier who has anappropriate HACCP plan in place and has analyzed the likelyhazards will have already identified any hazards associated withdrugs or chemicals, he says.“FDA also visits countries that ship a lot of aquaculturedproduct to the U.S. and countries where we have had problemswith aquacultured product in the past, so we can assess how46 F o o d S a f e t y M a g a z i n e

SEAFOODthey regulate their aquaculture industry,” he says. “We look atthe availability of aquaculture drugs, the permitted use of thedrugs, and how they test for drug residue.”Cianci says that when seafood comes into the country, FDAcollects a subset of the product inspected on the wharf for labtesting. Because FDA inspects only 1 percent of all the seafoodcoming into the country, an even smaller fraction is tested forchemical additives such as antibiotics.“The challenge is that some seafood industry sectors havemade a big deal about incoming fish being contaminated withdrugs, and that has created this impression that a large part ofimported seafood is contaminated,” MacMillan says. “That isvery, very misleading.”In 2010, for example, the news media gobbled up the storythat Alabama scientists who tested more than 250 samples ofcatfish and related species from the Far East found 44 percenttesting positive for an antibiotic not approved for use or withno established tolerance in the U.S. Alabama is home to thecountry’s second-largest domestic catfish industry, and criticsresponded that the tests were done on behalf of U.S. aquaculturefarmers who want to reduce competition from overseas.Likewise, testing in the European Union in 2001 found aprohibited broad-spectrum antibiotic called chloramphenicolin a number of food products, including seafood from severalAsian countries. Testing in the U.S. later identified chloramphenicolin some imported seafood, and malachite green,nitrofurans, fluoroquinolones and gentian violet have also beenfound in seafood ranging from crab and shrimp to catfish andtilapia.“It is undeniable that some imported farmed seafood doeshave detectable drug residues. Are the antibiotics unsafe?”MacMillan asks. “With the exception of chloramphenicol, theantibiotics are not toxic. They are not supposed to be in thefood because there is no established tolerance in the U.S., butthere may be a tolerance for the drugs in other countries. Ideally,there should be international agreement as to what is safeand not safe, but that will take a long time.”Farm-raised seafood is indeed a fast-growing sector of theworld food economy. U.S. seafood is imported from morethan 60 countries, and a significant percentage of that seafoodis raised on farms. Some domestic farmed fish producers claimthat the use of antibiotics that are not approved for use in theU.S. gives foreign competitors an unfair advantage. MacMillanis among those who counter by saying the “antibiotic problem”is vastly overstated because antibiotics are not that effective ingiving producers a competitive boost. In fact, he says, the useof antibiotics may increase production costs, and their efficacyis a real question.“To say antibiotics enable them to outcompete is a realleap,” MacMillan adds. “The domestic channel catfish industryis suffering a good bit, but the crux of the problem is morethat labor costs in Southeast Asia are a lot less compared to theU.S., and that decreases the costs of producing and processing.”In fact, he says, focusing the public attention on antibioticD e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 47

SEAFOODresidues in catfish could have a paradoxical effect, becauseconsumers who can’t differentiate between catfish from Chinaand catfish from Mississippi might just stop buying the productaltogether.International CertificationsThe fact is, Cianci says, that FDA really has no idea howmuch seafood around the world would be considered safeenough for the U.S. market, because the agency’s emphasis ison protecting what actually gets into this country. The perceptionthat all foreign seafood is automatically unsafe is incorrect,however. For example, MacMillan says, seafood is actuallymore closely regulated in some countries than in the UnitedStates.“We have a long-term contract with a rainbow trout growerin Chile, and they are subject to their own government’s foodsafety requirements that are more stringent than ours,” he says.“Chile requires mandatory testing every three months or so,with the government actually coming in and pulling samples.”Nevertheless, consumer demand has led to several expensiveinternational third-party certifications requiring annual audits,and MacMillan says some large domestic customers are requiringthese certifications for all the seafood they buy, even if it isdomestic or comes from a country with stringent regulations.That leads to a perplexing catch-22 for some producers—shouldthey pay a lot of money to become certified by an internationalorganization?“It’s becoming more difficult to compete in the U.S. becauseyou have all these customers demanding a certain certification,which takes both human and financial resources,”MacMillan says. “The question is, do we really need these internationalcertifications for producers in the U.S.?”When Will FSMA Regulations Be Final?There could be a real problem if FSMA requirements endup being expensive to implement—and possibly redundant forproducers and processors who have HACCP plans in place andin some cases are paying big bucks for international certifications.The question of when final regulations will be formulatedto ease industry anxieties is still open, however. A lawsuit filedin August by the Center for Food Safety and the Center forEnvironmental Health against FDA and the White House Officeof Management and Budget seeks a court order requiringFDA to enact FSMA regulations by a court-imposed deadline.Although FDA has been criticized because all necessaryregulations haven’t yet taken shape, some work has been completed.One of FSMA’s provisions was to update the fish andfisheries products’ HACCP guidance, which happened onschedule, but FDA was also supposed to issue a report evaluatingthe impact of any changes to the seafood HACCP regardingpostharvest processing on the competitiveness of the domesticoyster industry in the United States and in internationalmarkets. That report doesn’t yet exist.“Publishing the FSMA rules is a priority for the agency,”Cianci notes. “While the rule-making process can be complex“The increasing globalization of our food supply—food imports havemore than tripled in the past decade—is one reason given for whyFSMA is needed, and one of the law’s priorities is creating a new systemof import oversight.”and demanding, it will eventually provide for a framework thatwill have an enormous impact in modernizing the food safetysystem. We have made every effort to engage with all interestedstakeholders throughout the process and will continue to do soafter the rules are published.”Everyone recognizes that building a new food safety systembased on prevention will take time, and FDA says it is creatinga process for getting this work done. FDA funding, which affectsstaffing and vital operations, affects how quickly FDA canput FSMA into effect. So for now, questions remain.FSMA’s Section 104 says the FDA can determine there arehazards for which standards need to be determined, and NFI’sWeddig says that could impact the industry in the future. Theact also calls for protecting the food supply against intentionaladulteration—which would include antibiotics—and that particularregulation doesn’t yet exist either. Finally, regulations regardingsanitary transportation of food will impact everyone in thefood industry, Weddig says, and that regulation hasn’t beendeveloped either.“Until there are regulations, it is hard to tell how FDA willdeal with seafood suppliers,” Weddig says. “From everythingwe’ve heard, regulations won’t apply to you for preventive controlsregulation and foreign verification—but other aspects ofFSMA will apply.”•Jacqueline Kochak is communications director for the AuburnUniversity Food Systems Initiative, an interdisciplinary multiinstitutionalprogram integrating research, outreach andacademic efforts to enhance the safety of the nation’s foodsupply, from producer to consumer.For more information on seafood regulations, safety and testing,please visitwww.foodsafetymagazine.com/signature.asp.48 F o o d S a f e t y M a g a z i n e

There’s an App for ThatDownload the current issue ofFood Safety Magazinefrom iTunes orAndroid Marketplace today.Food Safety Magazine is proud to have the support ofAgilent Technologies as sponsor for our app

Product ShowcaseIQF FreezerGEA RefrigerationTechnologies, formerly GEAAerofreeze Systems, hasintroduced a new A-series(Aerofreeze) Individual QuickFreezing (IQF) tunnel forfreezing raspberries withoutthe need for liquid nitrogenor cryogenic precrusting.The new tunnel, referredto as the AY series, deliverssuperior product qualitywith significantly reducedoperation costs to fruitprocessors.GEA Refrigeration Technologies,49 (0) 234.980.2862 • www.gea.comMeat RackUltratainer Inc. presents astainless steel Bolo Rack thatcan be customized to fit anysize. It is suitable for cookedmeat plants, meat processingplants and frozen andprepared foods plants. Thisrack offers many advantages,including easy sanitization,sanitary welds, 100 percentstainless steel construction,is perfect for bologna, deli,cooked meats and loaf pans,is corrosion-proof and rustfree,and has outstandingperformance in hot or coldtemperatures.Ultratainer, 800.665.3651www.ultratainer.comAutomated WasherAutomated washing equipment from CM Process Solutionsensures food processing containers are consistently cleanedand sanitized, improving throughput speed and reducing laborcosts. It is an integral part of the food processing line, whereinstead of manually washing containers with a hose or pressurewasher, companies are installing automatic systems that meettheir washing and sanitizing needs.CM Process Solutions, 951.808.4376 • www.cmpsolutions.netHand-Held ThermometerThermoWorks has introduced the Saf-T-Log—an innovativehand-held thermometer that measures, stores, downloads andprints temperature reports for easy Hazard Analysis and CriticalControl Points and food safety compliance, all with the convenienceand price of a traditional hand-held thermocouple meter. Very simpleWindows ® desktop software allows users to build lists of food items orequipment and set pass/fail temperature ranges.ThermoWorks, 800.393.6434 • www.thermoworks.comGC-TOF InstrumentJEOL’s newest AccuTOF GCv model mass spectrometer—the “4G”—now offers even faster dataacquisition rates and higher resolvingpower than its predecessor. Theinstrument has a maximum dataacquisition rate of 50 spectraper second and mass accuracyof 4 ppm or better. The 50-Hzacquisition rate now makesit possible to acquire highresolutionmass spectra incombination with thirdparty,two-dimensional GC(GC×GC). Applicationsinclude environmentalsamples, petrochemicals,polymers and materials,forensics, foods and flavors.JEOL USA, 978.535.5900 • www.jeolusa.comFoam SanitizerArmchem Internationalmarks their 30th anniversarywith the introduction ofthe InstantFoam Deluxe, amedical-grade, hands-freefoam sanitizer that is perfectfor high-traffic areas andkills 99.99 percent of mostcommon germs, includingEscherichia coli. Because theproduct is foam, it saves oncosts, since one applicationdelivers nearly twice theamount as gel products ofthe same size and won’t leavehands feeling tacky.Armchem International,800.886.0423 • www.armchem.comAntibacterial PaperTowelCascades Tissue Grouphas announced the U.S.launch of the CascadesAntibacterial Paper Towel.These towels minimizehand contamination bykilling 99.99 percent ofharmful bacteria almostinstantly, unlike ordinarypaper towels. First clearedby Health Canada, this paperproduct now complies withthe regulation and policiesof the U.S. Food and DrugAdministration.Cascades Tissue Group, 800.246.0711www.afh.cascades.com50 F o o d S a f e t y M a g a z i n e

Circulating Bath for Coliform TestingHighly accurate and easy to use, the PolyScience Coliform Bath is speciallydesigned for fecal coliform and Escherichia coli testing. It features an ambient+10 °C to 135 °C temperature range, ±0.7 °C temperature stability, a 28-L reservoirand is equipped with the company’s economical MX temperature controller. Thebath is equipped with a hinged see-through gable cover, single-speed pump, useradjustabletemperature alarms, calibration capability and chemical-resistant topplate.PolyScience, 800.229.7569 • www.polyscience.comCooking/ChillingEquipmentUnitherm Food Systems hasintroduced a line of cooking and chillingequipment that is ideal for smallerfood processors that want to expandproduction. The line includes equipmentthat is compact yet surprisinglyproductive and affordable, such as miniflamegrills and continuous mini spiralovens and chillers.Unitherm Food Systems, 918.367.0197www.unithermfoodsystems.comATP Test Swab3M Food Safety has announced thatthe 3M Clean-Trace Water – TotalATP test swab will be moving to aninnovative, liquid-stable formulationthat allows for improved temperaturestability and test result accuracy. Theaqueous test is designed to rapidlyassess standards of hygiene, equipmentsanitation processes and the efficiency ofclean-in-place procedures by detectingthe presence of microbial contaminationand/or product residues.3M Food Safety, 800.328.1671 • www.3m.comProcessing Support RackUnique Metal Solutions has launcheda patented conduit and pipe supportsystem for use in food and beverageprocessingplants. The ROCKET RACK ®eliminates on-site fabrication because it’sprefabricated and ready to install. Thepatented slot design allows for lines to beadded in the future without drilling overthe product.Unique Metal Solutions, 636.742.5272www.rocket-rack.comD e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 51

SANITATION(continued from page 17)has been dominant. The primary GFSIbenchmarkedfood safety schemes include:British Retail Consortium, FoodSafety System Certification 22000 (FSSC22000), Global GAP, International FoodSafety and Safe Quality Food.The primary focusof audits under theseGFSI benchmarks ison the overall foodsafety managementsystem, includingHACCP and relatedprograms. Food equipmentdesign, constructionand maintenanceare addressed to avarying degree underthe HACCP prerequisiteprogram requirements,as well as inother provisions ofthe standards wheregeneral terminologyis used. The FSSC(e.g., ISO 22000/PAS 220) scheme has,perhaps, the most specific verbiage withregard to equipment and provides thatfood contact equipment be designedand constructed to facilitate appropriatecleaning; of durable materials; of materialsdesigned for food use; be impermeable andrust- or corrosion-free; and meet establishedprinciples of hygienic design.Summary and ConclusionsFood equipment hygienic design ismore important than ever before and isaddressed in a general manner in mostregulatory and industry food safetyprograms. However, the terms used areonly broadly defined, and interpretationof acceptability is left to the individualauditor and her or his particular aptitudefor equipment evaluation.As we move forward with the implementationof food safety programs,we also need to give more scrutiny tohygienic design features of equipmentthrough the development of more specificand meaningful equipment standardsto ensure compliance and foodsafety. The American Meat Institute andGrocery Manufacturers Association have“Food equipment mustbe constructed andfabricated to ensurethat interior surfacesare free of cracks,crevices or sharpangles.”recently issued guidelines that includehygienic design principles. 25 While thisis definitely a step in the right direction,more specific standards are needed.Many segments of the food industrycould benefit from developing standardsthat are specific toequipment used in aparticular commodityarea. Accomplishingthis goal will take aconcerted effort andpartnership betweenthe food industry andregulatory communities.•Ron Schmidt, Ph.D., professoremeritus, recently retired after36 years in teaching, researchand extension in the FoodScience and Human NutritionDepartment, University ofFlorida. The primary emphasisof his academic career hasbeen in dairy foods, food safety,food regulations, food fermentationand biochemistry. He taught a varietyof undergraduate and graduatefood science classes throughout hiscareer, most recently Food Regulationsand HACCP Systems. Through his extensionand outreach programs, he is recognized for his foodindustry training and consulting programs in dairyprocessing, food safety, HACCP and other areas. Hehas served in a leadership role in various food scienceprofessional organizations and is currently on theboard of directors of the NCIMS Program and is thechairperson of 3A SSI.References1. Hennessy, T. W., C. W. Hedberg, L. Slutsker,K. E. White, J. M. Besser-Wiek, M. E. Moen, J.Feldman, W. W. Coleman, L. M. Edmonson, K. L.MacDonald and M. T. Osterholm. 1996. A nationaloutbreak of Salmonella Enteritidis infectionsfrom ice cream. N Engl J Med 16:1281–1286.2. www.phac-aspc.gc.ca/alert-alerte/listeria_200808-eng.php.3. www.cdc.gov/salmonella/typhimurium/update.html.4. www.cdc.gov/listeria/outbreaks/cantaloupesjensen-farms/120811/index.html.5. www.ehedg.org/.6. ag.purdue.edu/foodsci/cifm/Pages/default.aspx.7. www.nsf.org.8. www.3-a.org/.9. edis.ifas.ufl.edu/FS119.10. Tuthill, A. H. and R. A. Covert. 2000. Stainlesssteels: An introduction to their metallurgy andcorrosion resistance. Dairy Food Environ San20:506–517.11. Schmidt, R. H., D. J. Erickson, S. Sims and P.Wolff. 2012. Characteristics of food contact surfacematerials: Stainless steel. Food Prot Trends32(10):574–584.12. Anonymous. 2007. Passivation of stainlesssteel: Summary of guidelines recommendedby 3-A Sanitary Standards and the EuropeanHygienic Engineering Design Group (EHEDG).Trends Food Sci Technol 18:S112–S115.13. Tuthill, A. and R. Avery. 1992. Specifying stainlesssteel surface treatments. Adv Mater ProcessDecember:34–38.14. ISO. 1984. Surface roughness — terminology— Part 1; Surface and its parameters. ISO4287-1, International Organization for Standards,Geneva, Switzerland.15. Bilgili, S. F. 2006. Sanitary/hygienic processingequipment design. Worlds Poult Sci J 62:115–122.16. Eastwood, C. A., D. L. Woodall, D. A. Timperley,G. J. Curiel, P. Peschel and G. Hauser.1993. Welding stainless steel to meet hygienicrequirements. Document 9. European HygienicEngineering Design Group (EHEDG).17. www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode2009/default.htm.18. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110.19. www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5048589.20. www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/JuiceHACCP/ucm073594.htm.21. www.ncims.org.22. www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MilkSafety/CodedMemoranda/MemorandaofInformation/ucm080156.htm.23. www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRD3641024.24. www.mygfsi.com/.25. Higgins, K. T. 2012. Standardized sanitation.Food Eng August 6.52 F o o d S a f e t y M a g a z i n e

SAVE THE DATEco-locating with the National Grocers Association.MEATXPO is a major event ofNorth American Meat Association.Get the latest in technology, governmentregulations, market trends and so much more.NAMA is noted for its exceptional marketing andnetworking opportunities, as well as the sharing ofinformation among peers.Educational programs include roundtable seminars,forums and specialty meetings.An exciting addition to this year’s program is NGA’sOpening Keynote Session featuring former U.S.Senator Alan Simpson and former White HouseChief of Staff Eskine Bowles... a session you don’twant to miss!WHAT TO EXPECT......EDUCATION ON TRENDS & TECHNOLOGYEVENTS FOR NETWORKING & FUNEXPERTS ON INDUSTRY ISSUESEXHIBITS ON INDUSTRY PRODUCTSand don’t forget toENJOY THE CITY LIGHTS OF LAS VEGAS!Mark your calendar now and plan to attend!For more information go to www.meatxpo.com or www.meatassociation.com * or call 510-763-1533 * 703-758-1900 * 613-739-8500

Testing(continued from page 21)the supplier to terminate only for limitedreasons and provide the companywith damages in the event of wrongfultermination. In the same vein, the outsourcingcompany should not assumethe supplier’s business risks, and thus,the supplier’s rightto claim damages forlost profits should beeliminated or capped.Dispute Resolution.In an effort to mitigateor reduce risk shoulda dispute arise, theoutsourcing agreementshould specify a mechanismfor dispute resolution.Typically, outsourcerswant to avoidlitigation. The criticalissue is the relationship,and litigation thattakes a long time to resolve may causedamage to the relationship separate fromthe underlying dispute. Consequently,it is critical that the agreement address“...a company mustassess how theprocess or operationto be outsourcedfits within its overallbusiness.”clearly and in detail the mechanism forresolving disputes, including a clear statementof the parties’ obligations pendingresolution to ensure the continuation ofservices, if appropriate. Equally critical,the agreement should contain a provisionfor the law and venueof the company’schoice. When the supplieris located abroad,arbitration may be thepreferred means to resolvean internationaldispute. When theparties are from differentcountries, the foodcompany should besure to determine whatinternational treatiesand conventions maygovern the outsourcingrelationship.It is important to consider a situationwhere a customer sues the food companyover operations or processes thatare outsourced. Often, companies seekLab OutsourcingIncreased consumer and government concern for food safety, plus heightenedregulatory oversight, has made food product analysis more important thanever. Consequently, food companies are turning to outside laboratories moreoften for the technical expertise needed to meet those demands.Typically, outsourcing testing functions allows companies to more economicallykeep abreast of and satisfy regulatory requirements, and take advantageof advances in testing technology and techniques. However, absent a properoutsourcing relationship, including an agreement that memorializes the parties’interactions, such benefits may be fleeting.For an outsourcing laboratory relationship to be successful, a food companymust define standards that are critical to the relationship and set operationalmetrics by which to measure the relationship, including but not limited to thefollowing criteria and issues:• Food industry experience• Relevant accreditation or certification• Pertinent analytical experience• Acceptable and consistent testing methodologies• Up-to-date facilities and equipment• Appropriate quality assurance policy• Required outputs• Adequate logistics for storing, handling and shipping product• Necessary management and personnel• Competitive and flexible pricingIn short, a food company must set well-defined objectives for itself and itslaboratory partners before it enters into an outsourcing relationship.indemnity and duty-to-defend provisionsover consumer claims. As part ofthe external due diligence, the companyshould assess whether the supplier hasthe ability to pay judgments and whetherit would be prudent to have the supplierdefend such an action. Depending onthe circumstances, such as where thecompany’s reputation is at stake, thecompany may not want the supplierto directly defend. One way to resolvethis dilemma is to allow the companyto choose whether it wants the supplierto defend, with a right to assess costs ofsuch litigation against the supplier regardlessof which option it selects.Careful Management of theOutsourcing RelationshipEven with an effective agreement, afood company must still closely managethe relationship. To that end, a companyshould make sure that the outsourcingagreement provides it with an appropriatelevel of oversight and control overthe supplier’s operations and the abilityto communicate directly with key supplierpersonnel. (The company must alsoensure that it retains personnel knowledgeableenough to do so.) Rote relianceon a supply partner may undermineprotections the company builds into theoutsourcing agreement.ConclusionOutsourcing business functions andmanufacturing operations may increaseefficiency and cut costs. With properplanning, careful contracting and ongoingoversight of the outsourcing relationship,any potential monetary loss ordamage to the company may beeliminated.•John T. Shapiro is a partner andmember of the food industry team(http://foodlaw.freebornpeters.com) at the Chicago law firm Freeborn& Peters LLP. His areas offocus include solving clients’complex business disputes, counseling clients on litigation,employment and business issues and providinggeneral corporate advice. Reach him at 312-360-6389or jshapiro@freebornpeters.com.54 F o o d S a f e t y M a g a z i n e

POWERINGINNOVATIONS INFO DSCIENCEAttending Pittcon, the world’s largest annual conference and expositionfor laboratory science, gives you the power to get a hands-on look atinnovative equipment, learn about industry trends and discover newapplications and methodologies used in food science and safety. Thelatest analytical techniques and innovative solutions to solve new andrecurring problems are key topics in our technical program.Pittcon App Now AvailableFor more information on technical sessions, exhibitors and short courses,visit www.pittcon.org.follow usScan this or go towww.pittcon.org to save50% on registration.

99th AnnualNW FOODPROCESSORS EXPOand ConferenceJanuary 14 -16, 2013Portland, OregonEXPONW Food ProcessorsEXPO and ConferenceJANUARY 14-16, 2013 PORTLAND, ORexpo@nwfpa.orgwww.nwfpa.orgEducateCollaborateInnovateMEAT AND POULTRY(continued from page 35)cess control and often on desired quality. A substantial amountof bacterial reduction (both numbers and prevalence) can beaccomplished in a properly balanced chiller, where controlsare in place to monitor and maintain pH, temperature, flowrate, flow direction, chlorine concentration and concentrationof organic material. 5 The continuous flow of water in theseimmersion-type systems is crucial in keeping these chillers frombecoming a stagnant communal bacterial bath, as they are oftenportrayed.“As is true with on-farmproduction, effective food safetymanagement programs arenecessary to reduce or eliminatethe risk and hazards associatedwith poultry processing.”Many poultry processors are installing a final antimicrobialspray or dip in their process. The placement of these systemsat the terminal, post-chill point is advantageous in that thecarcasses are as clean as they will be throughout the process,and the ability of any given chemical to contact bacteria on thesurface of the skin without interference from organic material ishighest. 5 However, and a reality for poultry, unlike many otherspecies, is that the skin remains attached to the product, the exceptionof course being further processes for skinless products.For skin-on products, such as whole birds and parts, microorganismslocated between the skin and meat surface as well asthose that may become trapped in feather follicles can becomepotential problems as these products are further processed andprepared.ConclusionsAs mentioned previously, the prevalence and level of pathogenicorganisms on poultry vary widely and may be affectedby the time of year, region of the country, animal managementand processing practices. Outbreaks of foodborne illness associatedwith Salmonella and Campylobacter in poultry productsare often the result of inadequate cooking, mishandling,recontamination or cross-contamination from raw meats toother uncooked foods during processing and preparation in aprocessing plant, or commercial or home kitchen. In 1999, TheNational Advisory Committee on Microbiological Criteria forFoods identified cross-contamination during the preparationof raw chicken and the consumption of inadequately cookedpoultry as significant sources of campylobacteriosis. 6 Therefore,eliminating cross-contamination between raw and ready-to-eatfoods during preparation, and proper cooking and storage ofmeats and poultry are essential to minimize the risk of illnessassociated with these products.56 F o o d S a f e t y M a g a z i n e

MEAT AND POULTRYEnsuring the safety of poultry, no matter where it comesfrom, is a responsibility shared by all industry stakeholders, including,but not limited to, farmers, producers, processors andretailers as well as federal and state agencies. We must rememberthat food safety cannot be inspected into the product and thatend-product testing is costly, time-consuming and unreliable atbest. Instead, food safety must be built into the processes usedin the production, manufacture and preparation of food products.This is done by focusing on building a strong foundation“We must remember that foodsafety cannot be inspected intothe product and that end-producttesting is costly, time-consumingand unreliable at best.”on common ground for food safety. These challenges becomeeven more important as countries try to develop and maintainharmonization across international and cultural borders. Consumerscannot discern the safety of their food before buying it.They count on producers and processors to ensure that foodsafety is already built into their food by building it into theirprocesses. Consumers have the right to expect the highest assuranceof food safety and that it is the same everywhere, everytime and for everyone—no matter where they live or where theyeat. Furthermore, the poultry industry will need to stay aheadof the game and keep leading the charge in food safety as theconsumption of poultry worldwide continues to grow. •Margaret D. Hardin, Ph.D., is vice president of technical servicesat IEH Laboratories & Consulting Group. She has held positions asassociate professor of food microbiology at Texas A&M University,director of food safety and quality assurance with Boar’s HeadBrand and director of food safety at Smithfield Packing Co.,Sara Lee Foods and the National Pork Producers Council. She iscurrently on the editorial advisory board of Food Safety Magazine and works closelywith the food industry in food safety.References1. www.fao.org/giews/english/fo/index.htm.2. www.cdc.gov/outbreaknet/pdf/2008MMWR-Table2.pdf.3. Stillwell, S. 2009. Food safety programs across an integrated poultryindustry. International Association for Food Protection 96th Annual Meeting.Grapevine, TX.4. www.thepoultrysite.com/articles/2002/link-between-broilerintensification-and-foodborne-pathogens-explored.5. pubs.caes.uga.edu/caespubs/pubcd/b1222.htm.6. NACMCF. 1999. FSIS microbiological hazard identification guide for meatand poultry components of products produced by very small plants. Meatand Poultry Subcommittee of the National Advisory Committee on MicrobiologicalCriteria for Foods.D e c e m b e r 2 0 1 2 • J a n u a r y 2 0 1 3 57

News Bites(continued from page 9)Advertisers IndexGMA Selects Deloitte to Harness “Big Data”The Grocery Manufacturers Association (GMA) has announced the selection ofDeloitte Consulting LLP to conduct research on how food, beverage and consumerproduct companies can translate “Big Data” into useful analytics and business intelligenceto support effective decision making.Big Data is a name for the recent increase in largely external and unstructuredbusiness and consumer information. The explosion of Big Data has already causedmany companies’ data warehouses to overflow. Consumer packaged goods companiesneed to determine how to capitalize on data from social media, smartphones, onlinebehavior, sensor networks, purchase tracking and other sources.Trace One North American Headquarters Comes to BostonTrace One, an e-collaborative solutions company for private-label product development,has announced the launch of its North American headquarters in Boston.Trace One brings to the U.S. decades of expertise in helping the largest retailers andmanufacturers worldwide ensure the fast delivery of high-quality and safe private-labelproducts. The company’s clients already include 30 of the world’s leading privatelabelbrands around the globe.People & PlacesJohn Ruff, formerly senior vice presidentof Kraft Foods, is the new presidentof the Institute of Food Technologists.Harry DeLonge has recently joinedAquatech International Corporation’s WA-TERTRAK team as a senior advisor for itsfood and beverage industry division.SafetyChain Software isvery pleased to announce thatDavid Acheson, M.D., hasjoined its board of directors.Grocery Manufacturers Association(GMA) has appointedElise Fennig as vice president, industryAchesonaffairs, and Emilia C. Lonardo, Ph.D., asvice president, consumer product safetyand science policy. GMA also presentedthe 2012 Industry Collaboration LeadershipAward to Joe Sheridan, presidentand COO of Wakefern Food Corporation,and the Hall of Achievement Award toRichard Jurgens, chairman and CEO ofHy-Vee Inc., and Dean Pappas, CEO ofClement Pappas and Company Inc.Carlisle Companies hasappointed Trent A. Freibergas president of CarlisleFoodService Products.Meg Miller has beenFreiberg promoted from manager todirector of the Produce Marketing Association’spublic relations activities.The Chefs’ Warehouse Inc. has announcedthe appointments of tworegional managers. Ed Kauffeld will beregional vice president of the easternregion of the United States, and BarryWeinstein will be general manager of theNew York market.Daemmon Reeve hasbeen appointed group chiefexecutive officer of Treatt plc,a global ingredient supplier.Ruiz Foods has appointedRachel Cullen as president Reeveand CEO.Inmar, a technology companythat operates collaborativecommerce networks, hasannounced that John Rosswill join the company’s leadershipteam.RossKatherine M.J. Swanson,Ph.D., assumed the presidencyof the International Associationfor Food Protection (IAFP)at the conclusion of IAFP 2012in Providence, RI.SwansonKey Technology has promotedGovert van Drunen tothe position of EMEIA salesmanager at KeyTechnology BV,Van Drunen the company’sEuropean operation, and appointedMarco Azzaretti tothe position of optical product Azzarettimanager.Allied Blending and Ingredients.................57800.758.4080 • www.alliedblending.comAmerican Proficiency Institute....................29800.333.0958 • www.foodpt.comBioControl Systems, Inc...............................27800.245.0113 • www.biocontrolsys.comFoodHACCP.com............................................56www.foodhaccp.comFood Safety Connect.......................................2www.foodsafetyconnect.comFood Safety Summit.......................................3www.foodsafetysummit.comGlobal Food Safety Conference...................51www.tcgffoodsafety.comHygiena, LLC..................................................33888.HYGIENA • www.hygiena.comMeatXpo........................................................53510.763.1533 • www.meatxpo.comMichelson Laboratories, Inc........................57888.941.5050 • www.michelsonlab.comMicro Identification Technologies...............45www.micro-indentification.comMicrobiology International..........................41800.EZ.MICRO • www.800ezmicro.comNeogen Corp.................................................37800.234.5333 • www.neogen.comNorthwest Food Processors Association....56www.nwfpa.orgPittcon............................................................55www.pittcon.orgQ Laboratories, Inc.......................................13513.471.1300 • www.qlaboratories.comQC Laboratories............................................47215.355.3900 • www.qclaboratories.comR-Biopharm...................................................60877.789.3033 • www.r-biopharm.comRefrigerated Foods Association...................59770.303.9905 • www.refrigeratedfoods.orgRoka Bioscience, Inc................................ 7, 43855.ROKABIO • www.rokabio.comRomer Labs Inc...............................................5855.337.6637www.romberlabs.com/rapidchekSpartan Chemical Company, Inc.................47800.537.8990 • www.spartanchemical.comStainless Motors, Inc....................................15505.867.0224 • www.stainlessmotors.comStrategic Consulting Inc.................................9802.457.9933 • www.strategic-consult.comWaters...........................................................19www.waters.com/xevotqsWeber Scientific............................................11800.328.8378 • www.weberscientific.com58 F o o d S a f e t y M a g a z i n e

REFRIGERATED FOODS ASSOCIATIONrd33 Annual Conference & ExhibitionFebruary 24 - 27, 2013Doral Golf Resort & SpaMiami, FloridaWarm Up to New IdeasNetwork With Today’sIndustry Experts& Explore Tomorrow’sSolutionsat the premiere conference & exhibition formanufacturers and suppliers of prepared,refrigerated food products.• SPEAKERS: Exceptional lineup ofspeakers on industry trends, foodsafety & regulatory updates, thelatest technology, and bestpractices.• NETWORKING: Exhibition featuringthe newest offerings in packaging,equipment, ingredients andservices, one-on-one CEOsessions, and entertainmentevents.REGISTER TODAY!www.refrigeratedfoods.org770.303.9905

eFood® Allergenl-time PCRtenctionat -20°CNo: 04449SureFood® Allergenreal-time PCRGlutenInhibitionStore at -20°CLot No: 04449SureFood® Allergenreal-time PCRGlutenPositiveStore at -20°CLot No: 04449SureFood® Allergenreal-time PCRGlutenTaqStore at -20°CLot No: 04449SureFood® Allergenreal-time PCRGlutenStore at -20°CLot No: 04449R-Biopharm Inc.Analytical Test Kits toensure Gluten-free Food• Surface and hygiene controlRIDA®QUICK Gliadin is ideal for swab tests within production sites.• Product testingRIDASCREEN® ELISAs are available in sandwich and competitiveformat. Hydrolyzed samples like beer should be analyzedwith RIDASCREEN® Gliadin competitive.LateralFlowELISARIDA®QUICK GliadinSwabbingRIDASCREEN® Gliadin• AOAC-OMA (2012.01)• AOAC-RI (120601)• AACCI (38.50.01)• Codex Alimentarius Method(Type I)PCR1Control Mix 2Control DNA 3Polymerase 4FDE 5SureFood® GlutenR-Biopharm, Inc. • 870 Vossbrink Drive • Washington, MO 63090 USA • Phone: (877) 789-3033 • www.r-biopharm.com