Food Safety Magazine 2010-10-11
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Transcript of Food Safety Magazine 2010-10-11
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4 F O O D S A F E T Y M A G A Z I N E
Editorial Advisory BoardDANIEL W. BENA
PepsiCo Beverages International
REGINALD W. BENNETTCFSAN, U.S. FDA
ROBERT E. BRACKETT, PH.D.National Center for
Food Safety and Technology
JOHN BUTTS, PH.D.Land O’Frost
BRIAN CAMPBELLKroger Manufacturing
LARRY COHENKraft Foods
MICHAEL M. CRAMERWindsor Foods
BETH ANN CROZIER-DODSON, PH.D.Kansas State University
VIRGINIA DEIBEL, PH.D.TRAC Microbiology
JONATHAN W. DEVRIES, PH.D.General Mills/Medallion Labs
WILLIAM FISHERInstitute of Food Technologists
RUSSELL FLOWERS, PH.D.Silliker, Inc.
VENY GAPUDFieldale Farms
KATHY GOMBASCFSAN, U.S. FDA
JIM GORNY, PH.D.CFSAN, U.S. FDA
DONALD J. GRAHAMGraham Sanitary Design Consulting
PAUL A. HALL, PH.D.AIV Microbiology and Food Safety
Consultants, LLC
MARGARET HARDIN, PH.D.IEH Laboratories & Consulting Group
LARRY KEENERInternational Product Safety Consultants
HUUB L.M. LELIEVELDGlobal Harmonization Initiative
ANN MARIE MCNAMARA, PH.D.Jack in the Box, Inc.
MARTIN MITCHELLCertified Laboratories/
Refrigerated Foods Association
DOUG PEARISOContemporary Process Solutions LLC
ROBERT POWITZ, PH.D., MPH, RSR.W. Powitz & Associates
SCOTT M. RUSSELL, PH.D.University of Georgia
THOMAS M. SAUERWell’s Dairy
RICHARD F. STIERConsulting Food Scientist
JOHN G. SURAK, PH.D.Surak and Associates
ALEXANDRA VEIGA, PH.D.ITQB-UNL and EFFoST
DON L. ZINK, PH.D.CFSAN, U.S. FDA
Science-Based Solutions for Food Safety & Quality Professionals Worldwide
October/November 2010 • Vol. 16, No. 5
F E AT U R E S
Cover Story38 Product Tracing in Food Systems: Legislation versus RealityJennifer C. McEntire, Ph.D.
Category Feature: Meat46 Listeria monocytogenes: Controlling the Hazard inRTE Meat and Poultry Processing EnvironmentsRobin M. Kalinowski, M.S.
Feature50 Hygienic Design of Food Processing FacilitiesFrank Moerman, M.Sc.
C O L U M N SProcess Control10 Building an Effective Calibration ProgramRichard F. Stier
Sanitarian’s File14 Lessons Learned and a Bit of HistoryBob Powitz, Ph.D., MPH
Focus: Food Safety 16 ChallengesMeeting Consumer Demands while Maintaining a Safe Food SupplyJames C. Griffiths, Ph.D. and Markus Lipp, Ph.D.
Sanitation20 Creating a Positive Partnership Between Foodservice Establishments and InspectorsAqualia L. Nelson, MS, REHS/RS, Aiko Allen, MS, Suzanne R. Hawley, Ph.D.,
MPH, Theresa St. Romain, MA and Shirley A. Orr, MHS, ARNP, NEA-BC
D E PA R T M E N T S6 From the editor 56 Product ShowcaSe
8 NewS BiteS 58 advertiSerS iNdex
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Fall is the time of year that brings many things to mind: leaveschanging color (a big deal here in New England!), cooling
weather, a spate of holidays and, of course, elections and politics.Ignoring for a moment the midterm elections (if you can), oneWashington D.C.-related item we should not ignore is the future offood safety legislation.
It is disappointing to note that the UnitedStates Senate has decided not to take up theFood and Drug Administration (FDA)’s FoodSafety Modernization Act before the midtermelections, according to a recent news releasefrom the Food Marketing Institute.I don’t think there’s any disagreement among
those in the food industry (or even among con-sumers, for that matter) that bi-partisan food safety legislationshould have already been passed in Congress. Given the plethora ofproduct recalls that blanket the news far too often, it is certainlytime for this country to focus on balanced solutions that will bothprevent food safety problems at the source and protect our globalfood supply in the future.While there are arguments for industry to police itself (and by
and large, the food industry has done a good job), we only need tolook at the financial, housing and energy industries to know thatsome regulation is, in fact, good regulation. Providing the FDA withthe necessary resources and authority to enforce the current regula-tions would be a step in the right direction. But just what potentialfood safety legislation may look like is still unknown.Our cover story this issue both asks and attempts to answer this
question in terms of the effects of the pending food safety legisla-tion on product traceability. Drawing from her experience in foodmicrobiology and at the Institute of Food Technologists, JenniferMcEntire, Ph.D. analyzes the issues presently confronting the in-dustry, the current food regulations and where we stand today. Shealso offers some clarification of the pending bills and what their en-actment would mean to the industry, identifying the challenges stillahead and offering her suggestions as to where we should go next.Her dissection of these issues is very timely, in light of the politicalchanges that appear to be on the horizon.No matter what your political bias, I think there is one thing we
can all agree on: food safety is the ultimate goal. We may differ inour opinions as to how we get there, but working in the same for-ward direction seems like a good place to start.
Best Regards,
Barbara VanRenterghem, Ph.D.Editor
6 F O O D S A F E T Y M A G A Z I N E
Food SaFety Magazine (iSSn 1084-5984) is published bimonthly by
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FROM THEEDITOR
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8 F O O D S A F E T Y M A G A Z I N E
NEWS BITES
NEWS FLASH:Highlights of the FSM eDigest
Articles in our September eDigest (availableat the eDigest archives at www.foodsafety
magazine.com/exclusives.asp focused onthe issues of recall preparedness and trace-ability programs, topics that go hand in handfor processors who wish to be on top of pro-tecting their brands.
Coming up in our October eDigest will bean article on Anticipating Changes in Food
Packaging by Richard Fama, a member of thefood liability practice group at law firm CozenO’Connor. Changes in food packaging tech-nology will be discussed.
Pan-American NutritionAward 2010The Pan-American Nutrition Award 2010 rec-
ognizes the best research papers of the year in thefields of human nutrition and food science andtechnology. Awarded only bi-annually, the awardsare granted to both established professionals andyoung scientists in the four zones served byGrupo Bimbo: the United States of America,Mexico, Central America and South America.Each zone will have two winners: professional
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• Professional: Must have carried out unique,valuable research projects alone or as part of ateam, with at least five peer-reviewed publica-tions in the last 3 years and have supervisedpostgraduates; must have taught and partici-pated in activities promoting science. Prize$5,000.00/zone.Award submissions should be registered at
premiopanamericano.grupobimbo.com. The dead-line to submit papers is October 15, 2010. Con-testants may submit multiple applications. Anindependent Scientific Jury from each geographi-cal zone, composed of renowned researchers andexperts in human nutrition, food science and tech-nology, will rate the submitted projects based onthe evaluation criteria. The projects with the high-est ratings will win the awards.
PortaFab Modular Building Systems Achieves ISO 9001:2008CertificationPortafab Modular Building Systems was assessed by NSF-ISR, Ltd. earlier
this year and found to be in conformance with ISO 9001:2008 standards.The company manufactures environmentally friendly modular constructionproducts and provides technical support to architects, contractors and devel-opers in the construction industry. Organized into integrated systems that streamline the construction
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the increasing application of Portafab’s modular systems in creating clean-room and environmentally controlled areas served as a catalyst for achievingISO 9001:2008 certification.
AIV Forms Strategic Alliance with Crozier-Dodson Food Safety ConsultingAIV Microbiology & Food Safety Consultants, LLC, a provider of food
safety management and technical solutions to food industry and governmentcustomers worldwide, has announced a strategic alliance with Crozier-Dod-son Food Safety Consulting, LLC (CDFSC) to provide specialized foodsafety and microbiology training to global food industry clients.Under the agreement, CDFSC will develop a menu of new and innova-
tive food safety and microbiology short courses and workshops to support allaspects of AIV’s consultancy services. Beth Ann Crozier-Dodson, Ph.D.,president of CDFSC has extensive experience as an independent consultant,teaching microbiology and food safety workshops throughout the world. Herexpertise also includes work as the assistant director of the Kansas State University International Food Microbiology Rapid and Automated MethodsWorkshop for 16 years, which was founded by Dr. Daniel Y. C. Fung.
Recent Articles Available Online atwww.foodsafetymagazine.com/signature.asp
Water quality is of critical importance for food and beverage manu-facturers. Read Food and Beverage Manufacturers Tap into Industrial
Water Treatment Solutions to Help Meet Sustainability Goals by Ed Orvi-das from Culligan International to learn more about food plant water-saving strategies.
A case study of mustard maker G.S. Dunn (Case Study: G.S. Dunn
Quality Control Facility in Hamilton, Ontario) shares tips for saving en-ergy and improving quality assurance by employing LED high bay fixtures by Dialight.
Seeing product go to waste means a loss of profit, which can impactthe bottom line. Read the article by United Air Specialists on Smart Dust
Collection: Reducing Ingredient Shrinkage, which profiles how AlliedBlending & Ingredients successfully reduced product waste, while keep-ing the facility dust-free and reducing dust collection system mainte-nance costs.
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10 F O O D S A F E T Y M A G A Z I N E
• Observe the employees doing the cal-ibration procedure to ensure they arefollowing the procedures; or, auditthird parties contracted to do similarwork.It is also important to assign some-
one to manage the calibration programto ensure that it is properly designed,implemented and maintained.
Who Manages the Program?So, who should manage the calibra-
tion program? This depends on eachand every company. What happens fre-quently is that processors do not assignan individual to manage the calibrationprogram, but allow it to be done by dif-ferent operating groups. The productionpeople might be responsible for unit op-erations such as metal detectors or mag-nets, whereas engineering takesresponsibility for temperature-indicatingdevices (TIDs) and pressure gages. Thequality manager or laboratory supervisorwill ensure that the instruments in thelaboratory are properly calibrated. Theremay be other groups that get involved.For example, the warehouse peoplemight be responsible for looking afterrefrigerators, freezers and relative humid-ity controls.
What can happen in a situation likethis is that there are many different cali-bration programs that use differentforms and procedures. In addition, theremay be critical instruments that “fallthrough the cracks” and are either notbeing calibrated or not being calibratedfrequently enough to adequately ensuresafety or quality. It is okay to have dif-ferent persons responsible for theirareas, but one person needs to managethe entire program. His or her role is toensure that there is a consistent programthat addresses all calibration activitiesthat need to be done to ensure productquality and safety. The calibration man-ager needs to work with his group to es-tablish a standard format for procedures.The manager must also evaluate allmonitoring instruments in the plant anddetermine not only whether calibrationis necessary, but how often this should
CCalibration: The comparison of a
measurement instrument or system of
unverified accuracy to a measurement
instrument or system of known
accuracy to detect any variation from
the required performance specification.
–American Society for Quality
It is absolutely essential that calibration be an integral part of a food or ingredi-ent processor’s quality and safety program. Almost all regulations and managementstandards that address food quality and safety include language that stresses the im-portance of calibration. The low-acid canned food regulations found in the U.S.Code of Federal Regulations 21 CFR Part 113 reference the need for calibration:
“Each thermometer should have a tag, seal or other means of identity that includes the dateon which it was last tested for accuracy.”
As does the Hazard Analysis and Critical Control Points (HACCP) regulationsthat are mandated for meat and poultry, seafood and juice:
“Records that document the calibration of process monitoring instruments.”And, finally, ISO 22000, the food safety management system’s requirements for
any organization in the food chain, states in Section 8.3:“The organization shall provide evidence that the specified monitoring and measuring
methods and equipment are adequate to ensure the performance of the monitoring and meas-uring procedures.”
The bottom line is that all instruments used for ensuring quality, safety, sanita-tion and legal compliance must be calibrated. In addition, if there are monitoringdevices that are necessary to ensure worker safety and/or safe operation of equip-ment, they must be included in the calibration program. An example of such a de-vice would be a pop-off valve on a pressure vessel.
To achieve this goal, processors need to perform the following:• Develop effective procedures for calibration;• Document those procedures;• Maintain records of calibration activities, including corrective actions;• Review records to ensure that procedures are being followed;
Building an EffectiveCalibration Program
PROCESS CONTROL
By Richard F. Stier
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12 F O O D S A F E T Y M A G A Z I N E
be done. By conducting a risk assess-ment, they can determine not onlywhich devices are essential for the pro-duction of safe, wholesome and high-quality products, but also whether theprocedures are being employed properly.
The job description of the managerresponsible for calibration should clearlystate that this individual is responsiblefor managing the program. He or shemust accept their job description, ac-knowledging responsibility. Among theirduties will be to ensure that the programremains on schedule, that it is auditedper established schedules and that cali-bration records are being reviewed perestablished schedules. In addition, thecalibration manager must ensure that allpersons responsible for calibrating in-struments or ensuring that they are cali-brated have been trained on theprocedures and/or work instructions re-quired to do the work and that recordsof these sessions are maintained.
Developing and DocumentingProcedures
It is absolutely imperative that allprocedures involved in the calibrationprogram be documented. There shouldbe a general protocol that describes howthe calibration program will be devel-oped and implemented, plus work in-structions that describe how eachinstrument or class of instrumentsshould be calibrated.
The general protocol should includethe following elements:• Objective of the program• Responsibility• Calibration procedures • Documentation responsibilities• Corrective actions
Each work instruction should includestep-by-step procedures on how the cali-bration should be done, the standardsthat will be employed, the tolerancesand how the results shall be reported. Ifthe instrument is out of calibration, theprocedures must not only describe whatwill be done with the instrument, but
more importantly, it must address whatto do with any product that might be af-fected. Most operations “tag” their in-struments after calibration. Thecalibration tag may include who did thework, the date the work was done andthe date of the next scheduled calibra-tion. These tags should be made of ma-terials that are water- and oil-resistant sothey will survive the rigors of produc-tion, including cleaning. Additionally, iftagging is part of the program, removalof outdated tags and replacement withnew ones should be included in the pro-cedures.
With instruments such as pressuregages or TIDs, it is best to calibrate theunit at three points that bracket the nor-mal operating parameters. The risk as-sessment exercise should be used to helpestablish how to calibrate the instru-ment.
There is a difference between calibra-tion and verification. Perhaps the bestexample to use when differentiating thetwo is a scale. Scales are usually cali-brated one or two times per year by aregulatory agency or a licensed calibra-tion organization. These groups test theunits against known standards and adjustthem as needed. Many operations rou-tinely verify their scales. To do this, theyroutinely check performance using stan-dard weights.
Calibration procedures must addressinstruments used for monitoring processoperations and performing quality tests,and any standards used in-house. Proces-sors must send standard thermometers(National Institute of Standards andTechnology or American Society forTesting and Materials), weights and otherdevices to an outside agency for calibra-tion at regular intervals.
Procedures for sending instrumentsout must also be documented. If a stateagency comes into your facility once ayear to calibrate scales, load cells andother devices, procedures describinghow this is done, who is responsible andwhat needs to be done if the instrumentis found to be out-of-calibration are necessary
One of the most valuable tools fordocumenting and organizing a calibra-tion program is a master calibrationschedule (Table 1). Rolling all instru-ments that require calibration into thismaster list allows a processor to easilymonitor the program and makes lifemuch easier for auditors. The whole pro-gram is summarized in one document.Of course, hard copy records of calibra-tion records must be available for reviewand to verify that the work was not onlydone, but done properly.
Records and Corrective ActionsRecords of all calibration activities
must be maintained either as hard copiesor electronically. Many processors rolltheir process instrument calibration intoa maintenance management softwareprogram. These systems are availablecommercially or can be developed inter-nally using programs such as Excel™ orAccess™. If your company decides topurchase or build an electronic system tomaintain and monitor a calibration pro-gram, consider incorporating the follow-ing features:• Maintenance scheduling• Flags when items are due• Flags for past-due items• Procedures for doing work• Automatic entry by workers• Ability to have records scanned and
accessed by the system
“It is absolutely essential that calibration be an
integral part of a food or ingredient processor’s
quality and safety program.”
Table 1: Master Calibration Schedule
Instrument Serial # Location Frequency Test Standards/ Person Date last Date next Commentsof calibration method tolerances responsible calibration calibration
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O C T O B E R n N O V E M B E R 2 0 1 0 13
• Ability to verify that work has beendone
• Print capability: summaries, schedules• Ability to “talk” to other systems
Be forewarned, however, electronicmaintenance management systems take agreat deal of time and effort to get upand running. There is a huge amount ofinformation to input into the system. Inaddition, it is absolutely imperative thatseveral persons be trained to manage anduse the system. This is one situationwhere “putting all your eggs in one bas-ket” can be huge mistake. I have seensuch systems abandoned when the onlytrained person leaves the company.
As noted above, calibration recordsare mandatory for all instruments usedto monitor Critical Control Points(CCPs) in a HACCP program. In addi-tion, the importance of developing doc-umented calibration procedures thatinclude corrective actions cannot beoveremphasized. One of the gaps ob-served in many calibration programs isthat the corrective actions do not in-clude what to do with product that may
be affected. The protocol may containstatements like the following:
“If the instrument is not in calibration,make the necessary adjustments to bring itback into calibration and retest,” or
“If the instrument is out-of-calibration,take it out of service and send it to the vendorfor repairs. If it cannot be repaired, replace itimmediately.”
It is imperative that the proceduresaddress any product that might be af-fected. Here is an example: many yearsago, a processor of acidified peppers, aseasonal item, received a visit from theU.S. Food and Drug Administration(FDA) at the end of the season. Thecompany’s records indicated that all ofthe products packed throughout the sea-son had a pH of 4.6 or below. When theFDA began checking the pH values ofproducts, they found pH values of 4.8and above. These findings indicated thatthe product was potentially unsafe as itcould support the growth of Clostridiumbotulinum. Unfortunately, the companyhad no records documenting that theirpH meters had been calibrated. The
company said that they did it each andevery day, but they had failed to docu-ment that the work had been done. TheFDA told them to embargo the entireseason’s pack and develop a samplingplan to show compliance. The companyelected to destroy the entire season’spack, estimating that the testing wouldcost too much. So in this case, a failureto maintain proper calibration recordscost a company a full season’s pack.
There are many instruments or piecesof equipment that processors look tooutside agencies to calibrate, which mayinclude scales, load cells, TIDs and oth-ers. If an outside agency does the work,make sure that their reports include themethod used for calibration, tolerances,any adjustments or actions and results.Simply sending a report that the instru-ment is satisfactory is unacceptable.
Record/Review Verification ofthe Program
The pepper packer scenario discussedabove is an excellent example of the im-
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14 F O O D S A F E T Y M A G A Z I N E
II just celebrated my third anniversary as
a Medicare cardholder. The time has fi-
nally come to sit back and relax a bit
and let a younger, more energetic and
better-trained generation launch us into
the next era of food safety. I’ve earned
the right to make those difficult choices about whether to meet publi-
cation deadlines or go fishing. So now is a good time to cut bait and
forget the flashing icon on my computer screen. No, I’m not putting
away my thermocouple thermometer or holstering my brand new
LED flashlight just yet. I still enjoy being a sanitarian too much to
leave this exciting profession entirely; as the playwright Noel Coward
once said, “Work is more fun than fun,” and I fully intend to keep the
fun going until I can’t anymore. But just before the fat lady sings, I
would like to present a little bit of local regulatory history of the food
safety movement as I lived it, and perhaps give a little insight into the
future.
Views from the PastForty-five years ago I started working as a district sanitarian for the New Jersey
State Department of Health. There were eight of us who covered the state in fourhealth districts. Our job was to inspect all state-licensed food establishments and toserve as a resource (most often playing the role of “Bad Cop”) for the local sanitaryinspector who, for whatever reason, was faced with a recalcitrant retail food propri-etor. Occasionally, we were the ‘epidemiologists du jour’ charged with chasing afterfoodborne misadventures. Our entire approach to food safety was quite different
than it is today. Our main focus was onfood adulteration, rather than contami-nation, and we were very much into the“walls, floor and ceiling” mentality withregard to sanitation. I came into the pro-fession at the tail end of The Jungle(Upton Sinclair’s 1906 novel) era.
The references we had reflected thefood protection philosophy at the time.I recall using the 1962 Public HealthService (PHS) Foodservice SanitationManual as my basic marching orders, abriefcase full of NSF standards as en-forcement adjuncts and a copy of Ehlers& Steel’s Municipal and Rural Sanitationas a text reference. As state sanitarians,we were lucky to have copies of the Na-tional Association of Sanitarians’ TheSanitarian’s Desk Reference and Dr. BenFreedman’s Sanitarian’s Handbook in ouroffice. These were invaluable referenceswhen everything else failed.
Our food safety field instrumenta-tion consisted of a bimetal thermometerand a maximum-registering, mercury-filled thermometer in an armored case.That was it. The rest of our gear in-cluded a Hobart fat tester, hydrometer,brix and salinity refractometers; a drop-per bottle filled with a Malachite Greensolution to detect sulfite adulteration inmeats; a phosphatase milk testing kit,Mason jars and sealing wax for takingfood samples; and a WWII Army sur-plus metal oil can that was filled withthe foulest smelling kerosene to ensurethat condemned foods stayed con-demned. All this was hauled around in a’55 Dodge. The tools provided intriguewhen I found violations and the Dodgeprovided the comic relief. Damn, Iloved that job.
Forward Ho!In 1976, the second iteration of the
PHS Foodservice Sanitation Manual wasissued. It did several important thingsfor those of us in local enforcement,particularly in the way our professionstarted looking at the retail food indus-try. Yes, it still emphasized the good ol’walls, floor and ceiling sanitation para-digm, but it also introduced, albeit sub-
Lessons Learned and a Bit of History
THE SANITARIAN’S F ILE
By Robert W. Powitz, Ph.D., MPH
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tly, cross-contamination protection andan emphasis on the control of poten-tially hazardous foods. It was then that Ibecame fascinated with the concept ofusing both time and temperature as ameans of preventing foodborne illnessesin the retail trade. Unfortunately, the ’76code did not include Hazard Analysisand Critical Control Points (although itcertainly was around at that time) orspecifics on contamination control. Forthese, we had to wait until the 1995Food Code was issued. As a result, muchof our enforcement activities were basedon what the legal profession cobbled to-gether in the form of case law and law-suits filed in response to a spate offoodborne illness outbreaks. Seeking re-dress through the courts was far more ex-peditious than going through regulargovernmental channels when it camedown to actual food safety.
In about 1980 when I was fairly freshout of graduate school, I had my first ex-perience as plaintiff’s expert witness in acase involving foodborne intoxication.The defendant’s counsel was a seasonedcriminal trial lawyer, and I learned, per-haps the hard way, the importance ofknowing the art and science of my pro-fession and using my knowledge, skillsand attributes to the best of my ability. Ican distinctly remember being asked bythe opposing counsel whether I had writ-ten anything for which I professed ex-pertise. At the time I hadn’t, and the restof that session was a battle of wits be-tween attorneys as to whether or not Iwas qualified to render the opinions Ihad put in my report regarding my find-ings in the case. Although our side pre-vailed, it was about as uncomfortable assitting on a fire ant hill. This scenariowas not so much about my credentials,but rather it had more to do with thelack of information available to both theretail food industry and legal commu-nity when dealing with the aftermath ofan unintentional incident as well as de-veloping a prevention model so that itwould not happen again. However ad-verse this situation was, it served as awakeup call. So, for the past threedecades, I have doggedly written aboutenvironmental health and safety issuesand conditions in institutions and retailfood establishments that are not found
in text books, journals or in the popularpress. I’ve always made it a point to ad-dress something that I had recently en-countered in plying my profession, orwhat I saw as the next new idea in con-trolling risk. Needless to say, it’s beenquite rewarding.
A Fond FarewellSo, I gently bow out of another era,
one in which we’ve witnessed significantchanges in attitudes, policies and prac-tices. We’ve seen significant initiatives inconsumer protection, and we havebegun to question the whole issue of“farm to fork” and sustainability. Thiswill be our future. In thinking ahead, Irealize that our science has barelyscratched the surface in working withfood safety, including embracing theGreen movement. There is so much leftto do, so many things to find out aboutfood safety strategies and so many waysto discover how to control risks in newcost-effective and cost-efficient ways.Hopefully, we will all seize the opportu-nities in this field and run with them.
We’re bound only by the limits of ourimaginations.
Finally, I want to thank all my readersfor their support and particularly thosewho provided feedback…good, bad andindifferent…about my work. I sincerelyappreciated every comment, recommen-dation and suggestion. I’ve enjoyed ex-changing ideas, and most importantly,I’ve learned so very much from all ofyou. I would like to think that we’ve allmade a difference for the better.
With warmest regards, Bob Powitz, Sanitarian n
Forensic sanitarian Robert W. Powitz,
Ph.D., MPH, RS, CFSP, is principal con-
sultant and technical director of Old Say-
brook, CT-based R.W. Powitz &
Associates, a professional corporation of
forensic sanitarians who specialize in envi-
ronmental and public health litigation sup-
port services to law firms, insurance
companies, governmental agencies and
industry. Dr. Powitz can be reached at
[email protected] or through his
Web site at www.sanitarian.com.
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16 F O O D S A F E T Y M A G A Z I N E
TThe food business is one of the most
exciting industries to be a part of today.
To address consumer preferences and
needs, the food industry needs to con-
tinuously develop new products, new
processes and new supply chains at a
rapid pace. New advances that broaden consumer access to an
array of foods seem to come to fruition continuously—from novel
sweeteners and salt substitutes to international flavors to the ever-
growing category of functional foods and beverages.
Consumers are increasingly demanding—they want tasty food that supportsgood health, they want seasonal food year-round, they want food incorporating theflavors of the day (yesterday’s pomegranate is today’s açaí), they want food in con-venient portions and packaging that suits their busy lifestyles and they want food atlow prices, particularly given today’s economic realities. Manufacturers must workhard through innovations, improved processes, business functions and new supplychains to meet these expectations—many of which the manufacturers set themselvesthrough the marketing of their products. Of course, underneath it all, there is theultimate consumer expectation that goes without saying: that the food available forpurchase is safe. However, this may very well be the toughest challenge of all tomeet, given the complexities of modern food production, ingredient sourcing andproduct distribution through long and complex supply chains.
A safe food supply requires several different elements, which have been high-lighted quite comprehensively in previous articles. These include regulatory bodiesequipped with appropriate resources, ethical manufacturers and suppliers, tightlymanaged supply chains and the existence of and adherence to independent stan-dards of quality. When we speak of foods, we speak not only of finished food prod-
ucts but also of the various ingredientsthat comprise these foods—which, ofcourse, can impact overall productsafety and quality. As is common wis-dom for food producers, it is much eas-ier to control the end-product byensuring safe ingredients and processesthan by testing the end-products forsafety.
Focus on Food IngredientsThe U.S. Pharmacopeial Convention
(USP), as an independent, standards-set-ting body, promotes public health bypublishing standards for the identity,quality, purity and consistency of foodingredients via the Food Chemicals Codex(FCC) compendium. With these ingredi-ents—such as colorings, flavorings, nutri-ents, preservatives, processing aids andsweeteners—continuing to play an in-creasing role in the modern consumer’sdiet, ensuring their quality is essential asthe industry seeks to assure safety toconsumers.
Because we hear far less about foodingredient quality and safety than, say,microbial contamination of fruits, veg-etables and meats, the question becomeswhether there is actually a need to focustime, energy, expertise and resources tothis area. The answer is yes. This hasbeen proven through the problems thathave received widespread media cover-age over the past few years, such as in-fant formula and pet food adulteratedwith melamine—incidents that harmedconsumers and pets–caused by the un-detected hazard that was intentionallyintroduced into the food supply chainas an adulterant to a bona fide food in-gredient for pure economic gain. Thisexample not only demonstrates clearlythe hazard of an unsafe food ingredient,but also the wide segments of con-sumers and industry that are detrimen-tally exposed and harmed from suchaction. Long supply chains contributefurther to these crises by making it diffi-cult to directly pinpoint and isolate thesource of the problem. The outcomewas tragic for the affected consumersand devastating for the industries im-
Meeting ConsumerDemands while Maintaining a SafeFood Supply
FOCUS: FOOD SAFETY CHALLENGES
By James C. Griffiths, Ph.D. and Markus Lipp, Ph.D.
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18 F O O D S A F E T Y M A G A Z I N E
pacted by it. Therefore, preventing suchincidents is a priority not only to safe-guard consumers against grievous harm,but also to protect brands and brandnames for the industry. Exactly at thisjunction, where quality defects impactthe safety of food ingredients, the qual-ity standards of the FCC are a critical aidto the industry and ultimately to theconsumer to ensure the appropriatequality of food ingredients and to main-tain trust that our food supply is safe.
Beyond these types of incidents,there are other quality issues, which maynot garner such extensive attention, butthat nevertheless can still be serious.“Quality” takes into account a host offactors: that the ingredient is what itclaims to be (identity); that it is not acontaminated, adulterated, diluted orotherwise inferior product; and that it isconsistent from batch to batch. Thesemay affect the safety of a product—ormay influence the taste or texture of aproduct or other factors that may notharm a consumer but may result in theirrejecting a product or brand. That issomething no manufacturer wants.
Focus on Standards—Finding Common Ground
Ingredients are produced around theworld, and manufacturers source theiringredients from a host of countries.Global sourcing is a strategy that mostmanufacturers pursue to minimize costsand to secure a single (or more) sourcefor their global needs. This further en-sures that the manufacturer benefitsfrom the economy of size to answer toconsumer interest in ever-lower prices.As a consequence, one product couldcontain ingredients produced in 10 ormore countries. This poses a formidablechallenge to food manufacturers. Whatsort of assurance does a manufacturerhave that an ingredient is what it claimsto be? How does a manufacturer know itis getting what it paid for? Economicsare key factors in the food business, butdo we need to ask if there is a reasonwhy one source of an ingredient is lessexpensive than another?
Take extra virgin olive oil. Some esti-mates conclude that there are notenough olive trees in the world to ac-count for all the purported extra virgin
olive oil being sold today. (To improvethe situation regarding adulterated extravirgin olive oil in the United States, theU.S. Department of Agriculture recentlyissued new standards tightening the re-quirements for the product.) The samegoes for pomegranate juice. What thismeans is that finished product manufac-turers—and consumers—may not be get-ting what they paid for. Some seem to begetting a low-quality product, and theconsequences can range from safety con-cerns to taste, texture or other implica-tions. As we’ve discussed in a previouscolumn,1 a major incident could result ina recall, and even a comparatively minorepisode (e.g., one that impacts taste butnot safety) could result in a consumerswitching brands or rejecting a product.With fierce competition in the foodmarket, it will be very challenging tobring back those consumers once theyhave switched brands.
One can also look at the flip side ofthis scenario. How does an ethical ingre-dient supplier differentiate itself fromother suppliers who may be pushing less-expensive versions of the “same” ingredi-ent that may be of questionable quality?How does an ethical supplier protect it-self, its products and the buyers of itsproducts?
This is where independent standards,such as those provided by the FCC,come into play. With the availability ofan independent standard to define andassess the authenticity and quality of afood ingredient, suppliers and manufac-turers can more easily meet each other’sexpectations with regard to critical qual-ity attributes. Manufacturers can de-mand that their products adhere to anFCC standard, and suppliers can usetheir adherence to these standards as ameans of differentiation. As new ingredi-ents emerge, as pressures to keep foodprices low continue and as the globaliza-
tion of the industry persists, ensuringquality can become very difficult. Inde-pendent quality standards can be a keypart of supply chain management. Ob-servance of these standards may be usedin conducting day-to-day business trans-actions as part of contracts, for instance.They also may be used for maintainingregulatory compliance in all of thosecountries that recognize the FCC in law.
Focus on Infant FormulaInfant formula offers an ideal case
study on the importance of ensuringquality, for many reasons. First, the mar-gin of error here is very slim given theend consumer is part of a highly vulnera-ble population. Second, formula is de-signed to be the only source of nutritionfor infants, making it critical that theyare receiving all the ingredients and ben-efits of the product necessary to sustaingood health and development. Typically,the infant’s diet is not supplementedelsewhere during this pivotal period. Fur-thermore, the ratio of food to bodyweight in infants is significantly higherthan in adults. Their undeveloped or-gans do not possess all the metabolicclearing pathways of an adult, makingthem much more susceptible to poten-tial health risks. Third, infant formula isan area where consumer trust is ab-solutely critical; no parent wants to com-promise the safety of their children. If aproduct were to be subject to a recall orany public questioning regarding itsquality or even safety, it would be verydifficult for a manufacturer to earn backthat trust. Fourth, infant formula has un-dergone various innovations and majorimprovements over the years, includingenhancing the product with specific in-gredients such as nucleotides (which arepresent in higher doses in human milkthan in cow-based infant formulas—andare thus routinely added to infant for-
“To address consumer preferences and needs,
the food industry needs to continuously develop
new products, new processes and new supply
chains at a rapid pace.”
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mulas today) and docosahexanoic acid(DHA) and arachidonic acid (ARA) oils.DHA and ARA oils contain essentialomega-3 fatty acids present in fish andare frequently added to both infant for-mula and a host of functional foods fortheir claimed benefits in maintaininggood health and development. As newinformation has emerged over the yearsregarding the benefits of these ingredi-ents, parents often consciously select in-fant formula products that contain theseingredients. Furthermore, supplementinginfant formulas with DHA and ARA issupported by the World Health Organi-zation at levels of 0.35% and 0.7%, re-spectively. U.S. infant formulamanufacturers began to offer formulascontaining DHA and ARA in 2002.
Quality standards serve an importantfunction here. Consumers deserve toknow the product they are feeding theirinfants contains ingredients that are pureand of high quality—as do manufacturerswho seek to provide the best possibleproduct to their customers. In January2010, USP announced it was proposingnew standards for three nucleotides andtwo DHA oils. The three new nucleotidestandards were for disodium 5’-uridylate,5’-adenylic acid and 5’-cytidylic acid.The new standards for DHA oils werefor DHA algal oil, Crypthecodinium typeand DHA algal oil, Schizochytrium type.The distinction between the two DHAalgal oils is essential as the first can beused in infant formulas as well as for awide variety of other products consid-ered functional foods; the second is usedfor functional foods but cannot beadded to infant formula. Following a pe-riod of public comment in which manu-facturers and others were invited toreview these draft standards and provideinput (as per the public process throughwhich all FCC standards are proposedand reviewed), these standards were sub-sequently published this past August in asupplement to the FCC, and will be-come effective November 30, 2010.USP’s monographs also contain all ana-lytical methods necessary and suitable toverify compliance with the monograph’squality specifications. Additionally, USPoffers reference standards (authenticatedchemical specimens) for the nucleotides,thus enabling any test laboratory to con-
firm the correct execution of laboratoryprocedures used for the verification ofthe quality specifications. USP thus doesnot just set quality standards, but also of-fers all the necessary tools to verify bothcompliance with such standards and thecorrect execution of such procedures asdemanded in quality systems for test lab-oratories, such as those required underISO 17025.
Focus on “The Big Picture”With infant formula, as with all ingre-
dients, the case for quality standards iscompelling. Quality standards serve aunique function. Those provided by theFCC are independent, scientifically de-veloped, public standards, often with as-sociated reference standards. Foodmanufacturing is global, providing op-portunities for good (e.g., expandingconsumer access to foods and promotingnew nutritional enhancements), but alsointroducing complexities that can havenegative and sometimes catastrophic ef-fects. Consumers can and should expectnew innovations, but above all, they ex-
pect food to be safe and require foodproducts they can trust. Manufacturersalso need assurance that they can trustthe ingredients they source (and theirsuppliers). Additionally, ethical suppliersmay require a means to prove their in-gredients’ quality. Standards can play asignificant role for all these parties, con-tributing to a better—and safer—food supply. n
Markus Lipp, Ph.D., is director of food
standards for USP and has 20 years of ex-
perience in food and food ingredient is-
sues.
James C. Griffiths, Ph.D., DABT, is
vice president of food, dietary supplement
and excipient standards at USP and has
over 25 years of experience in food, di-
etary supplement, personal care regula-
tory and safety issues.
References1. Lipp, M. and J.C. Griffiths. 2010. Focus on
Standards. Food Defense in the Global Envi-
ronment: The Role of Quality Standards. Food
Safety Magazine 16(1): 16-19.
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20 F O O D S A F E T Y M A G A Z I N E
ditional local interventions, such as in-creased inspection frequency and foodsafety certifications, are necessary to im-prove sanitation in restaurants.6-8
Traditionally, the relationship be-tween EHS and restaurateurs has beenadversarial, often due to assumed differ-ences between the two groups. Foodser-vice workers frequently fear theinspection process, believing that themission of EHS is to find violations andreprimand, rather than to work collabo-ratively toward a common goal of foodsafety. As a result of this sometimestense relationship between EHS andfoodservice employees, traditional regu-latory approaches do not necessarily en-sure the adoption of desired food safetybehaviors.9 Non-traditional approaches,such as announced inspections, empha-size the importance of food safety,rather than focusing on compliance withregulations, and have proven to be moresuccessful than traditional approaches torestaurant regulation.10
To date, an understudied area re-mains the knowledge, attitudes and in-tentions of EHS and restaurateurs thatmay influence their willingness to col-laborate on food safety at the local level.This study, conducted in JohnsonCounty, KS, utilized a survey and focusgroups to assess the attitudes of EHSand restaurateurs toward one another,and examined barriers to and methodsfor creating partnerships between thetwo groups.
MethodsStudy Setting
Johnson County is an urban countyin northeast Kansas that includes severalsuburbs of the Kansas City metro area.Johnson County contains 1,467 foodser-vice establishments: restaurants, schools,mobile units and 231 retail foodserviceestablishments, which include groceryand convenience stores.
Survey Participants and InstrumentSeven EHS, under the auspices of
the Johnson County Environmental De-partment (JCED), are responsible for
TThe restaurant industry has a significant
impact on environmental health, and the
magnitude of that impact has been in-
creasing in recent years. Americans’ de-
pendence on restaurants is noteworthy;
on average, 48% of money spent by
Americans on food goes toward restaurant meals.1 As a result, in
2009, projected restaurant food sales grossed $565.9 billion, and
9% of the national workforce was employed at approximately
945,000 restaurant locations across the United States.1
The combination of these factors has led to a greater potential for foodborne ill-ness (FBI) due to improper food handling; that is, contamination by other foods orby food handlers themselves.2 With this heightened risk comes the need for in-creased food safety sanitation efforts. In recent years, the Centers for Disease Con-trol and Prevention has formed numerous national-level partnerships between keyrestaurant industry stakeholders.3 However, much of the responsibility for ensuringthe safety of restaurant food still rests on the shoulders of one party: the local-levelenvironmental health specialist (EHS), commonly known as a food inspector.
EHS are responsible for local inspection-related activities to promote safety andprevent outbreaks. They generally employ a combination of educational and en-forcement techniques, as well as legislative and regulatory approaches, to correct vi-olations. Previous research has shown that the education of food workers is farmore effective in promoting safe behavior—including proper food preparation—than is enforcement.4 However, education alone does not guarantee that foodworkers will employ safe food-handling practices.5, 6 Studies have indicated that ad-
Creating a PositivePartnership BetweenFoodservice Establish-ments and Inspectors
SANITATION
By Aqualia L. Nelson, MS, REHS/RS, Aiko Allen, MS, Suzanne R. Hawley,Ph.D., MPH, Theresa St. Romain, MA and Shirley A. Orr, MHS, ARNP, NEA-BC
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conducting inspections at foodservice es-tablishments in Johnson County. TheseEHS conduct a variety of inspection ac-tivities that include routine, follow-up,complaint, courtesy, disaster, HazardAnalysis and Critical Control Points(HACCP), modified complaints, plan re-view and FBI investigations.
A Johnson County EHS developed asurvey with the input of a biostatistician,public health consultant and a food in-spector with 25 years of experience, andadministered the survey to the other sixEHS. The 32 survey items assessed cur-rent workload, the inspection process,communication efforts, training, compli-ance/enforcement actions and relation-ship between EHS and diningestablishments. Answers were reportedon a five-point Likert scale ranging from“Strongly Disagree” to “Strongly Agree,”or from “Very Dissatisfied” to “Very Sat-isfied,” depending on the item.
Focus Group Participants and InstrumentFoodservice employees were recruited
randomly for focus groups from among
the pool of restaurant employees inJohnson County. Recruitment occurredthrough letters, emails, telephone callsand onsite requests. Restaurateurs wereasked to participate voluntarily and wereinformed that the purpose of the focusgroups was to obtain their opinions andsuggestions on services, barriers andways of creating partnerships. The finalpool of 21 focus group participants in-cluded three kitchen managers, one chef,two lead preparation workers, nine gen-eral managers, two district managers, twoestablishment owners, one Director ofOperations and one whose position wasnot reported.
A list of discussion topics was devel-oped by the researchers and was partiallyinfluenced by responses from the above-mentioned EHS surveys to ensure thatpotential areas of convergent or diver-gent opinions were addressed (Table 1).Common issues such as services pro-vided, educational material, enforcementactions and barriers faced were placed onboth the survey and focus group ques-tionnaire.
ProceduresThe survey was administered to six
Johnson County EHS. Respondentswere given a copy of the survey, thenasked to complete it in a private roomand place it in an unmarked collectionenvelope for the research team. After allsix respondents completed the survey,responses were collected and descriptivestatistics analyzed.
Three focus group meetings with 21participants were conducted at theJCED in Olathe, KS. Each focus grouplasted approximately 1.5 hours. Partici-pants engaged in an open discussion ofquestions posed by a group moderator.Topics discussed by participants in-cluded: 1) services provided by JohnsonCounty EHS/food inspectors; 2) materi-als, training and educational tools pro-vided by EHS; 3) enforcement andcompliance actions taken when foodcode violations exist; 4) barriers to foodsafety within the industry; and 5) waysto create positive partnerships with EHS.Items for discussion were chosen basedupon their direct influence on the rap-
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22 F O O D S A F E T Y M A G A Z I N E
port established between EHS andrestaurateurs.
Focus group discussions wererecorded on audiotape and then tran-scribed. During each focus group, ascribe wrote out keywords and responsesfrom participants while the moderatorcontinued to engage participants in fur-ther discussion. Authors reviewed thenotes and transcripts to identify and categorize common themes among responses.
ResultsSurvey of Environmental Health Specialists
Johnson County EHS completed sixsurveys, for a response rate of 100%.There were four male and two female re-spondents. All EHS had a 4-year collegedegree or beyond and were ServSafe cer-tified. The respondents had served asJohnson County EHS for a length oftime that ranged from 1 to more than 10years. Of the six respondents, one was acertified food safety specialist, and fivewere registered EHS with two certifica-tions provided through the National En-vironmental Health Association.
The majority (60%) of the EHS be-lieved the services they provide to be ef-fective. Overall, EHS were satisfied withtheir relationships with foodservice es-
tablishments, although the great major-ity of EHS agreed that improvementswere needed in the following areas: • Effective enforcement actions in re-
sponse to food violations;• Ability to influence decisions that af-
fect job performance (unclear);• Ability to provide training opportuni-
ties to foodservice establishments.Four EHS (67%) also indicated that
they either “disagreed” or “strongly dis-agreed” with the following statements:“Establishments do not face any barriersthat would prevent compliance,” and“There is not much more that we can doto ensure compliance.”
Focus Groups with Restaurateurs/FoodserviceWorkers
Each restaurateur/foodservice workerfocus group was comprised of four to 11participants, for 21 participants. Feed-back that emerged from the focus groupsessions included perceived positives andnegatives of the current inspectionprocess, satisfaction with educationaltraining and materials, barriers withinthe food industry that affect food safety,satisfaction with regulatory and compli-ance actions, motivating factors for foodsafety and suggestions for improving theinspection process and fostering partner-
ships between EHS and the food industry. • Positives of the inspection process. EHS
were perceived by many restaurateursand foodservice workers as beingwell-prepared, responsible, profes-sional and willing to provide infor-mation and address questions. Theinspection process was viewed as ben-eficial because EHS were consistentin their methods. Additionally, in-spection reports issued by EHS wereviewed as helpful, since they allowedrestaurateurs to focus on problemareas, thereby allowing them the op-portunity to improve.
• Negatives of the inspection process. Someparticipants provided contradictoryinformation by expressing that EHSlacked professionalism and were nei-ther consistent nor helpful in suggest-ing solutions to problems. Inaddition, some participants reportedfrustration in dealing with differentinspectors from the same agency,since this inconsistency did not allowthem the opportunity to build rap-port with a specific inspector. Finally,a significant number of participantsindicated they were not well in-formed about services provided byEHS.
• Educational training and materials. In-formational handouts and food safetybooklets, provided in English andSpanish, were viewed as being highlyeffective by focus group participantsand were frequently utilized for train-ing purposes. Materials written inSpanish were considered very usefulwhen training Latino workers withlimited English-language skills.
• Barriers within the food industry that af-fect food safety. Participants cited sev-eral barriers that hinder their abilityto comply with food codes and main-tain food safety: language, high em-ployee turnover rates, lack ofeducation, lack of current informa-tion regarding health regulations andfailure of EHS to notify them con-cerning such changes.
• Regulatory and compliance actions. Par-ticipants indicated that restaurateurswant to be held accountable for vio-lations in their restaurants. However,they desired that the process be fairTable 1: Focus Group Questions
1. What do you like about the service that we provide?
2. What do you dislike about the service that we provide?
3. What suggestions do you have to improve our services?
4. What do you think about the training/educational tools available (i.e., hand-outs, signage, focus on food safety booklets, food safety disks, food safetyclass, etc.)?
5. Of the materials we just discussed, which ones do you pay attention to anduse more often? Why?
6. Which ones do you not use and why?
7 Are there any barriers within your restaurant that affect customer service orfood quality?
8. What barriers do you face as foodservice workers that may affect your ef-forts to comply with food code regulations?
9. What regulatory and compliance actions do you feel are reasonable whenfood violations exist?
10. What would motivate you to stay in compliance and be proactive aboutfood safety?
11. Do you feel like you can call the health department with any problems,questions or concerns?
12. How do you view the inspection process (negative/positive)?
13. How can we build a better relationship/create a positive partnership so thatthe public continues to enjoy dining out safely?
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and just. For example, participantswelcomed the opportunity to discussviolations with EHS and explain theirknowledge of health codes. Throughsuch a cooperative process, theyhoped to avoid fines and disciplinaryactions for infrequent, accidental vio-lations. Furthermore, participants ex-pressed a desire that EHS beunderstanding and constructive inthe inspection process. They statedthat fines are hard on strugglingrestaurants and are not necessarilyconstructive. Finally, participantsstated a need for more warnings,teaching and coaching for establish-ments with violations.
• Factors motivating food safety. Partici-pants reported being motivated bythe desire to serve safe food. Thethreat of citation or closure due to vi-olations was only a secondary moti-vator. Restaurateurs expressed thatthey strive to deliver the best servicepossible, and that food safety, as op-posed to avoiding citations, is themost important reason to complywith food codes.
• Inspection process. Participants indi-cated that email is the most effectivemethod of communication, provid-ing them with up-to-date informationregarding changes in food code regu-lations, changes in the inspectionprocess, classes and training offeredby the health department and soforth. They reported that email also isuseful for allowing them to commu-nicate openly with EHS outside ofthe inspection process. They alsoshowed strong interest in increasedfrequency of inspections as well asannounced or courtesy inspections,which they claimed would help theirstaffs feel more at ease with EHS.Participants indicated the need for training videos that utilize blatantly unpleasant visuals, stating that such images are difficult to forget and serve as constant reminders regarding the importance of food safety.
• Fostering partnerships between EHS andfoodservice workers. Constant commu-nication with EHS through emails,courtesy inspections or drop-ins wereamong methods suggested for creat-ing positive partnerships between
restaurants and EHS. Participants feltEHS need to be more available by at-tending weekly or monthly staffmeetings at restaurants and settingup training workshops at restaurants.In addition, public education fromJohnson County EHS was recom-mended to address misconceptionsabout the restaurant industry. For ex-ample, participants felt that the pub-lic held misconceptions regardingfood code regulations, violations andcauses of FBI. These misconceptionstend to be negative, according to par-ticipants, and cause the public to be-come wary of their restaurants.Participants felt that violation post-ings on the state health department’sWeb site lead to false negative as-sumptions about their restaurants.Many felt this Web site should onlylist repeat violators.
Discussion and ImplicationsResults of this study indicate a great
need for emphasis on training and edu-cation of restaurateurs and foodservicepersonnel, better communication anddissemination of up-to-date informationbetween restaurateurs and EHS and theimplementation of revised county-levelinspection policies. The contradictoryopinions expressed about EHS—thatthey were professional, communicativeand knowledgeable, as well as unprofes-sional and inconsistent—could indicaterespect for the EHS in general, but diffi-cult specific encounters with inspectors,or perhaps a belief that EHS have know-ledge regarding food safety that they arenot sharing with the food industry.
Currently, before being employed,foodservice workers in Johnson Countyare not required to undergo food safetytraining. The lack of food safety knowl-edge, coupled with factors such as lan-guage barriers, improper food handling
practices and high turnover rates, onlyadds to the challenge of getting foodworkers to implement behavioralchanges. JCED—and other county-levelfood inspection agencies across the na-tion—need to respond to the realities ofthe foodservice workforce by developingmore appropriate education and trainingprograms for foodservice workers.
It is also important that local agenciesfocus on building relationships that fos-ter trust and understanding through ef-fective communication and constanteducation. As of 2008, Johnson CountyEHS offer food safety training classes tofoodservice workers once every quarter.To be effective, the county will need toincrease the number of classes offeredand provide varying times for thoseclasses, which will allow the flexibilityand accessibility needed to accommo-date the needs of different restaurateurs.Furthermore, these classes should beopened to the public so that consumerscan be educated along with foodserviceworkers. Consumers, too, need to under-stand the importance of food safety, theeffectiveness of handwashing in reducingthe spread of disease, how to identifyfood code violations and when to callthe health department for intervention.
Because the sample size for this studywas relatively small, it may not be repre-sentative of Johnson County as a whole.In addition, the majority of the focusgroup participants held high-level man-agement positions within their prospec-tive restaurants. Therefore, responses toquestions such as barriers faced withinrestaurants may have been guarded. Inaddition, this project did not includenon-English speaking restaurateurs.While the researchers acknowledge theselimitations, the results can still be usefulin guiding future studies about the vitalrole of partnerships within the food industry.
“Restaurateurs expressed that they strive to deliver
the best service possible, and that food safety, as
opposed to avoiding citations, is the most impor-
tant reason to comply with food codes.”
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24 F O O D S A F E T Y M A G A Z I N E
The restaurant inspection processshould be advantageous for both theEHS and restaurateur, who both sharethe goal of serving safe food to con-sumers. The results of this study indicatethat improvements can be made to in-crease positive interactions betweenrestaurateurs and EHS as they evaluatefood safety practices. This study mayprove useful for other communities whowish to evaluate local-level food safetyrelationships. n
AcknowledgmentsThe authors would like to acknowl-
edge the following: Kansas Public
Health Leadership Institute staff; theKansas Department of Health and Envi-ronment/Kansas Department of Agricul-ture; and the restaurateurs andfoodservice workers of Johnson Countywho took time out of their busy sched-ule to participate in the focus groups.
References1. www.restaurant.org/pdfs/research/2009Factbook.pdf.2. www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/FoodProtectionPlan2007/ucm132565.htm.3. Radke, V. 2006. The need for partnerships forfood safety. J Environ Health 69:34-35.
4. Allwood, P.B., P. Borden-Glass and L.Petrona. 1999. The vital role of restaurant healthinspections. J Environ Health 61:25-28.5. Cotterchio, M., J. Gunn, T. Coffill, P. Tormeyand M. Barry. 1998. Effect of a manager trainingprogram on sanitary conditions in restaurants.Pub Health Rep 113:353-358.6. Mathias, R., R. Sizto, A. Hazlewood and W.Cocksedge. 1995. The effects of inspection fre-quency and food handler education on restaurantinspection violations. Can J Public Health 86:46-50.7. Bader, M., E. Blonder, J. Henriksen and W.Strong. 1978. A study of foodservice establish-ment sanitation inspection frequency. Am J
Public Health 68:408-410.8. Raval-Nelson, P. and P. Smith. 1999. Foodsafety certification and its impacts. J Environ
Health 61:9-12.9. Jenkins-McLean, T., C. Skilton and C. Sellers.2004. Engaging foodservice workers in behav-ioral-change partnerships. J Environ Health
66:15-19.10. Reske, K., T. Jenkins, C. Fernandez, D. VanAmber and C. Hedberg. 2007. Beneficial ef-fects of implementing an announced restaurantinspection program. J Environ Health 69:27-34.
Aqualia L. Nelson, MS, REHS/RS, is at the Munson Army Health Center. She may be
reached at [email protected].
Aiko Allen, MS, is an independent public health consultant in Wichita, KS.
Suzanne R. Hawley, Ph.D., MPH, is an Assistant Professor in the Department of Pre-
ventive Medicine and Public Health at the University of Kansas School of Medicine-Wi-
chita. She may be reached at [email protected].
Theresa St. Romain, MA, is a Senior Coordinator in the Department of Preventive Med-
icine and Public Health at the University of Kansas School of Medicine-Wichita.
Shirley A. Orr, MHS, ARNP, NEA-BC, is Director of Local Health within the
Bureau of Local and Rural Health at the Kansas Department of Health and
Environment.
5th International Conference for Food Safety and Quality
November 2-3, 2010Redondo Beach, CA
For more information visit:www.foodhaccp.com
FoodHACCP.com
1 1
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Special Supplement presented by Food Safety Magazine n October/September 2010 n www.foodsafetymagazine.com
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Food processors face an ever-evolving set of challenges in their en-deavors to ensure the safety and quality of their products. Until re-cently, efforts to control and eliminate pathogenic bacteria from food
have primarily focused on well-known organisms such as Salmonella,
Listeria and Escherichia coli O157:H7. However, there is growing interest inthe potential public health risk associated with a broader group of E. coli
commonly referred to as “the top six non-O157 STEC” or “Top STEC.”
What Are STEC/VTEC/EHEC? One aspect that often causes confusion is the variety of terms
and acronyms used to refer to this group of organisms. Three ofthe most commonly used terms are Shiga toxigenic E. coli (STEC),Vero toxigenic E. coli (VTEC) and Enterohemorrhagic E. coli
(EHEC).STEC/VTEC refers to those strains of E. coli that produce at
least one member of a class of potent cytotoxins called Shiga toxin.Because the terms Shiga toxin and Vero toxin both refer to the samegroup of toxins, STEC and VTEC can be used interchangeably.EHEC is a subset of the STEC group that has been implicated in
the clinical illness hemorrhagic colitis (HC) or the potentially fatal hemolyticuremic syndrome (HUS).1
E. coli are also categorized based on their serotype, defined by the Oantigen determined by the polysaccharide portion of cell wall lipopolysac-charide (LPS) and the H antigen due to flagella protein. The most prevalentand widely recognized EHEC serotype is E. coli O157:H7.
Which Organisms Are Significant?While the literature suggests that there are 100 to 250 different
serotypes of STEC, not all serotypes are necessarily pathogenic. Most sur-veillance studies of clinical isolates report that the following six STEC Oserogroups, in addition to O157, represent the greatest public health risk:O26, O111, O102, O121, O145 and O45.2,3 Karmali et al. present a classifi-cation system based on the specific serotype’s prevalence and associationwith either HC or HUS (Table 1).
Most experts agree that the pathogenicity of a specific strain of E. coli isdetermined by the presence of two specific genetic targets, the eae gene,responsible for the formation of an attachment and effacing lesion on thehost’s intestinal epithelial cells, and one of the two stx genes (stx1 and stx2),responsible for production of the cytotoxin.
Impact on IndustryAt the International Association of Food Protection annual meeting in Au-
gust, the USDA Food Safety and Inspection Service provided an overview of
26 F O O D S A F E T Y M A G A Z I N E
their current method under developmentfor detection of the top six non-O157 STECserogroups from beef trim and groundbeef. In summary, the method involves anovernight enrichment followed by analysisvia multiplex polymerase chain reaction(PCR) for the presence of both eae and thestx genes. Positive enrichments are subse-quently screened via a series of reactionsfor the presence of one of the top six O-serogroups (O26, 0111, 0102, 0121,0145 and O45). Enrichments found to bepositive for eae, stx and one of the top sixO-serogroups will proceed to confirmationvia immunomagnetic separation (IMS) andselective agar plating. Typical colonies willbe struck for isolation and purification andsubsequently tested via agglutination pro-cedures to establish their O-serotype.USDA and beef industry representativesagreed that faster, more streamlined meth-ods would be required for industry to im-plement an effective system for detectionof these organisms.
Assurance GDS® for Top STECAs a leader in pathogen detection,
BioControl Systems has developed a newmethod to satisfy industry’s need for aneasy, fast and accurate method for the de-tection of the top six non-O157 STEC.Using the proven Assurance GDS platformand enrichment media common to boththe E. coli O157:H7 and Shiga toxin geneassays, the method consists of a simpleand innovative IMS-based sample prepa-ration procedure that helps narrow the fieldto the six target O-serogroups prior to mo-lecular analysis with the Assurance GDS ®
Rotor-Gene™. The instrument’s unique ro-tary design and the probe-based detectionsystem combine to provide results in lessthan 12 hours including enrichment. Withassays for E. coli O157:H7, Shiga toxingenes, Top STEC, Salmonella, Listeria
spp., Listeria monocytogenes andCronobacter (Enterobacter sakazakii), thispathogen detection system is ideallysuited to help food processors to meettheir food safety objectives. For more infor-mation about the Assurance GDS ® Sys-tem, please contact BioControl Systems atwww.biocontrolsys.com.
References1. www.cfsan.fda.gov/~ebam/bam-toc.html.2. Gyles, C. L. 2007. J Anim Sci 85:E45-E62.3. Eblen, D. R. 2007. Food Safety and InspectionService.4. Karmali, M. A., et al. 2003. J Clin Microbiol41:4930-4940.
FOOD SAFETY INSIDER: Solutions in Rapid Microbiology
Pathogenic Non-O157 Escherichia coli
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Type Serotype Incidence Frequency Causes Severe Disease
A O157:H7, O157:NM high common yesB O26:H11, O111:NM, moderate uncommon yes
O103:H2, O121:H19,O145:NM
C O91:H21, O104:H21 low rare yesD multiple low rare noE multiple non-human NA* NA
*NA, not applicableTable 1: Seropathotype Classification of STEC4
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Learn how Assurance GDS can turn your testing challenges into solutions.Visit www.biocontrolsys.comor contact us at 1.800.245.0113 for more information.
Now available for Listeria spp., Listeria monocytogenes, Salmonella, E. coli O157:H7, and Shiga Toxin genes.
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FOOD SAFETY INSIDER: Solutions in Rapid Microbiology
28 F O O D S A F E T Y M A G A Z I N E
Eggs are a staple in most Americans’ diets. On average, Americansconsume 220 million eggs daily. This summer, the U.S. experiencedone of the largest recalls involving eggs potentially contaminated
with Salmonella Enteritidis (SE), implicating over 500 million eggs andlinked to more than 2,000 reported illnesses. SE is the second mostcommonly human-isolated Salmonella serotype according to theCenters for Disease Control and Prevention, responsible for over200,000 illnesses a year in the U.S. About 64% of those illnesses areattributed to eggs or egg-containing products.
Also this summer, the U.S. Food and Drug Administration (FDA)enacted a new Final Rule entitled “Prevention of Salmonella Enteritidisin Shell Eggs During Production, Storage and Transportation” (74 FR33030). The Rule mandates testing of the layer house environment forSE. If SE is detected, eggs are then screened to ensure no contami-nated eggs reach consumers. Despite the recent regulation governing
testing and control of SE in eggs, it remains a threat to consumer productsafety. Testing for SE will need to be made easy-to-do and cost-effective,with rapid test kits readily available to the market, which today is simultane-ously facing a new regulation and a costly recall.
How Does Salmonella Enteritidis Contaminate the Egg?SE egg contamination begins in the layer house environment. It is intro-
duced into the house by means of infected pullets or by vectors such asflies and rodents. Once inside the house, the hens ingest SE through con-taminated insects or feed. The pathogen begins to multiply in the organs ofthe hen, such as the ovaries. SE is then available to potentially contaminatedeveloping eggs before they are laid.
FDA Rule Focuses on SE in the Layer HouseIf contamination of the house is found through routine environmental
monitoring, it can be eliminated or reduced, thus halting or reducing SE ex-posure to the hen and ultimately to the egg. The new FDA Final Rule fo-cuses on monitoring the layer house for SE and keeping the house SE-free.
The Challenge: FDA BAM Method for Detecting SE inEnvironmental and Egg Samples
Part of the Final Rule includes a proposed method to test environmentaland egg samples for SE. This method requires multiple transfer steps, dif-ferent media and agar to prepare and store, two different incubators,trained microbiologists and at least 3–7 days for a negative result. Egg pro-ducers should not be asked to compromise on SE testing. Rather, theyshould look for alternative methods where they can get the accuracy, ease-of-use, training efficiencies, faster time-to-result and reduced overall test-ing costs they need to provide safe eggs and a sound business.
The Solution: RapidChek® SELECT™ Salmonella EnteritidisThe RapidChek SELECT SE test system is a breakthrough in Salmonella
testing for the industry, offering one of the first sero-specific rapid assays.This technology was developed with direct input from egg producers whoexperienced difficulty complying with the testing demands of the new FDAFinal Rule. The system generates exceptionally accurate results in the mostchallenging samples in a highly cost-effective and timely manner.
This system delivers results for envi-ronmental samples 1 day faster than theFDA BAM method and with increasedsensitivity and accuracy. The system alsodelivers results for egg samples 5 daysfaster than the FDA BAM method. Thesebenefits of time and accuracy allow eggproducers to identify SE in the environ-ment before it contaminates eggs, thusensuring safer eggs and reducing thechances of a costly egg recall. This abilityto screen for SE quickly and accurately isespecially relevant today given the recentegg recalls.
Easy, Cost-effective SE TestingThe RapidChek SELECT SE ensures
easy and cost-effective compliance withthe new FDA Final Rule. Labs that ran thissystem side-by-side with competitivemethods have realized a measurable re-duction in hands-on time, time-to-resultand overall testing costs. Moreover, thereare no up-front expenses for automatedequipment, annual maintenance fees orcontracts to sign.
Reasons to Choose RapidChekSELECT Salmonella Enteritidis 1. Accurate Results. Very low levels offalse positives and negatives provide mini-mal disruption to daily operations.2. Lowest Total Cost-in-Use. Hiddencosts of traditional or culture methods in-clude: time-to-result, analyst hands-ontime and lab equipment and space requirements.3. Simple. Continual training of staff oncomplex traditional and culture methods isexhausting, and it drains a company’s re-sources. The system’s simplicity will re-duce the number of potential errors. 4. Fast Time to Result. Users mustchoose a method that will give results in atimely fashion. The system reduces thetime-to-result by days.5. Provides Valuable Information. Thesystem provides an early indicator of po-tential environmental SE contaminationbefore the contamination becomes trans-ferred to the egg.
ConclusionUsing an accurate, easy-to-use
method to test environmental and, if re-quired, egg pool samples, will make tran-sition to and maintenance of complyingwith the FDA Final Rule easy. It will alsohelp egg producers advance the safety ofeggs while minimizing expenses but notdisrupting everyday operations.
Detecting Salmonella Enteritidis in Shell Eggs
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It’s not important which came first.
F O O D S A F E T Y www.sdix.com
IT’S WHAT COMES NEXT.
RapidChek and RapidChek SELECT are registered trademarks of SDIX.All rights reserved. ©2010 Strategic Diagnostics Inc. d/b/a SDIX. Printed in USA.
Introducing RapidChek® SELECT™ Salmonella Enteritidis Test System• Validated for environmental drag swab and pooled egg samples
• Highly accurate and specific to reduce the chance of product recalls
• Easier to implement and use than other tests on the market
• Low start-up and operating costs
• Time-to-result days faster than other methods
Learn how SDIX’s advanced technology makes it easy to comply with the new regulations.Visit www.sdix.com/SE or call 1-800-544-8881.
So whether it’s the chicken or the egg, we’ve got you covered.RapidChek. Simply Accurate.
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30 F O O D S A F E T Y M A G A Z I N E
Fast, accurate results are critical for delivering safer food productsfor consumers and more profitable growth for food companies.That’s why at DuPont Qualicon, our food safety science is focused
on continually developing state-of-the-art technologies that are fasterand more accurate. In fact, for more than a decade, we have been revolutionizing food safety.
DuPont Qualiconwas the first companyto apply polymerasechain reacion (PCR)technology to food test-ing with rapid, DNA-based assays forSalmonella, E. coli
O157:H7 and Listeria
monocytogenes. Ouruse of automated PCRprocessing with tablet-ed rather than liquidreagents created a dra-matic increase in speedand consistency—help-ing to usher in a newera of easy-to-use test-ing methodology.
Meeting a Global NeedFor years, leading food companies and government testing labs
around the world have relied on the genetics-based BAX® System toquickly and accurately detect pathogens such as Salmonella, E. coli
O157:H7, Listeria spp., L. monocytogenes, Enterobacter sakazakii,
Campylobacter, Staphylococcus aureus and more. In fact, governmenttesting agencies in the United States, Canada, Brazil, Japan and otherparts of the world have adopted or validated the BAX® System as an approved testing method to protect their food supply and their citizens.
The BAX® System has been certified by independent authorities suchas AOAC and the French Association of Normalization (AFNOR). It’s beenadopted by the U.S. Department of Agriculture (USDA) Food Safety andInspection Service and approved by government labs in Brazil, China,Canada, Japan and Russia. What’s more, the BAX® System has been included in the newly launched Emergency Response Validation (ERV) program of the AOAC Research Institute, a program designed to respondimmediately to emerging food contamination crises.
Delivering Innovations Year after YearWhile we’re proud to have been a part of food safety history, we’re
always looking ahead to provide the next breakthrough in food safety
science—with technological advancesand new assays that make food testing faster, more accurate and moreconvenient.
Our latest innovation is the BAX®
System Real-Time PCR Assay for E. coli
O157:H7. Developed in collaboration withthe USDA Agricultural Research Service(ARS), this assay delivers accurate,same-day results with no up-front concentration steps required. Certified byboth AOAC Research Institute andAFNOR, the assay has been validated asan effective method for detecting a singlecell of the pathogen in real-world samplesizes.
Our recent incorporation of highlysensitive and adaptable Scorpions®
technology enables us to develop rapidmultiplex assays for detecting micro-organisms that are often difficult to find.With cutting-edge technology like this,we are developing increasingly faster,more sensitive tests for pathogens andspoilage organisms. In fact, we recentlyentered into a collaborative agreementwith the USDA ARS to develop a newtest for non-O157 serotypes of Shiga
toxin-producing E. coli (STEC) that will bebased on the BAX® System.
From sophisticated analytical plat-forms to soluble packets of enrichmentmedia, DuPont Qualicon is a companyyou can trust to deliver the technology innovations you need to reduce risk,react to issues quickly and ultimately deliver the safest food possible to consumers.
Leading the Way in Food Safety Science
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Copyright © 2010 DuPont. The DuPont Oval Logo and The miracles of science™ are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. All rights reserved.
She doesn’t know how technology can make her food safer. But you do.At DuPont Qualicon, we believe that science— particularly biotechnology—offers the potential to help ensure the safety and quality of our global food supply. Our innovative science can help you perform fast, accurate food quality testing to address a broad range of challenges—so you can get products to market faster and help ensure the safety of the foods people enjoy every day.
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FOOD SAFETY INSIDER: Solutions in Rapid Microbiology
32 F O O D S A F E T Y M A G A Z I N E
Foodborne bacterial contamination is estimated to cause about 76million illnesses per year in the United States alone. In a reportfrom the United States Department of Agriculture Economic Re-
search Service, foodborne illnesses account for about 1 of every 100hospitalizations and 1 of every 500 deaths in the US. The most commonbacterial pathogens attributed to outbreaks are Salmonella, Listeria
monocytogenes, Escherichia coli O157:H7 and Campylobacter. Accord-ing to a Centers for Disease Control and Preven-
tion report tracking foodborneillnesses in 2007, of all the out-breaks attributed to a singlefood, 17% were from poultry,16% from beef and 14% fromleafy vegetables. Other foodcommodities have beenplagued by massive recalls dueto contamination includingpeanut butter, tomatoes,spices and, more recently,
eggs. The iQ-CheckTM real-time polymerase chain reaction (PCR) system
from Bio-Rad Laboratories was designed specifically with the needs ofusers in mind with kits available for Salmonella, L. monocytogenes, Liste-
ria spp., E. coli O157:H7 and Campylobacter. The use of highly specificprobes and primers results in excellent sensitivity and specificity, vali-dated by AOAC. With a high-throughput extraction, all pathogens can betested at the same time, making life for the laboratory a little bit easier.Two instrument platforms are available for all sized labs. The 96-well, 5color CFX96TM system is designed for high-throughout analysis while the48-well, 2 color MiniOpticonTM is perfect for smaller labs.
In Need of a Better MethodChestnut Labs (Springfield, MO) provides clients with food safety test-
ing, auditing, training, consultation and research including test kit valida-tions and shelf-life studies. In operation for more than 20 years, the lab isrecognized for its superior customer service and ability to be a value-added business partner for its clients. Chestnut Labs operates under theISO 17025 principles and is committed to providing clients with a com-mitment to quality and constant improvement.
Michael Clark, laboratory director at Chestnut Labs, mentions thatcost and turnaround time are very important to their customers. Thecompany needed a fast and dependable real-time PCR platform wheremultiple pathogens could be tested simultaneously. The laboratoryneeded a protocol that was user friendly and capable of high-throughputanalysis to eliminate the usual bottleneck areas common of real-timePCR tests. The iQ-Check method met those needs. With the combinationof the high-throughput extraction protocol, the CFX96 real-time PCR de-tection system and the CFX Manager Software, Chestnut Labs was able
to provide their customers with reliable,next-day results without passing on anadditional cost.
When asked what the advantages ofthis product were for their use, Clarkadded, “The use of a deep-well microplate allows for the high-throughputprocessing of 96 samples at a time. Thedeep-well protocol has eliminated themultiple heating, shaking and lysis stepsassociated with most commercial PCRkits by consolidating the steps into one.Using the deep-well plate protocol allowsmultichannel pipetting for most steps ofPCR preparation, saving time and reduc-ing cross-contamination. The software issimple to use and interpret, and the op-tion to email results with an attacheddata file helps reduce time. Faster PCRtimes increase productivity. The use ofnon-proprietary enrichment broths helpsus reduce the overall cost per sample.”Some additional benefits of the systeminclude no special sample preparation orpost enrichment re-grow step, the inclu-sion of an internal control to validate thePCR runs as well as a small footprint thatdoes not take up much bench space.
Standard methods, such as the U.S.Food and Drug Administration’s Bacteri-ological Analytical Manual (BAM) testingmethod, which involves a pre-enrichmentstep followed by a second selective en-richment step and plating (which can in-clude secondary plating), takes 72–96hours (3–4 days), which depends on thefood sample being analyzed and must befollowed by biochemical/serological con-firmation, increasing the time to results toup to 5 days minimum. The iQ-CheckListeria spp. and L. monocytogenes kitsonly require a 24 hour enrichment. TheSalmonella test requires a 20 hour enrich-ment, and the E. coli O157:H7 test canbe processed after an 8 hour enrichment.
Chestnut Labs tests for all significantfood pathogens and indicator organismsto provide the highest service for theirclients. For them, Bio-Rad’s iQ-Checkkits have increased productivity throughfaster and simpler sample preparation,faster PCR run times and the capabilityof running multiple pathogens at thesame time. Their customers also benefitby receiving results faster, which reducestheir product hold time.
High-throughput PCR Provides Real-time Solutions
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Bio-Rad Laboratories • Food Science
Faster, Easier, BetterBio-Rad introduces the new iQ-Check™ high throughput protocols,decreasing your time to results even further
• One step extraction in 96-well plate format,one transfer with a multichannel pipette
• Extract and run all pathogens on the sameplate at the same time
• Validated tests for Salmonella, Listeria spp.,Listeria monocytogenes and E. coli O157:H7
• One-stop shop for instruments, kits, media,consumables, and support
For more information, contact us at [email protected]
The Bio-Rad PCR Solution, Your Solution
Bio-Rad’s real-time thermal cyclers are licensed real-time thermal cyclers under Applera’s United States Patent No. 6,814,934 B1 for use in research and for all other �elds except the � elds of human diagnosticsand veterinary diagnostics. Practice of the patented 5’ Nuclease Process requires a license from Applied Biosystems. The purchase of these products includes an immunity from suit under patents speci�edin the product insert to use only the amount purchased for the purchaser’s own internal research when used with the separate purchase of Licensed Probe. No other patent rights are conveyed expressly,by implication, or by estoppel. Further information on purchasing licenses may be obtained from the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA.
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FOOD SAFETY INSIDER: Solutions in Rapid Microbiology
34 F O O D S A F E T Y M A G A Z I N E
Top-performing food microbiology laboratories realize the importanceof effective proficiency testing (PT) programs. Safety, reputation andaccreditation depend on it. Food microbiology laboratories turn to
PT providers to assess their competency and identify areas in need of im-provement. Successful performance in an external PT program is a key in-
dicator of high laboratory quality. Microbialstrains with confirmed identity, viability andpurity, backed by meticulous laboratory pro-cedures that minimize subculturing, are im-portant components of proficiency testingprograms. And, they are important to ATCC.
Since 1925, ATCC has set the standardfor authenticating and distributing biologicalmaterials for research and testing in the lifesciences. ATCC’s mission is to acquire, au-thenticate, preserve and distribute biologicalmaterials, information, intellectual propertyand standards for the advancement, valida-tion and application of scientific knowledge.
ATCC Proficiency Standard® Program ATCC established the Proficiency Standard program to improve the lab-
oratory PT system by raising the quality and consistency of the micro-organisms and biological materials used in PT samples. In addition, theprogram improves laboratory safety by working with PT providers andmanufacturers to qualify microorganisms for identity and biosafety level be-fore being included in a PT panel. The program also provides traceability ofthe PT sample materials. Microorganisms are tested for confirmation ofidentity using a polyphasic approach that incorporates traditional biochem-ical tests, phenotypic testing and genotypic tests. Fully authenticated PTmaterials bring consistency and reliability to PT and allow results to becompared within a group of laboratories.
In the past, microorganisms used in proficiency panels have been re-ported to have been subjected to excessive subculturing, have had un-known pedigrees, have been misidentified, contaminated and may havebeen stored under variable conditions. These factors can degrade the qual-ity of the PT programs and expose laboratory personnel to undue hazards.
“As a nonprofit company devoted to science and the public health, wetake very seriously our responsibility to ensure the quality of the materialsprovided by ATCC,” Raymond H. Cypess, DVM, Ph.D., ATCC Presidentand CEO explained. “Microbiologists deserve to know with certainty thatany materials they obtain for proficiency testing have been identified to thegenus and species level using polyphasic testing that is performed in anISO/IEC 17025:2005 accredited laboratory.”
ATCC is ISO/IEC 17025:2005 accredited. ISO/IEC 17025:2005 is an in-ternational standard that specifies the general requirements for the compe-tence of testing and calibration laboratories. The scope of the ATCCISO/IEC 17025:2005 accreditation, which extends across a wide range ofthe organization’s quality control testing, includes tests for biochemicalidentification, viability, titer, phenotypic identification and genotypic
identification including sequencing and riboprinting.
Whether in PT, quality control testing orprocess validation, the source of the mi-crobial strains used should be considereda vital factor in generating valid, accurateresults. If you think the inclusion of anystrains will do, you may want to thinkagain. To identify microbial strains that arehandled, stored and tested with the unpar-alleled expertise that comes from over 80years of experience, look for the ATCCsymbol of quality—the ATCC ProficiencyStandard® program. A select group ofcommercial manufacturers and providersare licensed to provide microbial strainstraceable to ATCC in their PT programs.
Program Users• PT service providers select specific
strains for use in their PT panels• Manufacturers use strains from the
ATCC Proficiency Standard Program toproduce PT panels
• Laboratories use proficiency panels intheir required and elective testing. Lab-oratories where PT is performed, in-clude food, clinical and quality controllaboratoriesThe following organizations are cur-
rently participants in the ATCC ProficiencyStandard program: • Accutest Laboratories, Inc.• American Academy of Family Physi-
cians (AAFP)• American College of Physicians Serv-
ices, Inc. (ACP)• American Proficiency Institute (API)• Centre Suisse de Controle de Qualite• Cleveland Clinic• College of American Pathologists
(CAP)• Kendle International, Inc.• MicroBioLogics, Inc.• R&D Systems, Inc.• Remel, Inc.• Wisconsin State Laboratory of Hygiene
(WSLH)
Symbol of QualityThe ATCC Proficiency Standard pro-
gram benefits both the public and privateindustry by helping to make PT as valid,accurate and safe as it can be. Don’t takechances on the quality of the strains pro-vided in your PT program. Be sure your PTprovider is using microbial strains trace-able to the ATCC Proficiency Standardprogram in their proficiency panels.
Setting the Standard forTraceability in ProficiencyTesting Programs
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FOOD SAFETY INSIDER: Solutions in Rapid Microbiology
36 F O O D S A F E T Y M A G A Z I N E
An increasing appreciation for the importance of food and microbio-logical safety has resulted in a demand for a rapid, high-through-put method for total viable count (TVC) quantification to deal with
the increasing numbers of samples that require testing. The industry standard for TVC determination
(ISO:4833:2033), also known as aerobic platecount (APC), is widely used but presents userswith some very significant drawbacks. Themethod is both material and labor intensive, re-quiring the preparation and analysis of multipleagar plates per sample. More importantly, themethod is slow, with 48–72 hours typically re-quired for a definitive result.
MOCON, in association with LuxcelBiosciences, has addressed these limitations withthe development of the GreenLight™ 900 Series,a breakthrough, low-cost system with reduced
labor and material, providing microbiological analysis in just hours. Rapid determination of TVC/APC levels has an immediate impact on
your business in the following ways:• Measures microbiology quality immediately after delivery• Fast decision-making toward suppliers• Standardizes internal microbiology quality control for goods received• Immediate grading of incoming products• Rapid hygiene indicator of products • Contributes to competitive advantage• Constant monitoring of production process (hygiene)This process results in safer foods for consumers.
How Does It Work? (The Really Simple Explanation)This sensor technology is based on oxygen sensing. As microbes grow,
they consume O2. The system measures bacterial O2 consumption andequates that to viable microbial load (live bacteria). Accuracy
A strong correlation is observed between the GreenLight and theISO:4833:2003 methods for the assessment of bacterial contamination, forexample, in ground beef samples; Pearsons correlation coefficient = 0.961.Available in Two Models • Model 960 (AOAC approved), a 96 micotiter plate-based assay that pro-
vides rapid high throughput.• Model 910 (AOAC approval pending), a vial-based system providing low
to medium throughput.Simple to Operate
The system does not require laboratory trained technicians to operate it.Model 960 is a simple ‘mix and measure’ assay 96-well plate system.
Using food homogenates, prepared as for traditional TVC/APC testing (withno further dilutions necessary) (ISO:4833:2033), probe, sample and oil areadded in sequence and resultant aerobic TVC/APC values quantified using
an appropriate calibration. The plate ismeasured kinetically on a fluorescenceplate reader.
Model 910 uses the same preparation(no further dilution is necessary) with thesamples being placed in a vial that alreadycontains the sensor. Readings are takenby placing the vial into the sample recep-tor slot of the instrument, and results arerecorded by the software. Each vial is sup-plied with a unique bar code that is auto-matically read during sensing, ensuringthat results are recorded against the cor-rect sample.Variety of Testing Protocols
Operators have the option of a varietyof testing protocols: • Simple two-point pass/fail• Multipoint mode – gives pass/fail and
semi-quantitative TVC/APC (CFU/g)level
• Continuous mode – gives pass/fail andabsolute TVC/APC (CFU/g) level
Wide Contamination RangeThis system can measure aerobic bac-
terial respiration across a wide contamina-tion range 100–108 CFU/g. Same-day Results (including samplepreparation time and incubation)
In comparison to the conventional ap-proach, the GreenLight 900 series pro-vides a much improved ‘time-to-result’with less than or equal to 103 CFU/g de-tectable in approximately 12 hours com-pared to the 49 hours required by thestandard method (≥108 CFU/g are de-tectable within 1 hour).Saves Money
The system reduces preparation timewith no further dilutions necessary, whichalso reduces media cost. It is less labor in-tensive, and there is no need to be an en-gineer or scientist to conduct tests. Itreduces incubator space: three plates(288 tests) can be stacked in the samearea occupied by six agar plates.Standardizes Procedures
Results are recorded automaticallywithin the software, removing the need fordifficult and tedious counting and subjec-tive observation of colony numbers.
Learn MoreTo obtain a copy of the GreenLight
White Paper or for more information onthe specific models, contact MOCON [email protected] or phone us at 763-493-6370 or www.mocon.com/foodsafety.php.
Breakthrough Same-dayBacterial Analysis for FoodProducts
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38 F O O D S A F E T Y M A G A Z I N E
By Jennifer C. McEntire, Ph.D.
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O C T O B E R n N O V E M B E R 2 0 1 0 39
It is easy to justify procrastination when you are in Washington, D.C., sinceyou know that Congress won’t pass legislation until after your article isnearly complete. By all accounts, food safety legislation should have passed
by now, and yet other major societal issues keep taking a front seat.Since the Institute of Food Technologists (IFT) published our reports on prod-
uct tracing in November 2009, the most commonly asked question has been,“What’s next? What will the U.S. Food and Drug Administration (FDA) do?” Atfirst, it was easy to refocus the question on the FDA (and the U.S. Department ofAgriculture) since a public meeting was scheduled for December 2009 and acomment period was open until March 2010. The FDA was collecting input be-fore deciding what to do. More recently, the question is refocused to Congress:until Congress decides what to do, the FDA may not act. However, as time haspassed and S510 and HR 2749 have been dissected, there seems to be a generalsense of where food safety legislation—at least in terms of product tracing re-quirements—might wind up.
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40 F O O D S A F E T Y M A G A Z I N E
Product tracing is the ability to trace po-tentially contaminated product, the con-sumption of which may cause an adversehealth impact, through the supply chain.There is some debate whether product trac-ing is related to food safety. It is. When a po-tentially contaminated product is in thesupply chain, and perhaps in the market-place, there is the potential for consumers tobecome ill—a food safety issue. Rapid, accu-rate product tracing allows that product tobe removed from distribution, protectingpublic health. Some in the food safety com-munity argue that product tracing is strictlyreactive, since it isn’t activated until after acontamination event has occurred. That’snot necessarily true. The ability to trace backand identify points of convergence can helpidentify the root cause of an issue and, hope-fully, put controls in place to stop that typeof issue from occurring again. A good traceback can help prevent a future event.
Outbreaks Drive Recognition of IssuesToo many outbreaks, each with individual nuances, have exemplified the inability
to trace products throughout a supply chain. Many firms report that they are able to traceproducts. When pressed for details, it might be revealed that they may have very goodinternal controls or may keep great records at receiving and shipping. This doesn’tmean that their supply chain partners have these systems in place. The supply chain isonly as strong as its weakest link. Hopefully, product tracing systems and practices will continue to improve so that
the Peanut Corporation of America incident will remain the prime example of prod-uct tracing gone wrong. If all firms in the longest supply chain used the maximum 24hours to identify one step forward and one step back (as required by the BioterrorismAct of 2002), all affected product should have been identified within days, perhapsweeks. Instead, for months after the problemwas identified, product recalls continued tobe announced, culminating in over 360firms issuing recalls of nearly 4,000 products. In contrast, the infamous tomato/pepper
outbreak might be viewed as product tracinggone theoretically right (with the epidemio-logical investigation going wrong). Althoughthe recordkeeping practices of the produceindustry were blamed for the inability toidentify the point of convergence of con-taminated tomatoes, and certainly, paperrecords slow things down, the fact that com-mon points along the supply chains werenot found could have suggested that toma-toes were not the culprit.
COOL Is Not Product TracingStill, these high-profile cases gave American consumers a glimpse into the complex-
ity of the food supply chain and left them wondering where their food actually comesfrom. When IFT conducted a study of product tracing in food systems, done undercontract with the FDA in 2008–2009, we spoke to 58 food companies along several
points in the supply chain for the pro-duce, ingredient and processed food in-dustries. Country of origin labeling(COOL), while intended as a marketingtool, was cited by many firms as provid-ing consumers with information aboutproduct origins. The loopholes associ-ated with COOL won’t be discussedhere, except to say that COOL does notprovide product tracing. As mentionedpreviously, product tracing is a require-ment of the system, with visibilityneeded at each point in the supply
chain. Simply knowing the country oforigin is insufficient, and for some prod-ucts, the complexity of the supply chainis such that the list of supplying coun-tries is long. As illustrated in Figures 1
Figure 1: Globalizing the Cheeseburger
Figure 2: Global Ingredients of the
Cheeseburger
Used with permission, courtesy of Shaun Kennedy and the National Center for Food Protection and Defense.
Used with permission, courtesy of Shaun Kennedy and the National Center for Food Protection and Defense.
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Food Defense.Don’t Gamble with It!
Identifying RiskDo you know the speci�c risks for your process, facility and supply chain? Have you taken the time to carefully evaluate them, or are you relying on generic standards and checklists? Does your customer really understand your business well enough to identify what you should be concerned about? Are you tired of con�icting requirements from third-party audits? There is a better way.
Managing RiskE�ective risk management does not involve one size �ts all �xes. Are you relying on audits to manage your risks? What are the audits really telling you? Compliance with generic standards will not protect your product. Instead, invest only in the improvements needed to minimize your real risks to protect both your product and your bottom line.
The Problem: Current food defense practice is too generic. Compliance with general guidelines could be costly and will not protect your product.
The Solution:Focused assessments that identify real concerns and cost-e�ective, targeted solutions.
Don’t gamble with food defense! Contact SAIC Food Defense Solutions.
For more information about how SAIC can help protect your product supply chain, please visit us at www.saic.com/food-safety
E�ective product protection requiresrisk identi�cation and risk management
SAIC Food Defense.pdf 1SAIC Food Defense.pdf 1 9/21/10 4:26:53 PM9/21/10 4:26:53 PM
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42 F O O D S A F E T Y M A G A Z I N E
and 2, even something as American as a cheeseburger can have ingredients sourcedfrom around the world.
Current RequirementsDifferent parts of the food industry are subject to different laws that are often ad-
ministered by different government agencies. However, the 2002 Bioterrorism Act pro-vided a major recordkeeping requirement that most equate with product tracing. TheAct requires what is commonly referred to as “one up/one back” recordkeeping.Specifically, recipients of a product are required to record from whom they received aproduct, and upon shipping, they must document to whom they sent product. The as-sumption that the requirements of the Act provide product tracing is wrong for atleast three reasons. First, some are exempt. Exemptions at the ends of the supplychain, such as the farm and retail, are not ideal, but with the one up/one back system,the primary recipient of a product from a farm should know where the product camefrom, making a matching record at the farm level redundant. The greater issue withthe exemptions is when they apply to those in the middle of the supply chain, such asbrokers, who play a major role in the food production system. A lack of records resultsin a break in the chain. The second issue with the Act is the inadequacy of the data re-quired to allow for product tracing. Lot numbers are critical pieces of information todistinguish product. Language in the Act reads that lot numbers shall be recorded “ifavailable,” and this provides a substantial amount of wiggle room. In fact, in the IFTstudy, a major barrier to improving product tracing was that suppliers did not providethe necessary information. Lastly, had the Act been written to provide perfect producttracing, requiring all in the supply chain—at least the part in the U.S.—to keep the ap-propriate information, the FDA could not impose these requirements around theglobe, nor could the FDA enforce them. Everyone involved in food understands thetangled web of food production and procurement, and the concept of worldwide foodtracing, though necessary, seems daunting.
Pending LegislationAt several points over the past few years,
a la carte product tracing bills have beenproposed by various members of the U.S.Congress, and are included in Table 1. Itnow appears that the greatest change toproduct tracing requirements will resultfrom the passage of some form of the FoodSafety Modernization Act (S510, which hasnot yet passed the full Senate as of this writ-ing, and HR 2749, which passed the fullHouse in the Summer of 2009).
Tracing in Senate Bill S510The product tracing requirements out-
lined in the current version of S510 givethe Secretary of the Department of Healthand Human Services (HHS), who overseesthe FDA, a great deal of flexibility regard-ing the implementation of product tracingsystems. It must be noted that the Senatebill has not yet passed the full Senate, witha manager’s amendment released in August2010. Despite the overall general languageon product tracing, there are two specific el-ements that may decrease the ability totrace food: 1) the legislation would not re-
quire product tracking to the case leveland 2) additional recordkeeping require-ments would be imposed for “high-riskfoods.” Part of the definition of “high-risk foods” pertains to the processingsteps that reduce likelihood of contami-nation. Clearly, lack of compliance withGood Manufacturing Practices is not ac-counted for, and many foods involvedin recent outbreaks would not have beendesignated “high-risk.”
Tracing in House Bill 2749In contrast to the Senate bill, the
House bill, which has already made itsway through the full House, providesmuch more detail on product tracing requirements. It would authorize theSecretary of HHS to “(i) identify tech-nologies and methodologies for tracingthe distribution history of a food that is,or may be, used by members of differentsectors of the food industry, includingtechnologies and methodologies to en-able each person who produces, manu-factures, processes, packs, transports orholds a food to (I) maintain the fullpedigree of the origin and previous dis-
Table 1: Recent U.S. Bills Addressing Product Tracing
Act Name Bill Number Summary
Trace Act of 2009 HR 814 Traceability system for all stages ofmanufacturing, processing, packagingand distribution
Food Safety HR 875 National traceability system of 2009Modernization Act that enables the Administrator to
retrieve the history, use and location of an article of food through all stagesof its production, processing anddistribution
Food Safety Tracking S425 Establish a national traceabilityImprovement Act system that enablesthe Administrator to retrieve the history, use and location of an articleof food through all stages of its production, processing and distribution
FDA Food Safety S510 Secretary (HHS) shall provide a report Modernization Act with recommendations for enhanced
surveillance, outbreak response and traceability
E. coli Traceability HR 6024 Secretary (Ag) must trace and Eradication Act contaminated beef samples to identify
all sites of adulteration and contamination, including preparation, packaging and slaughtering establishments
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Forecasting the FutureNo one knows what the final legislation on product tracing will look like. However,
there has been speculation that some key elements of the House bill might win out.
Pilot StudiesIt appears likely that the Secretary of HHS would be required to conduct some pi-
lots, and the only argument heard from industry on this aspect is that more pilotsshould be conducted. It will be very difficult to capture the nuances and specific prac-tices of each industry if only a few pilots are conducted. When IFT was contracted by
the FDA to perform a mock traceback of the tomato supply chain, industry and tradeassociations argued that the simplicity of the tomato supply chain was not representa-tive of the complexity of other produce supply chains. If the diagrams that the FDAshows illustrating the tomato supply chain are simple, I fear what complexity lookslike! A pilot study of a complex processed food will surely face some challenges—pri-marily in the acquisition of so much data.Industry, with support from trade associations, has begun making enhancements to
the way products are traced in anticipation of pending legislation, and in response tothe deficiencies illustrated by numerous outbreaks. Table 2 shows the vision for andobjective of product tracing in various sectors of the food industry, the way productsare currently identified and the way they might be identified moving forward. It ap-pears that many industries are adopting the GS1 system of global standards. Anoverview of the types of standards that GS1 supports (e.g., standards for expressingdata and transmitting data) can be found at www.gs1us.org for those in the U.S.
Culture ShiftsFor tracebacks and trace-forwards to become more rapid, some parts of the food in-
dustry will need to change the way they record information, and in some cases, theway they view product. IFT found that some firms assigned identifiers to pallets, or insome cases even entire truckloads, making it very difficult to distinguish how the com-ponents of the pallet or truckload traveled through the supply chain. Additionally, the“first in, first out” inventory rotation system, relied upon to a great extent by somesegments of the food industry, is wrought with exceptions, necessitating accuraterecordkeeping and not simply deduction of when a product was “likely” in inventory.IFT recommended to the FDA that product be distinguished at the level of the lot
and be traced at the case level. Recognizing that the rate product moves throughoutthe supply chain–particularly in and out of distribution centers and warehouses–is in-credibly high, we hope that technological innovations will enable foods to be traced atthe case level in an economical and efficient way. However, industry will not be alone in needing to make a change. While most rec-
ognize that providing records in an electronic format will increase the ability of regula-tory agencies to analyze data orders of magnitude faster than today, IFT was surprisedto learn that during the course of our study, the FDA’s Center for Food Safety andApplied Nutrition was resistant to collecting these types of records. It is discouragingto hear FDA representatives complain about receiving information on paper, whenIFT also heard industry report that they hit the “print” button when federal or stateauthorities asked for information, because hard copies were desired. Clearly, some seg-ments of the food industry have information in an electronic format, and mechanismsfor industry to share and government to receive this information must be developed.The FDA has taken positive steps with the Reportable Food Registry and PREDICTtool for import screening, which are both electronic systems.
tribution history of the food; (II) linkthat history with the subsequent distri-bution of the food; (III) establish andmaintain a system for tracing the foodthat is interoperable with the systems es-tablished and maintained by other suchpersons; and (IV) use a unique identifierfor each facility owned or operated bysuch person for such purpose, as speci-fied under section 1011 and (ii) to theextent practical, assess (I) the costs andbenefits associated with the adoptionand use of such technologies; (II) thefeasibility of such technologies for differ-ent sectors of the food industry; and(III) whether such technologies are com-patible with the requirements of thissubsection.” As a result, “the Secretaryshall issue regulations establishing a trac-ing system that enables the Secretary toidentify each person who grows, pro-duces, manufactures, processes, packs,transports, holds or sells such food in asshort a timeframe as practicable but nolonger than 2 business days….The Secre-tary may include in the regulations es-tablishing a tracing system (i) theestablishment and maintenance of lotnumbers; (ii) a standardized format forpedigree information; and (iii) the use ofa common nomenclature for food.” Thisbill also specifies that public meetingsand pilot projects should be conducted. Of particular concern is the authority
of the HHS Secretary to perform studieson and standardize formats for pedigree.While the term pedigree is not definedin the bill, the concept seems extremelyattractive: with a pedigree, you can seethe entire history and path of a productat a glance. There is no need to do a la-borious trace, since each handler of aproduct adds their name to the list as theproduct moves through the supplychain. In an industry where the barriersto entry are very low, resulting in numer-ous small operators (particularly in theworld of blenders, repackers and thelike), where price is a deciding factor inpurchasing decisions, where rework is afact of life and where substitutions arenot uncommon, accurately handling in-formation to provide a pedigree seemsunlikely to be successful or economicalin the near term. Currently, S510 doesnot explicitly require a full pedigree.
“The supply chain is only asstrong as its weakest link.”
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Technology CapabilitiesSome argue that the technology to manage food system data for the purposes of
tracking products is not available. The technologies commercially available may noteasily integrate into an existing system and may not readily accommodate paper batchlogs, but the third-party systems explored by IFT have phenomenal capabilities. Addi-tionally, many companies already use electronic systems that can be tweaked to enablethe capture of data needed to trace products (such as Enterprise Resource Planning,Warehouse Management and accounting systems).A main reason cited for the lack of implementation of third-party product tracing
systems is that individual firms believe they are already in compliance with the Bioter-rorism Act and do not view these systems as providing anything the company cannotalready do. However, they understandably fail to see the “bigger picture” of producttracing as a system-wide issue that transcends any single firm. With the exception per-haps of vertically integrated supply chains, it is rare to find a company that can truth-fully say they are able to trace their product forward and backward. Some systems that“connect the dots” will surely be superior to the pen-and-paper system used today.
Industry Implications: CostIt is impossible to predict the cost to improve product tracing when the current
practices are so incredibly varied and when the “standard” has not been set. Needlessto say, most firms will likely need to make some change to their operations, and with
change usually comes cost. It is impor-tant to note that more rapid and accu-rate product tracing can save both livesand industries. Saving lives is clearly aprimary concern. Being able to identifythe cause of illness and remove that sus-pect product from the marketplace has apublic health impact that can be quanti-fied. Some preliminary attempts at as-sessing how a change in the timing of atraceback could have mitigated the pub-lic health burden have been made, butmore work should be done in this area. Although societal benefits can be
shown, from the perspective of an indi-vidual firm, the impact on the bottomline needs to be quantified. Perhaps oneday product tracing will be so accuratethat the tomato industry would havebeen readily exonerated in the 2008 Sal-monella outbreak. The financial loss to
Table 2: Summary of Product Tracing Initiatives and Practices. Provided courtesy of GS1 US.
Sector Sector Vision Current ID Association Proposed Future
Case ID Data Item ID Data
Carrier Carrier
Produce Electronic traceability Price Look-up PMA, UFPA GTIN + GS1-128 GTIN GS1 at case level lot number DataBar
Meat & Poultry Guide consistent URMIS mpXML, AMI, NCBA, GTIN + GS1-128 GTIN GS1 application of key FMI, NGA/NCC, NTF, lot number ITF-14 DataBartraceability principles and NPB, IFDA, NRA UPC – A processes across the U.S. UPC –Type 2 meat and supply chain
Seafood Provide guidance to seafood Defined NFI, FMI, NGA, IFDA GTIN + GS1-128 GTIN GS1industry on information and Numerical NRA lot number ITF-14 DataBarprocesses to support trace- Identification UPC – Aability, based upon industry- UPC – Type 2identified best practices
Deli, Bakery, Defined IDDBA, IDFADairy Numerical
Identification
Prepared Foods Defined IDDBANumericalIdentification
Floral Bring efficiencies to PMA, FMI, NGA GTIN ITF-14 GTIN UPC – Afloral industry
Shelf-stable GTINs GMA Not applicable – already implemented GTIN, U.P.C., ITF
Foodservice Drive waste out of the GTIN IFDA, IFMA, NRA GTIN + GS1-128 GTIN UPCfoodservice supply chain; additional data ITF-14 ITF-14improve product information TBD GS1-128for customers; establish afoundation for improving foodsafety and traceability thatcompanies can choose toadopt
Retailers GTINs FMI, NGA Not applicable – already implemented GTIN, U.P.C., ITF
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tributors to a given silo. For other products, complete emptying is done rarely, if ever.However, this does not excuse the firm handling the product from keeping appropri-ate records. In this instance, although the records may show that the pool of con-stituents is in the hundreds, thousands or more, engineers who understand the waythe specific product flows through the silo can provide estimates of the amount of
constituent that might reasonably be expected to remain in the system. Obviously, themore time has elapsed since the addition of a specific input, the less of that inputwould be expected to be in the silo. Dilution is not always a good solution, but havinga sense of the relative amount of inputs in a silo or other bulk container could provevery useful when tracking products.
Commingled/Repacked ProductsTomatoes have served as the poster child for complex product tracing, somewhat
unfairly. Conceptually, commingling and repacking are no different than producingmulti-ingredient food products. It’s just that in the case of commingling, the ingredi-ents happen to be the same. Therefore, tracking commingled product should not beviewed as an exceptional circumstance. Like other multi-ingredient products, the in-formation needed to track incoming ingredients (e.g., multiple lots of tomatoes), suchas lot numbers or other identifiers, needs to be recorded and linked to the outgoingproduct (e.g., a box of tomatoes consisting of multiple sources). The same can be saidfor rework, which, according to many firms IFT spoke to, is already tracked as an in-gredient. Clearly, possible sources and routes of a problem increase in the case of re-work, but this is not an excuse to not maintain adequate records.
Recommended Next StepsWhether or not the House or Senate versions of a food safety bill pass, change is
coming. For some, the change could be small. For others, the changes might put themout of business.For now, IFT hopes firms will consider the recommendations it made to the FDA
with respect to the concepts of Critical Tracking Events and Key Data Elements. Webelieve that identifying the right points at which to capture information (the CriticalTracking Events) and generating or capturing the data needed to trace products (theKey Data Elements—such as lot number, production date, shipper, etc.) will provide asolid foundation for whatever Congress may mandate and the FDA (or the FoodSafety and Inspection Service) might implement. n
Jennifer Cleveland McEntire, Ph.D., is Senior Staff Scientist and Director of Science and
Technology Projects at the Institute of Food Technologists (IFT) in Washington, D.C.
ResourcesMcEntire, J., et al. 2010. Product tracing in food systems: An IFT report submitted to the FDA, Vol-ume 1: Technical aspects and recommendations. Comp Rev Food Sci Food Safety 9(1):92-158.
Mejia C., et al. 2010. Product tracing in food systems: An IFT report submitted to the FDA, Volume2: Cost considerations and implications. Comp Rev Food Sci Food Safety 9(1):159-175.
Read more about traceability solutions and food safety trends in our Signature Series
articles on our Web site at www.foodsafetymagazine.com/signature.asp
the affected firms could have been miti-gated. Another oft-reported tangiblebenefit from improvements in tracingcomes from tighter controls on inven-tory and being able to link product qual-ity with supplier information. Again, theextent of these benefits is firm-specificand depends on the difference betweenwhat is occurring today and what thefirm might do in the future.
Product Tracing ChallengesCost aside, there are other challenges
that various members of the food supplychain will face and need to overcome toimprove product tracing. Some are firm-specific and relate to changes in the flowof product that may result from the needto add identifiers to products. Manyfood processing environments are notamenable to things like labels: dust andwater are two commonly encounteredobstacles that complicate the ability toattach a label to a box. Within the foodmanufacturing environment, processeshave been developed to be highly effi-cient, and the addition of “another step”specifically for traceability may be a chal-lenge in some operations. Warehouseand distribution operations also dealwith high throughput, and the proce-dures for “picking” products may requiresome adjustment in order to capture theinformation needed for product tracing. Even if the recommendations made
by IFT are fully implemented, there willstill be some products that are more dif-ficult to trace than others because oftheir production processes. It is impracti-cal to expect a wheat farmer to mill hisown flour or for tomatoes to ripen at ex-actly the same time. The extent to whichfacilitating product tracing may compro-mise efficiency needs to be discussed.
Bulk Product TracingThe difficulties associated with trac-
ing bulk product have been voiced inmany forums. Tracing bulk ingredientssuch as wheat, sugar, oil, etc. is not im-possible, but it’s certainly complicated.Some product-storage silos need to beemptied and cleaned regularly. These“break points” enable one to determinethe finite (even if high) number of con-
“…many companiesalready use electronic systems that can betweaked to enable the capture of dataneeded to trace products...”
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L. monocytogenes has been recog-nized as a hazard reasonably likely tooccur in cooked, ready-to-eat (RTE)meat and poultry products. Numer-ous foodborne outbreaks have beenlinked to the consumption of RTEmeats, including hot dogs and delimeats. These products are consideredhigh risk due to the ability of L. monocytogenes to multiply at refrig-eration temperatures, coupled withthe high fatality rate of listeriosis.The U.S. Department of Agricul-ture’s Food Safety and InspectionService (FSIS) released an interimfinal rule in 2003 to address publichealth concerns with regard to L. monocytogenes in these productsand in processing environments.FSIS used a science-based approachin developing these regulations toaddress the most at-risk products andprocessors. Each processor of RTEmeat and poultry products couldchoose one of three alternative pro-grams for the control of L. monocyto-genes in their products:3
Alternative 1: A post-lethalitytreatment that reduces or eliminatesL. monocytogenes AND an antimicro-bial agent or process that suppressesor limits its growth throughout itsshelf-life
T
LISTERIA MONOCYTOGENES:
Controlling the Hazard in RTE Meat and Poultry Processing Environments
CATEGORY: MEAT
The public health significance of Listeria monocytogenes
is well known. Listeriosis, the illness caused by L. mono-
cytogenes, has a high fatality rate, ranging from 20-30%.1
High-risk populations include pregnant women and their
unborn fetuses, immuno-compromised individuals, can-
cer patients and the elderly.2 The manifestations of liste-
riosis include
septicemia, menin-
gitis, encephalitis
and intrauterine or
cervical infections
in pregnant
women, which
may result in
spontaneous abor-
tions or stillbirths.
Gastrointestinal or
influenza-like
symptoms, such as
nausea, vomiting, diarrhea and fever, may precede more
serious forms of listeriosis or may be the only expressed
symptoms.2
By Robin M. Kalinowski, M.S.
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Alternative 2: A post-lethality treat-ment that reduces or eliminates L. mono-cytogenes OR an antimicrobial agent orprocess that suppresses or limits itsgrowth throughout its shelf-life
Alternative 3: Sanitation controlmeasures, which may be incorporated inthe establishment’s Hazard Analysis andCritical Control Points plan, SanitationStandard Operating Procedures (SSOPs)or prerequisite programs are the onlycontrols to prevent L. monocytogenescontaminationFor establishments choosing to
operate using Alternative 3, consumerprotection depends on preventing con-tamination in those foods in whichgrowth can occur. Intervention strategiesand control measures used in these RTEprocessing environments will be discussed.
Control in the ProcessingEnvironmentProcessors that rely solely on SSOPs
and Good Manufacturing Practices toprovide safe, Listeria-free products wouldbe considered Alternative 3 facilities.Manufacturing under Alternative 3 ishigher risk and will enable more scrutinyfrom FSIS inspectors; however, if man-aged properly, these facilities can providesafe products with an extended shelf-life. Growth of L. monocytogenes within a
niche or harborage site in the post-pro-cessing environment is the major con-cern with regard to Listeria control.Thus, aggressive sanitation and sanitarydesign of both equipment and facilitiesare critical to identifying and eliminatingniche sites and preventing subsequentproduct contamination. Cleaning forListeria control includes breakdown ofequipment to cleanable levels so thatniche sites can be reached. If the equip-ment is not easily taken apart, niche siteswill not be reached, and product andmoisture build-up will occur in these un-cleanable harborage sites, leading to mi-crobial growth. The American MeatInstitute has developed principles for thesanitary design of facilities and equip-ment.4 The principles for sanitary designof facilities focus on three broad themes:provide zones of control, keep it coldand control moisture and design to facil-
itate sanitation. The 10 principles of san-itary design of equipment include thefollowing:4
• Cleanable to a microbiological level• Made of compatible materials• Accessible for inspection, mainte-nance, cleaning and sanitation
• No product or liquid collection• Hollow areas hermetically sealed• No niches
• Sanitary operational performance• Hygienic design of maintenance enclosures
• Hygienic compatibility with otherplant systems
• Validated cleaning and sanitizing protocolsOnce the sanitation and prerequisite
programs have been put into place andall personnel are trained, the processing“L. monocytogenes has been recognized as a
hazard reasonably likely to occur in cooked, ready-
to-eat (RTE) meat and poultry products.”
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environment must be monitored to ver-ify that the programs are working andthat harborage sites have not developed.Alternative 3 facilities are required tohave an environmental monitoring pro-gram in place that includes product con-tact testing in the post-lethality
processing areas to ensure that surfacesare sanitary and free of L. monocytogenesor its indicator organisms.3 The monitor-ing program must include details on thefrequency of testing, size and location ofsample sites and should include an ex-planation of why the testing frequency isadequate to ensure that effective controlis maintained.The establishment should also iden-
tify the hold-and-test procedures follow-ing a positive result on a product contactsurface.3 An effective monitoring pro-gram will identify the source of contami-nation, eliminate the microorganismfrom the environment and prevent fu-ture contamination by ongoing testingof indicator sites. These indicator sitesare non-product contact sites that “indi-cate” the presence of the microorganismin the processing environment or ancil-lary areas. The “zone” concept is widely used in
RTE meat and poultry plants for envi-ronmental monitoring programs; plantoperations are divided into zones basedon level of risk. Zone 1 represents prod-uct contact surfaces, the highest level ofrisk. Zone 2 sites are non-product con-tact sites that are directly adjacent toproduct contact surfaces and can includecontrol buttons, equipment frameworkand mechanics’ tools. Zone 3 sites arewithin the post-processing areas and in-clude floors, walls, drains, floor mats,forklifts, pallets and air handling units.Zone 4 sites are not in the post-process-ing areas, but if unchecked, can lead tocross-contamination of Zones 1, 2 and 3.
Zone 4 areas include hallways, loadingdocks, warehouses, coolers, bathrooms,locker rooms and break rooms. For a processing facility that is not in
control, sampling and testing effortsshould be focused on Zone 1 sites to un-derstand the prevalence and to identify
and eliminate growth niches. For a pro-cessing facility that is in control, sam-pling and testing focus can move intoZones 2, 3 and 4. Successful processorsfocus on prevention of contaminationby focusing their sampling efforts on in-dicator sites and then reacting to all posi-tive results, at both product contact andindicator sites, quickly and effectively.Note that Zone 1, or product contacttesting, is a requirement for Alternative 3processors and must be included in thesampling program.The environmental sampling pro-
gram is critical to preventing and con-trolling Listeria in RTE meat and poultryenvironments. The goal of this programis to find the microorganism. However,ongoing monitoring of the environmentwould be useless if no efforts were inplace to fix the problem once identified.Every successful sampling program mustinclude a corrective action plan to definehow the processor will respond to a posi-tive finding. These corrective actionsshould identify and control the sourceof the contamination, thereby prevent-ing future contamination.
Intervention StrategiesRTE meat and poultry processors rely
on numerous interventions for control-ling the transfer, development of niches,and growth of Listeria in the manufactur-ing environment. Industry sharing ofbest practices and lessons learned hasbeen a key component of the success ofthis food industry segment. Meat proces-sors have agreed that food safety infor-
mation should be shared on a non-com-petitive basis and are willing to sharebest practices for strategies that work intheir facilities through Listeria work-shops. Although many of these strategieshave not been validated in a laboratorysetting, processors routinely utilize themand have demonstrated success with re-gard to Listeria control.Successful processors have learned
that controlling Listeria on floors will re-duce the incidence of contamination ofproduct contact surfaces and that thiscan be accomplished with adequatecleaning and sanitation. Scrubbing floorswith caustic, rinsing and then sanitizingwith a high concentration of sanitizer(800–1,000 ppm quaternary ammoniumcompound as described by Tompkin), isan effective way to do so.5 Drying floorscompletely before start up and keepingthem dry throughout production is es-sential. Additionally, the use of varioussanitizers in high traffic areas, or areaswith a high level of moisture, can im-prove control. The use of powdered qua-ternary ammonium compounds hasbeen shared as a best practice that RTEmeat processors have implemented anddemonstrated successfully in control ofListeria. Other strategies for control of Listeria
on floors include the use of doorfoamers, which spray a foam-based sani-tizer upon entrance into an RTE area,and sole scrubbers, which combine me-chanical action to remove debris fromfootwear as well as a sanitizer to inacti-vate microorganisms. These interven-tions provide control, as demonstratedby plant environmental data. Further re-search to validate the effectiveness ofthese systems will aid the industry indefining the optimum usage levels andconditions for use.Another strategy used by successful
processors is the scheduled cleaning ofequipment, thus preventing niche devel-opment. This can include cooking orsteaming equipment that is difficult toclean or is not hygienically designed.Equipment that is small enough can beplaced directly in the smokehouse oroven. Some equipment, such as packag-ing machines, may be too large to moveinto the smokehouse. A best practice
“The environmental sampling program is critical to
preventing and controlling Listeria in RTE meat
and poultry environments.”
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that has a demonstrated record of suc-cess is steaming the entire packagingline. This technique has proven effectivefor a packaging line that had an ongoingproblem with Listeria contamination,but a niche could not be identified.Scheduling this equipment cookingprocess into the preventative mainte-nance schedule of the processing facilitycan prevent the development of aharborage site.Maintenance tools, if not controlled,
can be problematic with regard to con-tamination and transfer of microorgan-isms of concern. Maintenance personneland tools should be dedicated to raw orcooked areas within the processing facil-ity. Hand-held tools should be cleanedand sanitized daily and stored in a sani-tary manner. Some processors have re-ported success with scheduled “cooking”of maintenance tools, which is built intothe preventative maintenance schedule.Brine chill systems are used for chill-
ing certain deli meats and link products.These systems, although high in salt con-
centration, can easily become contami-nated with Listeria and can serve as po-tential harborage sources that can affectmultiple lines of packaged product.Brine chill systems pose a significant riskas a source of bacterial contamination,and all products produced with thesesystems are vulnerable to cross-contami-nation. The use of citric acid to lowerthe pH of these brines has proven suc-cessful at inactivating L. monocytogenesand preventing cross-contamination.Acidifying brine chill systems with citricacid is an effective treatment in control-ling Listeria in these systems, as long asthe pH remains in the 3.0–3.5 range (un-published data). The pH should be mon-itored throughout the production day toverify the pH is in the appropriate range. The RTE meat and poultry industry
has come a long way since L. monocyto-genes was first recognized as a foodbornepathogen. Many of the lessons learnedby processors have come the hard way,and they have the scars to prove it. Thewillingness within this industry segment
to share their stories and case studies, les-sons learned and best practices developedis a true example of collaboration. n
Robin M. Kalinowski, M.S., is a Research
Project Manager at the Silliker, Inc. Food
Science Center, South Holland, IL. She
possesses over 20 years of food industry
experience and can be reached at
References1. www.fda.gov/food/guidancecompliance
regulatoryinformation/guidancedocuments/
foodprocessinghaccp/ucm073110.htm.
2. www.fda.gov/Food/FoodSafety/
FoodborneIllness/FoodborneIllness
FoodbornePathogensNaturalToxins/BadBugBook/
ucm070064.htm.
3. www.fsis.usda.gov/OPPDE/rdad/FRPubs/97-013F/
Lm_Rule_Compliance_Guidelines_May_2006.pdf.
4. www.meatami.com/FoodSecurity/
11PrinciplesHandout.ppt.
5. Tompkin, R.B. 2002. Control of Listeria monocy-
togenes in the food-processing environment. J Food
Prot 65:709-725.
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50 F O O D S A F E T Y M A G A Z I N E
Increasing consumer demand for fresh foods
has led to the development of processing and
preservation methods that have minimal im-
pact on either the nutritional or sensory properties of
foods. Freshly prepared foods often contain less salt,
acid, sugar, additives and preservatives. Since the use
of mild preservation technologies primarily results in
pasteurized products, hygienic processing equipment
and a hygienic process environment are needed to
prevent microbial, chemical and physical contami-
nants from affecting these products while preventing
product exposure to sources of filth (pests, dust, etc.).
Combating product contamination may occur not
only at the equipment level but also at the factory
level. Incorporation of hygienic design into your
food processing facility can prevent development of
pests and microbiological niches; avoid product con-
tamination with chemicals (e.g., cleaning agents, lu-
bricants, peeling paint, etc.) and particles (e.g., glass,
dust, iron, etc.); facilitate cleaning and sanitation and
preserve hygienic conditions both during and after
maintenance. The facility infrastructure can be so de-
signed and constructed that it cannot contaminate
food products, whether directly or indirectly.
By Frank Moerman, M.Sc.
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Barrier TechnologyTo control food safety, providing barriers to food contami-
nation is a generally applied concept. The first barrier refers tooutside premises, such as fencing, to prevent unauthorized ac-cess to the facility. The access of transport vehicles with raw ma-terials and end-products, personnel, domestic andnon-domestic animals should be monitored and controlled.Factory site drainage and storm water collection must be suffi-cient; areas within a 3-m perimeter of the factory must be keptvegetation free to avoid pest breeding and harborage sites; a 10-cm thick concrete curtain wall around the factory foundation atleast 60 cm below ground discourages rodents from enteringthe building; effluent treatment plants and waste disposal unitsshould be sited such that prevailing winds do not blow micro-bial and dust aerosols into manufacturing areas. The second barrier concerns the closing of factory buildings.
All entrances/exits (i.e., window and door openings, openingsfor vents, air circulation lines, floor drains, etc.) must be de-signed for control over access, flow or exit of personnel, rawand finished food products, air, process aids (process water, pro-cess steam, food gases, etc.), waste, utilities (plant cooling andheating water, plant steam, compressed air, electricity, etc.) andpests (insects, birds, rodents, etc.). Floor drains must be scree-ned to avoid rats from entering the food plant via sewers; venti-lator openings, including vents in the roof, should be screenedto prevent the entry of roof rats, insects and birds; gaps at theentrances of electrical conduits, process and utility piping,which are convenient pathways for roof rats, must be closed.
The third barrier is the segregation of restricted areas (zones)within the plant, each of which have different hygienic require-ments and controlled access. The fourth barrier is the proces-sing equipment (including storage and conveying systems),which must have an adequate hygienic design and must be clo-sed to protect the food product from external contamination.
ZONING: A CORNERSTONE INPREVENTION OF FOOD CONTAMINATION
Zone B is an area in which a basic level of hygienic design re-quirements suffices. It encompasses areas in which products areproduced that are not susceptible to contamination or that areprotected in their final packages. A B0 zone is the area outsidethe buildings within the perimeter of the site where the objec-tive is to control or reduce hazards created by unauthorizedpersonnel entry and hazards created by water, dirt, dust andpresence of animals. B1 zones include warehouses that storeboth raw materials and packed processed products, offices,workshops, power supply areas, canteens and redundant build-ings/rooms. The objective for a B1 zone is to control or reducehazards created by birds and pests.
Zone M is an area in which a medium level of hygiene suffi-ces. It includes process areas where products are produced thatare susceptible to contamination, but where the consumergroup is not especially sensitive and where no further microbialgrowth is possible in the product in the supply chain. In thisarea, product might be exposed to the environment, duringsampling and during the opening of equipment to clear blocka-
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ges. The objective for zone M is to control or reduce the cre-ation of hazardous sources that can affect an associated area ofhigher zone classification. Another objective is the protectionof the interior of food processing equipment from contamina-tion when exposed to the atmosphere.
Zone H applies to an area where thehighest level of hygiene is required. A“High Hygiene” room, which, in foodprocessing is the equivalent of a clean-room, must be completely contained.Zone H is typical for open processing,where even short exposure of productto the atmosphere can result in a foodsafety hazard. Products and ingredientsthat are processed or stored and aredestined for a highly susceptible con-sumer group (e.g., infant nutrition), areinstant in nature or ready for consump-tion. They must be handled in a refrig-erated supply chain, as they aresusceptible to growth of pathogenic mi-croorganisms. The objective for Hzones is to control all product contami-nation hazards and to protect the interior of food processingequipment from exposure to atmosphere. Filtered air must besupplied to this area.These areas should be limited in size, must have a simple
equipment layout to facilitate process, cleaning and mainte-nance operations and should have utilities located outside.However, investing in an enclosed line that brings barriers veryclose to the product is more logical than trying to create a com-plete cleanroom around a partially open line.Zoning and the establishment of barriers to ensure that
product of acceptable hygienic quality is produced should onlybe applied where their use will help significantly to protectproducts. Designing the entire factory as a cleanroom is not thepurpose of food area segregation to protect both product andconsumer. Zoning and barrier technology must be applied in anappropriate and consistent way, thereby avoiding unnecessaryinvestment.
Construction of Facilities: Appropriate Layout The layout and design of the food factory must be adapted
to the hygienic requirements of a given process, packaging orstorage area. The interior of the factory must be designed sothat the flow of material, personnel, air and waste can proceedin the right direction. As they become incorporated into foodproducts, raw materials and ingredients should move from the‘dirty’ to the ‘clean’ areas. However, the flow of food waste anddiscarded outer packaging materials should be in the oppositedirection. Before building begins, simulation of the flow ofpeople, materials, products and waste can help the designer de-termine the most appropriate place for installing the processequipment and where the process and utility piping shouldenter the process area. Even the simulation of maintenance andcleaning operations can be useful to determine the most appro-priate factory layout. Graphical computer-aided design and 3Dvisualization programs can help in the hygienic design, posi-
tioning and routing of processes, process supports and utilitysystems. These programs allow the observer to “walk through”the facility, seeing the inside of the facility from different anglesand locations. To save building and renovation costs, potentialproblems can be solved before the onset of construction. Addi-
tionally, in the development of highhygiene areas, computational fluid dy-namics can help simulate and visualizeexpected airflows.To meet a possible increase of pro-
cessing activities within the food plantin the future, the building and its foodprocessing support systems should bedesigned so they can either be ex-panded, or another building and/orutilities can be added. Oversizing themain utility systems is a common prac-tice. If possible, the factory should alsobe made adaptable (i.e., the ability tomodify the production area for othermanufacturing purposes) and versatile(i.e., the ability to do different thingswithin the same room).
Construction of Facilities: Pest PreventionTo exclude flooding and the entry of rodents, factories
should be built at a higher level than the ground outside. Exte-rior doors should not open directly into production areas, andwindows should be absent from food processing areas. Thenumber of loading docks should be minimal and be 1–1.2 mabove ground level. Preferably, outside docks should have anoverhanging lip, with smooth and uncluttered surfaces that aresloped slightly away from the building to encourage water run-off. Areas beneath docks should not provide harborages forpests, should be paved and should drain adequately. To provideprotection for products and raw materials, docks can beshielded from the elements by roofs or canopies. However,these structures can become a serious sanitation problem due toroosting or nesting of birds. Bird spikes or nets can solve thatproblem. To prevent the entry of insects, dock openings shouldbe provided with plastic strips or air curtains, and external light-ing to illuminate these factory entrances should be placed in lo-cations away from the factory building. Intruding insects canstill be attracted and killed within the food factory by strategi-cally positioned ultraviolet (UV) light electric grids or adhesiveglue board traps.
Construction of Facilities: Interior Hygienic Design Construction MaterialsConstruction materials for equipment and utility piping
should be hygienic (non-absorbent, non-toxic and cleanable),chemical-resistant (to product, process chemicals and sanitizingagents), physically durable (unbreakable, resistant to moisture,cold, abrasion and chipping) and easy to maintain. Materialsused to construct process and utility systems located in thenon-food contact area may be of a lower grade than those ap-plied in the food contact zone. Surfaces that are frequently wet
“ZONING AND THEESTABLISHMENT OF
BARRIERS...SHOULD ONLY
BE APPLIED WHERE THEIR
USE WILL HELP
SIGNIFICANTLY TO
PROTECT PRODUCTS.”
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should not be painted as the paint can crack and chip.Lead, mercury and cadmium should not be used within the
factory. However, as part of many electric components, it isvery difficult to exclude their presence. In the food contactarea, electric components must always be enclosed in junctionboxes, casings, closed cable housings, cabinets, etc. or shouldbe installed in non-product contact zones or in technical corri-dors. Alloys for food contact may only contain aluminium,chromium, copper, gold, iron, molybdenum, nickel, platinum,silver, titanium, zinc, carbon, etc. However, zinc, copper, alu-minium, bronze, brass, carbon and galvanized and painted steelhave poor resistance to detergents, dis-infectants, acidic food and steam andmust be avoided in food contact areas.Polytetrafluoroethylene, polyether-
sulfone, polyvinylidene fluoride, phe-nol-formaldehyde, urea-formaldehyde,melamine-formaldehyde, epoxy andunsaturated polyester resins are used inthe construction of electric compo-nents, while other plastics likepolypropylene (PP), low-density poly-ethylene (PE), polyvinyl chloride(PVC), polyurethane (PU), ethylenepropylene diene monomer (EPDM),silicone, etc. are applied as jacket mate-rials for electrical cables or for the con-struction of pneumatic hoses andcompressed air tubing. PP, PE andPVC are also used to construct drainpipes, while shields of polycarbonate can protect the food areabelow light sources from shattered glass after accidental break-age of lamps. Silicone, nitrile, PU, EPDM and butyl rubber arelargely used as materials for gaskets, seals, etc. Epoxy is widelyused as floor, wall and ceiling coatings. Remember that manyplastics perform differently at -25 °C than they do at 20 °C.
Integration of Piping Utility piping in technical corridors or zone H areas should
be integrated into wall compartments or the ceiling. If this isnot possible, it is recommended to use open racks, fixed to theceiling, or walls and columns close to the ceiling. However, suf-ficient clearance must be provided between pipe runs and ad-jacent surfaces so that both are readily accessible for cleaningand maintenance. The pipe racks must be designed hygienicallyto minimize the presence of horizontal ledges, crevices or gapswhere inaccessible dirt can accumulate. Food processing support piping should be directly routed
from service rooms to process areas and should always be logi-cal and simple. The amount of utility piping should be mini-mized and should have—like process piping—a slope of 1/200 to1/100. Especially in process, hot water and process steam pip-ing, standing “pools” of liquid that can support the growth ofmicroorganisms must be avoided. To remove condensate, steamtraps should be located at all low, convenient points along anyextended pipe length. Steam purges for relief of steam conden-sate in a drain should be closely connected to that drain. Inopen systems, the steam vapor coming out of a drain can causehumidity and odor problems within the factory. Discharge of
condensate from the system should be via an air break to pre-vent back-siphonage. Neither process nor utility piping shouldhave dead legs.Like process piping, utility piping should be grouped to-
gether in easily accessible pipe trains whenever possible. Thepoints of use should also be grouped, in an attempt to mini-mize individual ceiling drops. Vertical entrance of piping intothe equipment or equipment jacket is more hygienic than hori-zontal utility piping runs. Running of process and utility pipingover open equipment in food preparation areas cannot be ac-cepted, and nesting of ductwork should be avoided. Piping
should not clutter the ceiling. Whennecessary, suspended racks that runover a product zone shall be equippedwith a drip pan that protects the prod-uct zone below and can be readily re-moved for cleaning. Bumper guardconstruction can also be installed inheavy traffic areas to protect pipingfrom external mechanical forces.Piping should be installed at least 6
cm from walls and floors to encouragethorough cleaning around it. Piping incorners should be avoided, as it ham-pers thorough cleaning. Process equip-ment shall be installed such thatenough space is provided to facilitatepipe cleaning.As piping (utility and process) can
affect or disrupt the airflow pattern inzone H rooms, a fog test can control airflow patterns. The geo-metry of the utility piping can destroy the desired air pattern(e.g., piping with a square or rectangular profile is less favorablethan circular). Square and rectangular shapes create turbulenceand depressions where dust can accumulate, but cylindrical pro-files make cleaning easier.
Penetration of Piping through Walls, Ceilings and FloorsPiping that transports dirty fluids should not run in the
vicinity of or cross utilities that transport process aids, especiallyif these process aids are in direct contact with the food to beprocessed. Like process piping, food processing support pipingshould run unidirectionally, with the support piping runningfrom the cleanest area toward the least clean areas. Support sys-tems should deliver a certain process aid first in the process areawith the highest hygienic risk (zone H) and last in the zone oflowest hygienic risk (zone L). Pipeline penetration through walls, ceilings and floors
should be minimized, as holes in these areas can lead to sanita-tion problems and can invite the entry of insects and rodents.Openings in floors for pipes should be guarded with a sleeve toavoid spill of cleaning solutions onto a lower floor. When sev-eral pipes penetrate the floor, a larger curbed floor can replaceseveral pipe sleeves to improve the cleanability of the surround-ing process environment. However, that curbed floor may cre-ate a large opening where pests may harbor, and where dirt,water, etc. may accumulate. It must be a completely closed curbwith a cover that leaves no gap around the penetrating piping. Holes in walls for pipe traverse need not to be sealed water-
“THE LAYOUT ANDDESIGN OF THE FOOD
FACTORY MUST BE
ADAPTED TO THE
HYGIENIC REQUIREMENTS
OF A GIVEN PROCESS,
PACKAGING OR STORAGE
AREA.”
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54 F O O D S A F E T Y M A G A Z I N E
with a cover that leaves no gap around the penetrating piping. Holes in walls for pipe traverse need not to be sealed water-
and air-tight when both sides of the wall are in rooms of thesame hygienic zoning, but any opening should be large enoughfor access and cleaning. However, if a wall separates rooms ofdifferent hygienic zoning, all holes for pipe traverse must besealed. The exterior surfaces of the pipes that traverse walls orceilings should then have water- and air-tight contact with thewall or ceiling. Foaming-in-place is an appropriate method toclose the gaps formed between pipe surfaces and walls as are theapplications of plastic caps around the piping and flashingflanges. If running of process and util-ity piping through walls or ceilings inzone H rooms cannot be avoided, theapertures through the walls and ceilingsshall be properly closed against air leak-age, as they give excessive air volumelosses which may affect product.
Sanitary Insulation of PipingHot piping should not run in the
neighborhood of piping that transportscold food products, cold process water,etc. The warm-up of these cold liquidscan give rise to the growth of foodpathogens. Insulation of hot piping isrequired, not only to economize on en-ergy, but also to prevent excessive heat-ing of the food productionenvironment above acceptable temper-atures. Poorly insulated ethylene glycoland cold/chilled water piping can sweator be covered with ice, resulting in dripping water. To avoidingress of dust, vermin, etc. into the insulation, it is highly rec-ommended fully welded metal cladding or plastic covering beinstalled. It should be impossible to walk on the insulation dur-ing maintenance. Damage to insulation can be inhibited bycovering the pipe insulation with a smooth, hard, non-electro-static, plastic cover, rather than steel sheet cladding.
Hygienically Designed Transfer PanelsFlexible hoses can be used for performing transfers within a
given process area. However, hoses are impractical to performtransfers between rooms, especially if these rooms have a differ-ent level of “cleanliness.” To make connections between differ-ent processing units in adjacent rooms, the use of hygienicallydesigned transfer panels is recommended. Interconnection be-tween the different ports should be made with sanitary U- andJ-bends. Piping behind the transfer panel and the panel portsmust be sloped to ensure proper drainage of residual liquid to-ward a drain pan. For the same reason, the whole transfer panelcan tip a little bit forward. Ports should be capped when not inuse to prevent any potential spill or contamination.
Chemical and Wear-resistant FloorsFloors should be sloped toward drains and provided with
curbed wall floor junctions, with the curbs having a 30-degreeslope to prevent accumulation of water, dust or soil.Concrete flooring, including the high-strength granolithic
concrete finishes, are especially suitable in warehouses whereexcellent resistance to heavy traffic is critical. However, untre-ated concrete can be dusty if dry and highly susceptible to da-mage from water and acids when wet. Concrete flooring is notrecommended for high-care production areas, because it canspall and absorb water and nutrients, allowing microbial growthbelow the surface.Epoxy flooring provides a durable, seamless, chemical-resi-
stant and readily cleanable surface. However, over time thecoating can crack and buckle due to exposure to cleaning che-micals or wear caused by heavy traffic. Once this happens, moi-
sture pockets under the coating cancreate a microbiological niche. Tile flooring is an excellent surface
for food plants. However, with heavywear and in more aggressive cleaningenvironments, tiles may lose some oftheir grouting, allowing the penetra-tion of water beneath them. Plastic orasphalt membranes may be laid be-tween the underlying concrete surfaceand the tiles. Brick floors also may besatisfactory but tend to be somewhatfragile and, unless vitrified, permitwater penetration. Welded PVC sheets have excellent
chemical resistance. However, they arenot suitable in hot and wet areas, andthe welded PVC may be damaged byheavy cart traffic. Steel plates may beused on balconies, for example, andon loading docks and walkways in the
vicinity of the process. However, they may corrode and are dif-ficult to bond to concrete. Wood floors are satisfactory in pac-king and warehouse areas; however, the wood should beimpregnated and coated with a durable plastic such as PU. Ge-nerally, wood floors may become worn, porous and absorbent,requiring expensive maintenance, and thus are not typically in-stalled in modern food plants.
Pocket-free Drains Drains should have appropriate capacity to avoid “ponding”
of water and hence contamination in the area to be drained.The drain bodies must be free of pockets that can hold foodsoil; otherwise, they will cause odor problems. Only drains withan internal P-trap and atmospheric break should be used. P-traps create a water-lock that keeps sewer gases out of the plant.
Balanced Air Supply and Exhaust System Exhaust systems should have sufficient capacity to remove
excess heat, dust, vapor, aerosols, odors and bioburden fromprocess rooms. However, a positive overpressure must always bemaintained. The supply of filtered air in the room by the he-ating-ventilation-air conditioning system must thus be largeenough, otherwise the exhaust system will attempt to draw therequired amount of air from adjacent less clean areas throughdoorways and windows. Exhaust fans must be located outsidethe building to maintain a negative pressure in the portion ofthe duct system located within the building. If they are installed
“HYGIENIC FOOD
FACTORY DESIGN STARTS
WITH THE SELECTION OF
AN APPROPRIATE
LOCATION AND THE
APPLICATION OF A
HYGIENIC BUILDING
CONCEPT THAT PREVENTS
THE ENTRY OF PESTS.”
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in the exhaust hood, the exhaust air is pushed through the ductand not pulled out. By pushing vapors, fumes, etc. through thatduct, the system puts the exhaust duct under positive pressure,which can force dirty air back into the room through holes andgaps in the duct work.
Hygienically Designed Lighting Lighting must illuminate horizontal and vertical working
surfaces evenly, without causing glare and at an intensity ofabout 300–500 lux at normal working height. Walls and ceilingsshould be light-colored because that permits fast detection ofdirt and soil on their surfaces. In contrast, dark-colored wallsand floors require additional lighting. Preference should be given to lighting mounted on ceilings
rather than on walls, because process equipment, storage racks,etc. can form shadows that make cleaning and inspection offloor, walls or ceilings difficult. For the same reason, overheadpiping may not obstruct lighting. Selected lighting should produce little heat and UV light to
prevent attraction of insects. Because high-intensity dischargelamps (metal halide, and high- and low- pressure sodium lamps)have high penetration depth, they are used as high-bay lightingin warehouses; fluorescent luminaires are preferred as low-baylighting, giving good illumination with less glare when coveredwith a prismatic cover or opalescent diffusing panel. Lighting systems and their supports may not create horizon-
tal ledges, legs or surfaces. To avoid projections that can accu-mulate dust, they can be built into the ceiling or wall with ahermetically closed seal, a procedure that is typical for clean-room areas where lamps are changed via the technical area.
Hygienic Supply and Application of ElectricityIn zone M areas, installing individual cables or multiple ca-
bles of small diameter, sharing the same route, in conduits isrecommended. When two or more cables partly share a com-mon route but go to different termination points, the creationof unsealable openings that allow the cable(s) to enter or exitthe conduit is possible. However, this practice is only recom-mended for short distances. For long distances, straight line,non-bundled electric cables should be mounted on wire trays,preferably separated from each other. Vertical cable trays are lessprone to dust accumulation, and are more accessible for inspec-tion and cleaning. The use of horizontal racks for electrical ca-bling should be minimized, or they should be protected by aremovable lid or installed vertically (on their side) to minimizehorizontal surfaces. When two or more cables partly share a common route, but
go to different termination points, unsealable openings allow-ing cable(s) to enter or exit the conduit should be avoided.Conduits should be suitably sealed at both ends with a propri-etary cable/sealing gland where a cable does pass through. Inthe food contact and splash areas, cables can also be protectedfrom dirt, penetrating liquid and damage by encapsulatingthem in hermetically closed cable housings. However, the useof pipe rather than conduit should be discouraged because ofthe difficulties in maintaining the integrity of the piping systemat cable entries and exits. Cable mounting in pipes still creates ahollow body and hence a hygienic risk.Electric components should be enclosed in dust- and water-
tight cabinets or field boxes with all connections made at thebottom. Connections of cables and wires to housings must besealed. The enclosures should be spaced away from equipmentor walls and should be provided with an easily drainable 30°top roof. The heat generated by the electrical installationswithin these enclosures, and concomitantly the dust that pene-trates the electrical installation during its cooling by means offans, should be ventilated toward a technical area or a centralventilation system.
Control Panels Control panels with high ingress protection rating should be
provided with hygienically designed control and indicator devi-ces. However, the more modern and hygienic membrane panelsor touch-screen display panels now often replace these older,non-computer-based control panels.
ConclusionsMany food manufacturers only make use of the classic food
preservation approach to control food safety. In the past twodecades, however, the European Hygienic Engineering & De-sign Group has demonstrated that hygienic design of food pro-cess equipment and factories can contribute significantly toenhanced food safety. Hygienic food factory design starts withthe selection of an appropriate location and the application of ahygienic building concept that prevents the entry of pests. Thefactory layout must permit the correct flow of materials, waste,air and personnel without compromising food safety as well asthe installation of hygienic zones that offer maximal protectionto the food produced. Process equipment and process and uti-lity piping must be designed from food-grade materials that arecompatible with the food product produced and the cleaningagents and disinfectants applied to sanitize the production envi-ronment. To avoid the introduction of new contaminants,equipment and piping must be hygienically integrated withinthe factory’s premises. Walls, ceilings and floors must have anappropriate finish, lighting must provide sufficient illuminationand drains should guarantee proper drainage to facilitate clean-ing and to maintain hygienic conditions within the factory. Theaim of this article is to serve as an introduction to proper hygie-nic food facility design. n
Frank Moerman received his M.Sc. in bioengineering from the
University of Ghent in Belgium. In 2002, he became a member of
the European Hygienic Engineering and Design Group (EHEDG)
responsible for Belgium. More about EHEDG can be found at
www.ehedg.org.
Resources:Lelieveld, H.L.M., M.A. Mostert, J. Holah and B. White. 2003. Hygienein Food Processing: Principles and Practice. Cambridge: WoodheadPublishing Ltd.Lelieveld, H.L.M., M.A. Mostert and J. Holah. 2005. Handbook of Hygiene Control in the Food Industry. Cambridge: Woodhead Publishing Ltd.Lelieveld, H.L.M. and J. Holah. 2011. Hygiene Control in the Design,Construction and Renovation of Food Processing Factories.Cambridge: Woodhead Publishing Ltd., in progress.
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Rapid Salmonella DetectionFluoroVei LLC has introduced its Fluo-
roQuik test for Salmonella, providing resultsin 4 hours. The company’s innovative bac-teria detection system was created to meetfood industry requests for results withinone work shift. The test utilizes a sensitivehand-held fluorometer and assays that can detect as low as onecolony-forming unit. Multiple assays have been developed forthe system, which utilizes the detection of specific enzymesthat are unique to a particular genus of bacterium, allowing forrapid detection.
FluoroVei LLC, 925.755.0611 • www.fluorovei.com
Near-infrared MetersKett has announced hand-held, desktop and online pro-
duction models of near-infrared meters for instant, non-con-tact measurements of moisture, fat, protein and other foodcomponents for both solids and liquids using optical ab-sorbance. Ranges from 0.01% to 100% can be accuratelyand repeatedly measured within ± 0.01%. Models include au-tomatic zero adjustment, online calibration, large digital dis-plays, memory, output options, computer interface andindustrial design.
Kett U.S., 800.438.5388 • www.kett.com
Cleaning UnitsMork has introduced S Series cleaning units, capable of de-
livering customized cleaning solutions in the food and bever-age industries. These units are suitable for the majority ofapplications, ranging up to 5,000 gallons in size. Versatile andeasy to use, the S Series allows the development of recipes cus-tomized to the cleaning needs of the processor and comes withsuch available options as inline sanitation, sterilization-in-placeand central storage of cleaning agents with local refill.
Mork Process Inc., 330.928.3728 • www.MORKusa.com
Time-of-Flight Mass SpectrometryJEOL USA has announced the introduc-
tion of the company’s first commerciallyavailable matrix-assisted laser desorption/ionization-time-of-flight (MALDI-TOF) massspectrometer, the JEOL JMS-S3000 SpiralTOF™. This instrument reinvents TOFion optics with an extended flight length ina compact footprint, delivering a resolving
power of greater than 60,000 over a wide mass range of m/z10–30,000. This patented technology consists of a staggeredfigure-8 ion trajectory of 17 meters. By refocusing the ionpackets during each turn, the divergence of the ions is re-duced over the flight distance. The system is engineered toovercome the limits of delayed extraction with kinetic energyconvergence, resulting in high sensitivity, resolving power andmass accuracy (<1 ppm) over a wide mass range.
JEOL USA, 978.535.5900 • www.jeolusa.com
56 F O O D S A F E T Y M A G A Z I N E
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portance of record review. Management must develop a pro-gram to review all calibration records deemed critical to qualityand safety by the risk assessment. Procedures on how to reviewthe records should be developed and implemented. In addi-tion, employees who conduct the reviews must be trained onsaid procedures. For CCPs, review of the records for calibrat-ing the instruments would be incorporated into the HACCPplan.
Processors should also establish programs to verify that thecalibration program is being properly followed. Persons doingthese internal audits should be independent of this area. For ex-ample, if calibration is managed by the production group, theauditor could be drawn from quality, warehouse operations orelsewhere. The verification activities should include the follow-ing elements:• Procedures – The auditors should make sure that the persons
responsible for doing work are following established proce-dures. Auditors should use procedures and work instruc-tions as a guide when doing this phase of the audit. Auditors should also look to see that calibrations were car-ried out according to schedule.
• Competencies/Training – This starts with the auditor reviewingthe training records. However, training should lead to com-petencies. To verify the latter, the auditor needs to observethe individual doing the calibration to determine if the per-son is actually following the procedure. When work is doneby an outside agency, confirm that the group doing thework is competent and that there is some protocol for se-lecting and evaluating potential contractors.
• Records – The auditors should also review records, whichwould include looking for deviations and corrective actions.The review should also look for evidence of management review. The individuals conducting these audits must be trained on
audit procedures. In addition, records of training must bemaintained. This is something that may be done internally orthrough an outside agency. Many processors send their peopleto programs that certify them as ISO auditors. Again, this is achoice that each company should make.
Evaluating the ProgramCalibration and, in fact, all programs should be evaluated
on a regular basis. The program should be reviewed by theplant manager and the management team at least once a year.The review should draw heavily on the verification activitiesand on the company’s performance related to quality andsafety goals. The objective of this exercise is to look at the pro-gram as it exists and look for ways to enhance it. One of the re-sults of the management review should be an improvementplan that includes programs, assigned responsibilities, timelinesto complete the project and the resources needed to completethe work. If such a program has been operating, the reviewshould also address past improvement plans, their status andsuccess or failure. This is an essential element for continuousimprovement and an integral element of ISO 22000.
Making the Calibration Program “AuditFriendly”
As mentioned, calibration is an integral part of a processor’squality and safety program. Getting the program organized,particularly ensuring that it is managed by one person ratherthan many, will help make the program “audit friendly.” Themaster calibration schedule provides users and auditors with anorganized summary of the program. In fact, to make it eveneasier to manage, processors should add one more field: the lo-cation of the records for that instrument. Of course, the bestmeans for getting everything in one place is an electronic sys-tem. As noted, maintenance management software programsare a tool that can capture the whole program; so rather thanlooking at piles of records, one can audit the complete programby sitting in one place in front of a computer. If electronic sys-tems are used, the computer should have security systems thatmeet 21 CRF 11, the electronic recordkeeping requirements.
So, take a long look at how calibration programs are beingmanaged and ask yourself, “Is this the best we can do?” Myguess is that you can do better. n
Richard F. Stier is a consulting food scientist with international
experience in food safety (HACCP), plant sanitation, quality sys-
tems, process optimization, GMP compliance and microbiology.
Among his many affiliations, he is a member of the Institute of
Food Technologists and an editorial advisor to Food Safety Maga-
zine. He can be reached at [email protected].
PROCESS CONTROL (continued from page 13)
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58 F O O D S A F E T Y M A G A Z I N E
ATCC • atcc.org .......................................................................................35
BioControl Systems, Inc. • 800.245.0113 • www.biocontrolsys.com...27
Bio-Rad Laboratories, Inc. • [email protected] ......................33
California League of Food Processors • www.clfp.com......................56
DuPont Professional Products
888.6DUPONT • www.proproducts.dupont.com...............................60
DuPont Qualicon • 800.863.6842 • www.realtime-ecoli.com ................31
EtQ Management Consultants • 800.354.4476
www.etq.com/foodsafety .....................................................................5
FoodHACCP.com • www.foodhaccp.com..............................................24
InfinityQS • www.infinityqs.com..............................................................19
Intralox, Inc. USA • 888.387.2358 • www.intralox.com ...........................2
M&D Printing • 309.364.3957 • www.mdprint.com................................56
Marel • 888.888.9107 • www.marel.com ................................................47
MEATXPO • www.meatxpo.org...............................................................49
Michelson Laboratories, Inc.
888.941.5050 • www.michelsonlab.com ...........................................24
Microbiology International
800.EZ.MICRO • www.800ezmicro.com...............................................51
MOCON Inc. • 763.493.6370 • www.mocon.com/foodsafety.php ........37
NSF International • 800.NSF.MARK • www.nsf.org .................................9
Q Laboratories, Inc. • 513.471.1300 • www.qlaboratories.com............15
R-Biopharm, Inc. • 877.789.3033 • www.r-biopharm.com....................13
Refrigerated Foods Association
770.452.0660 • www.refrigeratedfoods.org .......................................57
SAIC • www.saic.com/food-safety ..........................................................41
SDIX • 800.544.8881 • www.sdix.com/SE ..............................................29
Spiral Biotech • 781.320.9000 • www.aicompanies.com ......................21
Thermo Scientific, Inc. • www.thermoscientific.com/foodsafety ............7
3M Food Safety • www.3m.com/foodsafety/FS .......................................3
TÜV SÜD America Inc. ...........................................................................59
800.TUV.0123 • www.tuvamerica.com/detection
Waters • www.waters.com/food .............................................................17
Weber Scientific • 800.328.8378 • www.weberscientific.com...............11
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FoodSafteyMag FS9 2010 indd 1 9/16/10 8:39:16 PMR i d F d S f Ad f F d 1 1R i d F d S f Ad f F d 1 1 9/22/10 11:00:15 AM9/22/10 11:00:15 AM
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Always read and follow all label directions and precautions for use. The DuPont Oval Logo, DuPont,™ The miracles of science™ and Advion® are trademarks or registered trademarks of DuPont or its affi liates. Copyright © 2010 E.I. du Pont de Nemours and Company. All rights reserved.
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Perhaps Advion® is becoming the preferred gel bait of choice by pest management
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