PLUS Identifying Counterfeits ■ Rapid Pesticide Analysis ■ Automation in HACCP Management

Volume 21 Number 6 DECEMBER / JANUARY 2015

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DecembeContentsr/JANUARY 2015 • VOLUME 21 NUMBER 6 • www.foodqualityandsafety.com Innovative molecular detection for food safety made simple, Adopting a systematic Features ­allergen risk assess- accessible, and affordable ment for industry will provide­ accurate­ allergen­ 18 ­information to consumers, Cover story allowing them to make informed­ decisions

By Evangelia Komitopoulou, PhD

Confusion ­ Surrounding The FIRST AOAC-RI certified Allergen vertical flow-based molecular test Labeling

®

Veriflow represents a new, ultra sensitive and user- © Foto li a. c om friendly class of diagnostics: molecular flow-based technology for the rapid detection of food pathogens. The patented Veriflow® system combines the sensitivity of VERIFLOW® LS Quality 27 real-time PCR tests with the ease of use associated with For detection of Listeria species from food and vertical flow-based diagnostics. The result is an effective environmental matrices 24 Intercepting Food and rapid system that minimizes sample preparation, ® Uncovering Product Fraud Before It Hits speeds time to results, and provides easy to interpret VERIFLOW CA For detection of Campylobacter species from Vulnerability the Shelves data for the end user. poultry carcass rinsates Addressing the risk of ­economically Techniques to identify the authenticity ® motivated adulteration in imported and purity of products are in demand Three easy steps to achieve results: VERIFLOW LM as more counterfeit foods enter the For detection of Listeria monocytogenes from foods with vulnerability assessments consumer supply chain Enrich, Amplify, Detect food and environmental matrices By Karen Everstine, PhD and Jeffrey Moore, PhD By Stephen Harrison © LINDE ® VERIFLOW SS Food Quality & Safety (ISSN 1092-7514) is published 6 times a year in Feb/Mar, Apr/May, Jun/July, Aug/Sept, Oct/Nov, Dec/Jan by Wiley Subscription Services, Inc., a Wiley Company, 111 River St., For detection of Salmonella species from food Hoboken, NJ 07030-5774. Periodical postage paid at Hoboken, NJ, and additional mailing offices. Subscription for U.S. is $126 erp year. International subscription is $160. and environmental matrices Food Quality & Safety is a proud member of: United Fresh Produce Association Folio Ozzie and ASBPE award winner for editorial and graphics excellence. Cov e r: © Foto li a. c om POSTMASTER: Returns and address changes to Food Quality & Safety magazine, PO Box 986, Levittown PA 19055-0986 P. 215.966.6118 | [email protected] | www.invisiblesentinel.com Invisible Sentinel® and Veriflow® are trademarks of Invisible Sentinel, Inc, of Philadelphia, PA. December/January 2015 5 Contents December/JANUARY 2015

Features Cont. Quality Manufacturing & om c

29 The Rise of Product Distribution a. Diversion and li 43 Automation Manages

Counterfeiting Foto - r e

Robust HACCP (and HARPC!) t Serialization and tracking and Programs s

tracing have potential to reduce tor_ma

How automation helps define all ec

counterfeit products in food v © HACCP plan parameters, manages and beverage as well as the CCPs and workflow, and sees pharmaceutical supply chains process through to pre-shipment Industry Insights By Barry McDonogh programs and reporting 12 When Food Brands Merge, By Barbara Levin Consumer Safety Must and Dan Bernkopf Come First mergers and acquisitions can Testing cause a difficult transition period for plant managers as they struggle 31 Crustacean Residues to integrate two distinct food safety in Foodstuffs Food Service & Retail programs an increasingly widespread issue in 46 Bridging Industry and By Katie Moore regards to food allergies, crustacean Regulatory to Enhance test methods must be very specific Safety and detect minute quantities of the cross-functional collaboration allergen in complex food matrices of educational programs will enable By Lilian Kuster managers to properly respond to Around The World an illness outbreak or recall 14 Food Safety Down Under

By Rance Baker australia’s food protection and Elizabeth Landeen system sets high standards for In The Lab accountability 33 Pesticides in Imported By Linda L. Leake, MS Produce rapid pesticide analysis for fruits Columns and vegetables by using gas and liquid chromatography coupled mass spectroscopy Departments By Joe Anacleto 8 From The Editor 37 Importance of Certified 9 news & Notes Reference Materials 48 Product Focus: availability of CRMs for food Diagnostic Testing testing procedures would ensure

50 New Products S e rg y N i v ens - Foto li a.C OM consistent, reliable results and could © be used to establish sensitivity, 51 advertiser Directory linearity, and specificity during the 51 Events validation of microbiological quality Washington Report control methods 10 Whole Genome Sequencing: A Two-Edged, Cutting-Edge By Cara N. Wilder, PhD Tool and Liam Gormley this emerging technology has Exclusive Online 40 Lab Implementation potential to revolutionize food of ISO 11133:2014 tracking, but some worry that Content using it as a monitoring and New mandatory standard for the To read this article, go to the enforcement tool will expose December/January issue on preparation and quality control companies to unnecessary risk of culture media will reduce www.foodqualityandsafety.com: the workload for the qualification By Ted Agres • Food Product Recall of new culture media batches Insurance: Lackluster Name, procured from suppliers Important Service By Barbara Gerten facebook.com/FoodQualityandSafety

6 FOOD QUALITY & SAFETY www.foodqualityandsafety.com OPTIMIZE YOUR TESTING WORKFLOW. (AUTOMATION + FLEXIBILITY = PRODUCTIVITY)

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Find out more at bio-rad.com/ad/productivity Publisher Lisa Dionne, [email protected] Associate Publisher Ken Potuznik, [email protected] Editor Marian Zboraj, [email protected] Design Maria Ender, [email protected] From The Editor Production Claudia Vogel, [email protected] Christiane Potthast, [email protected] Elli Palzer, [email protected] MANAGER, DIGITAL MEDIA & STRATEGY Jason Carris, [email protected] eing the proud daugh- Editorial Intern Candace Mitchell ter of parents who both Advertising Sales Director were raised on farms in Stephen Jezzard 350 Main Street Eastern Europe, I was Malden, MA 02148-5089 B pleased to learn early in the year (781) 388-8532 [email protected] that the United Nations declared 2014 as the International Year of Sales Office U.S./Canada/International Family Farming (IYFF) to high- Ken Potuznik light the importance of family and 29822 N 51st Place, Cave Creek, AZ 85331 (480) 419-1851 • fax (480) 718-7719 smallholder farmers. Throughout [email protected] the year, organizations like Food Tank joined with Food and Editorial Office Agriculture Organization (FAO) and over 360 civil society and 111 River Street, Hoboken, NJ 07030-5774, USA Reprints: E-mail [email protected] farmers’ groups in celebrating the role these farmers play. According to the FAO, of the more than 570 million farms Editorial Advisory Panel in the world, more than 500 million are family farms. With the Betsy Booren, PhD Jennifer McEntire, PhD Chief Scientist VP and Chief Science Officer world population expected to reach nine billion by 2050, FAO American Meat Institute Foundation The Acheson Group stresses that family farms can play a key role in scaling up food Gerry Broski Mary Ann Platt production to meet the needs of a growing world population. In Sr. Marketing Director, Food Safety President Neogen Corp. CNS/RQA, Inc. fact, FAO dedicated its annual report to agricultural innovations Christine Chaisson, PhD in family farming. Director Mike Robach The Lifeline Group Vice President, Corporate Food Safety, The Institute of Food Technologists also put the spotlight Quality, & Regulatory Virginia Deibel, PhD Cargill on agricultural innovations with its FutureFood 2050 program, Director, Microbiological Consulting Covance Laboratories which highlights the people and stories leading the efforts in Bob Swientek Caroline Smith DeWaal Editor-in-Chief, Food Technology finding solutions to safely feed these nine billion people. The Food Safety Director magazine Center for Science in the Public Interest Institute of Food Technologists program includes interviews with agriculture pioneers who are Sara Elhadidy Purnendu Vasavada, PhD mixing and matching technology, both old and new, to boost ag- Senior Food Scientist PCV & Associates and Professor of ricultural production sustainably in the years ahead. Unilever Bestfoods Food Science Philip H. Elliott, PhD University of Wisconsin However, in order to accommodate the needs of a growing Food Safety, Global Quality Assurance W.K. Kellogg Institute Patricia A. Wester population, government also needs to support more new and President Daniel Y.C. Fung, MSPH, PhD PA Wester Consulting young farmers entering the field of agriculture. Professor, Food Science & Animal Sciences Kansas State University Craig Wilson Noting that the global average age of farmers is 55, the Food Vice President, Food Safety Steven Gendel & Quality Assurance Tank created a petition calling on government officials to pro- Food Allergen Coordinator Costco Wholesale vide more resources, aid, and infrastructure to make farming FDA Tim Jackson Steven Wilson economically viable and environmentally sustainable for a new Director, Food Safety U.S. and Canada. Chief Quality Officer generation of farmers and food system leaders. Nestle USDC Seafood Inspection Program “Increased access to education means that young people can Printed in the United States by Dartmouth Printing, Hanover, NH. be a force for innovation on family farms, increasing incomes Copyright 2014 Wiley Periodicals, Inc., a Wiley Company. All rights reserved. No part of this publication may be reproduced in any form or by any means, except as permitted and well-being for not only farmers, but also local communities,” under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior says Mark Holderness, executive secretary, Global Forum on Ag- written permission of the publisher, or authorization through the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923: (978) 750-8400: fax (978) 750-4470. ricultural Research. “Young people can develop the agricultural All materials published, including but not limited to original research, clinical notes, editorials, reviews, reports, letters, and book reviews represent the opinions and views of sector by applying new technologies to current work methods.” the authors and do not reflect any official policy or medical opinion of the institutions with Both in developing and developed countries, family farming which the authors are affiliated or of the publisher unless this is clearly specified. Materials published herein are intended to further general scientific research, understanding, and is the predominant form of agriculture in the food production discussion only and are not intended and should not be relied upon as recommending or sector. The IYFF emphasized that we must do more to support promoting a specific method, diagnosis or treatment by physicians for any particular patient. While the editors and publisher believe that the specifications and usage of equipment these farmers, especially young farmers. As the Food Tank points and devices as set forth herein are in accord with current recommendations and practice at the time of publication, they accept no legal responsibility for any errors or omissions, out, the future of farming depends on younger generations— and make no warranty, express or implied, with respect to material contained herein. people who see agriculture as an opportunity and something Publication of an advertisement or other discussions of products in this publication should not be construed as an endorsement of the products or the manufacturers’ claims. Readers they want to do rather than something they feel forced to do. are encouraged to contact the manufacturers with any questions about the features or limitations of the products mentioned. Marian Zboraj Editor

8 FOOD QUALITY & SAFETY www.foodqualityandsafety.com

NEWS & NOTES

Produce Traceability For Dummies The new guide, Produce Traceability For Dummies by Todd Baggett from RedLine Solutions, helps grower-shippers to understand produce traceability requirements and how to

i Molin - Fo t oli a .co m © K at implement them in their own companies. The book pro- vides insight into several topics surrounding produce traceability including the Produce Traceability Initia- tive, government regulations, choosing a traceability solution, and what to do in the event of a recall. It also shows how implementing the proper traceability solution has the potential to save a company time and money.

FDA to Reach Final Rule on Food Additives The FDA is expected to reach a final rule by August 2016 regarding its food additive approval process. The FDA has been operating under a proposed rule that allows food manufacturers to get approval of food additives by informing the FDA that the additive is generally recog- nized as safe. The timeline to reach a final rule was part of a settlement agreement that was reached after the Center for Food Safety sued the FDA, arguing that the proposed rule did not Learning Module for Seafood adequately protect consumers from potentially harmful food additives. Product Labeling The FDA’s online learning module is designed Business Briefs to better assist the seafood industry, retail- The Modernization of U.S. Meat ers, and state regulators in properly labeling Inspection System AIB introduces a new Environmental seafood products in the U.S. marketplace. “Meat and Poultry Inspection 2.0,” a new Monitoring Consulting Service to assist Offered on the FDA’s website, the module report by The Pew Charitable Trusts and the clients in establishing and improving includes a summary of specific laws, reg- Center for Science in the Public Interest that their programs to comply with FSMA. ulations, guidance documents, and other compares U.S. meat and poultry inspection materials pertinent to labeling seafood. It Global Food Protection Institute and also offers tips for identifying mislabeled International Food Protection Training seafood in the wholesale distribution chain Institute (IFTPI) have consolidated and or the point of retail and describes FDA’s role are now operating under the ­IFTPI brand. in the labeling process. BioSafe Systems opens a new branch in Sparks, Nev. to house its line of acti- vated peroxygen products. Analyzing Microbiology Testing Strategic Consulting recently published its SGS inaugurates a new Pesticides “Industrial Microbiology Market Review, ­Maximum Residue Limits Laboratory in Fourth Edition: Global Review of Microbiology Mombasa, Kenya. Testing in the Industrial Market.” The report tracks and compares past, current, and future Eurofins Scientific announces the © m iz a r_21984 / ExQuisin e - Fo t oli .co microbiology test volumes, market values, practices with those of five other countries, ­potential acquisition of SF Analytical and test methods for six sectors of the indus- finds that the U.S. is in need of an update to Laboratories­ ; at press time, the transac- trial market, including Food and Beverage. its inspection system to help better protect tion was scheduled to close at the end of November. According to the report, more than 90,000 consumers. One of the recommendations industrial plants worldwide conduct close to includes having the U.S. require slaughter Mérieux NutriSciences acquires Kalite 2 billion tests each year, representing a mar- facilities to collect better information on the Sistem Laboratories Group, an ket value of $6.5 billion. Report also includes status of animals and flocks and regularly independent food testing lab in Turkey. profiles of major diagnostic companies. monitor data on plant performance.

December/January 2015 9

ashington Washington 10 W it willalsouse WGS to analyze samples during outbreaks; the agency announced accessible nationally andinternationally. in large databases, which will be publicly store thesequenced genomic information outbreaks offoodborneillnesses. They will will increasingly useWGS to investigate FDA andstate publichealth laboratories quencing equipmentcontinues to decline, Asthe samestrain. thecost ofgene se - even slight variations bygeography within tween different ofabacterium strains and precision that they can distinguish be- pathogens and otherorganisms withsuch scientists to map thegenetic sequence of

But FDA willemployWGS notonly FOOD

QUALITY ing technology thatallows sequencing isanemerg (WGS) ornext-generation genomehole sequencing & S AFETY utn-de Tool ­Cutting-Edge - Whole Genome Whole Genome food tracking, but some worry A Two-Edged, has on theotherhand, isfarmore reliable and ated withprevious contaminations. WGS, guish between samplesofisolates associ- sensitive. Bypairing apathogen’s genomic ate of certain strains other limitations, PFGE cannotdifferenti- older andlesssensitive technology. Among pulsed-field gel electrophoresis (PFGE), an rial subtyping hasbeenperformedusing when nooutbreak hasoccurred. pointed offoodcompanies atthehearts potentially saving lives, butalsoadagger of anoutbreak, preventing illnessand one thatcanquickly pinpointthesource WGS may become atwo-edged sword— Act (FSMA) andotherregulations. Thus, ance withtheFood SafetyModernization inspections inorder to monitor compli - from food companies taken during routine that using it as a monitoring Sequencing: Sequencing: For years, pathogen testing andbacte- This emerging technology and enforcement tool will ­potential to revolutionize expose companies to unnecessary risk Salmonella By By Ted Agres ordistin-

Report Department of AgricultureDepartment & Markets. food bacteriologist attheNew York State its age, addsBrianSauders, PhD, asenior to theHubble.” PFGE hasbegun to show upgrading from anoldbackyard telescope of FDA’s Division of Microbiology. “It’s like dented,” says EricBrown, PhD, director us to dowithfoodtraceback isunprece- imported from different countries. rise offoodproducts containing ingredients contamination—a powerful tool given the investigators can identify the root source of ing theprinciplesofevolutionary biology, systems, amapping technology, andapply information withgeographic information support theagencysupport intaking regulatory human biological samples and it helped mental andfoodsampleswith the CDC’s genome sequencing to match theenviron- FDA suspendeditsfacilityregistration. Del. Inearly 2014, Roos issuedarecall and cheese produced byRoos Foods ofKenton, WGS to definitively linkit to Hispanic-style fections. After the molecular surveillance offoodbornein- regulatory agency laboratories performing an outbreak of state outbreaks in2014. involved The first help solve two widely publicizedmulti- The U.S. FDA and the CDC used WGS to Solving Outbreaks of PublicHealth Laboratories blog post ties,” Dr. Sauders wrote inanAssociation with zoom-to-point ofreference capabili- tailed features andasearchable database complete withnamesofmany key andde- map resolution oftheentire world surface WGS provides better thanGoogle Earth with only seven labeled continents, while “PFGE is like looking at a globe of the Earth CDC thatconnects publichealth andfood chived inPulseNet of theoutbreakbeen part using dataar used PFGE to identifycasesthatmay have as early asAugust 2013. Investigators first Reports oflisteriosis hadbeenreported isolated from patients, investigators used “What genome sequencing allows “This was time thefirst we used “This whole Listeria Listeria , a network run by the , anetwork runbythe www.foodqualityandsafety.com

monocytogenes strain had been hadbeen strain . - - .

© Sergey Nivens - Fotolia.COM action,” says Dr. Brown. “We were able to The answer, it seems, is yes to all the Networks of Data suspend food production at a facility to above. FDA and other public health agencies are minimize an outbreak.” FSMA has expanded FDA’s authority assembling national and even worldwide FDA also used WGS to identify a for obtaining records related to a specific networks to share genomic information multi-state outbreak strain of Salmonella food article that it “reasonably believes is derived from PFGE and WGS analyses of Braenderup and link it to almond and adulterated and presents a serious health food samples taken during outbreaks, peanut butter manufactured by nSpired threat to include records relating to any ar- from contaminated food products, envi- Natural Foods Inc. in Ashland, Wash. Re- ticle of food that FDA reasonably believes ronmental sources, and clinical isolates called brands included Arrowhead Mills, is likely to be affected in a similar manner,” from infected patients. These sequences MaraNatha, Trader Joe’s, Whole Foods, says FDA spokesman Douglas Karas. FSMA are archived and available in a global pub- Safeway, and Kroger. In both cases, FDA in- also allows the agency to obtain records lic database called GenomeTrakr, which spectors had collected pathogen samples related to “any food having a reasonable currently contains more than 7,000 Sal- during routine inspections of production probability of causing serious illness or monella, Listeria, and E. coli isolates. The facilities; in the case of Roos Foods, they death, and any other article of food it rea- network of local, state, and federal labs is also had collected samples from finished sonably believes is likely to be affected in a adding about 500 more isolates monthly. food products. similar manner,” he says. “This is huge,” Dr. Brown says. “As more Going forward, FDA promises to be “Once either of the above mentioned laboratories contribute to the database, it’s proactive. “This [genomic] information circumstances is met, the FDA may re- going to be an extraordinary new day in the can be used to help enforce compliance quest all existing records related to the field of public health and microbiology.” with FDA’s food safety rules and remove suspect food and any other food that the As good as WGS may be, FDA and other contaminated food from the food sup- FDA believes is likely to be affected in a agencies are seeking even more powerful ply before it results in any illness. This is similar manner that are needed to help pathogen detection tools. In October 2014, made possible by collecting samples and determine whether the circumstances FDA and CDC announced food safety cataloging gene sequences from food pro- that gave rise to the records request exist,” “challenges” in which they are offering duction facilities,” the FDA announced in Karas tells Food Quality & Safety maga- cash prizes to private sector scientists, a recent Consumer Update. zine. While declining to respond specif- academics, entrepreneurs, or innovators While few could object to employing ically to Dr. Acheson’s hypothetical pea- who submit the best ideas for “applying WGS during a foodborne illness outbreak, nut butter company scenario, Karas noted novel methodologies to foster revolution- some worry that using it as a monitoring that in the case of the nSpired recall, “the ary improvements in foodborne pathogen and enforcement tool will open companies important point to remember is that the detection.” FDA’s Food Safety Challenge to unnecessary risk. “Regulators want food samples were indeed taken by FDA staff targets “cutting-edge techniques” to sig- companies to put in preventive controls, during an inspection.” nificantly speed the detection ofSalmo - look for problems before they occur, and So what should food companies do, es- nella “with identification to the subtype/ if they find a problem, to fix it,” says Da- pecially those dealing with products hav- serovar level in minimally processed fresh vid Acheson, MD, founder and CEO of The ing a higher risk of potential pathogenic produce.” Of special interest are concepts Acheson Group and a former FDA associ- contamination? “If indeed the FDA did to accelerate or eliminate sample prepa- ate commissioner for foods. The agency’s have access to a company’s whole genome ration and/or enrichment in the testing recent revision proposal of the preventive sequencing library—even when there is a process. The contest “is a means to con- controls rule for human foods, for exam- for-cause inspection—it would raise some sider approaches (and possible solutions) ple, requires companies to undertake serious questions around the wisdom of through others’ eyes, with technology that environmental monitoring and product having such a library,” Dr. Acheson says, we may not have considered applicable,” testing for certain high-risk and ready-to- because the agency can compare those explains Palmer Orlandi, PhD, senior sci- eat foods. data with environmental samples taken ence adviser at FDA’s Office of Foods and “FDA expects a peanut butter plant to anywhere in the world. Should the agency Veterinary Medicine. look for Salmonella and if they find it, deal find a match, the company will likely find “Some of the greatest innovations are with it,” Dr. Acheson tells Food Quality & itself in trouble. born from ‘outside-the-box’ thinking and Safety magazine. “So if a food company is And should the company keep a sam- this is what we hope to achieve. The prize not actively looking for trouble, so to speak, ple of the Salmonella isolate in its freezer, purse [$500,000] doesn’t hurt as an added they will get dinged for not looking.” The “there’s an untested question of whether incentive, either,” Dr. Orlandi wrote in an quandary, Dr. Acheson says, could come or not the FDA can get that isolate,” Dr. FDA blog posting. The submission dead- after the peanut butter plant has found Acheson adds. “The FDA can get your re- line was Nov. 9, 2014. Up to five finalists Salmonella somewhere in its facility, say cords, and they can probably go after the will receive $20,000 each and will be eligi- in a crack in the floor, and eliminated it. isolate, run it through WGS, and see if it ble to snag the remainder of the $500,000 Could FDA obtain the company’s records, links to an outbreak that happened else- jackpot when the winner is announced its genome sequencing catalog if it has one, where. Obviously, don’t keep the isolate. If March 5, 2015. ■ and even a sample of the bacteria isolate if you found the Salmonella and got rid of it, Agres is a freelance writer based in Laurel, Md. Reach him retained in a company freezer? it’s gone.” at [email protected].

December/January 2015 11

12 A ery division was acquired byacompetitor. company when the company’s fresh bak was aplant manager at a large global food more challenging. companies merge, thattask becomes even sponsibility, and when food and beverage granted isfarfrom easy. It’s ahuge re- quality andsafetyconsumers take for turers knowthatensuring theconsistent the scenes, foodandbeverage manufac beverage products they enjoy. But behind turned raw ingredients into thefoodand food safety programs | for plant managers as they struggle to integrate two distinct Mergers and acquisitions can cause adifficult transition period Come First Must Consumer Safety When Food Merge, Brands

I’ve been there. Earlier in my career, I I FOOD manufacturing processes that put much thought into the at theirlocalgrocer, theyrarely s consumers scantheshelves ndustry ndustry

QUALITY & S AFETY b y Katie - - Moore to oven temperature, andin others, itmay may berelated to divider downtimes due out information.Insomeinstances, it facilities, equipmentconstantly churns In today’s connected foodmanufacturing you receive from your plantequipment. mustbeto thedata erations understand One ofthefirst goals when merging op Metrics are Key withoutahitch.transition through thedifficult merger/acquisition think canhelpplantmanagers make it our operations. Here are afewthings I navigating thecomplexities ofmerging our customers’ favorite baked goods while We worked hard to continue producing I

nsights - may notbethecase, soyou will need to on thesamefood safetysystem. Butthat pler because bothorganizations would be In aperfectworld, mergers would besim- Have forYour aPlan Standards decisions. operational ting theright informationto make smart nected machines canensure you are get running. Standardized metricsandcon- Resource Planning, orERP, system you are entities tracked dataandmeasured results. and connected to whichever Enterprise to work withtechnology thatisadaptable sorting through standardization isithelps stances. Onething to keep inmind when ent foreach company andsetofcircum- task, and the right approach will be differ dardizing metrics can be quite a daunting able insights from your plantfloor. Stan- then you are action- notgleaning smart, you’re notcomparing “apples to apples,” ensure thateverything isstandardized. If differences inhowtheformerly separate a merger, thiscanbecompounded bythe driven dataisthereal challenge. During picture” through thevolume ofmachine of allthat information andseeing the“big be metaldetector readings. Making sense A smart plantmanagerA smart will work to www.foodqualityandsafety.com - -

© .shock - Fotolia.com © vector_master - Fotolia.com

ogy canhelp. Providing employees on too late. so remedial actioncanbetaken before it’s ant to escalate potential problems quickly and costly recalls are atstake, itisimport on theplantfloor. Whencustomer safety how to proceed inthecaseofaproblem as possiblesothere isnoconfusion over tion protocols must be addressed as early according to plan—noexceptions. Escala to knowwhat to dowhen things donotgo quisition process, every employee needs duringand in particular a merger or ac No matter where you are as a company, Protocol Escalation date underonecommon platform. it makes senseforthefacilitiesto consoli- youstandpoint, needto consider whether from anadministrative andmanagement ent schemes atdifferent facilities? Ifso, like Are SQForBRC? you running differ a Global Food Safety Initiative scheme, plan to adhere to. Are theplansto follow figure outquickly which standards you This isanotherarea where technol - - - - - was notbaked appropriately. Thatiswhy bigger problem andyou have product that anomaly inanoven before itbecomes a Proficy software canhelpidentifyaslight For example,GEIntelligent Platforms’ avoiding or mitigating seriousproblems. quicker, canbeextraordinarily helpfulin the plant floorwithbetter information, and connected machines operational decisions. mation to make smart getting theright infor Standardized metrics can ensure you are - future fullofsatisfiedcustomers. the combined entitytoward asuccessful processes, you willbeready to helpguide quality, andtrueline-of-sight into your data. With a strong focus on safety and gleaning actionable intelligence from that getting the best possible information and listening to themachines andthepeople— process. You simply needto ensure you are without incident and it can be a smooth I say aplantmanager canget through it I speakfrom first-hand experience when While mergers canbeachallenging time, ensure continued foodsafetyandquality. into amerger, isto butthemostimportant There are many considerations that go Keep Top Safety ofMind and your are brand well protected. gether, theycan ensure your consumers your peopleandyour technology—to toit is so important foster synergy between Institute. [email protected]. systems as an SQF practitioner through the Safe Quality Food AIB International and is qualified in implementing SQF 2000 through certified HACCP advanced is Platforms, Intelligent Moore, globalindustrymanagerforfoodandbeverageatGE December/January 2015 ■ 13 -

14 A (FSANZ), to ensure Australia’s foodregu Food Standards Australia New Zealand ofHealthpartment andAging (DoHA) and government agencies, particularly the De works withindustry andotherAustralian ture (DoA) Food Regulation Policy Section that extends from farmto fork. food production andfoodsafetysystem tinent are thefruitsofahighly developed and othertastyfoodsproduced onthecon each continent. quality, safety, issuesof andregulatory series ofarticlesthatwillshowcase food inasix-part isthefirst Editor’s Note: This These unique local lip-smacking goodies These uniquelocallip-smacking Vegemite just ontoast, to thelist. start bequed snags, pavlova, lamingtons, and

The Australian ofAgricul Department Food Down Safety Under standards for accountability | Australia’s food protection system sets high A FOOD with beetroot, crab sticks,with beetroot, bar quick to mentionhamburgers their favorite foodsandtheyare sk Australians to share someof

QUALITY round round & S AFETY - - - - - the foodregulatory system andeach level these policies.” standards forAustralia, which reflect must beconsidered when setting food latory policy andpolicy guidelines that rum isinvolved indeveloping foodregu New Zealandgovernments. AndtheFo territories, aswell astheAustralian and representingdepartments thestates and of minsters from health andagriculture Dr. Crerar says. Forum “The ismadeup ernance Forum onFood Regulation,” determined bytheLegislative andGov those ofAustralia. its foodsafetyinitiatives collaborate with many ofthecontinent, land isnotpart of and Surveillance WhileNew Section. Zea- FSANZ’s Strategic Science, International according to Scott Crerar, PhD, manager of lations protect publichealth andsafety,

By There are three levels ofgovernment in “Australia’s foodpolicy framework is Linda L. Leake, T he he

MS Worl - - - standards,” Dr. Crerar says. to thefinalizationofnewor revised food transparency, andconsultation, prior and ensures ahigh level ofparticipation, Australia hasserved thecountry well system thathasbeenestablished within by state andterritory governments. Standards Code,thatis, inturn,enforced lished intheAustralia New ZealandFood line withthispolicy, which are thenpub tional FSANZ develops foodstandards in and New Zealand governments. The bi-na tation withAustralian state andterritory, to develop foodregulation policy. ment andstate andterritory governments laboratively withtheNew Zealandgovern Commonwealth Government works col nance Forum onFood Regulation, the imported food,Dr. Crerar explains. safety through regulating food,including plays arole inprotecting publichealth and gram (IFS)gram contributes to themaintenance inhibit market access potential. andtrade ered, andto restrict any thatmay barriers its industry interests andtrade are consid of international foodstandards to ensure Australia participates inthedevelopment International Food Standards requirements.” cessing requirements through to retail sale territory foodactsusually cover foodpro primary production legislation.State or at thefarmlevel istypically covered by explains. “Regulation of food production of the Food Standards Code,” Dr. Crerar which gives legal force to the requirements develop andadminister foodlegislation, tion, andthrough statutory authorities. of Agriculture/Primarypartments Produc through state of Health, Departments De- by theindividual states andterritories of thedomesticfoodsupply iscontrolled legislation across many sectors, thesafety While there isoverarching federal collaborative“The foodregulatory DoHA setspolicy onfoodinconsul Through theLegislative and Gover “The state andterritory“The governments The International Food Standards pro www.foodqualityandsafety.com d ------

© Ekler - Fotolia.com and development of international market access opportunities for overseeing and promoting sound management systems in industry the Australian food and beverage industries. This is achieved by to ensure safe and hygienic products. “MLA conducts research and providing scientific and technical advice in the development of develops systems to satisfy the needs identified by SAFEMEAT,” Australian positions in government-to-government negotiations Jenson points out. on international food standards. A key undertaking within SAFEMEAT is the Microbiological IFS is principally involved in a range of committees and task Food Safety Research and Development Program, Jenson says. forces of the Codex Alimentarius Commission (Codex). Working “Of relevance to the U.S. market, MLA has invested heavily in with Codex Australia, the Australian Codex Contact Point, IFS ac- understanding the behavior of E. coli in our production and pro- tively encourages the involvement of Australia’s food and beverage cessing systems,” Jenson relates, “demonstrating a low prevalence industries and government agencies in developing Australia’s po- of this microbe and a low risk of illness when Australian manu- sitions for Codex negotiations. facturing beef is consumed in hamburgers in the United States.” Through the Food Chain Resilience project within the Agricul- Recent MLA-funded research demonstrated the low preva- tural Productivity Division, DoA is involved in the development lence of antibiotic resistant Salmonella and E. coli in Australian of two initiatives designed to ensure Australia’s preparedness for beef cattle. “We want to stay ahead of the market on issues like significant national emergencies—the Critical Infrastructure Resil- antibiotic resistance,” Jenson emphasizes. “The very low preva- ience Strategy and Food Supply Chain Continuity Planning. lence we have found should give confidence to our customers and FSANZ develops and promulgates the food standards that are it tells us that we don’t need to make big changes to our production published as the Australia New Zealand Food Standards Code (the systems to stay this way.” Code, a collection of individual food standards that cover the use of ingredients, processing aids, food colors, additives, vitamins, Dairy minerals, and chemical and microbiological contaminants). “The The Australian Dairy Food Safety Regulatory Framework has three standards also cover the composition of foods such as dairy, meat, elements, says Helen Dornom, manager, sustainability including seafood, and beverages; food hygiene requirements; labeling and food safety and integrity at Dairy Australia (DA), a national dairy mandatory warnings or advisory labels; as well as new technolo- service organization. gies and novel foods,” Dr. Crerar adds. “First, under national legislation, it is mandatory for dairy “FSANZ only develops the standards and has no role in their farms and dairy companies to have a documented and imple- implementation,” he emphasizes. “Other roles undertaken by (Continued on p. 16) FSANZ include surveillance, coordination, and monitoring food recalls and food incidents in Australia.” Under the Code, food processors have a responsibility to imple- ment preventative-based food safety systems and for some sectors HACCP-based food safety programs are mandatory. The role of the State and Territory enforcement agencies is to approve and audit these food safety programs. “This is a significant point of difference from the United States,” Dr. Crerar notes. “Australia has implemented food safety programs, and there is less reliance upon inspection or final prod- uct testing. It’s all more about systems and audit.”

Red Meat With its national cattle herd at 27.5 million head, including 13.6 million beef cows and heifers, Australia has 3 percent of the world cattle inventory and is the world’s seventh largest beef producer, according to Meat & Livestock Australia Limited (MLA), an orga- nization that delivers marketing and research and development LOWER services for Australia’s cattle, sheep, and goat producers. MAINTENANCE “Australia produces 4 percent of the world’s beef supply, COSTS, INCREASE around 2.2 million tonnes of beef and veal in 2012-2013, and is EFFICIENCY, AND the third largest beef exporter,” says Ian Jenson, MLA’s manager PREVENT RECALLS. of market access science and technology. (One Australian tonne equals 2,204.623 pounds.) “Beef exports to the U.S. are likely to exceed 300,000 tonnes in From our comprehensive line of maintenance 2014, worth more than AU$1.5 billion,” Jenson notes. (As of Oct. 31, chemicals to our 2014, 1 AU$ equals .88 US$) “The majority of beef exported from exclusive DETEX™ ® Australia to the U.S. is manufacturing beef or trim for grinding.” technology, LPS has your food safe solution. SAFEMEAT is the food safety partnership between the Aus- tralian red meat industry and the government; its primary role is www.lpslabs.com

December/January 2015 15 AROUND THE WORLD

(Continued from p. 15) Produce Foodborne Illness Numbers mented dairy food safety program that is For the major horticultural product developed, validated, and approved to groups, fruit and nuts, and then vegeta- The Australian Department of Health national and international standards,” bles, gross value of Australian produc- ­recently released its “Foodborne Illness Dornom relates. “Secondly, individual pro- tion in 2011-12 was AU$4.09 billion and in Australia: Annual Incidence circa 2010” grams from farm through to retail or export AU$3.338 billion, respectively, according report to better understand the epide- are verified by government authorities. to the Australian Bureau of Statistics. miology of specific pathogens and food- Third, each business is licensed based on During that same time period, the coun- borne causes of gastroenteritis. The re- compliance and performance against the try exported AU$1.239 billion of fresh and port found that there was an “... estimated food safety program.” processed fruit, nuts, and vegetables. annual 4.1 million cases of foodborne gas- A significant exporter of dairy prod- Freshcare, the largest Australian on- troenteritis acquired in Australia, along ucts, Australia shipped approximately farm assurance program for fresh pro- with 5,140 cases of non-gastrointesti- nal illness and 35,840 cases of sequelae. AU$3 billion in dairy products during 2013- duce, provides food safety and quality and Norovirus,­ pathogenic E. coli, Campylo- 14, according to the Australian Bureau of environmental certification services to bacter spp., and non-typhoidal­ Salmo- Statistics. The U.S., while not in the top 10 more than 5,000 participating businesses nella spp. were the most common known relative to Australia’s dairy export destina- nationwide, according to Clare Hamil- causes of foodborne gastroenteritis, al- tions, imported 6,490 tonnes of dairy prod- ton-Bate, executive officer, Freshcare. though approximately 80 percent of ill- ucts in 2013-2014, including 1,891 tonnes of “The recently formed Fresh Produce nesses are of unknown pathogens. Ap- cheese and 1,386 tonnes of lactose. Safety Centre Limited, a not-for-profit proximately 25 percent of the 15.9 million Companies exporting dairy products company to enhance Australia and New episodes of gastroenteritis that occur in must be registered with the DoA and sub- Zealand fresh produce food safety, is ­Australia were estimated to be transmit- ject to compliance audits. “These audits are currently looking to review the Freshcare ted by ­contaminated food. This equates to an average of approximately one episode conducted by the State Food Authorities Guidelines for On-Farm Food Safety for of foodborne gastroenteritis every five on behalf of the DoA,” Dornom explains. Fresh Produce and maintain it, unpinned years per person...”—FQ&S “Moreover, importing countries regularly by current research, as a reference tool come to Australia to audit the Australian for Freshcare and other food safety pro- dairy food safety system. For Australian grams,” Hamilton-Bate says. dairy establishments to export to the U.S., “Freshcare has become the indus- retailers, food service providers, and sys- they must be registered by the U.S. FDA and try standard for food safety in the fresh tem owners (including Freshcare) to try to may be subject to on-site audits by the FDA.” produce sector,” says Alex Livingstone, define a single food safety standard that Even in the absence of any current chief executive officer of Growcom, an could potentially cut more than AU$40 dairy safety issues, the Australian dairy organization that provides services to the million out of auditing costs borne directly industry’s Issues Management Group Queensland horticulture industry. “How- by Australia’s produce farmers. (IMG) was developed in 2002 as a network ever, one of our major retailers still has “Freshcare is in the process of seeking of industry and government stakeholders their own food safety standard, and oth- GFSI benchmarking, whilst at the same coordinated by DA. The IMG’s objective is ers only accept international food safety this project is an attempt to align, as much to provide a comprehensive and indus- standards, benchmarked to the Global as possible, the food safety standards to try-wide approach to address issues that Food Safety Initiative (GFSI). In addition, reduce compliance costs,” Livingstone may affect the reputation and future via- the food service industry has a separate explains. “The project is making some bility of the Australian dairy industry. system again. Hence, some producers progress, although each participant will “We embrace a cooperative and proac- have to comply with three or more food still want to have some components that tive partnership approach to identify any safety standards.” are unique to them.” emerging food safety issues that may affect According to Livingstone, a recent “We have been very fortunate that we dairy product safety at any time down the project funded by the not-for-profit Hor- haven’t had a major food safety incident road,” Dornom says. ticulture Australia Limited has engaged in Australia’s horticulture industry and I think that is testament to the high quality of all the standards,” Livingstone says. ■

Leake is a food safety consultant, auditor, and award-win- ning journalist based in Wilmington, N.C. Reach her at [email protected].

For bonus content on food safety

in Australia, go to the December/Jan- A u s tra li a Da i ry uary 2015 issue on www.foodquality­

andsafety.com and click on “Food M L A Australia has 3% of the world cattle inventory and It’s mandatory for dairy farms in Australia to have Safety Down Under.” is the world’s seventh largest beef producer. documented and implemented food safety programs.

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© viperagp / chrisdorney / Balint Radu - Fotolia.com FOTOLIA.COM A systematic allergen risk assessment approach for industry will enable control of cross-contamination risks and provide accurate allergen information to consumers, ­allowing them to make informed decisions By Evangelia Komitopoulou, PhD

ccording to recent data, up to 15 million Americans formal procedures for rework, and adequate personnel training suffer from food allergies—affecting­ 1 in every 13 chil- programs. Publically accessible guidelines on effective allergen dren under the age of 18 and bringing the economic management and control have been published to use as a refer- cost of children’s food allergies alone to an estimated ence material. In Europe, FoodDrinkEurope published a guidance A$25 billion per year. Food allergies among children increased document on allergen management practices for food manufac- approximately 50 percent between 1997 and 2011 while hospital turers in January 2013. The document provided an overview of key admissions for severe reactions in children in Europe have risen elements in allergen risk management, such as staff training, sup- seven-fold over the past decade. In a world survey conducted by plier management, raw material handling, equipment and fac- the World Allergy Organization, the British Society for Allergy and tory design, documentation and record keeping, manufacturing Immunology reported that 25 percent of the adult and processes, product development/reformulation, and 25 percent of the childhood population in the consumer information. It also included some U.K. suffer from one or more allergic diseases; practical implementation tips, an allergen however, the overall prevalence of allergic risk assessment model, and an overview disease in the U.K.’s general population of the latest European legislation on has remained stable over the past 10 allergen labeling. In addition, the years. British Retail Consortium (BRC) Confusion ­ published a new best practice Allergen-Related Recalls guideline document on allergen Along with food allergies, al- management in March 2014 for lergen related product recalls food manufacturing sites that continue to be on the rise in the Surrounding aimed to provide additional ex- European Union (EU), while in planation of the allergen man- the U.S. undeclared allergens agement requirements of the were reported as the single largest BRC Global Standard for Food cause of food recalls, representing Safety. It was designed approximately 40 percent of recalls Allergen to assist individuals recorded in the third quarter of 2013 and companies to- alone. According to recent quarterly re- Labeling wards the develop- call index published by ExpertSOLUTIONS, ment of robust allergen USDA-registered product recalls increased by management systems and 33 percent in the second quarter of 2014 compared to procedures that would meet the the first quarter of the same year, with 50 percent of those recalls requirements of the Standard. initiated due to undeclared allergens. These product recalls are mainly a result of simple operational The Confusion errors such as failures in the review A recent industry survey carried out by SGS confirmed that al- and approval of product labels; though industry was familiar with the best practice approach to failures to load and/or change to allergen management and control and adopted recommended the correct product packaging; fail- practices to various extents, participants identified key knowl- ures to adequately review supplier edge gaps related to allergen labeling. Lack of a harmonized and information, such as supplier cer- consistent approach in allergen risk management and determina- tificate of analysis, to spot the pres- tion of safe allergen thresholds was identified as the top knowl- ence of allergens; etc. Unintentional cross-contamination edge gap (67.1 percent of respondents) while a gap in knowledge is considered to be an important cause of allergen-related product around allergen cross-contamination labeling rules came third withdrawals, although the majority of those recalls are a result of on the list (46.6 percent of respondents). Product labeling is an mislabeling and mis-packaging errors. important risk management and communication tool and should Prevention of cross-contamination can be achieved fol- help consumers make an informed choice about the products lowing different approaches listed amongst the recommended they are buying. There is no cure for the effective treatment of general practices: efficient cleaning of production lines and of food allergies and therefore sensitive consumers would need to equipment and utensils used in the product preparation and han- rely on avoidance, which is entirely dependent on the accuracy of

© Ba lin t R a d u - Foto li a. c om dling, strict separation of materials that may contain allergens, (Continued on p. 20)

December/January 2015 19 COVER story: Confusion ­Surrounding A­ llergen Labeling

(Continued from p. 19) this has been coordinated by the New Zealand and Australia Al- the information included on the product lergen Bureau that have developed what is known as Voluntary label. Even though guidance exists as Incidental Trace Allergen Labeling system, also known as VITAL. to what would constitute probable This is a risk management tool used to determine the concentra- contamination, such guidance tions of a food allergen present in a food product that could trigger A “zero threshold” cannot discriminate the actual the adoption of precautionary labeling. approach currently levels of such contamination that would be sufficient to Precautionary Labeling adopted is far from being elicit, or not, a reaction in sen- The first question in the use of appropriate precautionary label- operationally practical sitive individuals. ing is whether such warning is actually needed. General guidance or feasible. Some businesses have ad- for the use of precautionary labeling was published in 2006 by opted their own levels of an aller- the Foods Standards Agency in the U.K. in the form of a decision genic food protein that they consider tree. This included a series of questions that aimed to identify would constitute little or no hazard to the likelihood under normal operating conditions for cross-con- sensitive individuals (also known as refer- tamination of a specific food to occur with any of the allergens ence dose). Reference doses have then been extrapolated to derive of concern along with the role of such allergen(s) in the product the action levels, i.e. the concentrations of allergenic food protein recipe and its regulatory status—is it exempt from the within the actual product that could be considered as being safe to country’s mandatory labeling or not. According to the sensitive consumer. A lot of work has been carried out to reach the above decision tree, if a probable likelihood a consensus on action levels for allergens of common concern and for cross-contamination to occur exists, and the allergen is not already included in the product label as an ingredient and is not exempt from the mandatory labeling regulations either, i.e. it needs to be labeled if present, then hazard charac- How do YOU terization needs to follow and the question whether the risk of cross-contamination can be managed or not answered. If the risk cannot be managed despite optimizing Good Manufac- spot allergens? turing Practices, then a warning label, or precautionary label, is required. The use of allergen action levels in precautionary labeling was further discussed within a recently published guidance document from Campden BRI entitled Food Allergens: Practical Risk Analysis, Testing, and Action Levels. According to the guide, actions levels should not be used in cases where the food allergen of concern is part of the product recipe, i.e. it is intentionally added. Instead, labeling of that allergen should be covered by the applicable legislation. The action level approach is not applicable in cases where the food containing the allergen of concern is targeted for consumption by infants or people allergic to the specific allergen; infants are generally thought to have higher sensi- tivity to food allergens than adults and at the same time clinical research has used observations made in adults. Action Easy, Accurate On-Site Allergen levels cannot be used in products that are labeled as free-from a Gluten Detection Tests for Foods & specific allergen either. Kit: Foods, Drinks Surfaces: Milk, Egg, Why Important & Surfaces Soy & More Whilst existing legislation requires food known to cause signifi- cant food allergies, when intentionally used as part of the recipe, emportllc.com to be declared, currently there is no legislation coving the uninten- tional presence of allergens in a product as a result of cross-con- [email protected] tamination. It is for this reason that precautionary labeling has 866-509-4482 been extensively adopted by industry.

(Continued on p. 22) © ch r isd or ne y / Ba lin t R a d u - Foto li a. c om

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FQ Neogen Allergens Ad 1114.indd 1 11/7/2014 8:53:54 AM (Continued from p. 22

An increase in precautionary labeling being used in an inconsistent manner across different food types has significantly impaired its intended impact as an important risk reduction warning. (Continued from p. 20) allergen does not constitute a food safety hazard. Acknowledg- However, an increase in ment of the existence of population thresholds by regulators is precautionary labeling being required before the implementation of a single standard on aller- used in an inconsistent manner gen risk assessment, such as the VITAL program, is achieved as across different food types has significantly impaired its intended a recognized allergen labeling decision-making tool across the impact as an important risk reduction warning and therefore guid- food industry. ■ ance on its appropriate use is necessary. During the 2014 Global Food Safety Conference, SGS discussed its industry survey and Dr. Komitopoulou, the global technical manager for food at SGS, is a food microbiologist with specific areas of experience in microbiological risk assessment and specifications, food confirmed that lack of communication and interpretation of processing, and preservation. Reach her at [email protected]. available guidance on the use of action levels and the imple- mentation of precautionary labeling was a top challenge across References industry. It was concluded that inconsistency in allergen risk as- 1. Food Allergy Research & Education (FARE) Food Allergy Facts & Sta- sessment, management, and control is not necessarily a result tistics. Available online at http://www.foodallergy.org/facts-and-stats (accessed October 2014). of a specific knowledge gap in recommended practices, existing 2. WAO. World Allergy Organization White Book on Allergy, 2011. laws, or regulations governing allergen labeling. Instead such 3. ExpertSOLUTIONS. Quarterly Recall Index (Q3, 2013). Available online inconsistency could be attributed to uncertainty in the interpre- at: http://recall.stericycleexpertsolutions.com/index/ (accessed October 2014). tation of such laws and regulations that would in turn affect their 4. ExpertSOLUTIONS. Quarterly Recall Index (Q2, 2014). Available online effective implementation. at: http://recall.stericycleexpertsolutions.com/index/ (accessed October A “zero threshold” approach currently adopted is far from 2014). 5. FoodDrinkEurope. Guidance on Food Allergen Management for being operationally practical or feasible; it is therefore practi- Food Manufacturers, January 2013. Available online at: http://www. cally impossible to guarantee complete removal of every single fooddrinkeurope.eu/publication/fooddrinkeurope-launches-guid- ance-on-food-allergen-management (accessed October 2014). molecule of allergenic residue, especially so in facilities where 6. SGS. White Paper: “Allergen Management- An Integral Part of a Safe a number of products of differing allergen profiles are manufac- Food Supply Chain,” 2014. Available at http://www.sgs.com/en/White- tured. As a result, the use of precautionary labeling con- Paper-­Library/Allergen-Management-An-Integral-Part-of-a-Safe-food-­ Supply-Chain.aspx (accessed October 2014). tinues and will continue to be on 7. Food Allergens: Practical Risk Analysis, Testing, and Action Levels 2013, the rise. At the same time, Guideline No. 71. Campden BRI, U.K. scientific data currently 8. Food Standards Agency. Guidance on Allergen Management and Con- sumer Information, 2006. Available online at: http://www.food.gov.uk/ available confirm that al- sites/default/files/multimedia/pdfs/maycontainguide.pdf (accessed­October

lergen safe levels are higher 2014). / Zo nd a ch r isd or ne y Ba lin t R d u - Foto li a. c om akov le va 9. Ward, R., Crevel, R., Bell, I., Khandke, N., Ramsay, C., and Paine, than zero and that there are S. A vision for allergen management best practice in the food industry.

“thresholds” below which an Trends in Food Science and Technology, 2010, 21, 619-625. Y li ya © Nata

22 FOOD QUALITY & SAFETY www.foodqualityandsafety.com

24 T Figure 1: Between 2001 and2007,Between 2001 only 1percent of foreign facilitiesand domestic facilities. a large gap ininspectioncoverage among than 285,000 are foreign facilities. There is feed facilitiesregistered withFDA, more (EMA). Ofthemore than450,000 foodand and economically-motivated adulteration forbothfoodborneillness the opportunity of supply chains, andarguably increases ply increases thelength andcomplexity from 2007. Globalization ofthefoodsup lated products nextyear willbetriplethat FDA estimates of regu that importation exclusively from other countries. The ents, such asspices, are sourced almost from other countries. Many food ingredi- 80 percent ofseafoodproducts coming in theU.S. are imported, withasmuch as More than15percent ofthefoodswe eat in importedfoods with vulnerability assessments Addressing therisk of economically motivated adulteration ­Vulnerability Uncovering Product By By

Karen Everstine, PhD FOOD The number of or ingredients onadaily basis. consumers eatimported foods creasingly globalized andU.S. he food supply isbecoming in-

QUALITY Q & S EMA incidents in each food product category, by location of origin of adulteration. AFETY uality and A Jeffrey Moore, PhD uthenticity - - placement of afoodproduct oringredient following eight typesofEMA. versity ofMinnesotahas identifiedthe Food Protection andDefenseattheUni- gain oftheseller. TheNational Center for ingredient, withthe goal oftheeconomic tion ofthetruenature ofafoodproduct or line is that EMA involves misrepresenta- facturers Association, Thebottom orGMA. Convention (USP), andtheGrocery Manu Initiative (GFSI), theU.S. Pharmacopeial fraud, including theGlobal Food Safety Various groups have definedEMA,orfood Types ofEMA problem ofEMA. some debate about howto approach the and ingredients. However, there isstill lenges posedbyimported foodproducts programs aimedataddressing thechal The agency hasproposed anumberof foreign foodfirms were inspected byFDA. Substitution involves complete re-

- - Heinz ketchup bottles. counterfeit infantformulaandcounterfeit brand-name product. Examplesinclude a product byanunauthorized asa party theft ofinfantformulaandcargo thefts. proved channels. Examples include retail intore-enters commerce through unap where afoodproduct hasbeenstolen and halal foods, anddate-markings. produce, cage-free eggs, kosher foods, fication oflabel information fororganic ing information. Examples include falsi- tion withrespect to harvesting orprocess melamine to milk. dyes to chili powder andtheadditionof Examples include theadditionofSudan enhance theperceived qualityofaproduct. tion ofunapproved chemical additives to coast shrimp. mislabeling imported shrimpasU.S. Gulf Vietnam to avoid U.S. duties import and routing Chinesehoneyshipmentsthrough consumer demand.Examplesinclude regulatory oversight, orto benefitfrom origin ofaproduct to avoid duties, import tofers misrepresentation of the geographic meattothe additionofhorse ground beef. dilution of honey with sugar syrups and alternate ingredient. Examplesinclude of afoodproduct oringredient withan olive pomace virgin oilasextra olive oil. amples include fishspeciesfraud orselling with analternate product oringredient.Ex recent example ofEMAresulting in wide- gen-rich chemical melamineisthemost of milk supplies in China with the nitro the adulterants being used. Adulteration knowledgeable enough about thesafetyof tors domake mistakes andare notalways is to notbedetected. However,- perpetra deaths since thegoal oftheperpetrators do notresult inconsumer illnesses or ucts (seeFigure 1).EMAincidentstypically of dioxin-contaminatedport fish. peanut products andtheintentional ex tentional sale of contamination. Examples include the in- product despite knowledge offoodborne inated product istheintentional saleofa Counterfeit isfraudulent labeling of and refers resale toTheft situations Mislabeling refers to misrepresenta- Artificial istheaddi- enhancement involvesDilution replacement partial Transshipment EMA hasoccurred inmany foodprod Intentional distributionofacontam Intentional Salmonella www.foodqualityandsafety.com or origin masking re -contaminated -contaminated ------

NCFPD EMA Incidents Database spread illnesses and deaths. In 1981, thou- ity assessment type of approach that ho- quality standards for medicines, food sands of people in Spain became ill and listically considers several contributing ingredients, and dietary supplements, is- hundreds died after consuming fraudulent factors that underlie the opportunity and sued the first publicly-available draft guid- olive oil that was actually industrial-grade incentive for perpetrating EMA instead of ance on conducting EMA vulnerability rapeseed oil. just focusing on historical incidents. The assessments. The draft guidance for miti- In 1985, sweet white dessert wines im- GFSI Food Fraud Think Tank recommends gating EMA risk was designed to be gener- ported from Austria were recalled in the the food industry conduct vulnerability as- ally applicable to any food ingredient, and U.S. and other countries due to adulteration sessments and subsequently put in place any food fraud management system that with the chemical diethylene glycol (DEG). appropriate control measures. can be developed from this framework The addition of small quantities of DEG On Nov. 17, 2014, USP, a scientific stan- should be viewed as a dynamic and con- allowed the continuous production of de- dards-setting organization that develops (Continued on p. 26) sirable wines of a consistently high quality without causing short-term health effects in consumers. Ultimately, the adulteration was discovered by a tax inspector who in- vestigated the tax records of a winery. This incident illustrates two of the biggest chal- lenges of preventing EMA. The first is that perpetrators—in this case, a chemist—are intelligent adversaries that may have the technical expertise to effectively evade quality assurance and regulatory testing programs. The second challenge illustrated by this incident is that the most successful adulterant is the unexpected adulterant. At the time of the Austrian wine incident, there was no reason to expect the presence of DEG in wine and no testing was being done for this adulterant.

Vulnerability Assessments For all these reasons, food companies that want to proactively address the risk of EMA in food ingredients that they source need to go above and beyond what is currently outlined in the proposed rule on preven- tive controls in the recently-released up- date to the Food Safety Modernization Act (FSMA). In the “Current Good Manufac- turing Practice and Hazard Analysis and Risk-Based Preventive Controls for Hu- man Food” proposed rule, FDA indicated that additional requirements surrounding EMA would best be addressed as part of preventive controls efforts. The regula- tions as proposed would focus on “circum- stances where there has been a pattern of adulteration in the past” and adulterants that are most likely to cause illness. Re- lying only on these factors would likely not have prevented the tragic melamine incident of 2008 given the lack of histori- cal information about melamine adulter- ation of dairy products that was available at the time. There is general consensus among many organizations that effective mitigation of EMA requires a vulnerabil-

December/January 2015 25 QUALITY Authenticity

Table 1: Framework for conducting an EMA vulnerability assessment. Each contributing factor to EMA vulnerability should be evalu- ated separately in terms of its contribution to overall vulnerability of a food ingredient.

confidence in the integrity of raw materials and helps to establish trust in suppliers. Geopolitical Considerations. U.S.-based food companies and consumers are reliant upon the food safety and regulatory systems in other countries when importing food products. Therefore, it is recom- mended to include a consideration of the level of development of the food safety and regulatory system and other relevant factors such as system disruptions and corruption indices for the geographical source of the ingredient, as well as geo- graphic locations through which it is transported. Economic Anomalies. Since EMA is motivated by the potential for economic gain, monitoring of various forms of economic data may help provide insight into increased vulnerability to EMA in a particular food commodity or ingredient. This may be either macro-level or mi- cro-level data, depending on what is accessible to the organization con- (Continued from p. 25) tionship has been formed with ingredient ducting the vulnerability assessment. One tinuous process. The guidance includes suppliers and the history of food quality example is the sharp increase in global va- an assessment of the contributing factors and safety issues among those suppliers nilla prices beginning in 2000, and corre- to EMA vulnerability, which can then be can provide insight into the potential for sponding evidence of vanilla fraud during ranked on a low-to-high scale for vulnera- EMA vulnerability. the same time period. bility (see Table 1). Each of these contribut- Susceptibility of QA Methods and The horse meat adulteration incident ing factors is discussed briefly below. Specifications. EMA perpetrators are of- resulted in a 1 percent drop in sales for one EMA/Food Fraud History. One of the ten very familiar with industry standard U.K.-based grocery chain, followed by most basic indicators of EMA vulnerability QA methods and specifications. Therefore, a 5 percent drop in shares. In addition to in a particular food product or ingredient it is important to consider how effectively the cost to companies, EMA threatens the is its EMA history and pattern. Information the suite of methods and specifications health of consumers, has negative effects about EMA incidents and issues can be that are incorporated into a QA program on markets, and causes brand damage. found in the NCFPD EMA Incidents Data- can characterize an ingredient and detect Food companies that have a vested interest base and USP’s Food Fraud Database. inauthentic ingredients. in protecting their brand will need to adopt Supply Chain Structure. Visibility and Audit Strategy. The rigorousness of proactive programs to address EMA that go control along supply chains can mitigate the audit strategy and the inclusion of beyond traditional food safety measures. ■ EMA vulnerability. The degree of vertical anti-fraud measures in audits are an im- Dr. Everstine is a research associate at the National Center integration, oversight, and traceability portant consideration when assessing the for Food Protection and Defense at the University of Min- should all be considered as part of a vul- vulnerability of a food ingredient to EMA. nesota where she manages multiple federally-funded EMA projects. Reach her at [email protected]. Dr. Moore is a nerability assessment. Testing Frequency. The frequency senior scientific liaison at USP. He manages EMA projects Supplier Relationships and History used to test raw materials entering a food and develops standards and reference materials for veri- fying the integrity of food ingredients published in USP’s of Quality/Safety Issues. In addition to processing facility is an important factor in Food Chemicals Codex. Reach him at [email protected]. Claudia the structure of supply chains, the degree EMA vulnerability. Evidence-based testing Costabile, M.A. from USP is also a contributor to this article. to which an established and trusted rela- reduces EMA vulnerability by increasing References Furnished Upon Request

26 FOOD QUALITY & SAFETY www.foodqualityandsafety.com QUALITY Authenticity

Food standard authorities rely on Commonly Counterfeited Products food laboratories to use sophisticated Despite the best efforts of national food instrumentation and techniques to identify components of foodstuffs. safety authorities such as the U.S. FDA and the European Food Safety Authority, certain food and beverage product types continue to fall prey to counterfeiting. Notable examples include olive oil, goat’s milk, wines, basmati rice, honey, caviar, vanilla, and saffron. Olive oil is product that is produced to different standards by varying methods of production, and its quality is also deter- mined by the free acidity of the soil. The pro- duction and sell-by dates are also important because olive oil eventually oxidizes and becomes rancid. Since each of these factors determine the value of the end product, fal- sifying any of this information amounts to counterfeiting. In a similar vein, a variety of aromatic basmati rice types are sold at pre- mium prices on the world market, and the Intercepting Food Fraud increasing value consumers are placing on this product also makes it a prime target for Before It Hits the Shelves counterfeiters who adulterate the product Techniques to identify the authenticity and purity of products with the addition of cheaper types of long are in demand as more counterfeit foods enter the consumer grain rice. The average consumer, recogniz- ing the distinct aroma of the basmati rice, By supply chain | Stephen Harrison would probably not notice the presence of the other type of long grain rice. Goat’s milk can be diluted with cow’s he economic impact of counter- The world was made aware of this milk and the difference is very difficult to feiting products in the food and danger in 2008, when six babies died detect by taste alone. Honey can be coun- beverage industry amounts to and 300,000 babies fell ill after drinking terfeited in various different ways. It can millions in lost sales and prof- melamine-tainted milk products in China. be adulterated with sugar, corn syrup, and Tits to retailers, producers, and suppliers. Another major food scandal broke in Eu- other sweeteners, or the type of honey is Fake claims about the content of foods and rope in 2013, when it was revealed that misrepresented by a fake declaration of beverages also pose an unsuspected risk horse meat was being labeled as beef from botanical or geographical origin to attract to consumer health, as well as to people cattle. Although horse meat is suitable for a higher price on the market. For example, who base their food choices on their ethi- human consumption, the public health is- Manuka honey is broadly hailed as a won- cal and religious convictions. sue relates to the type of tests conducted to der product that demonstrates antiviral prove the suitability of the beef for human and antibacterial qualities. Not as sweet Consequences consumption. Since these tests differ from as normal honey, it is made by bees gath- Consumers make their purchases in good those applied to horse meat, applying the ering nectar from the delicate flowers of faith, putting their confidence in the hon- wrong tests to the sample could create an the Manuka bush, native to New Zealand. esty and integrity of the supply chain. opportunity for hazardous substances, When this rare and highly priced product Counterfeiting is at odds with this reason- such as residual chemicals from veterinary is misrepresented, consumers are not only able assumption that a product is all that medicines, to enter the food supply chain. duped financially, but are also cheated of it claims to be on its labeling. Coinciding Food and beverage counterfeiting syn- the health benefits associated with it. Cav- with the financial losses facing businesses dicates are motivated by greed and driven iar is another rare and expensive product on the production and supply side, the by the attraction of increased sales mar- that black market dealers substitute with consequences to consumers can range gins. Sometimes a reluctance to discard the roe of other fish, passing it off as the from simply being deceived about the products that have passed their sell-by roe of the sturgeon harvested only in the product’s content, or not benefitting from date leads to re-labeling and, in the case waters off Russia and Iran. the anticipated efficacy of the product, to of exported products, there is an objective Expensive spices like saffron and va- the more severe outcomes, including ill- to bypass or reduce Customs and Excise nilla are also frequently faked by being

© LINDE ness and death. duties on certain premium products. (Continued on p. 28)

December/January 2015 27 QUALITY Authenticity

(Continued from p. 27) turned into a gas, and then carried through from the burning of fossil fuels and volca- synthetically produced or by being sub- a column by a nonreactive “carrier” gas, or nic eruptions. NMR is also used to conduct stituted with cheaper spices that taste and a gas that will not impact the integrity of this analysis to determine the vintage of a look the same thanks to food flavoring and the food sample, such as helium or another wine quite accurately. dyes. Saffron is the world’s most expensive other inert gas like nitrogen. As the sample To determine whether caviar is truly spice, originating from a relatively rare is carried through the column, it is sepa- from a sturgeon or another type of fish, crocus flower that tends to produce only rated into its individual components. The analysts examine the product’s DNA, the about four blossoms in its lifetime. It is separate components can then not only be unique marker of a species. Sometimes often counterfeited with other harmless identified, but how much of each compo- enhanced with fluorescent dyes, samples plants, such as calendula or even dried nent present is can also be determined. can be examined by a photo spectrometer onion that has been dyed orange. Saffron Despite its name, liquid chromatogra- or, if more sophisticated test is required, and vanilla are grown in many countries phy also employs gas to analyze foodstuffs. the NMR is once again brought into play. where a cash crop is sorely needed and The food sample is dissolved into a solvent DNA testing is also proving an effective one of the consequences of counterfeiting (hence the “liquid”) and then carried by a way to identify the authenticity of basmati is to rob such communities of a percentage moving gas stream (helium or nitrogen) rice, since rice varieties have different DNA of their livelihood. to breakdown the sample into individual fingerprints. Wines and brandies also lend them- constituents. Liquid chromatography’s After saffron, vanilla is the world’s selves to counterfeiting through false infor- even more sophisticated cousin, high per- most expensive spice, and some manufac- mation on the labeling, particularly since formance liquid chromatography (HPLC), turers add coumarin to vanilla products certain vintages attract far higher prices can also help identify compounds as low to increase the vanilla flavor perception. than others. Counterfeiting in this realm as parts per trillion. Coumarin is a phytochemical found in includes adulterating these liquors with When more sophisticated analysis is many plant species, the main source be- the addition of cheaper products such as required, a technique known as Nuclear ing the tonka bean. It has a sweet herba- fruit juices, and sometimes with the addi- Magnetic Resonance (NMR) can be used. ceous odor and has been used in food, tion of harmful chemicals and sweeteners This advanced technique for food counter- tobacco, and cosmetics as a flavoring to compensate for color or flavor. feiting investigations involves generating and fragrance material. However, cou- Over and above the issues of public a very high magnetic field around the marin has been shown to be damaging health, fraud, and tax evasion, counter- nuclei in a particular molecule to allow to liver cells, and has been prohibited feiting of food impacts the spheres of eth- the nuclei to absorb and re-emit electro- from being added to food in the U.S. since ics and religion. Many consumers choose magnetic radiation. The pattern in which 1940. Liquid chromatography, HPLC, to avoid foods that contain beef, pork, or this occurs is detected to identify which and even ultra-high performance chro- other ingredients derived from animals, particular molecules are present. The matography (UHPLC) have proved to be and falsely labeled foodstuffs deceive them intense magnetic field is generated by a effective scientific methods to deter- into transgressing these principles. super-conducting magnet that can only mine the presence of coumarin in vanilla operate in extremely cold temperatures. extract products. Prevention This is achieved by immersing the elec- The demand for the specialty gases The increasing penetration of counter- tro-magnet in liquid helium—the coldest that facilitate the detection of ever lower feit food and beverage into the consumer substance on the earth. levels of chemicals in food is on the supply chain is prompting authorities to In all these techniques, high purity increase. For example, Linde offers the accelerate existing measures to intercept specialty gases, which do not interfere or food industry a range of high purity spe- and identify these products. For example, contaminate the food sample in any way, cialty gases that include nitrogen and during 2013, Customs and Excise laborato- play a critical role. helium for gas chromatography mass ries in France ran half a million analytical The authenticity of olive oil can be es- spectrometry, nitrogen for liquid chro- tests last year on wines and beers entering tablished to a high degree of certainty by matography mass spectrometry, liquid the country, bringing the role of scientific analyzing the most frequently occurring helium for NMR, and helium gas for HPLC analysis into sharp focus. Counterfeit chemical components and developing a and UHPLC. goods are invariably undetectable by sight “fingerprint” for a particular product. The However, the integrity and purity of and smell alone and therefore samples of technique most likely to be used to conduct the gas is only as good as the equipment suspect goods must be analyzed using so- this sophisticated fingerprinting and pro- that delivers it to the point of use. For in- phisticated chemical analysis techniques. filing of olive oil is NMR. stance, Linde says it can ensure its gases Food standard authorities typically One of the most reliable techniques for are delivered to the instrumentation with- rely on expert food laboratories, which determining the age of a wine or a brandy out comprising their quality—often up to a use sophisticated instrumentation and is looking at the quantity of carbon isotope purity level of 99.9999 percent—through its techniques to identify components of food- that exists in these liquors. This method specialty gases equipment. ■ stuffs. One of the most commonly used uses radioactive carbon isotopes left in Harrison is global head of specialty gases and specialty techniques involves gas chromatography the atmosphere by atomic bomb tests equipment at Linde Gases in Germany. Reach him at stephen. where the food sample to be tested is first carried out about 50 years ago, as well as [email protected].

28 FOOD QUALITY & SAFETY www.foodqualityandsafety.com QUALITY Authenticity

The Rise of Product Diversion and Counterfeiting Serialization and tracking and tracing have potential to reduce counterfeit products in food and beverage as well as the pharmaceutical supply chains | By Barry McDonogh

Figure 1: The rise in external ­product failures as ­represented by the number of Figure 2: The growth in the number of registered food facilities that are recalls recorded by the FDA in the food and beverage/pharmaceutical sectors. ­potentially subject to FDA inspection.

nternationalization and the emergence of new business mod- and holding of product. Irrespective of whether production is do- els has increased the complexity of the food and beverage mestic, offshored, or outsourced, manufacturers are still required to supply chain. The rise in complexity has resulted in a loss utilize facilities that comply with all FDA regulatory requirements. of supply chain visibility and control, which in turn has led While quality standards have been set, a real problem has Ito mounting product quality and safety challenges. This article arisen in the capacity of the FDA to monitor site compliance. The draws parallels between the food and beverage and pharmaceu- number of registered food facilities has more than doubled in the tical industry to illustrate that traditional efforts focusing on the period FY 04-11 with an ever-growing proportion of these sites lo- internal quality of manufacturing are no longer sufficient to safe- cated abroad. In 2011, the FDA inspected 318 international food guard consumer safety. manufacturing locations, equating to a little more than 0.1 percent The food and beverage and pharmaceutical industries share of the 271,272 registered sites. While legislation such as the Food many commonalities. One similarity is the importance of product Safety and Modernization Act (FSMA) has attempted to address safety, where an external quality failure can represent a serious this issue by increasing the planned number of inspections to threat to consumer well being. As the supply chains of both in- roughly 20,000 by 2016, this would still represent just 7 percent dustries have become increasingly globalized, they have faced of 2011 facility numbers. escalating incidents of external quality failure. The root causes The FDA faces a similar problem within the pharmaceutical of these failures can be classified into two broad categories:in - sector and has recently gone as far as increasing the annual facil- ternal—relating to manufacturing, and external—relating to the ity fees on foreign manufacturing sites as a means of funding the distribution chain. rising cost of foreign inspections. As markets become more competitive, corporations across With an estimated 15 percent of the U.S. food supply, 80 per- the world are driven to outsource and offshore manufacturing as a cent of active pharmaceutical ingredients, and 40 percent of fin- means of sustaining profitability. A consequence of these practices ished pharmaceutical drugs now being imported from abroad, the is a corresponding decline in quality performance. problem of managing quality in foreign locations is one that the FDA will have continuing difficulty in governing. Combatting Internal Challenges to Product Quality Manufacturers, insurance companies, and vendors can sup- Both the food and beverage and pharmaceutical industries have port regulatory efforts through diligent, conscientious procure- taken similar approaches to strengthen internal quality manage- ment and stringent supplier selection and management. However, ment through the implementation of current Good Manufacturing even the achievement of internal quality management standards Practices as a means of governing the manufacture, processing, (Continued on p. 30)

December/January 2015 29 QUALITY Authenticity

(Continued from p. 29) • A two-year study of U.S. fish supplies STT in the U.S. in outsourced and offshore facilities is in concluded in 2012 that approximately To ensure authenticity as products change itself insufficient to safeguard consumers, 33 percent of the 1,215 samples ana- custody within the supply chain, the FDA as globalization has also produced exter- lyzed nationwide were mislabeled. requires all pharmaceutical products sold nal threats to product safety in the distri- in U.S. to be serialized and scanned at a bution chain. Counterfeits in Other Industries unit or aggregate level through the Drug The incidence of counterfeiting of phar- Supply Chain Security Act by 2023. External Threats to Product Safety maceuticals has also grown dramatically However, there is no such unifying The problems in the external distribution in recent years. While the counterfeit framework in place for the food and bever- chain are both insidious and difficult to products may look the part, the reality is age industry. In fact, a recent comparison control. Here, the increasing complexity of far from that. They are regularly manufac- of global food traceability regulations and the supply chain has facilitated the rise in tured in squalid conditions with the in- requirements focusing on 21 industrialized both product diversion and counterfeiting. correct formulation, dosage, or no active countries found that the U.S. trails behind Diversion relates to the transfer of au- pharmaceutical ingredient at all. Some most other nations analyzed in terms of thentic product from its intended point of counterfeit pharmaceuticals have been basic food traceability. distribution with an aim to capitalize on even found to contain household cleaners, While no comprehensive traceability arbitrage opportunities. While not neces- heavy metals, and poisons. standards have been proposed to date, sarily illegal, diversion can compromise The World Health Organization esti- some market segments such as infant for- product integrity if the affected goods are mates that in the developing world coun- mula have begun to lay the foundation. not appropriately stored. terfeit drugs can account for between 10 In June 2014, the FDA revised the Infant Counterfeit goods are fraudulent or and 30 percent of the market. In devel- Formula Act of 1980 to tighten the controls adulterated imitations represented as gen- oped economies, approximately 1 percent related to internal quality assurance. One uine product that may pose a grave threat of drugs are counterfeit. provision was the requirement to serialize to consumers as they are produced with lit- production to enable traceability. tle concern for quality or safety standards. Combatting External Threats On a macro scale, FSMA references the One technique utilized to counteract the requirement for enhanced product tracing Food and Beverage Counterfeits problem of counterfeiting and diversion abilities going forward. The Institute of Valued at a staggering $49 billion dollars involves the serialization and tracking and Food Technologists (IFT) has also com- a year and growing, the counterfeit food tracing of products (STT). pleted pilots that demonstrate the value and beverage market presents a significant The STT model is predicated on using and achievability of such systems. risk to consumer safety. The counterfeits a product’s origin as a means of preventing The ever-increasing threat to consum- enter the market by a number of different counterfeits from entering supply chain. ers posed by counterfeiting, coupled with means. One ploy is to present cheap ver- By assigning unique numbers to each the work of advocacy groups like IFT, is sions of products as higher quality brands. product and introducing authentication likely to drive more action from the FDA. A second is to introduce cheaper ingredi- at various points, the potential for coun- ents into authentic products in order to terfeit products to get through the supply The Future increase profit margins. In both cases the chain undetected is substantially reduced. In the near future, consumers can expect risk to consumer safety is significant. STT systems also provide improved supply to self-verify that the food in their hands The U.S. Pharmacopeia Convention, or chain visibility so that instances of diver- is safe for consumption. To achieve this USP, is the global watchdog group whose sion can be identified and corrected. goal, manufacturers will be required to food and pharmaceutical standards are en- The STT architecture is typically make investments beyond traditional forceable by the FDA. It has logged more comprised of three elements: a method internal quality assurance and protect than 2,000 incidents of food fraud, impact- of marking products with a unique against the external threats outlined in ing a wide variety of food and beverages. number either through direct part mark- this article. The technology to do this Notable cases include the following: ing or on packaging—typically achieved already exists and is being utilized in other • More than 1,200 tons of fake/substan- through barcoding or RFID technol- industries. dard food and nearly 430,000 liters ogy; scanning infrastructure to capture As manufacturers make investments of counterfeit drinks were seized as specific events related to product move- in STT systems, they will find that the ROI part of Interpol/Europol operation ment within the supply chain; and a means goes far beyond defensive positioning and in 2014; of analyzing and reporting on these cap- the technology can be used to solve real • In 2013, multiple instances occurred in tured events. business problems and even offer a means the European meat supply chain where The STT system is considered one of of competitive differentiation.■ horse meat was presented as beef; the most effective in combatting coun- • In 2012, 20 people died in Czech Re- terfeiting and diversion. So much so that McDonogh is vice president, business development for Systech. Reach him at [email protected]. public and many others hospitalized pharmaceutical regulators across the and blinded after consuming fake li- world are in various stages of completion quor that contained methanol; and in terms of rolling the systems out. References Furnished Upon Request

30 FOOD QUALITY & SAFETY www.foodqualityandsafety.com to food proteins that the human body mistakenly identifies as harmful, affect approximately 5 to 8 percent of children and 2 to 3 percent of adults in developed countries, with rising prevalence. A true TestingSeafood allergic reaction is defined as a type-one hypersensitivity activating a specific type of white blood cells, the mast cells, lead- ing to an immunoglobulin E response. Crustacean Histamine and inflammatory mediators, such as cytokines, are released, leading to different symptoms, including itchiness, Residues in gastrointestinal disorders, dyspnea, or even anaphylaxis and death. Foodstuffs Crustaceans are among the eight food An increasingly widespread groups thought to lead to allergies trig- gered by immunoglobulin E antibodies issue in regards to food aller- worldwide. Hypersensitivity reactions to gies, crustacean test methods different ingested crustaceans, including must be very specific and shrimps, crabs, lobsters, and others are detect minute quantities of among the most frequent causes of food allergic reactions. Furthermore, crusta- allergen in complex ceans are the third most important food- food matrices stuffs inducing food-related anaphylaxis. by Lilian Kuster Several studies have shown that even min- ute amounts of ingested seafood allergens can trigger very quick allergic reactions. It is assumed that even inhaled airborne al- lergens can lead to sensitization and aller- gic reactions. Very commonly, crustacean owadays, seafood plays a very eight food groups, including crustaceans. allergies appear at later stages of life and important role in human nu- In the European Union, there are different the likeliness of them being outgrown, as trition worldwide. It is among regulations that establish labeling must it is very often the case in childhood aller- the major foods consumed be present in regards to the main types of gies, is very small. Nglobally, mainly due to a large movement food allergens to warn consumers. In the towards healthier eating. International U.S., the Food Allergen Labeling and Con- Crustacean Allergen trade in seafood and new seafood prod- sumer Protection Act of 2004 includes the The major allergen in shrimps and other ucts is growing rapidly and there are more eight major allergen groups—namely milk, crustaceans is the ubiquitous muscle pro- and more reports of adverse reactions in eggs, fish, crustacean shellfish, tree nuts, tein tropomyosin, which is responsible for the population consuming seafood. The peanuts, wheat, and soybeans. However, ingestion-related allergic reactions. It is a generic term “crustaceans” includes all allergens can be present in the final food highly conserved protein, is homologous arthropodic aquatic animals, with six ma- product even though the ingredients are in different species, and shows a con- jor subgroups and 44,000 species. Hidden not allergens due to cross-contamination siderable rate of identicalness. Its high crustacean proteins in food represent a between raw materials, equipment, or cross-reactivity even to insects like house critical problem for people with crusta- production lines. Therefore, there is in- dust mites means tropomyosin is consid- cean allergies. Sufferers have to avoid the creasing need for sensitive detection of ered as a possible cause of cross-reactivity consumption of food containing crusta- crustacean residues in foodstuffs, as well between food and respiratory allergens of ceans very strictly. Still, cross-contami- as diagnosis and treatment of seafood animal origins. There are other allergens nation can occur as a consequence of the allergies to protect the allergic consumer that have been identified in crustaceans production process. and to ensure supervision of labeling re- in the past few years, including arginine International organizations, such as quirements by the authorities responsible. kinase and myosin, but they have not yet the Codex Alimentarius Commission of been characterized completely. In contrast the World Health Organization, or WHO, Allergy Overview to other seafood allergens, tropomyosin and the Food and Agriculture Organiza- Food allergies in general have become seems to be relatively resistant to acidic tion, or FAO, have discussed a labeling sys- an important health problem and repre- digestion and heat. The heat stability tem for allergenic ingredients in processed sent a food safety issue. Food allergies, makes this protein suitable for the analysis

R om e r La bs food and labeling is now recommended for defined as an adverse immune response (Continued on p. 32)

December/January 2015 31 TESTING Seafood

(Continued from p. 31) flow devices are most often used as quick Testing Issues of crustacean residues in processed food screening tests for checking the cleanliness It must be stated that both methods, samples. Therefore, allergen-specific de- of production lines and production equip- ELISA and PCR, have their advantages tection assays in food products are avail- ment, therefore preventing one source of and disadvantages and that there is able for crustacean tropomyosin. contamination in the final product. no single method fulfilling all needs. An advantage of PCR is that DNA mole- Detection cules are more heat stable than proteins, The detection methods for food allergens, In a food sample which allows analysis of highly processed including crustacean protein, have to foodstuffs. Moreover, DNA extraction is be very specific and must detect minute containing­ crustacean more efficient than protein extraction quantities of allergen in very complex residues, antigens will in difficult food matrices and harsh lab- food matrices. At present, there are qual- bind to antibodies oratory extraction conditions can be itative and quantitative test methods for of the test solution. applied, as DNA is less prone to damage crustacean residues available. Few tech- than proteins. niques detecting crustacean protein, actu- The main disadvantage of PCR is that ally tropomyosin, are available, including the protein that causes the allergic reaction immunological methods based on a spe- The final product can be screened with is not detected itself. Even if the presence cific antigen-antibody reaction, such as a lateral flow device as well, but most often of DNA implied the presence of protein— lateral flow assays and enzyme-linked food producers prefer to carry out a quanti- how could someone convert a DNA copy immunosorbent assays (ELISA), as well tative method. Currently, two methods are number to mg allergenic protein? Without as DNA-based methods such as poly- mainly used for quantitation of crustacean knowing the expression level of a certain merase-chain reaction (PCR) technolo- protein in food stuffs: ELISA and PCR. allergenic protein in a certain matrix, this gies, mainly real-time PCR. The ELISA is the main immunological conversion is almost impossible. For crus- Lateral flow assays are a simple and method used for the quantitative detec- tacean allergen analysis, normally mito- rapid detection method for the qualitative tion of allergens in different matrices. For chondrial genes are used as DNA targets detection of crustacean residues in food, quantitative analysis of shellfish protein, as they are present in high copy numbers, as well as rinse water and environmental especially tropomyosin, the quantitative resulting in the increased sensitivity of the samples, including surface swabbing, in sandwich ELISA—a very specific and pre- assay. Again the downside is how someone production facilities. Real-time testing cise assay—is widely used. Commercial can convert copy numbers into mg aller- using on-site lateral flow methods is very test kits are available, offering limits of genic protein. Currently, only gluten and important, allowing for quick testing detection of around 0.5 to 1 milligram (mg) sulfites are officially regulated by thresh- and immediate decision making needed crustacean protein, depending on the old levels stating mg/kilogram concentra- when a fast turnaround or trouble shoot- matrix. Wells of a microtiter plate are pre- tions. But how could someone comply, if ing is necessary. Lateral flow tests require coated with polyclonal or monoclonal an- threshold levels for all the other regulated few skills and only a minimal amount of tibodies directed against tropomyosin. An allergens were introduced? training. The detection method is based extracted food sample is applied to these In general, testing issues are mainly on an antibody-antigen reaction. In a food wells leading to the binding of tropomyo- represented by the strongly varying matri- sample containing crustacean residues, sin to the antibodies. During the next step, ces that have to be tested (matrix effect). antigens will bind to antibodies of the test the reaction with an enzyme-conjugated The detection limit of any test, therefore, solution. A test strip being soaked into the secondary antibody directed against tro- will vary depending on the sample matrix solution after the binding reaction can be pomyosin leads to a complex formation to be analyzed. Although providers of test read immediately after a very short incuba- that can be visualized by the development kits often have a validation protocol to be tion time, with one line in the result zone of a colored reaction product between the submitted with the test kit upon request, indicating a negative result or two lines a particular substrate and the conjugated laboratories using commercial test kits positive result. Lateral flow assays for the enzyme on the secondary antibody. As must establish in-house controls on de- detection of crustacean residues in food are an ELISA easily can be used on a routine tection limits and quantification limits rapid, simple, and require no sophisticated basis, demonstrating high precision, it is in actual matrices. As there are no refer- procedures or expensive equipment, mak- probably the most utilized method for the ence methods and no certified reference ing them suitable for routine applications, detection of food allergens, as well as crus- materials for allergens available, one has e.g. for monitoring food production lines tacean residues. to keep in mind that results are not nec- and equipment in food processing facili- DNA-based methods, as traditional essarily comparable between different ties. Though these lateral flow tests are re- PCR and real-time PCR, detect the genome test systems. Accredited methods should liable, they are only qualitative, meaning of the allergenic food as a surrogate for al- be used in official controls. The National the result shows that either tropomyosin lergenic proteins. Therefore, the extracted Food Agency is accredited for the analysis is present (positive, a test line will appear) DNA is amplified by polymerase chain re- of shellfish protein in foodstuffs.■ or tropomyosin cannot be detected (nega- action and detected afterwards (traditional Kuster is the product manager at Romer Labs. Reach her at tive, no test line will appear). Thus, lateral PCR) or simultaneously (real-time PCR). [email protected].

32 FOOD QUALITY & SAFETY www.foodqualityandsafety.com In Tsamheple preparation Lab

10 g sample in 50- Modification: mL centrifuge tube • For fatty sample, use Pesticides in 2-5 g sample, add water , then 16 ml Imported ­Produce Add 10 mL Acetone, acetone/4 mL water. vortex for 10s, shake for • For low moisture 2 min sample, use 2-5 g Rapid pesticide analysis for fruits and sample, +10 mL water ­vegetables by using gas and liquid chromato­ +10 mL Acetone Centrifuge for 5 min • For high moisture graphy coupled mass spectroscopy @ 5000 rpm sample, use 5 g sample +10 mL Acetone By Joe Anacleto

Pull sample extract into UCT Extraction the 50-mL UCT Tube: extraction tube, vortex • 1 g C18 10 s onitoring pesticide residues in fruit and vegetables • 4 g MgSO4 remains a key priority for international food safety. Add 1 mL Petroleum • 4 g Fructose • 8 g NaCl Increasing imports from countries, such as China Ether, vortex for 10 s, centrifuge 5 min @ 5000 • 2 g PSA and India, with substantially different regulations Mto their Western counterparts, highlights the need for stringent rpm pesticide monitoring. Tandem mass spectrometry coupled to chromatography systems, such as gas chromatography mass Decant the supernatant, spectrometry (GC-MS) and liquid chromatography mass spec- filter with 0.45 µm filter trometry (LC-MS), operating in multiple reaction monitoring (MRM) mode has emerged as the industry standard for monitoring dilute with 3x water, Inject 1 µL directly residues in fruits and vegetables. However, a continuing challenge centrifuge, and inject to GC-MS/MS in multi-residue analysis is finding a sample preparation method 30 µL to LC-MS/MS that is as easy, fast, and cost-efficient as possible. The U.S. FDA recommends the QuEChERS (Quick, Easy, Cheap, Figure 1: A modified QuEChERS sample preparation protocol developed Effective, Rugged, and Safe) method for residue screening based at the U.S. FDA Lab at Irvine. on MRM with advanced gas or liquid chromatography coupled mass spectrometry systems. However, these QC methodologies on the use of pesticides is a barrier that limits producers from ac- can be complex and time consuming, particularly for trace pesti- cessing the full potential of the export market. Imports from re- cide analysis in complex biological matrices. A modified QuECh- gions where pesticide use is less restricted to those with stringent ERS preparation protocol developed by the FDA Irvine laboratory regulations are frequently subject to detention and often returned in California can extract multiple classes of pesticides from a wide to their country of origin or disposed of, resulting in an immediate variety of samples. This methodology presents an alternative to the loss in investment. conventional QuEChERS technique and allows the extracted ma- The benefits for global standardization have now been recog- trix to be directly injected into the instrument, saving preparation nized and governments around the world are beginning to take time. This article demonstrates that the modified QuEChERS sam- steps to bring the regulations guiding crop growth and mainte- ple preparation protocol is a simple, less expensive, and unified nance in line with their Western counterparts. For instance, China alternative to conventional QuEChERS protocol. has recently limited the use of harmful pesticides that are widely banned on international markets, while Pakistan has announced Challenges of International Trade its intention to bring rice and mango production in line with FDA The liberalization of global trade has greatly benefited emerging guidance. However, accurate and robust pesticide quantification economies around the world. Following its accession to the World methods are essential to determine whether consumable products Trade Organization in 2001, China is now a major global producer comply with international and domestic regulatory standards. of agricultural products, especially fruits, vegetables, rice, and Extracting multiple pesticide species from fruits and vegeta- pork. In 2009, China was the fourth leading global agricultural bles is a challenging process due to the complex biological matri- to nics exporting country (behind the U.S., Brazil, and Canada), with ex- ces. Conventional analytical techniques have, until recently, been ports to the U.S. alone reaching approximately $3.3 billion in 2010. unable to deliver the sensitivity required to achieve reliable trace

Bruk e r Da l However, the lack of global standardization or global consensus (Continued on p. 34)

December/January 2015 33 IN THE LAB Sample preparation

Figure 2a (left): MRM chroma- tograms for selected pesticides at 1 ppb in spinach extract by

LC-MS/MS; Figure 2b (right): to nics MRM chromatograms for selected pesticides at 5 ppb in

spinach extract by GC-MS/MS. Bruk e r Da l

(Continued from p. 33) known volatile analytes is required, GC-MS systems are a suitable level analysis. Consistently achieving the high levels of sensitivity and lower priced alternative. required can also be a time intensive and laborious task, which is Despite the increased availability of sophisticated GC-MS and undesirable for a high-throughput routine QC laboratory. Devel- LC-MS systems, the functionality of many commercially available oping analytical technologies and screening methodologies to be systems is still limited by technological aspects, struggling to de- able to quickly and accurately qualify and quantify trace pesticide liver the levels of sensitivity and specificity required. Yet, triple residues is therefore a priority for both instrument developers and quadrupole MRM overcomes many of these limitations and deliv- regulatory bodies. ers the performance levels required for pesticide detection.

Advancing Detection Procedures Technological Developments in GC-MS and LC-MS The USDA QuEChERS method for pesticide residue analysis was MRM helps to maximize reliability in pesticide detection by frag- presented at the 2002 European Pesticide Residue Workshop. menting ionized analytes into multiple ions. When MRM is in- QuEChERS simplifies the analysis of pesticide residues in food products, including fruits and vegetables, and takes advantage of advances in LC-MS and GC-MS. The method is now stan- dardized within AOAC 2007.01 EN15662, hav- ing proven more productive than conventional preparation techniques. The QuEChERS protocol uses less expen- sive and fewer solvents and provides a faster ex- traction method. Samples are homogenized via blending before centrifugation and extraction with a suitable reagent. The modified QuEChERS methodology developed by the U.S. FDA labora- tory in Irvine presents an even simpler alterna- tive to the conventional QuEChERS technique, allowing the extracted matrix to be diluted and injected directly into the GC/LC-MS to save fur- ther time. Advances in both GC-MS and LC-MS have led the U.S. FDA to recommend them as the platform

for QuEChERS screening. Modern LC-MS systems to nics are generally considered to be more powerful and

are able to separate a greater range of pesticide Bruk e r Da l products. However, where routine detection of Table 1: MRM transitions of 30 pesticides by GC-MS/MS and LC-MS/MS systems.

34 FOOD QUALITY & SAFETY www.foodqualityandsafety.com corporated into GC-MS and LC-MS, there is a dramatic increase Nothing escapes in signal to noise ratio, greater specificity, and better quantitative performance. Hardware advances in both GC-MS/MS and LC-MS/ Romer Labs. MS have refined the performance of triple quadrupole MS for pesti- cide detection to ensure high performance is maintained through- out high throughput analysis. In GC-MS/MS, an axial ion source reduces the contact of ions with hot surfaces and avoids the matrix build-up on the ion source. Higher signal to noise ratio is main- tained, reducing the need for instrument cleaning and the result- ing downtime, while ensuring high performance is maintained, crucial for a high-throughput laboratory.

VIP-HESI technology ensures high ­signal-to-noise ratios, superior robust- ness, and broadens the analysis range of liquid chromatography techniques.

Design advances in LC-MS/MS also deliver similar improve- ments in robustness and sensitivity by optimizing ion transfer. The systematic loss of sensitivity resulting from residue deposition is overcome by use of an open orifice rather than a capillary inter- face between the liquid chromatography and mass spectrometry elements. An Active Exhaust further reduces chemical noise and increases sensitivity and specificity of trace analyte detection by reducing gas recirculation within the ion source. A further point of development has been extending LC-MS/MS to cover thermally labile pesticide species that commonly break- down during liquid chromatography eluent “over-heating” prior to nebulization. This is achieved by the incorporation of a vacuum insulated probe within the ionization unit and around the liquid chromatography eluent to reduce heat transfer to the sample. Vac- uum Insulated Probe Heated Electrospray (VIP-HESI) technology ensures high signal-to-noise ratios, superior robustness, and broadens the analysis range of liquid chromatography techniques.

Advantages of CBS Developing a multiple reaction monitoring method can be a time consuming task as there can be hundreds of pesticides to identify in a single run. Traditionally a chromatographic run is divided into fixed segments and only the MRMs eluted in each segment are monitored. However, residues eluting near the joint of the two adjacent segments, MRMs must be set up in both segments to assure detection. The need for duplicated MRMs leads to slower

duty cycles that must be carefully optimized to ensure sensitivity is FIND OUT MORE ABOUT ROMER LABS TESTING SOLUTIONS not lost from short dwell times. Compound Based Scanning (CBS) AND CONTACT:

streamlines method development for multi-residue analysis. Fol- ROMER LABS INC. lowing a number of initial runs to locate the retention time win- 130 Sandy Drive dow for each compound, the optimal scan time is automatically Newark, DE 19713, USA calculated by the software, which processes all the overlapped Tel: 302 781 6400 RI¿FH#URPHUODEVFRP retention time windows. In this way, the duty cycle is optimized ZZZURPHUODEVFRP and fixed segments are no longer required, which is greatly advan- tageous in a high-throughput laboratory. (Continued on p. 36)

December/January 2015 35 IN THE LAB Sample preparation THE (Continued from p. 35) The CBS workflow focuses on the compounds rather than the EXPERIENCE individual MRMs. The MRM transition for an analyte does not need to be known. Instead the software auto-fills this information from YOU CAN a compound library containing more than 2,500 MRM transitions covering more than 900 contaminants. Each compound library is then linked to retention time, primary and secondary MRM tran- sitions and collision energy. Using this library, CBS dramatically Trust! reduces the time taken to set the initial MRM methods to give accu- rate data while simultaneously improving workflow productivity. The below case study explores how LC-MS/MS and GC-MS/MS systems incorporate these hardware and software developments to provide robust, fast, and simple analysis of complex food matrices.

Rapid Pesticide Analysis using LC-MS/MS and GC-MS/MS Three vegetable matrix samples of rice, avocado, and spinach, rep- resenting low moisture content, fatty content, and high moisture content vegetable groups respectively, were extracted using the modified QuEChERS protocol developed at the U.S. FDA Lab at Irvine, shown in Figure 1 on page 33. Thirty pesticides amenable for both GC-MS and LC-MS were spiked into three extracted vegetable matrices. Calibration solu- tions were diluted using extracted blank matrices and prepared for analysis using the EVOQ LC-MS/MS and the SCION GC-MS/ MS (Bruker). The MRM method development workflow was set up using Compound Based Scanning. The target pesticides (Table 1, page 34) were selected from the software’s MRM library before being exported to the CBS method editor. The dwell time for each MRM is then automatically calculated based on its retention time window (timed MRM). A “built-in” processing method allows for easy updates of the retention times and method parameters and automatically updates qualitative and quantitative ion ratios based on the standards. Excellent sensitivity was achieved for multi-residue pesticides in various vegetable matrices using both GC-MS/MS and LC-MS/ MS systems. Examples of 1 and 5 parts per billion spiked samples Testing for the Food & Feed Industry in a spinach QuEChERS matrix analyzed by LC-MS/MS and GC-MS/ MS are shown in Figures 2a and 2b on page 34. R-squared values Our technical and customer service staff averages show excellent linearity was achieved with each matrix. over 20 years of experience ensuring you: In Conclusion • The right testing protocol for your The monitoring of pesticides in fruits and vegetables is a key prior- food and feed analysis ity for international food safety. Many emerging export economies • The most cost-effective solution have substantially different regulations to their Western counter- parts. This means stringent monitoring of pesticides is therefore (only the tests you need) essential to meet international regulatory requirements and • A personal commitment to work in ensure product safety. However in complex biological matrices, partnership with you achieving the accuracy and robustness needed for these routine quality control methodologies can be complex and time consum- ing. Hardware and software developments in tandem mass spec- Put us to the test. trometry coupled chromatographic systems provide the sensitivity and selectivity needed for such routine operations, while reduc- ing operator input and instrument down time, and simplifying 800-423-6832 method development. ■ www.npal.com Anacleto is VP Applied Markets at Bruker Daltonics. Reach him at [email protected]. References Furnished Upon Request

36 FOOD QUALITY & SAFETY www.foodqualityandsafety.com IN THE LAB CRM

Importance of Certified Reference Materials

Availability of CRMs for food ­testing procedures would ensure ­consistent, reliable results and could be used to establish sensitivity, linearity, and spec- ificity during the validation of microbio- logical quality­ control methods

By Cara N. Wilder, PhD and Liam Gormley

oodborne illnesses pose a signifi- certified reference materials (CRMs), is provided a legislative mandate to require cant economic and public health imperative in food testing. preventative control protocols and com- burden associated with product Food products and raw materials can prehensive reference materials to identify recalls, epidemiological track- become contaminated during any stage contaminants throughout the manufac- Fing, extensive healthcare expense, and in the process of food production to con- turing process, as well as the authority to countless numbers of hospitalizations and sumption, or “farm to fork.” These con- prevent intentional adulteration. The FDA deaths. The global sourcing of raw materi- taminants can be biological, chemical, or now has oversight to ensure compliance als and distribution of products combined environmental in nature, encompassing with these aforementioned regulations, with the differences in regulations of ag- microorganisms, radiological hazards, including mandated inspections, access rochemicals and medicines mean that the natural toxins, drug residues, pesticides, to the records of food manufacturing fa- contamination of food can also impact harmful chemical reagents, allergens, par- cilities, requiring certain food testing to international trade. For food producers in asites, and adulterants originating from be carried out by accredited laboratories, the U.S., the FDA Food Safety Moderniza- soil, water, industry, and animals. When and the ability to develop a program that tion Act (FSMA) has made identifying and consumed, these contaminants may re- enables laboratories to become accredited. tracing foodborne adulterants in raw and sult in gastrointestinal symptoms such as processed food products throughout the abdominal cramping, nausea, vomiting, Emphasizing Accreditation manufacturing process a matter of public diarrhea, and dehydration. Depending While several local, state, and federal gov- law. However, as many food products are on the causative agent of the foodborne ernment food testing laboratories have complex systems, it can be challenging illness, other neurological, gynecolog- already pursued accreditation programs to identify biological, chemical, and en- ical, or immunological symptoms can such as ISO/IEC 17025:2005, the accredita- vironmental adulterants, as well as dis- present, which may lead to multi-organ tion of commercial laboratories is still in its criminate between those that are harmful failure, contributing to a high incidence of formative years. While accreditation is not from those that are not harmful. Thus, the mortality. yet required, it is emphasized by FSMA as use of highly characterized, homogenous, In an effort to update U.S. food safety it offers a means to support the generation

© Ale x011973 - Foto li a. c om authenticated control materials, such as laws, FSMA was enacted in 2011, which (Continued on p. 38)

December/January 2015 37 IN THE LAB CRM MEET THE MOST (Continued from p. 37) ESSENTIAL BOOKS of reliable and traceable data that is consistent among food testing laboratories. Similarly, a recent guidance document released by ON MEAT the USDA Food Safety and Inspection Service (FSIS), entitled Es- tablishment Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory, suggested that accreditation under ISO/IEC 17025:2005 helps to increase confidence in the ac- curacy of test results produced by a laboratory. Largely, accredita- tion ensures that all laboratory results are achieved through the Meat Inspection and Control in the Slaughterhouse proper obtainment and preparation of samples, the employment of scientifically sound testing methods and reference standards, Thimjos Ninios, Janne Lunden, Hannu Korkeala, Maria Fredriksson-Ahomaa and ethically-responsible, competent laboratory personnel. In 978-1-118-52586-9 • Hardcover turn, this provides additional confidence that a minimum stan- 728 pages • August 2014 This up-to-date references provides a dard of quality has been met throughout the food testing process. comprehensive guide to the ways that Laboratories that are ISO/IEC 17025:2005 accredited require meat inspection, food safety, hygiene, animal disease and animal welfare interact the use of CRMs when using reference standards for traceability; in the slaughterhouse. Section 5.6.3.2 of this guideline states, “reference materials shall, where possible, be traceable to the international system of units of measurement, or to certified reference materials.” Essentially, these materials are biological or chemical measurement standards that are homogenous and stable with respect to one or more spec- ified property and for which traceability and values of uncertainty Handbook of Fermented at a stated level of confidence are established, where applicable. 2nd Edition Meat and Poultry, CRMs are produced under an ISO Guide 34:2009 accredited process Handbook of 2nd Edition to offer confirmed identity, well-defined characteristics, and estab- Fermented Meat and Fidel Toldra, Y. H. Hui, Iciar Astiasaran, lished chain of custody, making them highly effective as standards Joseph Sebranek, Regine Talon Poultry in research and development as well as laboratory testing. More- 978-1-118-52269-1 • Hardcover

Editor-in Chief Fidel Toldrá 528 pages • January 2015 over, they are accompanied by a certificate that provides the value Consulting Editor Y. H. Hui Extensively revised and updated, the Associate Editors of the specified property, the expiration date, and the proper use, Iciar Astiasarán second edition of this comprehensive Joseph G. Sebranek Regine Talon reference covers the entire manufacturing thus confirming that the necessary procedures have been carried process of fermented meat and poultry products, from raw materials and starter out to ensure both validity and traceability. cultures through to finished product quality assurance. CRM Practicality Presently, a number of CRMs have been developed for use by ISO/IEC 17025:2005 accredited food testing laboratories for the analysis of quality assurance and product safety. For quality as- surance, CRMs are frequently used for method validations, such Handbook of Meat, Poultry as the calibration of laboratory equipment or the examination of and Seafood Quality, new identification, detection, or cleaning methods. This form of Second Edition testing is needed to assess the quality of the measurement results Leo M. L. Nollet, Terri Boylston, Feng Chen, Patti Coggins, Grethe Hydlig, as well as to demonstrate their traceability to a stated reference. L. H. McKee, Chris Kerth CRMs are also used to evaluate the performance of laboratories 978-0-470-95832-2 • Hardcover 576 pages • September 2012 and laboratory personnel through proficiency testing. The primary This book offers a single, reliable source aim of this latter form of testing is to enable laboratories to monitor of information on the different quality factors affecting muscle foods. Sections their performance for the detection and quantification of a given cover sensory determinants, shelf life, analyte or contaminant, and compare it with that of their peers. microbiological properties, and packaging, all as they apply to fresh and to frozen Moreover, it provides information to participants on any technical muscle foods. issues and methodologies relating to the testing of food products. Essentially, the use of CRMs in quality assurance testing helps to ensure that the data generated by a particular food testing labora- Discover these titles and more at tory is consistent, high quality, reliable, and traceable. www.wiley.com/go/food In addition to their importance in the quality assurance of food testing personnel and procedures, CRMs are essential for the internal quality control of routine food analyses. Because the performance of food testing methods can vary between lab-

53910 oratories due to technical and human factors, variations in the recovery of microbial contaminants or specific analytes, or the

38 FOOD QUALITY & SAFETY www.foodqualityandsafety.com References 5. Coffman, V., Plunkett, D., Wilson, G. & War- unpredictable nature of microorganisms, ren, W. The Food Safety Modernization Act - the use of homogenous internal controls, 1. World Health Organization. Foodborne A Series on What is Essential for a Food ­Diseases, http://www.who.int/topics/food- Professional to know. Article 7. Laboratory such as CRMs, can be employed to help borne_diseases/en/, 2014. Accreditation. Food Protection Trends, 44-48, demonstrate the credibility of analytical 2. Food and Drug Administration. Food Safety 2014. results and the comparability of results Modernization Act (FSMA) Fact Sheets & Pre- 6. iso/IEC 17025:2005 - General requirements sentations, http://www.fda.gov/Food/Guidance- for the competence of testing and calibration from different laboratories. This is par- Regulation/FSMA/ucm247546.htm, 2014. laboratories, 2010. ticularly true for standard procedures 3. Food and Drug Administration Food Safety 7. Encyclopedia of Food Microbiology, Second Modernization Act; Public Law 111-353, http:// Edition. Elsevier, 2014. designed for the microbiological analy- www.gpo.gov/fdsys/pkg/PLAW-111publ353/ pdf/PLAW-111publ353.pdf, 2011. 8. In’t Veld, P. The use of reference materials in sis of food products; often, these proce- quality assurance programmes in food micro- 4. Food Safety and Inspection Service. Estab- biology laboratories. International Journal of dures are designed for one specific strain lishment Guidance for the Selection of a Food Microbiology, 45: 35-41, 1998. and may not be applicable toward the Commercial or Private Microbiological Testing Laboratory, 2013. detection or quantification of other mi- crobial species. Currently, biological and chemical CRMs are available from both official and commercial manufacturers that are ISO Guide 34:2009 accredited, such as ATCC and LGC Standards. For CRMs specifically used in food testing, preparations can be ® obtained as either an inoculated (where applicable) and standardized preparation of a specific food material, or as a pre- served and defined preparation that can be used to inoculate or fortify various food preparations. This latter format, in partic- ular, is useful in that it allows the user to inoculate a known quantity of the defined CRM into an appropriate food matrix that resembles the routine samples as much as possible. This format allows for testing the influence of matrix constituents, which can significantly affect the accuracy of can be used for: measurements in microbial, biochemical, and chemical analysis of food. For micro- • Biocides biological CRMs, this format also allows • Plastic Additives for testing competitive microbial strains • Allergens as well as the development and valida- tion of growth media and species specific • Pesticides test methods. • FAMEs Overall, the contamination of food poses a significant health burden on the human population that is largely prevent- able and frequently under-reported. By Visit our website or request urging food testing laboratories to gain a catalog for a full range accreditation, and consequently, employ of environmental and food the use of CRMs for quality assurance and related standards. as internal controls in food testing proce- dures, we can be confident that the results generated from food testing analyses are high quality and reliable. In turn, this will help strengthen the food safety system by contributing to the prevention of food- borne outbreaks and the integrity and quality of food. ■

Dr. Wilder is a technical writer at ATCC. Reach her at [email protected]. Gormley is product manager at LGC AccuStandard.com 203-786-5290 800-442-5290 Standards.

December/January 2015 39

40 cation of newculture media batches procured from suppliers ­control of culture media will reduce theworkload for thequalifi- New mandatory standard for thepreparation and quality 11133:2014ISO Implementation of Lab By By I for useinlaboratories performing micro all categories ofculture mediaprepared requirements ofwhich are applicable to and qualitycontrol ofculture media, the EN ISO11133:2014 definesthepreparation performance testing ofculture media.” preparation, production, storage, and biology offood,animalfeedandwater— water standardization andtitled“Micro a joint ISOworking group from foodand ture media.Thestandard was compiled by of food, animal feed, or water using cul ries thatperformmicrobiological testing tory standard forallaccredited laborato IN

Barbara

THE 11133:2014, which isnowamanda- (ISO) introduced the revised EN ISO Organization for Standardization n March 2014, theInternational FOOD LAB

QUALITY

Gerten C ulture media & S AFETY - - - - from dehydrated to ready-to-use media cludes all typesofculture media,ranging in foodproduction. Thenewstandard in- as well as water for consumption or use ufacturing environment ofsuch products, animal feed, and samples from the man- analysis offoodforhumanconsumption, media intended forthemicrobiological is producing and/ordistributing culture mercial ornon-commercial entitythat ological mediaforwater testing). ISO 9998:1991 (Requirements formicrobi- both forfoodandfeedmicrobiology), and (Performance testing ofculture media, of culture media), EN ISO TS 11133-2:2003 places ENISOTS11133-1:2009 (Preparation biological analyses. Thisnewstandard re- EN ISO11133:2014 applies to any com- in compliance with An example of a quality control certificate EN 11133:2014. ISO 11133:2014.

testing mustnowbetested quantitatively, example, culture mediaforquantitative most accurate andmeaningful results. For closely aspossibleinorder to provide the the intended sampletesting conditions as for performance testing should resemble Under thenewstandard, allconditions and performance testing ofculture media. for thepreparation, production, storage, EN ISO11133:2014 covers requirements Overview 11133:2014 An ENISO because itisnowafullENISOstandard. ies worldwide recognize ENISO11133:2014 Inaddition,allaccreditationGerman. bod dard iscurrently publishedinFrench and adopting ENISO11133:2014 andthestan- ity andbatch-to-batch consistency. EN their workflows and to ensure high qual media from bothto suppliers streamline Many laboratories source theirculture Responsibilities Assurance Quality its are to bedetermined. describes howproductivity andlim ratios or CFU, per plate filter or membrane and optimal numberofcolony forming units, inoculation suspensions. It specifiesthe standardization ofworking cultures and crobial andthepreparation and strains instructions forthemaintenance ofmi- page 42). information(Tableand otherpractical 1, test criteria and/orcharacteristic reactions forming andevaluating performance tests. step instructionsandflowcharts forper specified indetail, which includes step-by- requirements forperformance testing are filters.nation withthesemembrane The filtersbrane mustnowbe tested in combi- and mediausedinconjunction withmem Centre forMicroorganisms numbers, and; um’s function,including theirWorld Data appropriate control for each medi- strains (productivity, selectivity, specificity);the dard; each medium’s functionto betested target microorganism; relevant ISOstan- ology. Thesetables include themedium’s media for both food and water microbi- sive specificationtables formostculture testing methods. for classical to alternative microbiological All European Union (EU) countries are EN ISO11133:2014 contains detailed The standard provides comprehen- www.foodqualityandsafety.com - - - - -

E MD Millipore formed according to the requirements of the standard. It is the end users responsibility to ensure that batch testing was performed according the requirements of EN ISO 11133:2014 by procuring the quality control certificate as a supporting document from the manufacturer. This certificate should disclose the test organisms used, the acceptance criteria of the performance tests, and the test results.

Performance Testing Suppliers must conduct rigorous qualitative and/or quanti- tative testing on all ISO 11133:2014 compliant culture media that they provide to laboratories. Below are a few examples of testing criteria for liquid and solid selective and non-selective culture media. Liquid Culture Media. Buffered Peptone Water (BPW) is used for the non-selective pre-enrichment of Salmonella bacteria in food. The EN ISO 11133:2014 testing criterion for BPW is turbidity, which must either be weak or good. Fraser broth is used for the selective enrichment of Liste- ria monocytogenes in food. The EN ISO 11133:2014 testing crite- rion for Fraser broth is the growth of more than 10 colonies on Listeria selective agar according to Ottaviani and Agosti. When in- oculated as a mixed culture with Escherichia coli and Enterococ- cus faecalis, only L. monocytogenes should be able to grow on this agar as characteristic blue-green colonies with opaque halos. Figure 1: Quantitative productivity testing results of selective (MRS) and (Continued on p. 42) non-selective (PCA) solid agar media for enumeration. The results show that the five batch samples of each culture media achieved the required performance for all test microorganisms. As the reference medium for MRS, a previously ­validated batch of MRS was used, and TSA was used for PCA as specified in EN ISO 11133:2014. Complete Protection ISO 11133:2014 takes into account the ever-increasing number of laboratories sourcing their culture media from suppliers by stip- ProtectProtect youryour equipmentequipment and keepkeep youryour productproduct pure.pure. ulating quality assurance requirements not only for laboratories Cartridge Style that continue to prepare their media in-house, but also for man- ufacturers of culture media. With a clear line drawn between the Magnetic Liquid Trap Designed to provide continuous, responsibilities of users and suppliers, laboratory managers can dependable permanent magnetic now reliably evaluate which duties and responsibilities will trans- protection in non-fibrous fluids fer to the manufacturer when they make the decision to procure environments. culture media from a supplier.

Many laboratories source their culture media from suppliers both to stream- MeatLINE™M 07 MetalM Detector line their workflows and to ensure high Metal separation for liquids or paste quality and batch-to-batch consistency. with simple integration with a vacuum filler.

For laboratories that continue to produce their culture media in-house, each batch can sufficiently be tested using a single test strain named in the standard. Manufacturers, on the other hand, must test each batch using several microorganisms. Laborato- ries can rely upon the performance tests that the manufacturer conducts for ready-to-use media only as long as the transport +1 316-284-2020 buntingmagnetics.com

E M D Millip or e conditions are observed and the manufacturer’s QC test is per-

December/January 2015 41 IN THE LAB Culture media E M D Millip or e Table 1: Two extracts from Table E.1 in the annex E of EN ISO 11133:2014. (Modified from ISO 11133:2014.)

(Continued from p. 41) Table 2 at right shows the results of qualitative tests performed for five batches of Fraser broth (EMD Millipore). TheE. coli and E. faecalis strains are included in the testing criterion to prove the selective properties of the medium. Solid Agar Media. Two common solid agar media from EMD Millipore are selective de Man, Rogosa, Sharpe (MRS) agar for enu- meration of lactic acid, and non-selective Plate Count Agar (PCA) E M D Millip or e for colony count. The EN ISO 11133:2014 quantitative productivity Table 2: Qualitative productivity testing results of the selective enrichment testing criterion for each of these solid media agar is recovery rates medium Fraser broth. of 70 percent or more for every test organism. Figure 1 on page 41 shows the results of quantitative tests performed for five batches and certified according to the latest international standard, EN of MRS and PCA medium. ISO 11133:2014, by procuring the quality control certificate as a supporting document. Ultimately, this standard should reduce Conclusions the workload for the qualification of new culture media batches EN ISO 11133:2014 is a mandatory standard for all accredited lab- procured from suppliers. In the supporting document, suppliers oratories that perform microbiological testing of food, animal should provide quantitative information about the growth of both feed, or water using culture media. The goal of this new standard “wanted” microorganisms (bacteria that should grow on a specific is to improve consumer safety with respect to food and beverage medium) and “unwanted” microorganisms (bacteria that should products, and the guiding principle is that performance testing not grow on a specific medium). The highest quality media will conditions should mimic the intended sample testing conditions support only the growth of “wanted” microorganisms. ■ as closely as possible. Gerten, an application training scientist at EMD Millipore, is a member of the ISO committee Under the new standard, laboratories that source their culture for microbiological standards regarding food and water testing, and was involved in the media from a supplier can ensure that the media is manufactured revision of EN ISO 11133. Reach her at [email protected].

42 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Manufacturing & Distribution HACCP

stream, and internally. In other words, they set a company’s food safety stan- dards “for what comes in, what you do with it, and what goes out.” The same will hold true for HARPC (Hazard Analysis and Risk-Based Preventive Controls) plans under FDA’s Food Safety Modernization Act (FSMA). But managing robust HACCP/HARPC plans presents many challenges, includ- ing monitoring multiple, complex plans across a company’s facilities/operations; verifying workflow and completion of all tasks associated with Standard Operating Procedures (SOPs), Prerequisite Programs (PRPs) and Critical Control Points (CCPs); validating that the plan elements are work- ing; getting timely non-conformance infor- mation for Corrective/Preventive Actions (CAPA); ensuring all requirements are met prior to sending product into commerce; analyzing data across the entire opera- tion, which is typically in paper form, for continuous improvement; and accessing accurate data and records for HACCP/ HARPC audits. This is why more and more food and beverage companies are deploying soft- ware solutions for HACCP/HARPC auto- mation. This wasn’t always the case. In the past, food safety technology adoption was difficult because safety and quality Automation Manages assurance folks for the most part aren’t sitting at their desks in front of comput- Robust HACCP (and HARPC!) ers—and enterprise systems were often too expensive for the food industry’s slim Programs profit margins. But today, highly secure, cloud-based How automation helps define all HACCP plan parameters, HACCP/HARPC automation technolo- ­manages CCPs and workflow, and sees process through to gies make this type of automation both pre-shipment programs and reporting possible and practical. Cloud solutions require no capital hardware/software in- By Barbara Levin and Dan Bernkopf vestments and can be accessed anywhere, at any time, from mobile devices. This HACCP (Hazard Analysis sessment, and risk control management makes them both affordable and effective Critical Control Points) Plan system, for inbound suppliers through to provide key benefits for HACCP/HARPC is the foundation for most internal manufacturing processes and management, including the ability to food safety programs. It pro- ultimately to pre-shipment review and automate food safety plans for every Avides for the food safety requirements sending finished products out the door product group and facility; access all of

© Foto li a. c om that accomplish a science-based risk as- and into commerce—upstream, down- (Continued on p. 44)

December/January 2015 43 MANUFACTURING & DISTRIBUTION HACCP

(Continued from p. 43) get out from under all of this paper with • If you have task scheduling features, your organization’s safety data from a functionality that manages, verifies, and all of your CCPs, PRPs, and other single, central repository for trending; maintains programs and associated data tasks can be defined and sched- respond “on demand” to USDA, FDA, and records. HACCP/HARPC automaton uled for due dates/times/frequency. and customer inquiries and audits; and allows for the following abilities. Non-completion notifications, which get real-time, non-compliance alerts for • Easily access and revise plans and can typically be sent via text and timely CAPAs. flowcharts for annual and/or man- email to identified stakeholders, can dated reassessments, new regulatory ensure that tasks get completed on How Does HACCP/HARPC Auto­ requirements, and new or revised time and help avoid rework and ship- mation Work? processes. ment delays. There are a variety of HACCP/HARPC au- tomation solutions on the market and you will have to evaluate which of the options Automatic COA generation…allows product to move best meet your needs, but in general, some faster to the next point in your value chain—­meaning of the capabilities you should look for in these applications include functionality that shipment to customers can be expedited. that allows you to do the following. • Define, manage, and maintain HACCP/ HARPC program and document re- quirements and records—for CCPs, • Automatically generate unalterable • Workflow verification can be auto-­ PRPs, SOPs, and more—for multiple time/date stamps on all records— generated, including pre-shipment plans and facilities. including non-conformance alerts review authorizations and positive • Automate workflow and task sched- and CAPA documents—to ensure releases, with e-signatures. Depend- uling—including CCP monitoring ac- greater efficacy of records. Some -au ing on the size and complexity of tivities; send auto-notifications when tomation solutions also support elec- operation, you may choose to inte- tasks are due; and issue escalating tronic signatures and 21 CFR Part 11 grate your HACCP/HARPC solution alerts if tasks aren’t completed on time. compliance. with Enterprise Resource Planning • Define specifications, and then cap- • Facilitate faster shipment of product or Materials Resource Planning sys- ture safety data—from suppliers, to customers—including Certificate tems—signaling product acceptance equipment, direct observation, and of Analysis (COA) generation or pos- and release. internal/external labs—electronically itive release documentation—when • Most HACCP/HARPC systems have a and in real time. no non-conformances are detected. variety of real-time dashboards that • Automatically analyze captured data, If using a cloud-based system with can display trends for compliance against specifications and require- roles-based security, you might even status of sanitation and environmen- ments, and issue non-conformance allow customers “visibility and trans- tal controls, pest control, preventive alerts in real time. parency” by allowing them to access maintenance, test/task data results, • Generate, resolve, and document CA- the FSQA documentation and records CAPAs, and other program compo- PAs before a food safety issue gets “out for the products they receive. nents. If the solution you implement of control.” Make Sure HACCP/HARPC Pro- has a mobile application, you can • Access all food safety and quality as- grams are Being Followed to a “T.” One monitor the program from anywhere surance (FSQA) data and records from of the biggest challenges to managing a there is an Internet connection via a a single, centralized repository for re- successful HACCP/HARPC plan is to en- laptop, tablet, or smartphone. porting, benchmarking, trending, and sure that you are “saying what you do, do- • Automation allows new and up- continuous improvement. ing what you say, making sure it works, dated requirements to be “cascaded” • Have on-demand access to the records and making sure it’s documented.” Are throughout your food supply chain so and documentation you need to re- all facilities and suppliers following your compliance is immediately enforced spond promptly to USDA, FDA, and most current plan(s)? Using the most up- by ensuring that only current plans customer inquiries and audits. to-date forms? Ensuring proper records and forms are used by suppliers, in for pre-shipment reviews? HACCP/HARPC your plants, and for documents sent Key Benefits of HACCP/HARPC automation addresses these challenges in to customers prior to shipment. Automation the following ways. Respond to Audits and Inquiries in Get Out From Under “Mountains” of Pa- • Some automated systems will provide a Matter of Minutes vs. Hours or Days. per. HACCP plans place a heavy burden pre-built form configuration tem- Responding to HACCP/HARPC program on FSQA departments trying to comply plates that allow you to easily set up questions—during a USDA inspection, using manual processes and records— your HACCP/HARPC program require- FDA inquiry, or perhaps a customer au- and it is expected that HARPC plans will ments and ensure that only the most dit—is time-consuming and disruptive to do the same. Automation can help you up-to-date plans and forms are used. operations. Additionally, if records can’t

44 FOOD QUALITY & SAFETY www.foodqualityandsafety.com be located or verified, regulatory audit ex- investments. If we think about the other mances are detected, allows product pansion is very likely to occur and business types of automation solutions that many to move faster to the next point in your relationships can be damaged. HACCP/ food companies have in place—such as value chain—meaning that shipment HARPC automation can help you be ready human resources or financial applica- to customers can be expedited. 24/7/365 for such audits and inquiries by tions—they were approved because they • Reduction in the cost of non-confor- allowing you to perform the following save time, save money, and create effi- mance: real-time data analysis and functions. ciencies to provide ROI. This same holds timely CAPAs help manage product • Search a central repository of the rele- true for FSQA technology, including risks, minimizes product rework, and vant program data—in most solutions HACCP/HARPC systems. These solutions expedites product release times. both current and historical—for fast, also save time and money and create op- accurate response. erational efficiencies that streamline In Summary • Auto-organize all relevant documents and improve program management. HACCP plan management does not have for each type of audit by product, fa- Examples of ways in which HACCP/ to be a time-consuming, error-prone prac- cility, incident, or any other parameter HARPC automation can create ROI in- tice that lends itself to food safety profes- required by HACCP/HARPC plan(s). clude the following. sionals spending more time entering data • Bring a new level of efficacy to FDA • Reduction of manual labor: auto- versus analyzing it to find areas for FSQA and USDA program compliance with mated task monitoring and popula- improvement. By leveraging HACCP/ unalterable time/date stamps offered tion of direct observation forms via HARPC automation innovations, food by some HACCP/HARPC automation mobile devices, or direct data entry and beverage companies can manage ro- solutions. into the system, not only increases bust and complex plans, maximize com- accuracy—these capabilities also pliance, minimize non-conformances, Building a Business Case for Buy-In result in time/labor savings due to a promote audit readiness, and create ROI. ■ This all sounds pretty good, right? But reduction in manual processes and Levin is the senior vice president of marketing and a given low food industry profit margins, related errors. co-founder of SafetyChain Software. Reach her at blevin@ it’s often necessary to be able to build an Faster product throughput: automatic safetychain.com. Bernkopf is the vice president of food • safety and quality assurance applications at SafetyChain ROI-based business case for technology COA generation, when no non-confor- Software. Reach him at at [email protected].

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F 46 I a better collaboration andresponse. roles, responsibilities, andperspectives ofeach profession to form to for an outbreak train investigationpractitioners andlookat the oratory, public health, environmental health, andepidemiology shops, calledEpi-Ready, brought together timelab forthefirst trainings thattheywere often These calledupon work to assist. professionals together to collaborate onfoodborneinvestigation (NEHA) developed aprogram thatbrought various public health. TheNational Environmental Health Association fects oftheestimated 48millionannualfoodborneillnesseson (I-FIIT-RR). try-Foodborne Illness Investigation Training and Recall Response for aprogram mostrecently fundedbytheFDA calledtheIndus pared to handleanoutbreak ora foodrecall, were theimpetus try professionals, who were eager to ensure theywould bepre- of a foodborne illness outbreak. It is not surprising that indus daunting aspreventing illness, andpossibly worse, asaresult fessionals face. Few challenges, however, are ascriticalor engineer, magician, recruiter, who andtrainer isable to: • • • •

The cross-functional collaboration of educational programs will enable managers to properly Many organizations are involved inefforts to mitigate theef These are just someofthechallenges foodindustry pro a foodincident. Diligently implementsafefoodhandling practices to prevent over, and Ensure training among allstaffdespite high employee turn - customers, Identify global sourcing to meet the demands of fickle Forecast changing consumer preferences andtrends, ood S manager suggests someonewho chef, teller, ispart fortune ever growing list of responsibilities for a successful food dustries are ascomplex orevolve asrapidly asthisone.The f you’re in thefoodservice industry you knowthatfewin- FOOD

QUALITY respond to anillness outbreak orrecall | & S AFETY Regulatory to Enhance Safety Bridging Industry and Bridging and Industry ervice &Retail regulatory Education ------

food products. Thiscompletes thecommunication loopbetween food industry, which provides adirect linkto theconsumer and collaborative training modelofI-FIIT-RR isdirected attheretail people who would beinvolved inanoutbreak investigation. The activities during afoodrecall andcan be usedto streamline com - latory agencies. for foodsafetyprofessionals thatbenefitbothindustry and regu were created andare nowavailable from www.nehafoodsafety.org only were collaborative relationships forged, butseveral resources regulatory counterparts. As adirect result oftheworkshops, not and recall process and guidance but needed support from their were committed to being active intheinvestigations participants sources to go italone,complemented industry professionals, who edge about illnessinvestigations butlimited timeandstaffing re- was immediately apparent. Regulators, who hadplenty ofknowl The success ofthefourI-FIIT-RR and2014 workshops heldin2013 Working Together facturing businesses. consultant who ownedher owncatering, café,andfoodmanu to knowsotheycantake action.”Rice isanationalfoodsafety course brings themoutofthedark,giving themwhat theyneed of Eastern Food Safety.” Theyhave theability to respond, and this in theinvestigations process,” says Cindy Rice, RS, CP-FS MSPH, they strive to protect. cause ofanillnessoutbreak orfoodrecall andthepublicwhom environmental health professionals who are tracking the potential receiving training industry professionals who could seetheimmensebenefitof

By The Recall Response Form allows industry to document their “Finally industry is brought into the fold as active participants News about theEpi-Ready workshops spread among food

Rance Baker prior and to anoutbreak alongside theregulatory

Elizabeth Landeen www.foodqualityandsafety.com - - -

© fovivafoto - Fotolia.com munication between industry and the regulatory agency during an advantage over others, having to learn more about the under- a food recall. Proactively forwarding this form to the appropriate lying biology, regulatory perspective, and equipment standards. food regulatory agency allows that agency to be fully informed I also see benefit in having this credential because the biannual early on in the recall process, improves collaboration, and enables renewal and the CE requirement forces me to stay current and also a more efficient process that maximizes use of limited resources. to engage other environmental health professionals in relevant Another resource was developed that sums up the collabo- discussions.” rative ideas from industry and regulators to improve food recall The advent of the Food Safety Modernization Act (FSMA) adds investigations. Suggestions to Improve Recall Response is also to the arsenal of required knowledge for those involved in any as- available at www.nehafoodsafety.org. pect of the food supply chain. The Global Food Safety Initiative NEHA now has a fully vetted and developed I-FIIT-RR train- aims to assure the safety of the food supply chain through collab- ing workshop on retail food industry outbreak investigations oration between the world’s leading food safety experts from re- and recall response. The workshop is also consistent with and tail, manufacturing, and food service companies, as well as others. incorporates the nationally recognized and approved guidelines, NEHA’s involvement with policy and these types of collaborations Foodborne Illness Response Guidelines for Owners, Operators, and in the food industry occurs on many levels and ensures that the Managers of Food Establishments developed by the Council to Im- food safety credentials it offers serves professionals who work in a prove Foodborne Outbreak Response. I-FIIT-RR trainings continue variety of settings, is relevant to their jobs, and remains current to to empower food establishments across the U.S. NEHA is also in keep pace with frequent changes in the industry. the process of developing an online version of this training, which will be available for industry and any other interested parties. In More Educational Options addition to these workshops, NEHA will be offering several live Two additional food safety credentials—Certified in Comprehen- webinars on food recalls and effective industry response in 2015. sive Food Safety (CCFS), which prepares those managing and evaluating food facilities and food production processes across A Thirst for Knowledge the entire food chain supply, and the Food Safety Auditor, which is With roots well-grounded in food safety, NEHA began in 1937 as a still in development—provide advanced levels of training to meet way for the then developing profession of environmental health to the goals of food safety professionals. The CCFS is geared toward establish standards of practice that prove an individual has mas- a more seasoned professional who upon successful completion tered a body of knowledge and acquired practical experience to per- of the credential is trained to manage the food flow; evaluate food form work responsibilities to protect public health. The Registered facilities and equipment; ensure regulatory compliance; prevent Environmental Health Specialist/Registered Sanitarian (REHS/RS) contamination and adulteration; and manage a food defense plan, credential proves demonstrated expertise in conducting facility adverse events, and a sample collection program. and systems inspections, leading complaint and epidemiology in- There is no shortage of programs that offer training in food vestigations, promoting public health awareness, and responding safety. When choosing where or how to obtain food safety training, to community emergencies. While food safety comprises a large managers have many factors to consider including reputation of percentage of an REHS/RS professional’s time, they are also called the organization, cost, relevance to meet the level of the trainee, upon to apply process and technical knowledge to areas of water availability of updates and revisions, and access to a variety of quality, air quality, hazardous material handling, and vector control. training formats. In addition, food safety professionals must un- The evolution of the U.S. and global food industry, from supply derstand local, state, national, and global regulations that affect to processing, distribution, and retail, created the need for more spe- their facility operations. The benefit of obtaining a nationally rec- cialized, in-depth food safety training that focused exclusively on ognized credential is the transferability across state lines, and the this unique and complex industry. Recognizing that retail food man- requirement for continuing education to maintain the credential agers are the frontline staff playing a crucial role in ensuring food ensures that the professional is up-to-date on the most recent safety for consumers, NEHA developed the Certified Professional– changes affecting the industry. Food Safety (CP-FS) credential. This credential can be obtained by Collaborating with industry and all levels of government pro- someone who has a food background; it provides expertise in: vides a bridge between regulators and food professionals in retail, • Developing food safety policies, procedures, and training; manufacturing, and processing—an opportunity to work together • Assessing food safety, hazard analysis and critical control towards the same goal. With the support of their food regulatory points (HACCP) principles, food microbiology, etc.; agencies, industry representatives can take coordinated steps to • Reviewing facility/building plans in compliance with local respond properly to an illness outbreak or food recall. Swift, appro- laws, regulations, and permits; priate action can help to minimize unsafe products ignored or left • Investigating foodborne illness; behind on the shelves of stores, in restaurants, and in homes and • Performing recall activities; restores faith in the food service industry. Individuals and organi- • Managing food defense practices; and zations with demonstrated success in facilitating cross-functional • Responding to emergencies. collaborations and with specialized expertise in the food supply “The CP-FS challenged me to study and grow in a specific area, chain will be a crucial factor in creating an efficient worldwide sys- which has served me well,” says Lars Johnson, CP-FS, president of tem that promotes best practices for a safe global food supply. ■ LAJ Consulting, LLC/FoodSafetyGuy, who has 25 years of food ser- Baker is the program administrator at NEHA. Reach him at [email protected]. Landeen is the vice operations experience. “I find that having the CP-FS gives me assistant manager, research and development, at NEHA. Reach her at [email protected].

December/January 2015 47 Market Expanding for Diagnostic Testing By Kathy Holliman

T he FDA’s growing focus on preventing food- borne illness rather than just responding after an out- break has occurred is prompting big demand and growth in the diagnostic testing market. Diagnostic testing kits are an essential part of this growing market as large food producers look for methods to monitor food pathogens while keeping their testing costs under control. As part of the Food Safety and Modernization Act (FSMA), the FDA will hold food companies accountable for preventing contamination, with the requirement for comprehensive, science-based preventive controls across the food supply. Food facilities must implement a written preventive controls plan that includes a moni- toring program to minimize or prevent hazards that can affect food safety. According to Tim Lawruk of Romer Labs in Newark, Del., his company has experienced increased interest in food pathogen tests in anticipation of FSMA implemen- tation. “This is particularly true as producers shift their ® emphasis to environmental monitoring for pathogens, iQ-Check Prep Automation Solution as opposed to finished products testing, as a preventa- from Bio-Rad Laboratories tive measure to detect pathogen issues in their facilities,” Designed for maximum flexibility, the iQ-Check Prep he says. system optimizes the complete menu of validated Additionally, smaller food producers are investing in iQ-Check real-time PCR pathogen detection kits, food allergen test kits as they try to make their facilities fitting seamlessly into your existing workflow without HACCP compliant, Lawruk says. disrupting it. Food producers can be expected to seek innovative products that improve the efficiency of testing for food Automation for real-time PCR testing pathogens, Lawruk explains. Many pathogens, such as >500 tests in an 8 hour shift Listeria, are very slow growers so this requires innova- Traceability with real-time monitoring tive enrichment media and sensitive detection methods. “The next big improvement in pathogen testing will be No vacuum pump system or liquid waste test results in a single work shift so that decisions can be www.bio-rad.com/ad/automation made the same day, with less product held in storage, and associated costs reduced.” ■

Holliman is a veteran journalist with extensive experience covering a variety of industries. Reach her at [email protected]. © yuuuu - Fo t oli a .co m

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Footwear Sanitization HACCP SmartStep Footwear Sanitizing System reduces Dual Energy X-ray cross-contamination from footwear before employees Ishida IX-G2 X-ray inspection system uses a enter the production area or other critical control zones. dual energy process that compares absorp- This foot-operated unit uses compressed air to deliver a tion of X-rays on two levels. The technology finely atomized mist of Alpet D2 Surface Sanitizer to the improves detection of low-density objects bottom of the employee’s footwear. The mist provides am- in overlapped products. Unit is adept at de- ple coverage to footwear soles, yet uses only 0.2 ounces of tecting thin pieces of metal, glass, rubber, chemical, which minimizes chemical waste and improves hard bones, and other foreign objects in moisture control. Multiple units can be placed throughout products that have uneven surfaces, like ce- the plant wherever pathogen reduction from footwear is real and certain frozen foods. The IX-G2 also needed, and with the optional handles and boot scrub- includes functions for weight verification ber, the HACCP SmartStep System can be customized and detection of missing items, incomplete to meet users’ needs. Best Sanitizers, 888-225-3267, filling, product defects, incorrect alignment, www.bestsanitizers.com. or products trapped in package seals. Heat and Control, 800-227-5980, www.heatand- In Other Product News control.com. Tetracycline Detection MaxSignal Tet- Romer Labs’ AgraQuant Gluten G12 racycline ELISA ELISA test is now an AOAC Official Enterprise Quality Hub Kit for the detec- Method and approved by AACCI; and its InfinityQS ProFicient 5.2 is a manufacturing tion of tetracy- AgraStrip Gluten G12 lateral flow test Intelligence platform powered by centralized cline residues obtains AOAC-RI approval. SPC analytical software engine. This version in meat, honey, Invisible Sentinel’s Veriflow assays are has more options for creating and custom- and other food now being distributed in New Zealand by izing reports in the cloud-based reporting samples fea- New Zealand Medical and Scientific. feature. Manufacturers can incorporate ac- tures ready-to-use standards that do not ceptance sampling plans of their choosing need to be re-suspended or diluted—fur- Rite-Hite Holding’s line of loading dock into the platform and comply with the U.S. ther simplifying tetracycline screening of seal and shelter products previously FDA and the ISO standards. ProFicient 5.2 Ac- multiple samples and increasing the repro- branded as Frommelt products are now ceptance Sampling derives actionable intel- ducibility of the assay. Extraction protocols branded under the Rite-Hite name. ligence from standard acceptance sampling have eliminated the need for immunoaffin- QIAGEN’s mericon Pathogen Detection data through in-depth comparative analyses ity columns during the sample preparation. Assays for Listeria species and ­Listeria from one lot, manufacturer, or supplier to The detection limit for honey is 3 ppb and monocytogenes receives AOAC PTM another. InfinityQS International, 800-772- 1.5 ppb for meat. Bioo Scientific, 888-208- ­certification from the AOAC-Research 7978, www.infinityqs.com. 2246, www.biooscientific.com. ­Institute.

50 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Advertiser Directory ADVERTISER PAGE ADVERTISER PAGE ADVERTISER PAGE AccuStandard 39 Eppendorf North America 49 P.A. Wester Consulting 51 American Proficiency Inst. 13 EtQ 23 The Pittsburgh Conference 2 American Oil Chemists’ Society 45 Invisible Sentinel 4 Romer Labs 35, 49 Bio-Rad Laboratories 7, 48 LPS Laboratories 15 RQA, Inc. 25 Bunting Magnetics 41 Neogen 21 Spartan Chemical 52 Emport 20 NP Analytical Laboratories 36 Waters 17

Events JANUARY 2015 MAY 16-18 22 19-21 49th Annual Microwave Power Symposium - Internal Auditor Workshop Food Microbiology Short Course IMPI 49 Twin Falls, Idaho University Park, Penn. San Diego, Calif. Visit www.techhelp.org Visit http://agsci.psu.edu/foodmicro Visit http://impi.org/symposium-short-courses/ or call 208-364-6188. or call 877-778-2937. or call 804-559-6667.

27-29 30-2 International Production & Processing Expo asm2015 July Atlanta, Ga. New Orleans, La. 11-14 Visit http://ippexpo.com. Visit http://gm.asm.org. IFT Chicago, Ill. Visit www.am-fe.ift.org/cms. MARCH JUNE 4-6 8-10 25-28 Global Food Safety Conference United Fresh IAFP Kuala Lumpur, Malaysia Chicago, Ill. Portland, Ore. Visit www.tcgffoodsafety.com. Visit www.unitedfresh.org. Visit www.foodprotection.org/annualmeeting.

8-12 9-11 Pittcon Food and Airborne Fungi and Mycotoxins New Orleans, La. Short Courses Visit http://pittcon.org. University Park, Penn. Visit http://agsci.psu.edu/fungi-mycotoxins or call 877-778-2937. APRIL 8-10 Thermal Processing of Ready-To-Eat Meat Products Columbus, Ohio Visit http://tinyurl.com/n29y6wy or call 614-292-4877.

28-30 Food Safety Summit Baltimore, Md. Visit www.foodsafetysummit.com.

(Continued on p. 51

December/January 2015 51