Booming to Bankrupt

PLUS FSMA Exemptions ■ Boat-to-Plate Traceability ■ Hygiene Monitoring Plans Volume 20 Number 2 April/May 2013

The Business of Recalls: From Booming to Bankrupt

Strategies on how to stay afloat amidst the growing frequency of food recalls

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For details, visit www.foodquality.com/award.htm Copyright © 2013 DuPont. All rights reserved. The DuPont Oval Logo is a registered trademark of E.I. du Pont de Nemours and Company or its affiliates. One Destination. Global Connections.

IAFP 2013 Charlotte, North Carolina July 28 — 31, 2013

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Food Quality 16 COURTNEY LAWRENCE BY SARAHBREWAND FDA meanforthefoodindustry the twoFSMArulesfrom An overviewofwhatexactly to Fork Regulations: From Farm New FSMA Proposed ® (ISSN1092-7514)ispublished6timesayear, bimonthly in Feb/Mar, Apr/May, Jun/July,Aug/Sept,Oct/Nov, Dec/JanbyWileySubscriptionServices,Inc.,aCompany,111 RiverSt.,

Hoboken, NJ07030-5774.Periodicalpostage paid atHoboken,NJ,andadditionalmailingoffices.Subscriptioneryear.for U.S.is$126p Internationalsubscriptionis$160. POSTMASTER: Returns andaddresschangestoFoodQuality magazine,POBox 9051MapleShade,NJ08052-9651

April/ MAY ontents Folio OzzieandASBPE award winnerforeditorialandgraphicsexcellence.

Food Quality 2013 • VOLUME 20NUMBER

® isaproudmemberof:UnitedFreshProduceAssociation 20 FSMA Exemptions Tip for theScales Small Businesses at whether theseexemptionsweakenFSMA’s effectiveness FDA’s proposed regulations,othersquestion While smallerfarmsandfacilitiesapplaud preventing foodbornedisease 2 •

www.foodquality.com g From Booing The Business ofRecalls: Business The To Bankrupt Strategies on how to stay afloat amidst Strategies onhowtostayafloatamidst the growingfrequencyoffoodrecalls BY Cover Story 10 NEIL CANAVAN BY TEDAGRES F eat April/May 2013 u r e s

5 CONTENTS APRIL/MAY 2013 In The Lab 40 Pathogen Control Departments A Close Look at a Molecular Detection Method Pathogens can be detected in food process samples with the combined help of isothermal DNA amplification and bioluminescence detection technologies BY NIKI MONTGOMERY

Quality 42 Training Employees Specialized Materials Analysis Training Pinpoints and Corrects Hazards As FDA decides if it should mandate training for employees and supervisors, food quality See Page 28. professionals need to know what type of training programs will meet the requirements BY CHARLES ZONA AND CHERYL MURLEY Safety & Sanitation Raw Materials 22 hygiene Monitoring 31 Ingredients/Additives Hygiene Monitoring Strategies When Safe May Not Be Food Service & Retail that Hit the Mark Safe Anymore 45 Introduction to Sanitation Rapid methods for soil Re-evaluating food additives on Five Essential Tips for detection, indicator microbial the GRAS list in light of current Effective Sanitation loads, and pathogen detection science and advanced testing in hygiene monitoring programs technologies New and old employees should have accelerated BY CHARLES BY MAYBELLE COWAN-LINCOLN be aware, or reminded, of the GIAMBRONE, MS fundamentals for controlling the risk factors associated with food contamination BY LORI VALIGRA 26 Pest Control Don’t Let Third-Party Audits Equipment ‘School’ You 34 Microbiological The five factors to consider for Organisms Product Focus pest management documentation Alternative Tubing Eliminates Reducing Risk of Microbial in order to be audit-ready at any Bacteria in Beverage 48 Contamination time BY ZIA SIDDIQI, PHD, BCE Delivery Systems High-quality microbiology Silver lined tubing and fittings, equipment and supplies meet along with replacements to PVC, the demands for producing rapid, have the potential to increase accurate results for today’s labs quality assurance and improve BY MARIAN ZBORAJ consistency of product at dispensing BY GREG KINNEY Manufacturing & Innovators Distribution 50 Peter Durand’s Metal Can 28 Traceability Instrumentation Led to a Food Safety Staple ‘Boat-to-Plate’ Traceability 37 Measurement English merchant Peter Durand With a global quality hub, Which Measuring Device is Better got the first patent for a tinplated the seafood industry can verify Suited for ‘Soft Solids?’ container in 1810 BY LORI VALIGRA product quality on the boat, Exploring the roles of viscometers at the fishery, with the at-sea versus texture analyzers in 44 INDUSTRY EVENTS and land processors, and at the measuring ‘soft solid’ materials distributor BY STEVE WISE BY ROBERT G. MCGREGOR 44 ADVERTISER DIRECTORY

6 FOOD QUALITY www.foodquality.com waters.com

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Editorial Office 111 River Street, Hoboken, NJ 07030-5774, USA Reprints: E-mail [email protected] Subscriptions: Go to www.foodquality.com and click on “Subscribe” Editorial Submissions: E-mail [email protected] ENABLE Editorial Advisory Panel Betsy Booren, PhD Jennifer McEntire, PhD Chief Scientist Senior Director, Food & Import Safety American Meat Institute Foundation Leavitt Partners Christine Chaisson, PhD Mary Ann Platt Director President DISCOVERY The Lifeline Group CNS/RQA, Inc. Virginia Deibel, PhD Mike Robach Director, Microbiological Consulting Vice President, Corporate Food Safety, Covance Laboratories Quality, & Regulatory Cargill Caroline Smith DeWaal Food Safety Director Bob Swientek Center for Science in the Public Interest Editor-in-Chief, Food Technology magazine Institute of Food Technologists Sara Elhadidy Senior Food Scientist Purnendu Vasavada, PhD WILEY ONLINE LIBRARY Unilever Bestfoods PCV & Associates and Professor of Food Science Philip H. Elliott, PhD University of Wisconsin Access this journal and thousands Food Safety, Global Quality Assurance W.K. Kellogg Institute Patricia A. Wester Vice President Regulatory Affairs of other essential resources. Daniel Y.C. Fung, MSPH, PhD Food Safety Net Services Professor, Food Science & Animal Sciences Kansas State University Craig Wilson Vice President, Food Safety & Quality Featuring a clean and easy-to-use interface, Steven Gendel Assurance Food Allergen Coordinator Costco Wholesale this online service delivers intuitive navigation, FDA Steven Wilson enhanced discoverability, expanded Tim Jackson Chief Quality Officer Director, Food Safety U.S. and Canada. USDC Seafood Inspection Program functionalities, and a range of personalization Nestle and alerting options. Printed in the United States by Dartmouth Printing, Hanover, NH. Copyright 2013 Wiley Periodicals, Inc., a Wiley Company. All rights reserved. No part of Sign up for content alerts and RSS feeds, access this publication may be reproduced in any form or by any means, except as permitted under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior written full-text, learn more about the journal, ﬁnd related permission of the publisher, or authorization through the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923: (978) 750-8400: fax (978) 750-4470. content, export citations, and click through to 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 references. the authors and do not reflect any official policy or medical opinion of the institutions with 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 discussion only and are not intended and should not be relied upon as recommending or 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 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, and make no warranty, express or implied, with respect to material contained herein. 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 are encouraged to contact the manufacturers with any questions about the features or limitations of the products mentioned. wileyonlinelibrary.com Make food pathogen detection Super Accurate

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10 H food-borne illnessesevery year. Thecost ofthese incidents to the estimated 300,000 hospitalizationsand5,000 deathsrelated to astonishingly expensive. after asecond plant was implicated inthe contamination, PCA than 700 casesofserious illnessandatleastninedeaths. Days ofAmerica(PCA).nut Corporation Theoutbreak resulted in more a California-based company isnowbankrupt. government.eral However, theassessmentwillgo unpaid, asthe million settlementwithnumerous plaintiffs, including thefed Westland/Hallmarkmillion. InNovember 2012, reached a$500 of beef.Initialcosts oftherecall to thecompany exceeded $116 FDA, Westland/Hallmark recalled more than143 millionpounds ject ofthelargest meatrecall inU.S. history. At thebehestof You may even go oroutofbusinessaltogether. bankrupt, the damage doneto products branded may take years to repair. recalled/destroyed product, and inthelong term, insomecases, result from lawsuits. Further, short-term revenue islostbecause of sumers, removing foodfrom shelves, andpaying damages that economy isestimated to be$7billion.Costs include notifying con share prices plummeted, thecompany was bought out. $42 million.Anadditional$24 was paidoutinlitigation. After The recall involved over 60millionunitsofpetfood,atacost of tion ofproduct tainted with theindustrial chemical, melamine. ducer of pet foods in North America is held liable for the distribu Salmonella

According to theCenters forDiseaseControl, there are an 2009: 2008: Westland/Hallmark Packing Meat Company isthesub 2007: A fewrecent examples: Strategies on how to stay afloat amidst Strategies onhowtostayafloatamidst the growing frequency of food recalls the growingfrequencyoffoodrecalls FOOD The Business of Recalls: Canadian-based, Menu Foods,Canadian-based, Menu once thelargest pro In one of the deadliest cases of food contamination, In oneofthedeadliestcases foodcontamination,

QUALITY (the problem) theimpactcanbevast inscope, and all oftheabove. That’swhy when there’s afoodrecall in Chicago, orSchenectady, orCucamonga, ormaybe ouston, we have aproblem. Ormaybe theproblem is outbreak occurred ataplantbelonging to thePea- By Neil Canavan

- - - - - From Booing forced to fileforbankruptcy. Minden, Nevada, makers oftheDetour energy brand bars, was ported recall-related losses of $70 million, and Forward Foods, of the recall extended farbeyond Kellogg, PCA.Thefoodgiant, re - permanently discontinued operations. Theeconomic impactof and enables real-time reporting to quickly meetauditor requests. comprehension, provides automatic documentation ofresults, remotes and interactive courseware, SISTEM validates employee regulations, andindustry bestpractices change. Using handheld industry specific courseware that’s updated regularly as laws, manufacturers andprocessors to upto train 150 employees with andcompliancetraining management platformthatenables food the sameprocedural page. everyone, throughout oracross multiple theplant, facilitiesison prehensive andconsistent employee training—consistent inthat plementing food safety education programs that provide com- preventive control thanjust nowrather regulatory compliance.” CEO ofAlchemy, Austin, Texas. “Ithinkpeopleseeitasmore ofa employee training inthefoodindustry oflate,” says Jeff Eastman, food safetywithinyour company. recall. Perhaps themosteffective meansis to create aculture of Nothing isfoolproof, butthere are steps to betaken to avoid a allergen concerns account forthebalance ofrecall incidents. E. coli at thehighest risk. all unitswere ofClassIrecalls, part items which putconsumers highest level recorded in more than two years. More than 55% of the numberofreported recalls forthesecond quarter, andthe involving 189companies, and8.5 product units. That’s 2.5 times the expansionofglobal supply chains are increasingly frequent. due toeral, newregulations, heightened detection sensitivity, and Avoiding A R ecall Recalls ofthisscaleare uncommon, however, recalls ingen- Designed forproduction workers, Alchemy’s SISTEM isa For thelastnineyears Alchemy hasbeendesigning andim- “We’ve seen much more awareness around the importance of In 74% oftherecalls theconcern was theFDAIn thethird quarter of2012, documented 414 recalls , and botulism contamination. Undeclared allergens or other Salmonella www.foodquality.com , Listeria ,

to Bankrupt

The message is also skewed towards the personal, which can The biggest challenge Mehring sees in recall events is loca- be a powerful tool. The training will incorporate familiar prod- tion, location, location. “Most people do traceability today in ucts—McDonalds, for instance—products that workers purchases what they call one up and one down look. They only know where themselves, and then using that association to drive home the they got it from, and where it went.” To really figure out if your message of food safety. “It’s like, this is something you would feed product’s affected, you have to go through a chain of companies your child,” says Eastman. “How would you like that product to to get the data, and that can take days. be handled?” Intelleflex’s solution is built around the hardware component A platform like SISTEM also enables repetition. “You have to (RFID tag) that travels with the product through the supply chain, constantly train and reinforce the behavior if you expect that cul- with the tags checking in automatically at every access point. The ture to be pervasive throughout your company.” data captured is then pushed to the cloud-based ZEST platform. “Not only does ZEST capture that data, but we’ve built in a notification engine, based on business logic set up by the user, “Most people do traceability which notifies the given individual (via smartphone or PC) should an event occur.” In other words, the information goes only to the today in what they call one up person who needs to know it, say the person to remove a specific and one down look.” lot number from the shelf. The idea here is to manage by excep- tion—meaning that the manager’s attention should be directed – Peter Mehring, CEO, Intelleflex exclusively to the thing gone awry, rather that on the mechanisms that are still humming smoothly along. Ensuring employees take part in a training program that However, some potential customers have taken issue with the advocates a food safety culture is a major factor in preventing additional overhead. Mehring counters with this: Traceability is a recall. an excellent way to ensure freshness of product (saving money) while at the same time operating as a sort of insurance policy Tagging Along for optimum response should a recall be required. Sure, nobody SISTEM allows you to follow the progress of an employee to help wants to pay for insurance when they think they are great drivers, avoid any mishaps that might lead to a recall, while the ZEST but as he sees it, particularly where leafy green produce is con- cloud-based data collection platform, from Intelleflex, Santa cerned, a recall is not a matter of if, it’s when. Clara, Calif., allows you to track the journey of your product. The technology facilitates two critical aspects—the ability to verify the When? That Would Be Now integrity of the cold chain; and the pinpoint location of product Precautions are not foolproof. Recalls do happen, and when they should there be need to pull it off the shelf. do, any future litigation may hinge on the manufacturer’s appro- “You can try traditional approaches, either through barcodes, priate, and above all, rapid response. or passive RFID (radio-frequency identification),” proclaims In- “A lot of companies do not possess the core capabilities to telleflex CEO, Peter Mehring, “but neither approach is very reli- support recalls,” says Jeri Cockrell, vice president of client strat- able.” A barcode has to be manually entered at each station, and egy for Telerx, Horsham, Pa., “But we’re equipped for an expe- passive RFID doesn’t work automatically around food of high dient response, setting up preferred channels of communication water content, like produce. “People have to go after it with hand- with a dedicated 800 number, social media contact, email, or helds, so that’s just like barcodes again…” Too much room for even website support. Whatever modality is required.” variability, for error. (Continued on p. 12)

April/May 2013 11 (Continued from p. 11) Once a recall is announced, a company like Telerx can be your point man in assessing the scope of the communication required, and addressing the concerns of your particular customer base. “We start asking questions of our clients immediately,” says Cockrell. “We ascertain the household impact (a few hundred households, millions?), how many units of product are involved, is it a full product line, a specific lot number, is there a particular demographic that we need to focus on, be it children, or the elderly…” And then Telerx staffs accordingly. For instance, a high volume recall can have as many as many as 300 reps en- Your gaged one recall program. “In some instances, the insurance companies will pay some, if not all of the cost of Partner doing a mock recall.” – Bernie Steves, managing director for Lab Supplies of Aon Risk Solutions

It’s also important to take into account the timing of a recall >Quality Products announcement. “If it’s Friday at 5 p.m., generally you’ll start seeing your volumes (customer queries) rising over the weekend, >Valuable Services then Monday, the media pick it up, you get hit hard,” notes Cock- rell. A 1,000 percent increase in queries is not uncommon. >One Dedicated Supplier It’s advantageous to be ready to handle the influx with as little as 24 hours notice. According to Cockrell, if the news breaks at 5 p.m., Telerx can be ready to answer customer questions by grainger.com/lab 8 a.m. the next day. Just five to 10 years ago you would merely set up an 800 number, says Cockrell, but today recalls are sup- ported through chat, social media channels, phone, email, web support, etc. “There are so many different ways that consumers can reach you today.” The bottom line is that in order to protect your brand you have to get the information out there, and be able to address any customer concern in real time. Without those options to assuage fears, whom else might a customer turn to—a lawyer perhaps?

Enter The Lawyer “We have worked closely with all segments of the industry in handling their regulatory crisis management and litigation in food safety,” says Shawn Stevens, an attorney at Gass Weber Mullins, LLC, in Milwaukee. If you have a recall that results in litigation, call an experienced attorney. Even before you’re involved in a recall, it’s a good idea to call an attorney with expertise in assessing client exposure. “I’ll come in and do brand protection audits for companies,” comments Stevens. “I can look with a new set of eyes at problems that companies are missing. Sometimes it can be the most basic food safety procedures from an operational standpoint, something that with little or no money can be modified.” One of the major causes of bankruptcy can be inadequate coverage. “Any insurance policy can be tricky once you look at ©2013 W.W. Grainger Inc. W-UCBM101 the fine print,” explains Stevens. Many policies do not cover all the contingencies that a company might face during a recall.

12 FOOD QUALITY www.foodquality.com The Business of Recalls: From Booming to Bankrupt

Consider a market withdrawal: You’ve proactively invested it and know how to effectively recall products, and how to properly traceability technologies, pathogen detection systems, etc., and get the message out. you caught a problem and traced it to the source before any out- “Most of the carriers will also make those consultants avail- break occurred. You retrieved the lots in question and dodged a able before an incident happens,” says Steves, “and in some in- bullet. But it was expensive, yet, because no formal recall was ex- stances, the insurance companies will pay some, if not all of the ecuted, your recall insurance is not going to pay for a dime of the cost of doing a mock recall—bringing consultants in and practic- action taken. “So the company would almost be better off by ignor- ing your recall plan.” ing the problem until someone gets sick—no company does that of Keep in mind that the insurers are there to help you because course—but this (gap in coverage) is a huge problem,” says Stevens. they don’t want to pay for a recall any more than you do. It’s their Another scenario: Many policies are written to provide cov- input that may make the difference between thriving, just surviv- erage only in the event of a government mandated recall. “The ing, or going under. ■ problem here is that every single recall in the history of recalls has been voluntary.” The FDA, mentions Stevens, doesn’t want to be Canavan is a freelance writer based in Brooklyn, N.Y. Reach him at [email protected]. in the position of overreacting, or mis- identifying a recall culprit, so they pass the responsibility on to the corporate suspect. They will only strongly suggest to the company that a recall is in order. “So what will happen is these companies, as they always have, will announce a vol- Recall Readiness untary precautionary recall of their food products, so technically coverage would not be triggered under the policy.” Are you ready for the call? Going For Broker RQA’s Recall Planning and Simulation processes challenge For a complete assessment of your recall your organization's capabilities, training and readiness, insurance needs, call a broker. Speaking from 25 years of experi- from initial incident identification to product recovery. ence, Bernie Steves, managing director of Aon Risk Solutions in Chicago, says it is not uncommon for companies to as- RQA’s assessment includes: sume a recall is already covered by their product liability, or general liability pol- s Initiation, investigation and icies, but that generally isn’t the case. A communication process broker can assess the recall-related util- s Team roles and responsibilities ity of your existing policies and look at the food safety systems being employed s Process flow and lot traceability (RFID, pathogen testing, training pro- s Retrieval capability and grams, etc.) to gain an overall picture of effectiveness checks a company’s risk; a broker asks upfront s Recall Plan review and optimization what the insurance underwriter is going to be asking later. “We look at each insured a little bit different,” says Steves. Are you a branded product? Are you a co-packer, or ingredient supplier, is your exposure more first party, or third party? And so on. Should you purchase a recall policy, and you really should, there are perks you may not be aware of. “One of the For more information most important aspects of these policies is that each of the insurance carriers has Email us at: [email protected] retained crisis consultants that are avail- or contact the Crisis Management able to assist the insured in the event of Hotline at: 630.512.0011 x400 an incident.” These crisis consultants are available to assist in managing that situa- www.rqa-inc.com tion, experts who have dealt with recalls

April/May 2013 13 EMD Millipore Advertorial

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Att EMD MilliMillipore,pore, food safety goes far beyond the visible. It starts wwithith lilisteningstening to your cchallenges.hallenges. RRapidlyapidly cchanginghanging regulations?gulations? We helhelpp you succeed with our extensive regulatorygulatory expertise.expertise. ComComplexplex pprocesses?rocesses? Increase efﬁ ciency andnd reliability with our state-ostate-of-thef-the art pproducts.roducts.

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EMD Millipore is a division of Merck KGaA, Darmstadt, Germany FSMAQuarterly UUpdate pdate © S ash ki n /Fotoli a . c o m / rs ooll/Fotoli

FNew Proposed FSMA Regulations: From Farm to Fork An overview of what exactly the two FSMA rules from the FDA mean for the food industry By Sarah Brew and Courtney Lawrence

fter much anticipation and Risk-Based Preventive Controls for Human develop new regulations that are practical delay, on January 4, 2013, the Food; and 2) Standards for the Growing, and not “one-size-fits all.” Food and Drug Administra- Harvesting, Packing and Holding of Pro- tion (FDA) released two produce for Human Consumption. The new CGMP & Hazard Analysis & Aposed regulations under the Food Safety rules are part of FDA’s overarching efforts Risk-Based Preventive Controls Modernization Act (FSMA) that will have to shift food safety focus from reactive to FDA’s proposals would add a new set a significant impact on food growers and preventive. FDA met with farmers, indus- of regulations implementing the Haz- producers: 1) Current Good Manufacturing try, consumer groups, the international ard Analysis and Risk-Based Preventive Practice (CGMP) and Hazard Analysis and community, and other key stakeholders to Controls provision of the FSMA. The new

16 FOOD QUALITY www.foodquality.com rules focus on preventing problems that controls may be required at points other small businesses” that are not exempt can cause foodborne illness through two than at critical control points and critical would have three years to comply after changes: Revisions to the existing CGMP limits would not be required for all preven- publication of the final rule, “small busi- and the addition of preventive controls. tive controls. nesses” would have two years to comply, Revisions to the CGMPs. The pro- The tentative proposed rule does not and all other businesses would have one posed rule would update or delete certain include requirements that companies en- year to comply after publication of the fi- requirements in the existing CGMPs and gage in either environmental monitoring nal rule. To help the industry, particularly generally “modernize” the language of or finished product testing. However, FDA small and mid-sized businesses, com- the CGMPs. It would clarify that existing continues to seek comments on these pro- ply with the new requirements, the FDA CGMP provisions requiring protection visions, and FDA recently indicated such helped establish a Food Safety Preventive against contamination of food also re- provisions would be in the final rule. Controls Alliance to develop a core train- quire protection against cross-contact of ing curriculum and to disseminate infor- food by allergens. Provisions directed to mation on hazards and controls. preventing contamination of food and The tentative proposed food contact substances would also in- rule does not include Standards for the Growing, clude preventing contamination of food requirements that Harvesting, Packing and Holding packaging materials. Certain other CGMP of Produce provisions would be deleted, including companies engage in FDA’s second set of proposed rules would provisions recommending temperatures either environmental establish minimum safety standards for for maintaining refrigerated, frozen, or monitoring or finished the production and harvesting of fruits hot foods. In addition, FDA is requesting and vegetables on farms. The FDA’s pro- comment on whether it should mandate product testing. posal builds upon prior produce safety training for food production facility em- activities by the FDA and the produce ployees and supervisors. industry to establish standards and best Preventive Controls. The proposed In general, with some exceptions, practices, such as the Leafy Greens Mar- rule would require facilities of a certain the preventive control provisions would keting Agreements in California and size to develop formal, written food safety apply to facilities that manufacture, pro- Arizona and the Model Code for Produce plans to prevent and correct food safety cess, pack, or hold human food and are Safety. In developing the rules, FDA con- issues. Specifically, a facility would be re- required to register with the FDA under sidered both the commodity and the quired to evaluate “known or reasonably Section 415 of the Federal Food, Drug and practices associated with growing, har- foreseeable” hazards; identify and imple- Cosmetic Act. Activities within the defini- vesting, packing and holding the produce ment preventive controls to address these tion of “farm” would not be subject to the as well as how produce will be used and hazards; monitor performance of the pre- proposed preventive controls. The pro- consumed after it leaves the farm. The re- ventive controls; establish corrective ac- posed rules provide exemptions for cer- sulting rules are designed to allow grow- tion procedures when needed; and verify tain facilities and for certain activities. For ers flexibility in their approach to on-farm that the preventive controls are adequate example, very small facilities or activities food safety, with the ability to implement to control the hazards identified. The pre- subject to and in compliance with existing food safety practices appropriate to the ventive controls would include, as appro- HACCP regulations for seafood and juice scale of production and type of agricul- priate, process controls, allergen controls, are exempt from the requirements for pre- tural practices used. sanitation controls, and a written recall ventive controls. In addition, the FDA is The rules focus on agricultural prac- plan. In all respects, FDA intends each fa- proposing modified preventive control re- tices and propose new standards in cility’s food safety plan to be tailored to fit quirements in certain circumstances, such working, training, and health and hy- the facility and the risks associated with as modified requirements for warehouses giene; agricultural water; biological soil the facility’s food. solely engaged in the storage of packaged amendments; animals in growing areas; Food facilities are also required to food that is not exposed to the environ- equipment, tools, and buildings; and document actions taken under the food ment. Modified requirements would also specific standards for sprouts. They cover safety plan, and those documents must be apply to “qualified facilities” (a very small most fruits and vegetables while they are made promptly available to the FDA upon business or one with three-year average in their raw or natural state, including oral or written request (such as during an annual sales of less than $500,000, with herbs and tree nuts, but exempt certain inspection), and to reanalyze the plan at more than half of sales going directly to categories that create less risk. They do least every three years. In addition, food consumers or to restaurants/retail food not apply to 1) produce rarely consumed facilities are required to appoint a “quali- establishments in the same state or within raw, such as artichokes, asparagus, or po- fied individual” to prepare and oversee the 275 miles). tatoes; 2) produce for personal or on-farm food safety plan. The proposed preventive Recognizing that smaller businesses consumption; 3) produce that is not a Raw controls align with Hazard Analysis and may need more time to comply with the Agricultural Commodity; and 4) produce Critical Control Points (HACCP) systems, requirements, compliance dates would intended for commercial processing with but the new rule differs in that preventive be phased in based on business size. “Very (Continued on p. 18)

April/May 2013 17 FSMA Update Quarterly Update

(Continued from p. 17) farms and farm “mixed-type facilities” Timeline for Implementation and a “kill step” that will adequately reduce with average annual sales under $25,000 Compliance microorganisms of public health concern. would not be covered under the new rules. The effective date for both proposed rules is Unlike preventive controls, the new pro- These farms, however, will continue to 60 days after the final rules are published in duce safety rules will require minimal re- be covered under the adulteration provi- the Federal Registry. FDA continues to seek cordkeeping. Growers would be required sions and other applicable provisions of comments on the proposed rules through to document that certain of the standards the Federal Food, Drug and Cosmetic Act. May 16, 2013. According to FDA, it will be at are being met, but the rule would not re- Farm mixed-type facilities (farms that least a year before the final rules are pub- quire duplication of records already kept are also engaged in activities outside the lished. Until then, food growers, manu- for other purposes. definition of “farm” that require food fa- facturers and distributors will have time to The proposed rules provide that farms cility registration), may be subject to both develop plans, policies, and procedures to may establish alternatives to certain re- the proposed produce safety rules and conform to the new rules. FDA recognizes quirements related to water and biolog- the preventive controls rules, such as an that partnership with the food industry is ical soil amendments if the alternative establishment that both grows and pro- essential to the success of the proposed is scientifically established to provide cesses fresh-cut produce. rules and will continue to provide tech- the same amount of protection as the re- Similar to the proposed preventive nical assistance and outreach through quirement in the proposed rule without controls, FDA proposes staggered com- public meetings, presentations, listening increasing food safety risks. In addition, pliance dates depending on the size of sessions, and guidance documents. ■ states or foreign countries may request the farm. “Very small farms” would have a variance from some or all of the rules four years from the effective date to com- Brew is a partner at Faegre Baker Daniels in Minneapolis if required by local growing conditions, ply, “small farms” would have three years and leads the firm’s nationally ranked Food Litigation and Regulation practice. She represents companies involved in provided the same level of public health to comply, and other covered farms would all aspects of food production and distribution. Lawrence is assured. have two years to comply. In all cases, the is an associate at Faegre Baker Daniels, practicing in food and agriculture litigation and regulation. She previously Certain farms would be subject to time period for compliance would be ex- worked for an international producer and marketer of food, modified requirements. For example, tended for some water requirements. agricultural, financial, and industrial products and services.

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18 FOOD QUALITY www.foodquality.com

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is based on two premises: That FSMA’s Small Businesses Tip the requirements would be too burdensome and expensive for small-scale growers and Scales for FSMA Exemptions producers, and that food products from small farms and businesses aren’t as risky While smaller farms and facilities applaud FDA’s proposed as those produced by large operators. regulations, many experts in the food industry question “Let’s face it: Dangerous foodborne whether these exemptions weaken FSMA’s effectiveness at outbreaks don’t start with family agriculture,” Tester said after introducing the preventing foodborne disease | By Ted Agres amendment in 2010. “Food produced on that scale shouldn’t be subject to the same expensive federal regulations as some big bout three-quarters of the U.S. and small business alliances laud the ex- factory that mass produces food for the farms that grow, harvest, pack emptions, many other food safety experts entire country.” A or hold produce, as well as food do not. The Tester Amendment exempts farms companies that manufacture, process, “Being a public health agency, FDA from most FSMA requirements if they have pack, or hold food, are likely to be exempt knows full well that small places can less than $500,000 in average annual from all or most of the requirements cause big problems,” says David Acheson, sales and more than half the sales go to of Food Safety and Modernization Act director of the food and import safety “qualified end-users,” defined as con- (FSMA). This is because these farms and practice at Leavitt Partners and former sumers anywhere or to restaurants or re- facilities will be considered to be “small” FDA associate commissioner of foods. “I tail food establishments in the same state or “very small” businesses based on the don’t honestly believe that FDA is very as the farm or not more than 275 miles value of their annual sales, end custom- comfortable with this, but they have to away. (These farms may need to comply ers, or both. do what they’ve been told and so will de- with certain labeling requirements even if On Jan. 4, 2013, the FDA published fault to using Small Business Administra- they are exempt.) FDA can withdraw the draft regulations on produce safety tion-type definitions, such as fewer than exemption if the farm is directly linked to (“Standards for the Growing, Harvest- 500 employees or certain dollar amounts a food-related outbreak or to mitigate or ing, Packing and Holding of Produce for so there will be some consistency across prevent an outbreak. Human Consumption”) and for preven- the federal government as to how ‘small’ The draft produce rule also excludes tive controls (“Current Good Manufac- and ‘very small’ businesses are defined,” any produce that is considered low risk turing Practice and Hazard Analysis and Acheson tells Food Quality magazine. with respect to biological hazards. Ex- Risk-Based Preventive Controls for Human amples include produce that is rarely Food”). The two proposed rules, which to- Tester Amendment consumed raw, such as potatoes, or that tal more than 1,200 pages, are the first of at As happens with nearly all major pieces will undergo processing that includes a least four regulations to implement FSMA. of legislation, a variety of interest groups kill step, such as green beans intended for Rules on preventive standards for animal and lobbyists sought to influence FSMA canning. The proposed rule also does not food facilities and on foreign supplier ver- as it was being crafted in Congress. For apply to produce for personal or on-farm ification requirements are expected some- example, supporters of sustainable ag- consumption. time this year. riculture and family-owned farms urged The rule, which is open for public But thus far, it appears that most U.S. Congress to exempt small growers and comment until May 16, 2013, exempts farms and food companies will dodge small processors, while many large corpo- farms having less than $25,000 in aver- many FSMA requirements. Despite this, rations and trade groups urged inclusion age annual sales. According to the FDA, the FDA estimates that about 90 percent regardless of size. In this case, the small 40,496 domestic farms (including 285 of the produce grown and consumed in farms won. The Tester-Hagan Amend- sprout farms) will be fully subject to FSMA the U.S. will either be covered by FSMA, ment exempts small farms from having rules. Fully or partially exempt would be consumed cooked, or be processed in to comply with most FSMA requirements. be 75,716 farms that fall under the Tester plants capable of handling biological haz- Named after its cosponsors, Democratic Amendment provisions and 34,433 farms ards associated with produce. However, Senators Jon Tester of Montana and Kay having less than $25,000 in sales. By this while family-owned farms, small growers, Hagan of North Carolina, the amendment count, 73 percent of all U.S. produce farms

20 FOOD QUALITY www.foodquality.com would be fully or partially exempt from must have a hazard analysis and preven- ventive control rule. If the exemption were FSMA requirements. However, FDA notes tive controls plan in place. (Farms are gen- set at less than $250,000 in annual sales, that, as a group, food businesses with less erally not required to comply unless they FDA says 46,097 of these firms, or 47 per- than $500,000 in annual sales produce are a “mixed use” facility that also em- cent, would be exempt from hazard anal- less than 1 percent of all U.S. food by dol- ploys a processing activity, for example, ysis and risk-based preventive controls. If lar value. chopping vegetables.) set at less than $500,000, 57,411 or about Small farms that do not come under The preventive control rule would es- 59 percent would be exempt, and if less the Tester Amendment would be given tablish modified requirements for “quali- than $1 million, 74,985 or about 77 percent extra time to comply with FSMA require- fied facilities”—that is, facilities that either of the firms would be exempt. ments. Sixty days after a final produce meet the Tester Amendment definition for Like the produce safety rule, FDA is safety rule is published in the Federal business size and customer base, or that accepting comments on the draft rule Register, non-exempt “small businesses” are “very small” businesses. For the latter, until May 16, 2013. Sixty days after publi- (those with less than $500,000 in cation of a final rule, large facilities annual sales) would have three will have one year to comply with years to comply with requirements. requirements, while non-exempt “Very small businesses” (those small businesses would have two having less than $250,000 in an- years and non-exempt very small nual sales) would have four years businesses would have three years. to comply, while other businesses “I’m not sure it makes that would have two years. The small- much difference whether a firm est farms, those having less than has $250,000 or a million dollars in $25,000 in sales, are exempt. sales,” says Acheson. “But part of “We know one-size-fits-all the reason FDA is asking for com- rules won’t work,” said Michael R. ment is if they get an overwhelming Taylor, deputy FDA commissioner response saying to make the defini- for foods and veterinary medicine, tion as stringent as possible, it gives when the rules were published them cover to do so. If they don’t get back in January. “We’ve worked to it, they will stick to where the com- develop proposed regulations that ments lead them.” can be both effective and practi- Both Acheson and Plunkett cal across today’s diverse food wish that small businesses had been system,” he said. treated differently. Others are not so sanguine. “If I were calling the shots and “Income has no relationship to had the resources, I would be put- risk of bacterial contamination,” ting preventive controls require- says David W. Plunkett, senior staff ments on all small businesses irre- attorney at the Center for Science spective of size if they ship through in the Public Interest in Washington, D.C. FDA is proposing three different categories interstate commerce,” Acheson says. “But “Therefore we see absolutely no reason to and is requesting comment on each. The I would also build robust programs to ed- suppose that these [small] facilities and options are average annual revenues of ucate and train the small producers. The farms are inherently safer than larger fa- $250,000, $500,000, or $1 million. challenge is that many of them are not so- cilities and farms. One likely result of the However defined, these very small phisticated enough to understand what Tester Amendment is that food from Tester facilities and the Tester Amendment-level they need to do.” facilities and farms will begin to bear a dis- firms would only be required to certify that Plunkett believes that all food proces- proportionate share of the illness burden,” they have identified potential hazards as- sors should conduct science-based assess- Plunkett tells Food Quality magazine. “We sociated with the food being produced and ments of risk and implement preventive can’t ignore the fact that Tester weakens are implementing and monitoring preven- measures. “The rule should be structured FSMA’s effectiveness at preventing food- tive controls measures. Alternatively, they to accommodate size without overlooking borne disease.” could submit documentation that they mitigation or elimination of risk,” Plunkett comply with a state, local, county, or other says. “There is a logical lapse in Tester’s Preventive Control Rule non-federal food safety law, including assumption that a processor who can’t A bit more complicated are small busi- relevant laws and regulations of foreign afford to implement reasonable preven- nesses exemptions in the proposed pre- countries. In either case, they wouldn’t tive measures is somehow going to always ventive control rule. In general, the rule have to submit any actual plans. produce safe food.” ■ would require facilities that manufacture, FDA estimates that about 97,646 do- process, pack, or hold food to register with mestic food manufacturers, warehouses, Agres is based in Laurel, Md. Reach him at tedagres@

April/May 2013 21

Safety & 22 and GFSI agendas increased verification enforcement from federal regulations have accelerated dueto newtechnologies spurred on by and pathogen detection inhygiene monitoring programs Rapid methods for soil detection, indicator microbial loads, Strategies that Hit the Mark Hygiene Monitoring T environmental surfaces. programs for Lmforfoodcontact and and anewtypeofriskbasedsampling trol measures coupled withtheEIAOs March 15, withthealternative 2006 con- June 430. with 9 CFR Part 2003 Then on program, thesubsequentrevisions in ucts fortheFSIS Verification Testing

FOOD QUALITY pling ofReady-To-Eat Prod advent oftheMicrobial Sam- had begun withthe in2002 he emphasisonvalidation | By Charles -

Giambrone, MS ket sectors have already have mandated Congress anumberofmar inearly 2012, ization Act (FSMA) enacted into law by newly established Food- SafetyModern FSSC 22000 here in North America, has here inNorth America, has FSSC 22000 proved versions ofSQF, BRC, andnow grams, especially inthelatest GFSI-ap Global Food Safety Initiative (GFSI) pro hygiene monitoring technologies. enforcement including validations using Also, due to therequirements by the The rise in implementation of the The riseinimplementationof the Hygiene Sanitation M onitoring - - - ous hygiene monitoring modalities. made validation mandatory viathevari- finally to the Zone 4 area that is the gen- zones around thefoodprocessing area, to Zone3, theimmediate environmental which are theindirect foodcontact areas, microbial control outward from Zone2, proach isto establish andmaintain from compromising thiscriticalzone. vent pathogens andspoilage microbes all hygiene control programs mustpre- the actualfoodcontact zone.Obviously, We eye” allknowtheZone1or“bull’s is multi-barrier system akinto adartboard. view pre-requisite program controls asa and knowledgeableexperts sanitarians food service operations, many foodsafety In bothfoodprocessing plantsaswell as Zone SamplingConsiderations tamination Control. emphasizes Chemical&Physical Con- ered aFundamental Clause. Also, 4.9.1 keeping &Hygiene clause isalsoconsid in Housekeeping &Hygiene. TheHouse- Validation-Verification inClause 4.11.4 there is thisenhanced enforcement on validation methodsandprocedures. vironmental surface hygiene monitoring (SSOPs) aswell asthefoodcontact anden chemical concentrations andprocedures umented andfrequency forvalidation of “mandatory elements.” Thisincludes doc in module 11andinmodule 12aswell as fication of hygiene monitoring/sanitation an increased emphasisonValidation-Veri Particularly, thenewSQFedition7has However, thesoundproactive ap Similarly, withthenewBRC Issue 6, www.foodquality.com - - - - -

© Ogerepus/Fotolia.com eral environmental environs of the food for sampling. But the critical factor is that with confirmation by selective platings. plant. The objective of any sound hygiene one must understand the limits of the Sponge systems are also utilized for car- monitoring program is to not merely focus sampling system. cass detection of EHEC microbes in nu- on the bull’s eye, but be as assiduous in For example, a swab is an excellent merous USDA plants. your program as you can to control Zones tool to assay a gasket or a tight area, but Soil detection systems. There are 4 and 3, thereby minimizing the risk upon has a lower recovery of viable microbes many different ATP units with varying fea- Zones 2 and 1. than a sponge or wipe. Meanwhile a tures. All have evolved into more compact Therefore your hygiene monitoring sponge swab or RODAC plate is effective units, with self-containing ATP swab pens validation programs must include both for a flat surface, while a curved tank wall coupled with excellent software to down- the Food Contact (Zones 1 and 2) and En- may prohibit the use of RODACs but is con- load and interpret data for your hygiene vironmental (Zones 3 and 4) for soil re- ducive to sampling by a sponge system. validation verification programs. moval, as well as indicator and pathogen There are many units on the market, microbe validations. The frequencies will but there has been consolidation of some of course vary based upon the risk assess- QAC sanitizers have companies the past 10 years. Examples ment of the plant’s HACCP program for of hygiene monitoring with ATP units each and every product manufactured at been known in some include: AccuClean (Neogen), Charm, a specific plant site. instances to create false CleanTrace (3M), Ensure (Hygiena), HyLite For example, on a post kill/cooked- positive readings with (EM Millipore), and SystemSure Plus RTE processing piece of direct food con- (Hygiena). Most utilize a swab that is tact equipment, the frequency that equip- ATP, while oxidizing pre-moistened. The AccuClean has a small ment unit will be assayed on a weekly sanitizers can create sponge-like sampling area instead of a basis will be far greater than a raw meat false negatives when a swab. Some utilize a lyophilized pellet of blender or mixer under the hygiene sam- the enzymes that gets reconstituted; oth- pling plan for that facility. freshly sanitized surface ers, like Hygiena’s Ensure and SystemSure The selection of sites either during is sampled for ATP. Plus use a liquid system. a pre-operational sampling or during a Once the surface is assayed, the ATP scheduled shift cleanup or even oper- swab pens are activated by twisting, ational assessments must be selected cracking the chamber containing the based upon a program’s risk assessment A comprehensive national study enzymes needed to activate the firefly of each site, but must be selected by the published in Applied and Environmental reaction, then placed into the ATP lumi- sampling team in a manner not to tip off Microbiology utilized both sponge sticks nometer chamber where the photodiode the sanitation staff. The sampling matrix (3M), and wipes to recover Bacillus an- measures the Relative Light Units (RLUs) in its entirety must cover all critical food thracis spores showed that the gauze released. The higher the RLU reading, the contact and environmental sites within wipes had 35 percent rate of spore recov- greater the soil. Unfortunately, RLU scales the program’s mandated frequency. This ery while the sponge sticks had a recov- vary widely between ATP luminometer. is vital in order to generate a validation ery range of 26 percent to 36 percent. This historically was done by manufactur- history that accurately reflects the realities Using both methods, the sponge, as ers to tie the user into one unit since all the of the facility’s design and operation. is typically done, is placed into a sterile surface ATP swab history is based upon a sampling bag or stomacher bag and is luminometer type’s specific scale. Methodologies transported with either a peptone water Years ago, faulty attempts were made There are a myriad of systems and de- or other recovery broth. A recovery or re- to correlate ATP with microbial levels. This vices to assess hygiene levels on both suscitation broth is critical for stressed/ is highly problematic because ATP assays food contact and environmental surfaces. sublethally injured vegetative microbes, measure organic soil load that is lowest Some employ sophisticated microbial but is not essential for spores. in bacteria. Yeasts and molds have much detection methods utilizing polymerase The utilization of the sponge stick or higher levels of ATP per microbe than do chain reaction (PCR) with sophisticated solar-cult devices enables one to use one bacteria, so if a soil matrix has active spoil- instrumentation. However, I will focus on sponge face for horizontal direction of age fungi, the RLU reading will be higher some of these companies that have both a surface, the other for vertical, and the than with vegetative bacteria. soil detection, indicator microbial detec- edges for the diagonal of the same sam- Establishing a baseline for pass/fail tion, and pathogen detection systems that pling surface. This is done omitting the for your food contact and environmental are designed for hygiene monitoring pro- variable of handling the sponge directly sites is critical. All these ATP luminome- grams in concert with plant sanitation. with gloved hands. ters enable you to set multiple pass/fail There are three primary tools to Best recovery of low numbers for enu- RLU readings for specific sites, plant ar- sample a surface: the classic swab, the meration is achieved via membrane filtra- eas, or equipment depending again upon sponge, and the wipe. Many studies have tion and plating. For pathogen presence/ the nature, surfaces, and dynamics of the been done through the years to ascertain absence sequential incubations in AOAC processing operation with that equipment which extracts the most soil or microbes BAM approved broths is done coupled (Continued on p. 24)

April/May 2013 23 Safety & Sanitation Hygiene Monitoring

(Continued from p. 23) systems like Neogen’s Reveal Rapid 3D ing a facility with a result for E.coli or En- or environmental site. Baseline studies kits using lateral flow technology are re- terobacteriacea in less than seven hours. need to be done very carefully when quired for allergen hygiene monitoring. It relies on a “bioluminogenic” reaction an ATP hygiene monitoring program is Hygiena also has an enzyme detec- involving specific enzymes generated by set up in a specific facility so the pass/ tion swab for lactose or sucrose soil resi- the specific indicator group to measure fail limits are meaningful, reliable, and due: SpotCheck Plus, which turns green in and detect the indicator reproducible. the presence of either sugar residue. This Like ATP, pass/fail levels for indicator There are specifically designed ATP is useful for dairy plants, confectionary microbes depend upon the food contact or pens to sample water and clean-in- candy, and beverage plants. environmental site being sampled. How- place (CIP) rinsate systems. Hygiena’s Indicator Microbe Testing. The typi- ever, a guideline I prefer is one advocated AquaSnap is one example to sample the cal methodology for sampling either food in the British Columbia Centre for Disease final rinse of a CIP cycle (prior to saniti- contact or environmental surfaces for Control’s document on environmental zation) and assess the level of ATP soil in indicator microbes involves a standard hygiene monitoring that has an interpre- the final rinse. This is a useful tool for hy- swab, in some cases with a neutralizing tation of a “clean” surface being <45 cfu giene monitoring of CIP system cleaning (colony forming units) , “contaminated” validations. surface being 140-260 cfu, with “very con- The other cautionary note both for taminated” being > 260. This document is ATP systems and for any other soil enzyme an excellent primer on how to approach detection system is the point in the sanita- hygienic monitoring, critical environmen- tion process it is best utilized. Many san- tal sites to assay in generic environmental itizers can and will interfere with the en- terms, and sampling using both swab and zyme reactions. Quaternary ammonium sponge assay methods. compound (QAC) sanitizers have been Air monitoring is also a vital compo- known in some instances to create false nent of your hygiene monitoring program. positive readings with ATP, while oxidiz- While many plants utilize the classic air ing sanitizers can create false negatives sedimentation method employing petri when a freshly sanitized surface is sam- dishes left exposed to a specific area for 15 pled for ATP. minutes, this method relies on the seren- I recommend that since ATP is a ba- dipitous deposition of microbial particles rometer of soil level, it’s best utilized after landing onto an agar surface. the cleaners have been completely rinsed buffer or a Letheen neutralizing broth that Air sampling units that either utilize but before the sanitizer is applied. That is needed to neutralize any residual san- an agar plate, or an agar strip that actively way if there is a fail reading, the surface itizer. In a hygiene monitoring program, pulls a defined volume of air within the can be re-cleaned prior to sanitization. one should be sampling for either indica- area/room to be sampled are preferred. This omits the chance of reactions be- tor or pathogenic microbes, after the sani- Particularly air sampling units like the tween ATP pen enzymes and the sanitizer. tizer(s) have been applied. RCS units (Reuters Centrifugal Samplers) It is also applicable for protein detection Indicator microbes will depend upon like the type manufactured by EM Biotest enzyme systems. Some will give a dra- the nature of the operation. In addition enable you to actively sample and count matic false positive when a clean surface to Total/Aerobic Plate Count, indicator an airborne microbial density for total sanitized with peracetic acid is sampled. microbial tests include coliform-E.coli, count, coliform, or yeast and mold. They Speaking of non-ATP soil detection Enterobacteriaceae, yeast and mold, and provide a cfu count/cubic meter or cubic systems, these are qualitative, colori- Staphyloccus spp. For example, meat, foot of sampled air. Seasonal air sampling metric swab pens that can detect, using poultry, or dairy plants will test either for enables a plant’s program to validate san- a color scale, the presence of protein res- coliform-EC or Enterobacteriaceae, while itation of air handling units, intake vents, idues. Neogen has its AccuClean for pro- bakery operations will typically assay for and cooling tunnels/spiral units. There- tein while Hygiena has its ProClean unit. yeast and mold. fore, air sampling has become a critical While these do not provide a quantitative Contact slides have been around for component of a facility’s hygiene moni- validation of the hygiene monitoring, they some time but some user-friendly ver- toring program. are user-friendly tools that permit sanita- sions include the Envirocheck line from Pathogenic Detection Systems. The tion supervisors or managers to ascertain EM Millipore or the Hylab dip slide pad- sponge swab methods mentioned previ- if a critical piece of equipment must be re- dles marketed by Neogen. In addition, as ously for indicator microbes are also typ- cleaned. However, these protein swabs are discussed, RODAC plates can be manufac- ically used for environmental and food not to be used for allergen validation since tured with a variety of agar media for the contact hygiene monitoring for Salmo- they measure general protein, and do not targeted indicators. nella and environmental Listerial species. target the specific allergen you are seeking Hygiena, using its multipurpose hy- Neogen, using the same lateral flow to remove via the SSOP for that equipment giene reader Ensure, has the capability technology utilized for allergen valida-

or area. Rather specific allergen detection with its Microsnap swab system of provid- tion, has a series of Reveal systems to © littletroll/ F otolia.com

24 FOOD QUALITY www.foodquality.com detect Listerial spp., Salmonella, and E. jured Listerial species even amongst a main stagnant, or, at worse, cause a ma- coli 0157:H7. These are rapid detection high microflora. jor food safety crisis in a plant. We can use systems and provide the end user with a 3M has a modification of their Petrifilm the hygiene monitoring program for both result after 15 minutes for environmental line (3M Petrifilm EnvironmentalListeria food contact and environmental zones in Salmonella, 20 minutes for environmental plates) that quantifies the level of environ- a reactive or a proactive manner. The soft- Listeria, and eight hours for E.coli 0157:H7. mental Listerial species and is AOAC ap- ware programs to organize and track the Because of its lateral flow design, the Re- proved. This is significant because in many data for many of these systems or devices veal systems are strictly presence or ab- instances for environmental or even food are already available. sence, but are very rapid in their result for contact surfaces, a presence or absence If we are truly promoting the contin- presumptive positives. test does not provide sufficient informa- ual improvement of a facility’s food safety Hygiena has a presence-absence test tion. By quantifying, you can correlate the program, the data must be utilized in a that employs a self-contained swab me- severity of the contamination levels with proactive manner to teach staff on every dium with a large swab head, InSite. The the zone sampled in the plant. The results level how to continually improve the fa- InSite swab gets incubated at 37 degrees are achieved in a 27 to 31 hour time frame, cility’s hygiene programs. To be sure, the Celsius for 30 to 48 hours and provides so corrective actions can be implemented GFSI programs and the regulatory bodies a color scale to qualitatively assess the into the plant hygiene program. now do demand that your data serve as severity of environmental Listerial spe- roadmap for continual improvement of cies for presumptively positive Listeria. Now What? your PRPs and HACCP programs. ■ The quicker the growth medium turns All the methods discussed have accuracy, a brownish color, the higher the level of reproducibility, and a sense of timeliness. Giambrone is the global technology and regulatory manager for Rochester Midland Corp.’s food safety division. He can be environmental Listeria sampled. This How we interpret the data and track the reached at [email protected]. method is cost effective and is user friendly, trends in a hygiene monitoring program and can successively grow stressed/in- will either improve a program, let it re- References Furnished Upon Request

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April/May 2013 25 Safety & Sanitation Pest Control

Quality Food (SQF), the British Retail Consortium (BRC), and American Insti- Don’t Let Third-Party Audits tute of Baking (AIB). Third-party auditors such as NSF and others use those stan- ‘School’ You dards to ensure facilities are compliant The five factors to consider for pest management with the criteria of the Global Food Safety Initiative (GFSI), which was created in documentation in order to be audit-ready at any time 2000 by a group of international food By Zia Siddiqi, PhD, BCE retailers to help ward off food safety hazards. Although GFSI does not conduct audits, major retailers like Wal-Mart require all suppliers to meet GFSI standards. That means your facility needs to meet or ex- Editor’s Note: This is the first in a five-part series of articles that will provide a practical ceed audit standards every time. approach to various pest control topics. Pest management can account for up to 20 percent of the total audit score, magine you’re a student who is party food safety audit. If a facility man- so ensure you are proactively preventing aware of a major exam scheduled ager leaves preparation for the last few pest activity by implementing an ongo- for the end of the month. Instead weeks leading up to the audit, it will most ing, comprehensive Integrated Pest Man- of studying throughout the week certainly spell t-r-o-u-b-l-e for his or her agement (IPM) program. With a focus Ileading up to the exam, you decide to food safety audit score. Because business on strategies like sanitation and facility cram the studying into the final 24 hours success hinges on an outstanding audit maintenance, IPM helps keep facilities prior to the exam. You might be thinking score, it’s easy to understand the danger- pest-free, which is exactly what audi- to yourself, “That leaves far too much to ous consequences a lack of audit-readi- tors like to see. However, without chance—what if there isn’t enough time ness can bring. proper documentation that to cover a certain concept in-depth, or to Three of the most spans a length of time, ensure a full understanding of the subject common third-party it will be virtually im- on the whole?” audit standards for possible to prove the Those are the same concerns that food processing success of your pest come along with preparing for a third- facilities are Safe program. Although the varying audit standards and criteria can be confusing at times, don’t let them “school” you. Keep in mind the following top five audit problems when it comes to pest management documentation in order to be audit-ready at any time and achieve high scores. 1. Lack of training or certification proof for pest management professionals. Although your pest management professional may have the proper training or certification required to perform the job, it won’t mean anything to auditors if that evidence is not housed at your facility. Auditors may require any or all of the following documents as part of their audit: © lordalea/ F otolia.com

26 FOOD QUALITY www.foodquality.com • A photocopy of the registration or certification document for every in- IPM and the New FSMA dividual who regularly executes pest A new rule under the Food Safety Modernization Act (FSMA) will require facilities to management services on the property, develop and execute written food safety plans that detail potential hazards, corrective if required locally actions, and more. • Confirmation of Good Manufacturing Many facilities will already meet the rule’s stipulations because they follow the Practices (GMPs) training for all in- standards of major third-party auditors such as AIB, NSF, Silliker, and GFSI compliant standards like SQF, BRC, etc. However, smaller food processing plants without dividuals who are held accountable formal food safety plans will likely be heavily impacted by the new FSMA regulation. for performing pest management Regardless, an Integrated Pest Management (IPM) program can help facilities— processes large and small—ensure they meet or exceed FDA standards. The following chart • Written evidence that the IPM provider demonstrates IPM’s role in the food safety plan mandated by the new FSMA rule, calling was trained in the proper and safe use attention to key elements of focus. of pest management materials 2. Written proof of changes to ser- FSMA Rule Requirements Elements of an IPM Program vice and materials, following signing of the contract. Successful IPM programs Hazard analysis to identify and evaluate Comprehensive inspection to identify reasonably foreseeable hazards pest hot spots and risks are dynamic rather than static and change over time based on a number of factors, so Preventive controls to minimize hazards Emphasis on pest prevention through it’s important that you remember to docu- sanitation, facility maintenance, and ment all changes to the program after you non-chemical methods sign the contract with your pest manage- Monitoring procedures to ensure preventive Ongoing monitoring to pinpoint pest ment professional. Written proof of even controls are performed consistently activity and conducive conditions the slightest changes to the elements of your current pest management services, Corrective actions to manage problems Corrective actions to help manage pest and prevent reoccurrence activity and reasons for the changes, is required. Also consider including a list of roles and Verification activities to measure effec- Regular service visits, combined with responsibilities that explains the duties tiveness of preventive controls, including an annual facility assessment and pest periodic reassessment trend analysis, to determine effectiveness and areas of improvement

Consider speaking with Recordkeeping to keep track of the plan Comprehensive documentation to record your pest management and all resulting actions pest issues and corrective action professional about

how you can work together inspected regularly. Documentation of improvement or necessary changes for to achieve high audit all services provided to light and phero- IPM programs. Again, you should ensure scores. mone traps are typically required by audi- that all of the corrective actions imple- tors. This includes the types of insects, as mented after the annual assessment are well as the quantities, that are found when documented, along with proof that those the traps are checked. Although you may actions were actually executed. Without of your facility’s staff against those of the include this in your documentation, that showing that the counteractive efforts pest management provider’s team. doesn’t paint a comprehensive picture for were executed and completed, you may 3. Corrective actions are not based auditors—they will also need to have an lose points on the pest management por- on pest sighting and pest activity re- understanding of the corrective actions tion of your audit. ports. Ensure that your pest trend anal- you took to manage the pest problem. It’s Now that you’ve armed yourself with ysis and recommendations for sanitation important that you can show written doc- this information on the top five common and building maintenance issues provide umentation of all steps: pitfalls when it comes to documentation, the basis for all corrective actions that a) services performed to the light and consider speaking with your pest man- help manage insect activity at your fa- pheromone traps, agement professional about how you can cility. Third-party auditors often deduct b) the results of each trap check, and work together to achieve high audit scores. points from audit scores when facilities c) the corresponding actions taken to By working hand in hand to cover your do not have written documentation of help mitigate pest activity. bases, you’ll be on your way to acing your pest sightings and pest activity, accom- 5. Missing record of actions that next big exam—your food safety audit. ■ panied by an explanation of the resulting were implemented following the an- counteractive efforts. nual pest control assessment. Almost Dr. Siddiqi is director of quality systems for Orkin, LLC. A 4. No records of insects found in all auditors require that pest management board certified entomologist with more than 30 years in the industry, Dr. Siddiqi is an acknowledged leader in the light traps and pheromone traps or cor- providers hold an annual facility assess- field of pest management. Dr. Siddiqi can be reached at rective actions, although the traps are ment, which helps determine areas of [email protected].

April/May 2013 27 M

anufacturing FOOD QUALITY land processors, and at thedistributor product quality ontheboat,at thefishery, with theat-sea and With aglobal quality hub, theseafood industry can verify ‘Boat-to-Plate’ Traceability

& T rac eability Distribution | By By Steve Wise

www.foodquality.com

consumed in the U.S. isimported, but keep illegal fishoutofthe U.S. market.” “in order to prevent seafoodfraud and traceability for seafood from boat to plate a letter to theU.S. government calling for ing solely to protect theworld’s oceans, in Oceana, thelargest advocacy group work and Michael Symon, among them—joined Thomas Keller, Jacques Pepin, EricRipert, Rick Bayless,rio Batali, DanielBoulud, nation’s top chefs—Barton Seaver, Ma- linary leaders, andmore than500ofthe heard. In October, restaurant owners, cu ensuring thattheU.S. foodsupply issafe. will move anotherstep closer to itsgoal of foodsafety auditsparty overseas, theFDA accreditation standards to improve third- tically produced foodanddetermining processed overseas are assafedomes to verify thatfoodproducts grown or target importers. Byimplementing ameans is imported byproposing rulesthatwould percent ofthefoodconsumed intheU.S. address thefactthatapproximately 15 ernization Act (FSMA), theFDA plansto In thenextphaseofFood SafetyMod FishySomething’s changes before compliance deadlines. look forways andmeansto implementthe process, pack, orholdhumanfoodmust procedures. Facilities thatmanufacture, supply chains to evaluate processes and food safetyrulesthatwillforce entire is theannouncement oftwo long-awaited imported foods. Thelatest advancement safety standards forbothdomestic and plement stricter andmore specificfood reasons thattheFDA continues to im- lettuce. Theseare only afewoftherecent L soon as it is produced. specific or not seafood meets means knowing whether A global quality hub Ninety-one percent oftheseafood The FDA isnottheonly voice to be

loupe. in peanutbutter andcanta- isteria salmon andapples. requirements inwildAlaskan sockeye E.coli as in spinach and inspinach and

Salmonella - - - -

can threaten human health with unex deadly—consequences. For example,it seafood fraud canhave costly—even packaging plants. the distributor, ortheprocessing and supply chain including the restaurant, for thesetypesoffish—atany pointofthe happen asoften as 70 percent ofthetime ies showthatseafoodmislabeling can of the wax esters in its flesh. Recent stud intestinal issuesdue to thelaxative effect ally beescolar, which canleadto severe ticipated shipmentofwhite tunato actu quite similar, makes itsimpleforan- the factthatmany fish when filleted look less than2percent isinspected. This, and menting available technologies. yond the basic regulations and imple- demands caneasily bemetbygoing be- the seafoodindustry. Inreality, thechefs’ cies are inserioustrouble. overfishing is abundant andmany spe- environment ishealthy, when inreality the general publicto believe themarine friendly, informed decisions; and mislead efforts when cannotmakeconsumers eco- nearly impossibleto sustainconservation business from honestfishermen; make it create amarket forillegal fishtaking pected contaminants, toxins or allergens; ments inthefrozen pizzaitsells, acream - can ensure that there are no metal frag a global qualityhub. Therefore, agrocer andanalyze input, collect, datathrough at allpointsofthefoodsupply chain to costs. Cloudcomputing enables facilities and minimizeITexpenditure andsupport ensure current andfuture compliance, intelligence to improve product quality, cloud computing andmanufacturing market asmanufacturers are utilizing A major shiftcanbeseenacross thefood HubGlobal Quality Beyond cheating thecustomers, This doesnothave to bethestate of - - - - porter to theU.S. Unlike theopen-water is thethird largest fish andshellfish imported tilapia comes from China, which the supplier. the time theproduct is being produced by (COAs) could becreated inreal-time—at ing dock when Certificates ofAnalysis wait forshipmentsto arrive atthereceiv is produced. There would notbeaneedto meets specific requirements assoonit means knowing whether ornotaproduct ately available to themanufacturer. This nearly any system, andmadeimmedi- from anywhere around theworld, from smartphones, datacanbeeasily collected gual, mobile devices such astablets and for theseafoodindustry. With multi-lin- can create the“boat-to-plate” traceability trol (SPC) engine, aglobal qualityhub they ordered from theirsuppliers. serving thesamefish to theirpatrons that pasteurized, andchefs knowtheywillbe to make ice cream hasbeenproperly flash ery feels confident that the milk it receives mented byseafood manufacturers, tilapia escolar along theway. less-than-reputable to make aswap with ing U.S. soil,making it quite simpleforthe pia may make several stops before reach- were caught. After the first check, the tila- the U.S. were infacthealthy when they sible to ensure that the fish being sent to quality checks by the fisherman, it is pos polluted environment. Byimplementing disease, increasing theriskofcreating a eaten food,andchemicals usedto treat limit the ease of expelling fish waste, un- tilapia. However, these closed systems cultures are two common ways offarming systems ofthe U.S., China’s pond and cage the receiving dock when COAs could becreated shipments to arrive at For example,nearly 70 percent ofim- Powered by a statistical process con- With aglobal qualityhubimple- There would not be a need to wait for in real-time. April/May 2013 (Continued onp.30)

- - Manufacturing & Distribution Traceability

(Continued from p. 29) cators, and general condition of shipping the product is also being displayed and can be checked on the boat, at the fish- materials and delivery vehicles to the gro- sold properly. ery, with the at-sea and land processors, cers and chefs to confirm the type of fish as well as at the distributor through easy they will receive, and ultimately ensure Beyond the Fishing Hole data entry via mobile computers and the highest quality of product for the cus- Ensuring traceability around the world smartphones. The seafood producers tomer. Supermarkets can take it one step and throughout the food supply chain is can then send the resulting, real-time further and enter point-of-sale data such just one of the benefits of a global quality dashboards, analysis reports or email as on-site inspection, shelf placement, hub. Because all the data is stored in a notifications displaying lot numbers, and in-store location into the same global single repository, food manufacturers im- temperatures, check-in times, visual indi- quality hub to inform the producer that prove their readiness for audits because they can run a report of data already in the system to prove they are in compliance with required quality checks. Furthermore, upon entering the second life of the data, there are numerous opportunities for process improvement due to variation or overfill. With minor adjustments, both waste and costs can Is your surface testing be driven down resulting in hundreds of thousands, if not millions, in cost sav- all it’s cracked up to be? ings. With tools available that incorporate real-time automation within a global quality hub, food manufacturers can meet time-specific regulatory requirements by scheduling quality checks at precise inter- vals and incorporating visual, audible, or electronic reminders. With the centralized data repository and specification limit automation capabilities of a global quality hub, these manufacturers can easily comply with SSOP (sanitation standard operating procedures), FSMA, 21 CFR Part 117, Hazard Analysis and Critical Control Points (HACCP), and other regulatory You can’t afford even a twinge of doubt when it comes to requirements. uncovering any hidden contaminants. Get cracking with As more regulations are passed, food Puritan environmental swabs — known to deliver superior manufacturers face the growing concern collection for reliable results. Our top-quality swabs come in of ensuring compliance based on many various sizes, shapes, and tip ﬁbers, with and without media. different stipulations. The key to compli- To request free samples of environmental swabs, ance with both traditional and the new scan the code at left or visit our website at regulatory framework is embracing ad- puritanmedproducts.com/enviro. vancements in technology, such as cloud computing, mobile devices, and global quality hubs. With an effective system 800-321-2313 • puritanmedproducts.com in place, food manufacturers can utilize Puritan Medical Products Company LLC, Guilford, Maine 04443-0149 USA manufacturing intelligence to mitigate An affiliate of Hardwood Products Company ISO 9001:2008 the risk associated with product contamination and recalls, and optimize manufacturing operations to deliver a low-cost, high-quality product to the customer. ■

facebook.com/PuritanUSA linkedin.com/company/PuritanUSA

twitter.com/PuritanUSA YT youtube.com/PuritanUSA Wise is vice president of statistical methods at InfinityQS International. He focuses on ensuring proper use of statistical techniques within InfinityQS’ software offerings and application in the customer base. He can be reached at [email protected].

US MANUFACTURED References Furnished Upon Request

30 FOOD QUALITY www.foodquality.com © fontriel/Fotolia.com

and advancedtestingtechnologies Re-evaluating foodadditivesontheGRASlistinlightofcurrentscience When Safe May Not Be Safe Anymore T Dr. Pepper Snapple Group. Derived from and SunkistSquirt Peach soda from the ange and Fresca and made by Coca-Cola fromtorade PepsiCo, Powerade, Fanta Or the U.S. including DewandGa- Mountain an emulsifierincitrusflavoredin drinks nated vegetable oil(BVO). ple are asking about theemulsifier bromi banned? That is the question many peo once considered safethatshould nowbe testing technologies? Are there additives rent toxicology knowledge andmodern get re-evaluated forsafetyinlight ofcur ered innocuousinthe1950s thatshould decades? Are there substances consid tives thathave beenconsidered safefor our behaviors. But what about food addi- Armed withnewinformation,we changed of assafemay have beenanything but. wagons knowthatwhat we once thought BVO isasynthetic chemical usedas seats of our parents’ station seats ofourparents’ station and standing upintheback ing bicycles withouthelmets hose of us who remember rid Raw ------and riseto thetop. Approximately 10per emulsifier, thefruitflavor wouldseparate base ofthedrink.Without BVO oranother and allowitto mixwiththesugar water atoms that weigh down the citrus flavor corn orsoybeans, BVO contains bromide cent of drinks sold in the U.S. contain BVO. gredient canbeincluded ontheGRASlist: safe (GRAS) There are list. two ways anin- was placed onthegenerally recognized as Food,federal Drug andCosmeticAct, it 1958 Food Additives Amendmentto the to the1930s. WhenCongress passedthe Materials | • • By By information entific dataand currently available ified experts” who have reviewed sci- GRAS basedona“consensus ofqual Newer substances canbejudged amount oftime number ofpeopleover asubstantial use infoodconsumed byasignificant indeed bemadebasedoncommon to 1958, aGRASdetermination can For substances like BVO, in use prior The useofBVO asanadditive dates Ingredients Maybell Cowan / Additives -Lincoln - - amounts of up to 15 parts per million. But amounts of up to per million. But 15 parts was safeinfruit-flavored beverages in ruling, pending more studies, that BVO of safetydata,theFDA made aninterim dogs, andpigs. After several submissions FEMA study the compound in mice, rats, GRAS statusofBVO andrequested that mendations, andin1970 theyrevoked the The FDA generally followstheirrecom- insufficient data aGRAS tosupport claim. At thattime,theydecidedthere was evaluate many of theseolderadditives. ciation (FEMA) paneldecidedto expert Flavor Manufacturers’ andExtract Asso inthelate 1960s andearlylist, 1970s, the stances grandfathered onto theGRAS Center forScience in thePublicInterest, andexecutiveco-founder director ofthe unacceptable. Michael Jacobson, PhD, terim statusremains unchanged. on BVO have beenconducted, andthein- now, over 35 years later, studies nofurther Although BVO was among thesub For many experts, thisissimply

April/May 2013 (Continued onp.32) 31 - - Raw Materials Ingredients/Additives

(Continued from p. 31) ical reactions that cause a fire thereby the ingredient in any food on a typical believes that the FDA takes too lax an slowing down the spread of flames. day, the size of the portion, and how attitude toward the dangers potentially Consequently, they are used in flame re- much of ingredient is found in the foods. posed by additives. “The FDA has not tardants that are added to polystyrene Simply put, if the EDI is less than the been nearly cautious enough in protect- foam cushions, children’s products, and ADI, the ingredient can indeed be consid- ing the public from food additives and plastics used in electronics. Research in ered safe. GRAS substances that cause, or may animals and humans has shown that bro- This safety equation is simple, but cause, health problems at the levels con- mide is building up in tissue and breast gathering accurate dietary exposure in- sumed,” states Dr. Jacobson. milk, and it has been linked to impaired formation to assess EDI is not. For the But the FDA is confident that they neurological development, reduced fer- daunting task of determining exactly have acted with proper vigilance. When tility, and early puberty. what and just how much Americans eat, questioned about the necessity of con- the FDA relies primarily on the National ducting further studies on BVO to remove What Makes a Substance Safe? Health and Nutrition Examination Survey its interim status—either by declaring it So how does the FDA define safe in a food (NHANES), conducted by the Centers for GRAS or banning if from the U.S. food sup- ingredient? There are two calculations Disease Control and Prevention (CDC). ply as it has been in the European Union the agency uses to evaluate the potential This survey asks thousands of partici- and Japan—Patricia El-Hinnawy, FDA toxicity of an additive. The first is the Ac- pants to recall everything they ate over a press officer, was dismissive. In an email, ceptable Daily Intake (ADI), derived from two-day period. From these answers, an El-Hinnawy states, “The FDA understands a review of the substance’s clinical nature overall view of American eating habits that some consumers may have concerns and available toxicology studies, plus rel- can be extrapolated. about brominated vegetable oil (BVO) in evant safety factors. It is an estimate of the Some experts, however, feel that two food products. Based on its review of the maximum amount of a substance that a days provides an insufficient sample of science, the FDA has determined that BVO person can consume daily over their life- eating habits, and asking consumers to is safe and presents no health risks at the time without significant risk of harm. The recall everything they ate for a period of permitted level of 15 parts per million.” other consideration is Estimated Daily In- time in the past leaves a large margin of However, BVO exposure is not limited take (EDI), the predicted dietary exposure error. So the FDA also relies on surveys to diet. Bromine atoms slow down chem- based on how often a person consumes conducted by private firms. These studies last 14 days and often use daily food diaries kept by participants. To further inform their EDI estimates, the agency uses data reporting how much of certain commodities enter the marketplace annu- ally, tests to monitor chemicals and pesticides as well as nutrient elements in foods and biomonitoring data from blood and urine specimens from randomly selected NHANES participants.

How do New Ingredients Make GRAS List? But since 1997, the FDA’s GRAS determi- nations have not involved testing by the agency’s staff. Rather, the fact gathering and proof have been left up to the private sector, usually to companies looking to market a new product with a new additive. The GRAS Notification Program is a voluntary process by which an individual can inform the FDA that a substance used in a particular product is GRAS. A notification, sent to the FDA’s Office of Food Additives, includes: • A brief description of the substance • The intended use of the substance • The basis for the GRAS determination The notification should include information about the chemical and toxi-

32 FOOD QUALITY www.foodquality.com cological properties of the substance and warding players with points for drinking It delivers reliable and reproducible re- any data that would not support a GRAS more of the soda. sults quickly that can be used to predict determination. Finally, the notifier must This level of exposure to bromide can toxicity in humans and minimizes ani- explain why, in light of the totality of the be dangerous. Emergency rooms have re- mal testing. information, they have concluded that the ported cases of headaches, fatigue, mem- But some industry experts believe substance should be GRAS. ory loss, and lack of muscle coordination that rather than wait for lifestyle changes as well as skin ulcers and swelling after or technology advances to trigger a sec- When is a Second Look in Order? extreme bromide exposure, along the ond look at toxicity, the FDA should have In November 2011, The Pew Charitable lines of 4 to 8 liters of citrus-flavored soda a standing schedule in place to periodi- Trusts, the Institute of Food Technology per day. This amount is not atypical for cally review GRAS substances in light of (IFT), and the journal Nature cospon- many video-game-loving teens. new technology or new information. Dr. sored the workshop Perspectives on Another factor that might demand Jacobson shares this viewpoint. “A peri- FDA’s Exposure Assessment to Ensure a second look at an ingredient is new odic review, such as every 10 years, would Substances Added to Human Food Are technology that can yield more com- help ensure that GRAS substances are not Safe. The event brought together more plete, more accurate toxicity data. One forgotten about.” than 70 experts from academia, industry, such breakthrough is the Toxicology PepsiCo announced in January of this government, and public interest groups in the 21st Century, or Tox21 program, year that it would no longer use BVO in who agreed that the FDA’s current system a collaboration of the National Insti- its Gatorade as a result of consumer feed- for monitoring food safety has room for tutes of Health, the FDA, and the Envi- back, although they will continue to uti- improvement. ronmental Protection Agency. The goal lize it in Mountain Dew and diet Mountain One suggestion that came out of the of Tox21 is to improve toxicity assess- Dew. BVO will be replaced by the emulsi- workshop was periodic reassessment of ments in order to rapidly and efficiently fier sucrose acetate isobbutyrate, another consumers’ exposure to GRAS substances. predict which compounds can cause GRAS substance. ■ Circumstances under which participants adverse health effects in humans. The would recommend a toxicity re-evalua- program uses a high-throughput robotic Cowan-Lincoln is a science/technical writer based in New Jersey. She is a frequent Wiley-Blackwell contributor who tion include: system to test hundreds of thousands of has been featured in numerous publications. Reach her at • Significant dietary changes chemicals using a diverse set of assays. [email protected]. • FDA receives a petition for a new use of an approved food ingredient or additive • New toxicological information be- comes available • Changes are made in manufacturing and sourcing of the ingredient that could affect its identity • Improved measuring tools are available • Congress or an international regulatory body questions the safety of a substance In the case of BVO, dietary exposure in at least one population has increased dramatically. “Gamers,” or teens who play video games hour after hour, use so- das to give themselves the energy boost they need to stay awake and focused. And according to the Pew Research Center, nearly every U.S. adolescent plays video games. Serious gamers who play for six, 10, or 12 hours often drink a 20-ounce soda every hour. When you do the math you discover that a 20-ounce soda every hour over eight hours adds up to more than 4.7 liters. This booming market has not gone unnoticed by soda manufacturers. In fact, one recently launched video game partnered with Mountain Dew, re-

April/May 2013 33 Equipment Microbiological Organisms

Alternative Tubing Eliminates Bacteria in Beverage Delivery Systems Silver lined tubing and fittings, along with replacements to PVC, have the potential to increase quality assurance and improve consistency of product at dispensing | By Greg Kinney

hile the term “antimicro- the product at the consumer level. Be- against the bacteria common in these bial” is well recognized in cause of this reality, the beverage indus- applications. the medical and biomedi- try has long sought after a solution to help cal fields, it is a relatively increase consistency and quality of their Antimicrobial Innovations Wnew term for the food and beverage indus- product between cleaning cycles. Initially, innovations in antimicrobial try. Bacteria and biofilm buildup has been Many in this industry are recogniz- products were driven by the medical and a continuing concern from manufacturer ing that the weakest link in quality con- to consumer. These microbes originating trol has been in the tubing that transfers from natural and external sources con- and dispenses their product. According The most impressive taminate foods by contact, which can to Matt Meadows, national director of result is the notable occur anytime between production and field quality for a major craft brewing consumption. Microbial contamination company in the U.S., the weakest link in reduction of Lactobacillus of foods can have many undesirable con- quality control is the PVC (poly vinyl chlo- brevis, which is sequences ranging from spoilage to food ride) tubing that is used throughout the determined to be the borne illness. industry. Meadows states, “PVC tubing most frequently detected Two major concerns for the food and has been the weakest link in draught beer beverage industry in relation to bacteria system design. Because of the challenges microorganism in beer. and biofilm buildup revolve around the of PVC and the constant buildup of biofilm consistency of quality control as well as within the tubing, it is difficult to keep the regulatory environment. This contin- consistent quality from manufacturing to ual battle for producers and dispensers consumer.” biomedical industries because of the need of food and beverage products is evident Meadows works for one of the larg- to eliminate HAI (hospital acquired infec- in the passage and enforcement of laws. A est craft breweries in the U.S. and, like tions). This same antimicrobial technol- prime example is found in the Connecticut most in the food and beverage industry, ogy is now being applied in everything Liquor Control Act. This law dictates that it prides itself on quality assurance at ev- from consumer products to industrial lines used in the dispensing of beer or wine ery level—down to the final dispensing uses in order to create a cleaner and safer are required to be cleaned once a week. systems delivering the products. And like environment. (Sec. 30-6-A.23 (b) Sanitation, pg. 84) most, the company has been hard pressed With the information stream con- Whether it is dictated by regulations to find an alternative to the tubing that is stantly flowing from new media, consum- or the need for quality control, a signifi- currently the industry standard. ers have never been more ready to embrace cant challenge for the beverage industry After hearing concerns from the antimicrobial products. Antimicrobial has been to assure adherence to the strin- food and beverage industry over biofilm solutions now go well beyond the medical gent cleaning standards required to elim- buildup, researchers quickly discov- and biomedical environment. New prod- inate the buildup of bacteria and biofilm ered the same innovation that met the ucts are emerging for applications like in beverage delivery lines. It is recognized high standards for the medical industry electronics, apparel/footwear, personal that businesses that dispense their prod- could be effective in the delivery and dis- care products, sports/fitness products, uct at the consumer level may not always pensing of food and beverage products and now food and beverage applications. follow these standards. This biofilm can as well. The next step was to determine With these applications becoming adversely affect taste and the quality of how effective this innovation would be more common, consumers are recogniz-

34 FOOD QUALITY www.foodquality.com SOURCE: Eldon James

cell growth inthree ways: This tri-modalactionfights to adestructive population. in themicrobe to prevent itfrom growing bacteria canthrive. food andbeverage applications where when necessary. Thismakes itidealfor lease ofthesilver ions—slow andsteady technology nowallowsforthe“smart” re microbial properties. Recently developed Silver haslong beenknownforitsanti- is ahighly effective antimicrobial agent. One ofthetop innovations issilver, which Silver AnAntimicrobial As Agent they utilizeonadaily basis. use thatcanpositively impactthethings ing there isnowtechnology thatissafeto the direct supervision oftheTUM(Tech- andisunder in itspresent form in2004 Experimental Station, was established State Brewing Technology Testing and many. The research center, formerly the for Brewing andFood Technology inGer by theResearch Center Weihenstephan timicrobial properties in beer and water technology. silver lining constructed ofthis“smart” mental effectsof PVC a coextruded with potential harmfulhealth andenviron- mer thathelpseliminate the tured withaPVC-free poly are currently being manufac products. Tubing and fittings systems offoodandbeverage in delivery anddispensing ble to include thistechnology silver have nowmadeitpossi- date technology thissmart for with polymers thataccommo tions andnewdevelopments optimal performance. to while hours maintaining populate ionswithinminutes to initially reduce microbial technology hasbeen shown croorganism, antimicrobial • • • One such tubing was tested foritsan- Manufacturing innova - Depending onthemi- Disrupts cell metabolism (reproduction) Inhibits cell division functions inthecell wall by inhibiting transport Prevents respiration Elemental ionsattack multiple targets - - - are four bacteria common in beer and other liquids and beverages. there A series of tests conducted by Weihenstephan determined that - - nische Universität München) administra of biofilmformation.In andbeer wort acid bacterium occurs intheearly stages beverages: ria common inbeerandotherliquids was determined thatthere are fourbacte- ing currently being produced intheU.S. It the antimicrobial activity ofexisting tub of tests over several monthsto determine competent partner. organizationslied trade and asaneutral suppliers, regulatory authorities, andal industries, foodproducers, associated stitute, serving the brewing and beverage tion. It isanunaffiliated, independentin- group ofslow fermenting yeasts andis of alcoholic beverages. It belongs to the spread among many production steps productsof foodandgrain and iswide- associated withspoilage orprocessing It’s anomala): merly: frequently Pichia and drinks. flowers, vinegars, andinfermented foods off-flavor. Itis commonly foundonfruits, teria canproliferate andcause anacidic with high oxygen content, acetic acid bac Acetobacter lovaniensis: Thisacetic Weihenstephan conducted aseries Wickerhamomyces (for anomalus - - - - - biofilm formationasslime-forming bacte pecially bythewater, andcontributes to ends upinthebrewing environment, es cause inflammationsandinfections. It haze, acidformation,andoff-flavors). acteristics ofbeeranddeteriorates itby spoiler (i.e. ittolerates allselective char in beer. It’s classified asan obligate beer most frequently detected microorganism formation was confirmed. vironment inbiofilm anditsparticipation detected inmany casesinthebrewing en- solvent-like off-flavors. Thisbacteria was in carbonated beverages responsible for • This can Thiscan aeruginosa: Pseudomonas Lactobacillus brevis: It isbyfarthe tests against siderable activity revealed through the result could be obtained as well. Con- water through the tubing, apositive After acirculation2,000 of liters of and theblanksample. ference ontaste between the“treated” cluded thatthere is no significant dif rials to smellandtaste”). It was con- 1998, “4.6 influence ofrubber mate- (acc. to MEBAK IV, 2ndedition,issue of rubber material to smell and taste” search Center Weihenstephan. Tubing Analysis” from theRe- reports called“Flexelene Silver marize excerpts from two recent mals, including humans. that cancause diseaseinani- rium. It’s acommon bacterium • • To determine whether taste taste whether determine To testhours period. up to 100.0 percent inthe24 tested microorganism species the cell concentration ofallthe ver linedtubing could diminish The test results confirm that sil microorganisms significantly. cell count of the four selected the tubeswas able to reduce the counts, thesilver coating of over real contamination cell ulation ofbacterial cells well as positive. Despite vast inoc can beconsistently regarded with thesilver linedtubing Without water flow, the test ducted called, “The influence ducted called,“The a concentrate test was con- can bedetected inthetubing, The following pointssum- Lactobacillus brevis April/May 2013 (Continued onp.36) (the (the 35 ------Equipment Microbiological Organisms

(Continued from p. 35) tests, slightly weaker, but still showed testing was conducted after 2,000 li- most frequently detected microorgan- a reduced concentration. ters, 10,800 liters, and 40,000 liters of ism in beer), Acetobacter lovaniensis, • Even after a water throughput of water circulation. The analysis con- and Pseudomonas aeruginosa where 10,000 liters, the tubing showed pos- cluded that the flow directed through the cell concentrations could be re- itive antimicrobial activity against the silver lined tubing had no detect- duced up to 100.0 percent in the 24 the acetic acid bacterium Acetobacter able silver traces in the water (detec- hours test period. The antimicrobial lovaniensis. tion limit of the method: 0.01 mg/l). activity against the yeast Wickerhamo- • To address potential concerns of the myces anomalus was, in two of three silver leaching into the flow path, © E ldon James RapidChek® Silver lined tubing was noted to reduce ... Simply Accurate. Lactobacillus brevis. Pathogen Detection Solutions

Overall, it was determined that the NEW silver lined tubing was 100 percent effective against the top four beverage spoiling ... for Faster Product Release bacteria and was successful in reduc- RAPID ing the concentrations of three of those bacteria in up to 2,000 liters of flow and VALIDATED RapidChek® Lactobacillus brevis up to 10,000 liters. COST-EFFECTIVE ODWHUDOÀRZWHVWVWULSV The most impressive result is the notable ® RapidChek SELECT™ reduction of Lactobacillus brevis, which is phage-based enrichment systems determined to be the most frequently de- RapidChek® CONFIRM™ tected microorganism in beer. LPPXQRPDJQHWLFFRQ¿UPDWLRQWRROV The Food & Beverage Industry With the issues facing quality assurance stemming from PVC tubing and biofilm buildup in food and beverage applications, solutions are coming from an industry that is familiar with high-quality standards—the medical industry. Inno- vations such as silver lined tubing and fittings along with excellent alternatives to PVC have given the food and beverage industry an opportunity to significantly increase and control quality from production all the way to the consumer. Salmonella As consumers become more educated Salmonella Enteritidis · Listeria on the health issues posed from bacteria along with a better understanding of an- E. coli O157 · Non-O157 STEC timicrobial products, manufacturers and dispensers will both be able to take advantage of these new innovations. ■ Call 1 302 781 6400 E-Mail [email protected] Kinney is the director of food and beverage for the Eldon www.romerlabs.com/rapidchek James Corp. He has worked in the beverage industry for over five years with a focus on beer and wine distribution. Leading the food and beverage division, Kinney develops new products that benefit the industry as a whole. He can be reached at 970-667-2728.

36 FOOD QUALITY www.foodquality.com SOURCE: Brookfield Engineering

B measuring ‘soft solid’ materials Exploring theroles of viscometers versus texture analyzers in Solids?’ Suited Better for ‘Soft Which Measuring Device is with Coaxial Cylinder Geometry Figure 1: Viscosity Test on Chocolate When at rest, which is most of the time, whichWhen atrest, ismostofthetime, known as“soft solids” to foodscientists. a candy. Theseeveryday products are ing on whether it is a sauce, a filling, or could fallinto bothcategories, depend smoothies andthick shakes. Chocolate could apply to viscous beverages like whipped cream. Thesameconversation ter, margarine, yogurts, ice-cream, and typified bydairyitems such astubbut behavior. Thiscategory ofproduct is measure “soft solid” materials forflow Analysis.com platformto discusshowto may be able to flow inliquid-like fashion. But once movement takes place, they Their structure seemsto bethatofasolid. they don’t move. Theyholdtheirposition.

Instrumentation experts via its www.Textureexperts - live interviews withindustry ratories recently conducted rookfield EngineeringLabo

- - - |

piscture? It’s aninteresting topic andone to usebothdevices to get anintegrated that change inappearance. Doyou need tion andtheassociated force thatcauses The texture analyzer measures deforma- The viscometer assessesflowbehavior. ter versus when to useatexture analyzer. basic questionofwhen to useaviscome- put thesematerials into? whatSo category offlowbehavior do you converted into viscosity inunitsofcenti- spindle movement, andthatnumberis ment measures torque, orresistance to and rotated atafixed speed.Theinstru disc-type inthefluid spindlesimmersed Rotational viscometers feature standard Viscometers about quite often. which foodindustry manufacturers think By By Figure 2a: Wire Probe Robert Pondering this a bit further raises the Pondering the raises thisabitfurther Measurement G . McGregor - Figure 2b: Spreadability Fixture surement includes: tion to note when making aviscosity mea geneous materials withparticulates are popular because theyinsure thathetero tion ofthespindle.Vane spindlesbecame fresh product ismeasured witheach rota - ward into the sample; this assures that paste-like materials while moving down- The T-bar was invented to cutthrough materials. There are several alternatives. tion about theflowbehavior ofsoft-solid curate andcomplete viscosity informa- for thedisc-type spindleto give more ac in temperature. informa- Theimportant viscosity isdirectly affected by variations equipped withatemperature probe since viscometers1mPa.s). Some alsocome outside theAmericas(fortunately 1cP= poise (cP)ormilli-Pascalseconds (mPa.s) • • • • • • scale measurement range Torque inpercent ofinstrument’sfull to make themeasurement Rotational speedsofspindleused (geometry) Spindle typeanddimensions R&D personnel haveR&D personnel usedsubstitutes when measurement isrecorded Elapsed timeofspindlerotation Sample temperature Viscosity incPormPa.s April/May 2013 (Continued onp.38)

37 - - - Instrumentation Measurement

(Continued from p. 37) These two numbers are sufficient to char- • Speed of probe descent into the measured as a mixture; the traditional acterize the chocolate for acceptability in material disc-type spindle may measure only the terms of stiffness and flow behavior. • Distance of penetration liquid carrier viscosity. The spiral adapter • Force measurement in g or N simulates an augur and, by running at dif- Texture Analyzers • Rate of retraction from the material ferent speeds, can provide viscosity versus In order to penetrate into a material, Both instruments clearly give numbers shear rate profiles that are not possible texture analyzers use probes of different that quantify viscosity and textural proper- with the T-bar, which is really a single vis- shapes and sizes (cylinders, cones, balls, ties for soft solids. Does one have an advan- cosity data point tool. blades, etc.). Similar to the viscometer tage over the other? The test in both cases One capability of viscometers, not with its controlled rate of rotation, the can be relatively quick, easy to set up, and widely used, is to analyze the viscosity texture analyzer displaces or cuts into the provide a valid means for QC to approve data to derive the yield stress for the ma- sample material at a defined rate of pene- or reject a component material or finished terial. This is the amount of force required tration (mm/sec) up to a specific distance product. Some soft solids may actually to initiate flow. Chocolate manufacturers (mm) and measures the force of deforma- benefit from being tested by both methods test the melted liquid in a coaxial cylinder tion (grams or Newtons). The instrument in a lab that has done a thorough investiga- system that controls temperature while can also measure the pulling force ex- tion. Most important, however, is to devise shearing the material at different rota- erted on the probe during retraction from a test which mimics the way in which the tional speeds. See Figure 1. The viscosity the sample, which is an indication of the end user will use the material. This is the data includes shear stress and shear rate material’s adhesive property. Some key key to assuring consumer acceptance. values that are plugged into a Casson math points to note when using a texture ana- Stick margarine can be solid-like model to generate a flowability index and lyzer include: when taken out of the refrigerator. A cut- the yield stress for the chocolate sample. • Shape and dimensions of the probe ting test with a blade or wire makes good sense. See Figure 2 a. Tub margarine, by design, should be softer by comparison Accredited Food Safety and more pliable. A spreadability test Certification Programs with cone fixtures will provide a good indication. See Figure 2b. The margarine is Certification for a Global Food Supply Chain placed in a cone-shaped well and a cone probe descends into it to measure the margarine’s resistance to being sheared, which is like a spreading action. So the CERT ID Offers: texture analyzer seems to be the better t GFSI Food Safety Initiative choice for these two soft solids as far as the consumer is concerned. BRC Food Safety Certification t Processing the margarine before it t SQF Safe Quality Food Certification turns into sticks and tubs poses a different t BRC Storage and Distribution challenge. The material is in a liquid state t CERT ID Non-GMO Certification and needs to be checked for consistency. In this case, the viscometer is the correct From CERT ID you can expect: tool because it analyzes the margarine’s t Prompt Scheduling of Audits flowability. Margarine, therefore, is a t Client-centered Service product which can benefit from both types t Resources for Audit Success of measurement. t Competitive Pricing Bottom line recommendation for proper assessment of soft solids is to review both the processing requirements on the production floor and the subsequent +++++ ways in which the end user manipulates $&35*%IBTBTUBSSBUJOH the product. Knowing these details will the highest rating by the BRC in its performance as a certification body lead to the most practical way to conduct testing in the QC lab. Chances are that t both the viscometer and the texture ana- www.cert-id.com lyzer have a bonafide role to play.■ 0öDFTJOUIF64"t#SB[JMt6, McGregor is the general manager, global marketing for CERT ID Services – a division of CERT ID Brookfield Engineering Laboratories, Inc. He holds MS and BS degrees in mechanical engineering from MIT in Cam- bridge, Mass. He can be reached at 508-946-6200 ext 7143.

Pure and simple. Pathogen testing.

Introducing the 3M™ Molecular Detection System. Fast. Accurate. Easy to use. Affordable. Compact. www.3M.com/3MMolecularDetectionSystem/FQA

40 I break canbeirreparable. bybeingsuffers associated withanout worldwide. Clearly, the damage a brand and $83 inannual losses billiondollars cast thatpathogens cause between $10 more often overlooked. Economists fore- businesses are similarly serious, butare it all.Thethreats thesebugs present to ting sick from foodbornediseasessays

FOOD high amountofAmericansget gens poseto human health; the danger that foodborne patho t’s hard to ignore the extreme QUALITY In the - - - Molecular Detection Method of 3MFood speaking Safetyexperts with encing day inandday It out. consisted est “painpoints” were itsusers experi- research process to thelarg understand whether itbeinternal foodtesting labs that could be employed bytheir labs, high ontheirwish-list ofnewtools ficiency inaddition to accuracyranked veloping nations. segments, from bothdeveloped andde- food processors across different industry In 2009, 3Mstarted acollaborative Themes ofsimplicity, speed,andef food and food process samples with thecombined Pathogen and bioluminescence detection technologies Pathogens can bedetected inenriched A Close Look at a at a A Close Look help of isothermal DNAamplification C ontrol Lab By By Nik Montgomery - - from foodsamples andsamplestaken approach thatcould detect pathogens conceived as a molecular microbiology DetectionThe 3MMolecular System was Molecular Detection compromise testing accuracy. tained fewer steps transfer thatmight gens inways thatwere intuitive andcon- tools would needto quickly spotpatho accurate, butalsolowmaintenance. The deploy detection technologies thatwere or outside reference labs. Users wanted to

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© WavebreakmediaMicro/Fotolia.com from processing environments. The sys- bioluminescence detection. In terms of To read and report the DNA ampli- tem is based on a combination of two tech- amplification, the system identifies and fication taking place, the 3M Molecular nologies: Isothermal DNA amplification targets multiple regions of a genome Detection System uses bioluminescence and bioluminescence detection. These through loop-mediated isothermal DNA technology that works simultaneously two “pillar” technologies work together amplification—commonly known as in real-time with the amplification. This to provide a molecular detection method LAMP for short. An emerging method enzymatic process occurs in two steps: that is pure and simple. Users only need First, pyrophosphate molecules are ex- an enriched sample, a standard laptop, ponentially generated during DNA am- and the 3M Molecular Detection Instru- The system identifies and plification and converted to Adenosine ment, a small peripheral device that Tri Phosphate molecules, or ATP. Second, has a footprint the same size as a tablet targets multiple regions the system then uses a special tempera- computer. Corresponding pathogen-spe- of a genome through ture-stable luciferase, an enzyme best cific assays, or test kits, are also available loop-mediated isothermal known for being present in fireflies, to specifically for identifying the unique convert that ATP into light. This light, or characteristics of Salmonella, E.coli O157 DNA amplification. bioluminescence, is read by the instru- (including H7), and Listeria. ment and used to determine the presence With these components in place, us- or absence of the organism being tested ers can run and read tests for multiple for in the sample. organisms in a single run with only two for rapid molecular detection, LAMP The end result is a streamlined and transfer steps after the samples have been has now been cited in nearly 1,000 sci- automated method of pathogen detection enriched, which saves hours of technician entific articles and has been recognized with resistance to sample interference. time. They only need to power up their for its ability to reliably and efficiently Third-party validation bodies both inside hardware, transfer enriched samples to target DNA compared to conventional and outside the U.S. have been consis- the pre-filled, color-coded lysis tube rack, Polymerase Chain Reaction (PCR) meth- tently examining and validating the Mo- and then place the rack on the provided ods. For example, whereas PCR typi- lecular Detection System and its various heating and cooling blocks. Once com- cally requires multiple steps for reagent assays. Companies are also putting the plete, the users transfer the lysed samples preparation and DNA extraction, the 3M technology to the test with their food ma- to special reagent tubes that are set inside Molecular Detection System uses pre- trices. Based on the feedback received, the the instrument via a 3M Molecular Detec- foiled, ready-to-use reagents and only method is not only highly accurate, but tion Speedloader Tray. From there, they requires two transfer steps with no sep- good for business operations given that can press start to begin the real-time am- arate extraction. More importantly, there only one preparation protocol is necessary plification and detection process. is no time-consuming thermal cycling for all pathogens and matrices, and that involved as in PCR. The system reaction batch-processing and simultaneous test- The Science operates at a consistent temperature ing can happen for multiple pathogens. ■ To understand the science behind the of 60 degrees Celsius, and the targeted 3M Molecular Detection System it helps DNA is amplified continuously and as Montgomery has more than 15 years of experience at 3M in quality control and operations, marketing, channel manage- to describe each part of the technolo- many as one billion copies of DNA can be ment, and finance. She can be reached at nmmontgomery@ gies—isothermal DNA amplification and generated in 15 minutes. mmm.com.

The 3M Molecular Detection System is a molecular microbiology approach that has the ability to detect pathogens from various food samples.

April/May 2013 41 QualityTraining Employees training that enables them to characterize and identify raw material and processing contaminants and their sources.

Specialized Materials Analysis The presence of foreign material from ingredients, processing equipment, and the environment is a frequent risk in the food industry. Foreign material can be a risk in and of itself, or it can be the source of foodborne illness (microbiological contamination), and can provide clues to the source of contamination. Well- trained quality employees can easily compare suspect contaminants to reference samples from the manufacturing process and eliminate or confirm sus- pects based on appearance. This type of training can also be advantageous Students expand their knowledge when addressing customer complaints and expertise in a HCAS classroom. for foreign matter contamination; successful identification of foreign matter is instrumental in determining the validity of complaints and developing the correc- Specialized Materials tive actions needed. Courses on materials identification Analysis Training Pinpoints can train food quality professionals to identify the specific hazards for their facility or industry so they can ensure that and Corrects Hazards preventive controls are appropriate for As the FDA decides whether it should mandate training the risk and not over-engineered. For for employees and supervisors, food quality professionals example, incompatible gasket materials need to know what type of training programs will meet commonly cause contamination in the food processing industry. Identifying the the requirements | By Charles Zona and Cheryl Murley offending material so it can then be replaced with a more compatible material is a simple step and is an easier solution he June 2012 passage of the FDA’s Food Safety Modernization Act, or FSMA, than installing filters or screens down- will soon require preventive controls for companies that manufacture, pro- stream and implementing routine QC cess, pack, or hold human food. These companies will be required to have checks of those controls. written plans that identify hazards, specify the steps that will be put in place Food quality employees regularly Tto minimize or prevent those hazards, identify monitoring procedures, record mon- attend microscopy courses at Hooke Col- itoring results, and specify what actions will be taken to correct problems that arise. lege of Applied Sciences (HCAS) with the These actions were initiated to prevent problems that can cause foodborne illness, but goal of becoming proficient in the iden- a frequent risk in the food industry is the presence of foreign material from ingredients, tification of food contaminants, in par- processing equipment, and the environment. Although the proposed rule aligns well ticular, contamination from extraneous with Hazard Analysis and Critical Control Points (HACCP), it differs in that preventive materials and particles. controls may be required at points other than at critical control points, and critical limits would not be required for all preventive controls. All-Inclusive Engagement To establish the correct preventive measures and develop a successful program that Learning to use specialized equipment

withstands FDA scrutiny, food quality employees need specialized materials analysis such as research-grade microscopes Hooke C ollege of A pplied S ciences

42 FOOD QUALITY www.foodquality.com can be challenging, especially if the microscope brand or those with more experience can share insight with their less model used in the classroom differs from the equipment at your experienced colleagues. During this final web-based portion of workplace. HCAS has found that using a blended learning ap- the course, students begin the process of self-directed learning proach—one that augments classroom training with distance and inquiry, reinforcing the acquired concepts and skills learned learning from the student’s lab—is an advantageous approach earlier in the pre-course modules and in the classroom. The post- for students. course environment encourages the exchange of ideas, such as A study by the U.S. Department of Education’s Office of Plan- alternative techniques and approaches used for identifying the ning, Evaluation and Policy Development’s Policy and Program unknowns. In addition, students are encouraged to analyze Studies Service recognized that blended learning produced a samples brought from their workplace during the hands-on por- larger advantage in learning outcome relative to purely face-to- tion of the class. face instruction than did purely online instruction. This study It’s important to receive training from an International As- focused mainly on post-secondary and adult learners. sociation for Continuing Education and Training (IACET) Au- At HCAS, blended learning begins with pre-course online thorized Provider. Organizations like HCAS offer CEUs for its content consisting of both narrated learning modules and fully programs that qualify under the American National Standards functional virtual microscopes. The narrated modules are 25 to 35 Institute (ANSI)/IACET Standard, which is widely recognized as minutes long. The microscope simulations offer virtual versions the standard of good practice internationally. The requirements of the instruments used during the course, allowing students to set forth by IACET create transparency in course structure, en- review the parts of the microscope, build the microscope from its abling learners to know who is teaching their course, the instruc- virtual parts, and engage all of the microscope parts, simulating tor’s experience level, the type of equipment to be used in class, the microscope’s function. and the expected student learning outcomes upon completion The hands-on portions of the courses are taught as three-day of each course. or four-and-a-half-day sessions, which follow a traditional class- (Continued on p. 44) room format. Each student has access to a microscope during class and is expected to successfully complete a variety of tasks related to the lecture material presented in the course. Tasks include hands-on practice, laboratory exercises, identifications of unknowns, and competency checks. Students are required to have 100% attendance during the course, participate in class, complete a student evaluation form, and complete a pre-course and post-course knowledge and skills assessment form. Each course is primarily taught by HCAS faculty, who are all 3.375 xmembers 4.625 of McCrone Associates’ technical staff. McCrone Asso- ciates is a microscopy laboratory, pioneering innovative particle identification and materials analysis methods. All instructors currently work in laboratories where they use the techniques they 3.875 xteach to4.75 the students. Techniques learned during training can be basic, such as the use of the stereomicroscope or polarized light microscope to get a better view of contaminants for basic characterization purposes. 3-1/4 xIs the4.875 contaminant glass, metal, or plastic? Does the material look corroded or thermally degraded? This will narrow down the de- tective work needed and allow the investigator to collect the appropriate reference materials from the manufacturing process to 3.3125xcompare 4.875 against the unknown sample. A contamination source can possibly be identified without definitively naming the components of the offending material. The techniques can be complex, such as the use of Fourier transform infrared spectroscopy (FTIR) to identify thermally degraded sugar or starch compounds, or the use of scanning electron microscopy (SEM) to determine the type of metal. After the classroom portion of the course, students login to access a live, online, instructor-led session, where they discuss unknown samples that were sent to their labs by the instructor. Post-course sessions offer students an opportunity to put into practice the skills learned during the course, while using the equipment available to them at their facilities. Sessions allow participants with little experience to build confidence, while

April/May 2013 43 Quality Training Employees

(Continued from p. 43) age and type of equipment being used When choosing a training provider, in the classroom, the types of learning Industry Events choose a materials analysis course that resources available, and the material ex- trains quality professionals not only pected to be learned upon completion of APRIL within a specialized academic environ- the course. Ensure your training choices 30-May 2 ment, but also with an online component have sufficient credibility to withstand SupplySide MarketPlace 2013, to be carried out in the student’s own lab- regulatory scrutiny. ■ New York, N.Y. oratory with materials specific to their Visit marketplace.supplysideshow.com Zona is the dean of Hooke College of Applied Sciences, industry. Ask questions to determine Westmont, Ill. Murley is the quality manager at McCrone or call (480) 990-1101 x1068. the instructor’s experience level, the Associates, Westmont, Ill.

MAY 6-8 Pasteurization Workshop, Murfreesboro, Tenn. Email [email protected] Advertiser Directory or call (205) 595-6455 x224. 7-9 Advertiser Page # Website Penn State HACCP for Meat and Poultry 3M Corp. 39 3m.com Processors, University Park, Pa. Advanced Instruments Inc. 25 aicompanies.com Visit foodscience.psu.edu/workshops. American Proficiency Inst. 18 api-pt.com

Bio-Rad Laboratories 2 bio-rad.com JUNE 4-6 Brookfield Engineering 32 brookfieldengineering.com Food Micro Short Course, University Park, Pa. Cert ID 38 cert-id.com Visit agsci.psu.edu/foodmicro. DuPont Nutrition & Health 3 foodquality.com/award.htm 10-12 International HACCP Certification Course, EMD Millipore Corp. 14 emdmillipore.com Sacramento, Calif. Eppendorf North America 52 eppendorfna.com Email [email protected] or call (205) 595-6455 x229. Grainger Inc. 12 grainger.com 12-14 Implementing SQF Systems Training Course, IAFP 4 foodprotection.org Sacramento, Calif. Nasco 46 whirl-pak.com Email [email protected] or call (205) 595-6455 x229. Nelson Jameson 43 nelsonjameson.com

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F F microbes from thecloth onto thefood.” they’ve transferred avast populationof ing. Andiftheydon’t change their gloves, wet cloth thathasbeenaround allmorn- hands andare wipinga off counters with land, Wis. have “They plasticover their Microbiology Solutions Inc.inMcFar dling itall,”says theheadofKornacki olives, lettuce, pickles, and they’re han- one setofingredients andthenanother— people making sandwiches reach into he says he can’t help himself. “I’ve seen looking atthekitchen ashewaits inline, idation. Andasmuch ashetriesto avoid fast foodrestaurants, butwithsometrep safety consultant admitsthatheeatsat Five EssentialTips forEffectiveSanitation New and old employees should beaware, orreminded,of thefundamentals for controlling ood Service & ood Service supermarket hevisits. Thefood corner inevery restaurant and PhD, danger lurks around the or microbiologist Jeff Kornacki, the risk factors associated with food contamination | - - in theformofpotentially improving the down to restaurants and supermarkets farms andprocessors, itsbenefitfilters produce safety. WhiletheAct focuseson preventive controls inhumanfoodand two major rulesfortheAct regarding venting TheFDA it. recently proposed responding to contamination to pre- supply issafebyshifting thefocusfrom (FSMA) aims to ensure theU.S. food consumer group. Science inthePublicInterest, anonprofit cus onsafety, according to theCenter for food processors, cooks, andservers fo today are preventable iffarmers, chefs, of thefoodborneillnessesexperienced potentially could contaminate food. Most people from to farmers foodservers who n Introductio The Food Act SafetyModernization And that’sjust onelink inthechain of to Sanitation - Sanitation Requirements (seesidebar). National Standard forBakery Equipment being upgraded, including theAmerican Safety Program. Otherstandards alsoare for Science inthePublicInterest’s Food Klein, seniorstaffattorney fortheCenter ing through thefood chain, says Sarah safety ofmeatandother foodstuffs mov with five frequently mentionedsani- other matter. control; andphysical meanshair, or dirt, ical includes cleaning solvents andpest logical includes microorganisms; chem- Biological, chemical, andphysical. Bio contaminants thatcancause unsafefood: There are three maintypesofhazards or inFoodSanitation By Lori

In ourresearch, we’ve come up R

Valigra etail April/May 2013 (Continued onp.46)

45 - - Food Service & Retail Introduction to Sanitation

(Continued from p. 45) above the wash sink.” Some chains, such as Clyde’s Restaurant tation tips to prevent foodborne illnesses in food service and Group, have periodic hand-washing competitions as a built-in in- retail businesses. They are: centive for cleanliness, she says. One company that is known for 1) Proper personal hygiene, including frequent hand and arm its sanitation controls is McDonald’s, adds Klein. “Those types of washing and covering cuts; entities are keeping control of their brand.” 2) Proper cleaning and sanitizing of all food contact surfaces While there are no national food safety standards that can be and utensils; imposed on restaurants and supermarkets serving food, Klein 3) Proper cleaning and sanitizing of food equipment; would like to see a mandatory nationwide adoption of the most 4) Good basic housekeeping and maintenance; and recent FDA Food Code (2009). 5) Food storage for the proper time and at safe temperatures. Proper employee education and training, as well as monitor- #1 Tip: Personal Hygiene ing and record-keeping by management of clean and sanitation Most foodborne illnesses are caused by bacteria or other microor- tasks, also are important, according to Joshua Katz, PhD, new di- ganisms spread by people who handle food, according to a report rector of the Food Marketing Institute’s Food Safety Programs in called “Serving it Safe” from the National Food Service Manage- Arlington, Va. ment Institute and the U.S. Department of Agriculture. The report But while procedures and training can be put in place, their also noted that every action in food service could potentially im- effectiveness depends on how they are enforced. One way is to pact food safety during purchasing, storing, preparing, holding, apply public pressure to those with cleanliness issues, says Klein. serving, or cleaning. “The Center for Science in the Public Interest makes the results of Perhaps the most basic step toward safe food is teaching the health department inspections more public. We believe the restaurant, supermarket, and other food-handling staff the im- transparency of those results…will serve as an incentive.” portance of basic hygiene. That includes washing their hands and Klein says restaurants need to bear some responsibility for the exposed arms frequently and at key times in food handling, such periodic training of employees and oversight. “They need to en- as when they switch from touching raw to cooked food. Covering sure materials that explain the responsibilities of employees are cuts also is critical. available to them in multiple languages, English, Spanish, Chi- The FDA’s 2009 Food Code cleaning procedures recommend nese, and that there are visual cues, such as hand washing signs that food employees clean their hands and the exposed portions of their arms, including prosthetic devices, for at least 20 seconds using a cleaning compound in a hand washing sink. To avoid re- FQ1304 contaminating their hands or prosthetics after washing, employees should utilize disposable paper towels or similar clean barriers whenever touching surfaces such as faucet handles and restroom door handles. Injuries on the hands or lower arms should be cleaned and treated immediately so they do not become infected and contaminate food and equipment, according to The Idaho Food Safety and Sanitation Manual. Rubber or plastic gloves should be worn until the injury is healed and to prevent a bandage from getting into food. In addition, do not wash hands in sinks designated for food preparation or equipment and utensil washing as that can contaminate food, equipment, and utensils. “Training is important,” says consultant Kornacki. “Fast food has rapid employee turnover, so you need policies in place and training programs.”

#2 Tip: Clean Contact Surfaces Proper cleaning and sanitizing of all contact surfaces and utensils is a must, according to food sanitation experts, as food can typically get trapped in places like counter cracks and in between fork tines. Unsanitary facilities and equipment may spread harmful organisms to people or food, according to the “Serving it Safe” report. Also, cockroaches, flies, mice, and other disease-spreading pests seeking food could contaminate food, equipment, or service areas. The report also warns against preparing raw meat and raw fruits or vegetables on the same surface at the same time to prevent cross contamination and microbial transfer. This means avoiding

require ciation, said inastatement whenthenew president of theAmerican Baker’s Asso- clean production R equipment,” and theability to effectively and efficiently ward-thinking inthedesign of its equipment proved bakery equipment. design, construction, and installation of im- standard sets parameters for thesanitary Equipmentery Sanitation R Z50.2 American National Standard for Bak sion of theAmerican Society of Baking’s ASB stitute last October approved the2012 ver issue, theAmerican National Standards In- itation experts. Inaneffort to address the breaks and product recalls, according to san- reduce therisk of foodborne illness out ier to break down, clean, and maintain may food safety. breeding grounds for pathogens that risk reach areas. and otherparticles can get stuck inhard-to- surfaces of bakery residual equipment, food Despite zealous efforts to clean the visible on Improved Equipment Design Bakery Sanitation Standard sanitize such asslicers andfillers, says still pieces ofequipmentthat are hard to merelythan six hours taking aslicer apart. ciently.” He notes thathehasspentmore designed to becleaned andsanitizedeffi- Kornacki. “Equipmentsometimesisn’t to acertain degree to clean them,” says ment thatneedto effectively betaken apart rial growth. get stuck andbecome ahotbedforbacte- ternal where parts apiece ofmeatcould can bedifficult to clean, especially thein- Food equipmentsuch asslicers andfillers #3 Tip: SanitizingEquipment same surface aslettuce. cleaning orcutting raw chicken onthe “The baking industry needs to befor Improved equipment design that is eas- With high-moisture foods, there are are going“There to bepieces ofequip ments wereapproved. They, inturn, can become moist equirements. obb M F ocuses ackie, - - he The - - - what iseffective.” need to balance what with ispractical ment every day,” Kornacki adds. “But you design going forward. challenges may leadto better equipment can beproblematic. He says thecurrent Kornacki. Dryfoodssuch aswalnuts also used correctly. data sheetsto assure theyare stored and clearly labeled, and to use materials safety awayers from food, make sure they are store chemicals intheiroriginal contain- employees how to use chemicals properly, The report urges establishments to teach detergents, polishes, andglass cleaners. sanitizers, pesticides, whitening agents, sick, andeven injure theemployee. could contaminate foodandmake people control, butifnothandledcorrectly they icals to clean andsanitizeforpest service establishments usevarious chem “Serving itSafe”report notes thatfood areasration ofastore orrestaurant. The keeping and maintenance to foodprepa- It’s to important apply good basichouse- #4 Tip: GoodHousekeeping isms from growing, to it is important To keep bacteria andother microorgan- #5 Tip: Storage Safe “Ideally, you’d break downtheequip Such hazardous chemicals include - - time-temperature requirements are met. stage offoodproduction to make sure the tures andkeep written procedures ateach service document tempera- operation the “Serving itSafe”report. and 135 degrees Fahrenheit, according to ture isbetween 41 degrees Fahrenheit zone where theinternal foodtempera- isms are more likely to grow inthedanger the proper amount of time. Microorgan- store food at the correct temperature for [email protected]. Valigra isawriterbasedinCambridge,Mass.Reachherat food andbeverages. in thesameice thatwillbeconsumed in nally, to it’simportant notcool fooditems tor where itcandriponto foodsbelow. Fi- ing meatonthetop shelfintherefrigera- that acommon mistake isto leave thaw tion. The“Serving itSafe”report notes tois important prevent cross-contamina- a warming tray forhours. says ofready-made foodthatmay linger in drops sufficiently, bacteria can grow,” she 165 degrees, butif theinternal temperature in advance. “A chicken may becooked to if foodisoutsettoo long, orifitiscooked tion after cooking,” says Klein.Thisistrue cially withmeatandpoultry, iscontamina “One ofthethings we’re seeing, espe- The report recommends that afood At thesametime,where foodisstored ■ April/May 2013 47 - - SPECIAL ADVERTISING SECTION

Reducing Risk of Microbial Contamination High-quality microbiology equipment and supplies meet the demands for producing rapid, accurate results for today’s labs

It seems the mainstream media’s attention vides a reduction in costs by eliminating up to 75 on the food industry gets more critical with each new percent of materials required with serial dilutions headline, making the issue of ensuring food safety by providing a 4-log dilution effect across a stan- more important than ever. dard plate in a 35 seconds cycle time. Meanwhile, “With bacterial outbreaks in the food industry, Roka Bioscience offers an all-in-one molecular microbiologists have looked for alternative methods pathogen detection design. Its Atlas system can in quality control,” comments Sinderella Abdallah, save valuable bench space and eliminate the need microbiology product manager at Advanced Instru- for additional equipment, like centrifuges or bio- ments, Inc. “With that in mind, the market has devel- logical safety cabinets. TandD ensures users don’t oped various systems, varying in speed have any gaps in data collection with and accuracy, to aid microbiologists.” its wireless instruments that deliver By Marian Zboraj Doris Engesser-Sudlow, diagnos- error-free record keeping. And be- tics global director at DuPont Nutrition sides food diagnostic systems for- & Health agrees. “Increasing regulatory require- merly available under the Qualicon name, DuPont ments for controlling pathogens, such as for STEC Nutrition & Health also offers its DuPont Danisco in the U.S. or Salmonella serotypes in Europe, are range of ingredients to provide enhanced protec- driving an increased use of rapid testing methods.” tion against unwanted microbes and other benefits. Engesser-Sudlow explains food companies are look- With the spotlight put on food contamination as ing at every step of their process, including improving of late, laboratories can rest assured there are com- shelf life, sample collection, automation, reduced la- prehensive solutions available that have the capa- bor cost, and testing accuracy. bility to meet all their microbial testing needs and Luckily, companies like Advanced Instruments, ensure their products don’t make headlines for the DuPont, and others are answering the call to provide wrong reasons. ■ diverse solutions for food companies. For instance,

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April/May 2013 49

50 Led to a Food Safety Staple Peter Durand’s Metal Can T preservation, accord are usedforfood year, billion some26 cans produced each the 131billionmetal sizes andstyles. Of day in600different million metalcansa use more than100 plated container. got patent thefirst foratin- merchant Peter can in1810, when English and durablepractical metal off after the invention ofthemore preservation, canning really took regarded asthefatheroffood before Whilehe’swidely sealing it. air andheatfrom foodinaglass jar claimed thatprizebydriving out Parisian confectioner Nicolas Appert would assure hismenhadsaferations. with a food preservation method that Mail tion/sterilization, according to the just behindrefrigeration andpasteuriza- food anddrinkinnovations ofalltime ranked canning among theTop 20 tute. intheU.K. Scientists recently ing to the CanManufacturers Insti commodity, freezing andcanning pro to fresh andfrozen. “Depending onthe comparing canned fruits and vegetables more than40scientific journal studies State University study thatanalyzed safety, asstated byaMay Michigan 2012

Nowadays, Americans In fact, canned foods help with food canned foodshelpwithfood In fact, newspaper. Innovators FOOD

prize to anyone who cameup poleon offered a12,000-franc long way since 1795 when Na - he ubiquitous canhascome a QUALITY Durand Durand - in Food Quality & Saf ety By - Daily Daily Lor - i Vali using vessels madeofglass, pottery, tin, vegetable, andotherperishable foods was foramethodofpreserving animal, which was re-filed inthe U.S. in1818, King George IIIofEngland in 1810, and smashed themwithrocks. opened earlydiers canswithbayonets or opener wasn’t invented until1855, sol their ownchallenges. Because thecan and Bill Knudson, professor, concluded. authors Steven Miller, visiting instructor, always true,” Michigan State University products, research reveals thatthisisnot as lessnutritiousthanfresh orfrozen while cannedfoodsare often regarded cesses may preserve nutrientvalue, and gr The first Durand patent granted by patent Durand granted by The first a The study alsostated thatcanned during thecanning process. logical contamination generated because to ofbarriers microbio foods are the safest form of food foods are thesafestformoffood At thetimeofDurand’s and for soldiers in the field. inthefield. for soldiers tial useofcanning was That’s because theini- and deathproposition. Appert’s inventions, food safety was literally alife Glass jars wereGlass jars cans presented fragile, but metal fragile, butmetal

- - using the method. The original inventor soups, and milk and boilingmeat, them tested theconcept thoroughly bysealing idea andobservations who byDurand, rand’s patent describesboththeoriginal foods attheRoyal inLondon. Society Du The Frenchman demonstrated canned flax spinning frame, Philippe deGirard. French engineer andinventor ofthefirst abroad, who is thought to have been tion more thanayear earlierfrom afriend patent thathegot theideaforinven- rubber seal,oracemented cap. sealed airtight byacork, screw cap witha open, butimmediately afterward it was ing procedure, thecap was left partly During theheating andsubsequentcool inwateror immersed andthenboiled. heated inanoven, stove, orsteam bath, capping Thefilledcan could thenbe it. and half-cooked orraw formeats, and fillingraw acanwithfood, for vegetables glass storage. The procedure involved only onthetincanto improve onAppert’s and othermetals, though focused Durand [email protected]. [email protected]. Valigra isawriterbasedinCambridge, Mass.Reachherat the early 1820s. and France before arriving to theU.S. in canned foodspread throughout Britain canned vegetables aswell. Theconcept of on live cargo orsalted butnowhad meat, Institute. previously Sailors hadto rely year, according to the Can Manufacturers up to 24,000 large cansonitsshipseach provisions. By1818,theRoyal Navy used military travel and longer farther on their Donkin andHallaimedto have theBritish poleon to have safefoodforhistroops, navy in1813. Like theincentive from Na - canned goods fortheBritisharmy and canning factory andproduced thefirst vation concept thensetupacommercial ThetwoHall, in1812. tested thepreser Englishmen, Bryan DonkinandJohn hesolditfor1,000rather poundsto two tution saidthefoodwas preserved. oftheRoyalbers andRoyal Society Insti- four to sixmonths, andreports bymem - the cannedgoods withtheRoyal Navy for pounds ofmeatinonecan.He also tested tion inthefuture andpreserved upto 30 hadexpectedDurand large-scale produc had tested only smallvolumes offood,but Durand does acknowledgeDurand in his first Durand didn’tDurand develop thepatent, ■ www.foodquality.com - - - -

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