Are They the Right Move? Strategizing How to Block the Risk of Cross-Contamination with the Proper GMP Pieces in Play

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FSMA’s GMPs: Are They the Right Move? Strategizing how to block the risk of cross-contamination with the proper GMP pieces in play

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By Virginia Deibel, PhD, and Tim Lombardo

Safety & 23 Sanitation

© blu e d sign - F o t li a . com The Value of GMPs in Achieving Globally 25 Recognized Certification Zoning in on An upstate N.Y. juice and sauce processor accounts Environmental how it incorporates Sanitation Programs nni F oo d G i ova GMPs in its certification How to best ensure control of environmen- to SQF Level 2 tal parameters via a thorough preventative BY Heather Angus-Lee maintenance sanitation program By Charles Giambrone, MS

Food Quality & Safety (ISSN 1092-7514) is published 6 times a year in Feb/Mar, Apr/May, Jun/July, Aug/Sept, Oct/Nov, Dec/Jan by Wiley Subscription Services, Inc., a Wiley Company, 111 River St., Hoboken, NJ 07030-5774. Periodical postage paid at Hoboken, NJ, and additional mailing offices. Subscription for U.S. is $126 per year. International subscription is $160. Food Quality & Safety is a proud member of: United Fresh Produce Association Folio Ozzie and ASBPE award winner for editorial and graphics excellence. POSTMASTER: Returns and address changes to Food Quality & Safety magazine, PO Box 9051 Maple Shade, NJ 08052-9651 COVER a nd C o nt e nts: © g w 288 - F t li . com

April/May 2014 5 CONTENTS APRIL/MAY 2014

Columns Washington Report 14 Will FDA’s New Budget Cover Food Safety Costs? Examining how FDA's budget request for Fiscal 2015 will affect FSMA implementation, FDA inspections, industry user fees, and more Features Cont. See Page 14 By Ted Agres

Safety & Sanitation Quality Industry Insights 29 Raising the Standards 41 Cultivating New 16 Do Meat and Poultry of Hygienic Design for Credentials in Cyberspace Handling Labels Really Processing Equipment A growing number of graduate Convey Safety? the best cleaning system and degree programs devoted to food In the wake of the Jack in the most effective sanitizers cannot safety and quality are springing up Box E.coli outbreak 20 years ago, work properly if the design of the on the Internet the USDA mandated food safe equipment does not follow basic handling labels on packages of By Linda L. Leake, MS hygienic principles raw meat and poultry to educate the general public—however, the By F. Tracy Schonrock 44 Getting the Most from a information on these labels may Crystallization Process have been incomplete from 31 When Is it Time to How scraped surface heat the start Clean for Facility exchangers technology can benefit By Darin Detwiler, M.A.Ed. Decontamination? the crystallization of food products A study was conducted to gain to optimize the quality of new and a better understanding as to existing recipes how clean a facility needs to be By Tony Mathis for a gaseous chlorine dioxide Departments fumigation to be successful 46 Five Ways to Prepare for From The Editor By Paul Lorcheim an Audit 8 Quick reminders to keep in check 10 Letters To The Editor when trying to implement an 12 news & Notes accredited standard 47 New Products By Scott E. Zimmerman, M.Sc, CP-FS Testing 50 Scientific Findings The Daunting Task 34 of Establishing Food Integrity 49 Events Along with verifying ingredient Exclusive Online 49 Advertiser Directory identity, the FCC Identity Standards include tests for substances that Content should not be present in certain To read these articles, go to complex ingredients the April/May issue on By Markus Lipp, PhD www.foodquality.com: § detecting Adulteration CORRECTION 38 Are Your Products in Olive Oil In the PEMP Decision Tree diagram for Gluten-Free? § Advances in Air Monitoring the “Components for an Effective Pathogen Third-party certification can Environmental Monitoring Program” help companies demonstrate article, page 35, February/March 2014 compliance with FDA labeling issue, the two lower right hand boxes were regulations through testing and mistakenly reversed. A corrected version other quality controls tools of the diagram/article is available at www.foodquality.com. By Jaclyn Bowen facebook.com/FoodQualityandSafety

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Find out more at bio-rad.com/ad/productivity Publisher Lisa Dionne, [email protected] Associate Publisher Ken Potuznik, [email protected] Editor Marian Zboraj, [email protected] Design Maria Ender, [email protected] From The Editor Production Claudia Vogel, [email protected] Christiane Potthast, [email protected] Elli Palzer, [email protected] MANAGER, DIGITAL MEDIA & STRATEGY, Custom Ventures Jason Carris, [email protected]

he Economist’s March 15th Advertising Sales Manager, Americas article, entitled “A La Sciences, Global Research, Commercial Sales Joe Tomaszewski Cartel: Organized gangs 111 River St. 8-01 have a growing appetite Hoboken, NJ 07030-5774 (201) 748-8895 • Cell: (908) 514-0776 Tfor food crime,” takes a look at the [email protected] increased number of criminals Sales Office turning their attention to food U.S./Canada/International fraud activities. Some crooks who Ken Potuznik 29822 N 51st Place, Cave Creek, AZ 85331 even once focused on drugs have (480) 419-1851 • fax (480) 718-7719 switched to food due to the potential of better profits, as the arti- [email protected] cle points out, “Not everyone is a junkie, but everyone buys food Editorial Office and drink.” 111 River Street, Hoboken, NJ 07030-5774, USA Unlike food defense, the intent of food fraud—which includes Reprints: E-mail [email protected] economically motivated adulteration (EMA)—isn’t to harm; none- Editorial Advisory Panel theless, it may damage public health as the related health risks are Betsy Booren, PhD Jennifer McEntire, PhD Chief Scientist VP and Chief Science Officer often more risky than the traditional food safety hazard because American Meat Institute Foundation The Acheson Group the contaminants are unconventional. Food fraud can be com- Gerry Broski Mary Ann Platt mitted through various methods, such as dilution, substitution, Sr. Marketing Director, Food Safety President Neogen Corp. CNS/RQA, Inc. mislabeling, counterfeiting, etc. Christine Chaisson, PhD The awareness of food fraud has recently grown due in part Director Mike Robach The Lifeline Group Vice President, Corporate Food Safety, to last year’s various meat scandals (horse, rat, donkey) that oc- Quality, & Regulatory Virginia Deibel, PhD Cargill curred across the globe. So what is industry doing to combat this Director, Microbiological Consulting emerging problem? Covance Laboratories Bob Swientek Caroline Smith DeWaal Editor-in-Chief, Food Technology The issue of food fraud prevention was one of the main topics Food Safety Director magazine discussed at this year’s Global Food Safety Conference in Ana- Center for Science in the Public Interest Institute of Food Technologists heim, Ca., where several members of GFSI’s Food Fraud Think Sara Elhadidy Purnendu Vasavada, PhD Senior Food Scientist PCV & Associates and Professor of Tank emphasized that an effective detection and deterrent strat- Unilever Bestfoods Food Science egy doesn’t mean more testing, but “SMART” testing: Specific, Philip H. Elliott, PhD University of Wisconsin Food Safety, Global Quality Assurance Measurable, Assignable, Realistic, and Traceable. The group W.K. Kellogg Institute Patricia A. Wester President also discussed the importance of understanding vulnerabilities Daniel Y.C. Fung, MSPH, PhD PA Wester Consulting Professor, Food Science & Animal Sciences in order to achieve prevention. The Think Tank created two new Kansas State University Craig Wilson Vice President, Food Safety Steven Gendel proposed elements for inclusion in version 7 of the GFSI Guidance & Quality Assurance Food Allergen Coordinator Costco Wholesale Document, which includes identification of risk through a vul- FDA nerability assessment followed by the creation of a vulnerability Tim Jackson Steven Wilson Director, Food Safety U.S. and Canada. Chief Quality Officer control plan to provide mitigation methods. Nestle USDC Seafood Inspection Program Framework for vulnerability assessment is also under development by USP. In the meantime, the organization’s Food Fraud Printed in the United States by Dartmouth Printing, Hanover, NH. Copyright 2014 Wiley Periodicals, Inc., a Wiley Company. All rights reserved. No part Database is available. This searchable database includes fraud of this publication may be reproduced in any form or by any means, except as permitted history by ingredient, available detection methods, and poten- under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the publisher, or authorization through the Copyright Clearance tial hazards. There’s also the NCFPD EMA Incident Database. In Center, 222 Rosewood Drive, Danvers, MA 01923: (978) 750-8400: fax (978) 750-4470. addition, NCFPD is collaborating with USP to evaluate the EMA 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 vulnerability of the 1,100 monographs in the Food Chemicals Co- 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 dex, a collection of quality and purity specifications and methods published herein are intended to further general scientific research, understanding, and for food ingredients. 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. As the Think Tank stated, when it comes time to identify your While the editors and publisher believe that the specifications and usage of equipment own company’s food fraud vulnerabilities, the best strategy to 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, have is to think like a criminal. 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 Marian Zboraj are encouraged to contact the manufacturers with any questions about the features or Editor limitations of the products mentioned.

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FDA Inspections in 2014 the U.S. food plants who worked as QA/ FEBRUARY/MARCH ISSUE QC managers, in R&D, and as food chem- FDA’s excuse in not completing the prom- ists. With a little training, they can perform ised number of plant inspections due to the much better than newly hired inexperienced budget is a typical bureaucratic explanation. FDA inspectors. How can they spend so much money to in- —Kuen Lee, food safety manager retiree, spect one foreign food plant? Do they think Unilever the inspection trip is their luxurious vacation Fingerprinting Food trip? Because they don’t know the culture, Brand Protection in a Social Media Age FEBRUARY/MARCH ISSUE area, people, and language, they hire an FEBRUARY/MARCH ISSUE Nice article, however NIR is an older tech- interpreter and take so much time to finish They [Don and Adrian] make great points. In nology, and may not catch everything. Try one plant—making more money for them. addition, social media can be used to share looking at https://en.wikipedia.org/wiki/ Why does FDA not hurry to establish third- best practices within industry to improve our Hyperspectral_imaging. The USDA has party auditor system? Furthermore, in the food defense strategies. The Food Defense spent a great deal of time, money, and effort U.S., there are many able foreign-born U.S. Strategy Exchange LinkedIn group is a great in developing this hyperspectral technology citizens who can understand the culture and case in point. I think our own blog, currently and are happy to provide the Research and language of the foreign countries that FDA in a series about the proposed intentional Development data to implement this detec- wants to audit. By hiring and training them contamination rule, is another case in point. tion equipment. as an inspectors, we can save lots of money. —Ned Mitenius, senior consultant, —Steve Baryschpolec, consultant,

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NEWS & NOTES

FAO Expands Food Security Knowledge Americans Want More Government More than 220 universities in Latin Amer- Oversight for Food Safety ica and the Caribbean are joining the Food The Harris Poll of 2,236 adults surveyed on- and Agriculture Organization (FAO) to ex- line indicates that strong majorities of U.S. pand learning opportunities and improve adults say food recalls have them at least © a ng or ius - F o t li . com policies for food security. With the support somewhat concerned (86 percent with 58 of the European Union, FAO has signed a percent somewhat concerned and 28 per- Memorandum of Understanding with the cent seriously concerned) and believe there Association of Universities of Latin America should be more government oversight in and the Caribbean to develop the education regards to food safety (73 percent). When Global Food Traceability Center program. The initiative will offer a new Mas- those who think there have been more food Strengthens Seafood Industry ter’s program in Food Security, in addition to recalls lately are asked who they hold most The Institute of Food Technologists Global elearning courses currently offered by AF O. responsible for this increase, the highest Food Traceability Center has received a grant The partnership will target current and poten- percentage by a dramatic margin place the to conduct research into the impacts of trace- tial policymakers in the region. Rollout of the blame on those responsible for packaging ability on consumer attitudes and business new courses is slated for January 2015. and/or processing food (50 percent), though performance in the seafood industry from the federal government (19 percent) and the Gordon and Betty Moore Foundation. The those responsible for growing and/or rais- purpose of the project is to strengthen the ing food (16 percent) also received blame. performance and proficiency of the seafood industry by providing knowledge about the Business Briefs impact of traceability on reduction of waste, enhancement of consumer trust, and in- opens ld ma n - F o t li a . com © famve crease of business efficiencies. Additionally, Shimadzu Scientific Instruments new Shimadzu Solution Center at its North the project will deliver a software application American headquarters in Columbia, Md. that can be used by stakeholders seeking to better understand their return on invest- Updated FDA Requirements for Covance expands its nutritional chemis- ments in traceability solutions. Infant Formula try and food safety services with a new FDA’s interim final rule amends the FDA’s 10,000 sq. ft. laboratory this summer quality control procedures, notification, and within its existing facility in Harrogate, Improving Cheese Ripening record and reporting requirements for manu- England. Processes facturers of infant formula products. The rule, A new E.U.-research project, SMARTRIPE, in part, will ensure that infant formula con- SGS Food Safety Services opens new ISO 17025 accredited food testing labo- aims to bring a number of improvements tains all federally required nutrients. It also ratory in Fairfield, N.J. in cheese ripening technology by adopting establishes cGMPs specifically designed for

sequential ventilation procedures and a infant formula, including required testing Universal Pasteurization purchases new monitoring concept in cheese ripening for microbial contamination. This microbial the assets of high-pressure processing rooms. The SMARTRIPE project builds on the testing includes testing representative sam- services provider GL Foods of Coppell. results of previous FP6 TRUEFOOD project ples of finished products to prevent the dis- on cheese ripening. These results proved tribution of products contaminated with the It’sFresh! Inc. expands to a new head- the concept of “sequential ventilation” as a pathogens Cronobacter and Salmonella. The quarters in Eden Prairie, Minn. mean to save around 50 percent of energy rule also establishes quality factor require- consumption in ripening rooms, and de- ments to support healthy growth. Applying ProcessPro, a mid-market ERP software fined strategies to control cheese mass loss only to formulas for healthy infants, the rule solution company, has become a member of the Northwest Food Processors (cheese water evaporation) while preserving is accompanied by two draft guidance docu- Association. cheese quality attributes. This two-year re- ments for industry, including one document search project funded by the Seventh Frame- that addresses the manufacture of formula The American Institute of Baking enters work Programme of the European Commis- products made for infants with unusual med- into an agreement to acquire Beijing Sino- sion aims to develop a new technology for ical or dietary problems, such as infants who Swiss ADC Service, an officially approved cheese ripening. are born extremely premature. certification body in Beijing, China.

12 FOOD QUALITY & SAFETY www.foodquality.com Key ResouRces in Food chemistry & Analysis

Food Carbohydrate FoodChemistry Carbohydrate ChemistryRonald E. Wrolstad Food Carbohydrate Chemistry Ronald E.Pr essWrolstad FoodRonald E. Wrolstad Carbohydrate Chemistry Press Ronald978-0-8138-2665-3 E. Wrolstad • Paperback • 240 pages • February 2012 978-0-8138-2665-3Food Carbohydrate • Chemistry Paperback clearly• 240 pages presents • February and applies 2012 basic carbohydrate Foodchemistry Carbohydrate to the quality Chemistry attributes clearly and presents functional and properties applies basic of foods. carbohydrate chemistry to the quality attributes and functional properties of foods.

The Chemistry of Food Additives Chemistry of Theand ChemistryPreservatives of Food Additives Food Additives Chemistry of andTitus A. M.Preservatives Msagati and Preservatives Food Additives Titus978-1-118-27414-9 A. M. Msagati • Hardcover • 336 pages • December 2012 andTitus A. M.Preservatives Msagati Titus A. M. Msagati 978-1-118-27414-9The Chemistry of Food• Hardcover Additives • 336 and pages Preservatives • December is 2012an up-to-date reference guide Theon the Chemistry range of of different Food Additives types of andadditives Preservatives (both natural is an up-to-dateand synthetic) reference used in guide the onfood the industry range of today. different types of additives (both natural and synthetic) used in the food industry today.

Analysis of Antioxidant-Rich Phytochemicals Antioxidant-Rich Phytochemicals

Analysis of Antioxidant-Rich Phytochemicals EDITED BY • ZHIMIN XU • LUKE R. HOWARD Analysis of Antioxidant-Rich Antioxidant-rich phytochemicals in plants and agricultural food products have become an attractive

Phytochemicals Analysis of subject for food, biomedical and nutrition scientists, as well as for food producers. Unlike synthetic food Antioxidant-Rich antioxidants, antioxidants from natural sources are generally recognized as safe for food applications and most have been confi rmedEDITED as BYhaving • ZHIMIN health-promoting XU • LUKE R. functionsHOWARD in relation to various human Analysis of epidemiological diseases such as cardiovascular diseases, cancers, obesity and diabetes. In addition Antioxidant-richto their antioxidant phytochemicals function, many in phytochemicalsplants and agricultural have been food found products to alter have cell become signaling an pathwaysattractive Phytochemicals Analysis of Antioxidant-Rich subjectand gene for expression,food, biomedical and thus and havenutrition the scientists,ability to regulate as well as numerous for food producers. physiological Unlike functions synthetic involved food Analysis of Antioxidant-Rich antioxidants,in the pathogenesis antioxidants of various from chronic natural diseases.sources are generally recognized as safe for food applications andNatural most antioxidant have been phytochemicals confi rmed as having usually health-promoting exist at a very functions low level, in relationand differ to variousfrom proteins, human EDITED BY • ZHIMIN XU • LUKE R. HOWARD epidemiologicalcarbohydrates, anddiseases lipids, such which as cardiovascularare macro-nutrients diseases, and cancers, abundant obesity in food and diabetes.products. In They addition are tomicroconstituents their antioxidant in function, plants and many agricultural phytochemicals and food have products. been found Furthermore, to alter cellthe typesignaling and quantitypathways of Phytochemicals Analysis of Antioxidant-Rich andantioxidant gene expression, phytochemicals and thus vary have signifi the cantly ability from to sourceregulate to numeroussource. Different physiological types of functions antioxidants involved may inhave the different pathogenesis antioxidant of various activity chronic and bioavailablity. diseases. Although most antioxidants have UV absorption, Phytochemicals Naturalusing the antioxidant traditional spectrophotometricphytochemicals usually method exist to quantifyat a very the low antioxidants level, and is notdiffer practical from proteins,because EDITED BY • ZHIMIN XU • LUKE R. HOWARD carbohydrates,they could be signifi and cantly lipids, masked which areor interfered macro-nutrients with by manyand abundant other compounds in food products.in the sources. They Thus, are microconstituentsthe analysis methods in plants for antioxidant and agricultural phytochemicals and food products. are more Furthermore, complicated theand type sophisticated and quantity than of antioxidantthose employed phytochemicals for macro-nutrient vary signifi compounds. cantly from source to source. Different types of antioxidants may

XU • HOWARD Zhimin Xu, Luke R. Howard haveThis isdifferent the fi rst antioxidant book to activityfocus onand the bioavailablity. sample preparation Although mostprocedures antioxidants and methodshave UV absorption,developed Phytochemicals usingfor identifying the traditional and quantifying spectrophotometric natural antioxidantsmethod to quantify in plants the and antioxidants food products. is not practical The principle because of theyquantifi could cation be methodssignifi cantly for maskednatural antioxidant-rich or interfered with phytochemicals by many other is compounds introduced, andin the current sources. methods Thus, theused analysis in the methodsdetermination for antioxidant of antioxidants phytochemicals in different are sources more complicatedare reviewed and and sophisticated summarized than by thoseexperts employed in the fi eld. for Asmacro-nutrient a handbook compounds.of analysis of natural antioxidant-rich phytochemicals, the volume

XU • HOWARD Zhimin978-0-8138-2391-1 Xu, Luke R. • Howard Hardcover • 408 pages • May 2012 Thisprovides is the practical fi rst book information to focus enabling on the researcherssample preparation to identify procedures the appropriate and analysismethods methods developed for forspecifi identifying c antioxidants. and quantifying This book natural may also antioxidants serve as ina lectureplants andresource food forproducts. courses Therelating principle to food of quantifianalysis, cation functional methods foods for and natural nutrition. antioxidant-rich phytochemicals is introduced, and current methods usedAbout in the the Editors determination of antioxidants in different sources are reviewed and summarized by experts in the fi eld. As a handbook of analysis of natural antioxidant-rich phytochemicals, the volume Dr Zhimin Xu, Department of Food Science, Louisiana State University, Baton Rouge, Louisiana, USA 978-0-8138-2391-1Analysis of Antioxidant-Rich • Hardcover Phytochemicals • 408 pages • May reviews 2012 and summarizes current provides practical information enabling researchers to identify the appropriate analysis methods for Dr Luke R. Howard, Department of Food Science, University of Arkansas, Fayetteville, Arkansas, USA specifi c antioxidants. This book may also serve as a lecture resource for courses relating to food analysis,Also available functional foods and nutrition. AboutFunctional the EditorsFoods, Nutraceuticals and Degenerative Disease Prevention procedures and methods used to identify and quantify various types of natural DrEdited Zhimin by G. Xu Paliyath,, Department M. Bakovic of Food and Science, K. Shetty Louisiana / ISBN 978-0-8138-2453-6 State University, Baton Rouge, Louisiana, USA Analysis of Antioxidant-Rich Phytochemicals reviews and summarizes current DrCoffee: Luke EmergingR. Howard Health, Department Effects ofand Food Disease Science, Prevention University of Arkansas, Fayetteville, Arkansas, USA Edited by YiFang Chu / ISBN 978-0-470-95878-0 Also available antioxidants in foods. FunctionalCover design: Meaden Foods, Creative Nutraceuticals and Degenerative Disease Prevention procedures and methods used to identify and quantify various types of natural www.wiley.com/go/food EditedCover images: by G. (left Paliyath, to right): ©iStockphoto.com/amriphoto; M. Bakovic and K. Shetty ©iStockphoto.com/grublee; / ISBN 978-0-8138-2453-6 ©iStockphoto.com/Serg_Velusceac ISBN 978-0-8138-2391-1 Coffee: Emerging Health Effects and Disease Prevention Edited by YiFang Chu / ISBN 978-0-470-95878-0 antioxidants in foods. 9 780813 823911 Cover design: Meaden Creative www.wiley.com/go/food Cover images: (left to right): ©iStockphoto.com/amriphoto; ©iStockphoto.com/grublee; ©iStockphoto.com/Serg_Velusceac ISBN 978-0-8138-2391-1

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ashington Washington 14 F $23 million orlessthan 1percent. would public support cy’s increase byonly or more than18percent, while theagen- fees, which would jump by$335 million lion increase comes from industry user more than93 percent ofFDA’s $358 mil oftheseassessments.portion Overall, constitute asmallerbutrapidly growing ucts. New andexisting foodindustry fees drugs, medicaldevices, andtobacco prod manufacturers of prescription and generic and existing userfees, imposedmostly on $2.16 billionwould beobtained from new lion would come from publicfunding and of over Fiscal 2014. Ofthetotal, $2.58 bil billion, a$358 million(8percent) increase March 4. FDA’s total budget comes to $4.74 istration’s budget Fiscal 2015 request on and inspection. andfoodfacilityregistration food import user fees, including proposed newfeesfor millioncomingof $229 from industry public taxpayer fundswiththelion’s share $24 millionofthatwould beprovided by ActSafety Modernization (FSMA). Butonly rected to implementprovisions theFood millionwould $253 bedi- Of thisamount, percent)(22 boostover current year

President Obama released hisAdmin FOOD safety activities, a$263 million ing $1.48 billionto food support October 1, theFDA isrequest or Fiscal 2015, which begins QUALITY & SAF ETY levels. - - - - -

associate commissioner forfoods. “And Acheson Group LLC and aformerFDA Acheson MD, president andCEOofthe FSMA implementation,”says David compared withtheresource needsfor FDA’s trivial proposed increase “looks ‘Insufficient Funds’ public health. the impactofantimicrobial resistance on setting; and research to better understand entities; riskanalysis to priority support state, eral, local,tribal,andinternational stakeholders and partners, including fed regulatory training andcapacity among are effective and efficient;foodsafety tonical support ensure safetystandards opment to regulatory support action;tech activities: rulemaking and guidance devel crease willallowitto focusonfive main our work to stakeholders.” to meaningfully demonstrate thevalue of ication ofFDA employees, andourability American people,thehard work andded ant work FDA performsonbehalfofthe for theagency to be atribute to theimport release. “Iconsider theadditionalfunding in astatement accompanying thebudget Commissioner Margaret A. Hamburg, MD, this tight budget environment,” saidFDA ally quite apositive outcome forFDA in FDA says theproposed foodsafetyin- The agency’s overall increase “isre - user fees, and more | mentation, FDA inspections, industry for Fiscal 2015will affect FSMA imple- Examining how FDA Food Costs? Safety Budget Cover Will FDA’s New - - - - - Report FSMA,” Dr. Acheson tells for inspectors sotheyfully understand awareness around FSMA andtraining It is about having the resources to raise this isnotjust about more inspections. and Human Services, FDA’s parent agency, ments. year, Last the Department of Health funding to implementthe law’s require- more than$580millioninadditional Office estimated that FDA wouldneed January theCongressional 2011, Budget Health inFebruary. ergy and Commerce Subcommittee on Taylor told the House Committee onEn- foods thatmeetoursafetystandards,” systemsport to facilitate prompt entryof efforts; andimproving ourdataandim- with foreign government to leverage their tions; working more closely onfoodsafety plan; conducting more foreign inspec adequacy verification oftheimporter’s new staffandskills to audit and verify the plier Verification Program, which requires includes implementing theForeign Sup sional testimony earlierthisyear. “This foods and veterinary medicine, incongres Safety R. Taylor,R. FDA deputycommissioner for oversight responsibilities,” saidMichael FDA willbeunable to adequately fulfillits is essential.“Without adequate funding, When FSMA was signed into law in Having sufficientfunding for FSMA magazine. ‘s budget request

Ted Agres Food Quality & Food & Quality www.foodquality.com

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© rendeeplumia - Fotolia.com lowered that estimate to $400 million to methods of food and feed contamination drop to $1 million. The already authorized $450 million based on different assump- can better prevent outbreaks and ensure Voluntary Qualified Importer Program, tions and a commitment to efficiency. To that resources are better focused on areas which is intended to expedite imports date, FDA has received $78 million for of greatest risk.” from certified foreign suppliers and im- FSMA, an agency spokesperson tells Food Authorization to impose the new user porters, would collect $5 million in new Quality & Safety. fees will require passage of new legisla- user fees starting next fiscal year. In ad- tion, something that is far from certain. The dition, FDA is requesting a new $5 mil- Boost in User Fees FDA’s Fiscal 2014 budget request had also lion food contact notification user fee “to The proposed new user fees include a proposed the facility registration and im- better position FDA to reduce microbial $169 million food import fee and a $60 port user fees. In his February congressio- food contamination through premarket million food facility registration and in- nal testimony, Taylor said the registration notification to ensure the safety of food spection fee. The import fee would target fee would allow FDA to increase its capac- contact substances.” activities associated with implementing ity to establish an integrated national food In a related area, the Fiscal 2015 bud- the Foreign Supplier Verification Program, safety system “and further strengthen food get request for USDA’s Food Safety and In- which includes recruiting and training safety inspection, research, and import re- spection Service, which provides federal FDA import staff to assess the adequacy of view.” The proposed import user fee would inspection of domestic meat, poultry, and importer supply chain management and assess a “minimal amount (approximately processed egg products establishments verification programs. The agency says it $20)” per line entry, defined as each por- as well as inspection of imported meat, will also invest in the staff, information tion of an imported shipment that is listed poultry, and egg products, would remain technology, and process improvements as a separate item on an entry document. relatively flat at around $1.0 billion. The needed to make timely import entry deci- “The improvements to the import process budget anticipates implementation of sions. “These fees will enhance both the with not only facilitate the entry of safe “modernized poultry inspection prac- safety protections for imported food and products, but also improve public health tices,” including efficiencies through the feed and the efficiency and speed of food by enabling FDA to focus its attention on rollout of the Public Health Information and feed entry decisions, thus supporting higher-risk products,” Taylor said. System to states, resulting in more stream- international trade in safe food and feed,” If the new user fees are approved and lined administrative and scheduling pro- the agency says in its “Justification of Es- enacted next year, FDA will use the funds cesses, USDA says in its budget document. timates for Appropriations Committees.” for comprehensive retraining of federal Under FSMA, firms are required to re- and state inspectors to ensure inspection Budget Outlook Murky new and update their registration informa- quality and consistency; training and Traditionally, release of the president’s tion every two years. In addition, all “high- technical assistance for small and mid- annual budget request marks the start of risk” domestic facilities must be inspected size growers and processors; and building the congressional appropriations process, by 2016 and no less than every three years the import oversight system mandated by with committees in the House and Senate afterwards. The law directs FDA to inspect FSMA. “A central theme of these invest- holding hearings on agencies under their at least 600 foreign facilities annually and ments is supporting and leveraging the jurisdictions. But it’s been five years since double those inspections every year for food safety efforts of both public and pri- Congress has passed a budget this fashion, the next five years. Despite deficiencies vate partners to make the most effective with legislators having largely ignored in its database systems, FDA had been use of available resources,” the agency the White House’s proposals. The sit- aiming to inspect all foreign and domestic says in its congressional justification. uation is further complicated this year high-risk facilities within three years, two But Dr. Acheson is skeptical that Con- because Congress has already agreed to years earlier than directed by FSMA, and gress will give FDA the green light. “Once two-year federal spending levels through is attempting to inspect all non-high-risk again the FDA has asked for user fees, and a budget deal spearheaded in December facilities within seven years, according to they did not get them the last several times, 2013 by House Budget Committee Chair- the agency’s “2013 Annual Report on Food and they will not likely get them this time, man Rep. Paul Ryan (R-WI) and Senate Facilities, Food Imports, and FDA Foreign either,” he says. “The last several budgets Budget Committee Chairwoman Sen. Offices” released last November. have also had amounts for re-inspection Patty Murray (D-WA). The new food facility registration fee fees, but as far as I am aware the FDA In fact, Murray announced in Feb- would be used to upgrade FDA’s inspec- has not put the system in place to collect ruary that Senate Democrats would not tion system “by increasing the effective- any of those. Maybe that is a ‘Catch-22’ bother passing a budget this year because ness of inspections through adoption of in that they don’t have the resources to “it wouldn’t be productive to relitigate it preventive controls, training of personnel put the system in place to collect the re- so soon after our two-year deal.” Ryan has to inspect against the new prevention sources they so desperately need,” Dr. said that Republicans in the House would standards, and developing new ways to Acheson says. wait to see Obama’s budget request before educate and inform industry,” the agency Indeed, the current year’s $15 mil- beginning the process of crafting a “bal- says. The fee would also support improve- lion food reinspection user fee would be anced budget” of their own for FY 2015. ■ ments in food and feed safety science and cut to $6 million in Fiscal 2015, while a Agres is based in Laurel, Md. Reach him at tedagres@ risk analysis, “so that knowledge of the current $13 million food recall fee would yahoo.com.

April/May 2014 15

16 O in response to theJack intheBox initiated apubliceducation program the start | the information onthelabels may have beenincomplete from of raw meat and poultry to educate thegeneral ago, theUS internal temperature of155degrees Fahr stitutions to cook hamburger pattiesto an the outbreak, required restaurants and in temperatures. up to date withmore accurate cooking at restaurants, neededto bebrought Familiesit. athome,aswell ascooks safely, butalsohowto properly cook handle raw meat and poultry products public understood notonly howto The USDA wanted to ensure thatthe outbreak thathitthePacific Northwest. In thewake of theJack intheBox ReallyLabels Convey Safety? Do Meat Handling and Poultry

Washington state law, atthetimeof I FOOD took office in1993, the USDA riculture Secretary Mike Espy andnewAgadministration nly weeks after theClinton ndustry ndustry QUALITY

By By DA mandated food safe handling labels onpackages Darin Detwiler, M.A. & SAF ETY E. coli E. coli - - -

Ed E. coli USDA have since revised require federal - would have gotten sick.” TheFDA and If theyfollowed thestandards...no one science, or they didn’t read the literature. intheBox] didn’tEither [Jack believe in guideline at the time of 140 degrees... law [of155degrees] afederal superseded vented.” He alsopointed outthat“State the [1993] epidemicwould have beenpre- an internal temperature of155 degrees, mandated thathamburgers becooked to Box followed state regulations, which Jackthe outbreak stated that“had inthe foodprogramdepartment’s investigating son, technical forthestate expert health (Spokane, Wash.) newspaper, Bartle Bert to a1995 article inthe only 140 degrees Fahrenheit. According whereas standardenheit, thefederal was . outbreak20 years public—however, Spokesman Review I nsights

- According to thestate theCDC, health de- beyond just some people getting sick. industry.” Thismultistate event went far with somany questionsandsuch arage 17-month-old son,Riley. four young children died,including my molytic Uremic Syndrome, andofthose pitalized, andofthose37 developed He - cases. Approximately 150 people were hos and Californiareceived reports ofover 600 ofWashington,partments Idaho, Nevada, Box for raw meatto 155degrees. ments, increasing cooking temperatures ent temperatures listed may lead to confu cooking temperatures, having thosediffer because meat andpoultry have different formation was vague. He responded that specifically asked why the cooking in- incomplete from thestart. that theinformationontheselabels was try soldintheU.S. Unfortunately, I believe raw (ornot-ready-to-eat) meat and poul tions to be displayed onallpackages of safety astheUSDA requires theseinstruc ployed to educate consumers about food the mostvisibledevice theUSDA hasem- try. For thelasttwo decades, thishasbeen affixed to packages of raw meatandpoul dated use of Food Safe Handling Labels public. Theprogram included theman- action”as a “bold to educate the general consumer awareness described portion Pathogen Reduction Program included a the wake oftheoutbreak, theUSDA’s new not-ready-to-eat meatandpoultry.” In about proper preparation andstorage of thing [it] can do to help inform consumers had never heard of a nuclear reactor onaNavy submarine—I inside. Only monthsprior, Iwas operating of thebacteria, theUSDA mustdo“every of away to detect orprevent thepresence prevented from ever happening again? American consumer? How could thisbe happen to my son,to my family, to the The day IburiedRiley, Istood there Many have calledthe1993 Jack inthe In a1993 discussionwith Espy, I Espy proclaimed that, intheabsenceEspy proclaimed that, E. coli outbreak the“9/11 ofthemeat E. coli. www.foodquality.com How did this How didthis ------

© ilposeidone - Fotolia.com sion on the part of the consumer. He also in the USDA’s intended Food Safe Handling tants expressed concern over the pres- stated that if there were different labels to Labels because of the deaths of two 3-year- sures associated with the labels and with be applied to different kinds of meat, mis- old Texas boys from E. coli. public awareness in general from within labeling could occur at the plant or at the Though some stores voluntarily labeled the industry, as some meat groups feared grocery store. their meat packages, the required labeling that an educated public would stop buying I left that meeting with a want to learn did not start until May 27, 1994—and even their product. Even the USDA was appre- more about the kinds of cooking messages then, only ground meat products required hensive of giving the consumer too much that they had previously used. Through labeling. All other meat and poultry prod- information as the consumer may not only some USDA contacts in D.C., I was able ucts required labeling as of July 6, 1994. be motivated to stop old behaviors associ- to find a 1990 Food Safety Inspection Ser- According to the Pathogen Reduction Pro- ated with the products, but be motivated vice fact bulletin in which the USDA sim- gram’s description of consumer awareness to discontinue purchasing the product as ply stated: in the Federal Register, the Food Safety and well. This highlights an inherent conflict of “Cook meat and poultry thoroughly— Inspection Service (FSIS) will “inform con- interest for the USDA, for its charge is not meat to at least 160 degrees Fahrenheit, and sumers of the risks associated with unsafe only to regulate the quality of meat, but poultry to at least 180 degrees Fahrenheit. food handling.” However, in order to get also to promote the sale and use. Using a meat thermometer is the best way the federal judge to release the injunction, According to a spokesperson for the to ensure that large cuts of meat are done. the labels had to be designed in such a way American Meat Institute, “Warning labels Greyish color and clear juices show when that they would state proper handling tech- really frighten the public, if consumers fol- patties and individual pieces are done.” niques, but not any health hazards. low safe handling procedures, there’s no This warning indicated that more de- “This product was inspected for your need to scare people about what is really tailed information can be put out in a sim- safety. Some animal products may contain a very wholesome and nutritious prod- ple, precise way that would not require bacteria that could cause illness if the product.” This description of the clean product different labels for many products. Why uct is mishandled or cooked improperly.” may be very easy for the general public to didn’t the USDA use this? Jeremy Rifkin, This message does not warn consumers believe, but what if a product is contam- then the leader of a consumer coalition of the possible dangers associated with inated? In its 1990 FSIS fact bulletin, the group called Beyond Beef, criticized the meats in general. Instead, the issue is now USDA described contaminated meat and USDA on this as he stated how the infor- discussed in terms of a public health, not poultry as causing “thousands of indi- mation was insufficient, thus creating a an industry or USDA, problem. vidual cases, hundreds of outbreaks, and weak message. His group even demanded I was dissatisfied that the labels do not several deaths each year.” The USDA went that “Cook thoroughly” be replaced with identify any potential hazards. Neither E. on to report “6.5 – 8.1 million Americans more explicit instructions. coli, nor any other foodborne pathogen is may actually suffer [foodborne illness] Though many newspapers across named on the labels. I was not surprised symptoms each year.” Mind you, this state- the country reported that the USDA’s de- that the labels don’t explain how the bacte- ment was made in 1990—four years before cision was motivated by the 1993 E. coli ria get into the meat in the first place. What the USDA declared E. coli as an adulter- outbreak, there was one more motivating angered me the most, however, was that ant and well before reporting of illnesses factor for their decision. In May of 1993, the labels do not describe the severity or from many food sources, let alone the sys- the government agreed to require the the consequences of the problem to con- tems to report, record, and monitor were Food Safe Handling Labels as part of its sumers. While I focused on the fact that in place. settlement of a lawsuit filed by the Beyond words such as “may” and “could” make Perhaps by placing a weak message Beef coalition in Washington, D.C.’s U.S. the problem sound insignificant, I also on the labels, the USDA was at least able District Court. The creation and mandates understood that not every package of meat to mandate that some form of food safe of the labels were not so much a result of will be contaminated. I had already been handling instructions be placed on every the goodness of the USDA as they were unwillingly dragged into the meat version package of meat and poultry sold in the part of a judicial order required by the de- of the game Russian Roulette—I knew far U.S. for the last 20 years. But requiring la- partment to carry out. too well that there is a great difference bels and enforcing their use is two differ- On October 14, 1993, one day before between something that “could cause ill- ent things. I have visited plenty of grocery the initial rule of the labeling was to take ness” and something that could cause tod- stores with their own butcher and packag- effect, the National American Wholesale dlers to suffer and, in too many cases, die. ing stations in which labels were not used Grocers Association convinced a Texas The lesson I learned next, however, on the products. ■ federal judge to issue an injunction to delay was something that has been one of the the labeling because “unlabeled meat was most painful elements of the tragedy of my Detwiler is a graduate lecturer on the economic and social aspects of food at Northeastern University. In the 1990s, not a significant health threat, and that the son’s death that I have carried for the last he worked with USDA in the early days of their Pathogen tainted meat outbreak in January was iso- two decades. Work with the USDA relating Reduction Program to gain the federal regulation of food safe handling labels on meat. He holds an FDA certification lated to the Pacific Northwest.” Ironically, to educating consumers was thwarted by as a food science educator and served two terms as a USDA though sad, only two weeks later, the Texas the efforts of the industry and the dual regulatory policy advisor on the National Advisory Committee on Meat and Poultry Inspection. Detwiler continues to consult State Department of Health issued a state- responsibilities of the USDA. Some of the about the history of food safety legislation and can be reached wide warning similar to the one contained department’s administrators and assis- at [email protected].

April/May 2014 17

FSMA’s GMPs: Are They the Right Move? Strategizing how to block the risk of Tim Lombardo cross-contamination, PhD, with and the proper GMP pieces in play Deibel They have data to suggest that governmental oversight is helpful. By Virginia For example, between 1976 and 1997, the average size of a Listeria T he FDA has announced, or per- monocytogenes outbreak was 53.8 cases. After PulseNet, between haps admitted, that the current Good Manufacturing Prac- 1996 and 2004, the average outbreak involved 21.5 cases and with tices (cGMPs) as outlined in 21 CFR 110 do not adequately address the CDC Listeria initiative in conjunction with PulseNet (2004 to the safety issues associated with the manufacturing, processing, 2008), the average outbreak was reduced to 7.2 cases. These data packing, or holding food products. Indeed, “high-profile out- suggest that increased surveillance decreased food safety cases breaks of foodborne illness…strik(ing) one in six Americans each in the U.S. from 1976 to 2008. Why then are there still multistate year have caused a widespread recognition that we need a new, outbreaks that include numerous deaths, as in 2011 when the larg- modern food safety system that prevents food safety problems in est Listeria outbreak occurred due to contaminated cantaloupes the first place.” The FDA, through the proposed Food Safety Mod- that sickened 1,476 and killed 33? The fundamental question is a 288 - F o t li . com ernization Act (FSMA), is attempting to decrease risk by imposing this: Will GMPs included in FSMA be enough to control the risk of w

regulations on how facilities manage their food safety systems. cross-contamination for hazards in food manufacturing? © a g

18 FOOD QUALITY & SAFETY www.foodquality.com COVER story

FSMA Proposed Revisions Vehicle Method The FSMA changes would require facilities to have a written Food Air n Air hoses Safety Plan to include the following elements: a risk-based hazard n Vents analysis, preventive controls for hazards determined to be reason- n Fans to cool workers ably likely to occur, monitoring, corrective actions, verification, n Cooling units and associated records and documentation. Concomitant to a risk-based hazard analysis, proposed FSMA Water n Sanitation hoses that are >40 psi regulations also state that there must be formalized and docu- n Drain backups mented supporting preventative control programs that reduce or n Roof/door leaks eliminate identified hazards. Hazard plans are only the start of a n Leaking hoses and pipes food safety process because they merely outline the hazards and n Equipment controls to minimize or reduce their risk. Once the hazards have been identified, it is incumbent upon the plant to devise preven- Direct Contact n Forklift tires or any vehicular traffic tative control programs to address activities of the manufactur- leaving a production room and ing process that can reduce or eliminate them. These programs, re-entering outlined in FSMA include Manufacturing Process, Allergens, San- n Shoes coming in from the exterior itation, and Recall. It is also stated that the facility must develop of a production room into the “other” programs “as needed.” production room n Pallets Proposed cGMPs n Employee gloves, aprons While FDA is not specifically requiring cGMPs as a Preventive n Dust (especially during construction) Control Program (at this time), subparts of the current 21 CFR 110 Table 1: Cross-Contamination Vehicles and Methods. may be redesignated and included in 21 CFR 117. Primary proposed provisions include programs that address: allergens, personal hygiene, plants and grounds, sanitary operations, sanitary facilities conducted immediately to reduce the risk, such as an intensified and controls, equipment and utensils, warehousing and distribu- cleaning procedure. This procedure is above and beyond the rou- tion, and employee training. tine cleaning and sanitizing. A preventative action is an activity While these specific cGMPs are outlined, the challenge to that will prevent future adverse results. We refer to preventative plants will be to fill in the outline with a detailed program that actions as one of the “4Rs,” namely, repair, redesign, replacement, is thorough and designed specifically for the plant, product pro- and/or removal. All too often, an adverse event means that the site duced, equipment used, plant condition and layout, and work- is cleaned and sanitized, as per the usual procedure, and that is all. force followed by verification of the outcome, scientifically, for On the contrary, this is a call to investigate, immediately reduce efficacy. How can this be done? The short answer is to learn from risk, and implement one of the 4Rs. Further, all activities are to be past and shared practices that have been already proven based on documented. We will outline a few of the cGMP programs followed the principle that food safety is not competitive. The long answer by components that we know are the “secrets” to their success. is to try something (anything) and do not stop until the system is proven to be effective through a rigorous verification process (en- Food Allergen Controls vironmental monitoring program, allergen testing program, visual Currently, there are no cures for those with food allergies or sen- inspection system, metal detection, etc.). So where do we start? For sitivities. Avoidance is needed to prevent allergic reactions. The the purposes of this article, we will focus on food safety as it relates FDA recommendations will include that food processing estab- to microbiology, since it is one author’s specified training. lishments handling any of the major food allergens develop and First, the principle of cross-contamination must be conveyed adopt a food allergen control plan that emphasizes the preven- to production, sanitation, maintenance, and quality assurance tion of cross-contact during processing. Since allergens are part employees. Cross-contamination relative to microorganisms, al- of a food and itself not a contaminate, FDA will be reserving the lergens, chemicals, or extraneous matter is the act of transferring term “cross-contact” as the unintentional transfer of allergenic an item from one place to another. Cross-contamination can occur proteins from a food containing that protein to food that does not. through different methods (see Table 1). The terms “contamination” and “cross-contamination” will then Secondly, include an environmental monitoring system that be reserved for food that has been adulterated with bacteria, for- has a site list consisting of product contact (Zone 1), non-contact eign matter, or other-than-allergen proteins. (adjacent to product contact; Zone 2), and indirect contact (floors, Allergen Best Practices. Verify the cleaning of food contact motors, chain drives, walls; Zone 3) for each piece of production equipment after allergen use. Do not verify allergens using ATP, equipment and test all vehicular traffic and traffic ways into/out which is not a protein, unless the ATP is validated against specific of a post-lethality and/or exposed product production room. allergen ELISA (enzyme-linked immunosorbent assay) test kits. Additionally, the program is to include specific activities to be ATP indicates the presence of adenosine triphosphate or a com- conducted when there is an out-of-specification result, such as ponent of biological material, whereas an allergen is a protein. An an investigation by a multifunctional team, and implement cor- ATP assay will not be as specific as an ELISA test and further, it may rective and preventative actions. A corrective action is an activity (Continued on p. 20)

April/May 2014 19 Figure 1: A Thorough Approach to Managing Food Safety.

(Continued from p. 19) the best protection when they are not removed from not be as sensitive. ATP assays are cheaper, which is production area. An anteroom, located just prior en- part of their popularity. When testing for allergens, tering the RTE room, or an area immediately inside use a test kit that will identify the allergen in ques- the production will allow employees to don, doff, store tion. For example, barley, rye, and wheat cannot be their outer garments and shoes, and wash and sanitize distinguished with some of the commercial gluten hands and shoes. If there is no space for an anteroom, methods. However, there are some commercial another alternative is to allow an area for donning and methods that are not suitable for barley so verifica- doffing of shoes in exchange with captive footwear. tion using barley as a control is a critical component This practice will assist with Listeria ingress. of the verification. Similarly, some processing will destroy the test kit’s ability to recognize an allergen. Plants and Grounds The facility must employ adequate food safety con- Personal Hygiene trols and operating practices or implement an effec- Driving up to some plants, we have witnessed em- tive design to include separation of operations in ployees taking breaks outside wearing lab coats and hair nets; which cross-contact and contamination is likely to occur. Separa- walking into production rooms after going on the roof, loading tion can be achieved by location, time, partition, air flow, enclosed dock, trash compactors; and sitting on picnic tables and leaning systems, or other effective means. on or sitting in their cars with hair nets and ID tags. All of these Plants and Grounds Best Practices. All areas of the facility seemingly innocent activities reduce the effectiveness of a lab must be zoned in order to identify the level of risk associated with coat, hair net, bump helmet, gloves, and shoes. Having an em- each. Areas of the facility where there is no further heat-treatment phasis on protection against cross-contamination of food contact and where the food is exposed is considered to be RTE, High- surfaces starts with limiting non-production room exposure. Hygiene, or High-Risk areas. Other areas of the facility should Personal Hygiene Best Practices. Many biological contami- be designated as Non-RTE, Low-Hygiene or Low-Risk, Raw Area, nates, such as Listeria, are carried in to food manufacturing rooms, and General Plant. Each area should have unique procedures that a 288 - F o t li . com either via people or equipment. Outer garments, such as smocks allow (or not) ingress/egress, uniforms, shoe specifications, ve- w

or lab coats, and shoes must be restricted to the more sensitive hicular/wheeled traffic designations, and employee departmental © a g areas of the plant, such as ready-to-eat (RTE) rooms, and offer (Continued on p. 22)

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(Continued from p. 20) re-clean when failing tests are returned. Remember determinations. Procedures should be developed for to perform a baseline study on the ATP swabs for each performed activities when unique and risky events plant. Then, immediately after sanitation, the QA team such as construction and the removal or introduction can swab for indicator organisms. Both provide what of equipment occurs in a high-risk area. we described earlier as a verification that the sanitation standard operating procedures are working Sanitary Operations as intended. Additionally, full equipment disassem- The proposed cGMPs will require that cleaning and blies and inspections (to include swabbing) must be sanitizing of utensils and equipment be conducted conducted on a routine basis (start with quarterly and in a manner that protects against cross-contact readjust as the swabs indicate) for equipment used in and contamination of food, food contact surfaces, support of food manufacturing and starting in the or food-packaging materials, as well as non-food high-risk areas. contact surfaces. Additionally, it would require that all food-contact surfaces, including utensils and Training food-contact surfaces of equipment, be cleaned as FDA analysis of recalls has indicated that ineffective frequently as necessary to protect against cross-contact and con- employee training was a root cause of 24 percent of cGMP-related tamination of food. primary recalls in the 2008 to 2009. As a result, proposed provi- Sanitary Operations Best Practices. A post-sanitation in- sions will require that supervisors and workers are appropriately spection is needed where equipment used for the manufacture trained and possess the necessary knowledge and expertise in food of food is visually inspected for cleanliness and then swabbed. hygiene, food protection, employee health, and personal hygiene Swabbing may be either for ATP (conducted after cleaning) or for to produce safe food products. Specifically, each person who is en- indicator microorganisms such as aerobic plate count, coliforms, gaged in food manufacturing, processing, packing, or holding (in- Enterobacteriaceae (after sanitation), or a combination of both. cluding temporary and seasonal personnel and supervisors) must The sanitation manager should be armed with the ATP swabs as receive training as appropriate to the person’s duties. Training a management tool to quickly assess cleaning and immediately must include: • The frequency of training, • The principles of food hygiene and food safety, • The importance of employee health and personal hygiene, and • Documentation with the date of the training, the type of training, and the person(s) trained. Training Best Practices. While there is a need for classroom training and presentations, in order to be truly effective, interac- tive training that is conducted as close to the jobsite as possible is ideal. When evaluating employees for understanding, practical exercises and direct observations is preferred over written tests. Short, frequent training bursts are also a good idea. For example, one plant conducts two four-minute training discussions daily on the plant floor from a list of topics, chosen at random, and documented. Also, while yearly training is important, the really best practice is to provide constant (hour-by-hour/day-by-day) encour- agement by on-the-floor management. Despite FSMA, companies should develop an approach to food safety by combining the efforts of Hazard Analysis and Critical Control Points, preventative controls, and GMPs into one entwined system (see Figure 1 on page 20) where each part works in concert with the others and the entirety is proven effective through scientific verification. So now again we ask will GMPs alone be enough to control the risk of cross-contamination in food manufacturing operations? What do you think? ■

Dr. Deibel is the director of microbiology (Food Safety Consulting) for Covance Laboratories, Nutritional Chemistry and Food Safety division. She has worked for over 20 years in the food microbiology field, specializing in food safety controls for pathogens. Reach her at virginia. [email protected]. Lombardo is the lead staff scientist (Food Safety and Microbiology) for Covance Laboratories, Nutritional Chemistry and Food Safety division. With over 20 years’ experience, he has held many key positions in the food manufacturing industry, including production, quality, and sanitation positions at factory and corporate levels. Reach him at

[email protected]. a 288 - F o t li . com w

References Furnished Upon Request © a g

22 FOOD QUALITY & SAFETY www.foodquality.com Nasco Whirl-Pak Division The Value of GMPsFood in Quality Achieving April/May 2014 Globally RecognizedFQ1404 Certification An upstate N.Y. juice and sauce processor accounts how it incorporated GMPs in its certification to SQF Level 2 | By Heather Angus-Lee

s this year marks the 10th anniversary of the current Good Manufacturing Practices (cGMP) Coalition— formed by 60 food companies and food trade associ- FQ1404 ations working with the FDA to revise guidelines for Apreventing adulterated foods in production, packing, and holding facilities—it seems a good time to review the role GMPs play today in the industry. As well as serving as the basic principles guiding personnel, equipment, facilities, production, and process controls, GMPs relate directly to Hazard Analysis and Critical Control Point (HACCP) programs, and serve as building blocks for Global Food Safety Initiative (GFSI)-recognized food safety and quality standards. SQF, BRC, FSSC 2200, and other global standard schemes are growing in importance as retail customers demand certification from their food suppliers. GMPs also play an increasingly vital role as the Food Safety Modernization Act (FSMA) emphasizes requirements for a food safety plan that are similar to what is needed for a HACCP plan. Giovanni Food Company knows all about HACCP plans and globally recognized food safety standard certification. The Syr- acuse, N.Y.-based company makes and sells salsas, spaghetti sauces, and juices to retailers as well as to the food service industry. Giovanni incorporates GMPs as fundamental prerequisites to their HACCP programs, including the juice HACCP program that is FDA-mandated. In turn, their HACCP programs tie into the SQF Level 2 certification that Giovanni received in 2013. A couple of years ago, Giovanni underwent a Cook and Thurber audit through NSF International, an audit that “doesn’t have the same recognition within the industry as SQF,” says Alan Patapow, quality manager at Giovanni. “So when it came time to renew our audit, we thought SQF would be more advantageous

nni F oo d G i ova (Continued on p. 24)

April/May 2014 23 The Value of GMPs in Achieving Globally Recognized Certification

(Continued from p. 23) to us.” They stayed with NSF for the SQF audits; NSF also oversees Quality Assurance International (QAI), the auditor of Giovanni’s organic certification and soon-to-be gluten-free certification. “SQF seemed more suitable to us than other GFSI-recognized food safety standards,” says Patapow. “BRC is a lot more involved, and we didn’t feel we needed it all.” A lot of BRC deals with marketing of goods in Europe and while Giovanni Food exports to Israel, Asia, and Canada, they don’t do much business in Europe. Unlike the BRC standard, SQF requires a full-time, onsite standard practitioner employed at the company before, during, and after audits. Patapow is the SQF practitioner at Giovanni; he underwent training at a NSF workshop prior to taking up his role in 2012. Patapow explains that there are modules within the SQF code that are either general—such as Module 2 that emphasizes food safety through traceability, recall, validation, verification, and management commitment—as well as modules more specific to Giovanni’s business, such as SQF Module 11 that has stipulations Giovanni uses a flat-screen TV that constantly features information about HACCP, SQF Level 2, as well as allergen management, handwashing, and other GMPs. around GMPs for personnel hygiene and welfare, building construction, equipment, and pest control. “SQF basically mimics the HACCP program for food safety and risk assessment,” says Budd thought TV would be a good way to make sure that critical data is, literally, in the face of his employees “instead of just standing in front of them talking at meetings,” he says. So the com- GMPs relate directly to HACCP pany mounted a large, flat-screen TV in the lunchroom on which programs, and serve as building information constantly scrolls about HACCP, SQF Level 2, as well blocks for GFSI-recognized food as allergen management, handwashing, and other GMPs, even photos such as right and wrong label placements on Giovanni safety and quality standards. products. “The information includes explanations,” says Budd. » “If you don’t explain the ‘why,’ it’s meaningless—you don’t get the Patapow, quoting part of SQF Module 2.4.3: “‘A food safety plan cooperation from employees.” must be prepared in accordance with steps identified with HACCP Patapow says “the TV approach certainly has bolstered our guidelines’…” He also notes the similarity of that alignment with training and awareness for our food safety and quality programs,” HACCP with that found in FSMA requirements. including helping workers prepare for “pertinent information for The SQF process “took us a little longer than we anticipated,” when the auditor came in.” Indeed, the SQF auditor from NSF told says Patapow, who spent about 18 months working on the cer- Patapow that she was “quite satisfied by the interviews conducted tification project with a quality assurance assistant. “We had to with employees.” get practitioner training out of the way, then develop the pro- Giovanni uses ERP software built for the food industry, gram. To help us out, we brought in a SQF consultant for several with functionality that includes automated traceability and days to conduct a pre-audit. Based on those recommendations, recall processes. “Our processes were very manual and time we made the changes needed to our facility and processes, and consuming before we started using JustFoodERP. Now it’s completed the final audit for Level 2 certification in September easier to show processes for food safety and quality, and 2013.” Giovanni demonstrated their exceptional food safety we’ve noticed large, rapid increases in the ways we can do the and quality control practices during the two-day facility audit traceability study and mock recall required in our various audits,” by NSF. says Patapow. Process changes were the biggest adjustments for plant Giovanni also uses quality holds within the ERP system with workers transitioning into SQF, says Tim Budd, plant manager, plans to expand the quality management functionality, says Vir- Giovanni. “GMPs and food safety were already top priority here,” ginia Shields, production and systems analyst. he notes, but there were changes to the scheduled processes for SQF Level 2 certification “affords us the opportunity to work the products and more formalized monitoring of CCPs for the var- with new retailers as we continue to look for ways to grow our ious HACCP plans. Working with Cornell University Cooperative business,” says Louis DeMent, CEO, Giovanni. “This certifica- Extension, processes were established that incorporated these tion exemplifies our continued commitment to providing safe, critical factors into HACCP programs to achieve not only food high-quality products to the marketplace.” The company intends, safety, but desired product quality and shelf stability. within the next couple of years, to begin working towards SQF Patapow says, “Our QA team would go out and do monitoring Level 3 certification, the highest level that includes more focus on training with plant employees, walk the facility and observe these quality, such as quality control points. ■ activities, and conduct mock SQF interviews to determine their Angus-Lee, a long-time business and trade journalist, now writes for IndustryBuilt. Reach

understanding of some of these changes.” her at [email protected]. nni F oo d G i ova

24 FOOD QUALITY & SAFETY www.foodquality.com Safety & SanitationHygiene

Zoning In on Environmental Sanitation Pro grams How to best ensure control of environmental parameters via a thorough preventative maintenance sanitation program by Charles Giambrone, MS © blu e d sign - F o t li a . com

n my career, advising food plants on being a bonafide psychrotroph gram pos- with mandated verification and valida- the priority to control the environ- itive, soil borne opportunist. While being tion of the sanitation processes inherent mental parameters increasingly has a gram negative pathogen, Salmonella in the operation. Preventive controls in- become paramount for processors. species have exhibited a marked tolerance clude an EM program to verify pathogen IEnvironmental Sanitation and EM (Envi- for dry environs persisting in niches with control effectiveness which includes not ronmental Monitoring) has become a key- lower moisture levels than Listerial species only food contact but environmental stone in a plant’s internal EM programs require. While not precluding the spore- zones. In addition, the revision of Good as well as with the Global Food Safety forming opportunistic pathogens like B. Manufacturing Practices, or GMPs, to in- Initiative (GFSI) and federal regulations. cereus, or C. perfrigens, the other group of corporate allergen cross-contact controls In my previous articles “Hygiene Moni- microbes that post persistent issues to a via preventative procedures is critical and toring Strategies that Hit the Mark (April/ plant’s environment impacting food qual- directly involves a facility’s environmental May 2013) and “Be Ready to Beat Listeria” ity are the fungal species. Since most result sanitation program. (April/May 2008), while food contact sur- in quality concerns rather than food safety The current focus by FSMA on ready- faces are a high priority, the environmental concerns, these opportunistic environmen- to-eat (RTE) produce products, the fresh niches/zones have increasingly had a pro- tal contaminants can profoundly impact cut, and commodity RTE produce prod- found impact and role on a facility’s food shelf life and form biofilm alliances with a ucts is that they must rely on sanitation safety-sanitation hygiene programs. variety of bacterial pathogens. While some controls both on food contact and envi- There are a multitude of studies that environmental niches are similar between rons of a plant or packing house in order to have demonstrated the ability of patho- vegetative pathogens and spoilage fungi, control pathogens and spoilage microbes gens like L. monocytogens and Salmonella some are distinct for each group. Below is (to enhance shelf life). The cantaloupe spp. to not only survive but flourish in a both a discussion of these environmental and other produce pathogen outbreaks multitude of problematic environmental niches and their control measures. underscore the need for environmental niches inherent in a wide range of food sanitation as a critical preventive control. processing plants. While both types of Regulatory, GFSI, Product Type The USDA FSIS 9 CFR Part 430 (2003 pathogens survive via their vegetative Perspectives onwards) program emphasizes Lm control state, not relying on spores for survival, The Food Safety Modernization Act in RTE meat and poultry products. Alter- both have their own modes for survival, (FSMA) cornerstone is prevention akin natives 2 and especially 3 rely on sanita- persistence and biofilm formation. to the proactive preventative philosophy tion measures and mandated validation As is well documented, Listerial spe- of Hazard Analysis and Critical Control and verification to demonstrate pathogen cies will persist and flourish in moist en- Points (HACCP). FSMA has expanded control of high-risk RTE products. vironments, and will out compete other prevention to include HACCP principles The GFSI programs, and specifically species in temperatures below 40 degrees to implement preventive controls. One of BRC and SQF, emphasize the mandatory Fahrenheit (less than 4 degrees Celsius) the key segments is sanitation controls (Continued on p. 26)

April/May 2014 25 Safety & Sanitation Hygiene

(Continued from p. 25) ing equipment and environment, storage adjacent to production lines that could development of environmental sanita- area, staff amenities, and toilet facilities create an actual physical, chemical (in- tion and validation programs. Not only do shall be documented and implemented.” cludes allergens), or microbial cross- clauses 4.4, 4.7, and 4.10 deal with issues In addition, Air Quality (11.5.7) pertaining contamination of a product on a line. and parameters involving environmental to compressed air hygiene is also empha- • Air conveying equipment—includes sanitation, namely Building Fabric, Main- sized by SQF. HVAC units and their condensate tenance, and Filters & Sieves, but clause Both BRC (Fundamental Clause 5.2) pans, air hoses used for processing 4.ll on Housekeeping & Hygiene is one of and SQF (2.8.2) clearly emphasize the equipment, or drying of equipment or BRC’s Fundamental Clauses. 4.11.1 clearly high importance of allergen management, for packaging equipment. These are states that “documented cleaning proce- which includes proper environmental verified and validated using both sur- dures shall be in place and maintained for sanitation procedures and programs to face swabs for soil and indicators and the building, plant, and all equipment.” prevent cross-contact onto a processing air sampling for airborne microbes. Also, 4.11.2 focuses on the cleaning and line. This becomes problematic for dry • Cleaning equipment, which includes disinfection procedures and frequencies sanitation processes where wet sanitation floor scrubbers (tank reservoirs, shall be validated. Furthermore, in the methods are limited based on processing squeegees, and brushes especially) BRC appendices, the emphasis of RTE line and facility engineering design. SQF, and condensate pads. Also refuse bins environmental sanitation is very clear in BRC, and other GFSI programs separate and containers. the Guideline on Defining Production Risk high-risk processes (perishable RTEs) • Control panels in close proximity to Zones by delineation of High Care (Appen- versus low-risk processes (raw or baked processing lines or mezzanines. dice 2.2) and High Risk (Appendice 2.3) in shelf stable). • Non-food carts. open product areas. “High-care” areas are Zone 4 areas can and do include practices inclusive of environment to min- The Environmental Zones ceilings, overheads, walls, and flooring imize pathogen contamination of chilled/ In high-risk operations, both the fre- that do not directly impact processing frozen RTE products with a high standard. quency and level of sanitation procedures, equipment or lines. However, the lack of High-care product examples include and standards are, of course, far more a proper environmental sanitation pro- smoked fish, fresh prepared meals and stringent than in low-risk product process- cedure at the appropriate frequency will salads, and uncooked garnishes on RTEs. ing. However, we can categorize high- or definitely cascade microbial and allergen This is inclusive of both FDA and USDA low-risk regardless of product type for this (chemical) contaminants to Zone 3 and RTE products. “High-risk” open areas also discussion. So let’s first focus on Zone 3 the products Zones 1 and 2. Some exam- involve RTE fully cooked products that items near the food contact zone. ples are included below, most of which are are susceptible to cross-contamination While there is no prescribed frequency either weekly or monthly frequency based by Listerial spp. High-risk areas are “de- for Zone 3 areas, based upon the prox- on traffic flows/usage. signed to a high standard of hygiene where imity to the process lines, below are Daily Zone 4 Areas: bathrooms, cafeteria practices relating to...environment aim to suggested frequencies for your Preventa- and break rooms, and offices. prevent contamination by pathogenic mi- tive Maintenance Environmental Sanita- Weekly Zone 4 Areas: receiving docks, croorganisms. High-risk product examples tion schedule. dry storage areas, hallways, and mainte- consist of fully cooked meats, meals, and Zone 3 Daily Sanitation Frequencies: nance shops. dairy products. • Flooring, drains, walls, and covings Monthly/Seasonal Zone 4 Areas: dry SQF deals with environmental sanita- adjacent to equipment that is floor or packaging storage, intake vents, over- tion control in a comparable manner. Mod- table mounted. heads in nonproduction areas, and load- ule 2 under Food Safety Fundamentals (a • Processing line catch trays or bins ing docks, which can be weekly if shared Mandatory module in both Levels 2 and that are used to capture soil or scraps with receiving or if they are high volume. 3) makes its clear the property, buildings, viewed as food waste not being repro- A plant/facility’s design flaws both re- and equipment shall be constructed, de- cessed into product. garding product flow and traffic patterns signed, and maintained to facilitate the • Sanitizer mats/troughs, walk-through strongly dictates the issues, frequencies, hygienic production…of safe food. Both for boot scrubbers, food transport carts, and degree of environmental sanitation Preprocessing of Plant products (i.e. pro- plastic RTE product pallets. required in your environmental sanitation duce packing houses) in Module 10 and for • Mezzanine or elevated platforms that program. The facility’s design blemishes food processing plants in Module 11, there cross exposed processing equipment/ or weaknesses will strongly dictate your is focus on the construction and control of lines. risk assessment for each and every site in product handling and storage areas. Mod- • Hand sink areas (sink, soap, and towel both Zones 3 and 4 in your plant. For ex- ule 11.2 discusses materials of construction dispensers) in the production facility. ample, a well-designed kettle deck mez- and design for all environmental surfaces Zone 3 Weekly Sanitation Frequencies: zanine with accessible surfaces, frames, and has a specific section (11.2.13.1) on • Cooler, floorings adjacent to the pro- and overheads will both speed up sanita- Cleaning and Sanitation which includes cess modes. tion efficiencies, and based upon proper “The methods and responsibility for the • Overheads, ceilings, covings, walls, design (i.e. 45 degree frame angles versus cleaning of the food handling & process- and hoses that are in the general area (Continued on p. 28)

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(Continued from p. 26) tion is performed on ensure to help control en- 90 degree), decrease sanitation frequen- vironmental surfaces, the vironmental microbes. cies of environmental Zones 3 and 4. By SSOP needs to include a A functional definition lowering the risk at each environmental sanitization/disinfection of fogging is the aerosol- site you also are able to decrease the Veri- step with a compatible ization or particles where fication-Validation frequencies and proce- biocide. When the bio- over 80 percent are under dures as well. cide will not be rinsed 20 micrometers in diam- Both improper plant design in terms of off, compatibility of the eter. This creates a dry structural issues inherent in high- to mod- biocides’ chemistry must mist that dries almost in- erate-risk production areas and poor traf- be determined with the stantly. Prior to fogging, fic floor design/practices can contribute surfaces being sanitized. dry vacuuming or use to high risk for pathogens. For brevity, I’ll For example, if one has of dusting attachments ti ve E q ui pme nt discuss the aforementioned. Salmonella galvanized steel and alu- must first be undertaken I nn ova for dry environs and Listeria for moist envi- minum structures and For areas that are either inaccessible for to remove as much dust rons. Both can survive either in senescent you will be applying an wet sanitation or for dry environments, and soil as is physically fogging of biocides can help control vegetative or biofilm forms. acid based quaternary environmental microbes. possible prior to fogging. Salmonella can persist in a sene- ammonium (QAC) or per- Fogging of any type of scent vegetative state in relatively dry oxyacetic acid (PAA), you either have to biocides should be done where the room conditions occurring in a baking or a rinse it off or chose a neutral based QAC to can be confined or is feasible from a cu- peanut butter processor. So there are avoid corrosion. bic meter/footage standpoint. In essence numerous niches where it can survive. Application of wet biocides, espe- if the room’s ceiling height is 20 feet high This dictates the Zone 3 or Zone 4 EM san- cially for aqueous environmental, is de- and the room is the size of a football field, itation frequencies. pendent upon the target microbes. If they foggers cannot handle the cubic area. Fog- Examples include air lines, ducts, as- are sporeformers like B. cereus or fungi, ging mandates very strict safety protocols pirators, and dry vacuums. Other areas a QAC or liquid PAA is not the preferred insuring personnel are not in the room include eroded or compromised walls, biocide to eliminate these sporeformers. being fogged, requiring automated timing coving, insulation, overheads, convey- Rather a foaming version of PAA sanitizer devices and a time period of 60 minutes ors, elevator buckets, fork lifts, and pallet is preferred for all environmental surfaces. to two hours prior to reentry into a fogged trucks, cat walks, employees, cleaning Foaming PAA penetrates sporecoats and room. The application of fogged biocides tools, and maintenance tools. Also insects, provides enhanced residence time of the includes coolers and HVAC units or cooling rodents, and birds are carriers. biocide on the target surfaces and attached units in a cooling or freezer spiral. Fogged Listerial niches are created and selec- microbes. As stated above, if one is apply- biocides penetrate deep into a HVAC unit tively promoted by moisture and refriger- ing foaming PAA to soft metals on a nor- and sanitize those environs in a HVAC ated temperatures. This includes drains, mal set frequency, after a 30 to 60 minute system that are inaccessible for wet san- walls, covings, and hoses, gaskets, and residence time, the foamed PAA should be itation. Again, QAC/liquid PAA sanitizers O rings, along with unsealed structural rinsed off to avoid corrosion issues. can be effective if vegetative microbes are tubing or railings. All these compromised If you’re applying foaming PAA or the primary contaminants, while activated areas promote biofilm formation, which a foaming QAC sanitizers to drains, one can chlorine dioxide is preferred if sporeform- primary survival mode for environmental inject foamed sanitizer deep into trough, ers, like fungi or bacilli, are an environ- Listeria. Also improperly maintained sani- square, or circular drains including deep mental contaminant issue. If the sanitizer tation items, such as squeegees, footbaths, into the drain pipes. Also, when one ap- applied in the fogging mode is above the floor scrubber compo- plies QAC above 600 mil- approved food contact level then either all nents, condensation ap- ligram/liter per U.S. EPA food contact surfaces must be draped with pliances, etc., all can be label instructions, QAC plastic or rinsed thoroughly post fogging. Listeria inoculators. typically foams. That is However, sometimes an approved food why it’s utilized quite contact level of a fogged biocide like chlo- What’s in Your successfully in wet en- rine dioxide is sufficient, which eliminates Toolbox? vironments with proper the draping or rinsing of contact surfaces. In plants where wet drainage for door foam- Similar provisions need to be applied in cleaning of environmen- ing units to control Liste- an organic plant which requires sanitizers tal areas is both permissi- ria cross-contamination. approved as food contact sanitizers like ble and feasible, typical For those environ- certified liquid PAA or chlorine dioxide foam cleaners can be em- mental areas that are sanitizers available on the market. ■

ployed to clean environ- either inaccessible for ti ve E q ui pme nt mental surfaces. wet sanitation or for dry Giambrone is the vice president of technical services for Foaming PAA penetrates sporecoats Rochester Midland Corp.’s Food Safety division. He can be I nn ova Obviously when a and provides enhanced residence time environments, fogging of reached at [email protected]. prescribed wet sanita- of the biocide on target surfaces. biocides is a good mea- References Furnished Upon Request

28 FOOD QUALITY & SAFETY www.foodquality.com SAFETY & SANITATION Hygiene Raising the Standards of Hygienic Design for Processing Equipment The best cleaning system and most effective sanitizers cannot work properly if the design of the equipment does not follow basic hygienic principles By F. Tracy Schonrock © Toh K he ng G u a n - fo t o li . com

n the more than 40 years that I have inspected processing contamination also reduce such engineering problems as stress facilities and evaluated equipment design, I have found and crevice corrosion. Proper selection of materials of construc- an alarming number of equipment buyers and users that tion can reduce the potential for pitting of surfaces and galvanic equate the mere shininess of stainless steel as hygienic. interactions between dissimilar materials. Ease of disassembly for IStainless steel and other noncorrosive materials are, of course, (Continued on p. 30) important but the hygienic aspects of the equipment come from the details of the design. The basics of hygienic design are universal. It does not matter if you are processing dairy products, meat products, fruits, bakery products, or any other of the myriad of Protect your equipment and food products manufactured, the basics are the same. There may be differences in the details of materials or design features of con- keep your product pure. struction to accommodate a specific product or process, but the overall principles won’t change. As the saying goes, “The devil is in the details.” And the devil is the potential for contamination and loss of customer trust. quickTRON™ 07 RH There are a number of false perceptions about hygienic design Metal Detector and hygienic processing, such as the following. High hygienic metal detector for inspection There are levels of cleanliness. This is false. Clean is like of material in gravity free-fall applications. being pregnant; you either are or you’re not. There are, however, levels of soiling that you have to consider as acceptable for your particular process. These may vary from the very slightly soiled, moderately soiled, heavily soiled, to call out the hazmat crew. Hygienic design costs more. In the short run this is often true for some equipment. The materials of construction, often stainless HF Series steel, and the design details increase the initial, up-front cost. The Drawer Magnet long-term benefits of hygienic design over the life of the equipment Designed for separation in enclosed will reduce the overall operating costs. Often run times can be ex- flow lines and equipped with the tended, cleaning times shortened, cleaning chemical and water most powerful magnetic cartridge. usage reduced, maintenance costs lowered, and a longer life of the equipment can reduce return on investment. When you purchase less expensive non-hygienically designed equipment, the old ad- age “You get what you pay for” applies. Hygienic design is bad, complicated engineering. This is false. Hygienic design when applied from the very first steps of the design process is very good engineering. Hygienic features such +1 316-284-2020 buntingmagnetics.com as the removal of cracks and crevices to eliminate microbiological

April/May 2014 29 SAFETY & SANITATION Hygiene

(Continued from p. 29) 3-A Sanitary Standards’ involvement di- drain, drop, diffuse, or be drawn into the sanitation purposes is also ease of disas- rectly benefits the equipment fabricator product or onto surfaces that come into sembly for maintenance personnel, reduc- and the processor through the routine contact with product surfaces of packing downtime. acceptance of the equipment during reg- aging materials.” This definition directs We can modify existing designs in- ulatory inspections. the designer to consider all of those ar- house to be just as hygienic. In theory Today there are 68 3-A Sanitary Stan- eas of the equipment, which may be over this is true. Any design can be retrofitted dards and nine 3-A Accepted Practices. exposed product or open containers in fill- to eliminate the hygienic hazard issues. These documents cover a wide range of ing machines. It’s just a matter of time and money—lots the basic equipment used in most food The possibility for successful CIP of time and lots of money. The end cost of processing applications such as pumps, cleaning has to begin with the basic con- retrofitting is routinely significantly higher valves, sensors, heat exchangers, and cept designs as the equipment develops. than the purchase of new hygienically de- vessels. There are also standards for Every aspect of the design has to be evalu- signed equipment. specialized equipment for packaging, ated through the filter of CIP. The concept I don’t have anyone on staff that can drying, conveying products, etc. A partic- of the elimination of creaks and crevices truly evaluate a new purchase for sani- ular piece of equipment can demonstrate must be paramount. Any surface that is tary design. You’re in luck; the lion’s share that it has been evaluated by a third-party exposed to product must also be exposed of this has been done for you and is already evaluation and conforms to the hygienic to the cleaning and sanitizing solutions. available in the market place. standard requirements with the display of Not only exposed, but with sufficient the 3-A symbol. tolerances so that the cleaning solutions Standards in Place Over decades of collaboration and can freely circulate to dislodge and flush The hygienic standards writing organiza- recognition among the key stakeholders, away product residues. This leads the de- tion for dairy and food processing equip- the 3-A brand has attained wide recogni- signer to consider the proper placement ment is 3-A Sanitary Standards Inc. Its tion in the marketplace for food process- of gaskets and seals, the elimination of Standards and Accepted Practices are rec- ing equipment and special stature built dead ends where product residues can- ognized internationally. During the 1920s, on a strong foundation of the following not be removed during either process- the need for more stringent and uniform elements: trust, independence, and ing or cleaning, selection of a cleanable standards for dairy processing equipment expertise. surface texture, selection of materials became evident as the U.S. economy and that will withstand the chemicals and consumers entered the modern era. Rep- From the Design Up temperatures encountered during pro- resentatives of three interest groups— Food processors continuously look for cessing, cleaning and sanitization, and processors, regulatory sanitarians, and the holy grail of increased production, the inclusion of a proper slope and drain- equipment fabricators—saw the need for reduced cleaning time, and reduction of age of the equipment. This list of design cooperative action and introduced the costs. These are the areas in which hy- considerations increases as the sophis- first industry standards for equipment. gienic standards excel. It is desirable to be tication of the equipment increases. In- These standards became known as 3-A able to clean the equipment fully assem- clusion of spray cleaning devices opens standards for the three interest groups bled or with a minimum of disassembly, up design consideration for flow pat- that forged a common commitment to im- and subsequent reassembly; clean-in- terns, component placement to eliminate proving equipment design and sanitation. place or CIP as it is known in the indus- the possibility of shadow areas that Unlike other types of standards, 3-A Sani- try. This is not as simple as just attaching will not be properly treated. The attach- tary Standards relate to the cleanability of a spray device and a solution return line ment of appurtenances, such as valves dairy equipment. to the piece of equipment. Even as basic and sensors and personal access ports, In 1944, the U.S. Public Health Ser- a piece of equipment as a storage vessel raise more issues that the designer must vice offered full cooperation with the 3-A with an agitator requires specific engi- consider to assure cleanability, as well as program, which marked the beginning neering to effectively and safely clean the inspectability of the interior product of a program to provide uniform equip- fully assembled. Saying that CIP is possi- contact surfaces. No matter how efficient ment standards for the protection of pub- ble in a sales brochure does not necessar- a cleaning system is designed, the surfaces lic health. This integral participation of ily make it so. have to be inspected periodically. Inspect- the regulatory sector of the industry has Hygienic design starts with the very ability and access to the product contact become important as the food industry first lines drawn on a blueprint. The first surfaces is a must for assuring continuing complies with the requirements of the task of the designer is to determine what is cleaning success. Food Safety Modernization Act (FSMA). to be considered a product contact surface If you want to gain the most efficiency Under FSMA, the industry must be able to in order to assure that the design will fully as possible for production and cleaning demonstrate and document that they have protect the product from contamination. while increasing your operational cost, implemented the necessary steps to assure In hygienic design, a product contact sur- equipment boasting hygienic design stan- the wholesomeness of the products they face is defined as, “All surfaces which are dards can be a significant benefit.■ produce and the effectiveness of the clean- exposed to the product and from which Schonrock is a consultant and member of the 3A SSI Board ing and sanitation programs they employ. splashed product, liquids, or soil may of Directors. Reach him at [email protected].

30 FOOD QUALITY & SAFETY www.foodquality.com SAFETY & SANITATION Hygiene

When is it Time to Clean for Facility Decon- tamination? A study was conducted to gain a better understanding as to how clean a facility needs to be for a gaseous chlorine dioxide fumigation to be successful By Paul Lorcheim

Simulated organic load with six common food products and dust covering the biological indicators. Cl orD i S ys So luti o ns

n association with sterilizing and dis- acid), ozone, and hydrogen peroxide by re- crobial life, including spores. Spore form- infecting agents for food processing, moving 5 electrons opposed to only 2 when ing bacteria is amongst the most difficult the term bioburden is exactly that—a reacting with organic loads. Through this bacteria to kill; therefore this is the reason burden. Materials which provide process, gaseous CD’s reacting power is why it is used to validate sterilization. In Ia safe-haven for unwanted microbes by sustained for longer periods of time, which almost all cases of facility decontamina- covering and protecting them from decon- in turn, makes it more penetrable. tion, validity is gauged by the results of taminating agents are considered biobur- To understand “how clean is clean,” BIs or through the practice of swabbing. dens. Whether that bioburden is dirt, varieties of bioburdens and an indicator The advantage of BIs is that they contain food remnants, or any other organic load, to denote the penetrability of gaseous CD a known amount of organisms and those facilities have always been encumbered needed to be established. In regard to the organisms are in the spore form, which is by the essential, timely, and overall costly former, powdered milk, powdered baby the most difficult to kill. Generally, a BI task of its removal. Failure to physically formula, protein powder, flour, sugar, used to validate the success of a gaseous rid focused areas of all bioburden prior grains, and general dust/dirt were selected decontamination consists of a spore form- to the administration of the decontami- to simulate various bioburdens. This se- ing bacterium inoculated onto a stainless nating agent will in all likelihood result in lection was based upon food material steel disc or paper strip. Otherwise known inadequate kill. Due to this constraint, a commonly found in food processing fa- as a carrier, the disc or strip is enveloped in study was performed to gain a better un- cilities that require physical removal prior either Tyvek or glassine. The population, derstanding as to “how clean is clean.” to any form of decontamination. Whereas or amount of individual spores that are The goal was to determine how clean a the latter, a Tyvek-wrapped biological in- inoculated onto the carrier, is critical in facility needs to be for a gaseous chlorine dicator (BI), was selected to validate CD’s determining the logarithmic reduction ca- dioxide (CD) fumigation to be successful. penetrability through the aforementioned pabilities of that decontaminating agent. Gaseous CD is an ideal sterilizer. CD organic loads while still demonstrating a The logarithmic reduction of microor- is a true gas under ambient pressure and 6-log sporicidal reduction. ganisms by a decontaminating agent di- temperature and, when paired with its rectly reflects its efficacy. Because BIs have small molecular size, can be easily distrib- Validation a fixed population of microbes, they are an uted into an area to reach inside nooks and Unlike antiseptics, germicides, sanitizers, ideal tool to gauge this effectiveness. In re- crannies smaller than a micron. Its unique or disinfectants, a sterilizer is the only an- gard to gaseous CD, it is easily capable of molecular composition can be advanta- timicrobial pesticide that is considered by yielding a 6-log reduction of all forms of geous over those of bleach (hypochlorous the U.S.-EPA to eliminate all forms of mi- (Continued on p. 32)

April/May 2014 31 SAFETY & SANITATION Hygiene Cl orD i S ys So luti o ns Cl orD i S ys So luti o ns Example 1. Example 2. Organic loading with protein powder. Organic loading with various grains.

(Continued from p. 31) trolled conditions, they indicate the base- seen in food processing facilities. A set microbial life. To better understand this, line for which to gauge penetration of gas- of three Geobacillus stearothermophilus a 1-log reduction reduces all microbes by eous CD through the organic loads used in populated Tyvek-wrapped BIs consisting 10 times or 90 percent, whereas a 2-log this study. of 1.3 x 106 spores were assigned to each of reduction reduces all microbes by 100 Upon loading and executing the these six varieties. Each set was dusted so times or 99 percent. Therefore, a 6-log re- standard decontamination cycle on the that the Tyvek side of each BI was covered duction reduces all microbes by 1,000,000 Minidox-M generator, “Pre-condition” not only in its entirety, but also generously times or eliminates 99.9999 percent of all is initiated. During this step, the cham- enough for the identifying text to no longer microbes. Of course the population of or- ber’s relative humidity (RH) is raised by a be visible. ganisms associated with the BI must be humidifier inside the chamber. Through A 17.0 foot3 polypropylene isolator sufficient enough to support its efficacy. continuous monitoring, via an RH/tem- was utilized as the chamber to conduct For example, a decontaminating agent perature probe, the Minidox-M effectively this study. The isolator was equipped cannot demonstrate a 6-log reduction by regulates humidification until the prede- with various ports and cables for the Min- inactivating a BI with a population of less termined RH set point is reached. Once sat- idox-M generator and a carbon scrubber than 1,000,000 microbes. isfied, the generator initiates “Condition,” to interface with. Each covered set of three For this study, a population of 1.3x106 whereby the 65 percent RH residing inside BIs and a single set of three uncovered Geobacillus stearothermophilus spores the chamber is maintained and resupplied control BIs were placed inside the isolator inoculated onto paper strips wrapped in accordingly for 30 minutes. “Condition” is along with a small fan, a humidifier, and Tyvek were utilized. Tyvek is comprised of critical in promoting the susceptibility of a probe that monitored both RH and tem- flash spun non-directional polyethylene, bacterial spores to the gaseous CD. perature. The RH/temperature probe was which makes it not only durable, but Subsequent to “Condition”, the Min- connected to an interfacing cable inside also porous. These microscopic pores are idox-M initiates the CD gas injection step the isolator, which was then connected too minute for not only the indicator mi- referred to as “Charge.” CD gas is injected, outside to the generator. Similarly, the crobes residing inside the Tyvek to escape, sampled, and monitored in real-time until humidifier was connected to a relay that but also for any microbes and particulate it reaches its predetermined concentration sat just outside of the isolator, which was outside of the Tyvek to penetrate. Gaseous of 1 milligram/liter (mg/L). Upon reaching then connected to the generator for hu- CD molecules and water vapor however, its set point, injection ceases and “Expo- midification control. The small fan was are easily able to maneuver in and out of sure” begins. Just as this step’s name im- plugged into an outlet located inside the these pores. plies, all contents located inside the cham- isolator and energized to speed up gas As a result of this combination, this ber are exposed to the recently injected CD distribution. A 0.375-inch CD gas injec- BI is capable of not only validating a 6-log gas. During “Exposure,” humidity and CD tion tube and a 0.25- inch gas sample tube sporicidal reduction, but can also be used concentration are continuously monitored were then connected on opposite sides of as a tool in determining CD’s penetrability in real-time and respectively supplied to the isolator to avert any false sample read- through organic loads. the chamber when either falls under their ings during the cycle. set points. This phase persists until 720 The decontamination cycle was Gaseous CD Decontamination ppm-hrs (parts per million-hours) has ac- started and the Minidox-M successfully For this study, a ClorDiSys Minidox-M cumulated, or 120 minutes of 1 mg/L con- raised the chamber’s RH to 65 percent, gaseous CD generator was utilized to au- tact time has lapsed. whereby both the chamber and its con- tomate the five step decontamination pro- tents were held at 65 percent RH for 30 cess in an effort to reduce human error. Procedure minutes. At the completion of this dwell Earlier studies have confirmed that Powdered milk, powdered baby formula, period, the single set of three control BIs the following cycle ensures a 6-log reduc- protein powder, flour, sugar, grain, and were extracted via BI ports on the isolator tion of spore forming bacteria. Though general dust/dirt were selected to sim- to avoid any contact with CD. These BIs these studies were conducted under con- ulate organic loads that are commonly were immediately incubated in modified

32 FOOD QUALITY & SAFETY www.foodquality.com soybean casein digest broth for seven days of three BIs covered with powdered milk, Findings from this study did not pro- at 57 degrees Celsius. powdered baby formula, protein powder, vide a specific answer regarding how much Following “Condition,” the Minidox-M flour, sugar, and grain, of that same lot, bioburden needs to be removed prior to stepped into “Charge” and injected CD gas indicated no growth. The set of three BIs administering a decontaminating agent, until its concentration reached 1.0 mg/L. covered with the general dust/dirt also in- or “how clean is clean.” The results do in- Upon satisfying its set point, “Exposure” dicated no growth. This confirms that gas- dicate visually however that gaseous CD is began and the CD gas was held inside the eous CD was able to penetrate all seven of powerful enough to penetrate bioburden to chamber for exactly 720 ppm-hrs. At the the organic loads and still obtain a 6-log some degree and still achieve a 6-log spori- completion of “Exposure” the carbon scrub- sporicidal reduction. cidal reduction. See photo Examples 1 and ber was energized and any gas inside the 2 for an indication of how soiled a surface chamber was evacuated within a matter of Conclusion can be, with a select choice of bioburden, a few minutes. Once concentrations were re- Bioburdens such as those tested have a and still be successfully decontaminated duced to 0.0 mg/L, the Minidox-M prompted notorious nature of providing refuge and with gaseous CD utilizing the standard for cycle completion, at which time the 18 sustenance for unwanted microbes. In a cycle dosage. Consequently, the physical experimental BIs were retrieved. The six perfect world, any bioburden formed in removal of significant bioburden remains sets of three BIs were then immediately a facility would be immediately and com- a necessity while complete removal does incubated, just as the control BIs removed pletely removed. However that is never not. Thus, even though the impractical- earlier, in modified soybean casein digest the case, as it is nearly impossible for fa- ity of cleaning every crack, crevasse, and broth for seven days at 57 degrees Celsius. cilities to sufficiently clean every crack cranny still persists, gaseous CD can be an and crevasse on every wall, ceiling, and ideal choice for combating bacteria living Results floor. As such, there is always some degree amongst overlooked bioburden. ■ After the seventh day of incubation, the of buildup of bioburden somewhere in a Lorcheim, the director of operations for ClorDiSys Solu- set of three control BIs resulted in posi- facility. This buildup of bioburden creates tions, Inc., is a licensed professional engineer responsible tive growth as expected; indicating that a more difficult location to clean, as most for directing the commercialization and manufacturing of various decontamination and sterilization equipment for the the specific lot of BIs used for this study decontamination methods would be im- pharmaceutical, life science, health care, and food indus- were viable prior to any testing. Each set paired by the existence of bioburden. tries. Reach him at [email protected]. the food supply chain that would impact food safety and public health. At U.S. Pharmacopeial Convention (USP), we try to confine food integrity to the food ingredient level, and that means TestingIngredients we develop tools to help manufacturers, formulators, regulators, and other parties to assert food ingredient quality (identity, purity, strength, as well as absence of contaminants). The analogy is that our Food Chemicals Codex (FCC) can be seen as a dictionary for food trade. The FCC is not a specialty dictionary, but it aims to establish a common language and to facilitate communication among the many players in this field. Just as an example, even though a manufacturer of potato chips may have a very nuanced understanding of what “salt” means and how important granularity and crystal flow are from a technological production perspective, his/her understanding of the identity and purity of this ingredient should not differ from how “salt” is described in the FCC. The logic seems simple, when applied to describe ingredients such as those consisting of well-defined simple salts or single molecules, but the more complex the chemical composition of a food ingredient, the more difficult it is to determine its integrity. Food integrity is intrinsic to food safety in the FCC context. Being able to determine the safety of food and its ingredients at the basic level depends on the knowledge of its composition. One can only make a safety assessment of those components that are known. Hence, if and when an unknown ingredient is introduced in the food supply chain, it is impossible to establish whether the ingre- The Daunting Task of dient and any food produced with it is safe or not, until the presence of such an un- Establishing Food Integrity known ingredient becomes transparent. Unfortunately, in some cases this happens Along with verifying ingredient identity, the FCC Identity only when consumers experience a nega- Standards include tests for substances that should not be tive health impact. present in certain complex ingredients | By Markus Lipp, PhD The Challenge The development and application of identity and purity standards for food in- s much as “food integrity” a global perspective that includes food gredients is no easy task. Vitamin A is an has been part of nearly every production, distribution, and everything example that illustrates what goes into discussion related to the food in between (procurement, processing, deciding which test methods to use. It is supply chain, the term is in it- packaging, testing, etc.); on the other an ingredient used both as a dietary sup- Aself unclear to many stakeholders in this hand, it could simply mean the absence plement and in food formulations. Often,

arena. On one hand, food integrity implies of any fraudulent, unknown ingredient in the term “vitamin A” is used to refer to a US P

34 FOOD QUALITY & SAFETY www.foodquality.com group of different compounds (including retinol, retinoic acid, present in a sample. While this method is capable of measuring and several carotenoids, of which beta-carotene is arguably the all water in certain ingredients, the method requires complete dis- best known). All these various compounds have their own features solution of the sample, and that is not always possible to achieve. regarding stability, bioavailability, isomerism, and other import- Besides, just as with the loss on drying method, there is a question ant parameters. An analyst will have to tailor his/her analytical of availability of water for microbiological growth, which may not methods to the specific compound (e.g., provitamin A or beta-car- be adequately addressed with this method (e.g. certain salt crys- otene to adequately assess its purity and identity). Right there, the tals have crystallization water that is not freely available, but part definition of what compound exactly is meant by “vitamin A” will of the crystal structure, which would not be liberated using the trigger a decision about the types of tests necessary to accurately loss on drying method, but it would be liberated and measured as establish authenticity. Questions that feed into the very definition water in the Karl Fischer titration). of the somewhat loose term “vitamin A” are: Which are the criteria So which water do we want to measure? we want to capture with vitamin A? For which purpose are we test- All these methods are valid and widely used, but they may ing? The analyst would measure vitamin A by international units return different results if applied to the same sample. So, it is im- if the purpose was related to biological activity and bioavailabil- portant to agree upfront on what is the most scientifically-sound ity rather than a milligram/milliliter concentration, which is how way to measure this one residue. Which method is considered the food ingredients are usually measured. most appropriate often involves a discussion of regulatory require- Moisture, or water content, as simple as it sounds, is an im- ments, scientific considerations, ease of use, cost, speed of analy- portant residue to consider and a good example to demonstrate sis, and availability of instruments. the challenges of setting standards. Moisture is important because it often impacts the chemical stability of an ingredient (e.g. too Identity Standards much water and your ingredient may disintegrate); and, more The examples above illustrate how complex it is to choose even importantly, it determines the risk of microbiological spoilage. If one type of test to help establish food ingredient integrity. When only very little water is available to microorganisms, this can be complex ingredients come into play, especially those derived measured through determining water activity, which will predict from biological sources, a multicomponent system needs to be microbiological growth and spoilage. Keeping water activity low considered. A food ingredient monograph many times suffices to is a control mechanism to minimize risks from potentially harmful establish the integrity of a particular ingredient and the FCC con- microorganisms. (Continued on p. 36) But how do you measure water? It seems relatively trivial at first sight (water is water, it is H2O, right?), but measuring it in food ingredients may be complex. There are many methods for measuring water, but the way we use them can vary depending if FOOD SAFE we want to measure water activity or water content. Due to a vari- MAINTENANCE ety of technical reasons, it is not easy to measure water activity in SOLUTIONS a reproducible and robust manner and test results depend even on the kind of equipment used. Water content can be measured by a simple method called loss on drying, which is performed as simply as it sounds. An amount of the given sample is weighed, put in an oven at a certain temperature (typically slightly above the boiling point of water) for several hours, weighed again, and the process is repeated until two subsequent weightings do not indicate further weight loss. The assumption is that all evaporated material is water. This method is not specific because any weight loss is counted as water, even if it is due to flavors, fragrances, and other volatile substances that evaporate. In this specific method, all weight losses LOWER MAINTENANCE COSTS, INCREASE are counted as water. The challenge with certain heat-sensitive EFFICIENCY, AND PREVENT RECALLS. ingredients, such as milk powder, is that a chemical reaction LPS® understands the challenges you face. And we’re dedicated takes place during the heating process and volatile substances to helping you lower costs while preventing contamination, are liberated, of which one is actually water, but not water that recalls, and downtime. has been freely available in the sample, and, therefore, available for microbiological growth. It is water that became available after From our comprehensive line of maintenance chemicals to our exclusive a chemical reaction took place. These types of heat-sensitive sam- DETEX™ technology, LPS® has your ples may actually continue to lose weight as the process continues food safe solution. and the measurement needs to be terminated after a fixed amount of time that is set by convention (e.g. after two hours in the oven). Learn more about the Another method is a chemical reaction based on a Karl revolutionary DETEX™ offering only available through LPS®. Fischer titration, which determines all water content that is www.lpslabs.com TESTING Ingredients

(Continued from p. 35) legitimate products. However, tains more than 1,200 of them. However, the specifications cannot be so different approaches may be necessary for broad that an unreasonable ingredients that are closer to raw agricul- number of illegitimate in- tural products, such as pomegranate juice gredients suddenly become and other fruit juice concentrates. FCC-compliant. Some of the components of pomegranate juice include sugars, polyphenols, ac- Risk-Based Assessment ids, minerals, and water that present nat- Sometimes, asserting food ural variability that is influenced by the integrity requires sound judg- species of pomegranate as well as environment paired with appropriate mental conditions (region where the fruit tests and reference materials. is grown, climate, harvest, and processing Skim milk powder is a widely conditions, etc.). used complex food ingredient that Recognizing the exhaustive challenge consists of variable compounds (pro- US P in developing monographs for complex teins as a group, which in itself can be food ingredients, USP last year proposed divided in numerous fractions, sugars, under which conditions the load of testing the creation of FCC Identity Standards, non-protein nitrogen, fats and lipid-like may be reduced. which will, more than other FCC Mono- substances, water, etc.) and could also An aspect of risk-based assessment graphs, not only establish ingredient iden- for skim milk powder, for example, takes tity, but also include tests for substances into account that nitrogen-rich adulterants that should not be present in certain com- Previous test methods other than melamine may present a new plex ingredients (in the case of pomegran- to measure the protein risk. Previous test methods to measure the ate juice, artificial sugars or compounds protein content of skim milk powder have that are not usually found in pomegranate, content of skim milk proved not sufficient to keep adulterators but may be found in other fruit juices with powder have proved at bay. To help offset the limitations of this which pomegranate juice has historically not sufficient to keep test method, USP is coordinating the de- been adulterated). velopment of additional tests that are less FCC Identity Standards are intended adulterators at bay. vulnerable to the presence of adulterants, as a trigger to perform additional tests as well as methods for the non-targeted to make sure users are not unknowingly detection of adulterants and the develop- purchasing an adulterated product. If an present natural variability dependent on ment of reference materials, or physical ingredient fails the specifications in an the species, animal’s lactation period, samples, adulterated with melamine. FCC Identity Standard, it could as well be animal’s nutrition, as well as processing Establishing food integrity should due to natural variability of that particular conditions—heat treatment for instance. be a task undertaken by all players in an ingredient. However, results that show a Food analysis is an intrinsic and es- increasingly global food supply chain. particular material is compositionally very sential part of helping to ensure the in- Therefore, USP is taking steps to bring different from the majority of the products tegrity of food ingredients, but it is not together representatives from industry, in that category should raise concerns, or sufficient by itself. It is impossible to test regulatory agencies, consumer groups, at least questions. an ingredient to safety, and good supply and other standard-setting bodies to dis- It is important to emphasize that the chain management practices are essential cuss proposed FCC standards and encour- FCC is limited to providing a routine mea- components complementing testing. Yet, age collaboration. sure to aid in the establishment of food better tools to help establishing integrity One of these steps is access to the FCC integrity for ingredients that are commer- for skim milk powder, for example, and Forum (www.usp.org/fcc/fccForum.html), cially available. It’s not the goal of an FCC therefore asserting that it is as safe an in- where FCC monographs and identity Identity Standard for pomegranate juice, gredient as possible is crucial, as instances standards are open for stakeholder feed- for example, to represent the composition of adulteration, such as the one in China in back. In-person workshops on selected of pomegranate juice that is obtained from 2008, have put public health at risk. topics of interest are also available (www. non-commercial processes or sources of For ingredients such as skim milk usp.org/meetings-courses/workshops). the fruits themselves that are not intended powder, USP, in conjunction with indus- In November 2013, USP held a workshop for the production of pomegranate juice as try and academy experts that comprise on food and dietary supplements adul- a commercial food ingredient. the Skim Milk Powder Expert Panel, is teration and in November 2014, USP The intent is to reflect products that are developing a risk-based testing structure, is scheduled to hold a workshop focused used for commercial formulations, and not which is designed to provide guidance to on food contamination. ■ all pomegranate juice is commercially vi- analysts to decide under which conditions able. Part of the challenge for USP is that more tests might be necessary to gain con- Dr. Lipp is the senior director for food ingredients at USP. our standards are not meant to exclude fidence in the ingredient’s integrity and Reach him at [email protected].

36 FOOD QUALITY & SAFETY www.foodquality.com Go by the Book

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FCC343A_2014-03

38 G manufacturers have untilAugust 5, 2014 claims across thefoodindustry. Food last August that defines gluten-free label confidence, theFDA issuedafinalrule are anecessity. To helpassure customer gluten sensitivity orceliac disease,they cans who sufferfrom gluten intolerance, the latest fad;forthe18millionAmeri- billion by2016. dustry, which isexpected to grow to $15.6 ten-free market isnowa$10.5 billionin- menu items. Theonce smallU.S. glu other quality controls tools | compliance with FDA labeling Third-party certification can help companies demonstrate Gluten-Free? Are Your Products TESTING

But gluten-free products aren’t just FOOD

rants haverants addedgluten-free numerous andrestau brands where: Food retailers carry luten-free products are every Ingredients QUALITY & SAF ETY

By - - - regulations through testing and Jaclyn tains thefollowing details. gluten.(ppm) In addition, the rule con- permillion parts and nomore than20 rye, barley, or crossbreeds of these grains gluten,” or“nogluten” contain nowheat, “gluten-free,” gluten,” “without “free of the newrequirements. to bring their labels into compliance with • • • taining that are grains refined butstill Foods withingredients ofgluten-con- wheat) may notusetheclaim. gluten-containing (such as spelt grain Foods withingredients ofany whole, may usetheclaim. (like raw carrots or grapefruit juice) Foods inherently containing nogluten The rulerequires thatfoodslabeled Bowen facturing facilities, food label reviews, ing periodic inspections offoodmanu activities to enforce thefinalrule,includ range ofroutine post-market monitoring the rule. claims onmenuitems shouldalsofollow beverages). Restaurants using gluten-free Bureau (such asdistilledspiritsandmalt or the Alcohol and Tobacco Tax and Trade (such as meats, poultry, and egg products) apply to foodsregulated bytheUSDA etary supplements. It doesnotcurrently lated foodsandbeverages, including di- • • As ofAugust 5, FDA may useitsfull The finalrule applies to allFDA-regu the claim. gluten containing may grains not use gluten as a result of cross-contact with Foods ppmormore thatcontain 20 ppm gluten. long asthefoodcontains lessthan20 wheat starch) may usetheclaim as fined to remove the gluten (such as containing thathave grains beenre - Foods with ingredients of gluten- may notusetheclaim. contain gluten (such aswheat flour) www.foodquality.com - - -

© Fotimmz - Fotolia.com follow-up on consumer and industry complaints, and gluten Nothing escapes analyses of food samples. If a manufacturer uses a gluten-free claim on its packaging, Romer Labs. but fails to meet the requirements of the FDA rule, the product may be deemed misbranded. FDA regulatory action against misbranded products includes monetary penalties, no-sale orders, product seizures, and/or injunctions. It’s important for companies at every stage of the supply chain—manufacturers, packers, distributors, and retailers—to have processes in place to assure they are not dealing in misbranded products, including components and packaging.

What Companies Need to Do Before Deadline Before the final rule goes into effect on August 5, manufacturers must bring package labels, suppliers, and testing and quality systems into compliance. Retailers and specifiers have the same timeframe to establish purchasing and labeling expectations and disseminate them to their suppliers so the products they carry on store shelves comply with the FDA gluten-free final rule. Considerations for Manufacturers and Suppliers. The FDA gluten-free definition of 20 ppm or less is clear, but the pathway to accomplish this has not been defined. Testing alone is not sufficient to ensure gluten-free compliance. Investing in a quality management system that evaluates supplier assurance, good manufacturing practices (GMPs), and ongoing training is the best option to demonstrate that products reproducibly meet the requirements of the rule. In order to credibly support gluten-free claims, companies must control for gluten at every step in the supply chain. Suppliers must be able to produce, deliver, and document consistently gluten-free ingredients. This could involve assessments of processes and sub-ingredients, supplier certification, a supplier internal monitoring program, pre-shipment verification testing, and certificates of authenticity. However, even the best supplier program in the world can be quickly undermined if the manufacturer doesn’t follow GMPs and cross-contaminates or comingles gluten-free ingredients with others. Gluten-free products, ingredients, and processes must be segregated. This includes separate ingredient storage, product warehousing, distribution, preparation, and processing as well as personnel, equipment, and smallwares dedicated only to gluten-free processing. All employees, including supervisors, should receive training that covers ingredients and processing as well as compliance with internal label controls and verification procedures. Em- ployees who handle, formulate, process, and package gluten- free products must receive specific training on awareness and proper procedures.

Considerations for Retailers and Specifiers. Like manu- FIND OUT MORE ABOUT ROMER LABS facturers and suppliers, retailers and specifiers must also have TESTING SOLUTIONS AND CONTACT: confidence in their sources of gluten-free products. A structured Romer Labs® Inc. and well-managed supplier qualification program and approval 130 Sandy Drive Newark, DE 19713, USA process is essential. Verification through supplier certification or OI¿ce: 307100 internal verification testing is a good approach. Separation and Email: [email protected] www.romerlabs.com hygiene rules also apply in-store, especially for products that are exposed in merchandising. (Continued on p. 40) TESTING Ingredients

(Continued from p. 39) through annual manufacturing facility in- the FDA uses. The kit and recommended Third-Party Gluten-Free spections and product testing. test procedures, which NSF follows, Certification NSF analyzes product labels for com- are performance tested by the AOAC Re- The final rule does not specifically require pliance, examines a company’s processes search Institute. manufacturers to test for gluten in their for shipping, receiving, storing, and Global Food Safety Initiative (GFSI) ingredients or finished foods labeled handling raw ingredients and finished standards (such as SQF and BRC) do not gluten-free. However, manufacturers are products, and verifies procedures for san- have specific requirements for gluten, but responsible for ensuring that any glu- itation, quality control, testing, record re- do require training, supply chain assur- ten-free claim it makes is truthful and tention, and product recalls. ance, and GMPs. Companies with these complies with FDA regulations. Quality During the onsite audit, an accredited procedures in place can combine GFSI and control tools to accomplish this include inspector collects random product sam- gluten-free audits, and companies already conducting in-house gluten testing of in- ples, verifies the company conducts ap- certified to a GFSI standard will likely al- gredients and/or finished foods, employ- propriate raw ingredient testing or sources ready meet some of the requirements for ing a third-party laboratory to conduct raw ingredients from a certified gluten- gluten-free certification. Likewise, train- gluten testing, requesting certificates of ing, supply chain assurance, and GMPs gluten analysis from ingredient suppli- are also core pillars of not only gluten-free ers, and participating in a third-party glu- compliance, but also of the Food Safety ten-free certification program. Modernization Act. “Third-party gluten-free certification shows that companies have the right Gluten-Free Labeling Globally processes in place (including a quality Regulations for gluten-free labeling don’t management system, good manufactur- stop at the U.S. border. Companies looking practices, supply chain assurance, ing to export need to be aware of other and employee training) to prevent gluten regions’ requirements. In general, the 20 contamination and to consistently stay ppm requirement of the FDA rule is consis- below 20 ppm gluten,” says Jim Bail, di- tent with international standards, includ- rector of food safety consulting at NSF ing Codex Alimentarius Commission’s International. revised Codex Standard for Foods for Spe- NSF International has seen a big in- cial Dietary Use for Persons Intolerant to crease in inquiries from companies about Verification through Gluten, European Commission Regulation gluten-free certification since the FDA supplier certification or No 41/2009 that concerns the composition rule was announced. To earn certifica- internal verification test- and labeling of foodstuffs suitable for peo- tion under the NSF program, companies ple intolerant to gluten, and Health Cana- must have a gluten-free compliance plan ing is a good approach. da’s Food and Drug Regulations. and undergo onsite inspections of their A difference is that the Codex Stan- production and handling facilities. Certi- dard, European Commission Regulation, fication also requires ongoing compliance free supplier, and confirms that the man- Australia New Zealand Food Standards ufacturer and its suppliers and handlers Code, and Health Canada include oats as have procedures to prevent contamination gluten-containing grains, whereas the U.S. Gluten-Free Popularity and comingling. final rule does not. NSF’s gluten-free certification pro- The Australia and New Zealand Food

gram is ISO/IEC Guide 65 accredited and Standards Code is more stringent and re- According to a 2013 gluten-free report from Mintel, the $10.5-billion gluten-free verifies that products contain 20 ppm or quires foods labeled “gluten free” to have food and beverage industry has grown less of gluten in ISO/IEC 17025 accredited no detectable gluten. The code doesn’t de- 44 percent from 2011 to 2013 as the rate labs. NSF microbiologists test food sam- fine “detectable,” but current technology of celiac disease diagnoses and inter- ples using scientifically valid methods can test accurately to 3 ppm. est in gluten-free foods increase. Some for replicable and reliable results. This in- Some areas allow more than one level 24 percent of consumers currently eat, cludes a step-by-step, systemic approach of “gluten-free” claim. In Europe, foods or have someone in their household who and duplicate methods and controls for containing less than 100 ppm can bear the eats, gluten-free foods. Perceptions of test validity. term “very low gluten” and in Australia gluten-free foods have moved from be- Scientists use an analytical bio- and New Zealand, food containing less ing bland, boring substitutes to everyday chemistry assay with antibodies and a than 200 ppm of gluten can be labeled items that appeal to those with and with- ■ out a gluten allergy. In fact, three quar- spectrometer to detect and quantify the “low gluten.” ters (75 percent) of consumers who do presence of gluten. Specifically, NSF uses a sandwich-based enzyme-linked Bowen is general manager of NSF International Agriculture not have celiac disease or sensitivity to and QAI (Quality Assurance International). Reach her at gluten eat these foods because they “be- immunosorbent assay, or ELISA, kit from 858-792-3531.

lieve they are healthier.” —FQ&S R-Biopharm, one of the same methods References Furnished Upon Request © Thoma s F ra n co is - o t li a . com

F senting 26 countries,senting 26 39states, andsome program. More than 435 students repre- Science inFood (MS) Safetygraduate professional working inindustry orgov erage student isamid-level, mid-career program since itslaunch “Our in2002. av employers have227 beenaccepted into the to food safety and quality are springing up on theInternet A growing number of graduate degree programs devoted in Cyberspace Cultivating New Credentials By By Linda Anywhere. That’show lexible. Adaptable. Anytime. its landmark online Master of its landmarkonlineMaster of State University (MSU) touts L. Leake, MS Q uality Michigan Education - - fessionals come to ouronlineprogram to DVM, PhD, director oftheprogram. “Pro ernment regulation,” says Julie Funk, 30 credits. food safetyproject ofrequired ispart In lieu of a thesis, a three-credit applied consists of 10 three-credit courses. ties andcurrent employment.” out having to leave theirhomecommuni- advance theirfoodsafetyknowledge with The MSU Food MS Safety program

- -

Kalro says. isatremendous benefit “This with authority onfoodsafetytopics,” degreeMaster’s empowers meto speak and Licensed Dietitioncredentials. “My a compliment to herRegistered Dietition completed theMSU program as in2007 plemental Nutrition Assistance Program, USDA Food andNutrition Service Sup Dr. Funk says. maximum offive for years completion,” average ofthree years, butwe doallowa students complete the degree within an ber ofcredits taken persemester. “Most two to three years, depending on the num or U.S. Food Laws &Regulations. Safety; andachoice ofeither International Research Methods; Applied Project inFood borne DiseaseEpidemiology; Food Safety Pathogens; Food SafetyToxicology; Food ment; Evolution andEcology ofFoodborne agement programs, according to James the implementation of food safety man- ing foodproduction andprocessing, and forcement oflaws andregulations affect includingment, thedevelopment anden- safety offood,water, and the environ- interestedothers inthemicrobiological signed for public health professionals and Management; andLeadership Studies. mental Science; Plant Science andPest and PublicHealth; Education; Environ - Food Safety; Biosecurity, Bioregulations, available degree forthisMS including changingety’s needsandexpectations. and non-formaleducation to meetsoci- leadership, andsocialchange, orformal agriculture, foodsafetyandregulation, human health andnutrition,sustainable to develop newknowledge andskillsin geared toward adult who learners desire nic Institute andState University (VT) is program offered by Virginia Polytech- of Agricultural andLifeSciences (ALS) Established theOnlineMaster in2006, Virginia Tech www.online.foodsafety.msu.edu F I serve.” to my career, my work, andthe consumers to Food SafetyandProfessional Develop or more information: Usha Kalro, a nutritionistwiththe The degree canbecompleted within The VT MS FoodThe VTMS Safetyoptionisde- Six degree concentration areas are The required courses are Introduction April/May 2014 (Continued onp.42) 41 - - - - - Quality Education

(Continued from p. 41) Onsite Curricula Anderson, II, VT’s director of distance and graduate education. The following are some on-campus gradu- “Thus far, food safety students have ate degree programs for food safety and represented seven states, but the welcome quality offered in North America. mat is always out for international enroll- §§Cornell University, Ithaca, N.Y.: ees,” says Jennifer Carr, graduate program https://confluence.cornell.edu/display/ coordinator for the online MS ALS. FOODSAFETY/Cornell+University+ Christy Brennan completed the VT MS Food+Safety+Programs § Food Safety program in 2009. She says her §Illinois Institute of Technology, Chicago, degree was instrumental in helping her Ill.: http://admissions.iit.edu/graduate/ programs/school-applied-technology transition mid-career from a corporate §§Kansas State University, Manhattan, quality control/food safety auditor posi- Kan.: http://foodsci.k-state.edu tion to her current role as rapid response (online MS Food Science program team/manufactured foods specialist with also offered) the Virginia Department of Agriculture & §§McGill University, Quebec, Ontario, Consumer Services in Richmond, Va. Canada: www.mcgill.ca/macdonald/ “It is very important for a food industry programs/fsqp professional to stay updated on the sweep- §§North Dakota State University, Fargo, ing changes in food safety,” Brennan em- N.D.: www.ag.ndsu.edu/foodsafety phasizes. “Everyone may know their small —L.L.

piece of the puzzle, but it is important to © Lju p co S m okov s ki - Foto l i a .co understand how that translates to the big picture of the entire food chain. I believe as traditional students to get an advanced viewed and published in Food Research that continuing education is instrumental degree, Dr. Bisbee notes. International. in understanding the entirety of today’s Students typically take one course Having the ability to develop a project complex food safety systems that impact per semester (Fall, Spring, Summer) for directly related to her work was invaluable, public health.” nine semesters and then work on a spe- Finstad emphasizes. “Not only was the For more information: www.cals.vt.edu/online cial food safety or quality problem. “The subject matter of interest to me personally, special problem is one of the student’s but it was also of interest to Tyson Foods,” University of Arkansas choosing and allows the student to set up she says, calling it “a win-win situation for Established in 2006 at the University of and conduct an experiment and evaluate the graduate student and the company.” Arkansas, the MS in Agricultural, Food the results using the all the skills learned For more information: and Life Sciences (MS AFLS) Food Safety in the MS AFLS Food Safety program,” www.globalcampus.uark.edu/Distance_ Education/Graduate_Degree_Programs/ is a 30-hour, Web-based, non-thesis MS Dr. Bisbee says. MS_Food_Safety/index.html degree designed specifically for people al- Anyone in the U.S. who meets admis- ready in a career track who are interested sions requirements can enroll. Interna- University of Illinois in an advanced degree in the area of food tional students who live outside the U.S. Since 2010, the University of Illinois (U of safety and quality. are not being admitted at this time. I) Department of Food Science and Human “This degree is designed to prepare Suzanne Finstad, director of food Nutrition has offered an online non-thesis students for higher positions in the food safety & regulatory compliance for Tyson MS Food Science degree. industry,” says Diana Bisbee, EdD, pro- Foods, Inc., Springdale, Ark., completed The U of I online MS program is unique gram coordinator. “The program provides the program in three and half years and in that lectures are delivered live and a subject matter core of courses in food mi- graduated in December 2009. scheduled during the evening, providing crobiology, sanitation, food processing, Her employer offers an educational students the ability to interact with in- epidemiology, food law, Hazard Analysis assistance program that provides 75 per- structors and classmates in real time and and Critical Control Points (HACCP) appli- cent tuition reimbursement in exchange outside of regular business hours. cations, human diseases, and other quality for good grades. “I’m proud to work for a To earn the degree, students must control areas facing the food industry. In company that fully supports and encour- complete 32 hours of coursework and then addition, the structure of the courses re- ages advanced educational opportunities successfully pass an oral examination. sults in the sharing of food safety knowl- such as this,” Finstad says. “Without the Courses offered include Food Chem- edge across food companies by address- support of Tyson Foods, it’s extremely istry; Applied Statistical Methods; Food ing complex issues and ever increasing unlikely that I would’ve found the time to Processing Engineering; Food Processing academic rigor.” pursue a graduate degree.” I and II; Package Engineering; Food and In a recent survey, students in the pro- Finstad’s graduate project was a lit- Industrial Microbiology; Fermented and gram said that if it were not for this pro erature review related to Salmonella and Distilled Beverages; Chemistry of Lipids gram, they would never go back to school broiler processing. Her paper was peer-re- in Foods; and Issues in Food Safety. Ad-

42 FOOD QUALITY & SAFETY www.foodquality.com ditionally, Food Science Advanced Topics China and South Asia. We will be gradu- degree, I am also enthusiastically looking are available. ating our first group of students this May.” forward to pursuing a career in food safety Melissa Jones, senior manager of sup- Fangliang Carpenter, technical service and regulation in the near future.” ply optimization at Diageo, Plainfield, Ill., administrator at Oberto Brands in Seattle, For more information: http://msag.wsu.edu/ food-science ■ a major premium drinks business, com- Wash., is one of those MS Ag FSM students pleted her Bachelor of Science degree at who expects to graduate in May 2014. Leake, a 2006 graduate of the MSU online MS Food the U of I campus in Champaign-Urbana, “The management courses are defi- Safety program, is a food safety consultant, auditor, and award-winning journalist based in Wilmington, N.C. Reach and then completed the online MS Food nitely helping me directly right now in my her at [email protected]. Science degree in 2011. workplace,” Carpenter says. “My graduate “Both my BS and MS degrees have project focuses on writing a review article FOR BONUS CONTENT, click on this helped me in product development and ev- about jerky and meat snacks, which ties article under the April/May issue at erything else I do in my job,” she says. “The very closely with my current work respon- www.foodquality.com. MS degree is a great extension of what I sibilities. Empowered with my graduate learned as an undergraduate and I found the online format to be a great way to earn the degree while working full time.” For more information: http://fshn.illinois.edu/online

Washington State University The online MS in Agriculture: Food Sci- ence and Management (Ag FSM) was launched in 2013 to provide food industry professionals with management skills along with a strong science-based program emphasizing emerging trends in food science, sustainability, and global competitiveness, says Barbara Rasco, FREE Educational Event BSE, PhD, JD, director of the Ag FSM program. Hilton City Avenue in Philadelphia June 17-18, 2014 This recent distance learning degree is affiliated with The School of Food Sci- Food Safety Exchange is the perfect opportunity to hear ence, a unique fully integrated department between Washington State University and from standard owners, certifying bodies, and companies the University of Idaho. just like yours that have successfully implemented process “Our graduates will be agricultural improvement strategies – all in one place! and business leaders moving freely between labs and boardrooms, between factory floors and corporate offices, and Based on the most current GFSI benchmarking requirements, we are all proud to be part of this,” Dr. learn about the latest changes from Rasco boasts. • SQF • BRC • IFS • FSSC22000 Professionals in this MS program can select a project emphasis in dairy, microbiological, or chemical food safety, enology, Don’t miss this exciting event, where you can garner more aquatic foods, functional foods, food pro- information about your food safety program in two days cessing, or law. than any other forum! The MS Ag FSM is a 30-credit, non-thesis program open to students from around the globe. Like all the other online MS All Day Networking Area: Visit table-top exhibits and interact programs showcased in this article, all with leading experts on food safety standards and programs, students pay the same tuition regardless training opportunities, surviving audits, product inspection, of residency status. “We are building a virtual community hygienic equipment design and much more! for these students and others in agriculture graduate programs across campus,” Dr. Rasco mentions. “Most of our students Learn More & Register Now! are U.S. residents, along with some from www.fse-event.com

44 C Quality mouth. Theproduction andcontrol of ice cream feelgrittyorsmoothinthe to 55microns, whether foods, such as man tongue able to detect crystals down product looksandfeelsand,withthehu ular margarine isspreadable, howoily a tablish factors such aswhether apartic surface andinsulate subsequentproduct product would crystallize onthecooling wall. Without thisscraping action the scopic crystal seedsfrom theheattransfer chine continually scrapes tiny, micro As amixture iscooled inaSSHEthema- How It Works (SSHE) technology. ized byscraped surface heatexchanger these crystallized foodscanberevolution

a Crystallization Process a Crystallization FOOD How scraped surface heat exchanger technology can to optimize thequality of newand existing recipes control over thisprocess canes and qualityofmany foods. Good determining thecharacteristics rystallization in isimportant

Getting the Most from Temperature QUALITY benefit the crystallization of food products & SAF ETY By Tony Mathis - - - - -

stream ofproduct inthemachine and, surface ofa SSHE get warmed from the by itsblades. Theseedsscraped from the uct wall iscontinually being scraped away becauseheat transfer thefilmatprod tion throughout theprocess. ensuring uniformcooling and crystalliza- efficiencytransfer asthe product thickens, the SSHEmaintainsturbulence andheat comparison, theagitation provided by sure pumping systems In foroperation. efficiencytransfer and requires high-pres machine. This, inturn,reduces theheat and results inlessturbulence withinthe ity increases asthetemperature drops If using atubularheatexchanger, viscos uct just flowsthrough theheatexchanger. product prevents cooling andwarm prod process where athinlayer ofsolidified blockages inthemachine oranineffective from theheatexchanger, eitherleading to A SSHEprovides aconstant rate of

- - - - required, the pre-formed solution added to is running andcrystallization achieved as Oncemelt theprocess attheSSHEinlet. amount ofpreformed crystals into the tals canbeencouraged byadding acertain difficult tosolidify, theformationofcrys concentration. Ifaproduct isparticularly separating itoutinsomething like freeze is useful, for example, if forming ice and grow thesecrystals further. Thistechnique the SSHEwhere thecooling process will machine canbefedback into theinletof tion ofthecrystallized discharge from the with excellent mouthfeel. fine crystals results inasmoothproduct tals are produced. Thiscollection ofvery into large crystals, millionsofsmallcrys thangettingrather afewseedsgrowing product. Inmore recent times, aware- resulting characteristics ofaparticular the constituents ofarecipe influence the and timeforthecrystallization process, Along withthecontrol oftemperature Healthier Applications flexible production. justed to handledifferent rates flow for The refrigeration temperature canbead ture andto maximizeprocess capacity. control oftheproduct discharge tempera- for continuousis important and consistent Control oftherefrigerant sideoftheSSHE used onthejackets oftheheatexchangers. bon dioxide, orotherrefrigerants are often mixture to setwithsmallcrystal structure. the SSHE,thiscooling forces thecomplete time. Combinedwiththeagitation from to crystallize atapproximately thesame cooling, however, forces all ingredients liquid weeping from themixture. Rapid quence which cancause with separation too slow, these ingredients willset in se- at different temperatures. If cooling is contain multiple ingredients which set factor.also animportant Many mixtures non-plastic product, thecooling rate is which prevents theformationofsolid As well astheagitation withintheSSHE, Factoring Temperature of theSSHE. the mixcancome directly from theoutlet high-capacity production, ammonia, car If larger crystals are required, apor To enable rapid crystallization for www.foodquality.com - - - - -

Proces Diagram.

ness of health concerns relating to the pressure and high motor shaft torque. The use of trans-fatty acids and the amount production of low trans- and saturated-fat of saturated fatty acids in food has led to bakery filling creams, however, also re- a drive to remove or dramatically reduce quires care within the process such as dis- these in product recipes. Such changes in tributing gas in the mixture. These creams requirements have led to enhanced use tend to get too soft if gas is distributed into of palm oil fat and its fractions in recipes, the mixture at the end of the process with If our environmental swabs but these oils have slower crystallization a mixing unit. don’t find anything, there’s speeds than previously used alternatives. Having the right configuration of nothing to find. Puritan’s To handle this slower rate, the mixture SSHE means that the gas can be added EnviroMax® and ESK® Sampling is super-cooled to temperatures below at the crystallization stage to achieve Kits are best-in-class. The the temperature required to form a solid. ideal homogenization while protecting EnviroMax® swab is oversized Although below the temperature for so- the structure of the crystallized oils and and ideal for sampling large lidification, the crystals form slowly and creating the desired consistency of the surfaces. The ESK® swab is the product remains as a liquid for a short filling cream for its application. Shorten- perfect for hard-to-reach areas. time. This gives a choice of secondary pro- ings and margarines require rapid cooling With various tip and solution cessing to achieve the desired structure of to avoid separation of the mixture and, as options, there’s something right the final product. the crystals form, temperature and agita- for every application. You’ll know your surfaces are so clean even a If the mixture is allowed to stand in tion can influence the resulting product mother-in-law would approve. static conditions, crystals will continue to characteristics. SSHEs can be used across Learn more at bit.ly/EnviroMax grow in a rapid solidification phase and a all these applications and more but it is strong, solid mass will result. If, however, important to completely understand all the cooled mixture is moved to a secondary aspects of the process to get the highest processing unit which agitates the product product qualities. and adds shear to the mixture, the crystals A continuous crystallization process will be kept small and be prevented from in a SSHE not only maximizes production growing together into a solid mass, cre- capacity but also minimizes operator in- ating a more fluid result. A pin rotor ma- tervention and facilitates repeatable, con- chine can be used for this purpose and the sistent quality results. The quality of the amount of agitation applied during solidi- crystallization process largely depends fication can be varied to get the right crystal upon the time taken to lower the tempera- size, texture, and final product character- ture to the point crystallization occurs, istics required. as well as the amount of agitation of the crystals during formation. Faster cooling Fats and Sugars and more vigorous agitation generally SSHEs are widely used to crystallize prod- result in the desired smaller crystal sizes 207-876-3311 • puritanmedproducts.com ucts containing fats or sugars which react within the mixture, giving smooth end [email protected] differently in the process. Fondants, for product results. ■ example, crystallize very quickly. Bakery ISO 9001:2008 ISO 13485:2003 sandwich or cookie creams have firm, poor Mathis is a process technical manager for SPX Flow Tech- nology. His 30-year career has primarily focused on sanitary flowing properties and require a machine SSHE heat transfer applications. Reach him at tony.mathis@ which can handle the associated high spx.com. US MANUFACTURED

46 D Quality should besufficient space between the beled andintheir designated place. There and office areas, are tidy and things are la throughout thefacility, especially storage the standard. Make sure thatconditions of training andoverall commitment to dressing theobvious issuesshowsalack your implementationofthestandard. the auditor will bemore comfortable with five steps to prepare for your and audit, will putyour auditor Follow onalert. these misinterpretation ofcompliance criteria a lack oforganization, staff,and untrained trols the outcome of the audit. Ingeneral, perspective, itistheapplicant thatcon- pliant withastandard. From anauditor’s with evidence are thatoperations com- an accredited standard | Quick reminders to keep incheck whentrying to implement for an Audit Five Ways to Prepare

1. Sweat stuff. thesmall Not ad FOOD

ability to provide theauditor dits are largely basedonthe speak louderthanwords. Au uring anaudit, actionsoften A QUALITY uditing & SAF ETY

By Scott - - - weeks before theaudit, have astaffmeet bers arebers comfortable withtheirroles and before theaudit to make sure team mem- conduct trace exercises atleastoneweek and validation. Management needsto and thedifference between verification with terms such as“corrective action,” HACCP, plan.Key staffshould be familiar Analysis andCriticalControl Points, or related to theCCPidentified intheHazard ble for. thehazards Theymustunderstand the monitoring records theyare responsi- iar withtheirwritten job descriptionsand ing to prepare. Employees shouldbefamil of theaudit. with your audit team to increase therigor ing athird walk party through your facility two months prior. You might consider hav internal audit should be conducted at least and cleaning activities to take place. Your wall andstored material forpestcontrol E . 2. Work a team. as Zimmerman, M.Sc

At least three , CP-FS

- - - the standard. the standard. steps thathave beentaken to comply with standard/audit andexplainsomeofthe should speakwiththeauditor about the management Senior rious commitment. Adopting anaccredited standard isase- to the meeting, and meet with the auditor. someone in a senior role to be briefed prior is inthebestinterest ofthecompany for either theopening orclosing meeting. It management isnotavailable to attend ing(s). closingmeet attends openingand/or an auditor. the day before the audit will not impress your pestmanagement service to come in or“sometimes.”like try” “we Scheduling audit isbeing conducted. Don’t useterms auditor, orcorrect deviancieswhile the Don’t filloutdocumentationinfront ofthe proach to implementing the standard. recall andtraceability. be able to explainthe difference between the exercise asawhole. Staffshouldalso certification.com. certification.com. and aquaculturedseafood. Reachhimatinfo@seafood wild for requirements regulatory and standards tification ciates, LLC.HisprimaryfocusisGFSIbenchmarked cer Zimmerman isfounder/CEOofSafeQualitySeafoodAsso audit willgo more smoothly. the report isissued.Stay positive andthe cess. You canchallenge theauditor after ings, take itupthrough theappeals pro collect data.Ifyou disagree withthefind you andtheauditor. It’s the auditor’s job to ply. Anaudit isalearning experience for auditor if it’sobvious thatyou don’t com- her job. It’s disrespectful to challenge an closing meeting. He/she isjust doing his/ if you have nonconformances during the fensive. comply with thestandard. explain someof thesteps that have beentaken to 5. Your bestoffenseisnotbeingde- 4. Make sure seniormanagement 3. Donottake minute alast ap the auditor about the the auditor about the Senior management Senior management standard/audit and and standard/audit should speak with I have been on several audits where Do notbeoffendedbythe auditor www.foodquality.com ■ ------

NEW ProducTs

Temperature Profiling The SCORPION 2 LITE Temperature Profiling Package measures and monitors temperature levels in commercial ovens, cooling tunnels, freezers, and dryers. The package consists of a SCORPION 2 LITE Data Log- ger and a Temperature Interface that can measure 10 temperatures at user defined positions in a thermal process. Developed primarily for producers in the baked snack food industry, the system has demonstrated potential for application in a range of manufacturing environments that utilize a continuous conveyor process, such as meat processing, nut processing, and aluminum can Sorting Capability production. Reading Thermal, 610-678-5890, www. The potato strips Sort-to-Grade feature is now readingthermal.com. available for all belt-driven G6 optical sorters, including Manta, Optyx, and Tegra. This software-driven intelligence enables sorters Biphenyl Columns to grade by count, accepting or rejecting Kinetex Core-Shell Biphenyl HPLC/UHPLC col- each defective piece to control the quality of umns give researchers the ideal orthogonal output to a defined grade, as stated by the selectivity to traditional C18 phases. This new processor. With Sort-to-Grade capability, phase is suitable for a range of complex-mix- accept/reject decisions consider how po- ture analyses in clinical research and forensic tentially passing a particular defect, based toxicology and food and environmental test- on its size and color, will affect the overall ing. Kinetex Biphenyl is initially available in final product quality in comparison to the 2.6µm and 5µm with a 1.7µm option expected processor’s specifications. It objectively next. In addition to 100% aqueous stability sorts by count in real-time with 100% inspec- and enhanced polar basic selectivity, the tion. Key Technology, Inc., 509-529-2161, Kinetex 2.6 µm Biphenyl offers versatility for www.key.net. HPLC/UHPLC methods while the Kinetex 5 µm Temperature Data Biphenyl offers ideal HPLC performance at Logger low backpressures. Phenomenex Inc., 310- The T&D Food Core Tem- Enhanced Beverage Quality Program 212-0555, www.phenomenex.com. perature Data Logger The NSF program that provides testing features a water- and oil-proof design and and certification of packaged beverages, complies with HACCP regulations. A clear bottled water, packaged ice, and flavored LCD shows current temperatures, battery beverages to verify compliance with na- level, and more. With one push of a button, tional and global standards has updated the device records temperature, measure- its evaluation criteria. These are now more ment time, item, and makes a judgment re- risk-based and support GFSI standards, sult by checking whether the measurement FSMA requirements, and HACCP. NSF Inter- is within the preset upper/lower limits. The national is offering bundled audits so that data logger can automatically collect and when a GFSI audit is undertaken, the prod- send recorded data to a designated email uct certification requirements can be cov- address or an FTP server over a wireless ered during the same visit. An additional and LAN network. It can also be used in con- certification focusing on the environmental junction with T&D RTR-500 series loggers, stewardship of a bottler’s source water is which can measure and monitor ambient also an option. NSF International, 734- temperatures in both indoor and outdoor 769-8010, www.nsf.org. environments. CAS DataLoggers, Inc., 800- 956-4437, www.dataloggerinc.com. (Continued on p. 48)

April/May 2014 47 NEW PRODUCTS

(Continued from p. 47) Amantadine Detection The MaxSignal Amantadine ELISA Test Kit detects amantadine residues in meat (chicken, beef, and pork). The test kit, with Egg Defoamer detection limits of 0.25 ppb in meat, is based Apex Egg Defoam Plus is a fast-acting, non-silicone, on a competitive colorimetric ELISA assay. free-rinsing defoamer that can be used in both alkaline Amantadine residue present in the sample and acid cleaning operations. It’s clear and colorless, will compete for HRP-conjugated antibodies and doesn’t leave an objectionable odor. It is highly con- against amantadine, preventing the aman- centrated and extremely dilutable in water at 1:1000 up tadine-HRP from binding to the antibody to 1:5000. Defoamer is available in 55-gallon drums or attached to the well. The resulting color in- 275-gallon totes. Zep Inc., 877-428-9937, www.zep.com. tensity, after addition of the HRP substrate (TMB), has an inverse relationship with the concentration of amantadine residue in the sample. Bioo Scientific, 888-208-2246, www.biooscientific.com.

Rheometers Brookfield adds three new instruments into its touch-screen family of rheometers: the RST-CPS Cone Plate Rheometer, the RST-CC Coaxial Cylinder Rheometer, and the RST-SST Soft Solids Tester Rheometer. They operate in both controlled stress and controlled rate modes and can perform of the following tests: viscoelastic modulus, yield stress, viscosity versus shear rate profile, thixotropy calculation, creep behavior, recovery after flow, and temperature sensitivity. Every rheometer offers a wide torque range to handle a range of sample materials. The rugged design allows for use in R&D, working in the QC lab, or on the production floor. Brookfield Engineering, 800-628-8139, www.brookfieldengineering.com.

In Other Product News

Roka Bioscienc’s Atlas E. coli O157:H7 EG2 Detection Assay and Atlas STEC EG2 Combo Detection Assay receive AOAC Performance Tested Methods certification from AOAC-RI.

Invisible Sentinel’s Veriflow Listeria species assay receives AOAC Perfor- mance Tested Methods certification.

Agilent Technologies and CambTEK sign agreement to co-market CambTEK’s Rapid Extraction System automated sample preparation technology with an assortment of Agilent’s liquid phase separation, life science, and chemical analysis instruments and software.

Clariant’s Container Dri II desiccant Safety Training for Retail Industry products meet new specifications from the Federation of Cocoa Commerce for The Food Safety Training Solution provides the retail food sector a comprehensive set of train- protection of cocoa bean shipments ing tools to ensure food safety and maintain regulatory compliance. This is achieved by pro- in containers. viding best practices of instructional design and proven adult training methodology. Offered through UL EduNeering business line, key components of UL’s training solution can lead to Silliker Food Science Center, a Merieux building a robust culture around food safety. Components include preparing participants to sit NutriSciences company, now offers pro- for one of the ANSI Accredited Food Protection Manager Certification Exams and offering mod- cess authority services to support manu- ules specific to sections of the FDA Food Code. UL (Underwriters Laboratories), www.UL.com. facturers of acidified foods.

48 FOOD QUALITY & SAFETY www.foodquality.com Advertiser Directory

ADVERTISER PAGE ADVERTISER PAGE 3M 27 LPS Laboratories 35 AIG 3 Mettler Toledo 43 American Proficiency Institute 33 Nasco 23 AOCS 10 Nelson-Jameson 22 Bio-Rad Laboratories 7 Puritan Medical Products 45 Bunting Magnetics 29 Roka Bioscience 9 Cascades 51 Romer Labs 39 Eppendorf North America 2 Spartan Chemical 52 IAFP 11 U.S. Pharmacopeial Convention 37 Invisible Sentinel 4 Waters Corp. 21

Events

APRIL MAY 13-14 22-23 6-7 Supplier Food Safety Management HACCP for On Farm Operations Quality Control Workshop - GMP Rosemont, Ill. Salinas, Calif. Western Dairy Center, Utah State University Visit http://sites.usdairy.com/foodsafety/Pages/ Visit www.scsglobalservices.com/ Visit www.usu.edu/westcent. supplychain.aspx. haccp-for-on-farm-operations. 13-14 17-20 24-25 Advanced Sanitation Workshop asm2014 JIFSAN Annual Spring Symposium: Western Dairy Center, Utah State University Boston, Mass. “The Case of Avoiding RISK: Truth or Visit www.usu.edu/westcent. Visit http://gm.asm.org/. Consequences” Beltsville, Md. Visit tinyurl.com/jifac14registration or call 301-405-8382.

28-29 HACCP Training San Diego, Calif. Visit www.scsglobalservices.com/haccp-training. 28-1 Fundamentals of Food Science Short Course University Park, Penn. Visit http://agsci.psu.edu/fundamentals or call 877-778-2937. 29-30 Dairy Plant Food Safety Workshop Kansas City, Mo. Visit http://bit.ly/J8ByIR.

Cleaning Tools & Brushesh Purchase Orders Accepted • 800-672-8119 unionjacktools.com

April/May 2014 49

Scientific Findings

For access to complete articles mentioned below, go to the “Scientific Findings” section of the April/May issue at www.foodquality.com.

ARTICLE: Alternative Sanitizing Methods to Ensure Safety and Quality of Fresh-Cut Kiwifruit In minimally processed vegetables, namely in sliced fruits, chlorine solutions have been widely used by the industry for sanitization purposes. However, reduced microbiological efficiency allied to the sensory alteration and eventual formation of carcinogenic chlorinated compounds pointed out the need for alternative decontamination methodologies. Also, conscious consumers are demanding minimization of the potentially negative impact of food processing on human health and the environment. Therefore, the effect of different sanitizing methods as alternative decontamination treatments to chlorinated-water on microbiological counts, packaging atmosphere composition, color, and firmness of fresh-cut kiwifruitunder refrigerated conditions was recently evaluated. The fruits were subjected to water, chlorinated water, ozo- nated water, UV-C, or heat-shock treatment to determine safety and quality. Journal of Food Processing and

ARTICLE: Factors Influencing the ARTICLE: Optimization of a Process for Freeze-Thaw Stability of Emulsion- Shelf-Stable Dietetic Chhana Kheer Based Foods and Changes in Physicochemical Many of the sauces used in frozen meals Properties During Storage are oil-in-water emulsions that consist of Dietetic Chhana kheer has a shelf life of one fat droplets dispersed within an aqueous to two days, even under refrigeration. Prob- medium. This type of emulsion must remain lems with such particulate foods have been physically and chemically stable throughout sought to be avoided by adopting retort processing, freezing, storage, and defrosting processing as there are inherent difficulties conditions. Knowledge of the fundamental in handling such products in a UHT system. physicochemical mechanisms responsible Use of retort pouch offers several advan- for the stability of emulsion-based sauces is tages, such as the ease of handling, reduc-

needed to design and produce high-quality © p i xe l cao s - F o t li a . com sauces with the desired sensory character- ARTICLE: Crystallization in Lactose istics. This review provides an overview of Refining—A Review the current understanding of the influence of In the dairy industry, crystallization is an freezing and thawing on the stability of oil-in- important separation process used in the re- water emulsions. It focuses on the influence fining of lactose from whey solutions. In the of product composition and homogenization refining operation, lactose crystals are sepa- conditions. Comprehensive Reviews in Food rated from the whey solution through nucle- Science and Food Safety, Volume 13, Issue 2, ation, growth, and/or aggregation. The rate

pages 98-113, March 2014. of crystallization is determined by the com- © ma nub ah ugun a - F o t li . com ing processing time, and faster heating rates. bined effect of crystallizer design, processing Since retorting has been used to increase the parameters, and impurities on the kinetics of shelf life for several dairy products, research the process. This review summarizes stud- was conducted to develop a process for the ies on lactose crystallization, including the preparation of shelf-stable dietetic Chhana mechanism, theory of crystallization, and the kheer in retort pouches with special refer- impact of various factors affecting the crystal- ence to its sensory and physicochemical lization kinetics. An overview of the industrial properties as influenced by various time and crystallization operation also highlights the temperature combinations. International problems faced by the lactose manufacturer. Journal of Dairy Technology, Volume 67, Is- Journal of Food Science, Volume 79, Issue 3,

50 FOOD QUALITY & SAFETY www.foodquality.com To receive a free sample box, please visit us at Food Safety Summit Booth 118 or visit www.afh.cascades.com/sample and enter promo code FDSS14.