Regulating Food Safety in 2019 Uncovering New Eff Orts to Improve Food Quality Standards and Prevent Future Outbreaks

PLUS Simplifying Allergen Control ■ Pathogen Detection in Low Moisture Foods ■ Traceability Using DNA

Volume 26 Number 1 FEBRUARY / MARCH 2019

Regulating Food Safety in 2019 Uncovering new eff orts to improve food quality standards and prevent future outbreaks

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Functional Foods Microbiology and Food Safety for the Handbook of and Beverages: Technology of 21st Century: Vegetables and In vitro Assessment of Fermented Foods, Managing HACCP and Food Vegetable Processing, Nutritional, Sensory, 2nd Edition Safety Throughout the 2nd Edition and Safety Properties Global Supply Chain, 2nd Edition 18-491302

www.wiley.com FEBRUARY/MARCHContents 2019 • VOLUME 26 NUMBER 1 • www.foodqualityandsafety.com Features 20 COVER STORY

Regulating Food Safety in 2019 Uncovering new efforts to improve food quality standards and prevent future outbreaks BY TED AGRES

Safety & Sanitation 27 24 Rodent Control with Proactive Pest Management Remote Monitoring

ORKIN LLC / ©PAKHNYUSHCHYY - STOCK.ADOBE.COM ORKIN LLC / ©PAKHNYUSHCHYY Traceable policies help identify what Understanding how sensors types of pests and how many are lurking allow pest management behind the scenes to establish approaches professionals to actively in preventing them from returning screen food facilities 24/7

BY MICHELLE HARTZER, BCE BY PATRICIA HOTTEL, BCE

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February / March 2019 5 CONTENTS

(Continued(Continued fromfrom p.p. 5)6) NEW COLUMN Quality Manufacturing & Food Defense 29 10 RESOLUTIONS TO Distribution 16 FOOD DEFENSE IS GOOD FOR ENHANCE QUALITY AND BUSINESS SAFETY PROGRAMS Addressing compliance Ideas to start the New Year qualifications and responsibilities right and improve upon food under the Intentional Adulteration safety management systems rule reinforces honest and BY RICHARD F. STIER effective communication between all stakeholders

BY DAVID K. PARK 39 FITTING TRACEABILITY INTO PRODUCE SAFETY: Testing KEEPING IT REAL NEW COLUMN 32 TARGETING SHELLFISH A traceability program is like Allergen Control TOXINS insurance coverage that is Stringent testing programs stop activated during recalls and 18 SIMPLIFYING COMPLEX unique threats in seafood foodborne illness outbreaks WORLD OF ALLERGEN CONTROL BY ALLISON HAMMERLY BY TREVOR SUSLOW, PHD, ED TREACY, JOHNNA HEPNER, AND VONNIE ESTES Practical tips on allergen swabbing and choosing a testing system In The Lab BY STEVE L. TAYLOR, PHD, AND Columns JOE L. BAUMERT, PHD 34 AIM HIGH WHEN DETECTING PATHOGENS IN LOW MOISTURE FOODS Market Initiatives From validated and verified 12 GO FISH! cleaning regimens to automated Seafood Departments pathogen testing practices, stakeholders are detailed workflows are helping continually casting 8 FROM THE EDITORS processors deliver safe products out advances in both 10 NEWS & NOTES BY RAJ RAJAGOPAL, PHD safety and product development BY LINDA L. LEAKE, MS 43 EVENTS NEW PRODUCTS 37 DNA AND FOOD TRACEABILITY 44 Next-generation sequencing is 45 ADVERTISER INDEX being used to assess the integrity Legal Update of food from a raw material to 46 SCIENTIFIC FINDINGS a final product 14 TO BE OR NOT TO BE BY MÁRIO GADANHO, PHD, AND USDA releases final National Bio FRANCK PANDIANI, PHD engineered Food Disclosure Rule BY SHAWN K. STEVENS, ESQ. AND

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Food Quality & Safety magazine Other articles at www.FoodQualityandSafety.com/issue/february-march-2019: welcomes letters to the editor on any relevant industry topic. Letters should • Case Study: Meeting Strict Customer • Breastfeeding vs. Formula Feeding: be no longer than 350 words. Standards in Potato Processing Debunking Myths BY BOB SCHUMANN BY JAMIE WELLS, MD, FAAP Submit letters to: • Going Mobile for Internet of Things Marian Zboraj, Professional Editor and Traceability Email: [email protected] BY CORY HOVANETZ (Letters may be edited for space or style.)

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KEYNOTE PRESENTATION What Will Drive Future Sponsored by Food Safety Progress? MICHAEL TAYLOR Co-chair of the Stop Foodborne Illness Board Former Deputy Commissioner for Foods and Veterinary Medicine, FDA

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PLATINUM SPONSOR GOLD SPONSOR MEDIA PARTNER PUBLISHER Lisa Dionne Lento, [email protected] SENIOR ACCOUNT MANAGER Ken Potuznik, [email protected] From The Editors PROFESSIONAL EDITOR Marian Zboraj, [email protected] DESIGN Maria Ender, [email protected] 2019 PRODUCTION Claudia Vogel, [email protected] Jörg Stenger, [email protected] his column was inspired Elli Palzer, [email protected] by the late, great Made- CO-INDUSTRY EDITOR Purnendu C. Vasavada, PhD, line Kahn and her role [email protected] CO-INDUSTRY EDITOR Richard Stier, [email protected] Countdown to just desserts: as cabaret singer Lili Von Advertising Director TShtupp in Mel Brooks’ comedy Dan Nicholas classic “Blazing Saddles.” Lili was 111 River Street, Hoboken, NJ 07030 tired of men, whereas I am tired of (716) 587-2181, [email protected] people trying to frighten me about Sales Offi ce U.S./CANADA/INTERNATIONAL non-existent dangers in my food A |S|B|P|E Fostering B2B editorial excellence Ken Potuznik American Society 29822 N 51st Place, Cave Creek, AZ 85331 Last Call and in the environment. One surfs the internet and runs into of Business (480) 419-1851 • fax (480) 718-7719 pieces about “Top 10 Most Dangerous Fruits,” or “15 Processed Publication Editors 2018 National [email protected] Foods to Avoid,” or “Chemicals that Cause Cancer.” Almost ev- PRINT Editorial Offi ce Award Winner erything is based on bad or non-existent science, but people can Revenue of 111 River Street, Hoboken, NJ 07030-5774, USA $3 million or under for Entries write what they want thanks to freedom of speech. Reprints: E-mail [email protected] As a resident of California, I am also constantly exposed to Proposition 65 warnings. Signs at hardware stores read, “This March 16, 2019 store sells products that contain chemicals deemed to be car- Editorial Advisory Panel cinogenic under Proposition 65.” The same signs appear in the Ellen Bradley, CFS Vijay K. Juneja, PhD Principal Food Scientist, Lead Scientist, The 2019 Food Quality & Safety Award coff ee shops, gas stations, car repair shops, and supermarkets. River City Food Group LLC Predictive Microbiology for Food Safety, USDA-Agricultural Research Service We are deluged by these warnings—so much so that I won- John N. Butts, PhD der whether people are simply tuning things out. Founder and President, Hasmukh Patel, PhD If your company is a food processor, service or FoodSafetyByDesign, LLC; Technical Director and R&D Fellow– Is there an answer? Well, maybe. Websites could be more Advisor to CEO, Ingredient Solutions, Dairy Foods R&D, Land O’Lakes, Inc. retailer, and you uphold the highest food standards diligent when it comes to reviewing the “science” that they pub- Land O’Frost lish, but that is a stretch. Cliff Coles Mary Ann Platt supported by quantifiable results, you need to enter. President, President Our best answer might be federal legislation that makes food Cliff ord M. Coles CNS/FoodSafe and RQA, Inc. Food Safety Consulting, Inc. labeling and other product claims a federal Manpreet Singh, PhD This prestigious award honors the dedication and Professor, Dept. of Poultry Science, Virginia Deibel, PhD prerogative. This could eliminate future University of Georgia I’m Tired Director of Microbiology, achievement of the food quality and safety assurance Proposition 65s and prevent states from Eurofi ns Food Integrity & Innovation Shawn K. Stevens team that has made exceptional contributions to their enacting labeling laws that Food Industry Attorney, Food Industry Counsel, LLC would aff ect the whole coun- James Dickson, PhD company’s commitment in supplying safe Professor, Patricia A. Wester try; an example would be GMO Department of Animal Science, CEO, The Association for Food Safety food products. labeling. But that is beyond me. Iowa State University Auditing Professionals, AFSAP Unfortunately, food fad- Steven Gendel, PhD Steven Wilson Senior Director, Director of Seafood Commerce and dism and fearmongering are not new. Perhaps the solution is the Food Science, Certifi cation, Offi ce of International Aff airs one proposed by San Francisco Chronicle columnist Art Hoppe Food Chemicals Codex at USP and Seafood Inspection LEARN MORE AND APPLY AT: in his April 1989 piece entitled “Safe at Last.” In the column, he tells the story of an overly cautious man named Harold who gave Printed in the United States by Dartmouth Printing, Hanover, NH. https://www.foodqualityandsafety.com/award/ up every food and product that was tested and deemed hazard- Copyright 2019 Wiley Periodicals, Inc., a Wiley Company. All rights reserved. No part of this publication may be reproduced in any form or by any means, except as permitted ous to his health. It wasn’t until Harold was reduced to a “safe” under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior diet of organic rutabagas, alfalfa sprouts, and spring water that written permission of the publisher, or authorization through the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923: (978) 750-8400: fax (978) 750-4470. his wife pointed out that every product that is tested seems to All materials published, including but not limited to original research, clinical notes, editorials, reviews, reports, letters, and book reviews represent the opinions and views of be hazardous—so it stands to reason that all products will turn the authors and do not refl ect any offi cial policy or medical opinion of the institutions with out to be dangerous as soon as they are tested. Seeing no choice: which the authors are affi liated or of the publisher unless this is clearly specifi ed. Materials published herein are intended to further general scientifi c research, understanding, and He [Harold] dug an organic hole in his backyard, placed discussion only and are not intended and should not be relied upon as recommending or therein an organic pine box and climbed inside. “At last,” he said, promoting a specifi c method, diagnosis or treatment by physicians for any particular patient. While the editors and publisher believe that the specifi cations and usage of equipment as he pulled the lid down over him, “I shall be safe.” and devices as set forth herein are in accord with current recommendations and practice (Read Art’s column in its entirety at https://bit.ly/2TExqEx.) at the time of publication, they accept no legal responsibility for any errors or omissions, and make no warranty, express or implied, with respect to material contained herein. Publication of an advertisement or other discussions of products in this publication should Richard Stier not be construed as an endorsement of the products or the manufacturers’ claims. Readers Co-Industry Editor are encouraged to contact the manufacturers with any questions about the features or

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Countdown to just desserts: Last Call for Entries March 16, 2019 The 2019 Food Quality & Safety Award If your company is a food processor, service or retailer, and you uphold the highest food standards supported by quantifiable results, you need to enter.

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FDA Reports on Avocado and Hot Pepper Sampling FDA releases two reports on its sampling of whole fresh avocados and hot peppers to determine the frequently of harmful bacteria. For the hot pepper sampling, FDA analyzed domestic and imported hot pepper samples for Salmonella, E. coli O157:H7, and other types of STEC. Of the 1,615 samples tested, 46 were positive for Salmonella and one was positive for STEC, but further testing revealed that the STEC strain could not cause severe illness. For the whole fresh avocado sampling, FDA analyzed 1,615 domestic and imported avocado samples for Salmonella and Listeria monocytogenes. Of the 1,615 samples, 12 tested positive for Salmonella. For the Listeria testing, the agency primarily tested the pulp of the avocado samples, and some samples of the fruit’s skin. Of the 1,254 avocado pulp samples, three were positive for Listeria. Of the 361 avocado skin samples, 64 were positive for Listeria. When FDA found positive samples in domestic product, it worked with the responsible firms to conduct recalls and followed up with inspections of growers and packinghouses to ensure they were following good agricultural and manufacturing practices. When FDA found positive samples in imported product, the agency refused entry to all product in lots associated with the positive(s), and placed the firms on import alert to stop additional product from entering the U.S.

Business Briefs Compliance Date for Food Labeling Rule FDA recently announced that Jan. 1, 2022, will be the uniform compliance date for final food ReposiTrak creates a Customer Advi- labeling regulations that are issued in calendar years 2019 and 2020. All food products subject sory Board to provide the company with to the Jan. 1, 2022, uniform compliance date must abide by the appropriate labeling regulations insights into challenges and opportu- when initially introduced into interstate commerce on or after Jan. 1, 2022. This doesn’t change nities facing the retail industry and to existing requirements for compliance dates contained in final rules published before Jan. 1, 2019. better align platform development with customer needs.

Kerry signs a license agreement with Global Food Safety Issues Increasing Renaissance BioScience to supply Through HorizonScan, FoodChain ID shares Renaissance’s Acryleast, a non-GMO its third quarter findings, noting an increase acrylamide-reducing yeast enzyme, to in food integrity issues in key categories in- food and beverage manufacturers. cluding poultry, seafood, vegetables, and nuts. Poultry and poultry products saw an Bühler creates a Consumer Foods seg- increase of issues by 14.3% over last quar- ment by combining the current choco- ter, following a decline in Q1, which followed U.S. Farm Bill Opens Door on Hemp late, nuts, bakery, and coffee business a record number of problems in 2017. These As reported by Reuters, FDA said on Dec. 20 with the Haas business. issues stemmed primarily from Salmonella it will consider creating new policy regarding Food Safety Net Services opens its contamination in chicken meat from Brazil. the marketing and sale of cannabis after latest analytical laboratory for the Seafood issues continue to rise, up by 23.1% President Donald Trump signed the Farm food and consumables industry in due to issues such as mercury, altered or- Bill, which legalized commercial production Greeley, Colo. ganolepsis or histamines in fish, and veter- of hemp in the U.S. The FDA said in a state- inary drugs in crustaceans. There were also ment that it hopes to make more efficient Bright Light Agribusiness selects issues with Listeria, E. coli, and Salmonella “pathways” for companies to introduce and TOMRA Food as its partner for an end- in smoked/dried fish and clams. Other is- market cannabis and cannabis-derived prod- to-end almond sorting solution for sues include pesticides found in peppers, ucts, including cannabidiol, into interstate its new processing facility in Hattah/ peas (with pods), strawberries, and goji ber- commerce. Hemp is a type of cannabis plant Victoria, Australia. ries; and aflatoxins in almonds, pistachios, with no or extremely low concentrations of enters into an hazelnuts, Brazil, and cashew nuts. On a the psychoactive compound known as THC, Cloverleaf Cold Storage agreement to merge with Zero Moun- positive note, milk and dairy product haz- the ingredient in marijuana associated with tain, a cold storage warehousing and ard reports are down 4.7%, and meat and “high” feelings. The Farm Bill removes hemp transportation company serving cus- meat product issues are down 14.1% after a from the Controlled Substances Act, allowing tomers in Arkansas. Q2 increase of 9.9%. for its commercial production as long as the plants contain no more than 0.3 percent THC. ©KOVALEVA_KA / BASTIAANIMAGE - STOCK.ADOBE.COM ©KOVALEVA_KA

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Market InitiativesSEAFOOD

“In cooperation with the Association of Food and Drug Officials, the Seafood HACCP Alliance has developed a uniform and cost-effective training program for importers, processors, and distributors of fish and fishery prod- Go Fish! ucts,” Dr. Otwell notes. Courses have been developed for Seafood stakeholders are training in basic HACCP programs and continually casting out the related Sanitation Control Proce- advances in both safety dures. Train-the-trainer courses are and product development also offered. “The audience for these programs is the seafood processing and BY LINDA L. LEAKE, MS importing industry, regulatory officials, and extension agents based in the U.S.,” Dr. Otwell relates.

Shrimp School hen it comes to reeling in finfish aquaculture, with 35.7 million In 2000, Dr. Otwell initi- seafood news, the catch of pounds produced. Atlantic salmon ated an annual Shrimp the day is that the U.S. in- produced was valued at $67.7 million. School based at the Uni- dustry is strong. Oysters had the highest volume for marine versity of Florida that has re- WIt’s no fish tale that fishing and sea- shellfish production, 36.6 million pounds. cently been adopted under food consumption in the U.S. increased the leadership of the National Fisheries in 2017, with landings and value of domes- HACCP Training Institute (NFI). The first NFI edition was tic fisheries continuing a strong, positive Hazard Analysis and Critical Control held in Manteo, N.C., in November 2018 trend, according to the National Oceanic Points (HACCP) training is strong in the and, based on the success of this event, and Atmospheric Administration (NOAA). seafood industry, says Steve Otwell, PhD, a follow-up session is scheduled for April Across the nation, fishermen landed 9.9 seafood specialist emeritus with the Uni- 2019 in the same location. billion pounds of fish and shellfish in 2017, versity of Florida. Through the Florida Sea “Some 50,000 seafood professionals while the U.S. imported 5.9 billion pounds Grant Seafood HACCP program, Dr. Ot- from every shrimp producing nation have of seafood, NOAA notes in its annual Fish- well serves as coordinator of the National attended the schools to date,” Dr. Otwell eries of the United States report released Seafood HACCP Alliance for Training and notes. “We cover how to monitor for bac- Dec. 13, 2018. The estimated U.S. per capita Education. teria, sensory evaluation, temperature consumption of fish and shellfish was 16.0 “The alliance provides science-based control, as well as product quality, safety, pounds in 2017. information about aquatic food prod- and integrity.” Overall, NOAA’s report says that the uct safety and quality through research, highest-value U.S. commercial species in publications, and community outreach Public Health Training 2017 were salmon ($688 million), crabs programs,” Dr. Otwell explains. “Through Barry Nash, MS, North Carolina Sea ($610 million), lobsters ($594 million), its participation in the Seafood HACCP Al- Grant’s (NCSG) seafood technology and shrimp ($531 million), scallops ($512 mil- liance, Florida Sea Grant provides curric- marketing specialist, and Jeff French, a lion), and Alaska pollock ($413 million). ulum and essential training materials that regional environmental health specialist By volume, the nation’s largest commercial enable seafood processors and importers with the North Carolina Division of Ma- fishery remains Alaska pollock, which had to comply with federal food safety regula- rine Fisheries (NCDMF), focus on training near-record landings of 3.4 billion pounds. tions, including the Food Safety Modern- local health department inspectors and NOAA notes that in 2016, estimated ization Act.” others regarding seafood safety. freshwater plus marine U.S. aquaculture Since 1995, the Seafood HACCP Al- “The NCSG and NCDMF developed the production was 633.5 million pounds, liance has trained over 90 percent of the North Carolina Seafood Quality and Safety netting a value of $1.45 billion. Atlantic nation’s processors in food safety and com- Workshop to focus on seafood safety and

salmon was the leading species for marine pliance techniques. handling concerns in restaurants and re- © HVOSTIK16 - STOCK.ADOBE.COM

12 FOOD QUALITY & SAFETY www.foodqualityandsafety.com tail outlets, which the federal rule doesn’t ing to meet challenges in sion off ers the major ben- typically cover,” Nash says. aquaculture.” efi ts of labor effi ciency, This annual two-day training program As of the end of 2018, improved product recov- is jointly organized by NCSG, NCDMF, and some 2,200 facilities in 35 ery, and precise control the North Carolina Environmental Health countries on six continents of temperature, shape, State of Practice Committee, French relates. are expected to be certifi ed texture, moisture, and “The target audiences are county-based against the BAP program, color.” environmental health specialists who Hedlund reports. “Our stan- These extrusion regulate restaurants and other retail food dards cover virtually 100 per- determinations came establishments and seafood businesses, as cent of the fi nfi sh, crustacean, about in July 2016, when Sannito shipped well as the general public,” he says. and mollusk species produced in aquacul- 500 pounds of frozen fi sh skins via FedEx According to Nash and French, topics ture settings around the globe,” he elabo- to the Clextral pilot plant in Tampa, Fla. presented include harvest methods, proper rates. “While there are other organizations “We ran the skins through an extruder receiving and handling of seafood prod- that off er aquaculture auditing services, and it transformed them under high pres- ucts, seafood-borne illnesses, economic BAP is the most comprehensive and is the sure and temperature, turning the colla- fraud, and wholesale and retail HACCP is- only one that covers food safety.” gen in the skin into gummy bear texture,” sues. Speakers are federal, state, and local Hedlund clarifi es that BAP addresses Sannito says. “We added a few additional experts in seafood safety and commerce. food safety for aquaculture facilities—the ingredients to achieve the desired consis- “This training program is important process, not the food. “The ultimate goal tency and bind up the moisture.” because new innovations in prepared with the BAP program is that the fi sh are Sannito opted for turning the pollock seafood meals are starting to come from born in a BAP-certifi ed hatchery, raised skins into a green rope (similar to licorice restaurant chefs and community-sup- on a BAP-certifi ed farm, fed feed from in appearance) and then cutting it into bite- ported fi sheries retailers who are not al- a BAP-certifi ed mill, and processed in a sized pieces. While experimenting with ways familiar with the safety rules that BAP-certifi ed plant,” he relates. natural and artifi cial red and blue food col- govern the production and distribution of ors during his day at the pilot plant, he de- packaged-food products,” Nash empha- Resource Utilization: cided the natural Army green was the best. sizes. “This course provides an overview Gone to the Dogs “The natural green color seemed of the vulnerabilities and control measures There’s defi nitely something fi shy about healthier and we wanted clean labels that prevent, eliminate, or minimize safety the new product in development for four- showcasing a wholesome product,” San- issues from dock to dish.” legged consumers at the Kodiak Seafood nito explains. “Our ultimate goal is to pro- and Marine Science Center, a component duce a high-quality product that is safe for Best Aquaculture Practices of the University of Alaska Fairbanks pets to eat, shelf stable, and enticing for The Global Aquaculture Alliance (GAA), (UAF) College of Fisheries and Ocean humans to purchase.” Portsmouth, N.H., off ers Best Aquacul- Sciences. “We are making high-end dog In May 2017, Sannito and Quentin ture Practices (BAP) certifi cation to ensure treats from pollock skins,” says Chris Fong, PhD, Alaska Sea Grant’s seafood that seafood products come from facilities Sannito, MS, an Alaska Sea Grant seafood marketing specialist, received the 2017 that are managed in an environmentally, technology specialist with this center, lo- Invent Alaska award for “innovation in re- socially, and economically responsible cated on Kodiak Island. search leading to commercialization” from manner, according to Steve Hedlund, “Currently, with pollock fi llet pro- the UAF Fairbanks Offi ce of Intellectual GAA’s communications manager. duction, only about 25 percent of the fi sh Property and Commercialization. “Established in 2002, BAP is the is recovered for consumption aft er har- “In 2018, a new funding opportunity world’s most comprehensive third-party vest,” Sannito notes. “Millions of pounds came through with the UAF Center Ice aquaculture certifi cation program,” Hed- of product are either discharged as waste Seed Fund,” Sannito says. “This award is lund relates. “It’s also the world’s only or processed for fi sh meal. But pollock is making a seed fund of $24,800 available to third-party certifi cation program encom- a valuable resource in our state, and pet move the pollock pet treats forward from passing the entire aquaculture production treats can be a much higher-value com- the experimental stage to the commercial chain. We oversee the standards develop- modity than fi sh meal, so our goal is to market.” ment process and certifi cation process for increase pollock’s utilization by adding To that end, Sannito and his longtime hatcheries, farms, feed mills, and process- further value to this fi sh.” friend and business collaborator, Jerry Pu- ing plants.” Aft er some experimentation, San- pillo, MS, a marketing consultant based in Hedlund explains that these standards nito determined that extrusion was the Hawaii, are currently pursuing industry are audited for GAA by third-party certifi - most viable manufacturing method for partners to develop the pollock co-product cation bodies, of which there are six cur- producing pollock pet treats. “At fi rst, we for wholesale and retail sales. rently. “We train their auditors regularly tried a forced air drying oven, but found According to Sannito, some pet food to ensure every audit is fair, objective, this would be cost prohibitive due to the companies already make pet treats with and traceable,” he says. “Our standards amount of labor required to prepare the fi sh components. “While some pet treat

February / March 2019 13 LegalUpdate

“bioengineered” is misleading. AMS, ostensibly in response to critics, wrote that it had considered a variety of terms, “but ultimately determined that bioengineering and bioengineered food accurately refl ected the scope of disclosure and the products and potential technology at issue.” Moreover, AMS was concerned that using terms such as “genetic engineering” or “genetically modifi ed organisms” would confl ict with preemp- tion provisions. Like almost any regulations that govern highly interpretive and controversial subject matters, it is nearly impossible to achieve consensus agreement. As for the fi nal BE Food Disclosure Rule, there are compelling arguments on both sides. It remains to be seen whether future changes will be warranted, or what types of amend- ments may eventually be enacted. For now, and for better or worse, we have a To BE or Not To BE Final Rule. USDA releases fi nal National Bioengineered What Is Bioengineered Food? Predictably, given the controversy sur- Food Disclosure Rule rounding bioengineering, much debate BY SHAWN K. STEVENS, ESQ. AND JOEL S. CHAPPELLE, ESQ. has centered around how to defi ne what is (or is not) a BE food. The Final Rule adopts the statutory defi nition of “bioengineered n December 2018, the Agricultural advocates have responded favorably to it. food” as codifi ed in the Amended Agri- Marketing Service (AMS) published The Food Marketing Institute, for instance, cultural Marketing Act of 1946. Thus, BE the fi nal National Bioengineered lauded the Final Rule as a consistent and foods are those foods containing genetic Food Disclosure Standard (Final transparent way to provide important in- material that has been modifi ed through IRule). Although mostly straightforward, formation to consumers regarding prod- in vitro recombinant DNA techniques, and the rule does contain some nuance and ucts containing BE ingredients. for which the modifi cation could not oth- complexity, which regulated entities The Final Rule is not without crit- erwise be obtained naturally or through should become familiar with before the ics, however. They charge that the rule is conventional breeding. It should be noted Final Rule takes eff ect. deeply fl awed, lacks transparency, and will that foods for which the presence of mod- In short, the Final Rule requires food likely further confuse consumers. The Or- ifi ed genetic material is due to incidental manufacturers, importers, and retailers ganic Trade Association issued a statement additives are not considered BE. who package and label food for retail expressing its deep disappointment with Even within the relatively technical sale or sell bulk food items (regulated the new rule. The Center for Science in the defi nition adopted in the Final Rule, sig- entities) to disclose the presence of Public Interest expressed concern about nifi cant points of contention remain. For bioengineered (BE) ingredients in their the potential for consumer confusion. instance, there are two countervailing products. Importers and domestic entities More broadly, critics are especially viewpoints regarding whether highly re- are subject to the same disclosure and com- unhappy with the lack of reference to fi ned foods and ingredients should be ex- pliance requirements. genetically modifi ed organisms (GMO) empted from BE disclosure requirements. The Final Rule has been met with and genetic engineering in the disclosure One view, favored by many in the food in-

mixed reviews. By and large, industry requirements. They argue that the term dustry, holds that highly refi ned products - STOCK.ADOBE.COM © SSSTOCKER / DEDMAZAY

14 FOOD QUALITY & SAFETY www.foodqualityandsafety.com should be exempt because the definition label, making it likely to be read and un- prescriptive requirements were deemed expressly requires the presence of “genetic derstood by consumers under ordinary too difficult to implement. material,” and genetic material is removed shopping conditions. from highly refined foods in the course of The use of a USDA-approved Recordkeeping Require- the refinement process. symbol is one form of BE food ments Another view, counter to the first, is disclosure regulated enti- Every regulated entity subject that the definition of “bioengineering” ties may use to designate BE to mandatory BE disclosure ought to include highly refined products foods. AMS initially proposed must maintain customary or because highly refined products that are three alternative symbols reasonable records that estab- derived from genetically modified foods (with variations), all designed lish compliance. Records may contain modified genetic material prior to to disclose a food’s BE status in a be kept in any format (hard copy processing and may still contain modified non-disparaging manner. Ultimately, or electronic) and may be stored at any genetic material—albeit at undetectable AMS adopted the two symbols located on business location. Examples of such re- levels—after processing. this page. cords include invoices, bills of lading, After thorough deliberation (the rule’s For regulated entities that do not wish supply chain records, country of origin draft documents included significant to utilize the symbol, there are other per- records, process verifications, organic written discussion on this topic), AMS has missible means of designating BE foods. certifications, and lab test results. Records elected to adopt the first view. Though we One is on-package text. For foods (e.g., raw must be maintained for two years after the understand and acknowledge both po- agricultural commodities or ingredients food is sold or shipped. USDA may request sitions, we believe AMS made the right produced therefrom), the required text records, in which case records need to be choice. Just from a practical standpoint, disclosure is “Bioengineered Food.” For produced within five business days. it would be virtually impossible to deter- multi-ingredient foods that contain both AMS maintains a list of BE foods on its mine whether a product containing no BE and non-BE ingredients, the required website. Foods on the list must be disclosed detectable genetic material was derived text disclosure is “contains a bioengi- unless records are available to demonstrate from modified genetic material. In any neered food ingredient.” they are not BE. Restaurants and similar event, foods that do not contain detectable Disclosure of BE ingredients may be retail food establishments, as well as very amounts of modified genetic material are also made through an electronic or digital small food manufacturers (< $2.5 million exempt from BE disclosure requirements disclosure. Such disclosures must include in annual receipts) are exempted from under the Final Rule. instructions to “scan here for more food the rule. The purpose of the BE foods list Nevertheless, regulated entities must information” or similar language. Alter- is to provide a straightforward method still be able to establish that their prod- natively, regulated entities can use a text of determining whether a food requires a ucts do not contain detectable amounts of message disclosure, stating, “Text [com- BE disclosure. For products that contain a modified genetic material. To do so, they mand word] to [number] for bioengineered food on the list, regulated entities would ei- must maintain records that verify: 1) the food information.” ther make a disclosure consistent with the food was made from a non-BE food; or, 2) In terms of placement, the disclosure National Bioengineered Food Disclosure the food was refined using a process vali- may be placed anywhere on the principal Standard or not disclose if they believe the dated to render the modified genetic ma- display panel or on the information panel food is not required to have a BE disclosure. terial undetectable; or, 3) the absence of adjacent to the statement identifying the detectable modified genetic material (i.e., name and location of the manufacturer/ Compliance Deadlines test results). Acceptable types of records distributor. If there is insufficient space This Final Rule becomes effective on Feb. may include, among others, supply chain on these panels, then on any other panel 19, 2019, and must be implemented by Jan. records, organic certification, or documen- likely to be seen by a consumer under or- 1, 2020, except for small food manufactur- tation that the ingredient is sourced from a dinary shopping conditions. ers, whose implementation date is Jan. 1, country that does not allow production of Small food manufacturers have addi- 2021. The mandatory compliance date is that specific ingredient in a BE form. tional options, such as directing consum- Jan. 1, 2022. Regulated entities may vol- ers to call or visit a website for more untarily comply with the Final Rule until Disclosure Requirements food information. This requires Dec. 31, 2021. All food manufacturers must Generally, regulated entities an accompanying phone comply by Jan. 1, 2022. have four options for disclos- number and/or website URL. The proposed compliance date of Jan. ing the presence of BE ingre- Disclosure on small and very 1, 2020, is intended to align with FDA’s pro- dients in their products: 1) a small packages may use an posed rule to extend the compliance dates USDA-approved symbol; 2) on- abbreviated disclosure. for the changes to the Nutrition Facts and package text; 3) electronic or AMS affirmatively decided Supplement Facts label final rule and the digital disclosure; or, 4) a text mes- against prescribing specific type Serving Size final rule from July 26, 2018, sage disclosure. The disclosure must be sizes for different disclosure options be- to Jan. 1, 2020, for manufacturers with $10 of sufficient size and clarity to appear cause, given the enormous breadth and million or more in annual food sales.

USDA AMS prominently and conspicuously on the variety of available packaging options, (Continued on p. 42)

February / March 2019 15 NEW COLUMN

pet food ingredients for economic gain (i.e. they substituted inferior ingredients)—the company was ordered to pay $7 million; Food Defense • A man from Belmont, Miss., plead guilty in a U.S. District Court to di- verting a possible 180 truckloads of packaged food and beverage products from 10 companies that were destined for destruction or use in animal feed, reselling these same goods for human consumption on the open market and also falsifying records on the pur- ported “destruction” of these goods; • A seafood business owner in New- port News, Va., was charged with committing Lacey Act (as amended) and the Food, Drug, and Cosmetic Act (FD&CA) (as amended) violations for blending foreign-sourced crab meat with Atlantic blue crab and mislabeling the crabmeat as “Product of USA;” and • In December 2018, after a long State food fraud investigation, the New York Attorney General reported the “common practice” of seafood fraud as verified by “rampant” high levels Food Defense of species mislabeling found in ge- nomically-tested seafood samples taken from New York State supermar- Is Good for Business ket chains. Addressing compliance qualifications and responsibilities These examples are what new FDA under the Intentional Adulteration rule reinforces honest and Food Safety Modernization Act (FSMA) intentional adulteration regulations, soon effective communication between all stakeholders to be implemented, address. Regardless BY DAVID K. PARK of the perpetrator’s motive (e.g., terrorism, sabotage, extortion, counterfeiting, theft, or economically motivated adulteration), am grateful to Food Quality & Safety ples of recent intentional adulteration— intentional or unintentional food tamper- magazine for the opportunity to economic and otherwise—include: ing can cause serious harm to humans share my professional viewpoints • Australian-sourced fresh strawberries, and animals. and personal experiences on the intentionally adulterated with sewing The arrival of FDA “Mitigation Strat- Isubject of food defense and its critical im- needles, with subsequent copycat egies to Protect Food Against Intentional portance to overall product security. As a metal contamination incidents, were Adulteration” (or as it’s perhaps better new column, I hope Food Defense will pro- discovered in New Zealand and Sin- known, “Intentional Adulteration (IA) vide subject matter knowledge, insight, gapore, causing consumer injury and Rule”), originally published as a Final and thought-provoking conversation re- significantly disrupting global trade; Rule in the Federal Register on May 27, garding experiences, challenges, and op- • The seizure of 45 tons of quality-ex- 2016 (81 FR 34166), will soon usher in new portunities that confront us in managing pired, chemically-treated tuna from regulatory requirements for large food food defense responsibilities. three seafood processing businesses businesses that must follow this rule. This In case food defense-related news has in Spain that marketed and sold the requires certain businesses that manufac- escaped your attention lately, a continuing seafood as “fresh;” ture, process/pack, or hold food must not pattern of intentional adulteration and eco- • Two Missouri-based U.S. pet food in- only be already registered with FDA as a nomic fraud incidents have been reported gredient companies and several in- Food Facility, but now must meet provi- by both private and government media dividuals were convicted on a misde- sions of Section 415 of the FD&CA, conduct

sources around the globe in 2018. Exam- meanor count of selling misbranded a formal Vulnerability Assessment, and - STOCK.ADOBE.COM ©WAVEBREAK3

16 FOOD QUALITY & SAFETY www.foodqualityandsafety.com develop and implement a Food Defense qualifications and responsibilities as con- 4. Does your facility pack, re-pack, la- Plan. The IA Rule’s upcoming implemen- tained within the IA Rule. In regards to the bel, or re-label food where the container tation and compliance date of July 26, 2019, qualifications: that directly contacts the food remains is nearly upon us. If you must comply and 1. Are you the owner, operator, or agent intact? (21 CFR 121.5(c)) haven’t already addressed required facility in charge of a domestic or foreign facility 5. Is your facility a farm mixed-type tasks that underpin the rule, the time to act that manufactures/processes, packs, facility that conducts activities that fall is now! or holds food for consumption in the U.S within FDA’s “farm” definition? (21 CFR and is required to register with FDA? (21 121.5(d)) IA Rule Basics CFR 121.1) 6. Does your facility produce alcoholic Acts of intentional adulteration may take beverages? (21 CFR 121.5(e)) several forms: Acts intended to cause 7. Does your facility manufacture, pro- wide-scale public health harm, such as As a food-related facility cess, pack, or hold food for animals? (21 acts of terrorism focused on safety of the covered under the require- CFR 121.5(f)) food supply, and acts of disgruntled em- ments of the IA Rule, 8. Is your facility a farm mixed-type ployees, consumers, or competitors and facility whose only activities that would their economically motivated adulteration trustworthiness must be be subject to section 418 of the FD&CA for financial gain. Acts intended to cause earned by partnering with are on-farm manufacturing, processing, wide-scale public health harm are asso- others occupying space in packing, or holding of eggs (in-shell, ciated with intent to cause significant hu- other than raw agricultural commodities) man morbidity and mortality. Other forms the global supply chain. and certain game meats? (Note that this of adulteration are typically not intended is limited to small and very small busi- to cause wide-scale harm, although public nesses. (21 CFR 121.5(g)) If applicable, health harm results from unintended adul- 2. Does your business (including any your business is exempt from compliance teration consequences that are unknown subsidiaries and affiliates) average less with the IA Rule. to the perpetrator prior to the attack. At- than $10,000,000, adjusted for inflation, If you must comply with the IA Rule, tacks intended to cause public health per year, during the three-year period the following are the principal tasks your harm to both humans and animals are preceding the applicable calendar year in food-related business must formally appropriately ranked as the highest risk. sales of human food plus the market value address: Food defense experts Capt. Jon Woody, of human food manufactured, processed, 1. Develop and implement a written Ryan Newkirk, and Colin Barthel of the packed, or held without sale (e.g., held for Food Defense Plan that includes (21 CFR FDA Center for Food Safety and Applied a fee)? If so, your facility is exempt, except 121.126): Nutrition Food Defense and Emergency that you are required to provide for official • A vulnerability assessment, including Coordination Staff have made every effort review, upon request, documents suffi- required explanations, to identify sig- to make all stakeholders aware and inform cient to show your status as a very small nificant vulnerabilities and actionable and educate the global food industry and business. (21 CFR 121.5(a)) process steps (21 CFR 121.130(c)); regulating bodies, writ large, on agency ex- 3. Does your facility hold food, except • Mitigation strategies, including pectations in how to comply with the new the holding of food in liquid storage tanks? required explanations (21 CFR FSMA IA Rule. In addition, these agency (21 CFR 121.5(b)) 121.135(b)); “owners” have also been instrumental in (Continued on p. 42) developing “Mitigation Strategies to Pro- tect Food Against Intentional Adulteration: Draft Guidance for Industry” (published in June 2018 with the public comment period closed in December 2018), on how to best comply with agency IA Rule expectations prior to the publication of its final guidance document. The IA Rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/ processes, packs, or holds food for consumption in the U.S and is required to register under section 415 of the FD&CA, unless one of the exemptions provided in 21 CFR 121.5 applies. (21 CFR 121.1) Let me briefly review the key FDA-di-

©NORDRODEN - STOCK.ADOBE.COM rected food defense facility compliance

February / March 2019 17 NEW COLUMN Allergen Control

also known as strip tests. Many allergen-specifi c commercial companies off er LFDs, including Neogen, r-Biopharm, Romer Labs, and 3M. Commercial LFDs exist to detect residues of peanut, milk, egg, soy, gluten (wheat, rye, barley), various tree nuts, crustacean shellfi sh, and fi sh. LFDs and swab tests are highly specifi c and based upon antibodies that bind to protein(s) from the allergenic food. These test methods are qualitative but capable of detecting very low residual levels of allergens on equipment surfaces. Practical tips on allergen swabbing These methods can also be used for de- and choosing a testing system tection of residues in clean-in-place (CIP) fi nal rinse water samples. Some compa- BY STEVE L. TAYLOR, PHD AND JOE L. BAUMERT, PHD nies use these qualitative methods on ingredients or processed food samples, but their use for such purposes is not recommended unless careful evaluations have DA has not mandated the use of develop an Allergen Control Plan, and ef- been done to ensure that the food matrix allergen residue testing to assess fective and consistent procedures for the does not interfere with the detection of the eff ectiveness of preventive al- cleaning of shared equipment. residues using LFDs. lergen controls such as cleaning In the U.S., the major allergens are de- Because food allergens are proteins, Fof shared equipment. However, the pru- fi ned as milk, eggs, fi sh, crustacean shell- allergen-specifi c swabs and LFDs are the dent use of such methods is very useful fi sh (shrimp, crab, lobster), peanut, soy- most relevant approach to determine if in determining whether allergen cleaning bean, tree nuts (walnut, cashew, etc.), and allergen residues remain on equipment procedures (SSOPs) are eff ective and con- wheat. Ingredients derived from the major surfaces. However, other swab approaches sistent. Increasingly, food companies do allergenic foods are also considered aller- are available, including general protein use swab testing of equipment surfaces gens for labeling purposes, although the tests (e.g., 3M Clean-Trace) and ATP tests for SSOP validation. comparative allergen loads (the amount (e.g., Charm AllerGiene). General protein The Food Safety Modernization Act of protein from the allergenic source) tests detect protein residues from any (FSMA) stipulates that allergens are a po- are highly variable from non-detectable source, allergen or not. ATP is a molecule tential hazard. FSMA requires preventive (e.g., butter oil, cold-pressed soybean oil) found in all biological organisms, so ATP allergen control implementation in man- to low (e.g., lactose) to high (e.g., wheat testing will detect soil residues on equip- ufacturing facilities that handle allergens. fl our, soybean fl our, casein, whey protein ment surfaces from many sources. In our The food industry makes extensive use concentrate). The eff ectiveness of allergen experience, general protein and ATP swab of shared manufacturing equipment for SSOPs is typically focused on the major methods are slightly less sensitive than al- multiple formulations, some containing allergenic foods and ingredients derived lergen-specifi c LFD methods. Due to their allergenic foods or ingredients and others from them, especially ingredients with specifi city, allergen-specifi c swabs with not. The cleaning of shared equipment is high allergen loads. LFDs are more suitable for validation of a critical preventive allergen control step. SSOP eff ectiveness. While FDA has not yet released its antici- Allergen Swab Testing pated guidance on preventive allergen con- Allergen swabs can be eff ective in assess- Deciding on a Testing System trol, it has already begun to conduct FSMA ing the cleanliness of equipment surfaces. Careful thought should be given to selec- inspections, and some of those inspections The swabs can be tested directly using tion of the optimal commercial kit. The have included assessment of preventive al- certain commercial kits such as Neogen following are some tips on choosing the lergen controls. Thus, food companies us- Alert kits. More commonly, swab use is correct test to help ensure allergen SSOPs

ing allergenic foods or ingredients should coupled with lateral fl ow devices (LFD), are as eff ective as possible. ©STUDIOLOCO - STOCK.ADOBE.COM

18 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Choose the right swab. Swabs must levels of the allergen residue are present, Use the right technique. Swabbing of remove protein residues that may adhere which overwhelms the detector antibodies hard-to-clean spots on the processing lines to equipment surfaces, but must also be in the strip causing most (perhaps all) of (nooks and crannies) is important. Multi- adsorbent. Swabs must also release the the allergen-antibody complexes to miss ple swabs should be taken, especially in proteins back into an extraction solution. binding to the allergen-specific antibodies the initial stages of cleaning validation on The swabs provided with commercial kits, bound at the test line in the strip—resulting a processing line to identify the spots that such as the environmental swabs from in a false negative response. Some com- are hardest to clean. Those spots can then Neogen, outperform regular cotton swabs. mercial LFDs have overload lines while become the focus of subsequent cleaning Sponges should be avoided for al- others do not, and the level of allergen validations and verifications. Allergen lergen testing, as they tend to hold on to needed to generate a false negative due cleaning protocol effectiveness should proteins, failing to release them into ex- to overloading will be different for each be re-validated periodically or whenever traction solutions. Furthermore, some commercial kit. With milk, overloading anything changes (product formulation, sponges may contain microbial growth occurs at concentrations from 100 ppm up equipment matrix, processing condi- media made from allergenic foods such as to >10,000 ppm (expressed as ppm NFDM), tions, etc.). The frequency of re-validation milk and soy. is not fixed and is dependent upon the Choose the most appropriate test frequency of changeovers. When using method. The choice of an LFD that fits Multiple swabs should the recommended environmental swabs, your purpose is relatively straightforward: the swabbing technique can vary without It must be able to detect the allergen res- be taken, especially much effect on the observations. Swabs idues in the product matrix of concern. in the initial stages of and surfaces can be either wet or dry. Essentially, will the LFD detect residues cleaning validation Interpret the results. LFDs offer qual- on the equipment surface before cleaning? itative results. Thus, results should be in- Different commercial LFDs targeted on a processing line to terpreted primarily as negative or positive. at residues of the same allergenic food are identify the spots that The goal for cleaning validation should be not created equal. LFDs contain antibod- are hardest to clean. “negative by swab” after documenting that ies raised against the allergenic food or the chosen LFD is fit for purpose. specific proteins from the allergenic food. Commercial LFDs provide sensitiv- Each commercial LFD kit has its own pro- ity limits in concentration terms, such as prietary antibody/ies that may respond dif- depending upon the type of commercial ppm, and relate to the allergen concen- ferently to the residues left on equipment kit. Serial dilutions of the swab or CIP rinse tration in the swab extraction solution. surfaces. Food companies use a variety of water extraction solution can be used to This term has no bearing on the allergen ingredients derived from a particular aller- avoid overloading. concentration that might be found on a fin- genic food (e.g., milk-derived ingredients Set an achievable cleaning goal. LFD ished product that comes in contact with can include non-fat dry milk, caseinates, swabs are used to validate the effectiveness the equipment surface. Swab test results or whey derivatives). Don’t assume that of SSOPs for removal of detectable allergen should instead be provided in terms of µg/ a given LFD will detect all forms of milk residues from shared equipment surfaces cm2, but that presumes users will swab equally well—some commercial milk LFDs (or CIP final rinse water). Each product uniform areas of the equipment surface. do not detect whey or whey-based ingre- and processing line should be evaluated Since irregular surface areas are swabbed, dients, for instance. The sensitivity levels separately. If formulations have similar the most appropriate expression of results of different commercial kits for the same physical attributes (e.g., dry powders), would be µg/swab. And since the degree analyte will also vary and be dependent on similar cleaning approaches can be used of hazard to the finished product cannot the nature of the ingredient derived from on multiple formulations. When formu- be determined from a swab result, the goal the allergenic source. lations contain multiple allergens, the should be “negative by swab” as noted Processing conditions also affect a assessment can sometimes be limited to above unless you are brave enough to test system’s ability to detect allergen residues the allergen that is present in the highest finished product (see below). on equipment surfaces. Heat processing allergen load. Know when to test finished product. causes protein aggregation, resulting in A corporate target level for effective The results of equipment surface swabs difficulty with removal of residues from the allergen cleaning should be set, such cannot easily be translated to finished surface and challenges with solubilization. as no detection of allergen residues on food products. Swabs with LFDs offer Fermentation can alter proteins through swabs using a specific LFD with a partic- qualitative results while finished product proteolysis, again affecting antibody rec- ular sensitivity level (e.g., no detection of testing is usually quantitative. LFDs tend ognition on the LFD. milk protein residues with an LFD having to be extremely sensitive; they can detect False negative results due to overload- a detection limit of 5 ppm). The LFD sen- extremely small amounts of allergen on ing LFDs is a particularly important con- sitivity level will vary to some degree with equipment surfaces. When the subsequent cern. Due to the “hook effect,” high levels the nature of the food matrix, but a general product is manufactured on the shared of allergen residues can cause false neg- statement such as “no detection by swab equipment, allergen residues will likely atives. The hook effect occurs when high with LFD” is usually sufficient. (Continued on p. 43)

February / March 2019 19 ©LENABSL / TALEX / DRAWKMAN - STOCK.ADOBE.COM / DRAWKMAN ©LENABSL / TALEX

20 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Regulating Food Safety in 2019 Uncovering new eff orts to improve food quality standards and prevent future outbreaks

BY TED AGRES

oth FDA and industry will come under increased pressure in 2019 to improve food safety, largely in response to If FDA doesn’t shorten last year’s widespread outbreaks of E. coli O157:H7 from the compliance romaine lettuce and other leafy greens from the growing Bregions of Yuma, Ariz., and California. Hundreds of people nation- deadlines for wide were sickened and hospitalized, and fi ve people died aft er agricultural water, more consuming contaminated romaine lettuce. Last year also saw scores of smaller outbreaks and recalls wide -spread recalls of leafy greens involving Listeria in deli ham, pork, vegetable dip trays, salad and other produce are likely, mixes, and imported crab meat; Shiga toxin-producing E. coli O26 in ground beef; and Salmonella in breakfast cereal, shell eggs, predicts David Acheson, MD, founder ground beef and turkey products, and even boxed cake mix. and CEO of The Acheson Group. Foodborne outbreaks occur with some regularity, but recent advances in whole genome sequencing (WGS) and other technol- A prime example is water used for agricultural purposes. Last ogies are allowing regulators to identify microbial pathogens with year, canal water containing E. coli O157:H7 was used to irrigate greater accuracy than ever before. Even so, tracing a contaminated romaine lettuce and other leafy green crops in the Yuma, Ariz., food product through the supply chain remains complex and time growing region. While a concentrated animal feeding operation consuming, requiring numerous regulatory and public health (100,000-plus cattle) was located adjacent to a stretch of the impli- agencies to collect and evaluate thousands of records. cated irrigation canal, the source or sources of the outbreak-related While the magnitude of food-related illnesses appears to be contamination remain unclear, according to FDA and CDC. increasing, FDA offi cials suggest this may be an appearance due This year, more farms will be subject to FSMA’s Produce to improved detection capabilities. Nevertheless, FDA, USDA, and Safety Rule, and starting this spring, FDA will begin inspecting state and local agencies are fi nding food safety regulation to be farms for compliance. But the agency has delayed the provision increasingly challenging, especially in this era of constrained bud- of the Produce Safety Rule pertaining to agricultural water. FDA gets and—for routine FDA inspections early this year—furloughs has extended the compliance deadline for the testing and safety because of the federal government shutdown. of water used in agriculture (other than for sprouts) by an additional two to four years to ensure the standards are “feasible Focus on Prevention for farmers to adopt in all regions of the country.” As a result, The Food Safety Modernization Act (FSMA) is intended to reduce agricultural water compliance will not begin until January 2022 food-related illnesses by shift ing the emphasis from inspection by for the largest farms, January 2023 for small farms, and January government agencies to prevention by the food industry. But sev- 2024 for very small farms. eral key FSMA provisions are still being adopted by industry, such “This is unacceptable in the wake of last spring’s outbreak and as the Produce Safety Rule and the Foreign Supplier Verifi cation the deaths and illnesses it caused,” says Sandra Eskin, food safety Program, and some major areas remain largely unaddressed. (Continued on p. 22)

February / March 2019 21 COVER STORY: REGULATING FOOD SAFETY IN 2019

(Continued from p. 21) says, noting that farmers in the Yuma region had already begun project director at the Pew Charitable Trusts. “FDA must end these planting their winter romaine crops. “It is unclear whether they delays and promptly finish any revisions [of the rules] guided by are being irrigated with untreated canal water,” she adds. results from relevant environmental assessments and outbreak If FDA doesn’t shorten the compliance deadlines for agricul- investigations.” tural water, more widespread recalls of leafy greens and other Further, federal and state agencies “should use their authority produce are likely, predicts David Acheson, MD, former FDA over canal water quality to require that water be treated to reduce associate commissioner for foods and founder and CEO of The foodborne pathogens before being used in produce fields,” Eskin Acheson Group. “FDA has kicked the can down the road,” Dr. Acheson tells Food Quality & Safety. “They don’t know how to control risks in FSVP Violations water very well through testing.” And should irrigation-related outbreaks continue after farm inspections begin, “there will be Failure to develop a FSVP was the single-most frequent continued criticism of the regulatory agencies and effectiveness food safety violation cited by FDA investigators last year, of produce inspections overall,” he says. with 278 Form 483s issued to U.S. companies for not having verified that the food they import meets the same Traceability and Labeling safety standards as domestically produced items. As good as WGS is at identifying specific pathogens, the trace- FSVP requires all U.S. food importers (not just those reg- back investigation of a contaminated commodity, such as ro- istered with FDA) to develop plans to and actively monitor maine lettuce, remains complex and cumbersome. their foreign suppliers’ compliance with FSMA provisions. “It’s a labor-intensive task. It requires collecting and evalu- Late last year, FDA’s Office of Regulatory Affairs- re leased summaries of routine field inspections and enforce- ating thousands of records while also trying to accurately doc- ment activities conducted during fiscal 2018 (Oct. 1, 2017, ument how the contaminated lettuce moved through the food through Sept. 30, 2018). The summaries identify the statu- supply chain to grocery stores, restaurants, and other locations tory areas under which thousands of Form 483s were is- where it was sold or served to the consumers who became ill,” sued to companies having conditions or practices that may said FDA Commissioner Scott Gottlieb, MD, and Deputy Commis- violate FDA requirements. sioner Frank Yiannas, in a recent joint statement. As in previous years, other common food safety violations While accurate records are essential for traceability, FSMA involved sanitation monitoring (188 citations); pest con- (implemented with the Bioterrorism Act of 2002) requires trol (183 citations); controls for sanitary manufacturing, FDA-registered firms (not including growers, retailers, or restau- processing, packing, and holding (175 citations); sanitary rants) to be able to trace only one step forward and one step plant maintenance (167 citations); and HACCP plan imple- backward in the supply chain. Late last year, after CDC warned mentation (136 citations). In total, nearly 2,600 Form 483s were issued for food safety related violations last year. consumers not to eat romaine lettuce, the industry adopted an U.S. importers are required to develop, maintain, and FDA proposal to voluntarily label produce entering the market follow a foreign supplier verification plan (also called an with the growing region and harvest date. “If it does not have FSVP) for each food they import, unless an exemption ap- this information, you should not eat or use it,” FDA announced. plies (such as for juice and seafood, which are covered by Consumer groups were less than enthusiastic. “[I]t relies on separate HACCP regulations, and certain low-acid canned the shopper standing in the produce aisle to know first that there foods). has been an outbreak, then remember which part of the country While fiscal 2018 was the first full year that FSVP regula- is involved, and also realize that they can check the label for the tions were in effect, not all U.S. companies had been re- information,” Consumer Reports said. quired to comply, depending on the size of their foreign Acknowledging that labeling alone is not a long-term solu- suppliers (rather than the size of the U.S. firm) and the types of food products. This year (fiscal 2019, Oct. 1, 2018, tion, FDA plans to use technology “to improve our ability to track through Sept. 30, 2019), more U.S. companies will come and trace products through the supply chain. We’ll be launching under FSVP’s purview. As such, the number of FSVP viola- a comprehensive effort in early 2019 to advance our work in this tions is likely to increase. area,” Dr. Gottlieb and Yiannas announced in December 2018, Furthermore, FDA’s focus last year had been on edu- without offering details. cation, generally allowing companies an opportunity to But many observers expect FDA to encourage industry to come into compliance with FSVP, unless dangerous prob- adopt blockchain and similar technologies to enhance product lems were uncovered. This year, FDA inspectors are more tracking and traceability this year. Prior to joining FDA as deputy likely to issue violations than warnings. “We’ll see more commissioner for food policy and response, Yiannas was vice FSMA enforcement in 2019 than in the past,” says Da- president for food safety at Walmart, where he had championed vid Acheson, MD, former FDA associate commissioner for foods. “FDA’s been in a mode of education, but more en- the mandatory adoption of blockchain on the part of its leafy forcement is likely to be coming this year.”—T.A. greens suppliers, starting this year. “We have a guy starting…the former head of food safety at Walmart who is going to be coming to the FDA to help us put in

22 FOOD QUALITY & SAFETY www.foodqualityandsafety.com COVER STORY: REGULATING FOOD SAFETY IN 2019

Shawn K. Stevens, food industry attorney, Food Industry Counsel LLC, recommends manufacturers “play FDA for a day” and do their own extensive testing using WGS or other environmental sampling .

place among other things better track-and-trace using tools like to still be in the consumer’s possession based on shelf life or blockchain maybe to even do track-and-trace on the food supply perishability. chain,” Dr. Gottlieb told CNBC in an interview. GMO labels. Starting this year, food manufacturers may begin using USDA’s approved “Bioengineered” symbol on labels to dis- FSMA Compliance Deadlines close the presence of GMO ingredients. Under a final rule issued A number of FSMA regulations become effective in 2019 for last December, food manufacturers must disclose the presence companies and farms, depending on the size of their business of foods or ingredients made from genetic engineering when the and the products they produce or handle. They include the bioengineered portion exceeds 5 percent by weight of each ingre- following. dient. Mandatory disclosure starts Jan. 1, 2022, but companies can Produce Safety Rule requires domestic and foreign farms voluntarily begin disclosure starting Feb. 19, 2019, when the final to have preventive measures in place for growing, harvesting, rule takes effect. packing, and holding fruit and vegetables. Small and very small Cell-based meat. USDA and FDA this year may hammer out farms (less than $500,000 and $250,000 in annual revenues, re- draft regulations for overseeing the production and distribution spectively), became subject to the Produce Safety Rule (except for of cell-based meat, or animal tissue produced without growing or agricultural water) in January. Routine farm inspections for com- slaughtering animals. FDA will oversee cell collection, cell banks, pliance with the rule are set to begin this spring. and cell growth and differentiation. USDA oversight will begin Foreign Supplier Verification Program (FSVP) requires U.S. from the cell harvest stage, and will continue during the produc- importers to verify that the food they import meets the same safety tion and labeling of food products. standards as domestically produced items. This year U.S. companies importing from “small” foreign suppliers (fewer than 500 full- Inspections and Enforcement time employees) and “very small” foreign suppliers (less than $1 Of wide industry interest, FDA inspectors this year will ramp up million in average annual sales) are subject to FSVP. testing for pathogens. “FDA will be pressing to make sure there are Intentional Adulteration Rule is designed to protect the food no more repeats of past outbreaks,” says Shawn K. Stevens, food supply from widespread public harm. Large businesses become industry attorney with Food Industry Counsel LLC, Milwaukee, subject to the rule in July. FDA is releasing draft guidance in install- Wis. “The agency will be working very aggressively to make sure ments throughout the year. food companies are following the rules,” he tells Food Quality & Voluntary Qualified Importer Program (VQIP) gives U.S. Safety. companies with a high level of control over the safety and security Stevens recommends manufacturers “play FDA for a day” and of their import supply chain expedited review and importation of do their own extensive testing using WGS or other environmental their foods. Applications are being accepted through May, and the sampling. “You should find out what’s there and respond to those first VQIP starts in October. findings aggressively and appropriately before the FDA arrives,” he suggests. Dr. Acheson agrees. “It’s better to know what’s going on Other Regulatory Activities in your food plant before the FDA tells you,” he says. Other activities taking place in the coming year include the However, possessing that information is probably discoverable following. by FDA. If a manufacturer does have a resident bacterial strain in Enhancing food recalls. This year, FDA plans to disclose the the plant and is trying to eradicate it, “the agency needs to be le- names and addresses of stores where recalled products may have nient and not penalize the company for it,” Dr. Acheson says. “We been sold. Previously, the agency had felt constrained because of need more regulatory clarity on this point because sometimes over- confidentiality agreements between suppliers and retailers. Now, sight shuts down good food safety practices at the plant level out FDA will disclose retailer information when the recalled product of fear of discovery.” ■ is not easily identifiable from its packaging (such as without a barcode or Universal Product Code) and when the food is likely Agres is an award-winning writer based in Laurel, Md. Reach him at [email protected].

February / March 2019 23 Safety &PEST Sanitation CONTROL

possible—require a strong partnership between the facility manager, employees, and the pest management professional to implement and continue to improve over time. Traceability is also an integral part of a strong IPM program, as it can help prevent pests internally and externally and ensure pest issues are resolved promptly. Every IPM program will have some form of documentation to record pest issues, and many pest management companies offer extensive data tracking to see how pest populations are trending over time to identify areas for improvement. Careful documentation is crucial for demonstrating compliance to an auditor, and it can help trace pest issues back to the source. Talk to partners throughout the supply chain to establish documentation protocols as well, since determining the source of an infestation is an important first step in resolving a pest problem. Make it a point to notify supply chain partners when pest issues are traced back to them, Proactive Pest Management as they might not be aware of these issues at their own facility. Traceable policies help identify what types of pests Traceability is a big part of food safety, and how many are lurking behind the scenes to establish especially as more global supply chains approaches in preventing them from returning are formed, but it can be confusing to determine which documents are most BY MICHELLE HARTZER, BCE important to maintain to create visibility and be prepared for an audit. The follow- icture this: A dad hands his Instead of waiting for pest issues to oc- ing documents are a great place to start. daughter a box of morning ce- cur, plan ahead. The Food Safety Modern- Food safety plan. The food safety real, which she rips opens in ex- ization Act mandates a proactive approach plan is the most important piece of doc- citement. While grabbing the toy to food safety, so sitting back and waiting umentation. Because this is a larger, over- Pout of the box, she drops it and screams, for issues to occur is no longer an option. arching document, focus on the pest man- spilling cereal all over the floor—there are Aside from the legal implications, being agement portion and what can be done to bugs in the cereal! proactive will help you protect your facil- update and improve it for now. While a It’s easy to see how pest problems ity and bottom line from pests. In today’s food safety plan should cover all aspects in a food processing facility can turn into globalized world, food processing facilities of the facility and products, for pest man- a big problem. Pests can directly hurt now have to pay attention to their supply agement specifically the plan should in- your bottom line by contaminating prod- chain too. clude details about all activities done to ucts or equipment, causing you to either proactively ensure products are protected throw out and/or replace costly ship- The Basics from pests. Make sure to incorporate all ments. If products make it all the way to Every food business should have an Inte- potential hazards, preventive controls, the consumer with pests, it could have grated Pest Management (IPM) program and corrective actions implemented to a devastating impact on your brand, to mitigate the risk of pest issues. These reduce risk. It’s also important to include especially with today’s social media programs—which emphasize customized, monitoring and verification procedures.

connectedness. proactive, integrated solutions whenever If possible, include information about ORKIN LLC

24 FOOD QUALITY & SAFETY www.foodqualityandsafety.com suppliers and their programs. A crucial issues need to be addressed immediately, safety plan every year. Specifi cally, look part of ensuring pest issues are traceable helping to make management decisions. at the facility’s pest problems and talk is to show that incoming and outgoing Pest management professionals should through how to resolve and prevent them shipments are being inspected, as this note activity each time they come out, and with a pest management provider. These will help catch pest issues before they get annual assessments will help uncover further down the supply chain. recurring problem areas and hot spots List of service changes. Every IPM around the facility, allowing you to better program needs to adapt and change as Make it a point to notify target the plan to address those concerns. pest pressure does. No two facilities are supply chain partners Also, auditors will be looking for these the same, and pest pressure can shift from when pest issues are yearly assessments. year to year depending on a variety of ex- traced back to them, Sighting reports. Pests and evidence ternal factors, like nearby construction of pests spotted within the facility should driving rodents from their homes. Any- as they might not be be recorded in a logbook. Typically re- time changes are made to the program, aware of these issues ferred to as a “pest sighting log,” this will note how and why the changes have been at their own facility. help a pest management professional re- made. At a minimum, review the plan at fi ne their investigation and better target least once per year. the areas most plagued. The report should Monitoring devices/traps. The best include information about the location of food safety plans include a map noting many already have systems in place that the pest problem within the facility, who monitoring equipment, traps, and any can pull together trend reports. Including found it, and the number of pests spotted. other devices used in and around the fa- this information will show any inquisitive Capturing the pest is ideal, but it’s not al- cility to minimize pest populations. For auditor you mean business when it comes ways feasible to do so. In that case, photo each device, record the locations and to proactive food safety. evidence helps with identifi cation, so ob- activity levels. The trend report from the Annual assessments. Review your tain a close-up picture of the pest(s) if pos- collected data will give insight as to what IPM program and how it relates to the food (Continued on p. 26)

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February / March 2019 25 Safety & Sanitation Pest Control

grease marks around corners and along Annual assessments will help uncover recurring problem areas and hot spots around baseboards. Search for gnaw marks the facility to better address concerns. around gaps and openings in walls and on products too. Remember, rodents want to be out of sight. That’s why they skitter along walls and stay away from humans as much as possible. Cockroaches. One of the most resilient and persistent pests around, cockroaches can get through miniscule gaps and will feed on just about anything, quickly becoming a terror for food processing facilities. If they’re not promptly removed, cockroaches can reproduce rapidly. A few cockroaches can create an infestation in a matter of months, especially with an abundant food supply. If a cock- roach is seen during the day, it’s a good sign it’s time to act quickly. Cockroaches are most active at night, so spotting one (Continued from p. 25) erator in charge of moving products into during the day likely means others are sible. Usually, employees will be the first to a warehouse could keep an eye out for lurking behind the scenes. see pest problems, so make sure they know stored product pests. Meanwhile, the em- To obtain this trend data and see the what to do when it happens! ployees working around the assembly line hot spots around a facility, monitoring It takes team effort to have a traceable, could be tasked with inspecting and wip- devices are likely necessary. Whether proactive IPM program. Typically, it’s rec- ing down equipment at the end of each using pheromone traps to reduce stored ommended that employees keep an eye day, which will help minimize attractants. product pest populations, bait stations to out for pests in areas most relevant to their There are a lot of ways to diversify roles trap rodents, or fly lights to capture flying job title and where they work. Don’t make it and make sure employees keep an eye out pests, these tools identify what types of too difficult for employees to complete -as for pests. If unsure about how to go about pests and how many are lurking behind signed inspections or else they won’t do it. this, talk to the pest management profes- the scenes. These documents can help trace when sional. For starters, employees need to Pests are resilient and persistent. and where pest issues began so businesses know the signs of pests. They’ll do whatever it takes to get to the can work on a customized solution to re- Stored product pests. Although there food, water, and shelter needed to survive. solve problems. Openly sharing news are many different species of stored prod- Pest pressure doesn’t just disappear about documented pest issues with sup- uct pests that can affect a food processing overnight. Consistent improvement and ef- ply chain partners can prevent pests from facility, all are adept at thriving in and fort are necessary to reduce it. But keeping sneaking into shipments and contaminat- around products undetected. The In- track of pest population trends around the ing product. dian meal moth, for example, has small, facility can help you and your pest man- cream-colored larvae that will eat just agement professional keep a pulse on the Making It Work about anything. Tiny and right at home in pests plaguing your business. To make this all work in reality, first, hold product packaging, these pests will wreck If your facility is affected by pests a training session in partnership with the a batch of products and then move on to and you haven’t implemented proactive, pest management professional and get as the next. Pheromone traps can help with traceable policies, you’re going to have a many employees there as possible. Discuss detection, so make sure employees know tough time finding and removing pests. the most common pests around the facility what they are and why they are there. Protect your brand from negative public- and where they’re most likely to be found. Rodents. Rats and mice can carry ity and your facility from costly shutdowns Then, arm employees with an action plan disease-causing pathogens, which can by keeping tabs on the pest populations they should use when a sighting does oc- rub off onto any surface the rodent comes and then do everything you can to keep cur. Everything should be recorded in the into contact with. Both rats and mice are them out. logbook, which will help ensure issues are capable of fitting through tiny gaps (mice The best time to implement a proactive resolved quickly. Make sure employees can fit through a hole the size of a dime, approach to food safety was yesterday. The know where to find it, and consider hav- while rats can fit through a hole the size of second-best time is now. ■ ing a few logbooks at different, convenient a quarter), so any gaps on the exterior of a Hartzer, a technical services manager for Orkin LLC, is a locations around the facility. building serve as a doorway. If rodents are board-certified entomologist and provides technical support and guidance across all Rollins brands in the areas of oper- Next, give some basic assignments to suspected but haven’t yet been spotted, ations, marketing, and training. Reach her at mhartzer@

employees. For example, the forklift op- look for droppings and yellowish-brown rollins.com. ORKIN LLC

26 FOOD QUALITY & SAFETY www.foodqualityandsafety.com SAFETY & SANITATION PEST CONTROL

PMP when a rodent is detected. Al- though features will vary by manufacturer, all systems will use three electronic devices: a sensor, a hub, and a mobile device. The sensor is placed in or on the rodent device, like a trap or station. The sensor communicates with an onsite Rodent Control hub, which communicates with an off -site data center. In turn, the hub is responsible with Remote Monitoring for communicating the sensor’s messages to the PMP via a text or email on a mobile Understanding how sensors allow pest management device. professionals to actively screen food facilities 24/7 The types of sensors used in pest man- BY PATRICIA HOTTEL, BCE agement programs vary depending on the manufacturer. Sensors currently on the market measure either motion, infrared, or a combination of both. It is important he ability to remotely monitor a These developments will allow pest man- to note that units incorporating motion wide variety of food safety-re- agement professionals (PMPs) to actively sensors can be subject to more false posi- lated processes is not new. Food control food facilities 24/7 in order to keep tive alerts, especially in high-traffi c areas. companies can remotely monitor all sites free of a variety of pests. For this reason, it is vital to consider the Teverything from door closures to food stor- While many food processors are ex- impact of human disturbance and vibra- age temperatures using this technology. cited for the opportunity to incorporate tions when determining proper placement There have even been several attempts in remote monitoring systems into their facil- of remote monitoring systems with motion recent years to use similar technology for ities, understanding these systems, along detectors. pest management purposes. Current re- with their advantages and disadvantages, The amount of back-end support of- mote monitoring systems primarily focus is crucial. fered with remote monitoring systems on rodent monitoring with the hopes of varies depending on the manufacturer. expanding to a variety of non-rodent mon- How Do They Work? For example, some manufacturers off er itoring devices in the future. Eventually, Remote monitors provide 24/7 monitor- mapping soft ware, which records place- the industry envisions to be able to utilize ing coverage of rodent control devices. At ments alongside tracking and trending these remote monitoring systems for other a minimum, remote monitoring systems capabilities. Others off er more basic soft - types of pests, including adaptations for will have a sensor to detect the pest, as well ware, which includes only sensor alerting

©PAKHNYUSHCHYY / LKESKINEN - STOCK.ADOBE.COM ©PAKHNYUSHCHYY insect light traps and pheromone traps. as a method of sending a message to the support. (Continued on p. 28)

February / March 2019 27 Safety & Sanitation Pest Control

Key Terms for Remote Monitoring Systems with the use of remote monitoring systems, False Positive False Negative McCloud used a sensor equipped multi- catch trap to prop open an exterior door A false positive signal occurs when the A false negative signal occurs when some- on a site. When the trap caught a mouse, a remote monitor sends an alert indicating thing has been captured or rodent activity service specialist was dispatched and un- there is rodent activity or capture, but has occurred, but the unit fails to send an covered certain employee behaviors that neither rodent activity nor a capture has alert of the activity. occurred. contributed to a potential pest problem. While the benefits of remote monitor- Impact of a false positive Impact of a false negative ing systems outweigh the detriments, the disadvantages include continuous techno- More of a nuisance factor. It causes inef- If the PMP has not been alerted to the logical advancements, as the development ficiencies as PMPs search for the reasons activity, they will fail to respond. The con- behind the false alerts. The false positive is sequences could include failure to control and launch of these systems have come not without consequences, but is typically an emerging rodent infestation or failed with challenges. This may explain the rea- less serious than a false negative event. audits. sons why it has taken so long to establish systems on the commercial market. Even manufacturers with products currently on (Continued from p. 27) monitoring systems can be particularly the market continue to tweak their systems Sites Most Conducive to Remote helpful. The pest management company to perfect the devices. It is like the regular Monitoring will still need to assess equipment and changes seen in other areas of technology, Some of the earliest adopters of remote strategize but daily visits may no longer be such as mobile phones. monitoring technology are those per- required. forming wildlife removal using live traps. To ensure trapped animals are treated Advantages and Disadvantages humanely, PMPs are required to visit the The main advantages of remote monitor- sites daily. This process can be labor in- ing systems are the ability to have 24/7 tensive and costly with no guarantee of a coverage and the opportunity to reduce capture. This is where remote monitoring routine inspection of equipment. McCloud systems are the most beneficial—since Services data reveals that on average 3 some systems utilize motion to signal ac- percent of interior rodent equipment is tivity, areas with less human disturbance showing activity in any one month, which and vibrations tend to be better locations requires weekly inspections to maintain for these types of sensors. Search for areas those monitors. Additionally, 24/7 cover- less subject to disturbance, as they are of- age creates an opportunity to gather more ten shadowy, protected areas that are more data and better understand the cause of likely to be visited by pests. It is important the rodent activity. When the sensor sends to avoid areas with the potential for move- an alert, a PMP can investigate and deter- Today’s remote monitoring systems are able to treat niche areas that were previously difficult to ment-related issues as this can prompt mine the “why” behind the capture right monitor. false positive reports due to station or trap away, reviewing potential causes like a movement, and can offset the value of the door left open, a certain product on the In addition to the systems themselves, systems. These false positives can also receiving dock, etc. costs associated with employee training cause PMPs to monitor an area more fre- Through continuous use and tests, need to be considered before implement- quently, causing an increase in labor costs. McCloud has learned how quickly a trap ing a system into a facility. Food processing plants, pharmaceu- may become ineffective. In one test, snap Remote monitoring systems provide a tical plants, and other sensitive facilities traps were triggered within hours of a visit. host of opportunities to learn more about are excellent candidates for remote mon- Once a snap trap is triggered, it is unable to rodents and increase the ability to effec- itoring systems because they can expedite capture additional animals. Learning this tively respond to pest intrusions in food the analysis of a rodent’s presence. These information has allowed PMPs to read- facilities. Professionals should become types of sites can benefit from niche uses, just their service visits to increase capture skilled in sensor placement in order to like monitoring the upper ledges of a pro- potential. protect from damage, false positives, and cessing plant that require assessing for There are also niche uses where moni- inaccurate detecting activity. And be pre- roof rats caused by exterior pressures. toring for rodents in the past was difficult, pared for the time required to manage and Monitoring systems also hold prom- including trapping rooflines, interstitial analyze the data each trap receives. This ise for use in intensive trapping programs areas, false ceilings, safety sensitive ar- includes further analysis of trends and where service follow-ups can be deter- eas where access is restricted, chronically root causes. ■ mined based on sensor alerts. For exam- blocked sanitation aisles, and roofs. With Hottel is a technical director at McCloud Services with close ple, in facilities with an elusive rat that is the advent of remote monitoring systems, to 40 years of pest management experience. Reach her at

not visiting the control devices, remote these niche areas are now treatable. In fact, [email protected]. MCCLOUD SERVICES

28 FOOD QUALITY & SAFETY www.foodqualityandsafety.com It is very obvious when management has a positive attitude toward food safety. That attitude echoes through the company as employees at all levels buy off on food safety. These operations are a pleasure QualityFSMS to work with and the term “food safety culture” is simply part of everyday life, whether they call it that or not.

2. Welcome Third-Party Audits Most operators are not overly thrilled about third-party audits. Many years ago, the National Food Processors Association safety audit was supposed to be the be- all and end-all for audits—an audit that would satisfy everyone. Today, the Global Food Safety Initiative (GFSI) audits are supposed to fill that role, yet many buyers do their own audits, so operators might end up having 10 or more audits over the course of a year. 10 Resolutions to Enhance Audits may be distasteful to some, but they should be treated as a learning tool and a means of improving operations. Quality and Safety Programs When I perform audits and am asked the Ideas to start the New Year right and improve upon question, “What do I need to pass?” my sense is that the company is not quite clear food safety management systems | BY RICHARD STIER on the concept. Audits are supposed to be a check on how an operation is performing, e are beginning a new year, steps to Hazard Analysis and Critical Con- that is, “Do you do what you say and say which often means it’s time trol Points (HACCP) as highlighted in the what you do?” Ideally, the auditor needs for New Year’s Resolutions. Codex HACCP document and those man- to look at what the company is doing and For individuals, this often dating the adoption of HACCP for seafood have the knowledge and experience to Wentails things like exercise regularly, lose and juice. Management responsibility was determine whether that is effective. Hope- 10 pounds, or get something fixed around also a key element of the ISO 22000:2005 fully, your auditor is not simply filling out the house. For food, beverage, and ingre- standard and remains so in the updated a checklist but digging down and looking dient processors, the new year may involve 22000:2018 standard. All food, beverage, at whether programs are both compre- implementation of new programs based and ingredient processors should seri- hensive and effective. Auditors are not on the previous year’s performance. Al- ously consider incorporating the com- supposed to consult, but there is nothing low me to present 10 points (or resolutions) munication element into their food safety wrong with picking their brains when on that might be considered as part of contin- management system. Far too many opera- site. The auditor may have observed things ually improving your food quality, safety, tions do not establish formal, documented elsewhere that can benefit you. and sanitation programs. protocols for communication. The importance of management taking 3. Appoint a Document 1. A Commitment from Management an active and all-encompassing role in a Control Officer Management commitment is an essential food safety program may be demonstrated With the emphasis on documentation in element for ensuring the production of by looking at what happened to the top guy the GFSI audit schemes, ISO 22000, and high quality, safe, and wholesome foods. at Peanut Corp. of America. He is now be- the Preventive Controls for Human Food Personally, I always felt it should have hind bars for what may be the remainder regulation in the U.S., documentation is

©FIZKES - STOCK.ADOBE.COM been included as one of the preliminary of his life. (Continued on p. 30)

February / March 2019 29 Quality FSMS

(Continued from p. 29) safety management system as a verifica- industry has for ensuring the production an absolute must to pass audits and ensure tion activity. It should also be compiled of safe food. Obviously, FDA believes sani- regulatory compliance. Documentation electronically so the company can easily tation to be important as it has specifically must include procedures, work instruc- look at how products perform historically. defined it as one of the preventive controls tions, and development of forms for re- If you are one of those operations that has within the Preventive Controls for Human cord maintenance. The company must piles of data sitting in old file cabinets, Food regulation. Sanitation preventive develop the protocols, properly document consider doing something with them. Hire controls will be required for many ready- them utilizing a standard format, imple- someone who can compile the informa- to-eat products and for products contain- ment the protocols including proper use tion and then follow your recordkeeping ing food allergens. of any recordkeeping forms, and maintain mandate to get rid of anything that should During hazard analysis, the processor programs—that is, make sure the system be disposed of. must determine whether there are haz- is working. ards that require sanitation preventive 5. Read Labels During Production controls. Ideally, the processor will then The most common cause of allergen recalls develop, document, and implement the Data need to be compiled is the use of the wrong label or package. necessary programs to ensure the haz- and turned into usable You would think processors would get the ards determined to require a preventive information that can message that putting the right label on a control are in fact controlled. The opera- package is an absolute necessity. Recalls tor should then validate the cleaning and aid in making decisions. cost money, time, and can damage a com- sanitation protocols and ensure the vali- pany’s reputation. dated program is followed. Validation is According to Amy Philpott, senior not required in the regulation, but it is a An integral part of implementation is director, Watson & Green, LLC, “A 2011 best practice. training and education: making sure the joint industry study by the Food Market- Processors should take a close look at persons responsible for doing a task know ing Institute and Grocery Manufacturers each cleaning and sanitizing procedure how to do it. The company must document Association estimated the average cost of they develop. This would encompass all each of these two elements. Development a recall for food companies to be $10 mil- equipment, utensils, floors, walls, ceil- and implementation are the responsibility lion in direct costs, plus brand damage and ings, drains, overheads, and more. They of the different operating groups within the lost sales. Although this is old data, it still should also conduct a risk assessment on company, but someone needs to manage seems to be the most commonly referenced each procedure to make a clear determi- all the necessary documents, and that per- in the food industry.” nation not only whether that area poses son should be a document control officer. Philpott also observes that recall costs a risk, but also whether the procedures This individual must ensure documents depend on a wide range of variables. that have been established are adequate are prepared using a standard format, that So, processors, I urge you to develop, to control the risk. they are signed off by developers when document, and implement programs to they are newly developed or revised, that ensure the right label on the right package. 7. Validate Processes and Products they are distributed to the proper individu- Look at the different scanning technolo- Validation is defined as obtaining evi- als, and that old documents and forms are gies; develop and implement programs dence that the elements of the HACCP collected and destroyed. The document to verify that new labels match the mas- plan are effective. The Preventive Controls control officer does not necessarily have to ters when they arrive; do what you can for Human Food regulation mandates all be part of the quality group, but they must to minimize the potential that the wrong process preventive controls, that is, the have computer skills and understand orga- label is applied by clearly segregating la- critical control points from HACCP, be nization. If you don’t already have a docu- bels in storage and when used; and make validated. The GFSI audit schemes, espe- ment control officer, consider establishing sure any old or discontinued labels are cially FSSC 22000, which is based on ISO such a position. destroyed so they cannot possibly be used. 22000, mandate that prerequisite programs used to control hazards must be 4. Use Your Data validated. In reality, this can pose a chal- It bothers me to see companies with piles lenge since some controls simply don’t of data that have simply sat in file cabinets lend themselves to being easily validated. and collected dust. Data need to be com- Food processors should also take a piled and turned into usable information close look at their products to determine that can aid in making decisions. whether they are bacteriostatic (inhibi- In today’s food industry, buyers often tory to pathogens) or bactericidal (lethal mandate that each lot of ingredients, raw to pathogens). There are a wide variety of materials, or finished goods they receive products on the market such as carbon- be accompanied by a Certificate of Anal- 6. Risk-Based Sanitation Programs ated soft drinks, soy sauce, syrups, and ysis (COA). The data generated when pre- Properly developed and implemented san- condiments that are lethal to pathogenic paring a COA may be utilized in the food itation is one of the best means the food bacteria. If a company allocates resources ©AUREMAR - STOCK.ADOBE.COM

30 FOOD QUALITY & SAFETY www.foodqualityandsafety.com to conduct a challenge study that shows 9. 5S Adoption liability issue. To ensure foods are safe, their products are lethal to pathogens, 5S may be defined as a program to reduce workers must follow the documented they should not only sleep easier know- operational steps and improve the overall procedures, so training must be based on ing their products are safe, but they would cleanliness of a work area, making it safer those procedures. Refresher sessions are not have to do environmental monitor- and more productive. This definition can recommended on a yearly basis. ing since the Preventive Controls regu- be expanded to say that development and lation in 21 CFR Part 117.130(c)(2) states implementation of the program can also the following: enhance overall food safety and quality. If Don’t forget to look at the (ii) The hazard evaluation required one wishes to summarize the 5S program, ingredients and finished by paragraph (c)(1)(i) of this section must it can be described simply as “Everything include an evaluation of environmental has a place and everything in its place.” product characteristics and pathogens whenever a ready-to-eat food is The program was first developed in Japan relate those how patho- exposed to the environment prior to packag- with the five “S”s asseiri, seiton, seiso, gens and spoilage organ- ing and the packaged food does not receive seiketsu, and shitsuke. These translate to a treatment or otherwise include a control sort, set location, shine and sweep, stan- isms may be inhibited. measure (such as a formulation lethal to the dardize, and sustain. pathogen) that would significantly minimize I encourage processors to consider the pathogen. the 5S method. It can, as noted above, en- Part of the education process is ad- hance food safety, quality, and sanitation dressing the potential worker safety issues simply by better organizing overall opera- and making sure they understand that tions. Companies that have implemented phase of the job. Are they handling chem- the program are generally amazed when icals? Then they must be taught about safe they discover how much junk they got rid chemical handling and proper use of per- of with the first step of “sort.” This frees sonal protective equipment. This needs to up space in the warehouses, production be documented. If a worker is injured on area, and other locations. Think about it: the job as a result of a chemical, the com- How much stuff do you have in your facil- pany will be liable for the injuries. If there ity that simply collects dust? Employees is no record that the person was properly 8. Get Back to the Basics of Food in the shop never want to get rid of things trained, then the company can be deemed Microbiology as they “might” use it someday. If you ask negligent and may pay penalties. Sometimes I wonder whether the food in- how long something has been here, you’ll It is imperative that training materi- dustry has forgotten the basics from food often get an answer like, “Before I joined als be applicable to the job and the plant. microbiology 101. The rapid methods and the company, which was 10 years ago.” Utilize group exercises, take pictures of new tools for testing and analysis are ex- operations in the facility so it is more ger- tremely powerful additions to the food mane to the tasks at hand, and encourage safety toolbox, but our goal is to produce participation. Make the learning enjoy- safe, wholesome, and high-quality foods. able. Many workers look at training as a This should be accomplished through for- pleasant break from their day-to-day job, mulation, and there are ingredients and so consider this aspect in developing and processes that, when utilized properly, scheduling educational programs. can create products that may be inhibi- Another potential benefit of such pro- tory and/or lethal to pathogens. grams is they may help a company keep One product characteristic often ig- its workers. With reduced turnover, a com- nored and definitely under-utilized is 10. Educate, Educate, Educate pany has a stronger and more knowledge- total acidity. Processors and regulators A company can never devote too many re- able workforce and educational costs may have become overly infatuated with pH sources toward educating its workforce. be reduced since it takes more time and and seem to forget that some foods have Education starts as soon as a worker effort to work with a new employee. greater buffering capacity. Mayonnaise joins the company. He or she will un- If you’re already doing some or all of is routinely blamed for outbreaks asso- dergo an orientation that should address these, I say “Bravo!” If not, there’s no time ciated with products like chicken or egg food safety, sanitation, allergen control, like the present to get started. Good luck salad, but it is not the mayonnaise that is personal hygiene, food defense, worker in 2019! ■ the culprit. Mayonnaise has a very high safety, and other topics. Workers need to total acidity, which makes it a very safe be trained on each task they perform, and Stier, industry editor for Food Quality & Safety magazine, is a consulting food scientist with international experience in product. Don’t forget to look at the ingre- those sessions must be properly docu- HACCP, plant sanitation, quality systems, process optimi- dients and finished product characteris- mented. It is not simply a question of mak- zation, GMP compliance, and food microbiology. Reach him at [email protected]. tics and relate those how pathogens and ing sure that a person knows how to do a spoilage organisms may be inhibited. task properly; it is, unfortunately, also a References Provided By Request ©LUCHSCHEN / AUREMAR - STOCK.ADOBE.COM

February / March 2019 31 cluding humans; the toxins do not harm the shellfish themselves, however. “Because these blooms tend to form in warmer waters, shellfish producers often ramp up their testing in summer months,” TestingSEAFOOD says Neogen’s Kevin Mullholland. “How- ever, in the face of gradually warming ocean temperatures, blooms have been popping up more frequently during the rest of the year in traditionally cooler waters around the globe. Experts have noted the possibility of more frequent algal bloom events in the future, requiring toxin testing more often across a wider area.”

Well-Known Types of Poisoning Amnesic shellfish poisoning (ASP). This condition is caused by domoic acid, which is produced by Pseudo-nitzschia spp. diatoms (a type of microscopic algae). Razor clams are most commonly associated with ASP, but mussels, crabs, and oysters can also be contaminated with domoic acid. In addition to nausea, vomiting, cramps, and diarrhea, ASP can cause neurological symptoms: confusion, dizziness, headaches, seizures, car- diac arrhythmia, and short-term memory loss that can become permanent. Symp- toms usually occur within a day, and neurological symptoms take closer to 48 Targeting Shellfish Toxins hours. Severe cases can lead to death. Stringent testing programs stop unique threats in seafood Diarrhetic shellfish poisoning (DSP). Okadaic acid produced by the dinoflagel- BY ALLISON HAMMERLY late Dinophysis causes DSP. The symptoms of DSP are generally more mild than other forms of shellfish poisoning, and include eafood products present unique ing effects of shellfish toxins, and to meet abdominal cramps, nausea, vomiting, food safety concerns beyond the regulatory limits for those toxins, is a strin- and diarrhea. usual pathogens and other risks— gent testing program. Shellfish toxins are Neurotoxin shellfish poisoning the marine environment from heat stable, meaning there is no cooking (NSP). Breve-toxins or their analogs cause Swhich they are harvested creates condi- kill-step to eliminate them in food. They NSP, which can trigger nausea, vomiting, tions that can threaten consumer health are also invisible to the naked eye, making and slurred speech when in different ways from the most common scientific testing the only way to iden- consumed. forms of food poisoning. Shellfish can be tify their presence. contaminated with a number of marine Shellfish toxins are produced biotoxins, and certain species of fish are naturally by marine micro-al- prone to building up damaging levels of gae, and they reach prob- histamine toxin in their systems as they de- lematic numbers only when compose. Proper sanitation and traditional large algal blooms form in the kill-steps cannot prevent these food safety water. Bivalve shellfish such Paralytic shellfish poisoning threats, so testing becomes the key way for as mussels and oysters are filter (PSP). An unusually high mortality rate producers to protect consumer health. feeders, feeding on small particles is associated with PSP. The condition is in the water including toxin-containing caused by any of about 20 toxins derived Shellfish Toxins micro-algae. The toxins from the algae can from the neurotoxin saxitoxin. It is most The principal way for shellfish producers bioaccumulate to levels that can harm any often associated with molluscan shell-

to safeguard consumers from the damag- organism that consumes the shellfish, in- fish, gastropods like moon snails, and ©BARAMEEFOTOLIA / ZIQUIU - STOCK.ADOBE.COM

32 FOOD QUALITY & SAFETY www.foodqualityandsafety.com crabs that feed on other shellfish. It vent are pumped through a column with takes usually under two hours for packing material that makes molecules symptoms to appear in an infected with certain properties travel faster, while person. Symptoms include tingling others travel more slowly. A reader ana- mouth, fingers, and toes, followed by lyzes the separated compounds to de- a loss of motor control in the arms and termine the substances that made up legs. If enough toxin is consumed, a per- the original sample. son might experience difficulty breathing or even paralysis of respiratory and chest Histamine muscles, causing suffocation. For these A chemical compound. histamine is re- reasons, PSP can quickly become deadly. leased by cells when damaged (or as part “The issue producers face, then, is For testers processing a of an allergic reaction). High levels of his- finding a consistent, accurate, and easy- large number of samples, tamine may develop in a variety of fish to-use method for testing their shellfish species as they decompose, especially for the toxins that produce these condi- immunoassays are avail- when they are not kept at suitably cold tions,” says Neogen’s Brooke Roman. able in microwell formats, temperatures. These species include tuna, “Testing methods can be qualitative, which allow the testing mahi-mahi, marlin, bluefish, sardines, meaning they simply screen for the pres- anchovy, bonito, herring, and mackerel. ence of any given toxin, or they can be of up to 96 samples Histamine poisoning is also sometimes quantitative, meaning they provide a pre- at the same time. known as “scombroid poisoning” because cise value that can be used to determine some of the earliest fish associated with where a product’s toxin level is at relative the condition were members of the subor- to regulatory limits.” der Scombridae. move user subjectivity when reading the When it affects humans, histamine Toxin Testing Methods test strips. The electronic readers can be poisoning can cause red blotches to appear There are multiple ways to test for shellfish networked and can also store test data, on the skin, nausea, a burning sensation in toxins, and the method a producer uses making recordkeeping easier for the user. the mouth, headaches, muscle weakness, depends on their capabilities and needs. “These tests are easy for anybody abdominal pain, diarrhea, wheezing, and A more recent technological devel- to conduct, and don’t require specialist swelling of the face and mouth. Symptoms opment in the field of shellfish testing training,” says Roman. “They’re portable, can appear within a half-hour of consump- is the lateral flow immunoassay. Often making them easy to use right on the boat tion and usually last a few hours. compared to home pregnancy tests, these or elsewhere onsite or in the field. They’ve “In rare cases, histamine poisoning test strips screen for the presence of spe- made testing easier and more affordable has been deadly, and so histamine testing cific marine biotoxins and offer results in for operations that use them.” of fish products is generally considered an just minutes. For testers processing a large number important part of a Hazard Analysis and An example of how these tests work is of samples, immunoassays are available in Critical Control Point plan for certain fish as follows: A shellfish sample, prepared microwell formats, which allow the test- species,” says Roman. for testing by a simple extraction process, ing of up to 96 samples at the same time. is absorbed into a test strip, and travels up- These formats are often known as ELISAs wards toward a reagent (a substance that (enzyme-linked immunosorbent assays) provokes chemical reactions). This reagent or EIAs (enzyme immunoassays). zone contains antibodies specific for the “For those unable to test onsite, send- targeted toxin. If the toxin is present in the ing samples to independent laboratories shellfish extract, a chemical reaction will is another method,” says Mulholland. occur, resulting in lines being displayed “These methods are highly scientific and on the test strip that indicate a negative are run by experienced chemists. Most or positive result—no toxin is present, or lab tests for shellfish toxins are liquid toxin is present above a predetermined chromatography methods, including liq- level. Most tests take under 10 minutes to uid chromatography-mass spectrometry Both lateral flow and microwell tests complete from start to finish. (LC-MS) and high-performance liquid are available for histamine testing and are Some test strips can be read visu- chromatography (HPLC). These are quan- just as easy to run as similar tests for shell- ally. However, visual interpretation of titative methods that can identify toxins fish toxins. Laboratory testing methods, the results between different people can in a wide range of shellfish from around such as HPLC and LC-MS, can also be used vary. Problems can arise when differen- the world.” to determine histamine levels. ■ tiating between low positives and high Both HPLC and LC-MS work by de- negatives. In light of this, some compa- constructing the compounds that make Hammerly is a writer for Neogen. She can be reached at [email protected]. ©JOSHHH / THOMAS FRANCOIS - STOCK.ADOBE.COM nies now offer electronic readers that re- up shellfish toxins. The sample and a sol-

February / March 2019 33 illness. Several studies have documented long-term survival of pathogens in LMFs, and Salmonella spp., STEC, and Crono- bacter survive from days to years in low moisture conditions. In addition, the In ThePATHOGEN CONTROL Lab pathogens show increased resistance to heat treatment in LMFs and exposure to low water activity confers cross-tolerance to other stresses, including low pH, bile Aim High When salt tolerance, resistance to disinfectants, UV irradiation, and heat. The pathogens Detecting Pathogens in LMFs have also been shown to have a low infectious dose (10 to 100 CFU) to in Low Moisture Foods cause illness. This is well documented from several studies of Salmonella out- From validated and verified cleaning regimens to breaks from LMFs (chocolate, peanut, automated pathogen testing practices, detailed work- paprika powder, and others), where very flows are helping processors deliver safe products low numbers of cells were present in the contaminated product (about 13 CFU/g) BY RAJ RAJAGOPAL, PHD in contrast with the high infectious dose (>105 CFU) for other contaminated foods. Consequently, there is a global recognition that these foods need to be moni- tored and managed for microbiological hazards, and many regulatory agencies including FDA, USDA, Health Canada, European Food Safety Authority, and Co- dex have developed guidelines for managing these foods. FDA has developed the Preventive Controls rule for human food and animal food that can come in contact with humans. Similarly, the Codex Ali- mentarius Commission has developed a Codex Code of Hygienic Practice for Low Moisture Foods. Increased surveillance of LMFs has been implemented under the Food Safety Modernization Act (FSMA), ow moisture foods (LMFs)—foods Salmonella and E. coli O157) need water Canadian Food Inspection Agency’s Food that are naturally low in moisture activities of 0.91 or higher to grow. Safety Action Plan, and Codex guidelines. or made through processes such However, just because these bacte- In addition, several industry guidelines as drying or dehydration from ria have growth challenges doesn’t mean describe methods to limit or reduce Salmo- Lhigher moisture foods—include but are they can’t survive. Numerous outbreaks nella and other pathogens in nuts, spices, not limited to cereals and grains, flours, of foodborne illnesses have been linked to and other foods (see Table 1). milk powder, powdered infant formula, LMFs contaminated with Salmonella spp. Pathogens are most often introduced spices, chocolate, dried fruits and vegeta- (peanut butter, chocolate, milk powder, in LMFs via contaminated ingredients bles, nuts and nut products, dried protein crackers, almonds, infant cereals, spices), or cross-contamination during process- items, coffees and teas, pet food, and ani- Bacillus cereus (rice, nuts, herbs, spices), ing. Regulatory agencies such as FDA mal feed. LMFs have low water activity, a Cronobacter sakazakii (powdered infant therefore recommend conducting haz- measure of free water that is an important formula), Clostridium spp. (herbs, spices, ard analyses for preventive controls for factor in food safety because it determines dried tofu), Shiga toxin-producing E. coli human food, and manufacturers need the amount of water available to help mi- (STEC) strains (flour, walnuts, almonds, to consider the potential for biological, croorganisms grow. rice, seeds), and Staphylococcus aureus chemical, and physical hazards relating For many years, it was thought that (rice, seeds, nuts, almonds). It is gener- to their raw materials and other ingredi- LMFs were safe from microbial contami- ally agreed that pathogenic bacteria can ents (ingredient-related hazards), pro- nation. After all, LMFs are defined as hav- remain viable in these foods for long pe- cesses (process-related hazards), and ing water activity levels less than 0.85 and riods of time and, given the opportunity the food-production environment (facili-

most bacteria (including pathogens like and right conditions, can grow and cause ty-related hazards). Regulatory guidelines - STOCK.ADOBE.COM ©JULIÁN ROVAGNATI

34 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Table 1: LMF industry guidance for pathogen reduction itation processes, and implementing and Source Guidance Link monitoring validated lethal processes—is GMA (2009a) The Grocery Manufacturers www.gmaonline.org/downloads/tech- critical to ensure safer LMFs. Although Association (GMA) Salmonella nical-guidance-and-tools/Salmonella- today’s thermal (heat) processes coupled control guidance ControlGuidance.pdf with continuous monitoring are proba- GMA (2009b) GMA’s annex to control of www.gmaonline.org/downloads/ bly adequate, there is significant room Salmonella in LMF wygwam/Salmonellaguidanceannex. for improvement. pdf Thermal processes for nuts include oil GMA (2010) GMA’s industry handbook for safe www.gmaonline.org/downloads/tech- roasting, dry roasting, and blanching as processing of nuts nical-guidance-and-tools/Industry_ more traditional practices, but heat can Handbook_for_Safe_Processing_of_ Nuts_1st_Edition_22Feb10.pdf also be applied through steam, infrared heat, and other means. Pasteurization has ASTA (2017) The American Spice Trade www.astaspice.org/download/129 Association’s clean safe spices been successfully applied to raw almonds to reduce the presence of Salmonella. Some AFIA (2010) The American Feed Industry www.ucfoodsafety.ucdavis.edu/ Association’s Salmonella control files/172958.pdf emerging technologies for LMFs include guidelines radio frequency and microwave heating, Anderson, Validating the reduction of www.opxleadershipnetwork.org/ nonthermal plasma, pulsed light, UV light, DG, Lucore, LA Salmonella and other pathogens food-safety-plan-validation/down- irradiation, propylene oxide, ozone, and (2012) in heat processed LMF, by the OpX load/validating-reduction-salmonel- novel drying technologies such as micro- product safety solutions group la-and-other-pathogens-heat wave drying, vacuum drying, super-heated steam drying, infrared drying, and freeze also recommend good hygienic practices, to FSMA, “Foods such as peanut butter, drying. Although high-pressure process- hygienic design of equipment, proactive soft cheeses, dried dairy products for use in ing has been successfully applied to high maintenance programs, control of incom- RTE foods, and roasted nuts are among the moisture foods, efficacy in LMFs is not well ing materials, and effective ingredient con- products for which manufacturing opera- understood. Additional research is needed trol in the LMF establishment to prevent tions would need to have an environmen- to understand these technologies’ applica- contamination. The Codex advises that tal monitoring program when such foods tion to LMFs. special attention be paid to those products are exposed to the environment.” exposed to the processing environment In addition, when environmental Pathogen Detection Technologies following a pathogen reduction step (such monitoring results are gathered both prior and LMFs as almonds and pistachios), products that to and following cleaning, manufacturers Eliminating or preventing pathogens en- are not subjected to a pathogen reduction gain a good sense of the overall effective- tering the production process through raw step (such as flour and dry mixes), and ness of their hygiene controls and sanita- material screening and finished product products for which ingredients are added tion program. Armed with strong before testing are key to ensuring safe product after a pathogen reduction step (such as and after data, they can make the nec- is delivered. Unfortunately, processes herbs and spices). essary adjustments to improve cleaning that rely on inadequate or incorrectly strategies, practices, and training. used technologies can thwart a lot of Beyond Finished Foods: Carefully designed and implemented well-meaning work. Production Environments sampling programs also bring the benefit High-performing pathogen testing In contrast to the historical focus on test- of detecting sites potentially harboring technologies are able to identify intact ing finished products for pathogens just pathogens. To that end, LMF manufactur- pathogens, as well as pathogen cells that prior to release with little or no attention ers are advised to perform environmental may have been damaged by freezing, dry- given to the processing operation and swabbing and analysis using a hygienic ing, antimicrobial treatments, or other environment, new guidelines and regu- zoning system based on food safety risk. processing conditions. Pathogen detection lations place more attention on environ- An example would be Zones 1 through 4, methods typically require an enrichment mental monitoring and entire process with Zone 1 being product contact sur- step to allow bacteria to grow to detectable operation as means to prevent pathogen faces, Zone 2 being surfaces immediately levels, and this nourishment and recovery contamination. over or next to the product, then moving to step is especially critical for LMFs. Patho- The FSMA Preventive Controls rule, for Zones 3 and 4, with Zone 4 being furthest gens in these foods can be severely dehy- example, focuses both on environmental from the product. drated due to the low water activity, and monitoring and finished product testing recovery and detection of desiccated bac- for human food. In addition to recom- Pathogen Control in LMFs teria from dry matrices and environments mending that raw materials, ingredients, Every step of the LMF production chain— is critical. and end products be tested, FSMA highly from sourcing of raw commodities and Manufacturers of food—LMFs or oth- recommends environmental monitoring of ingredients, preventing cross-contam- erwise—mostly utilize one of two test tools pathogens in LMF and ready-to-eat (RTE) ination from harvest, to post-process, for detecting the bacteria in their low mois- food processing environments. According employing effective dry cleaning and san- (Continued on p. 36)

February / March 2019 35 In The lab Pathogen Control

(Continued from p. 35) Table 2: LAMP vs. PCR comparison ture products: culture-based tests and LAMP PCR rapid methods. Traditional culture-based Isothermal reaction (60°C to 65°C) Thermal cycling reaction (repeated heating tests rely upon growth of pathogens in a and cooling at 95°C and 60°C to 72°C) selective media followed by counting of Uses four to six primers based on the six Uses only two primers visible colonies based on certain traits, distinct regions of the target gene such as their ability to grow in the pres- Loop primers accelerate the reaction Use of probes in real-time PCR add additional ence of a particular chemical (e.g., salts, and increase sensitivity (two additional specificity and enable ease of detection bile) or their ability to utilize particular recognition site) chemicals or nutrients. Rapid methods Simple, inexpensive instrument Needs thermocycler (heating and cooling) and for foodborne pathogen detection have expensive instrumentation for fluorescence evolved over the last several years with detection fundamental advances in immunology LAMP bioluminescent technology enables Results available at the end of the run and molecular biology and applications real-time detection (>1 hour) of these advances to testing methods. The Tolerant to sample matrix inhibitors Sensitive to sample matrix inhibitors accuracy of these rapid methods is gener- Streamlined protocols (similar for all targets), Varied protocols and run conditions ally validated against the same standard with minimal steps (depending on target) methods used in culture methods—FDA BAM, ISO, or USDA MLG, for example. amplify DNA, relying on instrumentation with other technologies. WGS is an emerg- However, compared to traditional culture capable of rapidly heating and cooling. In ing technology for food safety applica- tests, these rapid methods not only offer addition, PCR methods typically require tions, but it is mainly being used by regu- enhanced accuracy but drastically reduce multiple steps for processing enriched latory agencies such as FDA and USDA to the time-to-result of food testing (next day food samples and amplify target DNA for pinpoint sources of contamination during findings rather than three days to a week) detection of pathogens. outbreaks. Its wide use for routine food and provide greater ease of use. Newer DNA-based methods such as safety testing is debatable given the cost When it comes to rapid methods, the LAMP (loop mediated isothermal am- and complexity of the method. antigen/antibody-based assays such as plification) technology that 3M commer- ELISA or lateral flow have been in use for cialized offer an alternative to PCR (see LMF, High Economic Pressure many years, but a growing concern with Table 2). These tests are also globally vali- Businesses these methods is the cross-reactivity with dated for their ability to detect the Salmo- The LMF industry is focusing on major non-target organisms. DNA-based meth- nella, E. coli O157, Cronobacter, and other changes to produce the highest food qual- ods are generally considered to be more ac- key pathogens implicated in LMFs, but ity. New requirements are being enacted curate, as they target a specific and unique with fewer steps and simpler instrumen- in supply chain controls, environmen- DNA sequence of the bacteria. tation. LAMP uses Bst polymerase that tal monitoring programs, training, and Among the several kinds of DNA- has strand displacement activity, allowing recordkeeping. Greater enforcement of based rapid methods, polymerase chain amplification at a single temperature with- food safety laws and regulations is push- reaction (PCR) has been widely used for out the need for cycling through series of ing LMF manufacturers to place safety at foodborne pathogen detection, and there temperatures. In addition, Bst polymerase the forefront. are multiple vendors offering validated has been shown to be more resistant to in- LMF processors are forced to balance PCR methods to detect Salmonella, STEC hibitors from media or food matrices that countless procedural, competitive, and (O157 and non-O157), Listeria spp., L. may compromise PCR results. The 3M Mo- economic pressures alongside needs to monocytogenes, Cronobacter, and other lecular Detection System based on LAMP cut testing time and release products to organisms. PCR uses Taq polymerase and integrates a proprietary bioluminescence market faster. But as recent outbreaks and repeated cycling (heating and cooling) to solution for detection that offers a sample recalls attest, it’s imperative that they not preparation process with only two transfer take their eye off the ball when it comes to steps and no need for DNA extraction and food safety. With goals of mitigating risk purification steps. at every step and improving operational The PCR and LAMP assays have been efficiencies and productivity, thoughtful validated for various LMFs. Manufacturers workflows—from expertly designed, val- need to select an appropriate method to idated, and verified cleaning regimens to fit their purpose and need based on com- more automated pathogen testing prac- parative benefits such as cost, ease of use, tices to safe storage approaches—can help and validations. LMF products safely and sufficiently reach Lastly, whole genome sequencing consumers. ■ (WGS) provides the complete DNA makeup The 3M Molecular Detection System offers a Dr. Rajagopal is a senior global technical service specialist sample preparation process without DNA extraction of a test subject, allowing organisms to be with 3M Food Safety. Reach him at [email protected].

and purification steps. differentiated with precision not possible References Provided Upon Request 3M FOOD SAFETY IMAGE CREDIT:

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

generation sequencing (NGS). This method is dramatically changing the ana- lytic approach, moving from the detection of one or a set of species to determining all DNA and Food species in a sample. Currently, NGS is the only method that Traceability ensures the correct identification of species in complex foods. Its use by all major Next-generation sequencing is laboratories for food authenticity analysis being used to assess the integrity is increasing. of food from a raw material to The NGS method is based on DNA a final product analysis through DNA sequencing and produces millions of individual DNA BY MÁRIO GADANHO, PHD, sequences all grouped in a single file. AND FRANCK PANDIANI, PHD With NGS, different sequences can be produced from the various DNAs com- posing the food product. This means that the method is appropriate to use in products containing many ingredients visually not identifiable and mixed. Basically, since each different ingredient contains a unique DNA sequence (its own fingerprint), NGS will virtually sequence each one of the DNA molecules present in a sample to produce individual DNA sequences for each. Therefore, un- like the Sanger DNA sequencing method oday’s food industry is truly Within food traceability, one of the hot that originates only one DNA sequence global, involving producers and topics is food authenticity to guarantee the from a food sample, NGS is the method manufacturers from around the correct composition of a product according of choice for DNA sequencing identifi- world. Consumers are increas- to the description of that product and what cation of products containing multiple Tingly demanding transparency about food is expected to be included in it. ingredients. composition. However, ensuring trace- Today we are seeing food authenticity Using appropriate software, the scope ability along the entire supply chain, from being introduced to the routine testing of NGS is virtually unlimited and it can primary production to the end-consumer and regulatory arena. Recent food fraud be used on any kind of sample DNA, product, is challenging. The number of in- scandals mean it is imperative that the whether it contains different DNA termediaries and geographical locations industry be able to identify the food in- sequences or not. This means that any involved in manufacturing processes cre- gredients that compose each food prod- kind of species can be detected, as the ates a network that requires the most ad- uct, whether meat-, fish-, or plant-based. analytical method is no longer focused on vanced traceability systems. However, ready-to-eat products that are detection of a limited number of species. On the analytical side, food traceabil- generally composed of several ingredients Despite different NGS platforms avail- ity remains a challenging topic. The aim are more complex, particularly if those able in the market, all of them are used of the traceability system is to guarantee ingredients are sourced from different to obtain sequences of defined regions the integrity of food from a raw material geographical origins, each with its own in the DNA molecules and produce huge to a final product for the end consumer. requirements. This means that the global text files containing millions of individual Many methods have been proposed to food industry needs to adapt to the chal- sequences. track ingredient composition and iden- lenges presented by a dynamic and rapidly Specific genes are well known for spe- tification along the supply chain. How- growing food market. cies identification and include nuclear ever, until now, very few methods have (e.g., ribosomal RNA genes), mitochon- been identified that can really tackle this Popularity of NGS drial (e.g., COI), and chloroplast (e.g., complex problem. These include DNA- The introduction of DNA-based tracing rbcl). When a sample is analyzed the based methods more focused on species methods brings new and very powerful question is no longer: “Are species X, Y, or identification and chemical methods, like tools for identification of many ingre- Z present in the sample?” Using NGS the stable isotopic analysis, which is a very dients in processed food products. One question is: “Which species are present in powerful tool for origin and wild/farmed of the most recent DNA-based methods the sample?”

February / March 2019 37 In The Lab Authenticity

(Continued from p. 37) DNA regions and comparing the results laboratory working in food production. Since all sequences obtained can be with the same DNA/species databases Additionally, NGS has been introduced compared with a specific DNA database, used for the classic Sanger DNA sequenc- into standardization, namely at the ISO each match between the obtained NGS ing approach. level, to start to define the minimum sequences and the database originate requirements related with all pre- and a species ID result, producing a list of The DNA Sequence Database post-bioinformatic analyses required species instead of a presence/absence One of the key points when using a during NGS analysis. This includes not result for targeted species. Additionally, DNA-sequence producing method like only the DNA sequence itself that depends using appropriate software, a ratio of DNA NGS is the reliability of the databases that on the NGS platform used, but also the sequences obtained for each species can are used for species identification. Many definition of the DNA regions to be ana- be created. Due to the untargeted nature efforts have been made in recent years lyzed and the DNA databases used for spe- of this method even exotic species can to try to ensure the reliability of the DNA cies identification. be identified. sequences contained in the databases, The availability and use of an untar- including using reference material that is geted approach is of great importance. The Challenge of Fragmented DNA Experience tells us that when authenticity DNA-based methods are limited by the issues are involved, a targeted approach is need to obtain DNA fragments with the not suitable, as it will only deliver a result necessary integrity to perform the analy- for the species targeted. If a product consis. In some products, specifically those tains any additional species besides those that have been highly processed, ingredi- targeted by PCR analysis, no information ent DNA can be highly fragmented or even will be available. absent. When DNA is highly fragmented, it is essential to guarantee that the DNA- A Changing Regulatory Landscape based method used will allow the detec- Along with issues of authenticity, local tion of DNA fragments as small as 100 base regulators respond to increased concern pairs, or even lower. about anything that can impact human The smaller the DNA fragment to be health. This adds more layers of regulation analyzed, the more difficult it is to differen- to food markets. tiate between closely related species. The Recent food fraud scandals Furthermore, today’s consumers are best strategy is to use a DNA sequencing mean it is imperative that much more concerned about a product’s method that obtains the full nucleotide the industry be able ingredients. There is often a financial con- (A, T, G, C) sequence of the target region to cern that they are paying for something be analyzed. Real-time polymerase chain to identify the food ingre- that is not as labeled, or is not what they reaction’s (PCR’s) fluorescent signal is a dients that compose each paid for. Additional consumer concerns limitation for the detection of cross species food product, whether relate to allergens, food intolerances, spe- reactivity, and may produce false positive meat-, fish-, or plant-based cies protection, and species sustainabil- results, especially in complex food prod- ity, amongst others. Nutritional content ucts containing multiple ingredients. is highly dependent on a product’s ingredients, and the full or partial substitution DNA Barcoding Strategy sequenced and included on the database. of any specific ingredient can impact this. Probably the most well-known use of DNA Using bioinformatic tools to analyze pub- Any of these concerns can be highly dam- sequencing for food authenticity is the lic data is also valuable work so long as aging to a food brand as consumers can DNA barcoding strategy that is already the DNA sequence analysis tools are used rapidly lose confidence. in use by many regulatory entities in the correctly. The use of multiple DNA align- One of the biggest advantages of NGS sector. Perhaps one of the most widely ments and phylogenetic analyses is crucial testing is its untargeted nature that en- used barcoding methods is the one for for ensuring the reliability of the sequence ables full knowledge of the DNA content fish-based products, enabling fish species included on the databases. Because NGS of a food sample. In addition, virtually identification by regulatory bodies in the is highly customizable, it makes it possible any kind of DNA sequence can be identi- U.S. and Europe. However, this method for any lab to produce its own DNA data- fied using the appropriate bioinformatic is not suitable for processed samples that base to ensure its quality. tools available. The use of NGS can have a contain multiple ingredients (species) as huge impact on all matters related to food it only enables the identification of a Wider Availability of NGS integrity including authenticity, safety, unique species. Food products containing Given the recognition of NGS as a power- and traceability. ■ multiple species cannot be analyzed with ful tool, the first workflow for using NGS Dr. Gadanho is the global food molecular business devel- this approach. for species identification on food was opment manager for SGS Molecular. Reach him at mario. [email protected]. Dr. Pandiani is the global food molec- With NGS a similar barcoding ap- announced for the market in November ular business manager for SGS Molecular. Reach him at

proach can be used by sequencing defined 2018, making the method available to any [email protected]. ©NEW AFRICA - STOCK.ADOBE.COM

38 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Manufacturing & Distribution TRACKING & TRACEABILITY

advancements in produce safety systems are needed to provide the unseen but ac- cessible data and documentation layers behind the lot coding transaction ledgers.

Why Trace? Traceability is a key component in any modern food safety program and can be an important companion tool in quality management and improvement efforts. Adopting a sound- and scale-appropriate traceability system isn’t just good business practice—your operation may be covered by federal regulations under the Food Safety Modernization Act (FSMA). These regulations require a recall program, which minimally dictates having a rudimentary track and trace system in place. The basic requirement is to be able to determine one step back and one step forward in all aspects of product handling and distribution to the end-consumer. This necessitates the ability to determine what product was received, who it came from, and what was done with it. For raw Fitting Traceability into agricultural commodities, current market standards may require product receivers Produce Safety: Keeping it Real and handlers to have in place a routinely A traceability program is like insurance coverage tested and verifiable traceability system to rapidly get back to a harvest date, a that is activated during recalls and foodborne illness outbreaks harvest crew, a mobile or mechanized BY TREVOR SUSLOW, PHD, ED TREACY, JOHNNA HEPNER, AND VONNIE ESTES harvesting unit, and even a field location. Businesses meeting the current definition of a farm that are growing, harvest- he first step on the road to pre- assisting public health agencies during an ing, handling, or holding covered crops venting the next multistate food- emerging outbreak. subject to the FSMA Standards for the borne illness outbreak is honesty However, it is also a largely retrospec- Growing, Harvesting, Packing, and Hold- and openness throughout the tive tool as far as illness prevention is con- ing of Produce for Human Consumption Tsupply chain, and broader adoption and cerned. It is activated several steps after an (Produce Safety Standards, or PSS) are participation in existing and emerging outbreak is recognized and the hypothesis not required to have a formal food safety supply chain traceability tools is an im- generation and epidemiological process plan or traceability system. Regardless, portant part of this. The hard work ahead has begun to focus in on a common, impli- many handlers, market-standards, and to advance public health protection is cated food vehicle. “approved-supplier” audit requirements much more than instantaneous lot track- Having an unbroken and timely trace- from buyers mandate at least the one- ing based on distributed ledger technol- ability chain may prevent further exposure step-back-one-step-forward tracking ca- ogies (now often and more generically and illnesses by removing contaminated pability, including clear and defensible referred to as blockchain) or alternative product from distribution, inventory, food lot coding practices. Sprout growers are open-participation traceability platforms. establishments, and consumer kitchens, similarly covered under the PSS but have Clearly this is an important investigative refrigerators, and freezers. Significant en- additional testing, recordkeeping, and

©PRODUCE MARKETING ASSOCIATION tool needed to serve the food industry by hancements in training and foundational (Continued on p. 40)

February / March 2019 39 Manufacturing & Distribution Tracking & Traceability

The refinement and adoption of digital supply chain ledgers will greatly improve the speed and accuracy of traceability in defining outbreaks and removing implicated foods from the marketplace. PRODUCE MARKETING ASSOCIATION

(Continued from p. 39) and efficiently provide implicated lot in- • Physical location at which the prod- recall-motivated tracking requirement formation for public health investigators uct was last handled, whether at the expectations. as they conduct a traceback effort based packer, processor, or another location; Traceability and recall programs are on epidemiological evidence. Equally, • Incoming lot number(s) of product mandated for registered facility businesses rapid and definitive tracking allows you to received; that are subject to the FSMA Current Good communicate clearly and in a timely man- • Amount of product created, packed, Manufacturing Practice, Hazard Analysis, ner with your customers and, ultimately, shipped, consumed, or eliminated and Risk-Based Preventive Controls for your customer’s customers along the sup- from lot association; Human Food. They must encompass the ply chain. • Continuity of an incoming lot or record potential need, based on the hazard analy- of lots included—for example, follow- sis, for supply chain controls and oversight The Required Elements ing comingling or repacking to create management related to the FSMA Foreign The requirements of a good traceabil- a new lot code; Supplier Verification Program. ity system are capturing and recording • All physical locations to which cases The ability to trace product into and the key data elements at the critical track- were shipped; out of an organization is like taking out ing events. • Lot number(s) shipped to each an insurance policy: Most times it is not Critical tracking events are those in- location; needed, but when it is, it proves highly stances where product is moved between • Date(s) and time(s) product was re- beneficial. A well-designed and managed premises, is transformed, or any instance ceived and/or shipped to all locations; track-and-trace program will prove its that is determined to be a point where data • Date(s) and time(s) each lot was value in times of crisis and in preserving capture is necessary for effective tracing. packed, processed, or harvested; and your organization’s credibility. Recent ex- Specifically, the critical tracking events • If applicable, all ingredients used in periences during the 2018 romaine lettuce are: product, with lot numbers, facility at outbreaks have, once again, graphically 1. Transformation input (used to create which they were manufactured, and underscored the high potential for sub- another product or item); date(s) and time(s) they were received. stantial collective economic losses and 2. Transformation output (product cre- There are many system applications erosion of consumer confidence resulting ation or manipulation); that record the key data elements at all from lapses and gaps in step-wise, hand- 3. Shipment; critical tracking events in use in the fresh off-to-handoff supply chain traceability. 4. Receipt; produce industry today. Some of these Such a system can also be used defen- 5. Disposal; and applications are utilizing the blockchain sively or offensively in a product quality 6. Consumption. data sharing protocol while others run claim or dispute, in conjunction with an The ability to query and extract key on proprietary databases. These appli- internally or externally activated stock data elements in a seamless manner is cations are designed to provide supply recovery, market withdrawal, recall, or critical. The key data elements that should chain transparency while also providing related to an outbreak investigation. One be digitally captured, stored, and electron- traceability. The value of these visibility of the key benefits of a good traceability ically retrievable are: platforms is to gain a supply chain-wide system is that it expedites removing your • Item number or Global Trade Item view of the products from harvest through company from the implicated pool of Number (GTIN) and uniquely identifi- to point of sale to the consumer to identify suppliers in the event of a recall or out- able product description*; when there are delays, unnecessary steps, break. Another benefit is that it can rapidly • Quantity on hand; or less-than-ideal conditions. It is reason-

40 FOOD QUALITY & SAFETY www.foodqualityandsafety.com able to anticipate that transparency in and other technologies to collect data and As it stands, the too-common experi- time temperature controls for food safety, turn the resultant data mining and anal- ence is that the “last mile” to the point of alluded to briefly below, would also be ysis into insights and quick actions. This purchase or point of consumption is the captured and visible in modern traceabil- capability will benefit traceability as well weakest link in the currently complex ity systems. as other key aspects including the design, and too often gap-plagued supply chain Complete “mass balance” of each implementation, and oversight of produce trace-forward-trace-back sequence. This lot is an attainable goal of sound trace- safety systems. means that the lack of lot numbers and ability systems. Ability to account for 100 Clearly, these digital platforms will clearly identifiable product information percent of product received or created is be helpful in that they do allow investi- being recorded by buyers or distributors/ a must. It is equally as imperative for lot gators to trace data digitally all the way wholesalers creates a broken link and number and manufacturing facility to back to harvest, and beyond into crop barrier to establishing clear supply chain appear on each case of product, and lot management inputs, upon request. This convergence in traceback investigations. number(s), quantity, and shipping lo- is a significant advancement over the This invariably slows down or stalls the cation to appear on invoices and bills of basic requirement of bi-directional one- investigation, limits uncovering the full lading as well. step increments already in place within scope of implicated product distribution, A fresh produce industry best practice many traceability programs, and not just or results in failure to identify a minor, but capable of executing case-level tracking among the larger producers. A diversity widely distributed and consumed com- is the Produce Traceability Initiative (PTI) of data capture and software solutions modity or ingredient. are available, but, unfortunately, not all While blockchain technologies and inter-compatible. traceability systems will help close this Ability to account It is predicted that these digital plat- gap, traceability itself is unequivocally forms will be able to link a valid food safety incapable to fundamentally improve for 100 percent audit to each transaction. This will validate the foundation of food safety programs, of product received or that there is a credible, basic snapshot ver- and the prevention and mitigation of created is a must. ification of practices and all supporting re- contamination. Traceability programs, quired and additional documentation and in reality, are the insurance coverage records are in place from each participant activated only for recalls and foodborne in the supply chain. illness outbreaks. label, which is foundational in functioning Produce Marketing Association (PMA) People have a deep, emotional con- as the bridge between the physical goods recently led an effort to enable this process nection with their food. When they hear and any of the tracked information that by developing the Trellis Data Framework that there is a problem, they want to know would be contained within blockchain’s for digitally sharing audit data. There are what it is and that the information they virtual ledger—composed of blocks of also alerts that can and are being set up are getting about their food is accurate. linked and sequential data. All traceabil- to flag when there is a discrepancy or vi- We often speak about the “race to disclo- ity systems should be regularly audited, olation of time, temperature, humidity, sure.” Speed matters; the faster we can and effectiveness of recall implementation etc. that will complement supply chain get accurate information to the consum- tested to ensure the procedures and train- visibility applications/platforms in using ers, the better the outcome for all parties. ing are current and effective. blockchain technology to supplement food Traceability can help create strong food One of the mandates of FSMA is that safety systems. safety programs and help build con- FDA work with industry and both assess There are many examples of where sumer confidence. We as an industry need and conduct pilot traceability programs blockchain technology is being used all participants in the supply chain to do to improve public health protection. PTI is with PTI and the Trellis framework to their part in order to have effective whole- currently working in conjunction with FDA record and share relevant audit data chain traceability. ■ for evaluating the fidelity and sufficiency across the supply chain. Perhaps the of traceback data for these audits and tests, most well-known of these examples is Dr. Suslow is vice president of produce safety for PMA. Reach him at [email protected]. Treacy is vice president, supply as well as functionality, as in the event of a Walmart’s use of IBM’s blockchain tech- chain and sustainability, at PMA. Hepner is director, tech- product recall. nology to monitor and track the data of nology, at PMA. Reach her at [email protected]. And Estes is PMA’s vice president of technology. its fresh produce supply and distribution. Standardized and Interchangeable Other instances include the Dole Food Co. Platforms working with Centricity, a grower-owned * For specialty crops, a uniquely identifiable Data tracking and collection will be imper- partner, to leverage the Trellis framework product description should provide more de- ative in the coming years. Data stand to be- to connect audit data to the blockchain. tail than a category, such as sweet cherry, and come the next most used natural resource. These types of pilot programs and collab- should provide a recognized varietal name. Of the 2.5 quintillion bytes of data created orative efforts help provide the produce Variety differences have proved to be import- each day across all industries, only 1 per- industry with mechanisms to standardize ant in projections of defining shelf-life expec- cent is collected, analyzed, and used. data sharing for more efficient and time- tations during outbreak investigations and in There is a large opportunity for blockchain lier traceback. developing public advisory notifications.

February / March 2019 41 Go Fish! (Continued from p. 13) manufacturers have begun to utilize “These properties give our pet treat ning freelance journalist based in Wilmington, N.C. Reach her at [email protected]. fish meal and fish oil as ingredients, product some unique characteristics and our treats stand out because we are nutritional benefits that we believe make specifically incorporating fish skins into them very appealing to dogs and their For bonus content on the seafood mar- our product to take advantage of the owners.” ■ ket, go to the February/March 2019 issue at www.FoodQualityandSafety. unique functional properties of fish col- Leake, doing business as Food Safety Ink, is a food safety lagen found in fish skins,” he explains. consultant, registered SQF contract auditor, and award-win- com/issue/february-march-2019/.

To BE or Not To BE (Continued from p. 15) Enforcement key aspect of a meaningful labeling the Final Rule will not be perfect for Failure to comply with the BE food disclo- claim, and that rigorous enforcement every consumer every time, we am sure requirements is prohibited, but the provisions were necessary to effectuate pleased that the Final Rule, whatever consequences are relatively feeble. The the rule. AMS asserted that the enforce- its faults, will provide consumers with AMS enforcement authority is limited to en- ment process, which again includes a additional information from which to forcing compliance through records audits complaint process, investigations, audits, answer that age-old question: To BE or and examinations, hearings, and public hearings of limited scope, and resulting not to BE. ■ disclosure of the results of audits, exam- notifications to both regulated entity and inations, and hearings. The Final Rule the public, sufficiently meets the requisite Stevens, a food industry attorney, is a founding member does not authorize civil penalties or recall enforcement needs. of Food Industry Counsel, LLC. Reach him at stevens@ foodindustrycounsel.com. Chappelle is also a food industry authority for violations. Time will tell whether and how lawyer and consultant at the same organization. Reach him During the rule-making process, these regulations may need to be altered, at [email protected]. some argued that accountability is a added to, refined, or repealed. While

Food Defense Is Good … (Continued from p. 17) • Food defense monitoring procedures they are being consistently performed commercial agreements between supply (21 CFR 121.140(a)); (21 CFR 121.140); chain parties may still contain language • Food defense corrective actions proce- • Records of food defense corrective ac- that requires FSMA compliance to specific dures (21 CFR 121.145(a)(1)); and tions to be taken if mitigation strategies FSMA rules and their provisions prior to • Food defense verification procedures are not properly implemented (21 CFR engaging in the purchasing, manufactur- (21 CFR 121.150(b)). 121.145); and ing, and sale of goods. A relationship in 2. Food defense training and qualifica- • Food defense verification that monitor- food defense requires honest and effective tions of supervisors and personnel working ing is being conducted, that appropri- communication of clear expectations at actionable process steps. (21 CFR 121.4) ate decisions about corrective actions among all stakeholders. IA Rule records that must be prepared are being made, that mitigation strat- With the exception of an opportunis- and kept include: egies are being properly implemented, tic intentional terrorist attack using toxic • The vulnerability assessment—for each and that a reanalysis of the food de- agents, most perpetrators, in their deceit, point, step, or procedure in the facili- fense plan has been conducted, as ap- have no intent of harming life. Sadly, akin ty’s operation, it must evaluate the se- propriate, according to 21 CFR 121.157. to a food safety incident that occasionally verity and scale of the potential impact (21 CFR 121.150). escapes detection and control, supply on public health if a contaminant were chain food defense breaches that the IA to be added, and the degree of physical Maintaining Trustworthiness Rule now addresses can have serious ad- access to the product; So, why is food defense good for business? verse health consequences or death for • The ability of an attacker (from outside As a food-related facility covered un- human or animals. Everything possible or inside the facility) to contaminate der the requirements of the IA Rule, trust- must be done to intercept these product the product (21 CFR 121.130); worthiness must be earned by partnering security issues before they become public • The mitigation strategies applied at with others occupying space in the global health concerns. The chain of food pro- each actionable process step to signifi- supply chain. This is done by making a tection and product security custody and cantly minimize vulnerabilities—the management commitment and resource trustworthiness, once broken, has already facility must include a written expla- investment to ensure cooperative under- been proven to be both difficult and costly nation of how each strategy minimizes standing and sharing of responsibility to to regain. ■ the vulnerability (21 CFR 121.135); mitigate international product security Park is the principal for Food-Defense, LLC. He has practiced • Food defense monitoring of the mit- risks. Even if a food-related facility is not food protection technical and management consulting for 46 years, is an FDA-recognized international processing igation strategies with adequate fre- covered by regulatory statute under appli- authority, and an FSPCA PCQI Lead instructor. Reach him quency to provide assurances that cable FSMA rules, including the IA Rule, at [email protected].

42 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Simplifying Complex World of … (Continued from p. 19) be transferred to that product especially on For obvious reasons, food companies detected by swab with LFD, then it is very the initial amount of product made after are reluctant to test finished food products unlikely that allergen residues will be de- changeover. However, depending upon the for undeclared allergens because the pres- tected in the finished product. In those cir- amount of residue remaining of the equip- ence of such residues means that the prod- cumstances, testing of the finished product ment surface and the volume of the next uct cannot be sold. However, the ultimate does serve as the ultimate validation. ■ product that passes over that equipment validation of an allergen cleaning proce- surface, the residues may not always be dure involves ensuring that no detectable Dr. Taylor is the co-founder and co-director of the Food Allergy detectable in that next product. The testing residues are present in the finished prod- Research and Resource Program (FARRP) at the University of Nebraska, Lincoln. Reach him at [email protected]. Dr. of finished product is the only way to de- uct. If a robust swabbing strategy has been Baumert is the co-director at FARRP. Reach him at jbau- termine if detectable residues are present. used and no allergen residues have been [email protected].

Events

17-21 11-13 Pittcon 2019 Food and Airborne Fungi & Mycotoxin Philadelphia, Pa. Short Course Visit https://pittcon.org/pittcon-2019, University Park, Pa. email [email protected], or call 800-825-3221. Visit https://bit.ly/2FNgSZ7 or call 814-865-8301. APRIL 17-18 8-11 22nd World Congress on Nutrition High Pressure Processing Short Course and Food Sciences and Workshop Brisbane, Australia Bedford Park, Ill. Visit www.nutritionalconference.com. Visit https://www.eventbrite.com/e/high- pressure-processing-short-course-and-workshop- 18-20 registration-46418095774. 53rd Annual Microwave Power Symposium (IMPI 53) MAY Las Vegas 6-9 Visit http://impi.org/symposium-short-courses/, FEBRUARY Food Safety Summit call 804-836-7125, 25-28 Rosemont, Ill. or email [email protected]. Global Food Safety Conference Visit https://www.foodsafetystrategies.com/ Nice, France food-safety-summit. OCTOBER Visit https://www.theconsumergoodsforum.com/events/ 30-31 gfsi-conference. 21-23 China International Food Safety & Quality Food Microbiology Short Course Conference MARCH University Park, Pa. Beijing City, China 6-8 Visit http://agsci.psu.edu/foodmicro Visit www.chinafoodsafety.com. Consumer Food Safety Education Conference or call 877-778-2937. Lake Buena Vista, Fla. Have an Upcoming Event to Promote? Visit https://cfsec2019.fightbac.org JUNE or call 202-220-0651. If you have an upcoming industry event that 2-5 you would like considered for inclusion in our IFT19 online and print listings, go to www.foodqual- New Orleans ityandsafety.com/events/ for info or contact Ken Potuznik at [email protected]. Visit https://www.ift.org/.

February / March 2019 43 NEW PRODUCTS

Supply Chain Quality Management Detectable Food Temperature Probe The Version 8 of SupplyChainMetrix (SMX) Made from Detectamet’s detectable poly- includes several advancements in technol- mer, the company’s new temperature ogy and features for the supply chain qual- probes are both metal detectable and X-ray ity management solution. Updates to SMX visible. This digital food temperature probe include enhanced partner onboarding and features a smooth, durable surface and its maintenance, automated payment process- wide measuring range makes it suitable for ing, and a new option for document-based all food, storage, and equipment checks. specifi cation management. Customers can It can also be stored in a wall-mountable, now choose between managing specifi ca- detectable holder for easy access at each tions using data-driven forms or as docu- crucial stage in the food production and Food Processing Sanitation ment attachments, expanded ingredients storage process. Detectamet Ltd., sales@ Elite 360 with Precision Application Technol- and sourcing functionality, and enhanced detectamet.com, www.detectamet.co.uk. ogy electrostatically applies an antimicrobial confi guration management. In addition, intervention to cover a product, using the there are new features and reports for au- least amount of antimicrobial possible, while tomating the resolution of product- and still being as eff ective as possible. The Preci- guest-related incidents between restau- sion Application Technology not only reduces rants/retail locations, distributors, and pathogens, but according to the company it suppliers. ComplianceMetrix, LLC, 858- can reduce chemical and water usage by as 866-8888, [email protected], much as 95% and has shown up to a 2.0+ log compliancemetrix.com. reduction and 360° product coverage, as well as reducing wastewater treatment costs. Elite 360 is currently on the market for red meat Air to Air Heat Exchangers Business Briefs processors and will be available for use in the Lightweight and easy to install, the PKS produce and poultry industries in the second (Pfannenberg’s Kinetic System) Series Air Fapas launches profi ciency tests for poly- half of 2019. Birko, 800-525-0476, www. to Air Heat Exchangers take advantage of a cyclic aromatic hydrocarbons in shellfi sh birkocorp.com. cooler ambient environment when closed- and perfluoroalkylated substances in sea loop cooling is required, sealing against fi sh. It also releases two tests to identify gas, humidity, and dust. Designed for in- and quantify ergot alkaloids in multigrain Cloud-Based Label Management door, outdoor, remote, and washdown baby food products and tropane alka- System applications that require a closed-loop loids in cereals. Label Cloud is a soft ware-as-a-service solu- system to protect electronics, systems tion built on the NiceLabel Label Manage- are ideal for protecting against corrosion 3M Food Safety’s Molecular Detection ment System. It allows users to centrally and contamination in the food and bever- Assay 2—Campylobacter earns Perfor- manage label design, product data, and age industry. Available in fi ve confi gura- mance Tested Methods Certifi cate number 111803 from the AOAC Research quality control, with branches, suppliers, tions: 22, 45, 64, 100, 150, and 180 watts Institute. and partners able to access that informa- per °C. Pfannenberg, 866-689-0085, www. tion in the cloud and print their own labels pfannenbergusa.com. AIB International releases the new locally. IT is not needed for design and de- Baking Process Kill Step Calculator for ployment of labels. Quality assurance is fruit-fi lled pastry. digitalized, eliminating manual quality control processes, reducing labor requirements Testo North America achieves certifi ca- and costs, and minimizing risk and error. The tion for its Testo 104 family of food ther- system is ideal for use in manufacturing la- mometers according to NSF/ANSI Stan- beling, allergen and nutrition labeling, local- dard 2—Food Equipment. ized re-labeling, and supplier labeling. Label Registrar releases version 2.0 of the FDA Cloud requires no installation. NiceLabel, Compliance Monitor to facilitate indus- 262-784-2456, sales.americas@nicelabel. try compliance with the FSMA compli- com, www.nicelabel.com. ance tool.

44 FOOD QUALITY & SAFETY www.foodqualityandsafety.com Filter Cartridge Gold Cone X-Flo (GCX) filter cartridge for high-efficiency industrial dust collection uses a proprietary inner pleat pack with an open-bot- tomed inner cone of media that expands the usable surface area of the cartridge. Because the HemiPleat design exposes more media to the airstream, more dust is loaded on the filter and released during pulse cleaning. The cone is configured so that pulsed air is evenly distributed top to bottom along the outer pack of the filter and down through the inner cone pack. That means with each pulse, the GCX cone cartridge ejects more dust out of the collector, straight down to the hopper. These filters are available in a selection of regular or nanofiber media and meet EPA particle emission requirements. GCX filters were designed specifically for Camfil APC’s Gold Series X-Flo dust collector. Camfil APC, 800-479-6801, [email protected], www.camfilapc.com. Surface Sanitation System BioSpray-10 is a portable option for surface sanitation that is designed to limit the Statistical Process Control growth of bacteria and other pathogens that The new Statistical Process Control (SPC) can be missed with other methods of sanita- feature in Safefood 360°’s Food Safety tion. It has many of the same features as its Management Software system is an indus- predecessor, BioSpray-20, but in a smaller, try-standard methodology for measuring lightweight system. BioSpray-10 is safe for and controlling food safety and quality use around water-sensitive equipment and during the manufacturing process. Data in machinery. The system is non-electric, with the form of product or process measure- no power source required. Goodway Technol- ments are obtained in real time and an- ogies, 800-333-7467, www.goodway.com. alyzed to determine the capability of the operation to meet requirements. This is par- Dual Canister Water Filtering System ticularly helpful when it comes to controlling The Dual Canister Water Filtering System AI Label and Date Code Verification CCPs and operation PRPs. SPC automati- found on the new Sanitary Zero Maintenance APRIL Eye is an artificial intelligence-based cally crunches monitoring data to produce Screen from Lyco Manufacturing works by vision system for date code verification. The process control charts, distribution curves, automatically purging and switching filters system removes the operator from the date and calculate Cp and Cpk values to provide a without manually changing or isolating code verification process, achieving full au- clear picture of process capability. Safefood valves. These actions eliminate the need to tomation to reduce the risk of product recalls 360°, 855-3663-360, team@safefood360. have one or more employees monitor and and emergency product withdrawals caused com, www.safefood360.com. service their water filtration system. The sys- by human error on packaging lines. By tak- tem can filter between 50 to 400 gallons per ing photos of each date code, the system minute, and captures particulates as small as can read them back using scanners to ensure 200 microns, making the water clean enough they match the programmed date code for to be used a second time. CIP systems stop that product run, allowing manufacturers to blinding, rotating nozzles for sanitation. achieve unmanned full traceability. Running The Sanitary Zero Maintenance Screen is at speeds of over 300 packs a minute, it also designed for water reuse as it filters waste- allows them to increase throughput. The pro- water from food-based applications such as duction line comes to a complete stop if a inside/outside bird washers, and reclaims it date code doesn’t match, ensuring that no for re-use back in the processing lines. Lyco incorrect labels can be released into the sup- Manufacturing, 920-623-4152, sales@ly- ply chain. OAL, [email protected], www. comfg.com, www.lycomfg.com. oalgroup.com.

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February / March 2019 45 SCIENTIFIC FINDINGS

For access to complete journal articles mentioned below, go to “Food Science Research” in the February/March 2019 issue at www.foodqualityandsafety.com/issue/february-march-2019/, or type the headline of requested article in website’s search box.

ARTICLE: Irrigation-Induced Salinity Affects Olive Oil Quality and Health- Promoting Properties Olive oil, a functional food, is increasingly produced from trees irrigated with water containing high concentrations of salts. This review studies the effects of irrigation-induced salinity on quality and health-related compounds in olive oil. Trees were grown in lysimeters with continuous control and monitoring of root-zone salinity. Salinity in the root zone was altered by changing irrigation solution salinity or by changing the extent of leaching. Extracted oil was analyzed for quality parameters including free fatty acid content, polyphenol, tocopherol, ste- rol and carotenoid levels, fatty acid profile, and antioxidative capacity.Journal of the Science of Food and Agriculture, Volume 99, Issue 3, February 2019, Pages 1180-1189.

ARTICLE: Microwave Processing—Current Background and Effects on the Physicochemical and Microbiological Aspects of Dairy Products Overheating is still a major problem in the use of conventional heating for milk and various dairy products because it leads to the lowering of quality and sensory and nutritional values. Micro- wave (MW) heating has been credited with providing superior-quality dairy-based products with extended shelf life, representing a good alternative to conventional heat treatment. The main drawback of MW heating refers to nonuniform temperature distribution, resulting in hot and cold spots mainly in solid and semisolid products; however, MW heating has been shown to be suitable for liquid foods, especially in a continuous fluid system. This review describes the main factors and parameters necessary for MW heating technology in dairy processing, considering the theoretical fundamentals and its effects on quality and safety aspects. MW heating has demonstrated the ability to destruct pathogenic/spoilage microorganisms and ARTICLE: Cold Plasma for Effective their spores, and also inactivate enzymes, thereby preserving fresh characteristics of dairy Fungal and Mycotoxin Control in Foods products. Comprehensive Reviews in Food Science and Food Safety, Volume 18, Issue 1, Jan- Cold plasma treatment is a promising inter- uary 2019, Pages 67-83. vention in food processing to boost product safety and extend shelf life. The activated chemical species of cold plasma can act ARTICLE: A Review of the Use of Biostimulants in rapidly against microorganisms at ambient the Vineyard for Improved Grape and Wine Quality temperatures without leaving any known Foliar application of biostimulants (including resistance chemical residues. This review presents an inducers or elicitors) in the vineyard has become a strategy overview of the action of cold plasma against to prevent plant diseases and improve grape quality on the molds and mycotoxins, the underlying mech- grapevine. This also represents a partial alternative to soil anisms, and applications for ensuring food fertilization, avoiding some of the negative effects to the en- safety and quality. The cold plasma species vironment from leaching of nutrients into the groundwater. act on multiple sites of a fungal cell resulting The foliar applications that most promote the synthesis of in loss of function and structure, and ulti- secondary metabolites in grape berries are treatments with nitrogen, elicitors, other biostim- mately cell death. Likewise, the species cause ulants, and waste from the agricultural industry. However, the impact of their use in the vine- chemical breakdown of mycotoxins through yard depends on a number of conditions, including mainly the type of compound, application various pathways resulting in degradation rate, timing and number of applications, and cultivar. This article summarizes the influence products that are known to be less toxic. of biostimulants as foliar applications to grapevines on grape amino acids and their phenolic Comprehensive Reviews in Food Science and volatile concentrations to define the most important factors in their effectiveness.Journal and Food Safety, Volume 18, Issue 1, January

of the Science of Food and Agriculture, Volume 99, Issue 3, February 2019, Pages 1001-1009. 2019, Pages 106-120. ©DELPHOTOSTOCK / BUFKA BAIBA OPULE - STOCK.ADOBE.COM

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