Regulating Food Safety in 2019 - Food Quality & Safety

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Regulating Food Safety in 2019 - Food Quality & Safety
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 efforts to
                                                                              improve food
                                                                         quality standards
                                                                               and prevent
                                                                          future outbreaks

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Regulating Food Safety in 2019 - Food Quality & Safety
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Regulating Food Safety in 2019 - Food Quality & Safety
Contents
                                                                                    FEBRUARY/MARCH 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
ORKIN LLC / ©PAKHNYUSHCHYY - STOCK.ADOBE.COM

                                                                                   Safety & Sanitation

                                                                                   24                                                                                27
                                                                                                                                                                     Rodent Control with
                                                                                   Proactive Pest Management                                                         Remote Monitoring
                                                                                   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
COVER: ©LENABSL / TALEX / DRAWKMAN - STOCK.ADOBE.COM

                                                                                   in preventing them from returning                                                 screen food facilities 24/7
                                                                                   BY MICHELLE HARTZER, BCE                                                          BY PATRICIA HOTTEL, BCE

                                                                  Food Quality & Safety (ISSN 1092-7514) is published 6 times a year in Feb/Mar, Apr/May, Jun/July, Aug/Sept, Oct/Nov, Dec/Jan by Wiley Subscription Services, Inc.,
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                                                                                                                                                                                                               February / March 2019              5
Regulating Food Safety in 2019 - Food Quality & Safety
CO N T E N TS

(Continued
(Continued from
            from 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
     TOXINS
                                                   A traceability program is like
                                                   insurance coverage that is
                                                                                          Allergen Control
     Stringent testing programs stop               activated during recalls and           18 SIMPLIFYING COMPLEX
     unique threats in seafood                     foodborne illness outbreaks                WORLD OF ALLERGEN
                                                   BY TREVOR SUSLOW, PHD, ED TREACY,          CONTROL
     BY ALLISON HAMMERLY
                                                   JOHNNA HEPNER, AND VONNIE ESTES            Practical tips on allergen
                                                                                              swabbing and choosing
                                                                                              a testing system

In The Lab                                      Columns
                                                                                              BY STEVE L. TAYLOR, PHD, AND
                                                                                              JOE L. BAUMERT, PHD
34 AIM HIGH WHEN
     DETECTING PATHOGENS IN
     LOW MOISTURE FOODS                         Market Initiatives
     From validated and verified
     cleaning regimens to automated
                                                12 GO FISH!
                                                   Seafood
                                                                                          Departments
     pathogen testing practices,                   stakeholders are

                                                                                                                                             ©BAIBA OPULE / HVOSTIK16 - STOCK.ADOBE.COM / ©PRODUCE MARKETING ASSOCIATION
     detailed workflows are helping                                                       8 FROM THE EDITORS
                                                   continually casting
     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
37 DNA AND FOOD TRACEABILITY                                                              44 NEW PRODUCTS
     Next-generation sequencing is
                                                                                          45 ADVERTISER INDEX
     being used to assess the integrity
     of food from a raw material to             Legal Update                              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
                                                   JOEL S. CHAPPELLE, ESQ.

  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: mzboraj@wiley.com
                                                    BY CORY HOVANETZ
  (Letters may be edited for space or style.)

         facebook.com/FoodQualityandSafety            @FQSmag

6         F O O D Q U A L I T Y & SA F E T Y                                                                  www.foodqualityandsafety.com
Regulating Food Safety in 2019 - Food Quality & Safety
Addressing
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      SUPPLY CHAIN                   FOOD SAFETY COMMUNITY

                                                        May 6 – 9
                                               ®         2019
                                                         Rosemont, Illinois

   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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   www.FoodSafetySummit.com

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Regulating Food Safety in 2019 - Food Quality & Safety
From The Editors                                                                                                                                      Lisa Dionne Lento, ldionne@wiley.com
                                                                                                                                                PUBLISHER
                                                                                                                                 SENIOR ACCOUNT MANAGER          Ken Potuznik, kpotuzni@wiley.com
                                                                                                                                         PROFESSIONAL EDITOR Marian Zboraj, mzboraj@wiley.com
                                                                                                                                                DESIGN Maria Ender, mender@wiley.com
                                                                                                                                              PRODUCTION Claudia Vogel, cvogel@wiley.com

T
                                                                                                                                                   Jörg Stenger, jstenger@wiley.com
           his column was inspired                                                                                                                   Elli Palzer, palzer@wiley.com
           by the late, great Made-                                                                                                              CO-INDUSTRY EDITOR Purnendu C. Vasavada, PhD,
                                                                                                                                                        purnendu.c.vasavada@uwrf.edu
           line Kahn and her role                                                                                                              CO-INDUSTRY EDITOR Richard Stier, rickstier4@aol.com
           as cabaret singer Lili Von
                                                                                                                                                              Advertising Director
Shtupp in Mel Brooks’ comedy                                                                                                                                        Dan Nicholas
classic “Blazing Saddles.” Lili was                                                                                                                     111 River Street, Hoboken, NJ 07030
                                                                                                                                                       (716) 587-2181, dnicholas@wiley.com
tired of men, whereas I am tired of
people trying to frighten me about                                                                                                                                 Sales Office
                                                                                                                                                        U.S./CANADA/INTERNATIONAL
non-existent dangers in my food                                                                           A | S | B | P| E
                                                                                                          Fostering B2B editorial excellence                       Ken Potuznik
and in the environment. One surfs the internet and runs into                                               American Society
                                                                                                             of Business
                                                                                                                                                     29822 N 51st Place, Cave Creek, AZ 85331
                                                                                                          Publication Editors                           (480) 419-1851 • fax (480) 718-7719
pieces about “Top 10 Most Dangerous Fruits,” or “15 Processed                                              2018 National                                      kpotuzni@wiley.com
Foods to Avoid,” or “Chemicals that Cause Cancer.” Almost ev-                                              PR INT                                                Editorial Office
                                                                                                           Award Winner
erything is based on bad or non-existent science, but people can                                                Revenue of
                                                                                                            $3 million or under
                                                                                                                                                   111 River Street, Hoboken, NJ 07030-5774, USA
                                                                                                                                                       Reprints: E-mail kpotuzni@wiley.com
write what they want thanks to freedom of speech.
     As a resident of California, I am also constantly exposed to
Proposition 65 warnings. Signs at hardware stores read, “This
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,
coffee 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
                                                                                                                                                                              Technical Director and R&D Fellow–
                                                                                                                      FoodSafetyByDesign, LLC;
     Is there an answer? Well, maybe. Websites could be more                                                               Advisor to CEO,                                  Ingredient Solutions, Dairy Foods R&D,
                                                                                                                            Land O’Frost                                              Land O’Lakes, Inc.
diligent when it comes to reviewing the “science” that they pub-
                                                                                                                                                                                         Mary Ann Platt
lish, but that is a stretch.                                                                                                Cliff Coles
                                                                                                                                                                                            President
                                                                                                                             President,
     Our best answer might be federal legislation that makes food                                                        Clifford M. Coles                                          CNS/FoodSafe and RQA, Inc.
                                                                                                                    Food Safety Consulting, Inc.
                        labeling and other product claims a federal                                                                                                                  Manpreet Singh, PhD
                                                                                                                                                                               Professor, Dept. of Poultry Science,
     I’m Tired prerogative. This could eliminate future                                                                    Virginia Deibel, PhD
                                                                                                                         Director of Microbiology,
                                                                                                                                                                                      University of Georgia
                           Proposition 65s and prevent states from                                                        Eurofins Food Integrity
                                                                                                                                                                                        Shawn K. Stevens
                                                                                                                               & Innovation
                                   enacting labeling laws that                                                                                                                       Food Industry Attorney,
                                                                                                                                                                                    Food Industry Counsel, LLC
                                   would affect the whole coun-                                                     James Dickson, PhD
                                                                                                                         Professor,                                                   Patricia A. Wester
                                   try; an example would be GMO                                                 Department of Animal Science,                                 CEO, The Association for Food Safety
                                                                                                                    Iowa State University
                                   labeling. But that is beyond me.                                                                                                             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,                                      Certification, Office of International Affairs
                                                                                                                 Food Chemicals Codex at USP                                          and Seafood Inspection
one proposed by San Francisco Chronicle columnist Art Hoppe
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.
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
                                                                                                     written permission of the publisher, or authorization through the Copyright Clearance
diet of organic rutabagas, alfalfa sprouts, and spring water that                                    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 reflect any official 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 affiliated or of the publisher unless this is clearly specified. Materials
                                                                                                     published herein are intended to further general scientific 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
                                                                      ©REDBOXART - STOCK.ADOBE.COM

therein an organic pine box and climbed inside. “At last,” he said,                                  promoting a specific method, diagnosis or treatment by physicians for any particular patient.
                                                                                                         While the editors and publisher believe that the specifications and usage of equipment
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
                                                                                                     limitations of the products mentioned.

8      F O O D Q U A L I T Y & SA F E T Y                                                                                                                                              www.foodqualityandsafety.com
Regulating Food Safety in 2019 - Food Quality & Safety
2019

     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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Regulating Food Safety in 2019 - Food Quality & Safety
NEWS & NOTES
                                       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 avo-
                                                     cado 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.

Compliance Date for Food Labeling Rule
                                                                                                                 Business Briefs
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
                                                                                                                                                                     ©KOVALEVA_KA / BASTIAANIMAGE - STOCK.ADOBE.COM

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
                                                                                                                 Cloverleaf Cold Storage enters into an
hazelnuts, Brazil, and cashew nuts. On a                      the psychoactive compound known as THC,
                                                                                                                 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.

10      F O O D Q U A L I T Y & SA F E T Y                                                                                            www.foodqualityandsafety.com
Market Initiatives                                             SE A F O O D

                                                                                                        “In cooperation with the Association
                                                                                                     of Food and Drug Officials, the Seafood
                                                                                                      HACCP Alliance has developed a uni-
                                                                                                      form and cost-effective training pro-
                                                                                                      gram for importers, processors, and

                                               Go Fish!                                              distributors of fish and fishery prod-
                                                                                                   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
                                                                                                   also offered. “The audience for these
                                            and product development                                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.

W
                                                                                                          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-
     It’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
                                                                                                                                                       © HVOSTIK16 - STOCK.ADOBE.COM

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-

12     F O O D Q U A L I T Y & SA F E T Y                                                                               www.foodqualityandsafety.com
tail outlets, which the federal rule doesn’t   ing to meet challenges in                                        sion offers the major ben-
                                      typically cover,” Nash says.                   aquaculture.”                                                    efits of labor efficiency,
                                           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 certified                                       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 finfish, 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 fish 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 offer 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 clarifies 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 fish are          Sannito opted for turning the pollock
                                      seafood meals are starting to come from        born in a BAP-certified hatchery, raised      skins into a green rope (similar to licorice
                                      restaurant chefs and community-sup-            on a BAP-certified farm, fed feed from        in appearance) and then cutting it into bite-
                                      ported fisheries retailers who are not al-     a BAP-certified mill, and processed in a      sized pieces. While experimenting with
                                      ways familiar with the safety rules that       BAP-certified plant,” he relates.             natural and artificial 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 definitely something fishy 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., offers Best Aquacul-         Sciences. “We are making high-end dog              In May 2017, Sannito and Quentin
                                      ture Practices (BAP) certification 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 fillet pro-      the UAF Fairbanks Office of Intellectual
                                      GAA’s communications manager.                  duction, only about 25 percent of the fish    Property and Commercialization.
                                          “Established in 2002, BAP is the           is recovered for consumption after 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 certification 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 fish meal. But pollock is    making a seed fund of $24,800 available to
                                      third-party certification 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 fish meal, so our goal is to      market.”
                                      ment process and certification 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 fish.”                  friend and business collaborator, Jerry Pu-
                                      ing plants.”                                       After some experimentation, San-          pillo, MS, a marketing consultant based in
© ALTA OOSTHUIZEN - STOCK.ADOBE.COM

                                          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 first, 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       fish components. “While some pet treat
                                      are scientific, rigorous, and always evolv-    material for drying,” he explains. “Extru-                                 (Continued on p. 42)

                                                                                                                                                    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 bioen-
                                                                                            gineering and bioengineered food accu-
                                                                                            rately reflected the scope of disclosure
                                                                                            and the products and potential technol-
                                                                                            ogy at issue.” Moreover, AMS was con-
                                                                                            cerned that using terms such as “genetic
                                                                                            engineering” or “genetically modified
                                                                                            organisms” would conflict with preemp-
                                                                                            tion provisions.
                                                                                                 Like almost any regulations that gov-
                                                                                            ern highly interpretive and controversial
                                                                                            subject matters, it is nearly impossible to
                                                                                            achieve consensus agreement. As for the
                                                                                            final BE Food Disclosure Rule, there are
                                                                                            compelling arguments on both sides. It re-
                                                                                            mains 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 final 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 define what is
                                                                                            (or is not) a BE food. The Final Rule adopts

I
                                                                                            the statutory definition of “bioengineered
      n December 2018, the Agricultural       advocates have responded favorably to it.     food” as codified in the Amended Agri-
      Marketing Service (AMS) published       The Food Marketing Institute, for instance,   cultural Marketing Act of 1946. Thus, BE
      the final 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 modified through
Rule). 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 modification 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 effect.                      deeply flawed, 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-     ified 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
                                                                                                                                                © SSSTOCKER / DEDMAZAY - STOCK.ADOBE.COM

sale or sell bulk food items (regulated       the new rule. The Center for Science in the   definition adopted in the Final Rule, sig-
entities) to disclose the presence of         Public Interest expressed concern about       nificant 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         fined foods and ingredients should be ex-
pliance requirements.                         genetically modified 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 refined products

14     F O O D Q U A L I T Y & SA F E T Y                                                                        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
USDA AMS

           of sufficient size and clarity to appear       cause, given the enormous breadth and             million or more in annual food sales.
           prominently and conspicuously on the           variety of available packaging options,                                        (Continued on p. 42)

                                                                                                                             February / March 2019       15
NEW COLUMN

Food Defense
                                                                                                 pet food ingredients for economic gain
                                                                                                 (i.e. they substituted inferior ingredi-
                                                                                                 ents)—the company was ordered to
                                                                                                 pay $7 million;
                                                                                               • 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 mis-
                                                                                                 labeling 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

Food Defense                                                                                     as verified by “rampant” high levels
                                                                                                 of species mislabeling found in ge-

Is Good for Business
                                                                                                 nomically-tested seafood samples
                                                                                                 taken from New York State supermar-
                                                                                                 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,

I
                                                                                            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-
subject 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
                                                                                                                                                ©WAVEBREAK3 - STOCK.ADOBE.COM

    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

16     F O O D Q U A L I T Y & SA F E T Y                                                                        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, op-
                               erator, or agent in charge of a domestic or
                               foreign food facility that manufactures/
                               processes, packs, or holds food for con-
©NORDRODEN - STOCK.ADOBE.COM

                               sumption 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-
                               rected food defense facility compliance

                                                                                                                                                  February / March 2019       17
NEW COLUMN

              Allergen Control
                                                                                                also known as strip tests. Many aller-
                                                                                                gen-specific commercial companies offer
                                                                                                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 shellfish,
                                                                                                and fish.
                                                                                                     LFDs and swab tests are highly spe-
                                                                                                cific 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 lev-
                                                                                                els of allergens on equipment surfaces.
  Practical tips on allergen swabbing                                                           These methods can also be used for de-
                                                                                                tection of residues in clean-in-place (CIP)
  and choosing a testing system                                                                 final rinse water samples. Some compa-
  BY STEVE L. TAYLOR, PHD AND JOE L. BAUMERT, PHD                                               nies use these qualitative methods on in-
                                                                                                gredients or processed food samples, but
                                                                                                their use for such purposes is not recom-

F
                                                                                                mended 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 effectiveness 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,
of shared equipment. However, the pru-           fined as milk, eggs, fish, crustacean shell-   allergen-specific swabs and LFDs are the
dent use of such methods is very useful          fish (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 effective 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.     flour, soybean flour, casein, whey protein     ment surfaces from many sources. In our
The food industry makes extensive use            concentrate). The effectiveness 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-specific LFD methods. Due to their
allergenic foods or ingredients and others       from them, especially ingredients with         specificity, allergen-specific 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 effectiveness.
While FDA has not yet released its antici-       Allergen Swab Testing
                                                                                                                                                    ©STUDIOLOCO - STOCK.ADOBE.COM

pated guidance on preventive allergen con-       Allergen swabs can be effective 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 flow devices (LFD),       are as effective as possible.

18      F O O D Q U A L I T Y & SA F E T Y                                                                           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
your purpose is relatively straightforward:
                                                  Multiple swabs should                         the recommended environmental swabs,
                                                                                                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)

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