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The Podcast for
Food Safety Professionals
Produced by the Food Safety Magazine editorial team – the leading media brand in food
safety for over 20 years. Each episode features news and trends, or another surprise segment,
followed by a conversation with a food safety professional who shares their experiences
and insights about the important job of safeguarding the world’s food supply.
The Biggest Issues Discussed by Some of the Biggest Names

• Best Practices • Culture • HACCP • FSMA (a lot!) • Foodservice • Audits • GFSI • Sanitation
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• Will Daniels • Lee-Ann Jaykus • Mike Cramer • Bill Marler • Mike Robach
25+ Episodes available

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June/July 2018
Vol. 24, No. 3
FEATURES COLUMNS
10 Hygienic Zoning
28 COVER STORY The Importance of Hygienic Zoning to
The Foreign Supplier Verification Prevent Product Contamination
By Richard Brouillette
Program: Boon or Bane?
By Dr. Ramakrishnan Nara 14 Op-Ed
The Costs of Foodborne Illness,
Product Recalls Make the Case for
40 BAKED GOODS Food Safety Investments
Handling Food Safety Risks By Stephen Ostroff, M.D.
in a Retail Bakery 16 Testing

By Patricia Marden, B.Sc., Jennifer Forrester, B.Sc., M.Ed., Investigation and Identification of Physical
Contaminants in Food
Becky Swayne, B.Sc., Sadie Pulk, M.A., M.B.A., REHS,
By Samuel S. Liu, Ph.D.
and Ann Marie McNamara, Ph.D.
20 Food Safety Insights
Listeria: An Important Focus of
46 FOOD SAFETY CULTURE Environmental Monitoring
Company Culture and the Path to By Bob Ferguson
Improved Food Safety: Setting the Tone 22 Packaging

Ensuring the Safety of Food Contact
to Support a Strong Food Safety Culture Materials: GMPs and Beyond
By Lone Jespersen, Ph.D., Mike Robach, By George G. Misko, Esq.
Mark Beaumont, Ph.D.,
26 Natural Source Testing
John Helferich, and Sara Mortimore
Have Your Natural Ingredients Been
Adulterated?
54 FOOD DEFENSE By Anna Lykkeberg and Jasmine Garside
Current State of Intentional DEPARTMENTS

Adulteration 6 Editor’s Letter 60 Product Showcase
By The Food Protection and 8 News Bites 67 Advertisers Index
Defense Institute
Editorial Advisory Board Veny Gapud Gillian Kelleher Martin Mitchell

Food Safety Consultant Wegmans Food Markets Certified Laboratories/RFA
Gary Ades, Ph.D. Michael M. Cramer Tatjana Golikova, Ph.D. Hal King, Ph.D. Theodora Morille-Hinds, M.Sc.
G&L Consulting Group Ajinomoto Windsor National University of Food Public Health Innovations LLC The Kellogg Company
Technologies
Reginald W. Bennett Will Daniels Jeffrey L. Kornacki, Ph.D. Robert Powitz, Ph.D., M.P.H., RS
CFSAN, U.S. FDA IEH Laboratories & Consulting Kathy Gombas Kornacki Microbiology Solutions Inc. R.W. Powitz & Associates
Group Food Safety Consultant
Robert E. Brackett, Ph.D. Gina (Nicholson) Kramer, RS/REHS Thomas M. Sauer
IIT, Institute for Food Safety and Kurt E. Deibel, Ph.D. Margaret D. Hardin, Ph.D. Savour Food Safety International™ Food Safety Consultant
Health Heinz North America IEH Laboratories & Consulting Group
Sean Leighton, M.Sc., M.B.A. Darryl Sullivan
John N. Butts, Ph.D. Jonathan W. DeVries, Ph.D. Craig Henry, Ph.D. Cargill Inc. Covance Laboratories
Land O’Frost General Mills/Medallion Labs Intro Inc.
Huub L.M. Lelieveld John G. Surak, Ph.D.
Brian Campbell William Fisher Lone Jespersen, Ph.D. Global Harmonization Initiative Surak and Associates
Kroger Clackamas Bakery GFTC, retired Cultivate
Ann Marie McNamara, Ph.D. Wendy White, M.Sc.
Larry Cohen Timothy A. Freier, Ph.D. Larry Keener, CFS, PCQI Target Corporation Golden State Foods
Treehouse Foods Mérieux NutriSciences Intl. Product Safety Consultants
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Editor’s Letter
A Year of Milestones
CEO, The Target Group Inc. Don Meeker
T his year marks a number of milestones, the least of which

is my 10-year anniversary with this magazine. (How time
flies!) Most important, however, is the 25-year anniversary of

Publisher Stacy Atchison
In the Clear Bobby Meeker
Editorial Director Barbara VanRenterghem, Ph.D.
Director of Sales Adam Haas
the Jack in the Box Escherichia coli O157:H7 outbreak. Can we
Art Director/Production Craig Van Wechel
pause for a moment to think about how far
Digital Editor Tiffany Maberry
we’ve come, while at the same time realizing
Circulation Manager Andrea Karges
how much left there is to do?
Administrative Manager Allison Demmert-Poland
It was a year ago that we started our Publishing Office 1945 W. Mountain St.
podcast, Food Safety Matters, featuring none Glendale, CA 91201
other than Dr. Dave Theno as our inaugural Main 818.842.4777
Fax 818.955.9504
guest. Jack in the Box featured prominently customerservice@foodsafetymagazine.com
in that conversation with him. And only a short month Production Office 1113 Ellis Street
later, he was taken from us: gone but certainly not forgotten. Ft. Collins, CO 80524
Phone 970.484.4488
Countless guests of the podcast after him have spoken of his
craig@foodsafetymagazine.com
leadership and inspiration. I credit Dave with introducing
Editorial
the concept of food safety culture, long before the term itself Barbara VanRenterghem, Ph.D. • 508.210.3149
began to take hold. barbara@foodsafetymagazine.com
This year, we marked our 1-year podcast anniversary Tiffany Maberry • 678.853.1062
speaking with attorney Bill Marler, again with some emphasis tiffany@foodsafetymagazine.com
on his role in the Jack in the Box event. Additionally, this Advertising Sales
Bobby Meeker • 818.842.2829
year’s Food Safety Magazine Distinguished Service Award bobby@foodsafetymagazine.com
will be presented to Dr. Darin Detwiler, who lost his son, Adam Haas • 321.804.4319
Riley, because of the Jack in the Box outbreak, at the annual adam@foodsafetymagazine.com
meeting of the International Association for Food Protection
in Salt Lake City in July. At that same meeting, Dr. Ann
Marie McNamara, one of our Editorial Advisory Board
Food Safety Magazine (ISSN 1084-5984) is published bimonthly by
members, will be delivering the John H. Silliker lecture on
The Target Group Inc., 1945 W. Mountain St., Glendale, CA 91201;
“Heroes Past and Future.” It’s no secret, given her history at (818) 842-4777; Fax (818) 955-9504; E-mail info@foodsafety-
magazine.com. Periodicals Postage Rate paid at Glendale, CA, and
Jack in the Box, what she will talk about. additional mailing offices. Subscriptions: Free to qualified subscribers
As we remember those tragic events of 25 years ago, let’s as defined on the subscription card; $85.00 per year for nonqualified
subscribers. Back Issues: $10.00 per copy, prepaid. Change of Address:
also not forget the critically important work that everyone, Notices should be sent promptly; provide old mailing label as well as
from the CEO to the line worker, does to safeguard the new address. Allow two months for change. Editorial Contributions:
Unsolicited manuscripts should be submitted to: Barbara
world’s food supply. And let’s not forget to tip our hats once VanRenterghem, Ph.D., Editorial Director at: barbara@foodsafety-
again to Dave, for showing us the way it’s done. magazine.com. Notice—Every precaution is taken to ensure accuracy
of content; however, the publishers cannot accept responsibility for
the correctness of the information supplied or advertised or for any
Best Regards, opinion expressed herein. Postmaster: Send address changes to Food
Safety Magazine, 1945 W. Mountain St., Glendale, CA 91201. ©2018
by The Target Group Inc. All rights reserved. Reproduction in whole or
part without written permission is strictly prohibited. The publishers
do not warrant, either expressly or by implication, the factual accuracy
Barbara VanRenterghem, Ph.D. of the articles or descriptions herein, nor do they so warrant any views
or opinions offered by the authors of said articles and descriptions.
Editorial Director

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News Bites
IAFP Names Detwiler to Receive Food Safety Magazine

Eurofins as Distinguished Service Award
Recipient of Food Safety Magazine has recently announced that Darin Detwiler,
Ph.D., will receive the magazine’s Distinguished Service Award at
the Black Pearl the 2018 Annual Meeting of the International Association for Food
Award Protection (IAFP), July 8–11, in Salt Lake City.
Detwiler, currently the assistant dean at Northeastern University’s
The International Asso-
ciation for Food Protection College of Professional Studies, will be presented with the award dur-
(IAFP) has selected Eurofins ing the IAFP awards reception and banquet on Wednesday, July 11.
Scientific Inc. as the 2018 Detwiler’s work at the university includes quality assurance su-
recipient of the prestigious pervision for all undergraduate and graduate programs. He is also a
Black Pearl Award. Spon- professor of food regulatory policy, responsible for the development
sored by F&H Food Equip- and instruction of courses related to food safety, global economics of
ment Company, the Black food and agriculture, and food policy for graduate students who work
Pearl Award will be present- in the food industry. He additionally advises industry and govern-
ed at IAFP’s Annual Meeting ment agencies, addressing food safety and authenticity issues in the U.S. and abroad. After the
in Salt Lake City in July. loss of a son to Escherichia coli in a landmark outbreak 25 years ago, he consulted with the U.S.
This honor is given an- Department of Agriculture (USDA) in strengthening food safety policies, particularly in the ar-
nually to one company for eas of consumer education, product labeling, and the agency’s pathogen reduction program. In
its efforts in advancing food addition to serving in various educational and advisory capacities, he has done committee work
safety and quality through that includes appointments to two terms as a member of the National Advisory Committee on
consumer programs, em- Meat and Poultry Inspection for USDA, where his work improved standards and policies related
ployee relations, educational to risk-based sampling. As the senior policy coordinator for a national food safety organization,
activities, adherence to stan- he evaluated pertinent regulatory issues for the USDA and the U.S. Food and Drug Adminis-
dards, and support of the tration (FDA) as a consumer advocate in their stakeholder advisory group. He later
goals and objectives of IAFP. served two terms as a council member for the Conference for Food Protection,
The Eurofins mission is identifying and addressing emerging problems of food safety to influence model
to contribute to a safer and laws and regulations among all government agencies. Detwiler received his doc-
healthier world by providing torate of law and policy from Northeastern University with a research focus
innovative and high-quality on state implementation of the FDA Food Safety Modernization Act.
laboratory and advisory ser- Past recipients of the award include Reginald Bennett, M.Sc., Dane
vices for all food industries. Bernard, M.Sc., Larry Beuchat, Ph.D., Robert L. Buchanan, Ph.D., John
With a commitment to out- N. Butts, Ph.D., Keith Ito, Allen Katsuyama, Connie Kirby, M.Sc., John W.
standing client service, Euro- Larkin, Ph.D., Huub Lelieveld, Barbara Masters, D.V.M., Ann Marie McNamara,
fins has grown to become a Ph.D., William Sperber, Ph.D., Steve Taylor, Ph.D., David Theno, Ph.D., Bruce
global leader in food safety. Tompkin, Ph.D., and Don L. Zink, Ph.D.
ONLINE & Meat Lobbying Group Argues for USDA Regulation

OF NOTE of “Clean Meat”
The U.S. Cattlemen’s Association (USCA) has filed a federal petition with the U.S.
www.eatright.org/homefoodsafety Department of Agriculture (USDA) in an attempt to keep some meat producers
The Academy of Nutrition and Dietetics is the world’s from referring to their products as “meat.” What these producers make is actu-
largest organization of food and nutrition professionals; ally known as “clean meat,” which is grown by way of technology and animal
it was founded in Cleveland, Ohio, in 1917 by a visionary cells instead of traditional animal slaughter. USCA’s petition to the USDA is
group of women dedicated to helping the government somewhat groundbreaking as the group usually tends to oppose any regulation
conserve food and improve the public’s health and nutri- involving meat production.
tion during World War I. Today, the academy has over In addition to banning the use of the term “meat,” USCA would like USDA
100,000 credentialed practitioners committed to
to be the only agency regulating the small producers that make clean meat. This
improving the nation’s health and advancing the
would mean that the U.S. Food and Drug Administration would not be involved in
profession of dietetics through research,
education, and advocacy, including overseeing clean meat. A successful petition from USCA could keep clean meat from
home food safety. gaining ground in the market and crowding out conventional meat.

BizTracks
Rubber Fab Granted Patent for X-Ray-Inspectable PolySkope Labs Receives AOAC Certification
Materials PolySkope Labs has announced that it has received AOAC
Rubber Fab has been granted a patent for their X-ray Research Institute’s Performance Tested Method Certifica-
opaque polymeric materials, which complements their exist- tion for its revolutionary PolySkope 1.0 modular, multiplex
ing patent for metal-detectable gaskets. The new patent is a pathogen detection kits (Certificate no. 041801). This initial
fundamental part of the Detectomer® portfolio from Rubber approval certifies that PolySkope 1.0 is equivalent to standard
Fab, which encompasses a full range of detectable sanitary reference methods for the detection of all target pathogens in
gaskets and O-rings. These products provide food manufac- ready-to-eat deli turkey, raw ground beef, fresh spinach, and
turers with enhanced functionality, allowing them to reduce stainless steel environmental surfaces. PolySkope 1.0 can now
their process risks through better detection of nonmetallic be used by ISO 17025-accredited labs in the U.S. and certain
contaminants. international markets.
People & Places SUN Automation Group is pleased to announce that

Greg Jones has been promoted to vice president of global
The Institute of Food Science & Technology is pleased sales and aftermarket.
to announce that its past president, Margaret Patterson, Dynamic Conveyor Corporation has announced that
Ph.D., has been elected as a fellow of the International Andrew Hartline has been hired as sales
Academy of Food Science and Technology. manager to support the growing company. Jones
The National Livestock Producers Associa- NSF International awarded Hal King, Ph.D., founder
tion has recently hired Kraig Roesch as CEO. Patterson and CEO of Public Health Innovations LLC, as this year’s
Richard Fordyce has been appointed to recipient of the Food Safety Leadership Award.
serve as administrator of the U.S. Department of Agricul- Hartline Michael Best has announced that Emily R. Lyons has
Roesch ture’s Farm Service Agency. joined the firm as an associate in the transactional practice group.
F R O M F O O D S A F E T Y M A G A Z I N E
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HYGIENIC ZONING
By Richard Brouillette
The Importance of Hygienic Most food processing facilities are

not recent buildings; therefore, alterna-
tive measures preventing cross-contami-
Zoning to Prevent Product nation from existing sources need to be

assessed, and barriers and hurdles put
in place to protect exposed ready-to-eat
Contamination
(RTE) products. Some of the sources to
consider will be air, people, and materi-
als.
To assess microbial risk, processors
will determine whether RTE products
can support growth of spoilage microor-
ganisms or pathogens, or their survival.
Based on this determination, barriers
Different plants require and hurdles will be identified to protect
the product. A product supporting the
different approaches for growth of pathogenic or spoilage micro-
organisms will require more protection
zoning to prevent foodborne illness and quality
issues than a product in which microbes
I
will die off. The barriers may not only
be part of the infrastructure but may
f you are building a food processing facility, when do also be part of the product package
you begin thinking about hygienic zoning? Starting itself. A product that is pasteurized in
from the principles that the production environment package, aseptically filled, or retorted
should not be a source of biological, chemical, or will be protected by its packaging from
physical contamination for the product, we will ex- potential microbial contamination after
amine the different steps to mitigate those risks. the microbial log reduction; therefore,
The commercialization process really begins with the the building may not need to offer as
location of the property. If the piece of land is located much protection as it will for an RTE
in proximity to other industries presenting a biological product exposed to the environment
hazard (e.g., near a slaughter plant or waste disposal after the microbial reduction step. The
site), chemical contaminants (oil refinery, chemical building and infrastructure need to pro-
plant, contaminated soil, etc.) or physical contaminants vide the necessary conditions for prod-
(particles emitted during harvest, dust/sand storm, ucts to be made in hygienic conditions.
etc.), the barriers and hurdles necessary to protect food Different audit schemes and stan-
product are likely to be more robust than for a facility dards define hygienic zones differently.
located away from such contaminants. Before the different areas are named, it
The next question is where to locate the building on is useful to understand the risk to the
the property. Again, we would want to limit potential product. Some questions to consider:
contamination; if there is a retention pond or wastewa- Does the product already contain a haz-
ter treatment plant, the food processing building should ard? Is the product formulation bacteri-
be located farther away. Or if the property has a low cidal? Will pathogenic/spoilage organ-
point where water can accumulate, the building should isms survive in the RTE product? Will
be on higher ground. The Grocery Manufacturers As- pathogenic/spoilage organisms grow in
sociation facility design checklist is a useful tool to assess the RTE product?
different risks from buildings and infrastructure.1 The For example, in a bakery, the flour
checklist applies to greenfield land; some sections can receiving/storage and mixing areas basi-
also be used for existing facilities. cally have the same microbial risk (flour

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HYGIENIC ZONING
should be assumed to be contaminated etc., like soft cheeses such as Brie. As in size. This will typically require HEPA
with different pathogens), while the mentioned earlier, we will examine po- filters or a MERV 13 filter. The room
baked goods after the oven should have tential barriers and hurdles for different where the RTE product is exposed will
low microbial counts. Ideally, to prevent sources of contamination. also need to be positively pressurized to
microbial cross-contamination, there There are other reasons to separate other areas of the building to prevent
should be a physical separation (wall, different areas of the same hygiene level mold from entering the room through
doors, etc.) between the raw flour area by using barriers such as walls. For ex- openings, such as doors, pass-throughs,
and the baked goods; a facility may ample: etc. Typically, if the product is sensitive
also decide to place a wall between the • Preventing allergen cross-contami- to mold growth, the positive pressure
mixing area and the oven to manage nation between areas with different will be 0.05 inch in a water column.
the heat generated by the oven. Areas allergen profiles Keeping in mind that some bacteria
presenting the same risk may still need • Preventing species cross-contamina- are smaller than mold and mold spores,
to have physical separation for reasons tion in meat and poultry facilities if there is a risk of potential bacterial
other than potential microbial, chemi- • Maintaining claims such as genetical- cross-contamination from surrounding
cal, or physical cross-contamination. In ly modified organism-free, organic, properties (e.g., the facility is close to
this example, the baked goods are less or kosher/halal a farm or slaughter plant) or inside the
likely to support the growth of spoilage • Wet-cleaned and dry-cleaned areas plant (e.g., aerosols are generated), the
organisms and pathogens than other The European Hygienic Engineering filters will have a higher HEPA rating
RTE products, such as lunchmeat and & Design Group has provided simple and the positive air pressure might need
soft cheese. The latter may require more definitions of various hygienic zones to be higher.
stringent barriers and hurdles. and guidance to prevent biological, The product may be protected from
Table 1 shows examples of the micro- chemical, and physical cross-contamina- the environment if it is kept fully en-
bial susceptibility of different products. tion.2 closed, for example, in pipes or pressur-
There are many useful sources of infor- ized vessels. If a product that has a high-
mation to assess the microbial risks; for Protection from Environmental Air er risk of contamination will be made
example, many models are accessible Contamination in an existing facility making lower-risk
at www.foodrisk.org or by consulting While it is generally rare for patho- products, it is possible to create a “new”
with a competent microbiologist. Once gens to be transmitted by air, mold environment for the product by packag-
the microbial risk is known, the level of spores can be a source of microbial ing it in a filler that has its own HEPA
protection can be determined. Ideally, contamination, resulting in quality filter and positive air pressure.
product that can support the growth and potential food safety defects. If the Other methods to control the qual-
of pathogens would not be exposed to product can support mold growth, the ity of the environmental air exist. Some
the environment, but some foods need air should be filtered to remove mold companies are using ozone generators
to be exposed during processing, aging, spores that can be as small as 1 micron or UV treatments. These systems are
Hygiene Zones Type of Products Examples considered hurdles more than barriers
and require additional validation and
Non-Production Zones No exposed product in this type Outside the building, office areas,
of area storage areas verification to demonstrate their effec-
tiveness over an extended period under
Low-Risk Areas Raw agricultural commodities Raw meat, raw milk, flour
plant operating conditions.
that are likely to contain patho-
With time, the industry has also
gens/spoilage microorganisms
OR realized that controlling moisture and
Products with bactericidal Retorted products, some sauces, temperature can be critical to prevent-
formulation or with a microbial dressings, etc. ing microbial growth inside the room.
reduction step once in the final In general, keeping the room cooler and
package the humidity lower help delay microbial
Medium-Risk Areas Postmicrobial reduction step or Hot-filled/packed products, etc. growth in the production environment,
products that will not support the which reduces the risk of cross-contam-
growth of pathogens or spoilage ination. In existing facilities, moisture
microorganisms can also be reduced by eliminating
High-Risk Areas Postmicrobial reduction step or Some RTE refrigerated products such environmental sources, such as by re-
products that may support the as soft cheeses, lunchmeat, etc. placing foot baths or door foamers with
growth of pathogens or spoilage dry foot baths, by addressing any water
microorganisms leaks as quickly as possible, or by install-
Table 1. Microbial Susceptibility of Different Products ing dehumidifying systems.

HYGIENIC ZONING
Protection from People production areas and entrances where planned.
Once the positioning of the walls employees and contractors can enter di- In addition to waste areas mentioned
delimiting the different production rectly from the outside. These entrances above, other areas such as sanitation
areas is decided, people may still need will also need to have hurdles (e.g., rooms, employee welfare rooms, and
to move between the different areas. changing hairnets, smocks, footwear outdoor smoking areas may be shared
Ideally, people and material movements brushes and sanitizers, handwash sta- by employees working in areas with dif-
between a low-risk or raw product area tions, or hand sanitizers) for employees ferent levels of hygiene. Risk from these
and a high-risk or RTE product area are reentering production areas. areas will also need to be considered
limited or completely avoided. When and managed.
designing a new facility, this objective Protection from the Movement of Employee training is equally impor-
can be achieved by planning people and Materials tant. When new employees are hired or
material traffic to keep paths from cross- A key concept to prevent cross- when there is a change in the hygienic
ing. In existing facilities, passive barriers, contamination is to have the materials zoning program, it is important to
such as lines painted on the floor, may flow in one direction. explain the reasons
be needed to provide visual clues to Depending on the “Different audit behind the different
the employees about the separation be- material, this will be rules and behaviors
tween the different zones. Using differ- from the lower- to the they need to adopt.
ent colors of paint that can also match higher-risk area or vice schemes and standards Having physical barri-
the employee hairnets can provide an versa. If we look at ers and active hurdles
additional reminder. For example, lines the different types of define hygienic zones will promote behaviors
delimiting low-risk areas might be paint- materials: that will prevent cross-
ed in green, signs directing people to • Product should contamination.
that area can also be green and employ- flow from the low- differently.” The effectiveness of
ees working in the low-risk area may risk to the high-risk the hurdles and em-
be wearing green hairnets, while signs area by passing through the micro- ployee behaviors can be verified using
and hairnets for the medium-risk areas bial reduction step. different programs. The environmental
might be yellow and ones for high-risk • Packaging material should be re- monitoring program should include
areas might be red. ceived and stored close to the high- swab sites from the transition points to
Once the physical barriers or indica- risk area to limit the potential for verify the effectiveness of the hurdles.
tions are in place, hurdles are needed to cross-contamination associated with Audits of Good Manufacturing Practices
prevent contamination from nonpro- moving packaging through the low- and behavioral observations are other
duction areas or sources, which include risk area. tools to verify whether employees are
employees, visitors, and contractors • Waste should be transported from following the rules to prevent cross-con-
coming from outside the plant or of- the area where it is generated to a tamination. If the product is susceptible
fice area of the plant to the production nonproduction area or to a low-risk to mold growth, environmental air can
areas. In general, production entrances area. It should not be going from be monitored for mold count.
will be equipped with hairnet/beard net the low-risk to the high-risk area. Finally, whether you are thinking
stations, handwash stations, and foot- If the recycling/compactor area is about building a new facility or modi-
wear sanitizers. The level of control may shared between low-risk and high-risk fying an existing one, it takes a multi-
depend on the hygienic zone entered. products, precautions must be taken functional team and time to determine
For example, when entering a low-risk when waste containers are returned the optimum hygienic design that will
area, employees may walk through a to the high-risk area (e.g., cleaning consider all the different aspects of
footwear sanitizer in a transition area; the inside and outside of the waste effective zoning to ensure both opera-
however, when entering into a high- container, sanitizing the wheels). tional efficiency and safe food. n
risk area, employees may change their • When designing a new facility or
shoes to dedicated ones or don aprons modifying the wastewater system of Richard Brouillette is the food safety director at
or smocks over their uniform in a ves- an existing one, the wastewater line Commercial Food Sanitation.
tibule. Entrances to high-risk areas can for the low-risk product should not
be equipped with active hurdles, where be connected to the one from the References
employees need to activate the hand- high-risk product. 1. Grocery Manufacturers Association. 2010.
washing station to open the door. • Utensils and tools used in high-risk Facility Design Checklist. gmaonline.org.
Thought should also be given to areas are often dedicated and stored 2. European Hygienic Engineering & Design
remote entrances to production areas; in those areas. Sufficient space for Group. Hygienic Design Principles for Food
for example, if roof access is located in storage and cleaning should be Factories (VDMA Verlag, 2014).
J u n e n J u ly 2 018 13

OP-ED
By Stephen Ostroff, M.D.
The Costs of Foodborne 2012, the Grocery Manufacturers Asso-

ciation (GMA) and the Food Marketing
Institute estimated that the average cost
Illness, Product Recalls Make for a food recall in the United States
was $10 million. That number was just
for the direct costs to the company,
the Case for Food Safety such as the retrieval and disposal of the
recalled product. There are also indirect
costs, including lawsuits, damage to a
Investments company’s or product’s reputation, and

sales losses.
GMA also did a survey of several
dozen multi-national corporations, and
18 percent indicated they had been
involved in recalls with estimated costs
between $30 million and $99 million
each. Another 5 percent said they had
Prevention, not reaction been involved in recalls that cost more

than $100 million.
These days, FDA gets involved in
about 700 food-related recalls per year.
Some are small and some are big. Some
S
involve undeclared allergens or misla-
beling, some involve particulates (e.g.,
ince assuming the role of deputy commissioner glass, metal, or plastic), and some are
for foods and veterinary medicine at the U.S. due to microbial contamination.
Food and Drug Administration (FDA) in 2016, If anything, the cost of a recall today
I’ve had numerous occasions to speak publicly is higher than it was in 2012. But even if
about food safety. On one of these occasions, you use the 2012 average figure of $10
I was part of a panel asked to address this topic: Taking million and multiply it by 700 recalls,
food safety from risk management to growth generator. that comes out to $7 billion in direct
Knowing that many in the food industry look at costs alone to industry annually. Throw
regulations as something that costs them money—money in another $3 billion for the indirect
that could be invested instead in such areas as product costs to industry, and you’re talking a
innovation, facility upgrades, marketing, or other profit- lowball estimate of $10 billion a year. In
generating components of the company—I want to focus addition, there are numerous examples
here as well on the growth-generating potential of food of significant damage to the reputation
safety regulations. of brands and commodities, with an
Let’s consider some statistics on the economic accompanying loss of market share. In
cost of foodborne illness in the United States, such some instances, market share never fully
as medical expenses and deaths, along with lost wages recovers or takes years to occur. There
and economic productivity. A 2014 estimate from the are reasons to think the indirect costs of
U.S. Department of Agriculture placed the direct and recalls could be much higher.
indirect costs associated with illnesses caused by major Food safety problems are not bad
foodborne pathogens at $15.6 billion per year. A more just for companies that recall products.
recent estimate from Ohio State University that covered Even companies that market products
all causes of foodborne illness, not just illness from the similar to a recalled food can suffer,
major foodborne pathogens, was at least $55.5 billion. too. The worst thing that can happen
And what about costs associated with food recalls? In to a food sector or the food industry is

OP-ED
the loss of consumer confidence due to Just imagine a scenario in which and the food industry is building a
recalls or disease outbreaks. food recalls were cut in half. That saves culture of food safety, not only in the
Every food safety incident that is industry at least $5 billion per year and United States but around the world as
prevented, whether from the standpoint prevents a lot of foodborne illness. A well. That will save money and generate
of industry or consumers, is nothing 25 percent decrease in foodborne illness growth. Most importantly, it will pro-
short of money in the bank. For indus- saves at least $4 to $14 billion per year. mote health and save lives. n
try, that $10 billion in recall costs is I hope that with full implementa-
money that can be invested in growth- tion of FSMA, we achieve that and Stephen Ostroff, M.D., is the deputy commissioner
generating activities. For consumers, more. The partnership between FDA for foods and veterinary medicine at FDA.
there are billions in healthcare costs
associated with foodborne illness that
come out of their pockets and could be
used in other ways.
Food safety regulations can also
generate growth in developing coun-
tries. This summer, the World Bank is
expected to publish a report that shows
the economic impact of food safety
hazards, the consequences of the lack
of food safety capacity, and the scale
of economic returns from food safety
investments in developing countries.
This work should help make the case for
devoting policy and public resources to
strengthening food safety protections in
low- and middle-income countries. That
not only improves the domestic food
supply in those countries but also facili-
tates exports. After all, the FDA Food
Safety Modernization Act (FSMA) re-
quires imported foods to meet the same
food safety standards as foods produced
domestically.
But most importantly, as someone
who works at an agency that promotes
public health through regulation, I
know that food safety is good public
health. That’s why FDA has, for the last
7 years, worked so hard to implement
the FSMA requirements that will move
the food safety system from one that
reacts to problems to one that prevents
them from occurring.
The food industry has worked co-
operatively with FDA to implement
FSMA. The vast majority of food pro-
ducers want to protect their customers
from harm, and many have provided
key feedback as the FSMA regulations
have taken shape. These same food pro-
ducers want to protect their brand and
want to be known for having high food
safety standards. Food safety is good for
business.
J u n e n J u ly 2 018 15

TESTING
By Samuel S. Liu, Ph.D.
Investigation and Physical contaminants are also re-

ferred to as physical hazards or foreign
matter. Shrew teeth in a crop product
Identification of Physical or a piece of wire in a meat product are

examples. Glass pieces, metal fragments,
bone chips, and pits may all cause
Contaminants in Food serious harm when ingested. Com-

mon examples of bodily harm include
lacerations of the lips, the inside of the
mouth, teeth, gums, tongue, throat,
esophagus, stomach, and intestine, and
even choking. Children and seniors are
at greater risk and have the highest inci-
Steps for the investigation of dence of such harm.

Government agencies, food produc-
physical contaminants in your ers, manufacturers, distributors, and

retailers must all protect the health of
plant the consumer as one of their most im-

portant objectives and responsibilities.
If there is any evidence or reason to be-
A
lieve there are physical contaminants in
a food product that may cause illness or
mericans spend about $500 billion on food injury to consumers, government agen-
annually.1 When we consume food or drink, cies, including the U.S. Food and Drug
we expect to enjoy it and do not expect to Administration (FDA) and the U.S. De-
get sick or injured. Ingestion of a piece of a partment of Agriculture (USDA) Food
hard or sharp material such as glass or metal Safety and Inspection Service (FSIS),
could cause an unsuspecting consumer severe injury, reject the food product from sale in the
require surgery, or have deadly consequences. Therefore, U.S. market or request food recalls.
food contamination has always been a major concern of Huge economic losses to businesses
the U.S. government, the food industry, and consumers. may occur when a physical hazard is
Most physical contaminants of foods, such as pieces discovered. There were 456 food recalls
of hard plastic or wood, can cause consumers immedi- in the U.S. in 2017 and 764 food recalls
ate injury; this includes all types of foods, including in 2016, which were announced by
beverages, bottled water, and nutritional and functional FDA and FSIS. Of those, foreign matter
products. Any physical material in food that does not caused 42 recalls in 2017 and 44 recalls
belong in the product may be classified as a physical in 2016.2,3 According to FSIS,4 16.51
contaminant. million pounds of food were withdrawn
Sources Examples of Contaminants
Field Rocks/stones/sand, asphalt, metals/bullets, concrete particles, bones, wood fragments,
and thorns
Processing Glass, ceramic/shards, metal fragments, staples, blades, clips, needles, keys,
screws, magnet fragments, washers, bolts, screening, plastic, grease/lubricants,
rubber, insulation/seal materials, nail polish, jewelry, coins, pieces of gloves, finger
cots, bandages, cigarette butts, gum, bones, pits, fruit stones, nut & animal shells,
medications/tablets/capsules, wood, pens, and pencils
Storage and distribution Metal, plastic, and wood fragments
Table 1. Sources of Physical Contaminants in Foods

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TESTING
from the market following 56 food can be introduced into food products jewelry, insects/filth, insulation, bone,
recalls because of extraneous materials accidentally during harvesting or at any plastic, personal effects, bullets/BB
from 2015 to 2017. point during processing due to poor shot, and needles.5 Table 1 provides a
procedural practices anywhere in the summary of common sources.
Causes of Physical Contamination food chain, including manufacturing,
Physical contaminants in food could storage, transportation, or retail. The Investigation and Identification of
come from either external sources, such so-called Dirty Dozen, the 12 most Physical Contaminants
as metal fragments, or internal sources, common foreign material contaminants Food companies work hard to keep
such as bone particles and pits. They in food, are glass, wood, stones, metal, their products free of contaminants.
Investigation and control of physical
SPONSORED CONTENT contaminants in food should be con-
ducted throughout the whole processing
Foreign Object Detection Technology Update: chain or in food testing laboratories.
With accurate and timely informa-
Multiscan Metal Detection tion, a thorough investigation can be
Finding metal foreign carried out in testing laboratories in a
objects in food is vital to food cost-effective and efficient manner. It is
essential to have a professional investi-
safety and quality. Inspection
gation team with appropriate resources
for such contaminants is
and equipment to help food company
usually located at the end
quality assurance staff troubleshoot
of the line as the last line of
consumer complaints and answer ques-
defense before a product is on tions as to what the contaminants and
its way to the consumer. Yet, their sources are. It is often necessary to
1- to 2-frequency digital metal apply integrated, multidimensional ap-
detectors, ubiquitous in food proaches for complicated investigations.
plants over the past 25+ years, have come with key barriers to achieving 100 Comprehensive investigation can de-
percent metal-free products. Among the most difficult applications are dairy, mand microscopy-based examinations
meat, poultry, and bread. plus chemical techniques, on-site ex-
aminations, Fourier transform-infrared
Challenges include: (FTIR) analysis, and other techniques.
1. Finding anything, anywhere in any product—all of the time: Consider the The investigation processes and screen-
production volume in one of your lines in just one day and the different ing procedures depend on the particular
types of metal that might be in your factory or in the ingredients. physical contaminants and their sourc-
2. The use of electromagnetic fields to find things that are magnetic and es. The procedures can be combined or
conductive: Most food products are wet, have salt, or contain minerals,
modified methods found from the fol-
lowing: AOAC International, American
which, when subjected to electromagnetic fields, also look magnetic and
Spice Trade Association, FDA’s Mac-
conductive. Therefore, ignoring the product and finding the metal are not
roanalytical Procedures Manual, FDA’s
easy.
Laboratory Information Bulletins, USDA’s
3. The very small signals from small metal foreign objects: When a factory foreign matter identification docu-
has many possible noise sources, they can confuse the metal detector ments, the United States Pharmacopeia,
electronics and software. and other compendious sources.
A new approach to metal detection—called multiscan—overcomes the In general, special investigation pro-
limitations of previous technologies. At the critical control point in your cedures include:
process, this new technology can scan up to five completely adjustable • Inspect and target suspected sources
frequencies at a time to find metal types and sizes that were previously of physical contaminants
undetectable. The result? Reducing the probability of an escape by many • Identify the foreign matter
orders of magnitude. Think of it as having up to five metal detectors back • Determine or evaluate the root cause
to back in your production line; with multiscan, metals undetectable at one or sources
frequency can be detected at another. These procedures consist of eight
To learn more about multiscan, available now in the Thermo Scientific steps:
Sentinel Multiscan Metal Detector, visit www.thermofisher.com/SentinelFSM. 1. Target contaminants. In many
cases, it is necessary to select a suitable

TESTING
investigational procedure, including materials, such as synthetic polymers. ity, flexibility, flammability, temperature
sample inspection, preparation, and Spectroscopic techniques can reveal resistance, etc.
identification of target contaminants. specific functional groups of a chemical 4. Perform a chemical examination.
The sources of contamination are di- material. For example, different plastics Chemical analysis, including an elemen-
verse, whether individual or related, or may be identified by FTIR analysis. tal analysis, can reveal characteristic
even unknown. Often, little is known Physical properties can be classified by features that enable an understanding
about the contaminants, how many many characteristics and features, such of chemical properties. Histochemical
there might be, what size, what their as size, shape, thickness, magnetic char- staining techniques are useful to test
regulatory status might be, or whether acteristics, solubility, buoyancy, elastic- the chemical and (continued on page 62)
they might be in a food mixture.
Preexamination steps allow judg-
ments to be made as to whether the
targets can be separated by size, shape,
Do Your Products Conform
mass or magnetic properties, the type of
samples and contaminants (e.g., organic
to Your Brand Requirements
or inorganic), amount, circumstances of
contamination, and levels. It is normally and Regulations?
required to conduct resampling, inspec-
tion, macroscopic examination, extrac-
tion, filtration, floating, sieving, burn-
Partner with the product inspection
ing, dyeing, and further examination experts to ensure they do!
using X-ray, metal detectors/magnets,
and other screening or targeting tech-
nologies. An example might be to use
magnets to gather and identify ferrous
metal particles from liquid samples.
2. Identify contaminants. Once the
suspected foreign matter screening pro-
cedures are carried out using stereo or
dissecting microscopic examinations as
a starting point, one can obtain detailed
evidence, identifying the morphology
and deciding what methods of analysis
should be applied. For example, if a
complainant believes that pieces of
glass were observed by the naked eye
in a food, it may be that the material
consists of rocks, salt, sugar, plastics,
minerals, struvite, or tartrate crystals.
If needed, a compound microscope,
bright-field/dark-field microscope, po-
larized microscope, or scanning electron
microscope could be applied to reveal
more details. Further tests are deter-
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J u n e n J u ly 2 018 19

FOOD SAFETY INSIGHTS
By Bob Ferguson
Listeria: An Important Focus that they collect, roughly 15 percent

indicated that they would be decreasing
their sampling, and the remaining one-
of Environmental Monitoring half indicated that they would be mak-

ing no change (Figure 1). Interestingly,
of those reducing their sampling, the
average reduction was about 18 percent,
but for those increasing their sampling,
the average increase was 107 percent.
These numbers, however, do not tell
the entire story, and the data are skewed
Looking at changes in Listeria by some very large producers who are
planning very large changes in their test
testing volumes.
For instance, of those companies
that indicated that they would be re-
I
ducing their testing volumes, the five
companies with the largest change rep-
t is no secret that food processors are battling Lis- resented approximately 70 percent of
teria. The number of reported incidents and recalls
Food Safety Insights is a related to Listeria has been increasing, and proces- 50.3%
sors are making efforts to rid their facilities of har-
collaboration between
borage organisms. And, of course, South Africa is
recovering from what is understood to be the world’s 35.2%
Food Safety Magazine
largest and most deadly listeriosis outbreak in history.
and the food safety In the U.S., these concerns for food safety, as well
as new regulations and guidelines, particularly the U.S. No
market experts at Food and Drug Administration (FDA) draft guidance
14.5%
published in mid-2017, have processors reevaluating
Strategic Consulting Inc. their testing programs—especially their environmental
monitoring (EM) programs. The onset of Food Safety
to bring you the latest Modernization Act (FSMA) compliance dates and the
Increase No Change Decrease
accompanying inspections along with the prospect of
market research, insights, Figure 1. How will your environmental
FDA “swab-a-thons” has only accelerated this trend.
monitoring program for Listeria change next
and trends in food It was clear to us that testing for Listeria was grow-
year?
ing faster than perhaps any other microbiological test-
safety, analytical testing, ing category, and we wanted to find out more. the change and a volume of just under
In February, we surveyed 262 food processors 30,000 samples annually. Of those in-
diagnostics, laboratory across all processing categories, including 200 in the dicating that they would increase their
U.S. and Canada and 62 international processors. We sampling, the five companies with the
services, sanitation, and asked about overall test volumes and how they have largest change represented about 90
changed or may be changing in the next few years. We percent of the change in the sample and
related topics in quality also asked questions about specific changes to their 100%
about 330,000 samples annually—an
Listeria testing programs. increase in sample volume more than
10 times that of the reduction.32.0%
and safety testing and
Changing Patterns in Testing
Percent of processing plants
assurance in the food The trend is that the larger com-

When asked if they would be changing the volume
65.0%
panies that have already been doing a
of EM testing for Listeria, about 35 percent indicated 82.1%
higher volume of samples are refining
and beverage industry.
that they would be increasing the number of samples their programs but making only 40.0%
modest
11.7%
6.6% 23.3% 28.0%

11.3%
0 – 19 20 – 100 > 100
Number of samples analyzed per week
FOOD SAFETY INSIGHTS
reductions in the test volumes. Those reported a similar plan: Later this year, 100%
large companies that have been doing they will be increasing their EM test
fewer samples will be dramatically in- volume significantly, but the numbers 32.0%
creasing their test volumes from perhaps of samples for Listeria that they collect
Percent of processing plants

tens to up to hundreds of samples per at each plant will increase from tens to 65.0%
week. Many of these companies include hundreds of samples each week. 82.1%
a few large companies with multiple Another company planned to take 40.0%
locations. a somewhat different approach. A few
We spoke to several of these pro- years ago, in anticipation of regulatory 11.7%
cessors to get more information. One and inspection changes, they increased
processor that indicated that they were their EM sampling and doubled the 6.6% 23.3% 28.0%
planning to reduce their EM sample number of samples that they were col- 11.3%
volumes told us that they were changing lecting for both Salmonella and Listeria. 0 – 19 20 – 100 > 100
Number of samples analyzed per week
their program to take a more focused Although they were regularly collecting
Outside commercial lab
approach. They had been taking several EM samples, most of the increase in
Central corporate lab In-plant lab
hundred samples each week throughout their sample numbers came from “seek
Figure 2. Where are your EM samples
the plant, but this changed about 2 and destroy” sampling programs that
analyzed?
years ago. At that time, they adjusted they conducted three times per year.
their EM program to collect fewer They found this to be an effective way ported in December-January 2017, in
samples for pathogen analysis in key to hunt for difficult areas that may have which approximately two-thirds of pro-
problem areas, or, as they indicated, been missed by routine sampling. Fol- cessor locations will primarily outsource
they adjusted from a “shotgun” to a lowing their FSMA compliance date, sample analysis, but this results in a
“rifle” approach. The sample sites were they received an FDA inspection that 50/50 split in terms of overall pathogen
developed using data collected over included a “swab-a-thon.” They were sample volume.
previous years; this approach allowed happy to report that the FDA sampling
them to identify key problem areas and found no positive samples, but they An Opportunity for Testing Labs
reduce the sampling they conducted nonetheless increased their sampling Based on the data from this survey,
in those areas, which were shown to be projects to quarterly, further increasing as well as data that we have collected
under better control. their overall volumes another 10–15 for other projects, we anticipate that
percent. sample analysis for Listeria will be the
Intensifying Efforts against Listeria Many will be wondering where fastest growing category in food safety
In other interviews, processors told these samples will be analyzed. As we microbiology for the next few years. As
us about their plans to dramatically in- have seen in the past, where companies the largest companies set the standard,
crease their Listeria sampling, particularly send their samples for analysis largely others will follow, and we would expect
their EM sample volume. One com- depends on their sample volumes. As this trend to continue for the next 2 to
pany reported that they are dramatically shown in Figure 2, smaller and midsize 3 years until companies have completed
changing their program, with an aim users overwhelmingly send their sam- the adjustments of their programs and
to find and eliminate Listeria harbor- ples out to a commercial lab, but above growth levels off at this increased level.
age sites and as a response to the FDA the 100-samples-per-week threshold, the This increase in demand for Liste-
guidance released in 2017. Their plan balance tends to favor using a central- ria tests will drive competition in the
will include increasing their overall EM ized corporate lab or an in-plant lab. diagnostic and laboratory market, and
sampling volume approximately two- This figure shows the selection based on we can expect to see new products and
fold. They reported that all EM testing the number of facilities, but when the offerings emerge to capture this new
will increase, including tests for other data are weighted for volume, the num- demand.
pathogens, but the primary driver of the ber of samples being sent to commercial Processors are clearly attacking the
increase will be Listeria, mentioning that labs is roughly 50–55 percent of the to- Listeria issue. It is now up to the diag-
“we had been doing hundreds of Listeria tal sample volume in the survey. This is nostic companies and laboratories to
samples per month and will now be expected, as the few, very large facilities help them meet the challenge. n
doing hundreds of samples per week.” with high sample volumes tend to have
They also mentioned that end-product access to a central lab or in-plant lab, Bob Ferguson is the managing director of Strategic
testing will increase somewhat, but less whereas the higher-number-but-smaller- Consulting Inc. and can be reached at
than 10 percent, and routine microbiol- volume users are much more likely to foodsafetyinsights@gmail.com or on Twitter at
ogy will be unchanged. send their samples to an outside lab. @SCI_Ferguson.
Another company we spoke with This is consistent with the data we re-
J u n e n J u ly 2 018 21

PACKAGING
By George G. Misko, Esq.
Ensuring the Safety of tion of food. Section 402 of the act de-
fines “adulterated food” as food that:
• Contains any poisonous or deleteri-
Food Contact Materials: ous substances “which may render”

food injurious to health;
• Contains an uncleared food additive;
GMPs and Beyond

• Consists in whole or in part of any
filthy, putrid, or decomposed sub-
stance, or if it is otherwise unfit for
food;
• Is prepared, packed, or held under
insanitary conditions where it may
have become contaminated with filth
Requirements for food or may have been rendered injurious
to health;
companies to ensure the • Is in a container that is composed,
in whole or part, of any poisonous
safety of food packaging or deleterious substance “which may
render” food injurious to health.
The FD&C Act defines “food” to in-
T
clude food additives and defines a “food
additive” as “any substance the intended
he U.S. Food and Drug Administration (FDA) use of which results, or may reasonably
announced in January 2018 that it was exercis- be expected to result…in its becoming
ing enforcement discretion with respect to a component or otherwise affecting the
the Food Safety Modernization Act (FSMA) characteristics of any food,” unless the
Foreign Supplier Verification Program (FSVP) substance is generally recognized as safe
requirements for importers of food contact substances or the subject of an exemption. This
(FCSs). The news was met with a sigh of relief by the can include substances that are added
industry. The reasons for FDA’s decision centered on directly to food and that may become a
the vastly different hazard profiles and risks presented component of food indirectly, such as
between FCSs and traditional food. through packaging materials.
In meetings and through written correspondence, Prior to 2000, the only means to ob-
food packaging industry representatives had pointed tain FDA clearance for FCSs that were
out to FDA that requiring importers of FCSs to comply food additives was through the submis-
with the FSVP regulation would impose a burden that sion of a food additive petition. Once
is not commensurate with the risk presented. Many submitted, it would then take an average
importers of FCSs source materials from hundreds of of 2 to 4 years for FDA to promulgate
suppliers through a complex supply chain; yet, packag- and publish a formal regulation.
ing materials do not have a history of being a source of During a congressional hearing
foodborne illnesses. held in 1958 on the FD&C Act, it was
FDA cited its premarket review and oversight of pointed out that with respect to pack-
FCSs, and the regulatory framework for these substances aging materials, FDA was being called
as reasons for exercising enforcement discretion with upon to spend an inordinate amount
regards to FCSs and the FSVP regulation. of resources on a potential hazard that
There are some overriding requirements that apply time had shown was virtually no hazard
to both conventional food and food packaging. Chief at all.1 Industry kept pressing the point
among these is the Federal Food, Drug, and Cosmetic with the U.S. Congress and FDA, which
Act of 1938 (FD&C Act) prohibition on the adultera- finally paid off with the enactment of

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PACKAGING
the Food and Drug Administration them. Current GMPs for food3 describe the toxicity profile of the impurity and
Modernization Act of 1997 (FDAMA), the methods, equipment, facilities, and its dietary exposure must be considered.
which introduced a new framework for controls for producing food and pre- Oftentimes, with materials cleared by
obtaining FDA clearance of FCSs. scribe the minimum sanitary and pro- FDA by way of an FCN, these issues are
More specifically, FDAMA autho- cessing requirements for producing safe considered and dealt with by the inclu-
rized the Food Contact Notification and wholesome food. sion of specifications in the FCN itself.
(FCN) program. This program allows Pursuant to FSMA, the current GMP Sometimes, where FCSs may be cleared
a manufacturer or supplier of an FCS requirements for human food were by a regulation, this is not the case as
to submit an FCN that includes the updated in 2015. Among the changes the substance may not have been recog-
identity and intended use of the new were new requirements to establish nized as a carcinogen at the time it was
FCS, along with data supporting the Hazard Analysis and Risk-Based Preven- regulated, and even if it had been, some
conclusion that the substance is safe tive Controls for food products, which of the specifications may have been set
for its intended use. If shift the focus from so long ago as to now be woefully out
FDA does not object “There are responding to food- of date. A dated regulation does not
to an FCN submission borne illness to pre- relieve a manufacturer’s responsibility to
within 120 days, then
the new FCS, or mate-
some overriding venting it. Since FCSs
are rarely the cause
ensure a suitably pure product.
In addition to purity requirements,
rials made with it, may of foodborne illness, the GMP requirements for food packag-
be marketed. requirements GMPs for them, which ing apply to the use level of an additive.
So, what does this only specify generic This means that an FCS may be used
have to do with Good
Manufacturing Practic-
that apply to both requirements, were not
updated under FSMA.
only in an amount necessary to achieve
its function or purpose, and must also
es (GMPs)? Well, just The most critical not contain impurities at levels suffi-
as hazard and risk are conventional food and GMP requirement for cient to adulterate the food.
important elements packaging materials is The GMP regulation for FCSs speci-
in determining how
food packaging and
food packaging.” that they be suitably
pure for their intended
fies general rather than the detailed re-
quirements specified for conventional
other contact materials use. This means that food. The procedures that a manufac-
should be regulated and the extent of the FCS may not impart anything to turer of FCSs should follow to ensure
public resources that should be expend- food that can make it harmful or del- compliance with the GMP regulation
ed on them, so too are these important eterious to health, or impart an off-taste will vary based on the specific product
considerations in assessing the type and or -odor to food. While rare, off-taste and the manufacturing process. For ex-
nature of GMP controls needed to en- and -odor issues in food packaging do ample, a GMP program for a manufac-
sure the safety of FCSs. arise. In 2010, Kellogg voluntarily re- turing facility that produces defoamers
As a precursor to this discussion, it is called 28 million boxes of cereal due to for food contact paper products will dif-
important to note that even if an FCS complaints of off-taste and smell. It was fer from one for a plant that produces
is cleared by FDA and complies with postulated that the wax paper liners in trays for microwaveable foods.
the specifications and limitations set out the cereal boxes were releasing hydro- A well-designed GMP program will
in an applicable regulation of an FCN, carbons, including methylnaphthalene. address the entire production cycle of
its use will violate the FD&C Act if it Kellogg filed suit against its supplier of FCSs and products. This should include
does not also comply with the GMP the liners to recover the damages it in- raw materials, manufacturing equip-
regulation for food packaging materials, curred due to the faulty liners, and the ment and procedures, personnel, testing
“General provisions applicable to indi- liner manufacturer then interpleaded its procedures to ensure product purity,
rect food additives.”2 This regulation is coating supplier as the liable party. and quality control of finished prod-
central to ensuring the safety of FCSs in An important part of suitable purity ucts, along with record-keeping. Other
the U.S. involves the need to ensure that residual considerations for an effective GMP
components of starting materials are program are discussed below.
Good Manufacturing Practices sufficiently low that their presence will Assessment of raw materials should
GMPs ensure that products meet not result in a health or safety concern. include confirmation that specifications
food safety, quality, and legal require- Most of these concerns center upon are met. This may include obtaining
ments. Since the hazard profiles and harm from chronic exposure to certain certificates from suppliers that show
risk presented for conventional food substances that may be suspected of car- that raw materials are cleared for their
and FCSs are very different, FDA has cinogenic potential or other such health intended use by FDA or test results,
issued separate GMP regulations for hazards. In evaluating these impurities, such as migration testing. In addition,

PACKAGING
suppliers should be contractually obli- The Framework Regulation specifies The seven principles of an HACCP
gated to notify their customers of any that food contact materials and articles program are:
significant changes. The impact of any must be manufactured in accordance • Conduct a Hazard Analysis;
changes in raw materials or processes with GMPs, so that they do not transfer • Identify the Critical Control Points
should be evaluated before they are their constituents to foodstuffs in quan- (CCPs) where control can be applied
implemented. Finally, food contact and tities that could endanger human health to prevent, eliminate, or reduce a
nonfood contact materials should be or bring about an unacceptable change hazard;
stored separately. in the composition of the food or its • Determine limits for each CCP;
Manufacturing procedures should organoleptic properties. • Establish monitoring to ensure that
be written out and available at work- Once legal safety requirements are limits are being met at each Control
stations. The written procedures met, customers may require further as- Point;
should include spe- surance that FCSs and • Establish corrective actions when
cific raw materials and products are safe and limits are not met;
amounts, identifica-
“The most critical of a certain quality. • Establish record-keeping procedures;
tion of critical points For instance, many • Verify that the program is working.
in production that GMP requirement for food manufacturers, In summary, FDA’s GMP regulation
need monitoring, and especially large infor indirect additives is fairly general
required testing. Pro- ternational ones, are and includes the following requirements
cedures that should
packaging materials is mandating that their for food contact materials and their
be taken to correct packaging suppliers be components: They should be suitably
any deviations should that they be suitably Global Food Safety pure and comply with other provisions
also be specified. All Initiative (GFSI) certi- of the FD&C Act; they must not render
employees should be fied. food unfit for consumption; and they
trained in GMPs, and
pure for their GFSI was founded in should not be used at a level greater
details of the training 2000 due to concerns than necessary to achieve the intended
should be specified. intended use.” about overlapping technical effect.
The process for audit systems and in- This being said, as greater attention
the management of consistencies between is focused on the role of packaging in
changes—such as the source of raw mate- them. GFSI establishes requirements food safety, whether justified or not,
rials, a product formula, or the produc- for food safety management schemes food manufacturers may require their
tion process—should be written out. It and provides a framework against which packaging supplier to establish compli-
is important to clearly document the these schemes can be benchmarked. The ance with food safety certification pro-
management hierarchy so it is clear who organization does not undertake any grams that go beyond current require-
may approve specific types of changes. accreditation or certification activities. ments. But that is a subject for another
Documentation and record keep- Several certification programs for day. n
ing are critical to demonstrating that manufacturers and converters of pack-
a manufacturer is conforming to its aging and packaging materials are cur- George G. Misko, Esq., is a partner in the Washing-
Standard Operating Procedures. Includ- rently recognized by GFSI, namely, the ton, DC, office of Keller and Heckman LLP. He can be
ing all the factors mentioned above in a British Retail Consortium, FSSC22000, reached at misko@khlaw.com.
GMP manual will minimize the chance IFS PACsecure, and the Safe Quality
for errors. Food program.4 The GFSI-benchmarked References
food packaging standards establish a 1. See Food Additives: Hearings on Bills to
Customer Requirements minimum set of requirements. One of Amend the Federal Food, Drug, and Cosmetic
As discussed above, GMPs should these requirements is to have a Hazard Act with Respect to Chemical Additives in Food
ensure that FCSs meet legal prerequi- Analysis and Critical Control Points Before a Subcommittee Of the House Commit-
sites for safety and quality, and while (HACCP) program in place. Unlike tee On Interstate & Foreign Commerce, 85th
this article focuses on U.S. legal require- GMP inspections that can be flexible, Cong. 44 (1958); at 447 (testimony of Jerome H.
ments in our global economy, GMP re- GFSI-benchmarked audits are defined Heckman, Society of the Plastics Industry).
quirements of other countries may need by the owners of the standard. 2. 21 C.F.R. Section 174.5.
to be considered as well. In the Euro- A HACCP plan can be included 3. 21 C.F.R. Part 117.
pean Union, for example, food contact in a company’s GMPs. Its basis is to 4. See www.mygfsi.com/certification/
materials are subject to the Framework identify, evaluate, and control hazards. recognised-certification-programmes.html.
Regulation (EC) No. 1935/2004 and the For packaging, these can include foreign Keller and Heckman does not endorse any spe-
GMP Regulation (EC) No. 2023/2006. objects or chemical contamination. cific certification or audit program.
J u n e n J u ly 2 018 25

NATURAL SOURCE TESTING
By Anna Lykkeberg and Jasmine Garside
Have Your Natural Ingredients products is a well-established problem,

as many natural ingredients suffer
from high production costs and vari-
Been Adulterated? able supply. Using ingredients that are

cheaper and more abundant is appeal-
ing and when done surreptitiously can
introduce unknown food safety issues.
Although many adulteration methods
do not pose a clear food safety issue,
Carbon-14 testing may hold without the usual safety checks in place
for approved ingredients, any adulter-
the answer to a thorny—and ant has the potential to cause physical
harm. Some examples of the variety and
costly—question for the food potential of adulteration seen for natu-
ral products are highlighted below.
industry A report by the European Commis-
W
sion’s Joint Research Centre revealed
that 14 percent of honey samples were
ith the boom of the natural foods adulterated; the simplest method in-
industry, businesses must be attuned volves the addition of sugar syrup.5 A
to the specific food safety challenges similar case of bulking using a cheaper
that natural ingredients bring to the ingredient was seen for oregano, where
table. One is cost—problems of fluctu- products had been adulterated with ol-
ating supply and sometimes arduous processing mean ive and sumac leaves.6
that natural ingredients can have a significant price tag. The popular flavor vanilla is a clear
Another is food fraud—intentional adulteration. With example of a case where the synthetic
the value of the natural foods market estimated at $97.5 version is the more financially attrac-
billion in 2017 and consumer interest in the “natural” tive option. The key flavor component
label on the rise, having the analytical tools available to of natural vanilla extract is vanillin,
detect common adulterants is crucial for the industry.1,2 and this can also be produced through
This article focuses on the adulteration of natural various synthetic means. It is estimated
foods, what implications this holds for supply chain that synthetic vanillin makes up over 95
integrity and food safety, and how methods such as percent of vanilla flavoring used today.7
carbon-14 testing can be used to detect mislabeling or The natural vanilla flavoring from the
adulteration with petrochemical-derived synthetics. vanilla orchid is in short supply and
production is labor intensive, result-
Adulteration of Natural Food Products ing in the majority of vanilla flavoring
Adulteration of any kind throws the integrity of the coming from synthetic sources. These
supply chain into question, which in turn is cause for synthetic routes can use a host of source
concern over food safety. If an undeclared substance is materials, including lignin, a byproduct
introduced into a product or ingredient, then there may from the paper industry, or the petro-
be a risk that it causes physical harm. leum-derived guaiacol.
The challenge in identifying fraudulent ingredients A similar situation is seen for cur-
is that the methods of adulteration vary widely. The cumin.8 As demands increase, the as-
addition of peanut protein to cumin powder or the dilu- sociated difficulties of variable crop
tion of natural curcumin with synthetic curcuminoids output and limited supplying regions
are just two examples of a wide variety of adulteration make the cheaper petroleum-sourced
methods recently observed in the industry.3,4 synthetic route attractive to some.
The economically motivated adulteration of natural

Supply Chain Implications petroleum-derived synthetic material. lies on the differing carbon-14 content
The intent of adulteration is rarely between bio-based materials and petro-
to cause harm, since this would defeat What Can Carbon-14 Testing Do for leum-derived substances. Carbon-14 is
the purpose of slipping a cheaper ingre- Natural Products? a weakly radioactive isotope of carbon
dient under the radar.9 As a result, the Carbon-14 testing offers a useful that decays over time in line with ra-
incidence of food fraud is predicted to analytical technique to assist in the dioactive decay. It is produced in the
be higher than is actually reported, with detection of adulteration and any result- upper atmosphere and enters the global
advanced techniques or insufficient ing supply chain integrity problems. carbon cycle; hence, it is present in
quality assurance allowing some to get The basis for carbon-14 testing re- known amounts (continued on page 64)
by undetected. The disparity in aware-
ness is even greater for the public, as it
is often only when there are larger pub-
lic health consequences or lawsuits that
adulteration gets significant attention.
MORE
MORETECHNOLOGY
TECHNOLOGY
The bottom line is that if there is an
unknown adulterant being introduced
somewhere along the supply chain,
even if unlikely to cause a public health
risk, the final quality of the product is
already compromised.
Repercussions of Mislabeling
Adulteration, even with a chemically
identical synthetic substitute, can have
serious consequences when making
“all natural” claims. The ambiguity is
complicated by the U.S. Food and Drug
Administration not having set out clear
guidelines on what the “natural” label
means.10
With many consumers deliberately
seeking out natural foods, companies
seen as misusing the “all natural” label Captisol
Captisol is a
is a
proprietary
proprietarytechnology
technology that
thatis is
are not viewed kindly. This is highlight-
ed by the growing number of lawsuits rationally
rationally engineered
engineered totoimprove
improve solubility,
solubility,
against companies using “natural” or
“all natural” labels.10
stability,
stability,
bioavailability,
bioavailability,taste
taste
masking
masking and
and
In this context, what can the qual- formulation
formulation ofof
water-insoluble
water-insoluble ingredients.
ingredients.
ity assurance manager do to ensure the
integrity of his supply chain and screen
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ship with suppliers is important, but
it is often not enough. A number of
analytical methods are available to iden-
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tion when compared with a reference
standard for the material being tested.11 CAPTISOL.com
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One method of particular interest for
products labeled as natural is carbon-14
testing, which is able to differentiate be-
tween natural (bio-based) material and
J u n e n J u ly 2 018 27

By Dr. Ramakrishnan Nara
A
s the population of the U.S. becomes ethnically value of imports from the top 10 importing
more diverse and their appetite for a variety of countries and the value of food product
foods becomes insatiable, there is a growing categories coming through U.S. ports, re-
need to import a greater variety of food prod- spectively.
ucts. The U.S. imports food products from more than 90 High-profile food safety incidents from
countries. More than 20 percent of the total food supply 2000 to 2010 prompted Congress to imple-
in the U.S. is imported (70% of seafood and 35% of fresh ment a series of regulations in 2011—the
produce available in the U.S. are from other countries). Of Food Safety Modernization Act (FSMA)—to
these importers, 70 percent are small business entities. protect the food supply chain in the coun-
The data in Tables 1 and 2 provide information about the
1
try. Details of the seven rules of FSMA
FSM6718pg28-59,65Final.indd 28 6/5/18 1:28 PM

FSMA represents a sea
Value of
change for food safety, Imports 2014, Country
Country Million US$ Rank
not only in the U.S. but
Canada 22,018.5 1
also globally. The focus is Mexico 19,230.3 2
on prevention. It will have China 5,755.5 3
India 4,154.8 4
a dramatic and progres- France 4,084.2 5
sive effect on the safety Chile 4,074.1 6
Italy 3,953.5 7
of the food supply in the
Brazil 3,746.6 8
U.S. The most impor- Australia 3,485.0 9
tant regulation for food Indonesia 3,306.2 10
Table 1. Value of U.S. Imports from the
importers is the Foreign Top 10 Importing Countries1
Supplier Verification Pro- Food Category Metric Tons
gram (FSVP), published Live Meat Animals (× 1,000) 7,295.6
on November 27, 2015, Meats 1,717.2
Fish and Shellfish 2,451.0
with an initial compliance Dairy 225.6
date of May 30, 2017. It Vegetables 9,601.8
Fruits 12,686.7
contains a new set of re- Nuts 596.0
quirements for importers. Coffee and Tea 2,110.6
Cereals and Bakery 11,132.4
This article is about the
Vegetable Oil 7,767.6
impact of the FSVP on Sugar and Candy 4,293.1
the food production and Cocoa and Chocolate 1,297.1
Beverages (1,000 kL) 6,062.0*
processing entities in the Other Edible Products 1,534.4
domestic and foreign are- Table 2. Value of Food Product Categories
Coming through U.S. Ports1 (*Excludes
nas, and the challenges Liquors)
that importers face.
were published widely. According to U.S. What Are the Key Requirements of the FSVP?
Centers for Disease Control and Prevention The details of the FSVP have been widely published in
statistics, foodborne illness strikes 48 mil- the print media. However, in the opinion of the author, there
lion Americans each year, requiring hospi- is a big gap in understanding, particularly in the food im-
talization for more than 120,000 people and porter community. Therefore, a review of the requirements
resulting in approximately 3,000 fatalities, will be appropriate here. According to the rule, importers
particularly for vulnerable groups. The in- are responsible for ensuring the safety of food products
tent of the seven rules of FSMA is to com- they bring into the U.S. for distribution and sale for con-
prehensively and proactively prevent food sumption by the public. The FSVP rule requires importers to
safety incidents in the U.S. supply chain. perform risk-based activities to verify that food imported
J2u9 n
e n J u ly 2 018 F o o d S a f e t y M a g a z i n2 9
e

The Foreign Supplier Verification Program
into the United States is not adulterated [Section 402 of the Federal Food, Drug, or the foreign supplier’s performance.
and Cosmetic Act (FD&C Act) of 1938] or misbranded with respect to allergen If the importer receives adequate as-
labeling (Section 403 of the FD&C Act) and has been produced in a manner that surances that a subsequent entity in
meets applicable U.S. product safety standards. The rule is flexible in the sense that the distribution chain, such as the
importers have the flexibility to determine the appropriate verification measures for importer’s customer, is processing the
the foods they import based on food and supplier risks. food for food safety in accordance with
The FSVP applies only to importers of food products in the U.S. By defini- applicable FSMA rule requirements,
tion, an importer is the U.S. owner or consignee of a food offered for import into then reevaluation of product risks and
the United States. If there is no U.S. owner or consignee, the importer is the U.S. supplier performance is not required.
agency or representative of the foreign owner or consignee at the time of entry, as To proactively mitigate or eliminate
confirmed in a signed statement of consent. the hazards in imported foods, an im-
The specific responsibilities of importers with respect to food safety include: porter is required to identify and evalu-
• Determining known or reasonably foreseeable hazards with each food ate the known or reasonably foreseeable
• Evaluating the risk posed by a food, based on the Hazard Analysis, and the for- hazards for each type of food to de-
eign supplier’s performance termine whether there are any hazards
• Approving suppliers and determining ap- requiring control and document them.
propriate supplier verification activities The importer is also required to assess
based on the risks posed by an imported the vulnerability of materials/products
food and the supplier’s performance to food fraud. Importers will have to
• Conducting supplier verification activities
“High-profile food produce such documentation when re-
and taking corrective actions for deviations safety incidents quired during an inspection by the U.S.
and discrepancies Food and Drug Administration (FDA).
It is a requirement that importers import from 2000 to 2010 Another important requirement of
foods only from approved foreign suppli- the FSVP rule is that importers must
ers based on an evaluation of the risk posed
prompted Congress evaluate the performance of their for-
by the imported food and the supplier’s to implement a eign suppliers periodically. It should
performance. However, it does not mean include foreign manufacturers’ Hazard
that importers cannot import food products series of regulations Analyses, entities responsible for con-
from unapproved suppliers on a temporary trolling hazards (foreign manufacturer
basis, as long as these products are subjected
in 2011…to or their suppliers), their food safety
to adequate verification activities before protect the food procedures, processes, and practices,
importation. Per the FSVP, importers are their compliance with the applicable
required to develop, maintain, and follow an supply chain in the regulations, and food safety history. It is
FSVP for each food brought into the U.S. also possible for the importer to rely on
from each foreign supplier of that food. This
country.” another entity (other than the foreign
implies that if an importer imports a certain supplier) to perform an evaluation of
food from a few different suppliers, a separate risk, so long as the importer reviews and
FSVP would be required for each supplier. assesses the relevant documentation.
Similarly, if an importer imports many different foods from a single supplier, a sepa- It is again the responsibility of the
rate FSVP would be required for each food. importer to verify their foreign sup-
It is also likely that certain importers are also manufacturers/processors. The plier on a regular basis. You may want
question is: What is the applicability of the FSVP in such cases? These entities will to know what type of verification ac-
be in compliance if: tivities would comply with the FSVP
• the importer/manufacturer complies with the supply chain program require- requirements. The FSVP rule provides
ments of the preventive controls rules; or adequate flexibility for importers to
• the importer/manufacturer implements preventive controls for the hazards in the meet the requirements that are unique
food as per the requirements of preventive controls rules; or to the products and supplier character-
• the importer/manufacturer is not required to implement preventive controls istics. Some of the accepted verification
under specified circumstances, such as when the type of food could not be con- activities are annual on-site audits of the
sumed without application of a preventive control or when the customer of the supplier’s facility, sampling and testing,
importer-manufacturer will minimize or prevent the identified hazards. review of the supplier’s relevant food
Importers must evaluate the risk posed by the imported food and the supplier’s safety records, etc. Annual on-site audits
performance every 3 years and keep records of reviews. Evaluation of the identi- of the supplier’s facility are required
fied risks is also mandated when new information emerges about a potential hazard when there is a reasonable probability

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that exposure to a hazard controlled by the foreign supplier will result in serious ad- would be required to comply with the
verse health consequences or death to humans or animals (a SAHCODHA hazard). standard FSVP requirements (except the
However, the importer can also choose other means of verification, provided the Hazard Analysis requirement).
alternate choice will ensure that the foreign supplier is producing the food in accor- Very small importers and importers of
dance with applicable U.S. safety standards. An importer can also rely on another food from certain small suppliers: The defi-
entity to determine and perform appropriate supplier verification activities, so long nition of “very small importer” is an-
as the importer reviews and assesses the relevant documentation. nual sales of $1 million for human food
Taking appropriate corrective action by importers is the last piece of the puzzle and $2.5 million for animal food (aver-
in meeting the FSVP requirements. At times, an importer’s verification activities aged over a 3-year period) combined
may provide evidence that a foreign supplier has not provided the same level of with the U.S. market value of food that
public health protection as required under the Produce Safety and Preventive Con- is imported, manufactured, processed,
trols rules. This should promptly trigger corrective actions at the importer’s end. packed, or held without sale (e.g., im-
The appropriate corrective measure will de- ported for a fee). In this case, importers
pend on the circumstances and may include would not have to conduct Hazard
discontinuing the use of the foreign supplier. Analyses and would be able to verify
The FSVP rule requires importers to pro- their foreign suppliers by obtaining writ-
vide the name, email address, and unique
“It is also likely ten assurances from their suppliers.
facility identifier (UFI) for each line entry of that certain Importers of certain small foreign sup-
food product offered for importation into the pliers are subject to modified FSVP require-
United States. FDA has recognized the data importers are also ments: Those small suppliers are:
universal numbering system (DUNS) number • Facilities subject to modified require-
as an acceptable UFI for the FSVP. If the
manufacturers/ ments under the Preventive Controls
importer is temporarily unable to obtain the processors.” rules because they are qualified facili-
DUNS number, FDA intends to temporarily ties
allow filers to transmit the value “UNK” (“un- • Farms that are not covered farms
known”) in the UFI field. This option began under the Produce Safety rule be-
May 30, 2017, so that food offered for import cause they average $25,000 or less in
could be processed through the Customs and Border Patrol automated commercial annual produce sales or because they
environment system, even if the importer has not yet provided a DUNS number. meet requirements for a qualified
exemption
Are There Exemptions from FSVP Rules? • Shell egg producers with fewer than
Importers of the following categories of food products do not have to comply 3,000 laying hens
with the FSVP rule: • Products from countries whose food
• Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard safety system has been recognized as
Analysis and Critical Control Points (HACCP) regulations for those products, comparable or determined to be the
and certain ingredients for use in juice and fish and fishery products subject to equivalent of the U.S. system (e.g.,
the HACCP regulations Canada, New Zealand, Australia)
• Food for research or evaluation Please verify the applicability of the
• Food for personal consumption FSVP rule to you using the flowchart in
• Alcoholic beverages and certain ingredients for use in alcoholic beverages Figure 1.
• Food that is imported for processing and future export
• Low-acid canned foods (LACF), such as canned vegetables, but only with re- How to Develop and
spect to microbiological hazards covered by other regulations, as well as certain Implement a Robust FSVP?
ingredients for use in LACF products (but only with respect to microbiological Although FDA had been working on
hazards) the FSVP rule for quite some time, the
• Certain meat, poultry, and egg products regulated by the U.S. Department of requirements caught many an importer
Agriculture (USDA) at the time of importation off guard, specifically, those pertaining
to developing food safety plans to con-
Who Is Eligible for Modified FSVP Requirements? trol the safety of products they import.
In certain cases, importers need not comply with all the FSVP requirements. The Many importers simply do not have the
criteria for modified FSVP requirements are listed below. technical expertise or resources.
Dietary supplement importers: Importers complying with the requirements of 21 Traditional FDA inspections are pro-
C.F.R. Part 111 (Current Good Manufacturing Practices) regulation will be required duction-centric. FSVP inspections, on
to comply with the modified requirements. Importers of other dietary supplements the other hand, will be based on review

of records, according to Sharon Mayl, ucts manufactured in the U.S. and will not pose any public health issues in the U.S.
senior adviser for policy in the Office Your foreign suppliers may not be knowledgeable about the applicable Preventive
of Foods and Veterinary Medicine at Controls rules (human food or animal food), Produce Safety rule, or other relevant
FDA. Further, while most of the FSVP product-specific regulations. It is your responsibility to provide the relevant infor-
inspections will be at the importer’s mation to them.
place of business, FDA may also request You may request the foreign supplier or foreign manufacturer to assist you in
importers to provide FSVP records preparing your FSVP by providing relevant information regarding the potential haz-
electronically, or by other means, to ards and the control or mitigation strategies related to their products.
get them promptly. During the initial It is certainly a difficult task, at least for small importers, to meet such techni-
stages of FSVP implementation, FDA
inspectors may review records and pro-
vide importers opportunities to correct
them to support compliance. However,
this approach will not be applicable to
problems that pose a danger to health
or reflect intentional disregard for legal
responsibilities, according to Mayl.
A six-step approach to implementing
an effective FSVP is shown below.

Step 1: Determine type of food/food catego-
ries to be included in the FSVP
The first step is to determine what
food or food categories are to be includ-
ed in the FSVP. FSVP requirements are
risk based and depend on the type of
food, type of hazard, and performance
of suppliers. Per the FSVP rule, an im-
porter is required to prepare an FSVP
for each imported food or food category
from each facility and each country.
This is because the potential hazards
requiring preventive controls may be
specific to the type of food or food cat-
egory from each facility and from each
country. It may be possible to combine
products and include them all under
one FSVP, provided the hazards are the
same or similar. However, you are still
expected to prepare different FSVPs for
the various facilities and various coun-
tries from which you import these prod-
ucts. If this is not clearly understood,
you may get into issues with FDA.

Step 2: Assign responsibilities
As an importer, you must clearly
understand the roles and responsibili-
ties of the various entities, such as the
importer, foreign supplier, and qualified
individual (QI). Assigning responsibil-
ity does not absolve you from ensuring
that the food you import is equivalent
with respect to the safety of the prod-
J u n e n J u ly 2 018 33

cal requirements of the FSVP rule resource to help you with the responsibilities. It is a requirement of the FSVP rule
without the help of a QI. If you can that certain activities must be carried out only by a QI.
afford it, you may hire a full-time QI.
Alternatively, you may seek an external Step 3: Implement QI responsibilities
Are you the U.S. owner or consignee of an article of food that is being offered for import into
the United States? Or, if there is no U.S. owner or consignee of an article of food at the time of NO The FSVP does not apply to you.
U.S. entry, are you the U.S. agent or representative of the foreign owner or consignee at the
time of entry?
YES
Do you only import these foods? Includes fish and fishery products (in compliance with Part
123) or certain ingredients for use in fish and fishery products in compliance with Part 123,
juice (in compliance with Part 120) or certain ingredients for use in juice products in compli-
ance with Part 123, food for research or evaluation, certain alcoholic beverages or certain YES The FSVP does NOT apply to these foods.
ingredients for use in alcoholic beverages, certain meat, poultry, and egg products regulated
by the U.S. Department of Agriculture, food imported for personal consumption, food that is
transshipped, food that is imported for processing and export, and U.S. food that is exported
and returned without further manufacturing/processing in a foreign country.
NO
You do not need an FSVP with respect to
microbiological hazards for that food. Instead,
Do you import LACF in compliance with 21 C.F.R. Part 113? you must verify and document that the food
YES was produced in accordance with 21 C.F.R. Part
113. With respect to all matters that are not
controlled by Part 113, you must have an FSVP.
NO
Are you a receiving facility in compliance with requirements in the Preventive Controls rules You are deemed in compliance with most
related to implementation of preventive controls for the hazards in the food or supply chain YES aspects of the FSVP, except the requirement
programs, or are you not required to implement a preventive control under those rules in for importer identification at entry.
certain specified circumstances?
NO
You are subject to modified FSVP require-
Do you import dietary supplements subject to certain dietary supplement Current Good Manu- ments for those dietary supplements subject to
facturing Practices requirements in 21 C.F.R. Part 111? YES separate, preexisting Current Good Manu-
facturing Practices requirements for dietary
supplements.
NO
ments. An example of modified requirements
Are you a very small importer? (See definition in 21 C.F.R. 1.500 and 1.512.) YES for certain importers is that they would not
have to conduct Hazard Analyses and would
be able to verify their foreign suppliers by
obtaining written assurances of compliance.
NO
Do you import food from certain small suppliers (i.e., qualified facilities under the Preventive You are subject to modified FSVP requirements
Controls rules, certain farms that are not covered farms under the Produce Safety rule, and YES for food from those suppliers.
certain small egg producers)?
NO
Do you import certain food from a country with an officially recognized or equivalent food ments for food from those suppliers. (Includes
safety system? YES determining that the supplier is in compliance
with U.S. safety regulations or relevant laws in
country deemed equivalent.)
NO
You are subject to the FSVP.
Figure 1. Am I Subject to the FSVP?

A QI has the following responsibilities: or the supplier’s raw material or ingre-

• Document and implement the Hazard Analysis dient supplier, or perhaps a customer
• Conduct performance evaluation of foreign suppliers located in the U.S.
• Approve suppliers It is a requirement of the FSVP rule
• Document and implement verification activities that importers approve their foreign
• Document and implement corrective actions suppliers before importing food from
• Reevaluate FSVP and document reevaluation them. Again, you may use unapproved
• Maintain records suppliers on a temporary basis, but only
By definition, a food hazard is something that could cause illness or injury to hu- after ensuring the food is subjected to
mans or animals that eat the food. The first step in the FSVP is to evaluate known adequate verification activities before
or reasonably foreseeable hazards for the food that is being imported to determine importation. You need to consider eval-
whether each of the potential hazards requires control. uation of the risk posed by the food,
Hazards can be biological, chemical, physical, unintentionally introduced, or who is controlling the hazards, evalu-
intentionally introduced for economic gain (economic fraud). ation of foreign supplier performance,
The importer must use a QI to evaluate the hazards. It is quite acceptable for an and other relevant factors in approving
importer to rely on someone else’s Hazard Analysis of the foreign supplier’s food so your foreign suppliers. Your QI will
long as the importer’s qualified individual has reviewed the Hazard Analysis docu- have to be responsible for this activity.
ment and approved it. An importer’s Hazard Analysis is more than just accepting a As an importer, you must monitor
Hazard Analysis of your foreign supplier. the food safety performance of your
It is your responsibility again to monitor the performance of your foreign suppli- foreign suppliers. You have the flex-
ers. This process consists of examining their food safety procedures, processes, and ibility to determine the type of verifica-
practices. It should also include your verification of their compliance history with tion activity for your foreign suppliers
FDA food safety regulations and their food safety history. Further, your QI should based on the risk posed by the products
document in the FSVP plan the entity that will be significantly minimizing or pre- imported. FDA has identified the fol-
venting the hazards identified by the Hazard Analysis, such as the foreign supplier lowing supplier verification activities:
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on-site auditing, sampling and testing, review of supplier records, and other ap- maries every year, providing informa-
propriate measures. Annual on-site audits of the supplier’s facility are required only tion about the number of Form 483s
when there is a reasonable probability that exposure to a food hazard controlled by issued to companies producing drugs,
the foreign supplier will result in a SAHCODHA hazard. However, the importer foods, veterinary medicines, biologics,
may choose other means of comparable verification to confirm the foreign supplier medical devices, etc. A total of 5,045
is producing the food in accordance with applicable U.S. safety standards. Form 483s were issued from October
As a result of the verification activities conducted by your QI, you may discover 1, 2016, to September 30, 2017, out of
that your foreign supplier is not properly which 2,662 were issued to food com-
controlling the identified hazards. Should panies. One hundred eight Form 483s
this happen, you are required to take action were issued against 21 C.F.R. 1.502(a) to
to correct the deficiency. The QI may be re- importers for not developing an FSVP
quired to reevaluate the FSVP for the specific
“To proactively plan. It is already one of the top 20 vio-
food and foreign supplier, depending on the mitigate or eliminate lations in the food sector. Although the
deviations, and document them. first compliance date for implementing
Reevaluation of your FSVP by your QI is the hazards in the FSVP was May 30, 2017, it is inter-
required every 3 years or anytime you become esting to note that FDA inspectors have
aware of new information that may affect
imported foods, an already issued 108 Form 483s to import-
your prior evaluations. importer is required ers out of a total of some 300 importers
FDA is going to rely heavily on records inspected in 6 months. It is quite likely
during inspections to determine your compli- to identify and that FDA in 2018 will ramp up the
ance with FSVP requirements. Therefore, en- inspections of importers three to four
sure that your record maintenance procedures
evaluate the known times that of last year.
are robust. Failure to keep adequate records is or reasonably The second compliance date was
a violation of the FSVP rule and the FD&C March 19, 2018, for “small businesses”
Act. FDA can take enforcement action in such foreseeable hazards (foreign suppliers with < 500 full-time
cases. The list of records to be maintained employees) and March 18, 2019, for
includes the Hazard Analysis, the foreign sup-
for each type of “qualified facilities” and “very small
plier performance evaluation, procedures for food…” businesses” (foreign suppliers with <
approving foreign suppliers, foreign supplier $1 million in average annual sales). The
approvals, procedures to ensure use of only compliance dates for importers whose
approved foreign suppliers, determination foreign suppliers are subject only to the
and frequency of verification activities, perfor- Produce Safety rule are July 29, 2019,
mance of verification activities, corrective actions, and reevaluations of your FSVP. for small business and July 27, 2020, for
Records can be kept as original records, true copies, or electronic records. very small businesses. All other busi-
nesses must comply starting July 26,
Step 4: Determine applicability of other food safety requirements 2018. FSVP compliance dates are based
Your foreign supplier may not be aware of the applicable U.S. food safety regula- on the size of the foreign supplier and
tions. Your QI should determine whether other U.S. regulations apply to products not on the size of the U.S. importer.
that are imported. You should communicate such requirements to your foreign sup-
plier so that the foreign supplier is in a position to comply with these requirements Recent FDA FSVP Guidance
before the product reaches the U.S. port. Documents
Recently, FDA has released the fol-
Step 5: Communicate effectively lowing FSVP draft guidance documents:
The importance of communicating with your stakeholders cannot be overlooked.
You must ensure effective communication at all levels in the supply chain, including Application of the FSVP Regulation to the
your foreign suppliers, your clients/customers, and regulatory bodies. A good com- Importation of Live Animals: Guidance for
munication plan is all that is needed for effective communication. Industry, March 2018
This guidance document provides
Step 6: Be “FDA inspection ready” clarification regarding the applicability
This is the last step of the six-step approach to implementing a robust FSVP. It of the FSVP rule for the importation of
will automatically fall into place once you have taken care of the five previous steps. live animals. The food resulting from
the slaughter and processing of certain
Implementation of FSVP Rules and FDA Inspections live animals cannot be consumed with-
The Office of Regulatory Affairs of FDA releases inspectional observational sum- out slaughter and processing at estab-

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lishments subject to USDA-administered HACCP requirements (or equivalent state tain regulatory requirements as they
programs). FDA has clarified that FSVP importers of live animals that are slaugh- currently apply to certain entities and/
tered and processed at USDA-inspected establishments subject to USDA-adminis- or activities. This includes enforcement
tered HACCP requirements (or state-inspected establishments subject to equivalent policy for importation of food contact
requirements) do not have to meet any of the FSVP requirements. substances under the FSVP regulation,
enforcement policy for certain human
Application of the FSVP Regulation to Importers of Grain Raw Agricultural Commodities: food by-products for use as animal food
Guidance for Industry, January 2018 that is further manufactured/processed,
Many raw agricultural commodities (RACs) that are not fruits or vegetables, in- etc.
cluding grains, are imported into the United States. The importation of grain RACs Further, FDA recently posted a docu-
into the United States is subject to certain supplier verification requirements estab- ment on its website that lists all import-
lished in FSMA. FSMA amended the FD&C Act to add, among other food safety ers that have been identified at entry
requirements, provisions requiring the verification of the safety of food imported in connection with the FSVP regula-
from foreign suppliers of that food. tion. This posting is a statutory require-
To better align the FSVP regulation with the exemption from preventive controls ment under FSMA. The list provides all
requirements for facilities solely engaged in the storage of nonproduce RACs, and of the FSVP importer names that have
because of the nature of the hazards associated with grain RACs and how they are been declared at entry.
generally addressed in the distribution chain, FDA intends to exercise enforcement
discretion for importers of grain RACs that are solely engaged in the storage of Blockchain Technology and
grain intended for further distribution or processing [in accordance with 21 C.F.R. FSVP
117.5(j) or 507.5(g)] with respect to the FSVP regulation. This means that FDA will Blockchain is a new technology tool
not expect the FSVP importers of grain RACs (i.e., grain elevators and other facili- for storing and sharing of information
ties solely engaged in the storage of grain RACs intended for further distribution or in open virtual network space. It has
processing) to meet any of the FSVP requirements. However, these grain RAC im- wide-ranging applications from finance
porters remain subject to the statutory prohibition against the introduction or deliv- to the food industry. It is certain that
ery for introduction into interstate commerce of adulterated food {Section 301(a) of the technology will make the food
the FD&C Act [21 U.S.C. 331(a)]}. supply chain more transparent than
ever before by allowing users to look
FSVPs for Importers of Food for Humans and Animals: Guidance for Industry, January at the information associated with
2018 that food simultaneously. Further, it
FDA issued the final FSVP regulation for importers of food for humans and can greatly improve product traceabil-
animals on November 27, 2015 (80 C.F.R. 74225). The FSVP regulation, codified in ity in the supply chain. Realizing the
21 C.F.R. 1.500 through 1.514, specifies the foods and importers to which the FSVP huge potential of this technology, big
regulation applies and establishes requirements relating to: food corporations and retailers such as
• Use of qualified individuals to conduct FSVP activities Nestlé, Unilever, and Walmart, and IT
• Hazard Analysis corporations such as IBM have invested
• Food and supplier evaluation huge resources to tap the full potential
• Foreign supplier verification in the field of food safety. In addition
• Corrective actions to enhancing food product/ingredient
• Record keeping traceability, it can reduce food waste
This guidance provides questions and answers to facilitate importers’ understand- by helping organizations target and
ing of the FSVP requirements. withdraw only the specific batches of
affected products during recalls.
Considerations for Determining Whether a Measure Provides the Same Level of Public Health Another potential application of
Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls blockchain technology is its use in food
Requirements in part 117 or 507: Guidance for Industry, January 2018 fraud. Food fraud is quite prevalent in
This guidance describes FDA’s current thinking on considerations for determin- many countries with the sole objective
ing whether a measure or procedure used in lieu of an FDA requirement in 21 of economic gain. Unlike the com-
C.F.R. Part 112, 117, or 507 provides the same level of public health protection as mon contaminants in ingredients, raw
the corresponding FDA requirement. materials, and other food products that
are known to occur, food fraud is dif-
Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and ficult to detect. A well-known example
Preventive Controls, Produce Safety, and/or FSVPs: Guidance for Industry, January 2018 of food fraud is the melamine incident
The purpose of this document is to state the intent of FDA not to enforce cer- in milk powders and pet foods that

happened in 2008–2009. The need to the requirements of the rule; otherwise, there will be repeat failures on the part of
enhance traceability and transparency in importers. Kudos to FDA for making it clear that the initial phase of implementation
the food supply chain is overdue. of the rule is going to be an opportunity for importers to crawl before walking. n
The FSVP rule requires import-
ers to ensure their products are safe Dr. Ramakrishnan Nara is a technical adviser/consultant for the food, pharma, and dietary supplements indus-
and ensure the integrity of the supply tries. He can be contacted at nrkrish@rogers.com.
chain. The global food supply chain is
complex, loaded with several unknown Reference
factors that an importer in the U.S can- 1. www.ers.usda.gov/data-products/us-food-imports/us-food-imports.
not easily detect and control. While the
regulatory requirements to ensure the
integrity of the supply chain are clear,
importers do not have effective tools
to achieve these objectives. Blockchain
technology is the best solution for this.
Blockchain is nothing but a chain of
blocks (records) arranged in a chrono-
logical order. Therefore, the possibility
of altering records is greatly reduced.
Currently, the technology is in its
infancy particularly as it applies to food
safety. Nevertheless, it offers enormous
potential for improved product trace-
ability in the supply chain. Importers
will be able to trace the full history of
the products they are importing. It will
be much easier to protect the integrity
of the food supply chain and conse-
quently prevent major foodborne illness
as this new technology matures.
Challenges Ahead for FSVP

Implementation
It is going to be a tough task for at
least the very small importers to comply
with the requirements within the speci-
fied timeline, knowing their limited
technical capabilities and financial con-
straints. Implementation of the require-
ments of the FSVP rule is not a simple
task. It requires a good understanding
of the hazards associated with food
products and their control measures.
Although FDA has published guidance
documents, importers are not yet fully
prepared. The other major hurdle for
very small importers is maintaining
proper documentation and records. The
food importer community needs to be
more disciplined in this respect.
On the other hand, FDA may also
face some challenges in enforcing the
FSVP rule. The agency has to make sure
the importer community understands
J u n e n J u ly 2 018 39

BAKED GOODS By Patricia Marden, B.Sc., Jennifer Forrester, B.Sc., M.Ed.,
Becky Swayne, B.Sc., Sadie Pulk, M.A., M.B.A., REHS, and Ann Marie McNamara, Ph.D.
Handling Food Safety Risks

in a Retail Bakery
D
Due to today’s hectic lifestyles, bakeries are
taking the place of preparing homemade
baked goods for everyday meals, school func-
tions, and special occasions. Baked goods may
range from those prepared in manufacturing
facilities and sold at retail stores to specialty
Tips to reduce risk
of contamination in
baked goods
baked items prepared and sold in the stores themselves. Both
manufacturing facilities and bakery stores share common food
temperatures. Some items, like custard/cream-
filled pies/pastries, cheesecakes, and focaccia
breads topped with cheese and fresh veg-
etables, need further evaluation to understand
the food safety storage conditions, shelf life,
and general food safety risks. For example,
products with pH and aw above 4.6 and 0.85, respectively,
may be considered time-temperature control for safety (TCS)
safety challenges and require the proper design of food safety products and will require shelf-stability validation through a
programs to minimize the risks inherent in bakery products microbial challenge study if ambient storage is desired.
and their production environment. Several bakery products have been implicated in foodborne
illnesses involving Salmonella spp., Listeria monocytogenes,
Food Safety Challenges of Baked Goods Staphylococcus aureus, and Bacillus cereus, so it is necessary to de-
There are several factors to consider when evaluating food sign food safety controls into products to prevent subsequent
safety risks in retail bakery products. First, product assortment pathogen growth and toxin formation. Applying Hazard Anal-
and storage conditions must be understood. Generally, most ysis principles will help you understand the potential biologi-
bakery items have low water activity (aw), pH, and a validated cal, chemical, and physical hazards in the product and in all
kill step within the baking process, which will prevent the steps of the production process, from raw material purchasing,
growth of microorganisms and enable safe storage at ambient production, distribution, and sale. Once the hazards are deter-

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BAKED GOODS
mined and risk level assessed, Critical Control Points and/or preventive controls can allergen information. When foods are
be developed, including the product formulation, processing, and storage/handling labeled incorrectly, or an allergen warn-
controls, to mitigate those risks; for example, preservatives/pH/aw in formulation, ing is not properly declared, this can
time/temperature of baking, and storage temperature/shelf life. make a food product dangerous to sell
to certain sensitive individuals. Improp-
Safety Begins with Suppliers erly labeled food can cause someone to
Secondly, it is important to know your suppliers and to evaluate their food safety become ill and/or trigger a costly recall
and quality programs. What are the hazards to be controlled in the raw materials of your bakery products.
they supply, the critical limits, and actions to be taken if a deviation occurs? Hazard While you might not always be able
Analysis and Critical Control Points and the Food Safety Modernization Act are to provide nutritional information on
examples of such preventive controls. Some other parameters to consider in evaluat- a label of your bakery product due to
ing the risk posed by your suppliers include: the size of the label or variations in a
“There are several factors to consider when evaluating food safety risks in
retail bakery products.”
• Is the supplier certified against one of the audit schemes recognized by the Glob- specially created product, providing an
al Food Safety Initiative? accurate list of all ingredients is vital.
• How does the supplier control foreign material in their manufacturing facility? To provide a list of ingredients to the
• How are allergens controlled in their facility? For example, do they store allergens consumer, it is important to know the
separately from other ingredients? Is there an allergen matrix/production se- makeup of the components going into
quencing schedule to prevent cross-contact of allergens during production? How your product. In retail bakeries, provid-
are they ensuring adequate cleaning between allergen/allergen-free production ing standard recipes or product builds is
runs? key. This not only drives some consis-
• Does the supplier have a system to ensure correct labels are in use at each prod- tency when making the product, but it
uct/label changeover? also ensures the proper ingredients are
Suppliers also need to evaluate the effectiveness of their cleaning and sanitation used. Once all the ingredients that make
programs, be able to assess the overall microbial cleanliness of the manufacturing up a product are identified, it is easy to
environment, and to monitor the production environment for pathogenic bacteria. combine them and list them on a food
Monitoring effectiveness of sanitation processes and procedures is essential to mini- label.
mize the risk of product contamination by pathogens and/or spoilage microorgan- Beyond the basic labeling require-
isms, especially in the postbaking environment. ments of ingredients, nutritional, and
Traceability of ingredients and finished product is critical within the supply allergen information, manufacturers
chain. Batch sheets should record all lot codes of ingredients being used during the may choose to make claims highlight-
manufacturing process. This information should be stored in such a way that during product attributes. There are many
ing a recall event, all impacted product containing the impacted ingredient/lot code examples of claims in the marketplace
can be identified accurately and in a timely manner. The most common reason for today. Examples include, but are not
recalls in the bakery is undeclared allergens. Having a reliable allergen control pro- limited to, nutrient content and ingre-
gram within the manufacturing plant, as well as ensuring that your suppliers have an dient attribute claims. Some common
adequate allergen control program, can help prevent recalls. claims found on bakery products are
Knowing your supply chain is important. Procedures need to be in place to guar- “low fat,” “0 grams of trans fat,” “organ-
antee that product safety is maintained during storage and transportation. Some ic,” and “no genetically modified or-
questions to ask are: Is the product temperature being maintained? Is the product ganisms.” If a manufacturer chooses to
being transported in a clean vehicle? Are there any signs of dirt, pests, damage, or make a product claim, documentation
moisture? Has the load been properly secured to avoid tampering? is needed for substantiation. In addition
Knowing the specific food safety needs of each product and ensuring each step is to documentation, manufacturers need
traceable—from ingredient selection and production through the supply chain to the to ensure the claim is truthful and not
retail bakery and consumer—are key to an effective retail bakery food safety program. misleading. State and federal regulatory
agencies scrutinize product labels and
Proper Labeling for Consumer Safety may collect samples to monitor accu-
Once production of the items is complete, it’s time to package them for sale. racy. Enforcement action can be taken
Manufactured items need to have accurate label information. The primary purpose against the manufacturer if product
of food labels is to inform the consumer regarding nutrition, ingredients, claims, or claims or other label information is not

BAKED GOODS
accurate or within specified tolerances. ents, in type size that is no smaller than the type size used for the list of ingredients.
Some of the risks of noncompliance are For instance, Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron,
consumer illness, product recalls, lost thiamine mononitrate, riboflavin, folic acid), sugar, hydrogenated soybean oil, and/or cot-
consumer faith, agency warning letters, tonseed oil, whey, eggs, vanilla, natural and artificial flavorings, salt, leavening (sodium acid
increased regulatory surveillance, and pyrophosphate, monocalcium phosphate). Contains Wheat, Egg, and Milk.
consumer litigation. The FDA food allergen labeling policy does not require that labels have a supple-
When it comes to claims, growing in mental allergen statement, such as a “may contain” statement, although they are
demand on baked goods are “allergen- common within the bakery industry due to the nature of the bakery environment in
free” claims or “gluten-free” claims. which common manufacturing lines are used throughout the production day. While
More frequently, schools are requesting
that students bring treats that are “pea-
nut free” or “nut free.” Substantiating
these claims comes at a high risk. While
gluten is not one of the eight major al-
Scientific
lergens, “gluten free” is one of the only
“free from” claims that has been defined Expertise in
Food Safety
by the U.S. Food and Drug Adminis-
tration (FDA) with established testing
thresholds. In general, allergen-free
and
claims are unregulated, and there is no
standard across the industry.
Once all the ingredients in the
Quality Testing
product have been identified, you can
determine what allergens need to be
declared on the label. The Food Aller-
gen Labeling and Consumer Protection
Act of 2004 requires food manufacturers
to label food products that contain an
We are recognized for our unsurpassed
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from a major food allergen in one of
two ways:
• Microbiology
The first option for food manufactur- • Food Chemistry
ers is to include the name of the food • Nutritional Labeling
source in parentheses following the
common or usual name of the major
• Milling & Baking Expertise
food allergen in the list of ingredients. • COA Verification
This can be done in instances when the • Analytical Support for HACCP, FSMA, GFSI &
name of the food source of the major
allergen does not appear elsewhere in Regulatory Programs
the ingredient statement. For instance,
Ingredients: Enriched flour (wheat flour, Your single source for advanced analytical
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mononitrate, riboflavin, folic acid), sugar,
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acid pyrophosphate, monocalcium phos-
phate), lecithin (soy), mono- and diglycerides
(emulsifier).
The second option is to place the
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of the food source from which the ma-
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816.891.7337 • fax: 816.891.7450
after or adjacent to the list of ingredi- www.gpalab.com
J u n e n J u ly 2 018 43

BAKED GOODS
supplemental allergen statements can be helpful for the consumer, this type of label- While bakery products are typically
ing should not substitute for Good Manufacturing Practices (GMPs). They should viewed as low risk in terms of patho-
be considered only if the presence of a major food allergen is unavoidable even gens, recent contamination events have
when current GMPs are followed. illustrated the importance of conducting
Nutritional information, ingredient lists, claims, or allergen information may be a thorough risk assessment of all bakery
provided to the consumer in other formats that supplement regulatory labeling re- products where the potential for a TCS
quirements, for instance, supplemental in-store information provided at the point of hazardous food could occur.
sale or access to this information on websites. Food product information provided
on your company website is viewed as an extension of the label and falls under the Sanitation Basics
same jurisdiction as the physical labels themselves. Consequently, it is important to Sanitation in bakery settings can be
provide accurate information especially around ingredients, nutritional, and allergen quite challenging. Since the environ-
information. ment in bakeries faces constant dust
“Knowing the specific food safety needs of each product and ensuring each
step is traceable…are key to an effective retail bakery food safety program.”
buildup of flour and other dry ingre-
Shelf-Life Testing/Challenge Studies for Safety and Quality dients, adding liquid cleaners to this
Most finished products in a bakery setting are able to be stored and sold under environment can be precarious. Further-
ambient conditions. While many bakery assortments do not require refrigeration, more, adding water to the environment
consideration should be taken when temperature-sensitive ingredients are used in can cause harborage sites for formation
the production of an item. You should think about the number of refrigeration units of pathogens, such as Salmonella, which
that will be needed for storage and display of goods, as well as temperature regula- is inherent in raw flour. The recent
tion devices for the equipment. Escherichia coli O121 and O26 recalls on
Whether it is a TCS ingredient or finished product, both the temperature and flour have added further concerns to the
shelf life need to be controlled for safety from pathogens. This includes having the possible pathogens that are present in a
proper study design to evaluate risk, temperature control monitoring devices, and bakery environment.
appropriate protocols and procedures for production, transport, storage, and display. Many bakeries have historically
Conducting shelf-life studies of all items being produced in the bakery is integral, relied on dusting, scraping, and spot
not only from a safety perspective for nonambient items but also from a quality cleaning to clean equipment. However,
perspective. Due to the low aw of many bakery items, the most common indicator all equipment in the bakery needs to
of shelf life is mold growth. By conducting shelf-life studies on your products, you have a thorough inspection and risk
can determine how long after production the items can be stored before they exhibit assessment performed to understand
mold growth. Based on the amount of time you want the consumer to store the if the equipment poses a risk to the
item before this happens, these studies will determine the “best by” date(s) for the overall function of the facility. If the
item. food contact areas of the equipment
For items that have a complex interface, challenge studies should always be can’t be disassembled and cleaned,
considered, especially if these items will be marketed at ambient temperatures. Addi- replacement of antiquated equipment
tions of toppings and particulate ingredients to bakery items change the aw, and this should be considered. Newer bakery
new, finished product state needs to be considered. Fruit and vegetable toppings, equipment should be designed accord-
cheese, chocolate, and meats all change the water activity level of a finished bakery ing to sanitary design specifications to
product. allow belts, formers, slicers, and scoring
Conducting a challenge study with an accredited laboratory is essential to ensure equipment to be properly disassembled
that products are not potentially hazardous. Challenge studies are conducted by and cleaned.
inoculating a finished food item with any potential pathogens that could grow at the Wet washrooms where bowls, bins,
product’s pH and aw. Once the choice is made for the organisms that will be tested, containers, and pans are cleaned can
the item is inoculated and the bacteria are given the opportunity to grow. also pose a hazard to the bakery en-
Comparing results with an uninoculated sample, the outcomes of growth levels vironment. These areas need to be
and where a spike or unsafe level occurs become the pass/fail of the challenge study enclosed with adequate ventilation to
results. It is not enough to simply test the item at one interface. It is critical when prevent the aerosolization of mist/spray
testing to ensure all interfaces of the product are challenged. An example of item into or onto the production line. These
interfaces that would need inoculation for a lemon meringue pie would be the crust, areas also need extra monitoring and
where the crust meets the lemon filling, and where the filling meets the meringue diligence to ensure harborage sites and
pie topping. pathogens are not present.

BAKED GOODS
It is important to partner with a including eggs, milk, peanuts, tree nuts, and wheat (five of the major eight allergens),
chemical supplier that can help develop allergen management is key. While labeling and signage, mentioned above, are nec-
an adequate chemical sanitation pro- essary elements of an allergen food safety program, bakeries might also:
gram for the facility. These partners are • Segregate ingredients by storing allergens below and separate from other
instrumental in recommendations for ingredients
cleaning and sanitation chemicals that • Produce products working from those containing the least amount of allergens to
are effective in the bakery setting. Fur- the most allergens, with thorough cleaning and sanitization steps in between
thermore, their expertise can be utilized • Use separate equipment such as pans, knives, and cutting boards that are color
to train staff on monitoring the limits coded to indicate which allergen they are to be used with
of these chemicals and the steps to take • Ensure that employees know how to effectively use, clean, and store equipment
“All bakery employees should be taught the basics of food safety and their
role in producing safe food. Especially, they should be taught why their
behaviors are needed to keep food safe...”
when these chemicals fall outside the es- In any event, it is important to train employees to know the eight major allergens,
tablished limits. Based on the chemicals symptoms of an allergic reaction, and what to do in response to a customer having
identified for use in your facility, your an allergic reaction. It is important that employees understand that there is always a
chemical vendor can help you establish risk of cross-contact within a bakery setting and that they need to remain vigilant to
what the optimal water temperature minimize these risks.
is to ensure efficacy of detergents and Whether it is proper equipment use, health and hygiene practices, allergen con-
sanitizers. trol, proper cleaning, reduction of cross-contamination, proper labeling, or any other
food safety basic, it is essential that employees understand and follow good food
Food Safety Basics for safety practices at all times.
Employees
All bakery employees should be Conclusions
taught the basics of food safety and Bakery food safety programs minimize the risk of bacterial, physical, and chemi-
their role in producing safe food. Espe- cal contaminants in the final bakery products. Working with suppliers that have good
cially, they should be taught why their food safety programs and perform risk assessments on the products being sold is a
behaviors are needed to keep food safe, foundational element of any bakery food safety program. Designing and conducting
in addition to being taught how and shelf-life and challenge studies with a reputable laboratory determine appropriate
when to perform their required tasks. shelf-life, storage, and production practices for TCS products. Proper labeling and
Teaching employees why a behavior is signage of ingredients, nutritional, and allergen information help guide customers in
important ensures that they continue to choosing the best products for their health and well-being. Employees that under-
make good food safety decisions when stand the basics of food safety principles, and practice them in their daily behaviors,
unsupervised. Supervisors should be help ensure the safety of the baked goods produced. When combined, these program
diligent in rewarding employees prac- elements will provide safe, high-quality products for your bakery customers. n
ticing good food safety behaviors and
coaching employees whose behaviors Patricia Marden, B.Sc., is a food safety scientist at Target, specializing in vendor management.
do not meet expectations. Jennifer Forester, B.Sc., M.Ed., is a nutrition, labeling, and regulatory compliance scientist at Target.
Practicing proper employee health Becky Swayne, B.Sc., is a recall program lead at Target.
and hygiene requirements is key to Sadie Pulk, M.A., M.B.A., REHS, is a senior business partner in the food safety division of Target.
food safety success. Employees cannot Ann Marie McNamara, Ph.D., is the vice president of Target’s foods and essentials safety and quality assur-
work while ill and need to regularly ance division.
wash their hands thoroughly. Wearing All authors of this article are members of Target’s foods and essentials safety and quality
hair restraints and not wearing jewelry assurance division. This division is responsible for the food safety and regulatory compliance
help keep physical contaminants out programs of over 1,800 stores, distribution centers, vendors, labeling, data management, and
of products. Wearing gloves to prevent regulatory compliance activities.
bare-hand contact and wearing clean
uniforms help prevent cross-contamina-
tion of bacteria or allergens.
With common bakery ingredients
J u n e n J u ly 2 018 45

FOOD SAFETY CULTURE By Lone Jespersen, Ph.D., Mike Robach, Mark Beaumont, Ph.D.,
John Helferich, and Sara Mortimore
Company Culture and the Path to Improved Food Safety:

Setting the Tone to Support a
Strong Food Safety Culture
T
The World Health Organization has estimated
that almost 1 in 10 people is sickened by eat-
ing food processed or prepared by others;1 it
is estimated that approximately 50 percent of
cases of foodborne illness are due to failures
in the culture of the organizations responsible
for the safety of products.2 In other words,
much improvement is still required in under-
Practices for
moving beyond
compliance to
commitment
late and maintain a positive culture including
food safety”?
As visionaries looking ahead 10 years, we
see a landscape that goes beyond seeking com-
pliance to where food safety lives in all levels
of a food company—from the boardroom
to creating new food products to processing
lines and food counters: a landscape where
standing how culture can be improved to enhance food safety employees earn autonomy to meet and continuously improve
performance. food safety systems and where the company’s people system
Good news: A global study in 2015 showed that senior flexes with the increasing complexity of the workforce. A
leaders (e.g., C-suite, executive vice presidents) rank culture landscape where principles of social science blend seamlessly
as the number one concern in their organizations for its abil- with food science, and success is measured through behavioral
ity to meet the challenges of the future and for the business consistency and team dynamics.
to be sustainable and develop further.3 They no longer use The path to this vision lies squarely in the culture of your
statements such as “What if culture impacts business perfor- company. Not in better pathogen detection technologies, cer-
mance”? Instead, they ask, “How and what can I do to assimi- tification standards, or blockchain-like solutions, but in opti-

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BIA_FSM_AD_032017-06.indd 1 3/21/17 4:47 PM

FOOD SAFETY CULTURE
mizing the culture of your company to improve measurable culture. This special article series in Food Safety Magazine helps
food safety performance. Three cases from the food industry your company navigate this landscape of food safety; it was
show the very specific impact of focusing on maturing culture. designed and written to continue the “by leaders, for leaders”
In a midsize Australian produce company, the culture focus theme of GFSI and complement its position with practical
resulted in a 70 percent reduction in customer complaints and advice and learnings. As such, 19 leaders agreed to co-author
a 45 percent reduction in lost-time injuries. Similarly, a large five articles, each complementing a dimension of the GFSI
U.S. manufacturing company showed a 35 percent reduction framework (Figure 1).
in customer complaints, a reduction in employee turnover The GFSI framework4 consists of five dimensions based
from 23 percent to 12 percent, a 32 percent improvement in on a review of seven existing culture evaluation tools.5 If you
efficiency, and a 50 percent reduction in recordable injuries. are looking to better understand your current culture and
A large U.S. food distribution company surveyed its employ- improve it, you should look at all five dimensions. No one
ees after a focus on culture, and across 17,000 employees, 91 dimension alone can strengthen your current culture. As you
percent felt connected to the company’s values, 91 percent can see, each dimension consists of subdimensions, each
understood how they contributed to the success of the orga- identified by the GFSI group as important; for each dimen-
sion, you will find in this article series practical tactics and
Food S
a
stories to help you continue your journey. As such, to describe
fety the bus fety is
d sa
Foo iss sys
m
tem in In
alloca ess str tegra
tion ate t
the vision and mission of the GFSI position, the authors of
a r- and gy ( ed i
ne pri res nto
nd E
ducat
ion Busin
ess
Str
ori ou
tie rc
this first article recommend seven winning practices to set a
na Settin uct s) e
tio ur
a n
rm eme reness
t gD
Lead irecti
e,
Va positive tone from the top down, such as be consistent and
s k
fo g
cie is
In nga a ers on lu
Aw
en r
E Risk hip a es
et ific
d
an nd E transparent in your messages, don’t underestimate the signals
Or truc cta
ar ee
s
ga tur tion
mp ec
d d
, a cta g
oy an M x
Em az
ex
co e-sp
niz e a s
nd
H
rd e
p
of allocating resources around food safety, and show that you

az l
pe agin
yH p
ati nd
on
e
Pu ns
l
ss
Ro
HAZARDS
ati
on
rp
tio
nd
os
al
AND RISK VISION AND appreciate employees’ effort and engagement in food safety.
e
rif
Fou
Ve
AWARENESS MISSION The authors describe some great practical ideas for showing
Docu eg) for every proce s
ss
mented consequence
that you appreciate your staff. This is also a theme in the

Stakeholders | Governa
behavior change
ABC model for
Incentives, Reward
article on adaptability, entitled “The World Is Changing and

ment
Learning
CONSISTENCY PEOPLE So Must Your Food Safety Expectations,” which identifies the
anc ntation
easure
y
importance of setting targets and communicating specifically

lit
/n
tab i
Org
eM
for cume
(pos
s,
and consistently. The authors of this article also recommend

oun
a
a
nce
n
n
dR
iza
Do
Acc
m
| Co
tio
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specific and creative ways to engage everyone in food safety,

saf ss-fu
fo lts
ADAPTABILITY
og
Cro
n
m
r
ety nc
hm resu
Pe
ni
mu
r
ti
on
every day. The theme of engagement is at the heart of the
G
ni
rh n
M ion
ca
d tio
A
ti
Fo
t
on
e
y
ar ica
BA l fo
t
o tat
dS
tS third article, “The “A” in Culture: A Toolbox to Drive Positive
nd un
afe
w
rr e n
a
ty Ex
a
pe cta tio n s a n d Cu
m
lk
od s
Ch ng
Food Safety Behaviors,” where experts discuss several tools to
m
an l vi
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g e, A g i li t y So
C ris em
Ch is M a P ro bl s
(e. a
g., nge m
Kü
n a g e m ent , a n d
diff
ere
nce ensure that everyone learns what competencies are important
ble odel ltural iness)
r-Ro
ss) Understa n d
(e.g., nation
cu
al bu
s
to their job and what is expected, in more than the traditional
components of training. Such clarity of expectations and con-
Figure 1. Culture Dimensions and Tools sistency can be measured: The authors of the article “Measure
What You Treasure” discuss how this can be done by inte-
nization, and 82 percent felt management cared about their grating food safety into measures from behaviors as leading
well-being. These are just a few examples from the food indus- indicators and risk assessments. Risk assessments as we know
try that show the concrete values and the tangible connection them from food science and the proven principles of Hazard
between maturing culture and a company’s financial perfor- Analysis and Critical Control Points are topics of the fifth ar-
mance. ticle, “Food Safety = Culture Science + Social Science + Food
How do you deliver on this vision to show similar im- Science.” The authors suggest that these principles are just one
provements in your company? part of that equation and provide specific and practical com-
munication and engagement tools for balancing the equation
Find Your Path and delivering the results that we are all after: safe food, every
To break down the daunting task of finding the best path day, everywhere.
for your company, the Global Food Safety Initiative (GFSI) For each “petal” (Figure 1), you will find a summary of
has published its position, developed “by leaders, for lead- practical ideas for you to consider in your journey. Select the
ers,” in which 35 leaders from global companies joined the one that can be integrated into your culture and your system,
GFSI technical working group on culture in December 2015 and create a path that is unique and impactful for improving
and outlined what a culture of food safety is and how this and sustaining your company’s food safety performance!
sometimes-confusing topic can be segmented into five distinct It is no longer a matter of “whether culture impacts food
but integrated dimensions that are relevant for any company’s safety”; it is a matter of how and of finding and committing

FOOD SAFETY CULTURE
to the best path for your company to improve. Take these the organization. This consistency will support the enhance-
learnings and apply them within your company. Accept these ment of the organization’s food safety culture. Conversely,
as valid principles; build upon them instead of obsessing with inconsistent behavior can lead to chaos with deviations from
how to develop unique, bottom-up solutions. As consumers, food safety expectations and standards. This results in a less
we all deserve to be confident that we as food professionals coherent culture and will be easily recognized by customers
put our effort where it can have the biggest impact: on the and business partners to the detriment of the organization.
safety of our food. Executive reinforcement of the foundational need for be-
ing the best you can be in food safety has made an impact
Setting the Tone at Land O’Lakes. An opportunity was identified several years
Members of any organization look to their leaders for ago, when the company’s senior food safety leaders recog-
direction about organizational culture. A leader who sets a nized that training and education had largely focused on the
positive tone through word and deed and by consistently plants, which at the time was the same in many food com-
modeling and exercising good leadership principles will bring panies. Land O’Lakes determined that the leadership teams
alignment and enhance the effectiveness of the organization’s and cross-functional corporate personnel would benefit by
culture.
Executive leaders in food companies have an opportunity
to establish a dialogue within the organization to describe a
desired cultural framework for food safety excellence.
This article focuses on how senior leaders, namely CEOs,
the executive team, functional leaders, plant managers, and
their staff, can take steps to strike the right tone to achieve
their organizational culture objectives.
While we focus on the tone set internally in this article, the
tone set externally is also of great importance. External stake-
holders are interested in not only what product a firm makes
but also how it makes it. How the firm safely produces food
is increasingly of great import to consumers. Many organiza-
tions have adopted a corporate responsibility (CR) model.
Consumers, investors, and employees rightfully demand trans-
parency, trust, and credibility in how organizations fulfill their
role as responsible corporate citizens. This ensures sound and
ethical stewardship of the environment, sustainability, and
worker health and safety. Food safety fits into this same bas-
ket, and the CR model provides a way to create an executive
forum for routine review of performance in these key topics. Figure 2. Winning Practices to Set a Positive Tone
In this article, we share our observations of how leaders
successfully set a positive tone through their actions and com- having a greater understanding of what it meant to work in a
munications. You will learn how leaders can positively impact food company with the added responsibility for making and
food safety culture based on real-world examples. distributing food that is safe, for both people and animals.
Based on our collective experience, we have identified Commitment was given for a full-day food safety workshop;
“Seven Winning Practices” that we would expect to see from initially, all senior executives attended, including the CEO,
any senior leader in a food company (Figure 2). We also pro- who opened and closed the event. This was followed by open
vide you, a food safety leader, with some practical tips to help attendance for all corporate staff, 800 of whom have now been
your senior leaders set the right tone for food safety cultural through this experience. At the end of the session, each left
excellence. their own written commitment with food safety leadership.
This effort alone has driven food safety awareness to a whole
Practice 1: Ensuring Consistency new level across all corporate functions.
People in an organization pay attention to observed be- Practical suggestions for senior leaders to set the right tone
haviors, both good and bad. When the organization sees con- in maintaining consistency:
sistency from senior leaders, it reinforces its own behaviors. • Always ask food safety-related questions and provide direct,
Executive leaders will be noticed when attending team meet- immediate, and specific verbal feedback when on visits to
ings, visiting sites, engaging business partners, and in many manufacturing facilities. Use a visit as an opportunity to
other situations. Their consistent adherence to proper food reinforce how expected behaviors relate to the organiza-
safety behaviors will reinforce consistent standards throughout tion’s values and food safety system requirements.
J u n e n J u ly 2 018 49

FOOD SAFETY CULTURE
• Reinforce support for actions that assist and further the hood of project approval. Behavioral economists have
mission of cultural excellence. shown that framing requests in a way consistent with the
• Share with teams, if appropriate, summaries of all signifi- approver’s style increases the chance of project approval.
cant meetings, executive reviews, and of any engagement Food safety leaders should understand the company’s re-
with business partners where food safety is on the agenda. quirements and frame requests appropriately.
Sharing your own food safety objectives and deliverables
with your team is an excellent way to model accountability Practice 3: Transparency
and transparency, and shows how individual objectives are An unhindered view of the current state—the strengths,
intertwined with furthering the organization’s culture. weaknesses, and vulnerabilities—is an important transforma-
tional step in any cultural journey. This clear view requires
Practice 2: Allocation of Resources to Food building and sustaining trust, and reinforcing a mindset that
Safety knowledge and information sharing are paramount to achiev-
Allocation of financial resources by executive leaders sends ing excellence. Performance shortfalls and challenges along the
a strong message to the organization that food safety is impor- journey are important data points to share and reflect upon
“Sharing your own food safety objectives and deliverables with your team is
an excellent way to model accountability and transparency...”
tant. These resources could be capital for plant improvements constructively. This reflection will help build organizational
or IT system investments, expenses for training and education, resilience and envision prevention processes from the ground
travel for supplier audits, participation in external meetings, or up. This also reduces the likelihood of the same problem be-
having a requested expansion of personnel to drive and sup- ing repeated across the organization by another site.
port the food safety agenda. The impact of these allocations Learning from mistakes, failures, or near misses is an
goes beyond the immediate project. This speaks loudly to invaluable experience to propel positive culture change. A
employees about the importance of food safety in the organi- culture of safety excellence is well documented in the air
zation, thereby boosting the effectiveness of the food safety transport industry and is driven by an uncompromising com-
culture. mitment not only to studying failure and near-miss events in
An example that we have seen involves a major frozen depth, but also in systematically sharing these across the entire
food firm that decided to ring-fence capital funds strictly for industry.6
food safety initiatives. Previous management, a private equity At Glanbia, the “GPS” program (Glanbia Performance
firm, had not allocated resources to food safety, and therefore System) recognizes the principle of “celebrating and identify-
the organization did not believe that the new management ing losses.” A leader must be willing to openly recognize and
team would invest in food safety. The ring fencing of funds provide an appreciation for the transparency of sharing of the
sent a strong message to the organization that food safety potential losses, incidents, and identified risks. This recogni-
would be an investment priority. tion demonstrates appreciation (not consequences) for the
Another example of food safety investment sending a mes- identification of near misses and high-risk conditions that are
sage is a midsize confectionary company. The sole plant of then systematically shared as part of learning and improve-
this firm needed a new roof to stop roof leaks. A project to fix ment. Glanbia has developed a global near miss database
the roof languished until the CEO realized that this wasn’t that aggregates both internally and externally occurring cases,
just a nuisance: The leak endangered consumers. The CEO which Glanbia uses as part of analysis, leadership team review,
quickly approved the project. This action helped set the tone and reflection. Leaders from the individual site reporting the
that food safety was an important investment. incident will develop the case study, root-cause analysis, and
Practical suggestions for food safety leaders to help senior key learnings, which are shared in the wider leadership forum.
leaders set the right tone in managing resources: All sites are requested to confirm their scope and potential
• Work with the leaders of other functions to forge and needed improvement actions from the case.
maintain continuous dialogue to gain influence and sup- A question asked at Glanbia is prompted by a concern for a
port. The value of food safety in terms of minimizing risk, dashboard that is all green—Have we set the bar high enough?
protecting consumers, and adding value to the bottom line Did we aggressively identify emerging risks? Sometimes forc-
should always be at the forefront of any discussion. Re- ing a bell curve in standard reporting [e.g., reports must have
quests for resources should always fit within the corporate a minimum of 10 percent of their key performance indicators
and food safety culture model and lead to positive future (KPIs) in red to highlight where work is needed] can create a
benefits. more open sense to reflect upon vulnerabilities.
• Proper framing of resource requests can enhance the likeli- Practical suggestions for senior leaders to set the right tone

FOOD SAFETY CULTURE
and ensure transparency:

• Embrace the reporting of leading and lagging indicators
that both reflects a commitment to organizational learning
and removes any filters for good news only.
• Reward and recognize people for sharing their learnings
formally and highlight (whenever possible) the savings/
avoided losses by the solution they provide the organiza-
tion.
• Reward and recognize people who aren’t afraid to speak up
when they see something that doesn’t look right.
• Provide insights to your leaders on how other industries
excelled by embracing transparency and used challenges
as a forum for learning. Two excellent reads are Black Box
Thinking,6 and A Complaint Is a Gift.7
• Build trust and transparency by encouraging manufactur-
ing site leaders to share and debrief internally on a routine
basis with their entire team—condensing “what went well”
and “where can we do better.” Creating the dialogue in a
smaller, more familiar forum can encourage teams to share
more widely.
Practice 4: Appreciation
Positive reinforcement and acknowledging the effort made,
even without the desired results, is a winning approach that
encourages constructive behaviors. To be effective, feedback
must be timely, regular, balanced, and consistent. While ap-
preciation cannot be dished out randomly, a senior leader
should not miss the opportunity to praise great results, signifi-
cant ongoing efforts, and landmark achievements consistent
with the corporate values and vision. The positive upward
cycle of senior leader support and praise cannot be underesti-
mated. At Glanbia, the values of winning together and show-
ing respect hardwire the principles of praise and appreciation,
where appropriate and at all levels.
It is widely known that employee engagement and motiva-
tion are amplified by believing their contributions make a dif-
ference and when they have a belief in the organization’s mis-
sion and vision. When setting a path to excellence, recogniz-
ing important contributions to further that mission is essential
and adds a motivational multiplier across the organization.
Land O’Lakes has had an all-encompassing quality recognition
program for a number of years and celebrates winning and
diverse contributions from across the entire enterprise. Ad-
ditionally, Glanbia has implemented value-based recognition
programs across the business that call out each of their core
values in all activities and functions.
It is important to reflect on both the small and large contri-
butions, and ensure that all functions feel able to participate.
The recognition forum can be used to reinforce the organi-
zational mantra of food safety cultural excellence. The indi-
vidual efforts are not random events but small steps along the
journey.
Practical ideas for senior leaders to set the tone for appre-
ciation:
J u n e n J u ly 2 018 51

FOOD SAFETY CULTURE
• Establish an awards and recognition program specifically being drafted and through rollout to ensure true alignment.
for food safety and quality programs. This can be for indi- A well-represented review team can often flag significant
viduals, teams, or entire departments or locations. challenges and possible solutions at an early stage. A senior
• Provide special training, missions, or assignments for those leader can set the right tone by seeking to ensure visibility
who have the ambition to grow their careers and for pro- and buy-in at the earliest stage possible.
fessional development in food safety and quality manage- • A senior leader should advocate and support standardized
ment. risk assessment tools and models that drive local-level own-
• Award small, on-the-spot recognition at routine meetings ership in identifying risks and solutions to manage them.
and scheduled events that recognizes individual contribu- These will create a robust and factual discussion around
tions and behaviors. These can be small gift cards, memen- deviating conditions and how these are being managed.
tos, clothing with the company logo, or a personalized • Regular, focused, deep review of specific food safety pro-
certificate. grams, with the collective subject matter experts, will foster
“Executive and senior leaders must be fully accessible, highly visible

ambassadors and advocates for food safety excellence...”
• Create formally structured programs that encourage the an active and open dialog concerning solutions and the
identification of solutions (and celebrate them), as well as manner in which local adaptations have been applied for
losses, without fear of negative consequences. achieving the same principle requirements.
• Work on a “just-culture” approach to running the business.8
The just-culture approach focuses on finding why problems Practice 6: Accessibility
happen, not who is to blame. The tone this sets could lead Executive and senior leaders must be fully accessible,
to a positive attitude to uncovering problems and solving highly visible ambassadors and advocates for food safety ex-
them. cellence, both internally and externally. A proactive and delib-
erate approach to ensuring access and good collaboration is a
Practice 5: Adaptability must, especially in larger organizations.
Understanding and effecting cultural change within food In some sense, a senior food safety leader is a hub position
safety will require adaptation to existing cultures across diverse that needs to extend in all directions, hierarchically and func-
organizations, which may be geographically separated, have tionally, to ensure the message, the program, the progress, the
different customer profiles, use different processes, and have successes, and the opportunities are heard and shared. This is
different organizational maturity levels. This can also include about building a trusting relationship, and it’s not always easy.
incorporating new cultures integrated through joint ventures, While formal processes like newsletters and electronic updates
mergers, and acquisitions. are useful, a personal touch (through face-to-face contact) will
While some fundamental principles may remain sacred, be needed to build a respectful working relationship between
practicality dictates that there may not always be a one-size- stakeholders.
fits-all solution for every type of food safety standard or For senior executives and business leaders, a chronic fail-
policy. Adjustments that are necessary for underlying require- ure to be accessible by phone, email, or face-to-face could
ments are to be expected and, subject to review, can be accept- inadvertently send a message that food safety may not be as
able. important as other topics on the very busy corporate agenda.
When reviewing a specific policy or program deployment, Accessibility provides a forum for accountability check-ins and
a senior leader must understand the maturity of the operating a continuity of commitment that will be noticed by the work-
culture as well as the current food safety programs. Ensuring ing teams. This element is consistent with communication
a top-to-bottom understanding of hazards and risks is docu- and also manifests as leadership commitment, which are two
mented in several models of food safety culture, as outlined in important elements in a systems review.9
Jespersen et al.9 Having an understanding ensures that credible Practical ideas for senior leaders to set the tone for acces-
plans are in place to manage risks effectively. Sometimes, a sibility:
food safety team might be faced with a situation where there • Senior leaders should aspire to be highly visible ambas-
is not yet a definitive plan for full resolution. Adaptability sadors and advocates for food safety excellence wherever
should promote an open and rigorous review of risk mitiga- possible.
tion approaches. • Senior leaders should ensure that well-organized, agenda-
Practical ideas for senior leaders to set the tone for adapt- driven food safety review meetings are held routinely—even
ability: when there is no significant change or update—to keep ev-
• Have an open and challenging discussion of food safety eryone on message and focused on the mission.
policies and programs with key stakeholders when they are • Senior leaders should always be available for food safety

FOOD SAFETY CULTURE TM
A REVOLUTIONARY PLATFORM FOR

updates and issues resolution as needed. There are always FOOD PATHOGEN DETECTION
proactive opportunities to provide succinct and meaning-
ful review, commentary, and potential lessons learned on
cases outside the organization’s own walls, but present in
the media.
• Senior food safety leaders should schedule routine one-on-
one meetings with team members, functional leaders, and
executive leads.
• Senior food safety leaders should establish routine reviews
among key quality leaders and customer contacts.
Practice 7: Assessment
Regular review of food safety performance can ensure reas-
surance at the executive level that programs reflect corporate AutoXpressTM - AUTOMATION AND HIGH THROUGHPUT
values and demonstrate continuous improvement, as well as NOW PART OF OUR RAPID, ACCURATE AND LOW COST
provide governance for activities across the enterprise. The as- PATHOGEN DETECTION PLATFORM
sessment and reporting element is a senior food safety leader’s
opportunity to provide the dashboard, key measures, strategy, For additional info:
and direction to the decision makers and, conversely, provide
feedback and direction to the team. The critical importance of • Fully Automated
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cinct manner that highlights results, trends, needed actions,
and, ideally, the level of risk prioritization. Land O’Lakes,
Glanbia, Mars, and others have processes to share this critical
information with senior-most executive leaders and with their
boards for awareness and action. Any program without gover-
nance and routine progress review will quickly lose momentum
and risk becoming defunct. Executive leaders must be aware
of the risks to the organization’s performance and reputation,
and it is in the role of a senior food safety leader to ensure the
appropriate metrics are in place and routinely discussed.
Practical ideas for senior leaders to set the tone for assess-
ment:
• Senior leaders in food safety must ensure a regular and
disciplined review among the organization’s most senior
executives. They must also align on the appropriate KPIs
and measures, and provide a candid view on progress and
challenges, using leading and lagging indicators.
• Senior executives should make time to attend the food
safety review meetings and actively engage with other ex-
ecutive leaders. When unable to attend the main meeting,
request a one-on-one discussion.
• Having a corporate executive, other than the food safety
leader, communicate food safety news, summaries, and
activities at every board meeting is a great way to set the
tone that every senior leader can and must talk food safety.
• A policy statement, signed off by relevant senior leaders,
should be in place that clarifies reporting standards and
expectations for the food safety mission. CATALYST FOR SUCCESS
(continued on page 65)
J u n e n J u ly 2 018 53
Pickering_Glyphosate_FoodSftyMag_3.375x4.875_112317.indd 1 11/23/17 12:22 PM

FOOD DEFENSE By The Food Protection and Defense Institute
Current State of Intentional Adulteration
T
The last century has seen significant changes
in our food production and consumption.
The early 1900s were met with global challeng-
es in world wars, economic depression, and
food rationing. Rapid production and technol-
ogy growth in the second half of the twentieth
century introduced advanced capabilities in
Intentional
adulteration of food
can happen at any
time
ment at all levels of government presents new
challenges for maintaining and protecting
critical infrastructures, including food and
agriculture. In the food and agriculture sector,
a multitude of factors complicates the task
of protecting and maintaining critical infra-
structure. Food is produced, harvested, pro-
food production including advances in pres- cessed, formulated, packaged, and transported
ervation and packaging. These changes, along with advances through an interconnected network from farm to fork, with
in transportation, moved consumption patterns of food from challenges presented through global production, just-in-time
local to global sourcing. Today, our global food system is a delivery, and evolving consumer demands.
complex, integrated system of systems. While we will need to Whether at a restaurant or processing facility, intentional
produce a lot more food to feed an estimated 9 billion people adulteration perpetrated by disgruntled employees, terrorists,
by 2050, we can’t ignore the threats to our food supply from or those motivated by money can happen at any time. No
adulteration. doubt you’ve seen past headlines:
With the terror attacks of 9/11 seventeen years in our “Factory worker sentenced for lacing seafood with mala-
rearview mirror, response structures have evolved and fund- thion”1
ing scenarios have changed. The limited economic environ- “Woman draws jail sentence for contaminating chicken in

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LSCI17UKLO0752_FoodSafetyMag_Advertorial_Millipore.indd 1 20/12/2017 14:57

FOOD DEFENSE
2016”2 Cascading Events of Supply

“Michigan Man Charged With Sprinkling Poison on Food at Stores”3 Chain Failure
“Extortionist seeking millions by poisoning supermarket food: German police”4 Today, the food system from farm to
Intentional adulteration of food did not diminish in 2017. Adulteration cases fork is a global, highly integrated, and
of spices with undeclared ingredients to extend the product or boost color were complex system of systems. Failure in
documented.5 Terrorists’ plans and food adulteration tests were uncovered and one place has ripple effects downstream.
publicized.6 As evidenced by the headline above, a German man threatened to put When these infrastructure failures stack
antifreeze in the nation’s baby food supply chain. Disgruntled employees continued on top of each other, there are cascading
to adulterate food to get revenge on their employer or coworkers.6 effects that leave the companies without
We hear about terror attacks or foiled terror attacks involving explosives with in- product for the market and consumers
creasing frequency. However, a 2017 incident in the UK is one of the first we’ve seen without food. For example, a sign was
“Given the complexity of our food system and limited transparency of

supply chains from farm to fork, those willing and able to adulterate will
continue to do so in 2018.”
where an intelligent adversary met all three conditions of the food defense triangle posted in our local grocery not long ago
to present a threat—motivation, capability, and insider access to vulnerable food that read:
production.7 In this case, two people were found guilty of preparing for a terrorist Sorry for the inconvenience we are cur-
attack, including ties to a terrorist organization and the manufacture of ricin. One rently out of bananas
of the two was employed by a major food manufacturer. Inside attackers with legiti- The causes of the current shortages are
mate access to our food systems exist, and even though we may not be able to influ- many and complex:
ence their motivation and capability, we can certainly mitigate the vulnerabilities to • Typical low winter production from the
the resource we depend on for life. tropics, exasperated by both flooding and
Given the complexity of our food system and limited transparency of supply colder than normal temps in Costa Rica.
chains from farm to fork, those willing and able to adulterate will continue to do • Abnormal Heavy seas causing vessel de-
so in 2018. Certain trends or issues like consumer demands, global supply chains, lays both in delivery to the US and return
and disasters create new opportunities and motivations for adulteration or increase vessels to reload in the tropics.
vulnerabilities in the food system. However, we can all work together to decrease • The same weather front causing heavy
the vulnerabilities and risks of intentional adulteration through continued research seas bringing heavy rains in Guatemala.
and outreach, conferences and networking, and employee and public education, and • Political upheaval in Honduras. In
training. addition to unseasonable heavy rains,
Honduras has been under political unrest
Consumer Demand for two months after their election. Now
We speak with our dollars spent. And food companies listen. Food production there are major strikes going on causing
is driven by consumer purchasing, whether it is a flavor trend—sriracha-flavored a very small amount of bananas to leave
almonds—or a perceived health benefit—Golden Milk (juice with turmeric). Look at the country.
your local grocery aisles and you will find an ever-increasing section of “freedom The sign single-handedly demon-
foods.” These are foods that claim to be free of something, whether it be gluten, lac- strates our point. The “banana short-
tose, pesticides, or genetically modified ingredients. age” is a result of disruptions, including
With increasing frequency, consumers are also asking questions about the sustain- weather events, political unrest, and
ability and agriculture practices of the food they buy: How have the oceans been civil strikes. These precipitated a series
fished? Are my eggs from cage-free chickens? Does the food I buy protect the envi- of cascading infrastructure and supply
ronment? Based on current trends, consumers will continue to spend their food dol- chain failures. Extreme weather (flood-
lars on flavor trends, organic, “free of,” and sustainably produced food. Consumers ing and temperature) led to low produc-
are willing to pay the additional costs for these items, making it a lucrative business tion. Choppy seas disrupted transporta-
for both legitimate food companies and fraudsters. tion of product. Political instability in
This means food defense needs to have a keen eye on where those with intent to one region of the world resulted in labor
adulterate could enter the market with products representing these food trends. Such challenges. All these factors contribute
opportunities may come from an evolution in technology or policy where regulation to significant supply chain disruption.
or inspection has not caught up or from the sheer demand of a trendy food product. Obviously, the disruption in banana
supply affects consumers, but how does

FOOD DEFENSE
it impact protecting our food from in- of adulterated food. This critical work of “sense making,” or putting disparate infor-
tentional adulteration? mation pieces together to share a complete picture of potential or actual disruption,
Another recent example illustrates is the focus of projects like the Food Protection and Defense Institute (FPDI) Fo-
how easily intentional adulteration, cused Integration of Early Signals.11
economically motivated adulteration
in this case, may occur with supply Current State of Food Defense
chain disruption. A major fast-food “Food defense” is the sum of actions and activities related to prevention, protec-
chain experienced catastrophic failure in tion, mitigation, response, and recovery of the food system from intentional acts of
their supply chain as they transitioned adulteration. We have seen global expansion of food defense activities to counter all
to a new transportation company. The motivations of intentional adulteration (terrorism, sabotage, and EMA). Typically,
“…we can all work together to decrease the vulnerabilities and risks of
intentional adulteration…”
fast-food chain has been forced to tem- there has been some intentional adulteration threat or event that has led countries
porarily close more than 80 percent of around the world to change their food defense posture. In the UK, the 2013 horse
their stores in one of their significant meat scandal created reform to address this issue, which led to EU funding for food
markets.8 This in itself is significant, but integrity.12 New Zealand initiated its reform in 2015 after a blackmail case where the
when paired with headlines like “Work- perpetrator threatened to lace infant formula with a pesticide. Some countries have
ers filmed smuggling chicken through added policies under their food safety laws and others have labeled this work as food
the backdoor,” damage to the brand protection.
grows even more due to the mistrust In the U.S., the Food Safety Modernization Act (FSMA) initiated the largest food
sown in the consumer mindset about policy reform in decades. Two of the published U.S. Food and Drug Administra-
the quality of product in the restau- tion (FDA) rules relate to food defense activities. EMA must be addressed under the
rants.9 Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive
Intelligent adversaries constantly Controls for Human Food rule. EMA is considered a hazard that is reasonably fore-
look for new vulnerabilities to exploit in seeable, and companies must develop preventive controls to address the risk. The
the food system, whether to make mon- second rule related to intentional adulteration is the Mitigation Strategies to Protect
ey (economically motivated adultera- Food Against Intentional Adulteration rule, which requires, for the first time in the
tion, EMA) or cause harm to humans, United States, that food companies develop a plan to defend and protect the food
animals, or brands. A significant shift in system from terrorism and acts by insiders with legitimate access that may cause
supply and demand offers an opportu- wide-scale public health harm.
nity for adulteration when there is less The Final Rule for Mitigation Strategies to Protect Food Against Intentional
product available in the marketplace. Adulteration, also known as the Intentional Adulteration or “IA” rule, requires FDA-
It is imperative that we start integrating registered food facilities to identify specific vulnerabilities in their facilities that
our information and make sense of what could allow someone with bad intentions to deliberately introduce an adulterant.
it is telling us to make evidence-based This vulnerability is named an actionable process step by the IA rule. Food compa-
decisions. While the banana shortage nies must also create a food defense plan to prevent or mitigate those vulnerabilities
case is one example among many (e.g., at the actionable process steps. The IA rule also requires that employees who work at
transshipment of product, species sub- actionable process steps in food facilities must have:
stitution of meat and fish), it is a great • Education, training, and necessary experience to perform their responsibilities
example of predictable surprise. The • Knowledge of the mitigation strategies at the actionable process step
concept articulated by Bazerman and • Training in food defense awareness
Watkins10 defines these circumstances as Any employee who is responsible for an identified actionable process step in a
“an event or set of events that take an food facility—and the supervisors of those employees—must complete food defense
individual or group by surprise, despite awareness training. Furthermore, any employees responsible for writing the parts of a
prior awareness of all of the informa- food defense plan (e.g., vulnerability assessment, assignment of mitigation strategies,
tion necessary to anticipate the events plan reanalysis) will also have to complete appropriate topical training to perform
and their consequences.” With data and the task according to regulation and guidance.
computing power available, we can, and
need to, identify these cascading infra- What Can Food Companies Do Now?
structure failures sooner. We can prevent Compliance with the IA rule for many food companies will be required in July
and mitigate catastrophic consequences 2019. To prepare, companies should take time in the next 12 months to strategize
J u n e n J u ly 2 018 57

FOOD DEFENSE
and initiate activities that will be required for compliance. One approach is to start FPDI’s research and education pro-
small by taking a single food product and considering the following: grams aim to reduce the potential for
Assess: How much information is already available through past food safety and contamination at any point along the
food defense planning? Identify and document where action may be needed. food supply chain as well as the mitiga-
Understand Hazards: Select a food product and document the hazards that may tion of potentially catastrophic public
affect this product. Think outside the typical safety hazards. What could cause harm health and economic effects of such
beyond the normal concerns you have? Consult incident reports, published litera- attacks. FPDI’s programs incorporate
ture, and known cases. Have you considered introduction of pesticides, undeclared cutting-edge research across a wide range
allergens, or cleaning and sanitizing agents? of disciplines, including supply chain
Assess the Supply Chain: Map the supply chain of the food product including the management, logistics, epidemiology,
supply chain of ingredients. Where is the product coming from? Indicate how it risk assessment, economics, molecular
travels and where there are inspection points. Can you document all the way back to biology, food microbiology, biomedical
“farm”? engineering, toxicology, information
“Today, the food system from farm to fork is a global, highly integrated, and
complex system of systems.”
Plan: Do you have a food defense plan? If yes, evaluate to see that it meets the sharing, supply chain security, cyber
requirements of the IA rule. Does it consider all hazards identified above the trans- security, and risk analysis.
portation network? Determine the last time the plan was challenged or exercised; FPDI education professionals and
was it more than a year ago? If no, find a resource to aid your planning (e.g., FDA subject matter experts have extensive
Food Defense Plan Builder, U.S. Department of Agriculture, FPDI). Determine who experience in designing, developing, and
within the food company can initiate a food defense plan and start identifying and delivering a continuum of food defense
prioritizing where vulnerabilities need to be mitigated first. Create a timeline for training. FPDI also offers in-person
development and review. programs developed to address food
Conduct Vulnerability Assessments: Evaluate the production of the food product to defense needs at all levels within an
determine where it may be susceptible to intentional adulteration. organization—entry level to C-suite—and
Determine Actionable Process Steps: From the vulnerability assessment, identify the across a variety of disciplines: national
processes during food production where mitigation strategies can be applied and are to local government, law enforcement,
essential to substantially minimize or prevent the significant vulnerability. food manufacturing and retail, supply
Mitigate: Identify mitigation strategies for each actionable process step based on chain and logistics, and foodservice,
your assessment. FDA has a database of mitigation strategies13 that may be helpful. catering, and restaurants.
Next, determine the cost of those strategies and prioritize what strategies should be In addition, a variety of training
implemented first. Finally, initiate a plan to implement selected strategies. opportunities and course offerings are
Educate and Train: Different team members need various levels of training or available that address FSMA IA train-
awareness. Identify who will have a role in food defense and align the appropriate ing requirements, FSMA Preventive
training. There are many training opportunities already available at the FDA Food Controls requirements regarding EMA,
Defense website. In addition, FPDI offers a variety of in-person food defense train- increasing awareness of food defense on
ings14 as well as a food defense awareness online training15 for those looking to be a global scale, understanding and apply-
trained from the comfort of their home. ing food defense principles, identifying
food defense vulnerabilities, creating tai-
The Food Protection and Defense Institute lored food defense plans, and challeng-
In 2004, the Department of Homeland Security (DHS) created the FPDI. The in- ing preparedness and response planning.
stitute was formerly known as the National Center for Food Protection and Defense. FPDI’s programming supports industry,
It was one DHS Center of Excellence established to evaluate and research the terror- government agencies (law enforcement,
ist threat to the homeland. Over the past decade, the work at FPDI has evolved to emergency responders), nongovernmen-
consider food system disruption regardless of motivation. Today, FPDI operates with tal organizations, international partners,
a mission of “Providing the highest impact innovation, education, and outreach to undergraduate and graduate students,
defend the global food supply.” By taking a comprehensive farm-to-table view of the and educators. FPDI strives to provide
food system, encompassing all aspects from primary production through transporta- strategies for prevention, mitigation,
tion and food processing to retail and foodservice, FPDI’s work addresses both the response, and recovery from potentially
vulnerabilities requiring assessment by the IA rule and vulnerabilities throughout the catastrophic public health and econom-
food system. ic effects of attacks on our food supply.

FOOD DEFENSE
Conclusion 2. www.foodsafetynews.com/2017/12/
Food defense is a critical aspect of woman-draws-jail-sentence-for-contaminating-chicken-in-2016/#.Wjp5-FQ-fVp.
ensuring the availability of safe, nutri- 3. www.nytimes.com/2016/05/06/us/michigan-man-charged-with-sprinkling-poison-on-food-at-
tious food on a global scale. Our food stores.html.
systems are a global, complex, intercon- 4. www.reuters.com/article/us-germany-extortion-poison/extortionist-seeking-millions-by-poisoning-
nected system of systems. Defending supermarket-food-german-police-idUSKCN1C3232.
this system, the integrity of the food 5. lovin.ie/news/this-popular-food-seasoning-has-been-recalled-due-to-undeclared-ingredients.
produced by it, and the health of the 6. foodprotection.umn.edu/fair.
public it feeds, from malevolent ac- 7. www.derbytelegraph.co.uk/news/derby-news/derby-man-accused-planning-uk-753090.
tors—both terrorist and criminal—re- 8. www.businessinsider.com/kfc-shuts-750-uk-stores-in-chicken-logistics-crisis-2018-2.
quires engaged collaboration from all 9. metro.co.uk/2018/02/20/kfc-workers-filmed-smuggling-chicken-backdoor-7326886/.
stakeholders, including domestic and 10. hbr.org/2003/04/predictable-surprises-the-disasters-you-should-have-seen-coming.
“Food defense is a critical aspect of ensuring the availability of safe,

nutritious food on a global scale. Our food systems are a global, complex,
interconnected system of systems.”
international food producers, academic 11. foodprotection.umn.edu/innovations/food-systems/fides.
researchers, nongovernmental organiza- 12. www.bbc.com/news/uk-21335872.
tions, and many government agencies. 13. www.accessdata.fda.gov/scripts/fooddefensemitigationstrategies/.
This collaboration must include shar- 14. foodprotection.umn.edu/professional-development.
ing information and robust discussion 15. z.umn.edu/fpdi-food-defense-awareness.
about 1) the latest scientific advances
in detection, risk and vulnerability as-
sessment, and prevention and response
methods; 2) analysis of emerging threats
and important evolutions in long-
standing ones; and 3) emerging regula-
tory and policy issues. These activities,
accomplished through work initiated
at FPDI, are critical for advancing food
defense knowledge and achieving the
coordination of effort required to suc-
cessfully protect the food supply and
public health. n
The Food Protection and Defense Institute (FPDI),

formerly known as the National Center for Food Pro-
tection and Defense, was officially launched as a De-
partment of Homeland Security Center of Excellence
in July 2004 at the University of Minnesota. Developed
as a multidisciplinary and action-oriented research
consortium, FPDI addresses the vulnerability of the
nation’s food system. FPDI takes a comprehensive,
farm-to-table view of the food system, encompassing
all aspects from primary production through transpor-
tation and food processing to retail and foodservice.
References
1. www.japantimes.co.jp/news/2014/08/08/
national/crime-legal/factory-worker-sentenced-
for-lacing-seafood-with-malathion/#.WjKjN1Q-fVo.
J u n e n J u ly 2 018 59

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TESTING
(continued from page 19)
Wireless Sensor System physical properties of the contaminants. For instance, chemical reactions can be
Swift Sensors Inc. is providing a cloud-
based wireless sensor system for industrial used for determination of lignin characteristics and enzymatic reactions.
and commercial applications. This system 5. Confirm. In many cases, no single method is 100 percent guaranteed to
fundamentally replaces manual processes complete an investigation and identification. Further testing may be required to
and mixed sensors with a low-cost, uni- validate the findings or disprove them. For example, analysis by atomic absorp-
fied sensor system that delivers real-time, tion spectroscopy or other elemental analysis techniques reveals different types
actionable data—dramatically transforming of metals. Examination of the combustion qualities of a sample can be used to
business process efficiency and reliability. find and quantitate foreign ferrous metal particles. Protein quantitative tests can
Swift Sensor technology monitors tempera- confirm the presence of animal matter.
ture, humidity, vibration, motion, activity, 6. Compare. Building a reference library is necessary for a forensics labora-
location, electric voltage, and current. tory. Identification relies on the availability of good reference library texts and
Swift Sensors, 866.308.1340
official methods containing authentic reference materials as well as spectral data-
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bases to obtain definitive confirmation of the contaminants.
7. Evaluate the root cause. Whether a contaminant went through a specific
processing step and was introduced into the product prior to or after packaging,
Synthetic Long-Life, High- potential sources could be uncovered through a prudent review of all test results
Temperature Grease and existing factors. If a piece of glass was confirmed, the following question will
be raised: Is it more likely to be from a lightbulb, bottle, window glass, or drink-
Klüber Lubrication has recently intro-
duced Klüberfood NH1 74-401, designed ing glass? This evaluation can be done to obtain more detailed information and
evidence from the contaminant’s size, shape, mass, and characteristic features,
especially compared with authentic reference materials. Any reference samples
provided by clients are helpful to address the root cause.
8. Prepare a comprehensive report. After the investigation and identification
are complete, a comprehensive report should be prepared, containing a sum-
mary of the project goals, sample information, test methods, imaging evidence,
findings, evaluations, and/or suggestions.
for incidental food contact in food and Conclusions

pharmaceutical processing. The grease A considerable variety of contaminants are possible in food that can render
combines the high performance and load- a food undesirable as a potential health hazard. Food companies rely heavily on
carrying capacity of a synthetic base oil a wide range of methods to minimize contamination and to detect it when it
with the versatility of an innovative urea occurs. Investigation, identification, and remediation of food contaminants are
thickener. This high-temperature grease powerful means to proactively avoid safety threats to consumer health and ma-
can be used in a variety of food processing jor losses to a company’s reputation and finances.
sectors. Applications include drive roller Food safety investigation and hazard prevention are complex and challeng-
bearings in ovens and proofers, conveyors ing. A strong, well-networked investigatory team is essential. A forensics team
and motor bearings, and roller bearings in equipped with a wide range of knowledge, skills, and experience is crucial. These
packaging and labeling machines. investigators must have good judgment when adverse incidents occur and be
Klüber Lubrication, 603.647.4104
able to determine the precise characteristics and features of the physical contami-
www.klueber.com/us/en/
nants. Because each incident varies, the capability to develop relevant techniques
for a complex investigation is challenging and essential to the forensic labora-
tory. n
Certified Listeria Test
Romer Labs has introduced a new Samuel S. Liu, Ph.D., is a science officer and chief entomologist in the food forensics department of Certified
pathogen testing system: RapidChek® Lis- Laboratories Inc.
teria monocytogenes. In its Performance
Tested Methods program, AOAC has certi- References
fied the testing system for detecting the 1. www.fsis.usda.gov/wps/wcm/connect/8018601c-12c2-47d8-93a4-9511558711f7/PHVT_New_
pathogen on environmental surfaces and Employee_Orientation.pdf?MOD=AJPERES.
ready-to-eat foods, including hot dogs, 2. www.foodsafetymagazine.com/enewsletter/a-look-back-at-2017-food-recalls/.
frozen breaded chicken, frozen cooked 3. www.foodsafetymagazine.com/enewsletter/a-look-back-at-2016-food-recalls/.
shrimp, cured ham, and ice cream. 4. www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-summaries.
Romer Labs, 302.781.6400 5. www.foodsafetymagazine.com/magazine-archive1/aprilmay-2003/the-dirty-dozen-ways-to-
www.romerlabs.com reduce-the-12-biggest-foreign-materials-problems/.

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in living or recently living plants and based carbon content compared with its The Road Ahead for Natural
animals. Once no longer alive, the plant petrochemical-derived carbon content. Product Adulteration
or animal will cease exchanging carbon As discussed, the complex nature of The necessity of strict quality as-
and the carbon-14 level will decrease at adulteration in the food industry means surance and testing has become abun-
a known rate. Petroleum and its deriva- that there is no single analytical technique dantly clear as the natural product mar-
tives are old enough that no carbon-14 guaranteed to detect adulteration. For ket has grown and various food safety
remains in them. By measuring the car- natural ingredients, carbon-14 testing is a scandals and legal cases have hit the
bon-14 content of a material, it is there- reliable way to specifically check for the headlines. As with many foods, the op-
fore possible to give its percentage of bio- presence of petroleum-derived chemicals. portunity and means of adulteration are
plenty. Although the regulatory defini-
tion of the “natural” label is not always
clear, an important preliminary step for
2018 Fall Symposium

checking the purity of a product sold
as plant-derived is to screen for cheaper
petroleum-derived synthetics with car-
Will be Heading to Columbus bon-14 testing. n
Anna Lykkeberg is a research associate at Beta

Analytic.
September 24–26, 2018 Jasmine Garside is the global operations man-

ager at Beta Analytic; www.betalabservices.com.
Columbus, Ohio
References
1. blog.euromonitor.com/2016/11/intangible-
appeal-natural-growing-consumer-interest-
unregulated-product-label.html.
2. www.prnewswire.com/news-releases/
all-natural-food--drink-market-
report-2017-2027-300498648.html.
3. www.fda.gov/Food/RecallsOutbreaks
Emergencies/SafetyAlertsAdvisories/
ucm434274.htm.
4. www.sabinsa.com/index.php/press-
release-2017/190-sabinsa-takes-action-against-
biotikon-for-synthetic-curcumin-adulteration.
5. www.foodqualitynews.com/
Article/2017/04/12/Prevalence-of-adulterated-
and-mislabelled-honey-revealed.
6. www.smh.com.au/business/consumer-
The Refrigerated Foods Association’s Fall Symposium
affairs/food-fraud-popular-oregano-brands-
is an exciting three-day event that combines expert selling-adulterated-products-20160404-gnygjo.
speaker presentations, excellent plant tours, and html.
great networking opportunities. 7. uk.businessinsider.com/how-is-artificial-
vanilla-made-2016-5?r=US&IR=T.
Highlights include: 8. www.gminsights.com/industry-analysis/
curcumin-market.
Tours of Nestle QAC Dublin, Grote Company, Mettler Toledo, 9. fas.org/sgp/crs/misc/R43358.pdf.
Kroger’s Columbus Bakery and Coalescence 10. www.washingtonpost.com/news/wonk/
Visit to Ohio State University Food Science Center wp/2017/08/30/the-raging-legal-battle-over-
Presentations on industry topics and RFA Technical Forum what-makes-a-food-natural/?utm_term=.
fd215672141a.
11. media.allured.com/documents/
www.refrigeratedfoods.org | info@refrigeratedfoods.org PF_29_01_032_10.pdf.
(678) 426-8175
FSM half-page ad.indd 1 6/6/18 9:43 AM

FOOD SAFETY CULTURE
Helping Senior Leaders Set o Provide candid and regular reviews, education, and measurements:
the Tone for Food Safety • Be completely honest in the assessment and communication of the food safety
Excellence: Conclusions and maturity of the organization. Educate such that the information being shared
Final Thoughts makes sense and be pragmatic regarding issues and solutions.
Consumer goods and other business- • Set up frequent food safety status reviews with senior leaders, either in a group
es are increasingly measured by their setting or in a one-on-one meeting—both can be very effective. For a group meet-
commitment to corporate responsibility ing, you’ll need to ensure active participation and discussion. In a one-on-one
and accordingly will be held to ever- meeting, you’ll have the undivided attention of the leader.
increasing standards of transparency, • Provide updates on what is happening external to the organization—examples of
ethical behavior, and trustworthiness. new technologies and food safety management approaches, as well as examples of
Financial results alone—even in the ab- other company failures and key learnings, which can be very helpful in keeping
sence of “issues”—are not enough. That interest alive.
organizations are fostering a proactive
and comprehensive view with culture o Identify and drive your specific must-win food safety priorities:
driving prevention and resilience will be • Communicate and agree on well-aligned priorities for strengthening the food
increasingly open to scrutiny by external safety program. The kind of areas that could be in scope for prioritization could
stakeholders. This very public lens will include: hygienic upgrade of buildings and equipment, technology/systems in-
significantly influence the reputation vestments, Hazard Analysis and Critical Control Points program deep dives and
and trust of food and ingredient produc- revisions, sanitation validation excellence, high-risk raw materials supplier quali-
ers, and calls for evidence and measures fications, environmental risk assessments, or formulation risk review processes.
of their commitment, in this case, to A key is that these are rarely new areas but areas already known and identified as
food safety excellence, are increasingly priorities that could be elevated in importance for a 6- to 36-month focused effort
being heard. to reach a milestone.
In this frame, food safety is not a • Senior leaders must also align on appropriate KPIs and provide, with one voice, a
result of materials, people, and processes candid view on progress and challenges against the agreed priorities, supported by
alone, but must be in the organizational
DNA and psyche, and safeguarded by
embedded cultural “guard rails.” Well- Qlaboratories.com
founded and communicated corporate
values are the first, basic building blocks
from which food safety culture (and all
corporate responsibility themes) can be
meaningfully derived. These values must
be manifest in the organization and pro-
vide a true compass on the direction and
decisions that occur every day across the
enterprise. How to define, measure, and
report this culture of excellence remains
a subject of vigorous discussion among
the leaders in this field, with several it-
erations and models available.
A great way of thinking about the
food safety culture journey is to relate it
to the 20-mile march described by Jim
Collins in his book Great by Choice:11
“Whatever comes at us, we keep moving ANALYTICAL CHEMISTRY, MICROBIOLOGY
forward, a bit at a time, every day, fully sup- AND RESEARCH & DEVELOPMENT
ported by the organization and from the top.” LABORATORY SERVICES
As a leader in food safety, how do
you support and encourage your or- World-Class Science With A Consultative Approach
ganization’s senior leaders in setting a Scientifically Accurate Results Your Business Can Absolutely Trust
positive tone for food safety in today’s Service Beyond Expectations
environment? Let’s review the three
takeaways:
J u n e n J u ly 2 018 65
Q Labs Third Pg Ad PRINT.indd 1 6/6/17 8:46 AM

....................75 Protect your brand. Protection for your assets.
....................41
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Challenging the Future through Engineered Solutions 844-511-5999
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FOOD SAFETY CULTURE
......................3
....................75
leading and lagging indicators, and surfacing hurdles and
......................7
....................45 solutions. The KPIs should be consistent with and aligned
ab.com .......70 to the agreed priority areas of the program.
....................27
o Foster ownership among the wide community of leaders:
....................15 • Recruit a senior leader other than the food safety leader-
ship; communicating food safety news, summaries, and
....................76 activities at senior management meetings is a great way to
eson.com ...72 demonstrate the expectation that everyone, including se-
................1, 25 nior leaders, must own food safety.
....................35
• Ensure a clear and intuitive link of organizational values
....................72
and vision to the food safety agenda. Reputation, consumer
com ............66
m ...................65 trust, and brand integrity are integral to organizational suc-
.com ...........49 cess. Ensuring senior leaders in all functions understand
....................65 this and embrace their role in protecting and building trust
through food safety excellence will be a catalyst to cultural
....................23 transformation. n
....................68
.................... 71 Lone Jespersen, Ph.D., is the principal of Cultivate.
Mike Robach is global vice president, corporate food safety, quality, and regu-
....................33 latory affairs at Cargill.
......................5
Mark Beaumont, Ph.D., is group head, quality and safety at Glanbia.
Sara Mortimore is vice president, product safety, quality & regulatory affairs,
om ...............73
Land O’Lakes Inc.
....................61
com .............11 Food Safety Magazine wishes to acknowledge the recent death of contributor
John Helferich.
75
References
1. www.who.int/foodsafety/areas_work/foodborne-diseases/ferg/en/.
2. Personal communication.
3. dsqapj1lakrkc.cloudfront.net/media/sidebar_downloads/Korn-Ferry-
6/1/17 12:09 PM
Institute_RealWorldLeadership_Report-3.pdf.
4. GFSI position paper, under review.
5. Jespersen, L, et al. 2016. “Measurement of Food Safety Culture Using
Survey and Maturity Profiling Tools.” Food Cont 66:174–182.
6. Syed, M. Black Box Thinking (UK: J. Murray Press, 2015). Re
7. Barlow, J and C Moller. A Complaint Is a Gift (Berrett-Koehler Press, Trap
2008). Mar
8. Dekker, S. Just Culture: Balancing Safety and Accountability (Ash- Wils
gate Publishing, Ltd., 2012) borh
9. Jesperesen, L, et al. 2017. “Comparative Analysis of Existing Food Hola
Safety Cultural Evaluation Systems.” Food Control 79:371–379. Con
10. Yiannis, F. Food Safety Culture, Creating a Behaviour Based Food
Safety System (Springer, 2009).
11. Collins, J and MT Hansen. Great by Choice (New York: Harper Col-
lins, 2011).
NEW! 2018 Exclusive

Food Safety Culture Collection
Visit go.foodsafetymagazine.com/culture
to download your copy today!

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Millipore Sigma...................................................................................... 3, 55
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Pickering Laboratories, Inc. • www.pickeringlabs.com........................53
Q Laboratories, Inc. • 513.471.1300 • www.qlaboratories.com.............65
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678.426.8175 • www.refrigeratedfoods.org
Solus Scientific Solutions, Ltd..................................................................35
+44 (0)1623.429701 • www.solusscientific.com/solus-one
Spartan Chemical Company, Inc.............................................................59
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Thermo Scientific • www.thermofisher.com/SentinelFSM....................18
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J u n e n J u ly 2 018 67

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