Foodsafety20190203 DL

FSM2319pg1-2,59-60.
indd 1 2/8/19 9:52 AM

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 • Blockchain • Culture • Environmental Monitoring • Food Safety Law • HACCP
• FSMA (a lot!) • Foodservice • Audits • GFSI • Sanitation • Process Validation • Allergens
• Process Control • Food Fraud • Norovirus • Produce • Lessons Learned from Outbreaks
• Preparing for Inspections • Retail • and a lot more
• Dave Theno • Larry Keener • Lone Jespersen • Steve Taylor • John Spink • Joe Corby • Scott Brooks
• Bill Sperber • Mike Taylor • David Acheson • Patricia Wester • Hal King • Will Daniels • Lee-Ann Jaykus
• Mike Cramer • Bill Marler • Mike Robach • Bob Brackett • Sean Leighton • Dane Bernard • Frank Yiannas
• Maple Leaf Foods • Shawn Stevens • John Butts • Keith Warriner • Chris Elliott • Sara Mortimore
43+ Episodes available

New episodes posted twice a month
Produced by
Listen and subscribe on your favorite podcast player
or visit our website: www.foodsafetymagazine.com/podcast
FSM2319pg1-2,59-60.indd 2 2/8/19 9:52 AM

Addressing
EMERGING ISSUES
throughout the and the
SUPPLY CHAIN FOOD SAFETY COMMUNITY
May 6 – 9
® 2019
Rosemont, Illinois
KEYNOTE PRESENTATION
What Will Drive Future Sponsored by
Food Safety Progress?

MICHAEL TAYLOR
Co-chair of the Stop Foodborne Illness Board
Former Deputy Commissioner for Foods and Veterinary Medicine, FDA
FULL AGENDA NOW AVAILABLE

www.FoodSafetySummit.com
PLATINUM SPONSOR GOLD SPONSOR MEDIA PARTNER
FSM2319pg3-7,59Final.indd 3 2/5/19 1:31 PM

February/March 2019
Vol. 25, No. 1
FEATURES COLUMNS
8 Process Control:
34 COVER STORY: Radiofrequency Pasteurization of Low-Moisture
Rethinking the Future of Food Recalls Foods: Critical Process Control Parameters
By William K. Hallman, Ph.D., By Long Chen and Jeyamkondan Subbiah, Ph.D., P.E.
and Cara L. Cuite, Ph.D.
12 Regulatory Report:
The Safe Food for Canadians Regulations:
42
FOOD SAFETY

What This Means for the Food Industry
By Lyzette Lamondin
CULTURE:
14 Testing:
Measure What You Treasure Foods Produced by Biotechnology:
By Melanie Neumann, J.D., M.Sc., A Toxicologist’s Perspective on Intended vs.
Marie Tanner, M.Sc., Randy Huffman, Ph.D., Unintended Changes
and Mike Liewen, Ph.D By Alex Eapen, Ph.D., DABT
18 Food Safety Insights:

46 MEAT SPOTLIGHT: Recalls and Outbreaks:
How WGS Will Change the Rules
High-Pressure Processing during By Bob Ferguson
Drying of Fermented Sausages to
Enhance Safety and Stability 24 Packing:
Plastic Packaging in a Circular Economy
By S. Balamurugan, Ph.D.
By George G. Misko, Esq.
28 Sanitation:
50 BEVERAGES: Validation, Verification, and Monitoring of
Advances in UV-C Light Technology Cleaning in Food Processing Factories
By Duane Grassmann
Improve Safety and Quality
Attributes of Juices, Beverages, DEPARTMENTS
and Milk Products 6 Editor’s Letter
By Tatiana Koutchma, Ph.D. 7 News Bites
59 Advertisers Index
Editorial Advisory Board Michael M. Cramer Tatjana Golikova, Ph.D. Hal King, Ph.D. Theodora Morille-Hinds, M.Sc.
Ajinomoto Windsor National University of Food Public Health Innovations LLC The Kellogg Company
Technologies Jeffrey L. Kornacki, Ph.D.
Gary Ades, Ph.D. Will Daniels Robert Powitz, Ph.D., M.P.H., RS
G&L Consulting Group IEH Laboratories & Consulting Kathy Gombas Kornacki Microbiology Solutions Inc. R.W. Powitz & Associates
Group Food Safety Consultant Gina R. (Nicholson) Kramer, RS/REHS
Reginald W. Bennett Thomas M. Sauer
CFSAN, U.S. FDA Kurt E. Deibel, Ph.D. Margaret D. Hardin, Ph.D. Savour Food Safety International™ Food Safety Consultant
Heinz North America IEH Laboratories & Consulting Group Sean Leighton, M.Sc., M.B.A.
Robert E. Brackett, Ph.D. Tim Stubbs, CFS
Cargill Inc.
IIT, Institute for Food Safety and Jonathan W. DeVries, Ph.D. Craig Henry, Ph.D. Dairy Management Inc.
Health General Mills/Medallion Labs Intro Inc. Huub L.M. Lelieveld
Global Harmonization Initiative Darryl Sullivan
John N. Butts, Ph.D. William Fisher, M.Sc., CFS Lone Jespersen, Ph.D. Eurofins Food Integrity and
Land O’Frost GFTC, retired Cultivate Steven Mandernach, J.D. Innovation
AFDO
Brian Campbell Timothy A. Freier, Ph.D. Larry Keener, CFS, PCQI Ann Marie McNamara, Ph.D. John G. Surak, Ph.D.
Kroger Clackamas Bakery Mérieux NutriSciences Intl. Product Safety Consultants Target Corporation Surak and Associates
Larry Cohen Veny Gapud Gillian Kelleher Martin Mitchell Wendy White, M.Sc.
Treehouse Foods Food Safety Consultant Wegmans Food Markets Certified Laboratories/RFA Golden State Foods
4 Food Safety Magazine

“This year, take pathogen
reduction to a whole
new level with products,
training and guidance
from Best Sanitizers.”
To learn more, call 888-225-3267

or visit: www.bestsanitizers.com
Alpet® Q E2
Sanitizing Foam Soap
Alpet® E3 Plus
Hand Sanitizer Spray BSI Industrial Cleaners and
Alpet® D2
Dispensing Equipment
Surface Sanitizer Alpet® D2 Quat-Free Alpet® No-Rinse
and Wipes Surface Sanitizer Quat Sanitizer
Largest Variety of Hand Hygiene

Dispensing Options in the Industry
HACCP SmartStep™ and HACCP Defender™
Footwear Sanitizing Units
BSX Boot Scrubber™ Series

Editor’s Letter
B y the time you read this, the partial U.S. government shut-
down may or may not be over. At the time of this writing, it
has gone on for over a month, but the impact on food safety is

CEO, The Target Group Inc. Don Meeker
Publisher Stacy Atchison
nebulous at best. Why? Because food processing facilities are still New Patriots Fan? Bobby Meeker
performing internal reviews, third-party auditors are still conduct-
Editorial Director Barbara VanRenterghem, Ph.D.
ing audits to specified standards, and state departments of health
Director of Sales Adam Haas
are still operational. In other words, if the food
industry is doing what it is supposed to be do- Art Director/Production Craig Van Wechel
ing, the short-term impacts on food safety and, Digital Editor Tiffany Maberry
thus, on public health, will be insignificant. Circulation Manager Andrea Karges
That leads us to consider longer-term effects Administrative Manager Allison Demmert-Poland
on food safety: Training courses on the Preven- Publishing Office 1945 W. Mountain St.
tive Controls and Produce Safety rules have Glendale, CA 91201
been cancelled; IT infrastructure improvements Main 818.842.4777
to support FSMA inspections are on hold; and federal employee Fax 818.955.9504
morale continues to decline (we always encourage those in customerservice@foodsafetymagazine.com
the food industry to “do the right thing,” but, in this case, fur- Production Office 1113 Ellis Street
loughed regulators who wish to put public health first are being Ft. Collins, CO 80524
threatened with disciplinary action if they work). Phone 970.484.4488
craig@foodsafetymagazine.com
We’ve learned from the Twitter feed of FDA Commissioner
Dr. Scott Gottlieb that the agency restarted high-risk food in- Editorial
spections and compounding inspections the week of January 14, Barbara VanRenterghem, Ph.D. • 508.210.3149
2019. This prompted some discussion on the Food Safety Matters barbara@foodsafetymagazine.com
podcast (and with some of my colleagues who are former FDA Tiffany Maberry • 678.853.1062
officials) about what is really meant by a “high-risk” food? Com- tiffany@foodsafetymagazine.com
monly found lists of high-risk foods that are attributable to FDA Advertising Sales
(but do not appear anywhere easily found on FDA’s website) Bobby Meeker • 818.842.2829
include foods that have been implicated in a large number of bobby@foodsafetymagazine.com
outbreaks (produce), those with a higher-than-average risk of eco- Adam Haas • 321.804.4319
nomically motivated adulteration (seafood), and those consumed adam@foodsafetymagazine.com
predominantly by vulnerable populations (baby formula). But
what about the foods that the majority of people consume? Is
risk based on the number of complaints received? Is turkey riskier
around Thanksgiving? What about ground beef during summer
Food Safety Magazine (ISSN 1084-5984) is published bimonthly by
holidays? And does a greater dependence on consumer handling The Target Group Inc., 1945 W. Mountain St., Glendale, CA 91201;
(think USDA-regulated products) factor in at all? (818) 842-4777; Fax (818) 955-9504; E-mail info@foodsafety-
There don’t appear to be easy answers. What is your definition magazine.com. Periodicals Postage Rate paid at Glendale, CA, and
additional mailing offices. Subscriptions: Free to qualified subscribers
of a “high-risk” food? Is the distinction more black-and-white
as defined on the subscription card; $85.00 per year for nonqualified
than it seems, or does the proverbial “it depends” hang overhead? subscribers. Back Issues: $10.00 per copy, prepaid. Change of Address:
Send me your thoughts about what makes a food high-risk, and Notices should be sent promptly; provide old mailing label as well as
we’ll include them in the next issue. Please put “high-risk foods” new address. Allow two months for change. Editorial Contributions:
Unsolicited manuscripts should be submitted to: Barbara
in the subject line and email me at barbara@foodsafetymagazine.
VanRenterghem, Ph.D., Editorial Director at: barbara@foodsafety-
com. 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. ©2019
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
Editorial Director or opinions offered by the authors of said articles and descriptions.

News Bites
USDA’s 2018 Food Safety JAMA Study Reveals Some Adults

Accomplishments Falsely Believe They Have Food Allergies
Just before the new year, U.S. Department of Agriculture A new study in the Journal of the American Medical As-
(USDA) Secretary Sonny Perdue released a list of accomplish- sociation (JAMA), entitled “Prevalence and Severity of Food
ments made by USDA in 2018. A couple of those achieve- Allergies Among U.S. Adults,” provides new insight about
ments related to food safety agencies are as follows. just how common food allergies are. Over 40,000 U.S. adults
Animal and Plant Health Inspection Service played a vital were surveyed via Internet and phone interviews between
role to ensure the free flow of agricultural trade by keeping October 2015 and September 2016. Participants were re-
U.S. agricultural industries free from pests and diseases. An cruited from the National Opinion Research Center at the
example of this critical work is the group’s recent efforts to University of Chicago’s probability-based AmeriSpeak panel,
prevent African swine fever from entering the U.S. through and also from the nonprobability-based Survey Sampling In-
a series of safeguards that includes working with producers, ternational panel.
states, and industry to ensure they are following biosecurity The study reported that 51 percent of participants experi-
recommendations, restricting pork imports from affected enced a “severe” food allergy reaction, nearly 50 percent of
countries, and working with U.S. Customs and Border Protec- food-allergic adults had at least one adult-onset food allergy,
tion to train inspection dogs and increase screening vigilance 48 percent developed food allergies as an adult, and 19
for passengers and products arriving from affected countries. percent believed they had a food allergy. However, only 10.8
Food Safety and Inspection Service (FSIS) inspected more percent of the participants had a confirmed food allergy at
than 160 million head of livestock and 9.47 billion poultry car- the time of the survey.
casses. FSIS inspectors also conducted 6.9 million food safety Based on these findings, researchers concluded that food
and food defense procedures across 6,500 regulated establish- allergies are common and severe among U.S. adults. Also,
ments to ensure meat, poultry, and processed egg products because some participants believed they had a food allergy
were safe and wholesome. when they did not, researchers suggest that confirmatory
You can see all of the agency’s 2018 accomplishments at testing be performed. Those interested can view the entire
USDA.gov. study at JAMANetwork.com.
People & Places Kreza to the position of vice president, global

human resources, and Dr. Elisabeth Hagen,
its new CEO. Schiller is a veteran of Pinnacle
Foods, where he most recently served as chief
AIM, the worldwide industry food safety adviser and former federal policy commercial officer, overseeing such brands as
association for the automatic maker and regulator, to its board of directors. Duncan Hines and Birds Eye.
identification industry, has named Microbiologics Inc. has ap- Certified Laboratories has announced Klara
William Fisher, M.Sc., CFS, a pointed Mark Ellingson as direc- Kalfa as the company’s new director of busi-
recipient of the 2018 Bert Moore tor of business development, over- ness development.
Excellence in Journalism Award. Fisher seeing the business-to-business Food Safety Net Services has
United Fresh partnerships for Microbiologics announced that Bob Cox has
Produce Association Chairwoman and its subsidiaries, Virapur and Ellingson joined the company as senior vice
Cindy Jewell, California Giant Gibson Bioscience. president of human resources –
Berry Farms, has appointed Sarah Jason Brown has been named manager of chief human resources officer.
Grady to fill an open seat on the the analytical chemistry department at Q Labo- Lakeside Foods Inc. has an- Cox
Grady United Fresh Board of Directors. ratories. nounced several new hires at its corporate
Grady is the U.S. strategic supply chain man- BioConsortia Inc., provider office in Manitowoc, Wisconsin:
ager at McDonald’s Corporation for produce, of microbial solutions for natural Matt Brown, vice
fruit, potato, and beverage categories. plant trait enhancement and yield president of sales;
Bühler Aeroglide has named Tom Bar- improvement, has announced the Trey Taylor, director
ber vice president of capital sales and Jason promotion of Dr. Hong Zhu to of marketing; and
Pintuff as director of process engineering. Zhu senior vice president of research Brown Anne Smith, director
ESE Inc., a control system and development. of communications. Taylor
integration company that designs Motion Industries Inc., a Testo has announced that Eric
and develops plant automation wholly owned subsidiary of Genu- Moore, director of food safety
systems for the food and beverage ine Parts Company, is pleased and regulatory compliance, has
industry, recently hired Nicholas to announce the addition of Hal been appointed chair of the Amer-
Truehl as an information technol- Truehl Midkiff as product sales manager, Smith ican Frozen Food Institute’s newly
ogy technician. process pumps and equipment. Midkiff established Foodservice Training and Education
NSF International has appointed Karen Hain Celestial has named Mark Schiller Working Group.
February n March 2019 7

PROCESS CONTROL
By Long Chen and Jeyamkondan Subbiah, Ph.D., P.E.
Radiofrequency Pasteurization Advantages of RF Heating

RF has a longer wavelength and
penetration depth than those of micro-
of Low-Moisture Foods: Critical waves. Thus, RF heating has advantages

of more even electric field distribution
and more uniform heating compared
Process Control Parameters with microwave heating.3 Its longer

penetration depths make RF suitable for
bulk sample treatment in the food in-
dustry. Since RF heating is volumetric,
the whole sample can be heated rapidly.
In conventional heating, the heat is
transferred from the external surface to
Low-moisture foods present the internal center of the sample, result-
ing in longer come-up times to achieve
a formidable challenge to the target temperature at the cold spot.
To pasteurize egg white powder, for ex-
antimicrobial interventions ample, it is traditionally heat-treated by
storing packaged product in a hot room
A
at 58–60 °C for 10–14 days.16 However,
it took only 8 hours for RF-assisted pro-
ccording to the Food Safety Modernization cessing to achieve pasteurization at 90
Act regulations, any preventive microbial °C.17 The shorter come-up time allows
inactivation technology must be validated.1 It RF heating to be a high-temperature,
is necessary to identify a suitable non- short-time processing technology, which
pathogenic surrogate with a similar or higher is more energy efficient and could retain
heat resistance than that of the target pathogen before more food quality after treatment. This
thermal inactivation validation because pathogens can- is the major advantage of RF heating.
not be used in food processing plants. The safety of Because RF waves vibrate bound wa-
low-moisture foods is becoming a major concern after ter,2 it is a suitable technology for low-
several recent foodborne illness outbreaks.2 The thermal moisture foods, such as spices and milk
resistance of bacteria in these foods creates major chal- powder, which have more bound than
lenges in developing suitable food safety intervention free water.2,18 RF systems can be turned
technologies without deteriorating food quality. on/off instantly for better process
control. Since most food packages are
Radiofrequency Heating plastic bags or cardboard boxes that are
Radiofrequency (RF) heating involves utilizing elec- transparent to RF waves,13 food prod-
tromagnetic energy at a frequency range of 3 kHz to ucts can be pasteurized after being pack-
300 MHz. Only select RF frequencies (13.56, 27.12, and aged. Although heating uniformity is
40.68 MHz) are permitted for industrial, scientific, and better in RF than in traditional thermal
medical applications.3 RF is widely applied for steriliza- processing or microwaves, there is still
tion/pasteurization,4–10 thawing,11,12 disinfestation,13,14 room to improve heating uniformity
and drying.15 The heat is volumetrically generated by in RF processing to achieve superior
rotation and friction of ions and dipolar molecules in product quality.3,19–21 Computer simula-
food products because of an alternating electrical field. tion is a powerful tool to understand
The movement of positive and negative ions is ionic RF heating and improve uniformity.19–24
conduction, and rotation of dipolar molecules is dipole Therefore, RF heating has great poten-
rotation.3 Ionic conduction and dipole rotation are the tial to be applied for low-moisture food
dominant mechanisms of RF heating. pasteurization in the food industry.
FSM2319pg8-31,55-56Final.indd 8 2/5/19 1:21 PM

PROCESS CONTROL
Critical Process Control Parameters to be very optimistic. In food safety val- several outbreak strains are mixed as a
RF heating is influenced by many idation studies, conservative estimates cocktail and then inoculated. While the
factors, such as the dielectric proper- are critical to avoid potential recalls. results may not be attributed to any sin-
ties of food products, electrode gap, Therefore, it is important to equilibrate gle strain, the results are representative
configurations of the top electrode and the samples for several days for bacteria of the most thermally resistant strain.
package, and top electrode voltage of a to adapt before performing process
free-running oscillator with a two par- validation.5,7,31 Thermal resistances of Case Study: RF Processing of Cumin
allel-plate system. Dielectric properties bacterial strains vary dramatically. To be Seeds
of food products depend on moisture efficient in running validation studies, Spices are low-moisture foods that
content (MC), frequency, temperature,
density, and chemical composition.3
Among these factors, MC is a major
factor that affects the heating rate.3 The
dielectric constant represents a mate-
rial’s ability to store the electric field
energy, and the dielectric loss factor
determines how much electromagnetic
energy can be converted into heat.25 Nu-
merous researchers have measured the
dielectric properties of different food
products.11,25–29 Top electrode voltage
and electrode gap can regulate RF out-
put power.13,14 Electrical field strength
determines the power output of a piece
of equipment that impacts the heating
rate. Very strong electrical field strength
between two electrodes can cause arc-
ing. The configurations of the top
electrode and food package influence
electric field distribution in the RF cav-
ity, which can be optimized to improve
heating uniformity.22
Microbial factors that must be con-
sidered for validation include the selec-
tion of strains, inoculation methods,
stabilization, and equilibration time
before treatment.7 The thermal resis-
tance of bacteria in low-moisture foods
is a function of aw.30 Inoculation and
stabilization methods for pathogens in
low-moisture foods have a significant
effect on pathogen survival of validated
inactivation processes.31 The bacte-
rial culture is grown on a wet medium
before inoculation onto dry products.
When inoculated, bacteria may undergo
stress due to a drastic change in environ-
ment. If not enough equilibration time
is provided for bacteria to adapt to the
low-moisture environment before pro-
cessing, the processing technology may
easily kill the bacteria as they are already
stressed.7 The results on the efficacy of
intervention technologies may turn out

PROCESS CONTROL
add flavor to foods as seasonings in We monitored cold-spot temperatures for-low-moisture-foods/.
different cuisines. However, their micro- of both first- and second-batch samples 3. Marra, F, et al. 2009. “Radio Frequency Treat-
biological quality is a great concern be- and found that cold-spot temperatures ment of Foods: Review of Recent Advances.” J
cause most spices are grown in countries were similar when achieving more than Food Eng 91(4):497–508.
without standard Western hygiene and 5-log reduction of Salmonella. The cold 4. Liu, S, et al. 2018. “Microbial Validation of Ra-
sanitation conditions.32 Cumin (Cumi- spot of the third-batch sample with dio Frequency Pasteurization of Wheat Flour by
num cyminum L.) is one of the most the same MC was heated to the same Inoculated Pack Studies.” J Food Eng 217:68–74.
popular spices because of its distinctive cold-spot temperature of the previous 5. Wei, X, et al. 2018. “Radio-Frequency Process-
flavor and aroma.33 Cumin seeds are two batches, and a 5-log reduction was ing for Inactivation of Salmonella enterica and
susceptible to contamination with bac- achieved as expected. Therefore, cold- Enterococcus faecium NRRL B-2354 in Black
teria such as Escherichia coli, Salmonella, spot temperature and MC are two criti- Peppercorn.” J Food Prot 81(10):1685–1695.
Clostridium perfringens, and Bacillus cereus cal process control parameters in RF 6. Li, R, et al. 2017. “Verification of Radio Fre-
because of cross-contamination with processing. These two parameters must quency Pasteurization Process for In-Shell Al-
soil, water, and manure in the field, be monitored in the food industry as monds.” J Food Eng 192:103–110.
possibly causing public health risks Critical Control Points when this novel 7. Chen, L, et al. 2019. “Inactivation of Salmo-
and foodborne pathogen outbreaks.34 technology is deployed as a microbial nella enterica and Enterococcus faecium NRRL
Therefore, it is necessary to develop an intervention technology. B-2354 in Cumin Seeds by Radiofrequency Heat-
efficient spice decontamination method After the same RF heating time un- ing.” Food Control (in review).
to ensure food safety and maintain food der the same treatment conditions, 8. Hu, S, et al. 2018. “Inactivation Kinetics for
quality. E. faecium always showed a lower log re- Salmonella Typhimurium In Red Pepper Pow-
In one of our studies in RF process- duction than that of Salmonella. There- ders Treated by Radio Frequency Heating.” Food
ing of cumin seeds, we observed huge fore, we can conclude that E. faecium is Control 85:437–442.
variations in heating rate and microbial a good surrogate for Salmonella cocktail 9. Kim, SY, et al. 2012. “Radio-frequency Heating
inactivation when the two batches of strains in cumin seeds for RF process- to Inactivate Salmonella Typhimurium and Esch-
samples were equilibrated to the same ing.7 n erichia coli O157:H7 on Black and Red Pepper
aw.7 After the same RF heating time, Spice.” Int J Food Microbiol 153(1-2):171–175.
the population of both Salmonella and Long Chen is a doctoral student in the Department 10. Jeong, SG and DH Kang 2014. “Influence of
Enterococcus faecium for the first batch of Biological Systems Engineering at the University of Moisture Content on Inactivation of Escherichia
of cumin seed was under the detec- Nebraska–Lincoln. coli O157:H7 and Salmonella enterica Serovar
tion limit. But there were almost no Jeyamkondan Subbiah, Ph.D., P.E., is the Ken- Typhimurium in Powdered Red and Black Pep-
log reductions of both bacteria for the neth E. Morrison Distinguished Professor of Food per Spices by Radio-frequency Heating.” Int J
second-batch sample. When analyzed, Engineering in Biological Systems Engineering and Food Microbiol 176:15–22.
the moisture contents of the two batch Food Science & Technology at the University of Ne- 11. Bedane, TF, et al. 2017. “Experimental Study
samples were different due to variations braska–Lincoln. of Radio Frequency (RF) Thawing of Foods
in sample characteristics. Spices are im- with Movement on Conveyor Belt.” J Food Eng
ported from various countries and there References 201:17–25.
is a huge variability in samples.7 Ther- 1. U.S. Food and Drug Administration. 2015. 12. Li, Y, et al. 2018. “Radio Frequency Temper-
mal images of two batch samples clearly “Current Good Manufacturing Practice, Hazard ing Uniformity Investigation of Frozen Beef
show the differences in heating rates Analysis, and Risk-Based Preventive Controls for with Various Shapes and Sizes.” Innov Food Sci
(Figure 1). When conditioned to the Human Food.” Fed Regist 80:55908–56168. Emerg Technol 48:42–55.
same MC, the heating rate was similar 2. www.foodsafetymagazine.com/magazine- 13. Huang, Z, et al. 2015. “Computer Simula-
and so also the microbial inactivation. archive1/junejuly-2017/radio-frequency-heating- tion of Radio Frequency Selective Heating of
Insects in Soybeans.” Int J Heat Mass Transfer
90:406–417.
14. Birla, S, et al. 2004. “Improving Heating
Uniformity of Fresh Fruit in Radio Frequency
Treatments for Pest Control.” Postharvest Biol
Tec 33(2):205–217.
15. Zhang, B, et al. 2016. “Developing Hot Air-
Assisted Radio Frequency Drying for In-Shell
Walnuts.” Emir J Food Agr 28(7):459–467.
16. Handa A, et al. 2001. “Correlation of the
Figure 1. Top Surface Temperature Distribution Comparison between the First- and Second- Protein Structure and Gelling Properties in
Batch Cumin Samples after the Same RF Heating Time Dried Egg White Products.” J Agric Food Chem

PROCESS CONTROL
49(8):3957–3964. 31. Bowman, LS, et al. 2015. “Inoculation Prepa- biological Safety of Low Water Activity Foods
17. Boreddy, SR, et al. 2016. “Novel Radiofre- ration Affects Survival of Salmonella enterica and Spices (New York: Springer, 2014), 15–34.
quency Assisted Thermal Processing Improves on Whole Black Peppercorns and Cumin Seeds 33. Mathew AG and S Pushpanath. Indian Spices
the Gelling Properties of Standard Egg White Stored at Low Water Activity.” J Food Prot (India: Dee Bee Info Publications, 2005).
Powder.” J Food Sci 81(3):E665–E671. 78(7):1259–1265. 34. Al-Jassir, MS. 1992. “Chemical Composition
18. Awuah, GB, et al. Radio-Frequency Heating 32. Farakos, SMS and JF Frank. “Challenges in and Microflora of Black Cumin (Nigella sativa
in Food Processing (Boca Raton, FL: CRC Press, the Control of Foodborne Pathogens in Low- L.) Seeds Growing in Saudi Arabia.” Food Chem
Taylor & Francis Group, 2015). Water Activity Foods and Spices,” in The Micro- 45(4):239–242.
19. Chen, L, et al. 2015. “A Strategy to Simulate
Radio Frequency Heating under Mixing Condi-
tions.” Comput Electron Agr 118:100–110. SPONSORED CONTENT
20. Chen, L., et al. 2016. “Simulation and
Validation of Radio Frequency Heating with
Conveyor Movement.” J Electromagnet Wave
Radio Frequency Pasteurization:
30(4):473–491. The Wave of the Future in Food Pasteurization
21. Chen, J, et al. 2017. “Modeling Radio Frequen-
cy Heating of Food Moving on a Conveyor Belt.” Founded in 1946, Radio Frequency Company (RFC)’s 40,000 sq. ft. design
Food Bioprod Process 102:307–319. and manufacturing facility is located in the suburbs of Boston alongside the
22. Tiwari, G, et al. 2011. “Computer Simulation historic Charles River. RFC is a global manufacturer of advanced industrial
Model Development and Validation for Radio radio frequency (RF) processing systems for the rapid heating, drying,
Frequency (RF) Heating of Dry Food Materials.” disinfestation, and pasteurization of food products and ingredients.
J Food Eng 105(1):48–55. Today, RFC’s Macrowave™ pasteurization systems are treating more than
23. Jiao, Y, et al. 2015. “Improvement of Radio 500 million pounds of food ingredients, both for humans and pets, per year.
Frequency (RF) Heating Uniformity on Low Unlike irradiation and other
Moisture Foods with Polyetherimide (PEI) treatment methods, RF treat-
Blocks.” Food Res Int 74:106–114.
ment is certified organic, natu-
24. Zhu, H, et al. 2017. “A Novel Method to Im-
ral, and can be used on an FDA-
prove Heating Uniformity in Mid-High Moisture
approved clean label. In an RF
Potato Starch with Radio Frequency Assisted
Treatment.” J Food Eng 206:23–36. pasteurization system, the RF
25. Zhang, S, et al. 2016. “Dielectric Properties generator creates an alternating
of Peanut Kernels Associated with Microwave electric field between two elec-
and Radio Frequency Drying.” Biosyst Eng trodes, above and below the
145:108–117. system conveyor, which causes
26. Ling, B, et al. 2015. “Dielectric Properties of the treated product to heat rapidly and uniformly throughout its entire thick-
Pistachio Kernels as Influenced by Frequency, ness, whether it is processed in bags, or in bulk on a troughed conveyor. This
Temperature, Moisture and Salt Content.” Food rapid and volumetric heating means that there is no temperature differential
Bioprocess Tech 8(2):420–430. from the surface to the center of a product and no prolonged soak time that
27. Ozturk, S, et al. 2016. “Dielectric Properties of
can damage functionality and other organoleptic qualities. All Macrowave
Dried Vegetable Powders and Their Temperature
systems meet FSMA standards for a preventive control step and incorporate
Profile during Radio Frequency Heating.” J Food
the HACCP monitoring, data logging, and alarm functionality required for a
Eng 169:91–100.
28. Boreddy, SR and J Subbiah. 2016. “Tem- kill-step validation. Treatment systems are available in a broad range of sizes
perature and Moisture Dependent Dielectric to suit individual customer requirements and are designed and constructed to
Properties of Egg White Powder.” J Food Eng GMP standards for food safety and ease of sanitation. All Macrowave systems
168:60–67. are UL approved, FCC certified, and EU compliant. For all systems deployed
29. Nelson, SO. 1991. “Dielectric Properties of domestically or internationally, RFC maintains a complete spare parts invento-
Agricultural Products—Measurements and Appli- ry; factory-trained RF service technicians are available 24/7. RFC’s MacroCare
cations.” IEEE Trans Electr Insul 26(5):845–869. Preventive Service Plan assures customers that their system is operating at
30. Syamaladevi, RM, et al. 2016. “Water Activity peak performance, minimizing downtime and maximizing their ROI. Because
Change at Elevated Temperatures and Ther- RF treatment is a USDA Organic thermal process and is easy to own and op-
mal Resistance of Salmonella in All Purpose
erate, it’s no wonder why RFC’s Macrowave pasteurization systems are truly
Wheat Flour and Peanut Butter.” Food Res Int
“the wave of the future” in food safety.
81:163–170.

REGULATORY REPORT
By Lyzette Lamondin
The Safe Food for Canadians met immediately upon coming into
force on January 15, 2019, while oth-
ers are being phased in over a period
Regulations: What This Means of 12–30 months based on food com-

modity, type of activity, and business
size.
for the Food Industry

If a business has a previous food
registration or license with the CFIA,
and it expires after January 15, 2019,
it will remain valid as a Safe Food for
Canadians (SFC) license until its expiry
date, provided there is a statement on it
indicating that it is also a license issued
under the Safe Food for Canadians Act.
Some businesses need to As expiration approaches, the business
will be required to apply for an SFC
comply now, some have license.
more time Some businesses are affected immediately

In general, the new regulations apply
O
to sectors previously required to be reg-
istered or licensed with the CFIA if they
n January 15, 2019, the Safe Food for Ca- conduct any of the following activities:
nadians Regulations (SFCR)1 came into • Import food
force, marking a significant milestone in • Export any food that requires an ex-
food safety for Canada. These regulations port certificate or Certificate of Free
make Canada’s food system even safer by Sale
focusing on prevention and allowing the faster removal • Manufacture, process, treat, preserve,
of unsafe food from the marketplace. grade, package, or label food to be
For the food industry, the new regulations reduce the exported or sent across Canadian
administrative burden on businesses by replacing 14 sets provincial or territorial boundaries
of regulations with 1 and will help maintain and grow • Slaughter food animals from which
market access for Canada’s agri-food and agricultural meat products are derived for export
sectors. or to be sent across Canadian pro-
The following are some highlights and key informa- vincial or territorial boundaries
tion to help industry understand next steps, now that • Store and handle a meat product in
the new regulations are here. its imported condition for inspection
by the CFIA
What businesses need to know about the SFCR By consulting Table 1, such business-
On January 15, 2019, the Canadian Food Inspection es can determine whether the require-
Agency (CFIA) began to enforce the SFCR. The regula- ments related to licensing, preventive
tions include key new requirements related to licensing, control plans, and traceability apply to
traceability, and preventive controls, which apply to them starting January 15, 2019.
businesses that import food into Canada or prepare Businesses can access the CFIA’s
food in Canada for export markets or to be sent across interactive tools and sector-specific
Canadian provincial or territorial boundaries. timelines2 for more detailed information
Most businesses with more than $100,000 in gross on which requirements apply to them
annual food sales must prepare and maintain a written and when, based on the activities they
preventive control plan. Some requirements had to be conduct.

REGULATORY REPORT
Preventive Traceability ments for food businesses. To balance
Commodity License Control Plan Records the need to protect Canada’s food
Meat products and food animals √ √ √ safety system while supporting food
Fish √ √ √ businesses in their efforts to comply
Dairy products √ √ √ with the new regulations, the CFIA’s
Eggs and processed egg products √ √ √ enforcement approach emphasizes
Processed fruit or vegetable products √ √ √ working with businesses to help them
Honey and maple products √ √ (not required if √ understand the new requirements.
annual food sales Enforcement actions, where applica-
are $100K or less) ble, are proportionate to the food safety
Fresh fruit or vegetables √ (not applicable √ (except risk and the seriousness of the noncom-
for growing and growing and pliance. Factors such as potential or actu-
harvesting) harvesting) al harm, compliance history, and intent
Table 1. SFCR Requirements are being taken into consideration. More
Some businesses have more time to meet and interactive tools and other plain- information on enforcement is available
requirements language resources on general and com- at inspection.gc.ca/safefood.
Food sectors that were not required modity-specific requirements available The CFIA worked closely with in-
to be registered or licensed with the in the toolkit for businesses.7 dustry during the development of the
CFIA in the past will only need to SFCR and is actively engaging with
meet new licensing, preventive control, Entry of imported food certified before the businesses and industry associations to
and traceability requirements in 2020 SFCR help businesses meet the SFCR require-
or 2021, unless they require an export During the transitional phase imme- ments. The agency has a strong history
certificate or Certificate of Free Sale for diately following January 15, 2019, the of working with industry and is commit-
food that they export. This includes CFIA is following the usual process for ted to continuing this cooperation, so as
businesses in the following sectors, admitting imports of food at the border to ensure the successful implementation
among others: and is not preventing the clearance of of this significant improvement to food
• Confectionary shipments based on the new regula- safety in Canada. n
• Snack foods tions.
• Beverages Lyzette Lamondin is the executive director of Food
• Oils Requirements for Canadian food exporters Safety and Consumer Protection at the CFIA. She led
• Dried herbs and spices Businesses that require an export the initial development, drafting, and engagement for
• Nuts and seeds certificate including a Certificate of Free the SFCR from 2013 to 2015. She currently oversees the
• Coffee and tea Sale from the CFIA to export products implementation of the new regulations.
• Baked goods, cereals, and pasta need to apply for and obtain an SFC
For more information, consult the license. These businesses will then be References
timeline that applies to these businesses.3 included on the SFC License Registry, 1. inspection.gc.ca/food/sfcr/eng/
which will confirm that they are operat- 1512149177555/1512149203296.
What businesses need to do if affected right ing in good standing and will help them 2. inspection.gc.ca/food/sfcr/timelines/eng/
away maintain access to key markets, includ- 1528199762125/1528199763186.
Businesses affected by the new re- ing the United States. 3. inspection.gc.ca/food/sfcr/timelines/all-other-
quirements on January 15, 2019, should By 2022, the license requirements foods/eng/1527610633553/1527610633758.
now have their license. If not, they will apply to all food businesses that 4. inspection.gc.ca/about-the-cfia/my-cfia/eng/
should enroll in My CFIA4 and apply manufacture, process, treat, preserve, 1482204298243/1482204318353.
for one or more licenses immediately. grade, package, or label a food in Can- 5. inspection.gc.ca/food/sfcr/general-food-
Each SFC license costs $250 and is valid ada for export. Businesses that export requirements-and-guidance/licensing/obtain-a-
for 2 years. When applying for a license, food but do not produce the food, such licence/eng/1543359915240/1543360663242.
businesses will need to declare that they as export brokers, will need a license 6. inspection.gc.ca/food/sfcr/toolkit-for-busi-
have the necessary preventive controls only if they require an export certificate. nesses/handbook-for-food-businesses/eng/
and preventive control plans in place, More information is available in the 1481560206153/1481560532540.
where required. CFIA’s guidance on food exports.8 7. inspection.gc.ca/food/sfcr/toolkit-for-
The CFIA website has much infor- businesses/eng/1427299500843/
mation to help businesses, including Approach to enforcing the new regulations 1427299800380.
what to consider before applying for The CFIA recognizes that the SFCR 8. inspection.gc.ca/food/sfcr/exports/eng/
a license,5 a Handbook for Businesses,6 introduce a number of new require- 1323723342834/1323723662195.

TESTING
By Alex Eapen, Ph.D., DABT
Foods Produced by quired harvesting and purification from

animal sources. With advancements in
biotechnology, traditional products like
Biotechnology: A Toxicologist’s porcine- and bovine-sourced insulin

were replaced with recombinant human
insulin, which was more effective and
Perspective on Intended vs.

resulted in far fewer allergic and autoim-
mune reactions as well as reduced the
potential for exposure to viruses and
Unintended Changes
prions. Similarly, small-molecule drug
inhibitors, which tended to have many
off-target effects, were steadily replaced
with highly specific therapeutic proteins
and antibodies, effectively reducing
those undesired effects. Some of the
most significant improvements were
seen in the field of oncology drug devel-
Biotechnology methods need opment. The historical premise of che-
motherapeutic intervention for many
a lighter regulatory hand years relied on DNA-damaging agents
that would target both cancer and nor-
mal cells alike, resulting in significant
“T
toxicity. Using biotechnology, research-
ers were able to identify markers specific
he dose makes the poison.” Whether to cancer cells and develop antibodies
you attended a presentation or read a and antibody-drug conjugates to target
scientific article, if a toxicologist was in- cancer cells, effectively killing them and
volved, there is a good chance you have leaving normal cells unharmed, thereby
heard these words. While seemingly significantly reducing toxicity. Irrespec-
simplistic in its message, this concept, which is founda- tive of the specific therapeutic class
tional to the field of toxicology, has withstood the test or indication, it is well-accepted that
of time. It creates a distinction between intended and biotechnology has had a very positive
unintended effects. Depending on the specific industry impact on the development of more
and product class in question, intended effects are also precise and less toxic pharmaceuticals,
referred to as pharmacology, efficacy and therapeutic ef- replacing approaches that were more
fects, or technical function, while unintended effects can prone to unintended effects.
be regarded as off-target effects, adverse effects, or toxic- In stark contrast to the welcome
ity, based on the severity of the changes. Ultimately, it advancements in pharmaceutical de-
is crucial to understand the spectrum of these undesired velopment, biotechnology’s role in the
changes for any regulated product to maximize its ben- food industry, despite being introduced
efit while minimizing the risk to the end user, a concept around the same time, still faces signifi-
that has been dramatically influenced by modern bio- cant challenges in adoption. The general
technology. public’s uncertainties regarding the ben-
To illustrate how biotechnology has enabled us to de- efits to the consumer, combined with
velop more precise and less toxic products, let us exam- a complex and inconsistent regulatory
ine the changes we have seen in the past 30 years with environment and a general unwilling-
regard to new drug development. For many years, small- ness to accept broad scientific consensus
molecule drugs remained the mainstay of therapeutic on safety, have left the food industry
intervention, while early biologic-type treatments rein a constant state of tug-of-war. Our

TESTING
goal in the field of toxicology is to help for over 25 years to incorporate well- The resulting products have been des-
develop products that deliver on the characterized genes from a foreign (dif- ignated by the common moniker of ge-
intended effects while minimizing the ferent plant or nonplant species) donor netically modified organisms or GMOs.
unintended effects. When we apply into a plant host that endow it with The use of this transgenic method
this charge to biotechnology and its some desirable trait. This method has differs from conventional breeding
use in food production, it is important given us a number of crop varieties that techniques in that the number of genes
we critically compare and contrast the include traits such as herbicide tolerance affected is very low, sometimes limited
alternative methods of food production. and/or pesticidal effects, allowing for to a single gene. In addition, the speci-
Specifically, we need to carefully evalu- the decreased use of crop treatments. ficity of the genetic changes is very high
ate conventional breeding methods
against modern methods of genetic en-
gineering with regard to intended versus
unintended changes to gain a better per-
spective on the safety of these products
(Table 1).
Genetic changes through spontane-
ous mutations and natural selection
have been occurring throughout the
evolution of the plant kingdom over
millions of years. In addition, selective
breeding by humans has been in use
since the domestication of edible plants
and the development of agriculture over
the past several thousand years. Wheth-
er by the forces of nature or the hand of
man, selective breeding and spontane-
ous genetic mutations have given rise
to the vast diversity we currently see
in the plant kingdom, including most
of the plant varieties consumed by hu-
mans. Interspecies plant breeding is a
relatively more recent development. It
has been utilized for the past 200 years
to develop new plant varieties involv-
ing species that would otherwise not
be able to exchange traits. Mutagenesis,
a comparatively more recent develop-
ment, is another form of plant breeding,
which uses radiation or potent chemical
mutagens to introduce random genetic
mutations in plants to create new traits.
While these three varying techniques
are generally regarded as conventional
breeding methods, they also share an-
other characteristic in that their respec-
tive processes are known to randomly
modify a significant number of genes,
with little to no specificity toward the
desired trait. Most importantly, new
plant varieties generated using these
conventional breeding methods are not
subject to regulatory scrutiny that re-
quires testing to ensure human safety.
Transgenic methods have been used

TESTING
Selective Interspecies New Breeding
Breeding Crosses Mutagenesis Transgenesis Techniques
Mating plants of Mating of plants Use of radiation or Adding defined and Altering a gene
the same or similar of different chemical mutagens characterized gene(s) in a plant without
Description of Method
species to promote species that would to randomly alter to a plant to impart a inserting foreign
the maintenance of otherwise not DNA to produce desirable trait(s) DNA elements
desirable traits exchange traits desirable traits
Relative # of Altered Genes Very High Very High Very High Very Low Very Low
Relative Specificity of Genetic Changes None None None Very High Very High
Considered Conventional Breeding? Yes Yes Yes No No
Regulatory Requirement No No No Yes Yes
for Safety Testing
Table 1. Different Methods to Modify DNA in Plants (Earliest Methods → Modern Methods)
in that a given inserted gene of interest represents the primary concern from a From a toxicology perspective, the
has a known sequence, coding for a human health and safety perspective. current tools employed to evaluate the
known protein with a known function. Combining this with whole-genome safety of genetically modified plant
More recently, “new breeding tech- sequencing technology and the ability varieties seem appropriate in provid-
niques” represent the frontier of genetic to identify new potential open reading ing insights on both the intended and
engineering in plants and is a term used frames, researchers can utilize this bioin- unintended changes associated with the
to describe methods like gene edit- formatics approach to predict what pro- respective modification technique uti-
ing using CRISPR (clustered regularly teins will be expressed in a genetically lized. A testament to this demonstration
interspaced short palindromic repeats) modified plant variety, and whether of safety is seen in the high adoption
technology as well as RNA interference. they present any potential hazard to rate of common crops like maize and
These techniques allow for the modifi- humans or animals that consume them. soy globally, with no reported adverse
cation of host plant genes without the An additional approach is to evaluate health effects. However, one cannot
incorporation of any foreign DNA, the digestibility of newly expressed help but wonder why there are no
making it a highly precise mutagenesis proteins in simulated gastric fluids. regulatory requirements to make similar
method that could be limited to a single The premise behind this approach is assessments of safety when it comes to
gene, perhaps even a single base-pair that digestion-resistant proteins may new plant varieties created using muta-
substitution. Unlike plants produced via represent potential allergenic peptide genesis, which employs radiation and/
conventional breeding methods, plant sequences. While this may not always or potent chemical mutagens to induce
varieties generated by transgenic tech- be the case, the data from such a test DNA damage, resulting in all manner
nology or new breeding techniques are could add to the weight of evidence if a of genetic modifications including, but
generally subject to extensive regulatory particular incorporated gene codes for a not limited to, deletions, mutations,
scrutiny, including but not limited to protein that bears sequence homology and rearrangements. The number of
safety testing to show suitability for hu- to known toxins or allergens. An in vivo genetic modifications induced by this
man and animal consumption as well as test that has been employed for evaluat- conventional breeding method can
safety for the environment. ing the safety of recombinant proteins be astronomically higher than those
There are a variety of ways in which being expressed in plants is the acute created via the more modern genetic
the safety of genetically modified oral toxicity assay in rodents. While engineering methods. What is the ratio-
plant varieties can be assessed. One of this test represents an extreme case of nale in essentially turning a blind eye to
the most powerful tools available to exposure, the goal is to show that the evaluating the unintended changes asso-
researchers is the Basic Local Align- expressed protein does not present a ciated with this conventional breeding
ment Search Tool-Protein, which is clear health hazard, even if consumed method, when we have the technology
maintained by the National Center in large quantities. Finally, a basic readily available to do so? As a toxicolo-
for Biotechnology Information. This chemical characterization of the plant gist, I will continue to struggle with this
tool allows researchers to evaluate the variety with regards to nutrient content question as there is little to no apparent
protein sequences (encoded by inserted is warranted to demonstrate that the logic behind it. Anyone involved in
genes) added to a plant variety through new plant variety can still deliver on its evaluating the safety of our food supply
a genetic engineering technique for sim- intended function, which is to provide should question this apparent scientific
ilarity to known toxins or allergens. This nourishment. and regulatory gap.

TESTING
In reality, one could also raise ques- traits, including blight and insect resis- made via CRISPR gene editing would
tions about the safety associated with tance, also contained high levels of tox- not be regulated as GMOs as they are at
time-tested methods like selective breed- ic glycoalkaloids. People who reported least similar to, if not more precise than,
ing and interspecies crosses. Scientific consuming this potato developed symp- their conventionally bred varieties. The
evidence suggests that these methods toms similar to food poisoning, which USDA secretary made it clear that this
have the potential to generate a signifi- was clearly an unintended consequence determination was to “allow innovation
cant number of genetic changes. The of this potato created through this con- when there is no risk present.”1 USDA
prevailing argument ventional breeding is not alone in this thinking as a recent
for safety of these
older techniques, espe-
“Transgenic methods method. In 2003, a
very similar case was
Japanese government panel reached
the same conclusion, suggesting that
cially selective breed- also reported in New gene-edited products should not be
ing, is the long history have been used for Zealand, involving a held to the same regulatory scrutiny
of use. The problem zucchini produced via as GMOs in which foreign genes have
with this argument is
that it makes a very
over 25 years to conventional breeding
that also contained
been inserted. In addition, Australia’s
gene technology regulator has also
significant assumption high levels of a toxin, proposed not regulating products of
that genetic changes incorporate well- resulting in numerous gene editing, similar to the U.S. and
acquired through the reported cases of food Japan. While it is entirely possible that
processes of nature are
inherently safe. When
characterized genes poisoning-like symp-
toms. Taken together,
the EU court decision on gene editing
technology may become a minority
we consider that the it is clear that plant opinion in the future as other regula-
modern diversity we from a foreign…donor breeding methods tory bodies around the globe begin to
see in plants around considered to be “con- align with USDA’s view on the matter,
the world has evolved
from green algae over
into a plant host that ventional” may not al-
ways favor the side of
one has to wonder why there is such a
divergent view on this topic. To better
millions of years, safety. Given the high illustrate this discrepancy, let’s examine
it should become endow it with some potential for genetic a potential scenario where we use a
abundantly clear that changes, perhaps these “conventional” mutagenesis technique
nature doesn’t always
take the side of hu-
desirable trait.” “conventional” prod-
ucts should be held to
versus gene editing to generate a prod-
uct with the same desirable trait and
man safety. After all, the same scientific and consider the unintended changes (Table
nature’s ability to modify genes has regulatory scrutiny as plants produced 2). If we are able to achieve the same
given us plants such as hemlock, deadly via genetic engineering, which, not sur- desired outcome of a new plant variety
nightshade, and oleander, which are just prisingly, to date have had no reported with the intended trait from the same
a few of the known toxic plants with adverse health effects. starting point, which path should we
a proven ability to kill humans. Even Adding to this confusing narrative is follow? To a scientist whose focus is on
if we focus on edible plants, either by the recent ruling by the Court of Justice the safety of products, a path that helps
the hand of man or by nature, selective of the European Union (EU) indicating clarify the unknowns and minimizes
breeding has given us varieties that were that products made by new mutagenesis unintended changes would obviously
shown to be highly toxic. In 1967, the techniques, like CRISPR gene edit- be the preferred route as it presents the
Lenape (B5141-6) potato was developed ing, are considered GMOs with regard safest product for human consumption.
by crossing the Delta Gold potato with to regulatory scrutiny. This ruling is However, the EU court opinion would
Solanum chacoense, a wild potato found counter to the preliminary thinking run counter to this assertion as it would
in Peru. The resulting Lenape potato, by the U.S. Department of Agriculture favor the older and obviously more im-
while having a number of desirable (USDA) that certain plant varieties precise method (continued on page 55)
Starting Organism Technique Intended Changes Unintended Changes EU Court Opinion

Plant X Gene editing Desired plant trait None Regulate as GMO
Plant X Radiation mutagenesis Desired plant trait Potentially numerous DNA Unregulated
mutations, deletions, and
rearrangements of unknown
consequence
Table 2. Changes Associated with Traditional versus Modern Mutagenesis Techniques

FOOD SAFETY INSIGHTS
Bob Ferguson, Strategic Consulting Inc.
Recalls and Outbreaks: year in that regulators acknowledged

that much of the product had already
been consumed, but the recalls were
How WGS Will Change primarily targeted at those consum-

ers who may have kept some of the
product in their freezers. In the past,
the Rules without WGS, this ground beef out-

break may not have been recognized
as a foodborne illness and almost cer-
tainly would not have been linked to its
source. Now, however, these incidents
are being accurately traced to their
source, and alerts and recalls are show-
ing up on the screens of everyone’s
smartphone and on TV news stations.
Effects of whole-genome
WGS Improves Traceability
sequencing on food safety This change is echoed in official
statements by U.S. Food and Drug
Administration (FDA) Commissioner
L
Scott Gottlieb. In an FDA statement re-
leased on June 28, 2018, referring to the
ast year was a very unusual year in food safety. romaine lettuce Escherichia coli outbreak
Food Safety Insights is a This year, however, may be even more unusual from Yuma, Arizona, the commissioner
and show that 2018 was not an aberration but was quoted as saying:
collaboration between a harbinger of a change to what some may call “…In recent years, the FDA and the
a “new normal.” [U.S.] Centers for Disease Control and
Food Safety Magazine
What exactly am I talking about? In 2018, we saw Prevention (CDC) have advanced new tools
and the food safety an unusually high number of foodborne illness out- that make it easier and faster to identify
breaks and recalls. The year started out with a large outbreaks of human illness and to link them
market experts at recall of romaine lettuce, ended the year with another back to the food source that is the culprit re-
large recall of romaine lettuce, and in between, we saw sponsible for the illnesses…. While there have
Strategic Consulting Inc.
more recalls of ground turkey, ground beef, pet food, been many advances over the past years, one
to bring you the latest pre-cut melons, vegetable trays, breakfast cereals, and of the most powerful of the new technologies
the world’s largest Listeria outbreak (to date) in South we employ is whole-genome sequencing….
market research, insights, Africa. By using this technology, public health inves-
We have certainly seen foodborne illness out- tigators can link illnesses in different people
and trends in food
breaks and food recalls in the past, but those from and locations to reveal outbreaks with a level
safety, analytical testing, this past year were different. The recalls listed above of precision never previously available. Sim-
were prompted by epidemiological investigations of ply put, this means we’re better at identifying
diagnostics, laboratory outbreaks where the causative pathogens were recov- outbreaks and their source.”
ered from ill patients, and identified and traced back This use of WGS will completely
services, sanitation, and
to their sources through whole-genome sequencing change our understanding and assump-
related topics in quality (WGS). None were detected through routine sur- tions of what constitutes adequate
veillance by food processors. Also, in most of these pathogen surveillance and sanitation in
and safety testing, and incidents, the food volume being recalled had most the food industry.
likely already been consumed and caused most of the If that’s not enough to get your at-
assurance in the food
illnesses it was going to cause. This was the case for tention, as of last month, the pace of
and beverage industry. the recall of ground beef in the last few months of the this change has likely accelerated. In

Bia Diagnostics
LEADERS IN FOOD
ALLERGEN ANALYSIS
We are your lab, working with you to create the highest

standards of quality control for you and your company.
Now Offering real-time PCR for

GMO and Species ID testing utilizing
technology
Same Day Allergen Analysis

We specialize in food allergen testing and provide testing for label verification of the
following allergen proteins utilizing the most robust, up to date ELISA methodologies:
• Gluten • Casein • Fish
• Egg • Coconut • Shrimp
• Soy • Hazelnut • Mollusks
• Total Milk • Macadamia • Histamine
• Peanut • Pecan • Pistachio
• Almond • Sesame • Mustard ISO17025 Certified Laboratory
• β-Lactoglobulin • Walnut
• Cashew • Shellfish
Bia Diagnostics, LLC 802 540 0148

480 Hercules Dr. biadiagnostics.com
Colchester, VT 05446 info@biadiagnostics.com
Copyright © 2017 Bia Diagnostics, LLC. All Rights Reserved.
BIA_FSM_AD_032017-06.indd 1 3/21/17 4:47 PM

mid-January, CDC accelerated their Expect Dramatic Increase in there may be other ancillary issues that
transition of their PulseNet network Outbreaks, Recalls they may not.
to reliance on WGS from the previous I had an opportunity to discuss this “Consumers have seen the news
primary use of pulse-field gel electro- issue with Dr. Jeff Kornacki of Kornacki on outbreaks and recalls, and it seems
phoresis (PFGE). This change has been Microbiology Solutions and a member as if there has not been a food group
coming over the past few years as the of the Food Safety Magazine Editorial Ad- that hasn’t been affected,” says Shawn
number of WGS isolates added to the visory Board. Jeff has previously written Stevens of Food Industry Counsel LLC,
PulseNet database annually has grown about this issue in Food Safety Magazine a law firm that exclusively represents
from 0 in 2013 to more than 100,000 and predicted exactly what we are now the food industry. “These are not only
by the end of 2018—representing well seeing.1,2 your customers, but, as an attorney, I
more than one-half of the new isolates With the change in the PulseNet da- recognize that they are also your poten-
in the database. The use of PFGE tabase, Jeff projects that we will certainly tial jury in any trial. They have always
ceased on several or- see more outbreaks understood that they must cook their
ganisms at the end of identified and a resul- food, but now they are being told that
2018, and the priority “We have certainly tant increase in recalls. their food is dangerous. This will impact
in 2019 will be to ex- This has already been your legal risks.”
clusively use WGS on seen foodborne illness the case with more
Listeria monocytogenes numerous outbreaks A New Testing Environment
isolates, followed by related to Listeria be- The shift to WGS may also serve to
Shiga toxin-producing outbreaks and food ing uncovered and re- catch processors technically unprepared
E. coli, and then as ported, with a roughly to respond to this new environment.
many Salmonella recalls in the past, but fivefold increase in lis- Over the past few years of surveys for
samples as capac- teriosis outbreaks since our Food Safety Insights column, we
ity allows. CDC had 2015. He states, “This have asked processors about their cur-
already transitioned those from this past year, as more Salmo- rent and anticipated use of WGS. In
Listeria isolates from nella isolates are added those surveys conducted in 2017 and
PFGE to WGS by the year were different.” to the database, and 2018, we asked nearly 200 unique pro-
end of 2018. But this considering that Sal- cessors whether they have used WGS;
change in focus on monella infections are 91 percent (Table 1) said that they have
Salmonella should be a warning. Con- far more prevalent than Listeria (~1,000 not used, nor have considered using,
sidering that Salmonella causes orders times more Salmonella cases in the U.S.), WGS for any of their samples. With this
of magnitude more foodborne illness the number of previously undiscovered year’s coming changes, this potentially
than Listeria, even if not all Salmonella Salmonella outbreaks can be expected represents a significant “data gap” be-
isolates are sequenced and traced back to increase dramatically.” Jeff also asks, tween processors and regulators.
to their source, those that are will repre- “If the impact of the PulseNet database
sent a dramatic increase in the numbers on Salmonella cases is similar to what it Are you using or planning to use
of new Salmonella cases discovered and has been with Listeria, can you imagine whole-genome sequencing?
reported. what a fivefold increase in the roughly
And this considers only the samples 50,000 clinical cases of Salmonella would
collected by CDC through epide- look like?” Yes No
miological investigations and does not The most likely result will be many 9% 91%
include any other sequences added more highly publicized outbreaks and
through sampling efforts by the U.S. far more recalls with consumers fac-
Table 1. Percentage of Processors Using
Department of Agriculture Food Safety ing more and more dramatic headlines WGS
and Inspection Service or FDA. The (recalls declared “largest,” “longest run- Source: Food Safety Magazine Survey of 200
European Centre for Disease Prevention ning,” “most states,” etc.). Yet, even as Processors in 2017/2018
and Control (ECDC) also cooperates most of these outbreaks affect fewer When we ask processors why they
with the PulseNet program through its people per outbreak, this will not be are not using WGS, the most common
Food- and Waterborne Diseases and apparent to consumers—only the fre- answers we hear touch on issues such as
Zoonoses Network program, and reports quency of the outbreak headlines. This regulatory concerns, long turnaround
from ECDC have shown that most will dramatically impact consumers’ per- time, limited operational applicability,
European countries are currently using ception of the safety of their food sup- and high cost. All of these are perhaps
WGS and all but one plan to use WGS ply and create a market issue for food legitimate concerns currently, but with
by the end of 2019. processors that they may anticipate, but the coming changes in the management

and use of the PulseNet database, the tion, and auditing is good and has pro- And we have been communicating that
drivers for the use of WGS may quickly vided processors with the foundation message to corporate leadership as we
change. to produce safe food, but these alone find ‘routine’ positive samples and fol-
The oft-heard excuse related to com- will quickly no longer be adequate. low ‘routine’ responses. But you’ll have
pany approaches to food safety systems Continuing a “business as usual” to change your message. If you are see-
of ‘This is the way that we have always stance knowing that these outbreaks ing positives in your plant, even if they
done it and we’ve never had a problem’ have probably been occurring—but are only in areas like drains, they can
will no longer work. “You may have pre- have been unseen—will be a mistake. get into your product. This has likely
viously thought that no one was getting “Processors will have to develop a been happening intermittently for many
sick from your products, but if this has more rigorous environmental monitor- processors, but because of WGS, we are
been happening, they will discover that ing program (EMP), and specifically only now able to see it. The situation
now,” adds Jeff. “You a ‘Pathogen EMP,’ is like turning on a light in a dark base-
may have been going “The shift to WGS which allows them to ment—you may not have been able to
along with a less sensi- get into the plant and see the problems before, but now they’ll
tive environmental better understand the be clearly revealed.”
surveillance program, may also serve to microbial environ- Shawn continues, saying, “First,
thinking that it is OK, ment and eradicate food processors are going to have to
but that will no longer catch processors the source of patho- make a much greater effort than they
be the case. We are gen contamination,” have in the past to get pathogens out
going to have to better Jeff adds. The proof their plant. Second, food safety staff
learn how to clean a technically unprepared gram should include are also going to have to get corporate
plant.” “…a system to look leadership to understand this, especially
Shawn agrees with to respond to this new at positive environ- if they have been told in the past that
this recommendation. mental samples as an positive samples are ‘routine,’ and third,
“Processors are going ‘investigation’ and companies will need to act with much
to have to increase environment.” not just a routine more urgency than they have in the
surveillance: not only vectoring program past.”
in their own plants but also at the farm and follow-up process. Processors need
level, to ingredients, to every step in to ask why the positive was found and Conclusions
their supply chain. You’ll never get the not just follow the routine response Diligence in food safety has always
control you are going to need if you steps. Processors should include ‘ro- been a moving target. Food safety pro-
keep bringing in pathogens into your bust Zone 1 and Zone 2’ indicator fessionals recognize that continuous
plant from the farm or in your ingredi- testing for pathogen ecology as well as improvement is essential, and until
ents.” robust end-product testing.” Jeff also foodborne illnesses no longer occur,
Jeff also makes the point that while believes that the days of only accepting there is always more that needs to be
all sectors of food processing will be certificates of analyses from suppliers done. With the increased use of WGS,
affected by this change, some sectors should also be over with more ac- which will one day be recognized as a
may be at more risk than others. “The ceptance testing, perhaps based upon pivotal moment in food safety surveil-
difficulty of tracing back incidents in appropriate indicator organisms like lance, that pace of change just got a lot
the past may have been because the HTEB and HQA for Salmonella and faster. n
source of their foodborne illness was Listeria, respectively, and better use of
one that a consumer was unlikely to validated microbiological control treat- Bob Ferguson is president of Strategic Consulting Inc.
be able to identify, such as a spice ments for ingredients. and can be reached at insights@foodsafetymagazine.
or ingredient. Yet, it is a rare occur- This will also require a change in the com or on Twitter at @SCI_Ferguson.
rence that I look in a plant producing way food safety professionals communi-
low-water-activity foods and not find cate the issues internally. References
Salmonella. These infections have prob- Shawn mentions that he is busier 1. www.foodsafetymagazine.com/magazine-
ably always been occurring undetected these days speaking to corporate leader- archive1/december-2016january-2017/the-
in foods such as nuts, spices, dry milk, ship to explain the coming changes that coming-storm-in-the-spice-industry/.
chocolate, and other similar products, will undoubtedly impact their busi- 2. www.foodsafetymagazine.com/magazine-
but they will increasingly be found.” nesses. “We as food safety professionals archive1/februarymarch-2017/the-coming-
So, the response to this situation have understood that pathogens are like storm-in-the-spice-industry-part-ii-what-the-
requires the industry to be proactive. gravity—they’re everywhere and if we industry-can-do/.
The current system of testing, certifica- test for them, we are going to find them.

FOOD SAFETY INSIDER
Collecting and Interpreting

We developed the product with the goal
of creating a new sanitation monitoring
system that is superior to anything else
Multi-site ATP Testing Data on the market.”

The results in the AOAC validation
report (Performance Tested MethodSM
091601) provided evidence that Accu-
Point Advanced produces consistent and
A
reliable data for evaluating sanitation
denosine triphosphate (ATP) sanitation verification systems program effectiveness in food processing
are now the standard method for evaluating and monitoring and foodservice facilities.
sanitation efficacy at food production and foodservice organi- AccuPoint Advanced is an enhanced
zations around the world. version of the company’s earlier Accu-
Neogen has developed an innovative software system that allows Point test system. Improvements with
food safety directors immediate access to their facilities’ sanitation AccuPoint Advanced include improved
test results from an AOAC-approved test method—no sampler chemistry to produce more con-
matter where in the world their facilities may be. sistent results with even greater sensitiv-
Neogen’s NeoNet® is a cloud-based software ity; an enhanced instrument to produce
platform that enables corporate food safety direc- even faster results (less than 20 seconds);
tors to achieve new levels of access, insight, and and advanced data manager software to
control of the effectiveness of the sanitation pro- easily streamline the testing process by
grams at each of their facilities. With the NeoNet sys- creating test plans and syncing important
tem, each facility does routine ATP testing and seam- data, while keeping a permanent record
lessly transfers the results to their local computer of sanitation test results.
networks. The data are then automatically synced to AOAC International is a globally rec-
the customer’s universal NeoNet system. ognized, independent forum for finding
“Corporate quality assurance and sanitation direc- appropriate science-based solutions
tors have needed a way to quickly learn of potential through the development of microbiolog-
problems and compare results across facilities, as well as ical and chemical standards. The Applied
production groups and equipment within those facilities,” says Research Center at NSF International is a
Neogen’s James Topper. “Especially for organizations that have mul- not-for-profit global research group that
tiple, far-flung facilities, the challenge has been to efficiently collect provides product development support
and interpret that data company-wide. NeoNet greatly simplifies that to manufacturers and developers of prod-
process by presenting the collected data graphically without having ucts in the food safety, agriculture, clini-
to conduct extensive data analysis. This simplified process enables cal, and life science markets.
www.foodsafety.neogen.com
directors to respond more quickly to situations that need their im- In the NSF International study, a bat-
mediate attention—and potentially save their companies from the tery of tests was conducted to objectively
consequences of an ineffective sanitation effort.” measure five major commercial ATP hy-
Using NeoNet with Neogen’s AOAC-approved AccuPoint® Ad- giene monitoring systems. In real-world
vanced test system, a director can review results of each facility’s simulations, each system was tested
testing or compare one facility with all other locations. It also pro- using four different approaches to de-
vides historic ATP test result comparisons to current results. At each termine their accuracy and consistency.
level, the results are displayed with a bar chart and percentages of Accuracy was determined by measuring
pass, marginal, and fail results ranked by highest fail percent. Users the percent recovery of the commodity
can narrow the results to a selected timeframe, such as the past 24 from a 4 inch × 4 inch stainless steel sur-
hours, or by the week, month, quarter, or year. face. A higher relative light unit score on
“We’ve been very encouraged by the feedback we’ve received this measure indicated a more accurate
from companies that have been early adopters of the NeoNet sys- representation of the residue actually
tem,” says Topper. “They’ve found it to be very easy to use, and it ac- present on a surface. Consistency was
complishes what the industry requested.” determined by computing the coefficient
of variation (CV%) for the sample set.
The First ATP Test System with AOAC Approval A lower CV% indicated a more narrow
Neogen’s AccuPoint Advanced was the first sanitation monitoring range of scores for a given sample and,
system to receive AOAC approval, and this approval follows a recent therefore, a more consistent system.
study by NSF International that showed AccuPoint Advanced exceed- Across all real-world test simulations,
ed the performance of competitive systems. AccuPoint Advanced appeared to be more
“Each time we receive a validation from an independent third par- consistent and accurate in its detection of
ty on any of our tests, it provides further assurance to the food pro- the amount of ATP on a surface with its
duction and processing industry that our tests perform as expected,” patented flat-head samplers. In a produc-
says Topper. “The performance of our AccuPoint Advanced system in tion environment, more accurate and con-
recent independent evaluations by AOAC and NSF is very gratifying. sistent results mean more reliable data.

ATP Sanitation Verification System
What are the benefits of Neogen’s AccuPoint® Advanced?
• Rapid time to results (less than 20 seconds)
• The first AOAC-approved sanitation verification system
• Independently verified by NSF International
• Optional RFID technology reduces test time and increases test plan accuracy
• Data Manager software records and tracks test results
To learn more, contact your Neogen sales representative or visit foodsafety.neogen.com today
800-234-5333 (USA/Canada) • 517-372-9200

foodsafety@neogen.com • foodsafety.neogen.com

PACKAGING
By George G. Misko, Esq.
Plastic Packaging in a calls for all plastic packaging on the EU

market to be either reusable or recycla-
ble in a cost-effective manner by 2030.
Circular Economy It also aims to reduce the consumption

of single-use plastics and restrict the in-
tentional use of microplastics.
The intent of the Plastics Strategy is
to transform the way plastic products
are designed, used, and recycled in the
EU. To achieve these goals, the strategy
Transforming the design, use, calls for a more integrated supply chain,
elimination of substances that hamper
production, and recycling of recycling, development of innovative
materials and alternative feedstocks for
plastics plastic production, and improved col-
lection and sorting of plastic waste.
In announcing the Plastics Strat-
T
egy, the European Commission (EC)
noted that plastic packaging accounts
he European Union (EU) and others—includ- for about 60 percent of post-consumer
ing policy makers, companies, and organi- plastic waste in the EU. Yet, demand for
zations—have recently announced goals to recycled plastics currently only accounts
reduce or eliminate the amount of plastic for about 6 percent of plastics demand
packaging sent to landfills. For example, Kraft in Europe due, in part, to low commod-
Heinz announced in July 2018 that it aims to make 100 ity prices and uncertainties about mar-
percent of its packaging globally recyclable, reusable, or ket outlets.
compostable by 2025. The EC identified four action steps
A few months earlier, the American Chemical Coun- needed to meet its goals for achieving a
cil’s Plastics Division announced targets of 100 percent circular economy for plastics in the Plas-
of plastic packaging being recyclable or recoverable by tics Strategy:
2030 and 100 percent of plastic packaging being reused, • Improve the economics and quality
recycled, or recovered by 2040. As early as February of plastics recycling
2016, the Plastics Trade Association launched the Zero • Curb plastic waste and littering
Net Waste program, which recognizes plastics compa- • Drive innovation and investment
nies that take steps to reduce net waste in manufactur- toward circular solutions
ing. These goals fit in well with the drive toward the “cir- • Harness global action
cular economy” idea that is being pushed by the EU as
a way of meeting the dual objective of minimizing waste Good Intentions; Not so Good
and reducing the use of raw materials and energy. Follow-Through
The economics of plastics recycling
The Goals of the Circular Economy and the can be a hindrance to recycling. Speak-
Plastics Industry ing at the EU’s Circular Economy
By way of background, in 2015, the EU published an Stakeholders Conference in February
action plan for transitioning to a circular economy.1 A 2018, Olivier Francois, Group Galloo
significant development for those in the plastic packag- Recycling and European Recycling
ing industry took place in January 2018, when the EU Industries’ Confederation, pointed out
revealed its strategy on plastics as part of its transition that while the price of recycled plastics
toward a more circular economy. The “European Strate- is fully correlated with crude oil prices,
gy for Plastics in a Circular Economy” (Plastics Strategy)2 the market fails to internalize recycling’s

PACKAGING
net environmental benefits in price set- erate with EFSA to investigate safe use tries, found that the quality of plastic
ting. He called for incentives that take of recycled plastic materials other than materials available for recycling is the
into account the environmental benefits PET or plastics originating from closed- biggest barrier to greater use of recy-
of recycling. loop-reuse applications. clates as raw materials. Almost 60 per-
With respect to the regulation of In contrast to the EU, premarket cent of the European plastics-converting
recycled plastic for food-contact ap- clearance is not required for food-con- companies find it hard to get a supply
plications in the EU, the EC published tact plastics produced by post-consumer of recycled plastics materials that meet
Regulation No. 282/2008 in March recycling processes in the U.S. Rather, their quality standards, reported EuPC.
2008. Under this regulation, only food- recycled plastic food-contact materials In addition, almost 60 percent of the
contact materials and articles that con- must meet the same regulatory require- companies that took part in the survey
tain recycled plastic obtained from an ments as virgin plastic materials. That is, stated that the current regulations are
authorized recycling they must meet specified not suitable to support stronger use of
process may be mar-
keted in the EU after
“The intent of the compositional require-
ments, end-test extrac-
recycled plastic materials in the future.5
The EC is aware of this concern.
petitions for recycling tive limitations in many In Options to address the interface between
processes received by Plastics Strategy is to instances, and general chemical, product and waste legislation
December 31, 2009, suitable purity require- (Interface Document),6 which was pub-
are evaluated. Once
a petition is received,
transform the way ments. The specific
source controls used to
lished at the same time as the Plastics
Strategy, the commission acknowledged
the European Food ensure compositional that the composition of waste streams
Safety Authority plastic products are compliance and pro- is not fully predictable or constant, and
(EFSA) issues an opin- cessing steps to ensure added that in addition to the presence
ion on the safety of
the process, then the
designed, used, and suitably pure resin are
the responsibility of the
of substances of concern, there may be
incidental contamination. This could
EC either grants or re- producer of the same, include impurities in waste water, degra-
fuses authorization of recycled…” as is the case with a pro- dation products in the material, incom-
that recycling process. ducer of virgin resins. plete separation of materials between
However, while EFSA Nonetheless, a producer waste streams, or cross-contamination
has adopted more than 140 positive of recycled materials may ask the U.S. with other products.
scientific opinions on the safety of plas- Food and Drug Administration to re- In a presentation on the interface
tic recycling processes for food-contact view its recycling process and issue a between chemicals, products, and waste
applications, the EC has authorized not no-objection letter on the suitability of at the Circular Economy Stakeholders
one of the processes. its process for producing recycled plastic Conference, Michael Mansuy from Veo-
Several trade groups have urged the for use with food, and, in fact, many lia (an environmental services company)
EC to authorize the processes. One have pursued that path if for no other addressed this issue in part. He stressed
of these groups, the Plastics Recyclers reason than to gain a market advantage that information about substances of
Europe (PRE), expressed concern in an by providing greater assurance to its very high concern under REACH (an
October 2017 press release about the customers as to the suitable nature of its EU regulation adopted purportedly
lack of authorizations for plastic recy- product.4 to improve the protection of human
cling processes.3 The vice president and The EC is hoping to issue about 140 health and the environment from the
chairman of PRE’s polyethylene tere- authorization decisions on recycling risks that can be posed by chemicals,
phthalate (PET) working group, Casper processes in early 2019. while enhancing the competitiveness
van den Dunger, said EU businesses of the EU chemicals industry) should
were still in a “legislative no-man’s land” Recyclate Quality Is a Hindrance be made available to the whole value
due to the years of delay, adding, “This The poor quality of recyclates (i.e., chain, including the waste stage, so that
uncertainty leads to decline in invest- material intended to be recycled) is this factor can be taken into account
ments and more importantly to a pos- a major roadblock to increasing the with respect to recyclates.
sible mistrust in the legislation ruling amount of plastic food containers that In the Interface Document, the EC
food-contact materials.” is recycled. In May 2017, the European points out that limited information
In the Plastics Strategy, the EC stated Plastics Converters Association (EuPC) about substances of concern in waste
that it is committed to quickly finalizing launched a survey on the use of recycled leads to difficulties to complying with
the authorization procedures for over plastic materials in Europe’s plastics- REACH. As an example, the com-
100 safe recycling processes. The com- converting industry. The survey, which mission explained that with respect to
mission further stated that it will coop- included 485 participants from 28 coun- recycled plastics for food contact, “only

PACKAGING
recovered PET is currently suitable to use with food or other sensitive applica- to take measures to raise awareness of
be used in food contact materials pro- tions, then it makes little difference as the impact of littering and inappropriate
vided that adequate decontamination to the composition of the recyclates and disposal of waste on the environment.
processes are used, while other recov- what contaminants may be present as Just recently, the European Parliament
ered plastics cannot be used because of the recycled material is probably headed (EP) approved a report on the draft
a lack of information on the possible for a park bench, decking material, and directive8 that was prepared by its Com-
presence of contaminates.” the like. mittee on the Environment, Public
The EC plans to launch a feasibility Additional actions that the EC plans Health and Food Safety. The next step is
study on the use of different informa- on taking to improve the economics of for the EC to vote on the amendments
tion systems and other plastics recycling are approved by the EP; then EP can start
strategies that could “With respect to to work with the Eu- negotiations with Member States.
enable relevant infor- ropean Committee for In a response to the draft proposal
mation to flow along Standardization (CEN) on single-use plastics, the European
the article supply recycled plastics and industry to de- Organization for Packaging and the
chain to recyclers; it is velop quality standards Environment offered recommendations
expected to be ready for food packaging, for sorted plastic waste to ensure that the EC’s proposal meets
by the end of 2019. and recycled plastics, its intended objective.9 Concerning
With respect to and possibly imple- the substitution of single-use plastics
recycled plastics for the Plastics Strategy ment economic incen- with alternative materials, the group
food packaging, the tives to reward the use cautioned that “a net environmental
Plastics Strategy rec- recommends of recycled content in improvement must be considered on a
ommends eliminating the packaging sector. case-by-case basis, taking into account
chemicals of concern the full life-cycle of the individual
and, where this is not eliminating chemicals Curbing Plastic product and supply chain, including all
possible, reducing Waste relevant end-of-life aspects.”
their presence in addi- of concern and… The EC proposed a
tion to improving the directive on single-use Innovation and Investment
ability to track such plastics in May 2018, Noting that more than 80 percent of
substances in both reducing their which is intended to the environmental impact of a product
products and waste. reduce plastic waste. is determined at the design stage, the
The EC suggests that presence…” The draft “Directive EC said circularity will require mak-
decontamination tech- on the reduction of ing better and sustainable decisions at
nology, or analytical the impact of certain this stage. In particular, the EC would
and quality control approaches may be plastic products on the environment”7 like to see innovative solutions for
the only feasible way to guarantee that includes a ban on certain single-use advanced sorting, chemical recycling,
the supply of recycled materials is safe plastics, along with collection goals for and improved polymer design. Product
for specific end uses and will finance plastic packaging, extended producer designers will need to work with recy-
research and innovation projects on bet- responsibility schemes, and design cling engineers to develop materials that
ter identification of contaminants and requirements for beverage containers. maintain their original material proper-
on decontamination of plastic waste. More specifically, the proposal would ties throughout recycling and are safe
The EC officials in charge of this require member states (MS) to take and sustainable throughout their life
endeavor would be wise to look to their measures to significantly reduce the cycle and allow unwanted substances to
U.S. counterparts for assistance. For consumption of plastic beverage cups be extracted.
plastics other than PET, those intended and food containers. They would also The EC specifically mentioned the
for use in packaging must originate as be required to ban certain single-use need for innovation in developing
food packaging materials to meet neces- plastic products, including cutlery, materials that fully biodegrade in sea-
sary compositional requirements. Chal- plates, straws not intended for medical water and freshwater, and are harmless
lenge testing is then often used to judge purposes, and beverage stirrers. for the environment and ecosystems.
whether the process used to clean the Furthermore, the draft directive The Plastics Strategy pointed out that
recyclates is sufficient to remove poten- would establish a deadline of 2025 for alternative types of feedstock—such as
tial contaminants that may incidentally MS to achieve an annual 90 percent bio-based plastics (made from starch or
be present due to subsequent use of the separate collection rate by weight for fiber) or plastics produced from carbon
containers with products other than single-use plastic beverage bottles in a dioxide or methane—that offer the same
food. If the recycle is not intended for given year. MS would also be required functionalities as traditional plastics, but

PACKAGING
with potentially lower environmental is made from polymers and additives Global Action
impacts, are being developed. that hasten degradation of the polymers The EU Plastics Strategy mentioned
Currently, plastics made from these upon exposure to different conditions, China’s decision to ban the import of
types of feedstock constitute only a very such as UV light and/or heat, and certain types of plastic waste as of Janu-
small share of the market. This is due, oxygen. An applicable standard for oxo- ary 2018. In announcing the ban, China
in part, to the high cost of bio-based biodegradable plastic is ASTM D6954, cited the poor quality of much of the
feedstocks. The commission warned that which provides a framework to compare plastic waste that it received from other
it is important to ensure that these feed- and rank “the controlled laboratory countries, in addition to stating that it
stocks result in genuine environmental rates of degradation and degree of phys- wanted to focus on its own waste. Prior
benefits compared with nonrenewable ical property losses of polymers by ther- to the ban, more than 85 percent of the
alternatives and said that it plans to pro- mal and photooxida- EU’s exported plastic
pose harmonized rules for defining and
labeling compostable and biodegradable
tion processes as well
as the biodegradation
“Meeting the goals waste was shipped to
China. Much of EU’s
plastics, and will develop life-cycle as- and ecological impacts post-consumer plastic
sessments for these materials. CEN de- in defined applications aimed at making plastic packaging waste is now
veloped a standard, EN 13432, in 2000 and disposal environ- being shipped to other
that specifies requirements for packag-
ing recoverable through composting
ments after degrada-
tion.”
packaging part of a Asian countries.
The EC cautioned
and biodegradation. The EC has ex- that while plastics
In the U.S., the Federal Trade Com- pressed concern that circular economy will value chains are de-
mission issued updated Guides for the some supposedly veloped across entire
Use of Environmental Marketing Claims
(Green Guides) in 2012. The guides
biodegradable materi-
als do not have any
not be easy.” continents and plastic
waste is traded inter-
stated that a material can be called proven environmental nationally, uncertainty
“compostable” only if it breaks down advantage over conventional plastics. remains over its treatment in some
in a “timely manner.” The guides also In a January 2018 “Report on oxo- countries. “Adequate plastic waste
indicate that it is deceptive to make degradable plastic,”10 the EC concluded prevention, collection, and recycling
an unqualified degradability claim for that “there is no conclusive evidence on systems are needed in many parts of
items destined for landfills, incinera- a number of important issues relating to the world,” the EC wrote in the Plastics
tors, or recycling facilities. Furthermore, beneficial effects of oxo-degradable plas- Strategy.
unqualified degradable claims should be tic on the environment.” Consequently, The EC agreed to promote the de-
based on reliable scientific evidence that the commission plans to restrict the use velopment of international standards to
the item will completely break down of oxo-plastics in the EU. boost industry confidence in the quality
within 1 year of entering the solid-waste Shortly after the EC published its of recyclable and recycled plastics. “It
stream. The Green Guides do not ad- report on oxo-degradable plastics, the will also be important to ensure that
dress bio-based claims. Oxo-Biodegradable Plastics Association any plastics sent abroad for recycling
State laws can also impact what (OPA) published a response challenging are handled and processed under condi-
environmental claims are allowed on its findings.11 OPA stated that there is a tions similar to those applicable in the
packaging. For example, California re- “fundamental difference” between older EU under rules on waste shipment,” the
quires that any plastic products labeled “oxo-degradable” and “oxo-biodegrad- commission added.
as “compostable,” “home compostable,” able” plastics (OBP), adding that these A step toward global standardization
or “marine degradable” must comply plastics “have been designed to convert was recently undertaken by the Associa-
with one of several specified standards. at the end of their useful life into bio- tion of Plastics Recyclers and Plastics
One of these standards is D6400, which degradable materials and to biodegrade Recycling Europe when they jointly
was developed by the American Soci- under any conditions in the open envi- developed a global definition for the
ety for Testing and Materials (ASTM). ronment with a very much shorter tim- term “recyclable” as it relates to plastic
D6400 applies to plastics and products escale.” The organization also criticized packaging and products.12
made from plastics that are designed to the regulatory authorities in Europe for The proposed definition establishes
be composted under aerobic conditions not having developed an EU standard four conditions that a plastic product
in municipal and industrial aerobic for oxo-biodegradable plastics. Not all must meet to be considered recyclable.
composting facilities, where thermo- jurisdictions have the same concerns These are the following:
philic conditions are achieved. about OBP. Some governments in the 1. It must be made with a plastic that
Another type of biodegradable plas- Middle East, Africa, and Asia have is collected for recycling, has market
tic is oxo-biodegradable plastic, which made OBP mandatory, points out OPA. value, and/or (continued on page 56)

SANITATION
By Duane Grassmann
Validation, Verification, and • Establishing monitoring routines

• Creating and conducting cleaning
validation
Monitoring of Cleaning in • Some best practices for conducting

cleaning verification
Food Processing Factories

Definitions
Differences exist in the definitions of
cleaning verification, monitoring, and vali-
dation. For the purposes of this article,
I will define these as “past, present, and
future,” respectively.
Let’s start with verification. I consider
this as the process by which an evalua-
The difference good SSOPs tion is made of whether an SSOP has
been working as designed (in the past).
make in reducing risk This could include review and trend-
ing of cleaning success criteria results
and preoperational check failures (aka
“recleans”), environmental monitoring
M
results, and consumer complaints at-
tributed to ineffective cleaning. I think
y intention for this article is to give an of cleaning verification as, “Has the
overview of cleaning validation, verifica- performance of the SSOP delivered the
tion, and monitoring. These activities desired results in the past?”
are contingent upon Sanitation Standard Continuing with the definitions,
Operating Procedures (SSOPs) having I consider monitoring as the real-time
adequate detail to achieve their specific objectives. Un- observations and measurements of the
fortunately, many SSOPs do not cover all the important execution of an SSOP (in the present).
equipment, are “copy and paste” between different This could include readouts from de-
equipment, are buried in binders or databases, and are vices, visual inspections, and observa-
dusted off only during audits so a box can be checked. tions of the execution of procedures.
Does any of that sound familiar to you? Cleaning If a failure in procedure execution will
validation cannot be meaningful without a stable clean- be corrected before production opera-
ing process. In other words, it is critical that cleaning tions, I would consider the process that
designed to mitigate a food safety risk has SSOPs that, detected the failure as monitoring.
when followed, generate predictable and repeatable suc- Thus, rapid-testing methodologies, like
cess. Without this stable cleaning process, the execution, adenosine triphosphate (ATP) tests, gen-
monitoring, and verification of cleaning will have a lot eral protein or allergen tests, etc., would
of variability. Can your factory really afford that? also be considered monitoring. I think
To reduce confusion in this article, I offer my defini- of cleaning monitoring as, “Is the SSOP
tions of cleaning validation, verification, and monitoring as being followed and is it delivering the
they apply in food manufacturing factories. Addition- desired results in the present?”
ally, the article will touch on: Finally, the definition of validation is
• Which equipment needs to have validated cleaning the determination of whether an SSOP,
• The impact of sanitary design of equipment and when followed, is capable of delivering
surrounding areas on validation the established and mutually agreed
• Setting success criteria for cleaning validation upon success criteria (in the future).
• Creating SSOPs The focus of validation must be on the

SANITATION
repeatability of the SSOP and the pre- processes? Probably not. The point is, as a guide to select and prioritize their
dictability of the cleaning outcome. It just because a cleaning process has an equipment for cleaning validations. The
should not be a validation of the perfor- SSOP does not automatically mean the factory would be wise to also consider
mance of an individual. I think of clean- SSOP needs validation. the following:
ing validation as, “Is the SSOP, when The factory food safety team needs • Industry best practices
followed, able to deliver the desired to be aligned with the cleaning valida- • Possible regulatory requirements
results in the future?” tion process. They should use the facto- • Quality system requirements
ry’s Hazard Analysis and Critical Con- • Corporate policy
What Equipment Must Have trol Points (HACCP) risk assessment • Other quality attributes
Validated Cleaning and Which
Should Be Addressed First?
Which of the many pieces of equip-
ment in a food manufacturing factory
need to have a validated cleaning pro-
cess, and what criteria should be used
for prioritization? The answer is, “It
SOLUS SCIENTIFIC
depends.”
If the cleaning mitigates a food
safety risk, this cleaning process must be
validated. For example, in a ready-to-eat If you’re 100% happy with
factory with a validated lethality step,
the post-lethality food-contact equip- your Pathogen system,
ment must have a validated cleaning
process. Cleaning processes that have ignore this message
not been validated could allow vari-
ability and possible contamination of
the product. This equipment, due to the
risk, needs to be addressed first.
What if we were to look at the pre-
lethality food-contact equipment in
the same scenario as above? Does this
equipment need validated cleaning
processes? Again, the answer is, “It de-
pends.” Here are some considerations:
• Is this cleaning mitigating an identi-
fied food safety risk?
• Could contamination of the product PERFORMANCE TESTED
create a microbial load that a vali- AOAC

RESEARCH INSTITUTE
SOL 37/04-12/18
LICENSE NUMBER 101801
dated lethality step could not reduce ALTERNATIVE ANALYTICAL
METHOD FOR AGRIBUSINESS
to an acceptable level? http://nf-validation.afnor.org/en
• Would foreign material or product

accumulations create a food safety
Solus One Salmonella
risk?
• Will the factory be able to justify the
...More than fast!
decision of whether or not this clean-
ing process needs validation?
Solus One Salmonella assay
In most cases, the selection and pri-
oritization of equipment for cleaning
• Next day results
validation is a factory-level decision. • Maximise throughput
These decisions should be made in a
defensible manner as well as approached
• Reduced technician time
consistently and pragmatically. Should
palletizers, case erectors, forklifts, and
the break room have validated cleaning
www.solusscientific.com/solus-one

SANITATION
Sanitary Design and Cleaning from recurring. are often the true experts. Each of the
Validation Food safety risk mitigation is the stakeholders brings to the discussion
The ability to clean new or exist- most widely understood reason for insights that drive meaningful, value-
ing equipment depends heavily on cleaning. This is because it is this clean- added, and pragmatic criteria. Without
whether the equipment is capable of ing that protects your consumers, prod- stakeholder agreement, variability of
being adequately cleaned. Conducting a ucts, and brands. In most instances, this results will surely follow. These success
sanitary design evaluation is highly rec- cleaning focuses on microbiological criteria may include any of the follow-
ommended. Numerous sanitary design reduction and/or allergen management. ing:
evaluation checklists The factory’s HACCP • Visual cleanliness (pictures help for
and criteria exist. program will identify comparison of the standard to actual
These evaluations
“In most cases, the product risks and observations)
should be conducted the mitigations that • ATP readings
on the equipment to the selection and control them. Clean- • General protein tests results
be validated as well ing will probably be • Specific allergen protein tests results
as on the area where one of several preven- • Counts of microbiological organisms
the equipment resides.
prioritization of tive control strategies. • Compliance with label claims like
This is because great Numerous other non-GMO, gluten-free, kosher, halal,
equipment in a poorly equipment for cleaning reasons to clean most etc.
designed room, or vice likely exist. The fol- This article is not intended to ex-
versa, most likely will lowing is a list of other plore these individual success criteria.
not provide long-term
validations is a factory- reasons to clean for More information is available for each
success. Gaps affecting consideration in a fac- of these through a number of sources,
cleanability identi- level decision.” tory’s sanitation pro- including the suppliers of the testing
fied in sanitary design gram: supplies, industry and trade associa-
evaluations should be • Product accumulations, regulatory agencies, and aca-
addressed in the SSOPs until they can tions affect line efficiencies as clean demia.
be corrected through engineering solu- equipment typically runs better and
tions. with fewer unplanned line stoppages Creating SSOPs
• Product accumulations left on equip- At this point, the factory has deter-
Setting Cleaning Success Criteria ment for extended times can be rein- mined what equipment needs to have
To set criteria for cleaning outcomes, troduced into the product stream validated cleaning, why the factory is
one must first answer the question • Product accumulations create growth cleaning, and how clean the equipment
“Why are you cleaning?” Oftentimes, media for specific spoilage organisms needs to be. Now the SSOP can be de-
the answer is not fully understood. The (affecting shelf life) signed to predictably deliver the success
second question to ask is, “How clean • Environmental pathogen growth and criteria.
do you need to get it?” The answer to movement The stakeholders should again col-
this second question can spark interest- • Integrated pest management laborate in the design of the SSOPs
ing and engaging discussions depending • Employee morale is negatively af- that, when followed, will deliver these
on the audience. fected by unclean conditions predictable and repeatable success cri-
Two critical reasons exist for clean- The factory stakeholders must dis- teria. The factory is limited only by its
ing in a food manufacturing factory. All cuss and agree on all the cleaning objec- imagination on how to deliver this level
people in quality roles would agree that tives. The stakeholders should include of detail. Any combination of text, pic-
one reason is to mitigate food safety operations, sanitation, quality assurance, tures, and videos can describe the clean-
risks. Yes, you read that correctly; one maintenance, engineering, equipment ing process and the desired outcome. A
of two critical reasons. The other critical manufacturers, and cleaning chemical suitable SSOP will include the follow-
reason, in my deeply held opinion, is suppliers. ing:
to mitigate employee safety risks in the Once stakeholders jointly agree upon • Safety-related topics and concerns
factory. While the intent of this article is why they are cleaning, they can begin • Cleaning supplies and equipment
not to discuss employee safety in food setting the criteria for successful clean- needed
manufacturing environments, suffice ing. The criteria for cleaning success • Tools and equipment management,
it to say unsafe conditions caused by answer the question, “How clean does reconciliation, and sanitary condition
improper cleaning must be immediately the equipment need to be?” Important • Cleaning chemicals and their con-
corrected and preventive measures input comes from the associates who centrations, temperature, and contact
implemented to keep those conditions will ultimately perform the tasks, as they time

SANITATION
• Step-by-step sequences of activities general and specific protein tests. Many recommend three consecutive success-
with thorough detail of these monitoring measures, when ful trials and have never had this chal-
• Detailed descriptions of hard-to- properly recorded, become excellent lenged.
reach and hard-to-clean areas documentation of cleaning. Under what circumstances should
• Areas of the equipment needing spe- revalidation occur? Well, that depends.
cial attention Creating and Conducting Cleaning Generally speaking, when something
• Detailed descriptions of cleaning Validation significant changes, or when the valida-
success With highly detailed SSOPs, con- tion fails, revalidation becomes neces-
• What to do if the procedure cannot ducting the validation is relatively sim- sary. Significant changes may include:
be followed as written ple: just watch the associate and com- • Formula changes (harder to clean,
Detailed SSOPs be- pare what they do with introduction of a new allergen, a new
come the foundation what is written in the label claim, etc.)
for training associates
“To set criteria for SSOP. If there is any • Scheduling of longer production
performing the clean- discrepancy, stop and runs
ing activity. This will cleaning outcomes, correct the behavior or • Shortening of time for cleaning
be important in dem- go through the estab- • Equipment modifications or addi-
onstrating the qualifi- lished factory process tions
cation of the individu-
one must first answer of changing the SSOP. • Monitoring trends demonstrating
als performing these Only when the pro- failures
tasks during quality the question ‘Why are cedure is followed as • Changing cleaning chemicals
system certifications, written should the re- • Changes to the SSOP
internal audits, and sults be compared with • More-difficult-to-achieve success cri-
regulatory inspections.
you cleaning?’” the success criteria. teria
The documenta- The objective should The food safety team and manage-
tion of cleaning activities must also be be to try to make the validation fail. ment of change process should govern
considered during the creation of the Yes, that’s what I said. Try to make the the decision and consider cost/benefit
SSOP. Understanding what needs to be process fail. This will give defensible of changes versus revalidation.
documented for the factory quality sys- assurance of predictable and repeatable Besides predictable and repeatable re-
tem and applicable regulatory require- success. Consider evaluating against the sults, having detailed SSOPs allows for
ments is important. worst-case scenarios, including: controlled process improvements when
• The hardest-to-clean product these go through the factory’s manage-
Establishing Monitoring Routines • The hardest-to-reach areas ment of change process. Cost savings
Monitoring the results of cleaning • The longest-possible production and sustainability improvements, such
becomes more predictable when the schedule as reducing cleaning time, chemical and
SSOP has adequate detail, especially • The shortest allotted time for clean- water usage, water temperature, etc., can
in describing success. Results become ing happen only when the current process
more objective and troubleshooting fail- • The least experienced associate is under control by the SSOP. Such
ures becomes easier. The associate’s su- • Cleaning on different shifts changes to the SSOP must be evaluated
pervisor and the quality assurance group Grouping of “like” equipment for to determine whether cleaning out-
will become monitors of the procedure validations is perfectly acceptable, very comes will be negatively affected.
rather than the evaluators of the associ- efficient, and should be encouraged.
ate’s performance. Monitoring failures Ultimately, the decision of what consti- Verifying Your Validated
becomes a question of “Why didn’t the tutes “like” is up to the factory and must Procedures
procedure deliver the desired results?” be defensible. The food safety team Factory quality systems generally re-
Results of the procedure should be should be involved in this decision. quire verification of preventive controls
monitored in real time with meaningful For example, if the factory has multiple at least annually. Because cleaning that
criteria and pass/fail parameters. Clean- packaging lines with identical wrappers mitigates food safety risks is considered
in-place should have constant monitor- that run on the same schedule, package a preventive control, these validated
ing of parameters such as temperature, the same product, and have the same cleaning processes need verification.
time, flow/pressure, conductivity/pH, SSOP, then validating one of these lines Therefore, a formal annual verification
etc. The associate performing manual will be indicative of all of them. of validated cleaning processes should
cleaning should be looking for visual How many trials should be conduct- be conducted and documented to en-
cleanliness. Other objective tests can be ed when validating SSOPs? One trial sure the preventive control is still work-
employed in real time such as ATP, and would be a poor sample size. I highly ing as designed. (continued on page 59)

FOOD SAFETY INSIDER
Post-Sanitation Microbiology
for some time, a few recent changes
have breathed new life into this concept.
One new design is the MegaSampler™
Sampling with a 4.5-sq. in. sponge on a stiff plastic

rod. This is housed in a sterile bag that
can easily be opened and closed. The
sponge contains Dey Engley (DE) neu-
tralizing buffer to stabilize the microbial
sample while simultaneously counteract-
ing many common cleaning agents and
sanitizers. The flat sponge is secured
T
to the sampling handle using a unique
he lowly swab has long been a mainstay in the food safety pro- design that enhances sampling efficacy
gram in most, if not all, food and beverage plants. The swab, as by having twice the sampling surface.
we know it today, began its journey as a small piece of cotton Also, the sponge itself extends over the
wrapped into a bud at one end of a wood dowel. Clinicians around plastic handle, enabling the sponge to
the world used the swab to transfer small samples of tissue from move into difficult to reach areas. The
the human mouth, nose, MegaSampler stick has a scraping blade
wounds, surgical sites, etc. adjacent to the sponge, intended for
on the way to the microbiolo- lifting biofilms. Since biofilms are no-
gy lab. Over time, food microbiolo- toriously difficult to sample, physically
gists and a handful of suppliers adopted scraping a surface may help access a
the clinical swab and made good use of microbial population that a swab cannot.
it in microbiological sampling on sur- When a MegaSampler is returned to its
faces in the food plant. bag, any debris on the scraper can be
The swab is very good for reach- brought down to the bottom of the bag,
ing hard-to-sample crevices and and the sponge is easily removed from
piping in the production line. These the handle. At that point, a volume of DE
crevices can be difficult to clean neutralizing buffer can be extracted from
and sanitize, frequently making the sponge and subsampled directly to
them critical sampling sites. The a plate or to another broth. The Mega-
Sampler also does an excellent job of
sampling both large and small surfaces,
either flat or curved, with minimal effort.
Minimal effort means that the device will
be used and used consistently. There
might also be a small fun factor, which
can only help the overall program.
www.weberscientific.com
swab itself evolved into Multiple publications have shown im-

a flexible plastic rod proved recovery of Listeria spp., Salmo-
with a synthetic bud nella spp., and additional bacteria, using
manufactured with sponges as compared to swabs. This is
improved reproduc- not unexpected, simply based on the
ibility. The swab’s increased surface area of the sponge and
relatively small size the sponge’s ability to absorb material
enables techni- from a surface wetted by the neutralizing
cians to carry a buffer. This alone is incredibly significant
dozen or more in choosing the MegaSampler over a
in a pocket. swab.
However, the swab According to Weber Scientific sales
continues to have some limita- manager, Asif Rahman, the MegaSampler
tions. The sample size is small and sam- will enhance a plant’s food safety pro-
pling reproducibility is low (personal observation, gram. It will do a much better job than
J. Zindulis, Ph.D., production manager, Weber Scientific). The swab the swab in many, if not most, sampling
was not originally designed for quantitative use. As a result, people sites. Perhaps it is time to begin using a
have attempted to rectify this with a number of specified surface device expressly developed and tuned for
area measurements and techniques. However, few technicians ap- the food and beverage industries as con-
pear to enjoy the additional time spent to follow these procedures. trasted with a swab limited by its original
This further contributes to low reproducibility. design for clinical samples.
A viable alternative to the draconian use of the swab is the MegaSampler is manufactured and
sponge-on-a-stick. Although sponge samplers have been available distributed by Weber Scientific.

FS 2019 FullPage Ad MegaSampler.qxp_Layout 1 1/17/19 11:03 AM Page 1
Introducing the
NEW Weber Scientific
MegaSampler™
Sampling Device
Make Environmental Surface

Sampling Faster and Easier
A pre-moistened sponge, with 10 ml of DE
Neutralizing Broth, individually wrapped in a Return the sampler to the Grab the sponge and pull
reusable sample bag, is secured to the sampling bag after sampling. the handle oﬀ the sponge.
handle using a unique design that enhances
sampling eﬃcacy.
• Twice the sampling surface
• Sampling tip for hard to reach places
• Sponge is held in place
without glue or chemicals
• Sponge is easy to separate
from handle
Scraping blade
• Biofilm scraping blade Remove the handle from Release the sponge into
incorporated into the handle design the bag. the bag.
D WINN
AR
AW
IN
G
Legendary for quality and great prices since 1959

LAB
IER
800-328-8378 • weberscientific.com RA
PL
TO RY SUP
O

By William K. Hallman, Ph.D., and Cara L. Cuite, Ph.D.
F
ood recalls are an important tool that can be used to protect the
public from exposures to potentially unsafe products. Yet, carrying
out an effective recall presents obvious challenges. There are the lo-
gistical difficulties involved with the accurate identification, efficient
retrieval, and appropriate disposal of potentially contaminated food prod-
ucts. There are also substantial legal, regulatory, financial, and reputational
issues with which to contend.
However, once products have been sold to the public, the most signifi-
cant challenge involves getting individual consumers to look for, correctly
recognize, and discard or return food products that might make them ill.
Convincing individuals to act appropriately in response to a food recall of-

ten requires food companies, retailers, government agencies, and
consumer groups to interact with consumers in unique and conse-
quential ways that are atypical in their normal course of business.
Getting recalled foods out of the hands of consumers requires a
different set of strategies than those that put them there in the
first place. A recall is not food marketing in reverse.
Persuading consumers to act in response to a food recall is
not easy. Ten years ago, we conducted a nationally representa-
tive survey of American consumers to assess their awareness
and knowledge of food recalls and to understand their attitudes
and responses to them. We found that more than 90 percent of
Americans viewed recalls as essential to protecting public health
and saving lives. More than 80 percent said they paid attention to
news reports about recalls, and a similar percentage reported that
they told others about food recalls when they heard about one.
Yet, while most people believe that food recalls are important,
only about 6 in 10 reported that they had ever looked for a re-
called food in their homes, and only 1 in 10 said that they had
ever found one.
Much has changed in the intervening decade, including
more rapid and widespread dissemination of information
about recalled foods through the internet and social me-
dia. Detailed information about recalls, market withdraw-
als, consumer advisories, and health and safety alerts is
now widely available through foodsafety.gov and recalls.
gov, and through the individual U.S. Food and Drug Ad-
ministration (FDA) and U.S. Department of Agriculture
(USDA) websites devoted to these issues. The public
can also learn about these notices by following these
agencies on social media and having these notices
automatically emailed to them. Food companies and
some retailers are also using their own web pages to
share detailed information about recalled products and
what consumers should do if they find them.
According to the Pew Research Center, nearly 7 in
10 American adults now uses social media to view
and share news content, opinions, and other in-
formation. Both FDA and USDA share recall
information via social media, as do many
companies. Food marketers are well aware
of the utility of social media, with most

RETHINKING FOOD RECALLS
major companies actively using it to court customers, to encourage them to follow time, these warnings must be specific
and share information about the company’s brands, and to influence consumer pur- enough that consumers can recognize
chase intentions. They are also cognizant of the rapidity with which social media can when they are personally affected by
significantly damage the reputation of a product, brand, or company when some- the recall. They must contain enough
thing goes wrong, or is simply rumored to have gone wrong. details to enable consumers to identify
Yet, despite the enhanced ability to access information about recalled food prod- which products have been recalled, al-
ucts over the last 10 years, consumer responses to food recalls have not kept pace. In lowing consumers to differentiate these
our August 2018 survey of American consumers, we found that about 7 in 10 now from similar products that are unaf-
say they have looked for a recalled food product at some point (up from 6 in 10), fected. They must also include specific
while about 2 in 10 report that they believe that they have found a recalled product instructions to consumers about how to
in their homes (up from 1 in 10). While this represents progress, it is clear that the properly dispose of or return products
food industry, government, and consumer groups need to do more to help people that are affected.
respond appropriately to food recalls. So, what can we do? Recall warnings must be sufficiently
Ideally, we would eliminate the necessity to recall food products altogether. Food strong to demand consumer attention,
recalls are expensive, disruptive, and are meant to be a public health measure of last motivating people to look for potential-
resort, not a first line of defense. However, ly affected products and to take appro-
eliminating food recalls in the near term is priate actions if they find them. They
unlikely. In fact, advances in technology, “Persuading should prompt people to share accurate
including whole-genome sequencing, have information about the recall with oth-
enabled more rapid and precise charac- ers, spreading and drawing attention to
terizations of the pathogens involved in consumers to act the news, and should therefore be social
foodborne illness outbreaks, which makes media-ready to facilitate this.
it more likely that outbreaks will be identi- At the same time, these alerts must
fied and affected foods recalled. in response to a not unnecessarily frighten people or
Food companies are also paying greater cause them to avoid products that are
attention to food safety, instituting tighter not part of the recall. In fact, commu-
controls over the sourcing of their ingredi- food recall is not nicating about a food recall requires
ents and manufacturing processes. Many persuading consumers that only the spe-
have comprehensive internal testing and cific packages of the product they were
quality control systems designed to detect easy.” originally induced to purchase may be
allergens, pathogens, and physical con- unsafe for them to eat. Then, after the
taminants. Many have also become more underlying cause for the recall has been
aggressive in ordering voluntary recalls and product withdrawals as precautionary corrected, those same consumers need
measures intended to prevent their customers from coming into contact with poten- to be convinced that the product is safe
tially adulterated products. They have realized that while a recall may be damaging after it returns to the market.
to a brand or a commodity in the short term, it is far worse to be associated with a
foodborne problem that sickens, hospitalizes, or results in customer deaths. Understanding Consumer
Given that food recalls will remain a critical means to protect consumer health Responses to Recalls
well into the future, we need to improve their efficacy. We can do so by being more Unfortunately, as our research has
strategic in designing recall messages, beginning with an understanding that these are shown, even when they achieve the
significantly different from other messages that we send to consumers about food. right balance of urgency, specificity, de-
We can also be more effective through a more comprehensive understanding of how tail, and instruction, simply issuing food
consumers react to food recalls and by taking advantage of advances in technology. recall warnings is not enough to protect
public health. Providing information
Food Recall Communications Are Different to people is usually necessary, but not
Effective food recalls involve successfully alerting the public about the potential sufficient, to motivate them to respond
hazards associated with specific food products, ensuring that people are able to rec- appropriately to a recall.
ognize which products are involved and which are not, and motivating them to look After more than a dozen years of
for, find, and appropriately discard or return the affected products rather than con- studying public responses to recalls and
suming them. The stakes are high, as failure at any point in this process can result in advisories, we have found that many
people getting sick, or dying. consumers do hear about them and that
Therefore, these messages must be designed to be broad enough to reach every- they do pay attention. Some follow the
one who may be affected, including those who already have the food in their homes advice given and look for, find, and
and those who might purchase a recalled food still in the marketplace. At the same discard or return products that have

been listed as being recalled. Many also that have been recalled. This often includes discarding all packages of the products
share this information with others via named in the recall, regardless of whether they match the date or lot codes sub-
social media, drawing additional public ject to recall. Some avoid or discard products that are not part of a recall but were
attention to the recall. Some also visit manufactured by the same company. Others avoid similar products made by other
the websites of the companies involved companies that were not recalled. Some report avoiding products or commodities
in the recall, seeking additional infor- that have been the subject of a recall for months or even years after an outbreak of
mation, which they may also share. foodborne illness has ended.
Yet, some consumers remain Doing a better job at motivating consumers to act appropriately requires increas-
unaware of recalls that affect them ing consumer awareness of recalls, increasing their relevance to individual consum-
because they never see the warning
information, while others are aware of
Wireless Monitoring!
the recall but ignore it because they
don’t recognize the products being
recalled or believe that they own them.
Some hear about the recall, and intend
to look for the affected products, but
never do so, or they look for the prod- HACCP Control Point
ucts but cannot identify them. Monitoring Via
When they involve a single product,
or a small but complete list of products ● LAN
that quickly becomes available and
does not change, recalls can be rela- ● Wi-Fi
tively straightforward. In contrast, ex- ● Cellular
panding recalls, especially those which
ultimately impact dozens or hundreds
of products, are significantly more
complicated. In these cases, some con-
sumers learn of the initial recall notice
and look for affected products but are
unaware of the subsequent notices or
● Monitor Multiple Locations
ignore them, believing that they have ● Walk-In Freezers and
already taken action.
Our research has also shown that
Refrigerators
some consumers respond to recalls in ● Automatic Record Keeping
ways that are particularly imprudent.
Some who are fully aware of a recall
for HACCP Control Points
simply decide to disregard it, consum- ● E-Mail & Text Warnings
ing the recalled product despite being
warned not to do so. Why? Some do it
Without a PC
because they believe that the warning ● Reduce Waste & Spoilage
is “overblown.” Some are certain that
they can make a potentially contami-
nated product safe to eat by cooking
or washing it, while others believe they
are immune to foodborne illnesses.
Data Loggers
Finally, after discovering that they have
already partially consumed a recalled
from TANDD
product, some people decide that since
they didn’t get sick, it is safe to eat
whatever remains.
At the other extreme, some con-
sumers are hypercautious. Some adopt
a “better safe than sorry” strategy, dis- TandD US, LLC.
carding any product resembling those inquiries@tandd.com (518) 669-9227 www.tandd.com

ers, their ability to identify affected products, and their motivation to properly dis- the U.S.) does not, nor do many com-
pose of them, each of which is discussed in turn below. panies whose products are recalled.
While Spanish is the second-most-
Increasing Awareness often spoken language in the U.S.,
Increasing the effectiveness of recalls begins with improving consumer awareness. there are millions of Americans who
People cannot take action if they don’t know that they need to do so. Unfortunately, speak languages other than English
recall announcements must compete with the other information encountered by and Spanish, and who (based on self-
consumers every day. reported Census data) speak English
Our data suggest that consumers are most likely to be aware of recalls that are “not at all” or “not well.” Moreover,
covered by the traditional news media. Even if people learn about a recall through there are many Americans who cannot
social media, the origin of the news is most often a story that was covered in the read English or Spanish, making writ-
mainstream news. Unfortunately, national ten notices inaccessible to them.
news outlets typically only provide exten-
sive coverage of “newsworthy” recalls. A “Given that food Increasing Relevance
review of recent headlines suggests that Getting consumers to act appropri-
these typically involve a foodborne illness ately in response to a food recall only
outbreak resulting in a significant number recalls will remain begins with making them aware that
of illnesses or deaths, the recall of a large a problem exists with a product. For
quantity of food or of multiple products, consumers to pay attention and to act,
or of especially popular or well-known a critical means to they must also believe that the prod-
products. Other kinds of food recalls ucts affected are relevant to them. Yet,
rarely receive the same kind of coverage, in many ways, the greater availability
making it much less likely that consumers protect consumer of food recall information through
will become aware of them. As a result, traditional media, on the internet,
companies have to work much harder to and through social media has actually
publicize these smaller, less prominent health well into the made it more difficult for consumers
recalls, which often involve products sold to focus on the products that are perti-
within local or regional markets. nent to them.
Other challenges exist as well. In addi- future, we need The primary goal of food recall
tion to notifying retailers of a recall and communications is to broadcast warn-
working with them to remove affected ing information as rapidly and as wide-
products from their shelves and warehous- to improve their ly as possible to protect public health.
es, food manufacturers and distributors However, the reality is that the major-
often work with “brick and mortar” stores ity of recalls simply aren’t applicable to
to post recall notices at the point of sale. efficacy.” most people. Many involve food prod-
This has often involved posting written ucts that are produced in small quanti-
notices near the shelves that have been ties or sold in limited areas. Others
emptied of the affected product and printing recall messages onto customer receipts involve more widely distributed prod-
or on coupon slips. In fact, some participants in our studies have indicated that they ucts but apply only to those packages
don’t pay attention to news about recalls because they implicitly trust their grocery bearing specific lot numbers or “best
store not to sell recalled food products. by” dates. Others are for products
However, consumers increasingly purchase food products online and have them with limited shelf lives that are likely
shipped directly to their homes, bypassing local retailers. These sales often involve to have already been consumed or
small online vendors or third-party resellers operating through larger e-commerce discarded by the time a recall notice is
sites. Food manufacturers and distributors often have little or no relationship with issued. In addition, more than half of
these retailers, and as a result, they don’t receive direct notices of a recall. Many of the recalls of FDA-regulated products
these small online retailers also lack the personnel, training, and inventory systems in 2018 involved undeclared allergens,
necessary to appropriately identify and withdraw recalled products from sale on- which are potentially life threatening
line. As a result, consumers have reported instances of recalled food products being to those who are allergic to them. This
shipped to them by online retailers. is critical information that needs to be
Consumer awareness of recalls is also hampered by the fact that consumer advi- widely disseminated; however, many
sories, warnings, and recall notices are typically written in English. USDA also rou- who are unaffected by these allergens
tinely translates the recall and public health alert information it posts on its website are likely to view the information as
into Spanish; however, FDA (which has responsibility for 80% of the food supply in meant for others.

This means that the large majority who do this, our research indicates that most consumers value this service and that
of food recall notices are not relevant it may increase customer trust and loyalty to those retailers.
to most of the people who hear about Providing this kind of targeted, personalized recall information obviously re-
them. Repeated exposure to irrelevant quires that retailers be able to accurately track and connect consumers with their
information can be fatiguing and can purchases. Many do this through information provided by consumers when they
result in people ignoring recall infor- register for and use voluntary “loyalty card” programs or through membership cards
mation altogether. It can also result in required by some retailers. However, the idea that retailers are keeping track of their
a sense that food recalls are something purchases (and quite likely sharing this
that other people have to worry about. information with other companies) has
In fact, our research has shown that “Recall warnings raised privacy concerns among consum-
more than a third of Americans think ers who would prefer that some, or all,
that, compared with other people like of their purchases remain anonymous.
them, they are personally less likely to must be sufficiently In addition, consumers don’t always use
have purchased a food that had been their loyalty cards or keep the contact
recalled. information they supply to retailers up to
This “optimistic bias” is reinforced strong to demand date. Some purposely provide false infor-
by personal experience. Most people mation, believing that it will help protect
who report having looked for a recalled their privacy or prevent unwanted solicita-
food product say they’ve never found consumer attention, tions from marketers. This has led some
one. This view that recalls apply to retailers to be concerned about potential
others and not to themselves may also liability issues that might arise because
be reinforced by the vague language motivating of their inability to successfully contact
in the press releases that accompany every customer known to have purchased
announcements of product recalls. a recalled product. Some also worry that
These typically call on unidentified people to look for customers will come to rely on personal
“consumers who may have purchased notifications and will ignore other sources
these products,” urging them to return of information about recalls. In addition,
“those products” to an ambiguous potentially affected some consumers have come to expect that
“place of purchase” or to discard them. any retailer who has their contact infor-
Recent efforts by USDA and FDA mation will alert them when they have
to publicize the names and locations products and to purchased a recalled product.
of retailers (or consignees) known to
have received recalled products may Conveying Consequences
reduce the ambiguity of where these take appropriate For consumers to take the time to
products have been sold, helping look for recalled products in their homes,
consumers decide whether a recall is they also have to be convinced that the
relevant to them. However, the ability actions if they find consequences of consuming the product
of food manufacturers and distributors are serious enough to demand action on
to quickly and precisely identify the their part. However, our studies (and those
consignees of their products remains a them.” of others) have found that most Ameri-
significant challenge. cans have a tenuous grasp of the causes
and consequences of foodborne illness.
Personalizing Messages We have found that people generally underestimate the incidence of foodborne ill-
One way to increase the awareness ness and are unable to identify particularly vulnerable groups. Most Americans also
and relevance of recalls is to provide don’t recognize the symptoms of foodborne illness, and most don’t believe that
personalized recall messages to con- they have personally experienced it.
sumers who are known to have pur- Two of our national surveys included questions about eating recalled food prod-
chased potentially affected products. ucts. In both surveys, about 1 in 10 Americans reported that they had eaten a food
Some retailers already provide this they thought had been recalled, and nearly all reported having done so without
service to their customers, using email, adverse consequence. Unfortunately, disregarding warnings and eating a recalled
phone, and text messages to alert product without perceived ill effects can be self-reinforcing and may lead to an un-
people when something they have pre- derestimation of the consequences of consuming recalled products in the future.
viously purchased is subject to a recall. The notices of recalls, market withdrawals, safety, and public health alerts posted
Although there are costs to the retailers by both FDA and USDA on their websites do include information about the com-

mon symptoms and consequences of the illness that may be caused by a pathogen connect consumers to discounts,
associated with a product. The consistent inclusion of this information in notices, marketing information, social media
press releases, and other communications can help educate consumers about these sites, and other web-based content.
pathogens and the consequences of foodborne illnesses, and can reinforce the need Some companies have incorporated
to take warning messages about them seriously. QR codes into their blockchain trace-
Unfortunately, many of these notices undermine their own messages by includ- ability efforts, enabling consumers to
ing statements that “No illnesses have been reported to date.” While this may be track products from “seed to plate.”
true, it does not preclude illnesses being reported in the future and may unintention- Companies participating in the Smart-
ally communicate the idea that despite being recalled, the product is most likely Label™ Transparency Initiative are also
harmless. Similarly, informing consumers that a products is being recalled “out of an using QR codes to connect consumers
abundance of caution” may send the message that there is little likelihood that there to product nutrition facts, ingredi-
are serious problems with the product. ent, allergen, and other information.
Consumers can scan a QR code on
Improving Identification a product and be taken directly to its
Once consumers become aware of a food recall and are convinced of its personal relevant webpage at Smartlabel.org.
relevance and that the consequences are worth taking action to avoid, they must Connecting QR codes to accessible
also be able to identify the affected products. Both FDA and USDA recall an- recall information should be a logical
nouncements include relevant details such as container sizes, UPC codes, lot/batch next step.
numbers, use/best/sell by dates, as well as pictures of the products being recalled. Recognizing that a recall is not food
However, product labels are primarily designed to help sell foods, not to facilitate marketing in reverse is a first step to
their recall, and the lot numbers, production codes, and dates on products are often making recall communications more
printed in nonobvious places and in difficult-to-read typefaces and sizes. effective. Designing communications
that increase awareness and relevance
Moving Forward while conveying consequences and
The fundamental problem with food recalls is that they require individual con- providing enough information for
sumers to recognize that they own a recalled product with a food safety problem consumers to identify the affected
serious enough to warrant their attention and action. However, the current process products can increase the likelihood
is both inefficient and susceptible to failure. It ultimately relies on the right informa- that consumers respond appropriately.
tion somehow reaching the right consumers at the right time, who are then able to Technology has changed how consum-
use that information to identify the right products. ers become aware of recalls and how
In the current system, information is also designed to flow primarily in one di- they identify what is relevant. We now
rection: from the company issuing the recall to the consumer. Companies declare have additional technology that can be
to consumers, “This product may be unsafe, you may have it in your home, here is harnessed to help consumers identify
how to identify it, go look for it right now, and throw it out if you find it.” whether their food has been recalled. It
Unfortunately, the system is not well set up for consumers to ask “Has this par- may be time to use it. n
ticular product been recalled?” To answer the question, it is possible to conduct a Scan the QR code or click on the link for free
keyword search of recall notices through foodsafety.gov and USDA and FDA web downloads of Rutgers’s research on food recalls.
pages, although UPC codes can’t be used as search terms.
If the keyword search results in a positive match, it is necessary to click on each
individual recall notice to locate the detailed lot, date, or other information neces-
sary to identify whether a specific package of the product has been recalled. As a
result, answering the question “Has this been recalled?” for a single product is cum- bit.ly/2DghJOH
bersome and time-consuming. Screening an entire cabinet full of products is imprac- William K. Hallman, Ph.D., is a professor and
tical. Evaluating all of the foods donated to a community food pantry is impossible. Chair of the Department of Human Ecology and is a
What is needed is the ability to directly connect UPC codes or QR (Quick Re- member of the graduate faculty of the Department
sponse) codes to recall information. According to the Pew Research Center, more of Nutritional Sciences and of the Bloustein School
than three-quarters of Americans now have smartphones, including more than 90 of Planning and Public Policy at Rutgers, the State
percent of those ages 18–49. Existing smartphone applications can scan product University of New Jersey.
UPC codes and automatically search for price information. UPC information is also Cara L. Cuite, Ph.D., is an Assistant Extension
routinely supplied to FDA and USDA as part of recall notices and is used by manu- Specialist in the Department of Human Ecology and
facturers to help retailers remove recalled food products from their shelves. Thus, it a member of the graduate faculties of the Depart-
should be possible to maintain a consumer-searchable database of the UPC codes of ment of Nutritional Sciences, the Graduate School of
recalled food products that could be accessed through a smartphone app. Education, and the Bloustein School of Planning and
Food companies are also increasingly using scannable QR codes to directly Public Policy at Rutgers.

It’s a
Sure Bet!
Join more than 3,600 food safety
professionals at the world’s leading
food safety conference, and take part
in hundreds of informative symposia,
roundtables, and technical presentations
throughout four days. IAFP’s Professional
Development Group on-site meetings
provide additional opportunities to share,
learn and network with your peers about
today’s food safety challenges.
REACH FOR THE

FINISH LINE
WITH IAFP!
Our commitment to Advancing Food
Safety Worldwide® is second to none.
Go the distance by attending

IAFP 2019!
6200 Aurora Avenue, Suite 200W | Des Moines, Iowa 50322-2864, USA
+1 800.369.6337 | +1 515.276.3344 | Fax +1 515.276.8655
www.foodprotection.org
IAFP 2019 Food Safety Mag. Ad.indd 1 11/5/18 12:18 PM
IAFP 2019 Ad 10.30.18.indd 1 11/5/18 11:55 AM

FOOD SAFETY CULTURE By Melanie Neumann, J.D., M.Sc., Marie Tanner, M.Sc.,
Randy Huffman, Ph.D., and Mike Liewen, Ph.D
Measure What You Treasure
T
The single biggest threat to food safety is
culture. Robust food safety plans and quality
systems become ineffective when they are un-
dermined by the wrong culture. Culture is the
learned behaviors one extracts from the envi-
ronment. It can be described as the collective
values of an organization, family, and society.
Practices for
moving beyond
compliance to
commitment
ture of food safety is an environment where
employees hear, feel, and see food safety all
around them. These values are propagated by
cultural “carriers” who visibly prioritize and
bring focus to food safety.2
What is the business case to build the right
culture? The Conference Executive Board has
Culture is learned from the environment in stated that for every 5,000 employees, improv-
which we operate.1 ing culture can save a company up to $67 million. Improving
Leadership has a strong influence on the overall food the food safety/quality culture leads to fewer mistakes and
safety and quality culture of an organization. Employees pay more accountability, and drives an environment of continu-
attention to behaviors that are rewarded and to what goes un- ous improvement.2
noticed by leadership. They see who gets promoted and who Changing the culture of an organization is a burdensome
does not advance. They hear what leadership emphasizes and task. There are many factors to take into consideration before
what it fails to acknowledge. Employees absorb the overall embarking on this journey. First, don’t assume the entire
values of the organizational environment and adjust. global organization has the same culture. Societal/regional
It is imperative for leadership to walk the talk when it differences will have an impact on your corporate culture. Sec-
comes to food safety. Leadership behavior and actions that ond, measure your culture across the organization to obtain
are inconsistent with the values of the organization can have a baseline. Third, create cross-functional focus groups to pull
dire consequences on the effectiveness an organization. A cul- insights from the raw data. Different groups will have different

FOOD SAFETY CULTURE
interpretations of the same question. Fourth, start by making other industry, and arguably nearly every activity human be-
a few simple changes that are spearheaded by the top of the ings undertake. We are bombarded with data throughout our
organization. Different plants may need a different emphasis. day: the amount of sleep I got; how fast is my car going; how
One size doesn’t fit all when measuring culture. many unread emails are in my inbox—the list is almost end-
There will be societal differences within different regions less. We measure things in our daily lives to drive improve-
that will influence your culture and approach to driving ment, attain goals, mitigate risk for ourselves and our loved
change. According to Hofstede,3 societies are classified based ones, and comply with laws and regulations. Some of the met-
on the following social factors they tend toward: 1) collectiv- rics in our personal lives are things that we have consciously
ism vs. individualism; 2) masculinity vs. femininity; 3) rela- chosen to measure; others are metrics put in place by others.
tionship to authority and acceptance of social inequality; and Simply measuring something but not using the data and
4) uncertainty avoidance. You need to be aware of these differ- information generated is wasteful. Even worse is the scenario
ences and take them into consideration when designing your where data are generated, but the people who need the infor-
solution to drive change. mation do not see it or choose to ignore it.
Leverage a tool that measures the culture of food safety Drive Decisions, Actions, and Behaviors
and quality across your company. It is best to utilize a survey Food industry metrics exist for many of the same reasons
that you can benchmark against other companies to create a that we have metrics in our personal lives, and there are many
baseline and a competitive comparison. Don’t accept data at of the same challenges in using the data generated. Most food
face value. Create focus groups to draw meaningful insights companies have metrics to ensure that appropriate laws and
from the data, champion the process, and help define and regulations are complied with; that products are manufactured
implement the changes. Employee engagement is critical to a to formula or specification; that appropriate Standard Operat-
successful resolution. Visible leadership is also needed to re- ing Procedures are followed; and that products are meeting
inforce the desired change. This needs to be a bottom-up and the expectations of customers. An entire industry comprising
top-down endeavor. many successful companies has been established around de-
A Case for Metrics veloping and executing food safety audits and using the data
Measurement is a cornerstone of the food industry, every generated by those audits. The Global Food Safety Initiative

FOOD SAFETY CULTURE
was started to drive consistency and efficiency in food safety them rather than just measuring and recognizing “snapshot
audits around the world. Most food companies require annual in time” successes. Rather, companies should consider using
audits and proof of compliance from their various suppliers. additional measures that must be met on a daily, weekly, and
Yet there are many incidents every year of food safety prob- monthly basis, and place equal weight on these expectations
lems where companies have successfully conducted audits, and behaviors as you do that one audit score that happens
measured all of the right things, and still have food safety on one day in a year. Establishing incentives and rewards,
issues. In many cases, the problem was not that the right pro- as well as positive and negative consequences if the expecta-
grams or measures were not in place, but that the proper actions are not met, aids implementation and accountability.
tions or responses were not recognized or taken. The missing Consequences are often a sensitive topic; many companies are
element is often the culture of the company. uneasy to hand them out. Note that consequences are easier
Scientists are trained to identify and quantify a problem, to issue when you have the power of data to back you up and
drive solutions, and quantify progress. Yet measuring food are incentives for behavior change.
safety culture is a difficult and often foreign concept for scien- Choosing the “Right” Metrics
tists who are comfortable with hard data but often unfamiliar Creating simple, understandable measures is important for
with what drives human behavior. But the culture of an orga- buy-in and support at all levels of an organization. This is easi-
nization that drives engagement and action from senior execu- er said than done. The reality is continuous improvement and
tives to the technicians and line operators is often the most mature cultures in food safety require a robust, comprehensive
important and missing factor in a food safety plan. Data are measurement system, with timely review cycles, dashboards,
obviously useless if not used and acted upon. early indicators and alerts, root-cause investigations, corrective
Companies measure and collect data for many reasons: actions, and detailed documentation. Yet, remaining keenly
1) They are required to conduct audits by regulation and/or focused on the metrics that are most critical to success, that is,
customers; 2) they have internal policy requirements to com- the “critical few,” will go far in ensuring success.
ply with that are driven in large part by brand and consumer The right metrics also allow meaningful benchmarking
protection; and 3) in some cases, the reasons for measurement of performance across multiple facilities. This is encouraged
are historic or even unknown. Yet measurement itself accom- because it can create an opportunity for knowledge sharing as
plishes little other than generating data. What is done with data well as healthy competition between operational units. When
is the key to compliance and risk mitigation. The decisions, benchmarking is leveraged, standardization and normaliza-
actions, and behaviors that are driven by measurements like tion of the metrics are required to achieve fair and meaningful
audits and product testing are what make measurement useful. comparisons.
We Get the Results for Which We Reward The metrics chosen in any food safety benchmarking tool
Overreliance on metrics and data points comes at a risk, so will most likely be a mix of lagging and leading indicators that
a delicate balance must be achieved. A natural human desire is provide management the right perspective on how the food
to want to achieve the best possible score on a measurement. production and sanitation processes are working and how well
Many facilities incentivize their management and operators the people in that system are performing their jobs. Behavioral
through financial bonuses to perform well on food safety observations are important to understand the culture of the
audits. This strategy of incentivizing performance on audits operation. And, from a big-picture standpoint, a great indica-
may actually be counterproductive, however. While audits can tor of culture is to assess how the metrics and measurement
measure the presence of programs and deficiencies on a single systems are used by management! In other words, we can
day, they do not directly measure overall compliance with select the most appropriate metrics and design a perfect mea-
policies and procedures, and they do not measure the enthusi- suring tool, but if it is not reviewed and acted upon effectively
asm of a company’s workforce for ensuring that safe products in a timely way, with consequences associated with missing
are produced or doing the right thing, even when no one is performance criteria, it will have little impact on food safety
watching. Simply incentivizing a company to perform well on performance. In sum, any measurement system is worth-
an audit one day out of 365 without an expectation of contin- less unless it is paired with a rigorous and timely cadence of
uous, positive performance and behaviors that exude proper review, by the right people, at the right times, and is tied to
risk identification and mitigation skills on an ongoing basis short-, medium-, and long-term goals.
throughout the year is a risky and dangerous place to be. But,
who can blame the plant manager and quality assurance man- An Enterprise-Wide Approach to Making
ager if that is how they are incentivized and how their bonus Food Safety Risk Metrics & Reviews a Ritual
structure is based? We obtain the results through decisions, in Your Culture
actions, and behaviors, for which we reward. A challenge is to Goal setting is critical in everything we do in business.
motivate and incentivize companies and individuals to recog- Food safety performance is no different. The key to success in
nize problems and issues identified in audits, internal assess- achieving a goal is to first gain alignment from all key leader-
ments, measurements, or observations, and proactively address ship stakeholders in the business, including the CEO, on the

FOOD SAFETY CULTURE
long-term improvement goal, how it will be measured, the sure commonly seen and publicized in most factories is lost-
agreed-upon time frame for achievement, and the attached time accidents. Reducing and eliminating lost-time accidents
incentives for attaining the goal. And if the CEO becomes an generate personal motivation for operators and economic mo-
active participant in setting the goal and vocal champion, then tivation for management. One tool that engages management
all the better! and operators in managing lost-time accidents is measuring
Goals must be challenging but attainable. This balance is and recording “near misses”—those incidents that might have
important, and the leadership team must be prepared to adjust resulted in a lost-time accident.
the goals based upon learning and insight over time. Business PepsiCo has a policy of encouraging the recording and re-
scenarios change, production processes change, product in- porting of near-miss incidents. Every near-miss incident must
novation creates new challenges, supplier capability may fluc- be reported, recorded, and investigated, the root cause identi-
tuate over time, regulations may affect a process or outcome, fied, and preventive measures put in place. Additionally, facto-
and teams can improve or decline in performance over time. ries are incentivized by the number of near-miss incidents that
All these factors, and more, should be considered when the are recorded. Specifically, the more near misses that a factory
long-term goal is set and when a decision is made to adjust it. records, the better its rating is in this area. This system encour-
Gaining alignment from the line operators, quality supervi- ages the identification and reporting of risks that can lead to
sors, and supporting cross-functional departments who have lost-time accidents. PepsiCo also believes that encouraging the
an impact on food safety like R&D, marketing, purchasing, reporting of near-miss incidents improves the culture of safety
and others becomes an important next step. Once long-term in a facility by involving the entire workforce in risk reduction
goals are agreed upon, then appropriate short- and midterm activities and making them all owners of the process.
milestones can be set and tracked, and these can become the The near-miss program has been extended to food safety
ongoing mechanism to determine whether a team is meeting, near misses as well. The food safety near-miss program, like
exceeding, or falling behind the goal. the worker safety near-miss program, encourages the report-
The cadence of food safety metric review is vitally impor- ing of food safety near misses by incentivizing reporting—the
tant to success. This separates the great operators from the more near misses reported, the higher the score. And like the
good. Ad hoc, inconsistent, and nonstandard approaches to worker safety program, each near miss is required to be inves-
tracking and reviewing food safety metrics will lead to poor tigated and the issue mitigated if appropriate. PepsiCo is find-
performance and potentially tragic food safety errors. Food ing that factories with food safety near-miss programs have
safety reviews should become a ritual, just like brushing your higher food safety audit scores and better engagement of the
teeth morning and night, every day. Rituals can provide a workforce in food safety issues.
powerful mechanism for achieving consistent and constantly As part of its food safety culture journey, PepsiCo has
improving results. Leadership teams are encouraged to hone found many synergies between its worker safety culture pro-
the process of food safety metric review at each level of the gram and its food safety culture program. As such, the com-
organization. pany is combining the two programs into one “Culture of
Every organization and facility functions differently—one Safety” program that takes the best of both programs and uses
size does not fit all—and it is critical to work within the natural common tools and measurements.
rhythms of the business to coordinate the food safety reviews Case Study: How Maple Leaf Foods Measures Food Safety
with the other major operational reviews where appropriate. Performance
These reviews must be developed for each level, from the Maple Leaf Foods has launched a comprehensive food
line level “within shift reviews” to the daily, weekly, monthly, safety metric referred to as the Food Safety Incident Rate or
and quarterly reviews with operators, supervisors, manag- FSIR. This is an indexed, normalized, single numerical metric
ers, and the senior leadership team (including the CEO). Be that has six components that its teams deemed the most im-
all-inclusive in this process of developing the review cadence portant, key indicators of food safety performance. Some of
to achieve collective support from the business. This is the these metrics have been weighted more heavily in the overall
chance to hold functional area leaders accountable to deliver index to account for severity and risk. Once the FSIR baseline
against key aspects of food safety performance. These reviews for the first year for each of the company’s 21 facilities was
provide the opportunity to recognize great performance and established, alignment with all stakeholders to a 3-year goal for
identify opportunities for improvement. improvement was formulated (for Maple Leaf, a 75% reduc-
Case Study: Meaningful Metrics and Cross-Departmental tion in FSIR from the baseline year). The CEO played a key
Collaboration at PepsiCo role in pushing the team to seek this significant improvement
One area that has historically received more attention than over the 3-year span but also allowed a modest ramp-up im-
food safety culture in the food industry is environmental provement goal in the first year as the team adapted to this
health and safety, specifically worker safety. Certain parallels new measurement system—signifying the importance of senior
and learnings can be made from this space. The benefits of management commitment.
these programs are tangible and easy to understand. A mea- This FSIR result is tabulated each (continued on page 57)

MEAT SPOTLIGHT By S. Balamurugan, Ph.D.
High-Pressure Processing during

Drying of Fermented Sausages to Enhance
Safety and Stability
D
Dry fermented sausages (DFSs) are a class of
traditional ready-to-eat (RTE) meat products
that are manufactured without thermal pro-
cessing and are preserved by a combination of
acidification as a result of lactic acid fermenta-
tion by the added starter culture, controlled
drying, resulting in the reduction in water
A “cold” method
for significantly
reducing pathogens
in RTE meats
the manufacturing process results in a 5-log
inactivation of E. coli O157:H7. The combina-
tion of low pH and low aw was found to sig-
nificantly reduce E. coli O157:H7 (1- to 2-log
CFU/g) but was insufficient to eliminate the
pathogen when present at high levels. In most
cases, although the fermented sausages reach
activity (aw), and the addition of curing salts, the pH, aw, and MPr to be considered shelf
nitrate, nitrites, and spices, resulting in a shelf-stable product stable, the fermentation process is not sufficient to cause the
for extended periods when stored at room temperature. Shelf- required 5-log inactivation of E. coli O157:H7 and requires
stable DFSs have a pH, aw, and moisture protein ratio (MPr) extended drying to achieve the required inactivation of the
between 4.6 and 5.3, 0.85 and 0.90, and 1.9 and 2.3, respec- pathogen. This extended drying in most cases results in a
tively. Although DFSs have been generally regarded as safe product that is extremely dry and unacceptable for consump-
due to their low pH and aw, there have been several instances tion. Therefore, a nonthermal intervention that could enhance
where consumption of pre-sliced dry salami has been linked and achieve the 5-log pathogen inactivation without the need
to sickness due to Escherichia coli O157:H7 infection. Hence, for extended drying and loss in quality would be very useful.
regulations require that DFS manufacturers demonstrate that Researchers at Agriculture and Agri-Food Canada exam-

MEAT SPOTLIGHT
ined the effectiveness of using high-pres- Manufacture sausage

sure processing (HPP) during the drying (E. coli 0157:H7 cocktail
of the fermented sausages to achieve the at 7- to 8-log CFU/g)
highest inactivation of E. coli O157:H7.
HPP is a “cold pasteurization” technique
by which liquid or solid food products Fermentation (2 days)
already sealed in their final packages are
introduced into a vessel and subjected to Maturation (3 days)
isostatic pressures between 300 and 600
MPa transmitted through water. Pressures
can be applied at controlled temperatures,
Day 5 Day 12 Day 19 Day 26
and treated foods retain the characteristics (Day 0 of drying) (Day 7 of drying) (Day 14 of drying) (Day 21 of drying)
of the fresh product with very little change
to sensorial and nutritional properties,
depending on the pressure applied, and Microbial analysis Physiochemical analysis
have been shown to inactivate vegetative No HPP Vacuum-packed • E. coli 0157:H7 • pH, aw, MPr
HPP: 600 MPa, 3 min • Lactobacillus spp.
cells of bacteria, viruses, yeasts, molds,
• Pediococcus spp.
and parasites.1 However, the composition • Staphylococcus spp.
of the foods can have a dramatic effect
on the inactivation of microorganisms Wk 0 Wk 1 Wk 2 Wk 3 Wk 4
by HPP. Foods rich in proteins, carbohy- Store at 4 ° C
drates, and lipids have a protective effect Repeated three separate times
on microorganisms during pressure treat- Figure 1. Experimental Design
ment. In addition, pH and aw of food ma-
trices also have dramatic effects on the inactivation of bacteria. The efficacy of mi- tion of E. coli O157:H7 as a result of
crobial inactivation by pressure is reduced when the aw of the foods is lowered. The HPP was significantly reduced (Table 1).
nature and concentration of the solute used to reduce the aw also dramatically affects For instance, on day 0 of drying, when
the baroprotection of microorganisms observed during HPP of foods with a low aw.2 the aw and MPr of the fermented sau-
HPP has been successfully used to inactivate pathogens on RTE meats such as DFSs sages were 0.95 and 2.22 (MPr required
and ham. However, in all these cases, HPP had been used to inactivate pathogens on for being considered shelf stable),
sliced finished products after the fermentation, drying, and maturation steps but has respectively, the inactivation of E. coli
never been used as part of the fermentation and dry-curing processes. O157:H7 following fermentation and
Equipped with this knowledge, researchers prepared sausage batter containing drying was 1.54-log CFU/g. However,
18.46 percent fat and mixed a ground pork and beef blend, commercial meat fer- following high-pressure treatment, E. coli
mentation starter culture, and a five-strain E. coli O157:H7 cocktail (outbreak-associ- O157:H7 inactivation was enhanced by
ated strains of human and food origin) to obtain a final concentration of 7- to 8-log 4.94-log CFU/g, resulting in an overall
CFU/g. Salt (2.98%), salami cure (0.73%), and spices were added during the mixing, 6.48-log inactivation. After 7 days of
and the mixed batter was stuffed into 35-mm fibrous cellulose casings to make sau- drying, when the aw and MPr of the sau-
sages of lengths that were at least twice the diameter. The sausages were fermented at sages fell to 0.85 and 1.35, respectively,
26 °C and 88 percent relative humidity (RH) and then dried by a stepwise reduction inactivation of E. coli O157:H7 due to
in temperature and RH to 14 °C and 75 Days since DFS
percent, respectively, and then held for 21 manufacture E. coli O157:H7 (log CFU/g)
days. After fermentation (when the pH of (days of drying) pH aw MPr No HPP HPP
the sausages is less than 5.0), the sausages 0 5.71 0.97 3.65 0 NA
were transferred to the drying cabinet, and 1 4.86 0.96 3.38 -0.65 NA
six sausages removed weekly, vacuum- 2 4.77 0.95 2.93 -1.02 NA
packaged, and subjected to high-pressure 5 (0) 4.72 0.92 2.22 -1.53 -6.48†/-4.94*
treatment at 600 MPa for 3 minutes and 12 (7) 4.70 0.85 1.35 -3.25 -5.67†/-2.42*
then stored at 4 °C for up to 4 weeks. The 19 (14) 4.78 0.77 0.83 -4.75 -5.97†/-1.22*
untreated and pressure-treated sausages 26 (21) 4.98 0.75 0.64 -5.67 -6.36†/-0.69*
were then subjected to microbial and Table 1. Changes in E. coli O157:H7 Numbers Following HPP during Different Days of Drying
physicochemical analyses (Figure 1). of Fermented Sausages
Results indicate that as the fermented †Inactivation as a result of HPP, fermentation, and dry curing
sausages continued to dry, the inactiva- *Inactivation as a result of HPP

MEAT SPOTLIGHT
HPP was only 2.42 logs. The inactiva- generation of scientific evidence to support food safety guidelines, policies, and regulations.
tion of E. coli O157:H7 due to HPP was
further reduced as the sausages con- References
tinued to dry (Table 1). High-pressure 1. Buzrul, S, et al. 2007. “Thermal and Chemical Inactivation of Lactococcal Bacteriophages.” Food Sci
treatment of the fermented sausages Technol 40(10):1671–1677. doi: http://dx.doi.org/10.1016/j.lwt.2007.01.002.
did not significantly affect the popula- 2. Balamurugan, S, et al. 2016. “Effect of Salt Types and Concentrations on the High-Pressure Inacti-
tion of lactic acid bacteria in the starter vation of Listeria monocytogenes in Ground Chicken.” Int J Food Microbiol 218:51–56.
culture used. Examination of high doi: http://dx.doi.org/10.1016/j.ijfoodmicro.2015.11.010.
pressure-treated sausages stored at 4 °C
revealed that E. coli O157:H7 could be
SPONSORED CONTENT
recovered a week into storage, but the
numbers were not significantly different
from those in sausages examined right Hiperbaric Applications Team
after high-pressure treatment. No E. coli
O157:H7 was recovered from any high at Your Service!
pressure-treated sausage thereafter in
weeks 2, 3, and 4 of storage at 4 °C. Meat products have significantly benefitted of the high-pressure pro-
These results suggest that the inac- cessing (HPP) technology, as high pressure minimizes the risk associated
tivation of E. coli O157:H7 in DFSs with nonspore-forming foodborne pathogens, such as Listeria monocy-
following HPP is most effective when
togenes, while retaining the nutritional profile and sensory experience of
high-pressure treatments are applied
foods. Therefore, it is no coincidence that ready-to-eat (RTE) and dry-cured
prior to the fermented sausages reach-
ing an aw of less than 0.90 or an MPr in meats constitute one of the largest HPP food sectors.
the range of 1.9 to 2.3. These findings Hiperbaric, a worldwide manu-
highlight some very useful applications facturer of HPP equipment,
of HPP during the manufacture of appointed a group of HPP-
fermented, dry-cured RTE meats. First,
specialized scientists to
HPP can be used in conjunction with
fermentation and dry curing to enhance its Applications and R&D
pathogen inactivation. Secondly, high- department to actively
pressure treatment of fermented sau- collaborate in research
sages with a pH and aw of 5.0 and 0.90, activities for the con-
respectively, which happens very early
tinuous improvement
during the drying, could dramatically
reduce the duration of drying without of HPP RTE meats,
compromising safety. For instance, tak- providing a link between
ing the fermentation and dry-curing research and industrial
processes used here and subjecting the applications. Recent projects
sausages to HPP at 600 MPa for 3 min- investigate the effects of RTE
utes after the sausages reach a pH of
meat formulations that aim to es-
5.0 and before the aw falls below 0.90,
a shelf-stable and safe product can be tablish a safe harbor for HPP, as well as
successfully manufactured within 10 to the evaluation of spoilage microbiota inherently present in meats as a nat-
12 weeks, which is a significant reduc- ural approach to control growth of spore-forming microorganisms, such as
tion in the DFS production time. Meat Clostridium spp., and reduce the salt content in RTE meat formulations.
processors can easily incorporate HPP
Aside from research activities, Hiperbaric’s applications specialists pro-
without undertaking any significant
modification to their fermentation and vide technical support to validate commercial HPP food products for com-
dry-curing processes to produce a safe pliance with regulatory agencies around the world.
and shelf-stable product. n Do not hesitate to reach out if you have any questions about High Pressure
Processing, our equipment or HPP applications; Hiperbaric team is here to
S. Balamurugan, Ph.D., is a research scientist at
serve you!
Agriculture and Agri-Food Canada’s Guelph Research
www.hiperbaric.com • +1 305 639 9770 • apps@hiperbaric.com
and Development Centre. His research focuses on the

BEVERAGES By Tatiana Koutchma, Ph.D.
Advances in UV-C Light Technology

Improve Safety and Quality Attributes of
Juices, Beverages, and Milk Products
T
The growing consumption of premium cat-
egories of dairy, fruit, and vegetable beverages
has been attributed to the perceived health
benefits of the “all natural,” “made of organic
ingredients,” reduced-calories, and reduced-
sugar messages based on high levels of en-
zymes, nutrients, and bioactive constituents.
A promising
nonthermal
alternative for
beverage products
up and operational costs and batch processing
while also requiring a large amount of space
and use of plastic packaging.
Ultraviolet-C (UV-C) light is another
emerging nonthermal alternative that offers
less expensive, energy-saving continuous treat-
ment and packaging flexibility. Also, UV-C
To achieve these attributes, the products have at 254 nm is effective against all foodborne
to be minimally processed in terms of treatment temperature pathogens, natural microbiota, molds, and yeasts, with mini-
and exposure to oxygen. For instance, the growth of the cold- mum impact on quality and nutritional attributes.1 To achieve
pressed juice industry from local into regional and national high efficacy of UV-C processing in products with low UV
markets required higher stability, safety, and extension of transmission (UVT), such as the majority of juice and milk
product shelf life to at least a few weeks. Thermal pasteuriza- products, new engineering approaches have been developed
tion is an effective preservation technique but often negatively that differ from those normally employed for water treatment.
impacts both nutritional and quality parameters. An alterna- In case of water, UVT achieves values of 90 percent and high-
tive nonthermal processing strategy is the use of high-pressure er; for clear juices, the UVT is typically less than 30 percent
processing (HPP). However, HPP is associated with high start- and reaches 0 for turbid juices with particles. Due to the low-

BEVERAGES
UVT challenge, laminar or turbulent regimes using thin films, static mixers, or Dean specific applications. In the system
flow in coiled tubes must be employed to effectively deliver light photons to the tested, the UV irradiance is measured
whole volume of the products.1 The first UV system that was developed and used and controlled with two UV sensors.
to generate data for regulatory submission in the U.S. in 2001 was based on coiled The UV-C sensors are installed in the
tubing where liquid was treated in turbulent flow and low-pressure mercury lamps chamber considering geometry of the
that delivered a similar UV dose for a range of juice products. The current challenge tube and direction of the incident UV
remains because since the UV dose has not been established by regulators, the pro- light of surrounding lamps. This allows
cess has to be developed based on achieving product-specific process requirements not only monitoring of the UV-C irradi-
or so-called intended technical effect. This can involve a 5-log target pathogen reduc- ance but also accurately measuring the
tion in juices to meet Hazard Analysis and Critical Control Points (HACCP) and output power of the lamps and precisely
evaluating the absorbed dose delivered
Effects on Shelf life achieved
to the treated product. Products’ recipes
enzymes (15 or 30 days)
can be saved in the system program and
(PME, PPO, microbiogical,
Reduction of natural Effects on quality also can be used to adjust the UV dose
POD) chemical
microflora, yeasts, (color) and nutrients levels for individual products. Tempera-
molds, and spoilage (vitamins & ture sensors control air and product
organisms antioxidants) temperatures in the UV-C chamber.
Operational Operating UV-Processing

UV dose Conditions
5-log reduction of Effects on Developing a new UV-based process
at 100% output
most-resistant sensory and requires first establishing a proper opera-
pathogenic organisms appearance tional dose, a validation step to ensure
that proper UV dose is reliably delivered
Figure 1. Essential Components for Establishing Operational UV Dose in Beverages
to the product, and evaluation of the
shelf-life extension of fresh juices, pasteurized milk, or liquid sugars by eliminating microbial efficiency of a system. The
spores or spoilage organisms. This means that actual operational UV dose can vary examples of six processing conditions at
for different categories of juices, beverages, and liquid ingredients, and very much different output power levels that can
depends on product composition, absorption coefficient, rheological characteristics, be achieved in the system are shown in
initial microbial load, and reduction requirements. Also, the UV dose should be Table 1. The Keitz approach3 was used
optimized to achieve the best quality, nutritional, and sensory attributes, as shown to calculate the total UV output power
in Figure 1. After the UV operational dose is established, its effects on enzymes and from UV lamps with a monochromatic
stability of juice suspension should be taken into consideration.2 output at 254 nm.
Using a new commercial system, extensive experimental studies were conducted
to establish and validate operational UV dose for a number of beverage categories Applications: Juices
such as fruit and vegetable juices, cold teas, milk products, and liquid sucrose and Cold-pressed fruit and vegetable
fructose ingredients. The new UV technology delivers light photons to the entire liq- juices compose a growing market of
uid volume when it is pumped in a turbulent flow through the polymer tubing. The premium juice products due to their
use of food-grade polymer tubing in food processing facilities ensures that safety and high nutritional content and health
HACCP requirements are met by eliminating the hazards associated with the use of benefits. Cold-pressed juices are treated
glass. The size and geometry of the tubing along with product flow rate create a tur- using nonthermal technologies that
bulent flow regime with effective spontaneous mixing. Another feature of this tech- are considered more advanced chemi-
nology is that UV-C output power and Processing Regime 1 2 3 4 5 6
consequently UV dose level can be adjust- Low-pressure lamp output, W 320 320 320 320 75 75
ed for each individual product in several Lamp efficiency, % 32.8 32.8 32.8 32.8
ways, such as using lamps with different Operating amperage, A 2.1 1.9 2.1 2.1 0.425 0.425
power output and adjusting the current UV-C lamp output at 254 nm, W 105 105 105 105 31 31
(amperage) of the lamp without chang- Total UV-C output power, W (Puvc) 2099 2099 1050 420 186 124
ing the geometry of the reactor chamber Tubing UVT 0.6 0.6 0.6 0.6 0.6 0.6
(e.g., tube diameter, coil diameter, number Flow rate, Q, L/s 0.28 0.28 0.28 0.28 0.28 0.28
of UV lamps, lamps’ distance from the UV-C power input per pass (J/L) 308.8 282.6 172 49 2.3 5.3
coil). Two types of low-pressure amalgam Output power level based on the 100 100 50 20 30 20
and mercury lamps (LPA and LPM) with number of operating lamps, %
320-W and 75-W outputs were tested for Table 1. Levels of UV-C Power Output per Single Pass

BEVERAGES
cal- and heat-free processing options. As was shown previously,1 UV technology is ized milk by at least 30 percent under
effective against common pathogens of concern in juices, natural microflora, molds, refrigerated conditions. The main goal
and yeasts, and extends shelf life of juices such as popular leafy greens products and of the combined process is to achieve an
fruit-and-vegetable blends, while using various types of glass packaging. Additionally, extended shelf life (ESL) of milk with-
tests for evaluating compliance with HACCP 5-log reduction requirements with re- out exposing the milk to the high tem-
gard to inactivation of pertinent pathogenic organisms were performed. A variety of peratures and packaging under extreme
juice products from fruits, berries, leafy greens and vegetables, and black and green hygienic conditions that are common
tea inoculated with different types of bacteria (Escherichia coli ATCC 35208, yeasts, in regular ESL treatment. Extensive
and Bacillus atrophaeus spores) were treated at throughput of 1,000 L/h (4.4 GPM) research showed that UV treatment of
and 100 percent of UV power output of 308.8 J/L with all UV lamps turned on. whole cow and goat milk was effective
Particularly, the tests were conducted using 10 types of high-acid juices (pH < 4.6) against aerobic microflora, E. coli, Bacil-
10 lus cereus, and Bacillus subtilis spores, as
shown in Table 2. The effect of two UV-
9
processing conditions at 100 and 20
8 percent energy levels was tested due to
Logarithmic Count Reduction
7 concern about off-flavor formations in

milk products.
6
The higher UV energy level resulted
5 in the higher log count reductions of
4 all types of organisms tested. The more
efficient inactivation of natural bacteria,
3
E. coli ATCC 35208, and B. cereus spores
2 of more than 5 logs was observed after
1 treatment at 100 percent UV energy
0
levels in cow milk. The LCR of B. cereus
ppl
e
ppl
e ge ge cal ate
r rn err
y pe err
y spores was lower in goat milk (Table 2).
a da o ran ran r opi t w k tho Ch Gra eb
Cl ear rbi bid Clear
o T u
con Sea b
u c Blu Milk Product Cow Goat
Tu Tur Co
Figure 2. Efficacy of UV Treatment in an Industrial UV-C System to Reduce E. coli in Fruit UV processing 3 5 3
Juices at 308.8 J/L at 1,000 L/h regime and (100%) (20%) (100%)
output power
including apple (clear and turbid), orange (clear and turbid), tropical, cherry, blue-
level (from Table 1)
berry, cranberry, and grape juices. Additionally, five types of low-acid juices (pH >
Applied energy J/L 308.8 172 308.8
4.6) were tested, such as coconut water, sea buckthorn juice, carrot, wheat grass, and
Logarithmic count
celery juices, plus black tea.
reductions (LCR)
The results of juice microbial challenge tests with E. coli ATCC 35208 showed
Total count 5.5 3.2 2.6
that UV treatment could achieve a range of logarithmic count reduction (LCR) be-
E. coli ATCC 35208 ~7 3.1 6.2
tween a minimum of 5.0 in tropical juices and 8.1 in clear apple juice. The LCR of
B. cereus spores 5.2 1.2
E. coli bacteria in fruit juices obtained as an average of all tests is shown in Figure 2,
B. subtilis spores 2.9
demonstrating that UV treatment achieved higher than 5 logs in all tested products.
Table 2. Microbial Reductions in Cow and
Treatment at 100 percent UV-C exposure resulted in a reduction in the total Goat Milk after UV Treatment at 1,000 L/h
counts of natural microflora in green-blend juices including acid-uric and aerobic
total counts of 3.7 and 3.9 logs, respectively, as well as 2.1 logs for both molds and A triangle test (nine-person panel) was
yeasts. E. coli, lactic acid bacteria, and coliforms were not detected in any of the used to determine whether there was a
green-blend juice samples treated with UV-C.2 UV-C treatments ranging from 27.7 noticeable difference in sensory qualities
to 308.8 J/L have led from 1.0- to 3.0-log count reductions in these microorganisms between cow milk samples treated at en-
in fruit juices. Additionally, the UV treatment was effective against B. atrophaeus ergy levels of 100 and 20 percent. It was
spores in sea buckthorn juice and coconut water by achieving averages of 5.6 and 5.4 found that subjecting cow milk to the
LCR, respectively. higher UV energy input resulted in off-
flavor formation. No noticeable changes
Milk were found by the majority of profes-
UV treatment is also a promising technology for dairy processors as a safe, sional tasters when pasteurized cow milk
energy-efficient, and economical process to gain added value. UV treatment can be was treated with UV light at 20 percent
successfully employed as an alternative method of post-pasteurization to reduce the of full energy level or 2.31 J/L.
microbial count beyond normal pasteurization and increase shelf life of pasteur-

BEVERAGES
Sugar syrups output power levels, resulting in additional energy savings. The examples of products
UV technology can be of great value tested and established processing conditions are shown in Table 4. A 5-log reduction
in products that are using syrups such of pathogenic E. coli bacteria was achieved in all tested products with no noticeable
as liquid sucrose, fructose, and other changes in quality, nutritional, or sensory attributes. To achieve an extended shelf
sweeteners, and can replace traditional life, a higher operating UV dose can be required to reduce numbers of molds and
heat treatments. Although liquid sug- yeasts or bacterial spores that can survive pasteurization. To avoid photodegradation
ars and sweeteners are characterized effects in milk, UV sources with the lower output power or amperage can be used
by high viscosity, UV processing was to eliminate off-flavor formation. Advanced built-in features allowed modifying UV
found effective against not only com- source output and consequently power levels.
mon pathogenic organisms and high
UV-resistant spoilage microflora such Existing Regulations
as yeasts and molds but also against Another advantage of UV-C technology for juice and milk products is that it has
microbial spores. No formation of un- been approved by the U.S. Food and Drug Administration (FDA), Health Canada,
desired chemical compounds such as and the European Food Safety Authority (EFSA).4–6
furans that can be potentially promoted • 2000: FDA amended the food additive regulations to provide for the safe use of
during UV exposure was reported at the UV radiation at 254 nm to reduce human pathogens and other microorganisms
applied UV doses range. The results of in juice products. It was determined that the amount of UV irradiation necessary
the tests of liquid sucrose with 60° Brix for human pathogen reduction would depend on the type of juice, the initial
at 20 °C are summarized in Table 3. microbial load, and the design of the irradiation system (e.g., flow rate, number
UV Output B. of lamps, and time exposed to irradiation). Therefore, FDA did not specify a
Power atrophaeus minimum or maximum UV dose by regulation but concluded that this should be
Level (J/L) E. coli Yeasts Molds Spores achieved for individual usage situations in a manner consistent with Good Manu-
Log count reduction (LCR) facturing Practices.4
27.7 8.0 4.1 3.5 • 2004: Health Canada determined that there are no safety concerns, and it has no
172 5.1 objection regarding the sale of UV-treated apple cider to achieve a reduction in
251.6 4.2 the microbial load of apple juice and cider products.5
308.8 7.9 3.6 4.3 • 2016: EFSA concluded that UV treatment of pasteurized milk to produce ESL
Table 3. Summary of Processing Conditions products and increase vitamin D content is safe under the intended specified
and Microbiological Efficacy in Liquid conditions of use, which opened new opportunities for further technology com-
Sucrose at 65o Brix
Liquid Cold Clear Opaque Cow Milk
The UV treatment of liquid sugar Product Category Sugars Teas Juices Juices Products
was most effective against E. coli, result- UVT range, % 40–90 10–90 < 30 0 0
ing in more than a 7-log count reduc- pH > 4.6 > 4.6 < 4.6 < 4.6 > 4.6
tion. Yeast, molds, and B. atrophaeus Viscosity at 25 °C, cP 60 1 1–3 5–10 1.9–2.5
spores had higher UV resistance, and Intended effect of Safety, Safety, Safety, ESL Safety, ESL ESL of
the UV output powers of at least 172 UV treatment ESL ESL 3 weeks 3–4 weeks 3–4 weeks pasteurized
and 250 J/L were required to achieve milk
5.1-, 3.6-, and 4.2-log reductions, respec- Target organisms Molds and Yeasts Pathogenic Pathogenic B. subtilis
tively. Bacillus E. coli, E. coli, and
Therefore, testing of novel UV spores Listeria, and Listeria, and B. cereus
technology at an industrial scale dem- Salmonella Salmonella spores
onstrated its feasibility for a variety of Flow rate, L/h 400 1,000 1,000 1,000 1,000
commercial applications in the bever- Re-number range 234 18,000– 16,000– 10,000– 11,000–
age, juice, and dairy industries. The 21,000 21,000 21,000 13,000
challenge is to achieve specific safety Type of lamps emitting LPA LPA LPA LPA LPM
and shelf-life objectives for products in at 254 nm
the broad UVT, viscosity, and pH rang- Applied UV energy, J/L 27.7–308.8 308.8 89.9–308.8 308.8 49–308.8
es, with variations in UV resistance of LCR of pathogens >5 >5 >5 >5 2–6
target organisms and photosensitivities Reduction of natural > 3.6 > 6 (yeast) 3–6 1–6 1.5–5
of product compositions. The summary microflora, LCR
data of products and process parameters Effects on quality, No No No No No at 20%
demonstrate how product-friendly solu- nutrients, sensory energy levels
tions can be developed to achieve de- Table 4. Summary of Processing Conditions and Microbiological Efficacy in Juices, Tea
sired technical effects by adjusting lamp Products, Milk, and Liquid Sugars

BEVERAGES
mercialization in dairy applications.6 change in nutritional composition

• 2017: The Israeli food regulations agency approved the use of UV light to reduce and chemical safety at maximum 100
microbial load in pasteurized milk. The health committee approved an applica- percent energy level delivered to the
tion to treat pasteurized milk with UV light at 200 to 300 nm using a turbulent product in one pass.
flow regime. The treated milk must be free from microbial contamination and
will be labeled according to Israeli regulation as “UV-treated” and will be sub- Conclusion
jected to any changes in the regulation. The regulatory status of UV-C light
• 2018: Health Canada concluded that juices processed with UV technology are treatment emitted by LPM lamps at 254
not considered novel foods and are safe for consumption since there is no major nm for juice and dairy products, and
the growing premium beverages market,
SPONSORED CONTENT opens new opportunities for the further
development and commercialization
High Intensity UV LED for Pathogen Reduction of this technology at industrial scale.
High Intensity UV light-emitting diode (LED) technology for pathogen reduc- Food processors who wish to invest and
tion deserves serious consideration by manufacturing entities such as food pro-
test this technology should understand
the advantages and limitations of a
cessing where disinfection and decontamination are required. High irradiance,
UV light-based process. By monitoring
combined with appropriate wavelengths, targets specific bonds in DNA, RNA,
product parameters, the UV treatment
and proteins within microorganisms and conditions can be tailored to avoid over-
biomolecules, allowing shorter inactivation processing and developing off-flavors.
times while improving overall disinfection UV processing systems should also be
efficacy. The high absolute irradiance of these new integrated into the line to avoid cross-
solutions enable high-throughput processes for contamination and achieve maximum
manufacturing facilities. product shelf life. n
Phoseon is the first to develop a 275-nm UV LED disinfection system that
surpasses 5 W/cm², significantly higher than the 0.3 W/cm² levels reached by Tatiana Koutchma, Ph.D., is a research scientist in
other technologies in the market. This advance enables a level of irradiance that novel food processing at Agriculture and Agri-Food
Canada. She is on the graduate faculty at University
provides manufacturers the capability to think and act beyond traditional meth-
of Guelph, Ontario, Canada, a member at-large of
odologies. For the past 30 years, low irradiance has limited the efficacy of UV-C
the Nonthermal Processing Division of the Institute of
solutions. Phoseon has provided a new path based on high power that allows
Food Technologists, and Canadian Ambassador to the
our customers to build high-performance, long-lasting products that save time, Global Harmonization Initiative. The author thanks
lower operating costs, and provide improved disinfection capabilities. Motti Coren and Dror Livne of AseptoRay for sharing
Our research has proven that wavelength selection is essential to getting data and equipment.
the most out of our UV LED systems. We have discovered that using 270-nm
and 365-nm wavelengths yield synergistic effects in disinfection, thus allowing References
even faster reactions. Both nucleotides and proteins can be modified using this 1. Koutchma, T, et al. 2016. “Effects of Ultraviolet
light combination. Therefore, both microorganisms and biological materials can Light and High-Pressure Processing on Quality
be inactivated with the right dose, allowing for integration into many different and Health Related Constituents of Fresh Juice
industries including medical, food, semiconductor, and others. Our systems are Products.” Comp Rev Food Sci Food Safety
15(5):844–867.
well-suited to disinfection of sensitive surfaces due to their low heat emission,
2. Biancaniello, M, et al. 2018. “Feasibility of
high intensity, precise control, and long operating life.
a Novel Industrial-Scale Treatment of Green
Since 2002, Phoseon Technology has pioneered the use of LED technology
Cold-Pressed Juices by UV-C Light Exposure.”
for life sciences and industrial curing. Through our relentless innovation, we de- Beverages 4:29–44.
liver high performance, reliable, and patented LED-based solutions. Our strong 3. Keitz, HAE. Light Calculations and Measure-
focus on customer collaboration has resulted in worldwide market leadership ments (London: Macmillan and Co. Ltd., 1971).
position and presence. Phoseon is an ISO 9001-certified company manufactur- 4. FDA. 2001. “21 CFR Part 179. Irradiation in the
ing award-winning products that are covered by more than 300 patents global- Production, Processing and Handling of Food.”
ly. We are focused 100 percent on LED technology, therefore ensuring superior Fed Regist 65:71056–71058.
reliability, business economics, and environmental benefits. 5. www.hc-sc.gc.ca/fn-an/gmf-agm/appro/
For more information about Phoseon Technology products and services, dec85_rev_nl3_e.html.
please contact: lifesciences@phoseon.com. 6. www.efsa.europa.eu/en/efsajournal/
pub/4370.

TESTING
(continued from page 17)
of mutagenesis simply because of the evaluating the safety of new plant vari- lation, we need a more scientifically ro-
argument that it has a long history of eties, we should use all the tools avail- bust and risk-based regulatory approach
safe use. Even worse, this decision could able to best understand the technique to evaluate the safety of new plant
have long-term ramifications for bio- used and the modifications it creates. If varieties. We can start by simply con-
technology providers regulations require us sidering the vast number of unknown
and innovation in the to conduct extensive genetic modifications in edible plants
EU. “There are a variety risk assessments and made using traditional mutagenesis as
It has often been safety evaluations of compared with the surgical precision
stated that advances of ways in which the transgenic crop variet- of gene editing and ask which method
in technology tend to ies, the same standard should be subject to greater regulatory
outpace their accom- of safety should be and safety scrutiny. As a toxicologist re-
panying regulations. safety of genetically applied for the older, sponsible for safety evaluations, I think
In the case of modern conventional methods the answer is clear. n
biotechnology, there modified plant varieties of generating new crop
seems to be more of varieties. Otherwise, Alex Eapen, Ph.D., DABT, is principal scientist –
a divergence in food we are effectively Toxicology & Regulatory, R&D Scientific & Regulatory
and agriculture as op- can be assessed.” going backward by Affairs at Cargill. The content, remarks, and opinions
posed to other sectors, encouraging the use presented here are those of Dr. Eapen and do not
which have benefited tremendously of imprecise plant breeding techniques, necessarily reflect those of Cargill Inc.
from its use. The current state of global which do not always give the intended
biotechnology regulations for food is at result (recall the Lenape potato), instead Reference
best inconsistent in its approach and at of far more precise genetic engineering 1. Statement by USDA Secretary Sonny Perdue
worst carries a strong nonscientific bias techniques. To effectively use modern on plant breeding innovation (March 28, 2018 –
that discourages the use of biotechnol- biotechnology to meet the future chal- USDA Press Release No. 0070.18).
ogy. If we take a scientific approach in lenges of feeding a growing global popu-
圀攀洀愀渀琀愀椀渀琀栀攀栀椀最栀攀猀琀猀琀愀渀搀愀爀搀猀猀漀礀漀甀挀愀渀
瀀氀愀挀攀礀漀甀爀猀愀昀攀琀礀猀栀愀瀀攀礀漀甀爀戀甀猀椀渀攀猀猀
椀渀漀甀爀栀愀渀搀猀
䰀漀渀搀漀渀䌀漀渀猀甀氀琀椀渀最䜀爀漀甀瀀✀猀栀愀渀搀猀ⴀ漀渀洀攀琀栀漀搀漀氀漀最礀
愀渀搀瀀爀漀樀攀挀琀洀愀渀愀最攀洀攀渀琀猀攀爀瘀椀挀攀猀栀愀瘀攀愀瀀爀漀瘀攀渀
㈀㔀ⴀ礀攀愀爀琀爀愀挀欀爀攀挀漀爀搀⸀
圀攀挀愀渀栀攀氀瀀礀漀甀椀洀瀀爀漀瘀攀洀愀渀甀昀愀挀琀甀爀椀渀最愀渀搀猀甀瀀瀀氀礀
挀栀愀椀渀攀昀ǻ挀椀攀渀挀礀Ⰰ 爀攀搀甀挀攀琀椀洀攀琀漀愀挀栀椀攀瘀攀䘀漀漀搀匀愀昀攀琀礀
挀攀爀琀椀ǻ挀愀琀椀漀渀猀 ⠀䠀䄀䌀䌀倀⼀䘀匀䴀䄀⼀䜀䘀匀䤀⤀Ⰰ 爀攀搀甀挀攀挀漀猀琀猀
愀渀搀攀渀愀戀氀攀昀漀漀搀琀爀愀挀攀愀戀椀氀椀琀礀愀渀搀洀愀猀猀ⴀ戀愀氀愀渀挀攀⸀
䌀愀氀氀
䌀愀氀氀甀猀渀漀眀琀漀 ǻ渀搀漀甀琀栀漀眀眀攀挀愀渀栀攀氀瀀礀漀甀
猀栀愀瀀攀礀漀甀爀戀甀猀椀渀攀猀猀⸀
䘀漀爀洀漀爀攀椀渀昀漀爀洀愀琀椀漀渀
瀀氀攀愀猀攀挀漀渀琀愀挀琀㨀
挀漀渀琀愀挀琀䀀氀漀渀搀漀渀挀最⸀挀漀洀
㄀㠀㠀㠀㤀㌀㔀㠀㐀㐀㠀

Product Showcase PACKAGING
is supported by a legislatively mandated program;

2. It must be sorted and aggregated into defined streams for
Metal-Detectable Products recycling processes;
Detectapro offers an entire line of metal-detect- 3. It can be processed and reclaimed/recycled with commer-
able products to reduce a company’s risk of con- cial recycling processes; and
tamination from foreign metal objects. Commonly 4. The recycled plastic becomes a raw material that is used in
used in production areas and an integral part of the production of new products.
any quality assurance process, Detectapro products The trade groups emphasized that a global definition of
include keyhole tags, markers, pens, cable ties, recyclability “is an integral step to harmonize the worldwide
security tags, labels, sheeting, and scrapers. Cus- plastics recycling industry.”
tomized products are also available.
Detectapro, 866.441.5572 • www.detectapro.com Conclusions
Meeting the goals aimed at making plastic packaging
Food Processing Knife part of a circular economy will not be easy. In discussing his
company’s sustainable packaging goals, Kraft Heinz CEO
The food production industry demands the
highest safety standards, so when it Bernardo Hees stated, “Our collective industry has a massive
came to creating a food processing challenge ahead of us with respect to packaging recyclability,
knife that exceeds safety demands end-of-life recovery, and single-use plastics.” He added that
and is highly functional, OLFA Kraft Heinz will partner with packaging experts, organizations,
created the metal-detectable SK-14 stainless steel knife. The and coalitions to explore technical, end-of-life, and infrastruc-
knife’s open-blade channel is easy to clean, and it has a slip- ture solutions, and is already collaborating with Environmen-
resistant handle and improved blade actuator. The body of the tal Packaging International for consulting, tracking, and other
knife includes notches at the base to help improve grip and specialist services in the packaging space.
control, while the wider blade actuator lets users reveal the The EC also acknowledges the challenges of making plastic
self-retracting blade easily, even with gloves on. packaging part of a circular economy but added that the chal-
OLFA Corporation, 800.962.6532 • olfa.com
lenges linked to the production, consumption, and end-of-life
of plastics may be turned into an opportunity as well. n
Touch Screen Vacuum Control George G. Misko, Esq., is a partner in the Washington, DC, office of Keller and
BrandTech® Scientific has introduced
Heckman LLP. He can be reached at misko@khlaw.com.
the new Vacuubrand® PC3001 Vario™ se-
lect chemistry vacuum system with touch-
References
screen control for rotary evaporation,
1. eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52015DC0614.
centrifugal concentration, or nearly any
2. ec.europa.eu/environment/circular-economy/pdf/plastics-strategy.pdf.
other vacuum application. The inte-
3. www.plasteurope.com/news/PLASTICS_RECYCLING_EUROPE_
grated controller provides an intuitive,
t238090/.
smartphone-like interface on a powerful
4. www.fda.gov/Food/GuidanceRegulation/
speed-controlled 1.5-torr, 34-lpm polytet-
GuidanceDocumentsRegulatoryInformation/ucm120762.htm.
rafluoroethylene diaphragm vacuum pump for whisper-quiet
5. www.plasticsconverters.eu/single-post/2017/10/25/EuPC-publishes-
operation.
results-of-its-survey-on-the-use-of-recycled-plastics-materials.
BrandTech Scientific, 888.522.2726 • www.brandtech.com
6. ec.europa.eu/docsroom/documents/27321.
7. ec.europa.eu/environment/circular-economy/pdf/
Data Logger Storage single-use_plastics_proposal.pdf.
T&D Corporaton has announced the release of the 2.0 ver- 8. www.europarl.europa.eu/sides/
sion of its popular free cloud-based T&D WebStorage Service. getDoc.do?type=REPORT&reference=A8-2018-0317&language=EN.
The redesigned platform provides more data tracking features, 9. europen-packaging.eu/component/content/article/1112.html.
an improved user interface, and more options to manage com- 10. eur-lex.europa.eu/legal-content/EN/TXT/
patible T&D data loggers. This service provides real-time access ?qid=1516266600827&uri=COM:2018:35:FIN.
to a user’s logger data, such as temperature measurements re- 11. www.biodeg.org/OPA%20responds%20to%20European%20
corded for monitoring storage environments to keep products Commission%20%20-%20%20%2019%20January%202018.pdf.
safe. 12. plasticsrecycling.org/news-and-media/
T&D Corporation, 518.669.9227 • www.tandd.com 824-july-12-2018-apr-press-release.
Please send your product or service press releases and images to
barbara@foodsafetymagazine.com.

FOOD SAFETY CULTURE Food Virus, Pathogen,
Pesticides & Toxin Analysis
month, and the 21 company-owned facilities are placed into
quartile positions based upon their quarterly FSIR result—us-
in 72hrs* turnaround time
*most testing services
ing a green, yellow, amber, and red zone to mark the posi-
tions. These quartile rankings are reviewed monthly by senior
leadership in food safety and operations, and a quarterly re-
view is held with the CEO and all plant and food safety man-
agers. And finally, three times per year, the FSIR metric results
and trends are reported to the Maple Leaf Board of Directors
committee on safety and sustainability. This comprehensive
review process creates an opportunity for dynamic dialogue
between the plant leadership team and senior leadership on a
routine basis about food safety performance and plans to ad- • First Canadian Accredited Lab for Virus
dress gaps and to celebrate successes. (Hepatitis A & Norovirus) Testing
But the CEO quarterly review of the FSIR results are just
• Phenomenal turnaround time at no extra surcharge
the “tip of the pyramid.” The real change happens within the
plant, with the operators, supervisors, and managers who are We take pride in our knowledge, experience and capabilities to
responsible for producing safe food every day. The FSIR has remain in the forefront of food safety to “Make Food Safer”
six components, which are highly objective, numerical mea-
sures but are mostly lagging indicators. The plant teams iden-
Contact us today!
tify their key leading indicators that they believe will drive
improvement in one or more of the top-line FSIR measures.
These indicators get the focus at the in-shift, daily, and weekly
operational performance meetings that occur at the facility.
5055 Rue Fisher Saint Laurent • Quebec H4T 1J8 CANADA
Leveraging a Risk-Based Approach: (514) 446 -6500 • www.pathogenia.com • info@pathogenia.com
Enterprise Risk Management in Food Safety
Some companies have elected to incorporate the philoso-
phies and principles of enterprise risk management (ERM)
when designing and striving to achieve a more integrated, ma-
ture food safety culture.
ERM seeks to identify risks that may adversely impact a
company, then create a top-down, enterprise-wide view and
approach to manage those risks within the company’s risk
tolerance. It is a process of coordinated risk management that
places a greater emphasis on cooperation among departments
to manage the enterprise’s full range of risks, rather than as
independent units or “silos,” as the industry has come to
refer to such an approach. While ERM was initially adopted
by accountants and internal auditors to implement internal
controls in the wake of certain financial scandals, the model
has since been adopted into policy and regulation, and sub-
sequently developed into a framework to assist companies to
effectively identify, assess, and manage nearly any type of risk.
Applying this ERM definition to food safety and food
safety culture programs and witnessing its application,
whether intentional or not, in the case studies above, one can
quickly surmise that food safety is, and should be, viewed as
an enterprise-level undertaking. Beyond the historic and obvi-
ous need to control for microbiological food safety risks, food
companies today are faced with myriad additional operation-
al, reputational, and regulatory risks (e.g., implementing new
food safety regulations, being inspection- and audit-ready all
the time, managing the impact of evolving science such as the
use of whole-genome sequencing, dealing with increased so- CATALYST FOR SUCCESS
Pickering_Glyphosate_FoodSftyMag_3.375x4.875_112317.indd 1 11/23/17 12:22 PM

Advertisers Index H
Q UA L
FOOD SAFETY CULTURE
HI G
IT
Y
FO
ER
TN
O
SA R
D
F E T Y PA
Anritsu • detectionprevention.com ..........................................................13

Visit our website
AOAC
cial • www.aoac.org
media and mainstream ................................................................................69
media exposure of outbreaks and approach to food safety program implementation. While
to learn more.
Art’s Way
recalls, andScientific,
supplierInc. and ..........................................................................29
co-manufacturer management-related most companies already have parts of these programs in place,
risks,866.808.5609
etc.). All of• www.bestsanitizers.com/handtalk2
these risks must be effectively managed on proper verification is necessary to confirm that the effort to
aBest
dailySanitizers,
basis. A Inc. .....................................................................................9
cross-departmental approach to successfully generate hazard and risk awareness is succeeding.
888.225.3267 • www.bestsanitizers.com/nextstep6
managing these various exposures is necessary in the new age
Bia Diagnostics, LLC • 802.540.0148 • www.biadiagnostics.com ........57
of changing risk. Engaging departments outside the typical Conclusion
A As higher
extensively level ofabove, one critical key to success is
Bio-Rad Laboratories • www.bio-rad.com/info-foodsafety.................43
food safety and quality staff such as marketing, R&D, pur- discussed
BioControl Systems, Inc. ..........................................................................31
chasing, legal, and
800.245.0113 the C-suite is crucial to tomorrow’s thriv-
• www.biocontrolsys.com food
using safety
meaningful intelligence.
metrics to ensure each facility and the com-
ing food safety programs and creating an integrated, mature
bioMérieux ..................................................................................................47 pany as a whole are on a path of continuous improvement.
culture where food safety becomes embedded in the everyday
www.biomerieux-usa.com/industry/gene-up Metrics
Hitachimeasure
HiQ eSystems™ behavior. But the master key? The one that
monitors
behavior of the entireCo.
Carter Manufacturing organization.
........................................................................63 hasperishable
the potential assetstotounlock nearly
ensure safe, endless learning opportuni-
reliable,
As 616.842.8760 • www.carterbearings.com
such, applying ERM principles to food safety culture sanitary
ties? Action. transportation
It’s what weand storage. do with the outcome of
as industry
Copan Diagnostics
programs is highlyInc. • 800.216.4016Using
advantageous. • www.copanusa.com
this approach, ............53
the those metrics—this is the master key.
Diamond
food safety V •organizational
800.373.7234 • www.diamondv.com/foodsafety
structure and long-term goals ...........67
are Trackimportant
Equally back of house in real time via
is collaboration—whom we take action
ELISA Technologies, Inc. • 352.337.3929 • www.ezgluten.com ..........45 desktop, tablet, or smartphone
sculpted by senior leadership and the board of directors, much with on those meaningful metrics to create actionable infor-
Elution
like the Technologies
Maple Leaf .................................................................................59
Foods and PepsiCo case studies. This top mation.Record
This istemperatures
where cross-functional ERM principles can
802.540.0296 • www.elutiontechnologies.com automatically at all times
group weighs in on food safety strategy, ensures alignment be applied to this process, which ultimately contribute to a
Food Safety Connect • www.foodsafetyconnect.com...........................66 Alert
with the overall corporate strategy, participates in the risk
Food Safety Matters Podcast
mature foodviasafety
text, culture.
email, orThe call food safety and quality team
identification and assessment process ..............................................2
www.foodsafetymagazine.com/podcast to identify potential cannot Protect your assets
do everything alone,24/7,
and365 should not, as other depart-
events that, if they occur, will
Guardian Ozone • 321.631.4580 • guardianozone.com affect the organization, and
........................21 ments are dependent on the success of making safe food every
identifies ways to manage risk within its organization’s
Hitachi High-Tech • 844.511.5999 • hiqesystems.com ..........................75 risk Protect your brand. Protection for your assets.
day.
appetite.
Hollison, LLC • 270.713.0274 • www.hollison.com.................................41 As seen, we need to be smart about what and how much
Hygiena,
PepsiCo’sLLC •near-miss
888.HYGIENA • www.hygiena.com
program and Maple ...............................19
Leaf Food’s FSIR we measure. Data overload is a real concern and can lead to
Industrial
metric Test process
review Systems,are Inc.both• www.exactdip.com
part of a broader ...............................
hazard and17 an Challenging
environment of generating data that are hiqesystems.com
ignored and not
the Future through Engineered Solutions 844-511-5999
Kikkoman
risk awareness • KikkomanA3.com
program, serving ..................................................................51
as good examples of an ERM turned into action. Driving a culture of safety in an organi-
Kreyenborg Plant Technology GmbH & Co ..........................................68
Fwww.kreyenborg.com
ROM FOOD SAFETY MAGAZINE
Meritech • 800.932.7707 • www.meritech.com ........................................3
Michelson Laboratories, Inc....................................................................75
888.941.5050 • www.michelsonlab.com
Exclusive
Micreos • www.phageguard.com ...............................................................7
Micro Bio • 248.288.6098 • www.microbiollc.com ................................45
Micro Essential Laboratory Inc. • www.MicroEssentialLab.com .......70
Food
Microbac Laboratories, Inc. ...................................................................27
724.814.0973 • www.microbac.com/unseen
Safety
Microbiology International .....................................................................15
800.EZ.MICRO • www.800EZMICRO.com
Culture
MilliporeSigma • Sigmaaldrich.com/food ..............................................76
Nelson-Jameson, Inc. • 800.826.8302 • www.nelsonjameson.com ...72
Neogen Corp. • 800.234.5333 • foodsafety.neogen.com .................1, 25
Collection
PerkinElmer Inc. • www.perkinelmer.com/pesticides ..........................35
Pickering Laboratories, Inc. • www.pickeringlabs.com .......................72
Q Laboratories, Inc. • 513.471.1300 • www.qlaboratories.com ............66
R-Biopharm, Inc. • 877.789.3033 • www.r-biopharm.com ...................65
Radio Frequency Co. • 508.376.9555 • www.macrowave.com ...........49
Roka Bioscience, Inc. ................................................................................65
855.ROKABIO • www.rokabio.com
Romer Labs Inc. • 302.781.6400 • www.romerlabs.com ......................23
Download the
SAFE-pHix LLC • 719.661.8200 • www.safe-phix.com ............................68
complete collection today!
SmartWash Solutions, LLC....................................................................... 71
831.676.9750 • www.smartwashsolutions.com
go.foodsafetymagazine.com/culture
Solar Biologicals Inc. • www.solarbiologicals.com ...............................33
Spartan Chemical Company, Inc. .............................................................5
See page 42 in this issue for the latest installment
800.537.8990 x211 • www.spartanchemical.com
Sponsored by: Inc. • 844.US.STEAM • www.steamericas.com ...............73
Steamericas,
Sterilex Corp. • www.sterilex.com/indicongel........................................61
Weber Scientific • 800.328.8378 • www.weberscientific.com .............11
J5u8n e n J u l y 2 0 1 7 F o o d S a f e t y M a g a z i 75
ne
FSM6717pg1-2,75-76.indd 75
FSM2319pg34-54,57-58Final.indd 58 6/1/17
2/5/19 12:09
1:59 PM
PM
Advertisers Index
FOOD SAFETY CULTURE SANITATION
Art’s Way Scientific, Inc.................................9
zation is often most effective when The original validation was of an
866.808.5609
the metrics and programs are simple, SSOP and was conducted to ensure the
www.buildingsforscience.com
straightforward, and easy to understand, procedure would generate a predictable
and when results are generated that are and successful result. A verification, Avure Technologies.......................................47
valuable and immediately used and therefore, would be a review to deter- 614.255.6633 • Avure-HPP-Foods.com
turned into actions. mine whether the procedure has been Best Sanitizers..................................................5
The old saying that “what gets mea- under control and has been consistently 888.225.3267 • www.bestsanitizers.com
sured gets improved” is often misin- generating successful results. The fol-
lowing are just some of the records that Bia Diagnostics, LLC...................................... 19
terpreted when one does not explicitly
could be included in a review: 802.540.0148 • www.biadiagnostics.com
understand that implied in “measuring”
is the imperative that a team must carry • Post-sanitation/preoperation Culture Media Concepts...............................43
out a timely and ritualistic review of inspection data 714.773.1726
those measures with the intent to take • Preoperational checks www.culturemediaconcepts.com
specific actions to improve on identi- • Consumer complaints
• Environmental pathogen monitoring Food Safety Magazine Culture eBook......58
fied deficiencies. That is the only way
data go.foodsafetymagazine.com/culture
to create the accountability model
necessary to drive food safety improve- In addition to a records review, I Food Safety Matters Podcast........................2
ment to its most mature state where strongly recommend verifications in- www.foodsafetymagazine.com/podcast
food safety culture is embedded in the clude conducting one trial of the origi-
Food Safety Summit........................................3
organization; where doing the right nal validation. This ensures the success
www.foodsafetysummit.com
thing, even when no one is watching, criteria are still being delivered by the
becomes an inherent behavior that ev- validated SSOP versus a procedure that Hiperbaric........................................................49
eryone, from the CEO to the line op- was changed and not validated. A single 305.639.9770 • www.hiperbaric.com
erator to R&D and marketing, just does trial demonstrates if anything affect- IAFP Annual Meeting.................................... 41
because it’s built into the fabric of the ing the original validation of the SSOP www.foodprotection.org/annualmeeting
inner workings of the organization. n significantly changed and if the SSOP is
still being followed as written. London Consulting Group...........................55
888.935.8448 • www.londoncg.com
Melanie Neumann, J.D., M.Sc., is president, Neu-
mann Risk Services, a Matrix Sciences Company. Conclusion Michelson Laboratories, Inc........................58
Marie Tanner, M.Sc., is senior vice president, food Monitoring, verification, and valida- 888.941.5050 • www.michelsonlab.com
safety and quality, Dairy Farmers of America. Randy tion will be difficult at best without
Microbiology International......................... 15
Huffman, Ph.D., is chief food safety and sustainabil- control of the cleaning process. When
800.EZ.MICRO • www.EZMICRO.com
ity officer, Maple Leaf Foods. Mike Liewen, Ph.D., is there is poor control, monitoring of
senior vice president, food safety and quality assur- day-to-day cleaning success will prob- Neogen Corp...................................................23
ance, PepsiCo Inc. ably depend on the variable opinions 800.234.5333 • foodsafety.neogen.com
of individuals versus the variable per-
NexCor Technologies, Inc............................60
References formance of whoever completed the
770.831.9191 • KLEANZ.com
1. Global Food Safety Initiative. April 2018. A work that day. Verification activities will
show these historically variable results. Pathogenia......................................................57
Culture of Food Safety: A Position Paper from
Finally, validation of cleaning processes 514.446.6500 • www.pathogenia.com
the Global Food Safety Initiative (GFSI).
2. Srinivasan, A and B Kurey. 2014. “Creating a that are not under control is meaning- Phoseon Technology.....................................54
Culture of Quality.” Harvard Business Review less because there is little consistency. www.phoseon.com
92(4):23–25. Variability is the enemy. Is your factory
losing this fight with variability in the Pickering Laboratories, Inc.........................57
3. geerthofstede.com/research-and-vsm/
cleaning process? The best way I know www.pickeringlabs.com
vsm-2013/.
to combat this is to have validation, Radio Frequency Co...................................... 11
verification, and monitoring of clean- www.radiofrequency.com
NEW! Exclusive ing based on detailed SSOPs, which,
Solus Scientific...............................................29
Food Safety Culture when followed as written, are capable of
www.solusscientific.com/solus-one
predictably and consistently delivering
Collection mutually agreed upon success criteria. n TandD US, LLC.................................................37
Visit go.foodsafetymagazine.com/culture 518.669.9227 • www.tandd.com
to download your copy today! Duane Grassmann is the corporate hygiene manager
Weber Scientific.............................................33
at Nestlé USA.
800.328.8378 • www.weberscientific.com
FSM2319pg1-2,59-60.indd 59 2/8/19 9:52 AM

EVERYTHING FOOD SAFETY
IN ONE PLACE IN REAL-TIME
All departments
vs.
Spreadsheets 3-Ring Binders
Email
Manual Processes
Paper Files
Calendar Actions Phone

Filing Cabinets
AUDIT READY
EVERY DAY
• Risk Mitigation
• Transparency
KLEANZ.co
NEXCOR TECHNOLOGIES
770.831.9191 • info@kleanz.com
• Continuous Improvement KLEANZ.com
FSM2319pg1-2,59-60.indd 60 2/8/19 9:52 AM

Foodsafety20190203 DL

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Foodsafety20190203 DL

Uploaded by

Copyright:

Available Formats

FSM2319pg1-2,59-60.

indd 1 2/8/19 9:52 AM

The Biggest Issues Discussed by Some of the Biggest Names

43+ Episodes available

FSM2319pg1-2,59-60.indd 2 2/8/19 9:52 AM

Food Safety Progress?

FULL AGENDA NOW AVAILABLE

PLATINUM SPONSOR GOLD SPONSOR MEDIA PARTNER

FSM2319pg3-7,59Final.indd 3 2/5/19 1:31 PM

18 Food Safety Insights:

4 Food Safety Magazine

FSM2319pg3-7,59Final.indd 4 2/6/19 1:29 PM

To learn more, call 888-225-3267

Largest Variety of Hand Hygiene

BSX Boot Scrubber™ Series

FSM2319pg3-7,59Final.indd 5 2/5/19 1:31 PM

6 Food Safety Magazine

FSM2319pg3-7,59Final.indd 6 2/5/19 1:31 PM

USDA’s 2018 Food Safety JAMA Study Reveals Some Adults

People & Places Kreza to the position of vice president, global

February n March 2019 7

FSM2319pg3-7,59Final.indd 7 2/5/19 1:31 PM

Radiofrequency Pasteurization Advantages of RF Heating

of Low-Moisture Foods: Critical waves. Thus, RF heating has advantages

Process Control Parameters with microwave heating.3 Its longer

8 Food Safety Magazine

FSM2319pg8-31,55-56Final.indd 8 2/5/19 1:21 PM

February n March 2019 9

FSM2319pg8-31,55-56Final.indd 9 2/5/19 1:21 PM

10 Food Safety Magazine

FSM2319pg8-31,55-56Final.indd 10 2/5/19 1:21 PM

February n March 2019 11

FSM2319pg8-31,55-56Final.indd 11 2/5/19 1:21 PM

Regulations: What This Means of 12–30 months based on food com-

for the Food Industry

more time Some businesses are affected immediately

12 Food Safety Magazine

FSM2319pg8-31,55-56Final.indd 12 2/5/19 1:21 PM

February n March 2019 13

FSM2319pg8-31,55-56Final.indd 13 2/5/19 1:21 PM

Foods Produced by quired harvesting and purification from

Biotechnology: A Toxicologist’s porcine- and bovine-sourced insulin

Perspective on Intended vs.

14 Food Safety Magazine

FSM2319pg8-31,55-56Final.indd 14 2/5/19 1:21 PM

February n March 2019 15

FSM2319pg8-31,55-56Final.indd 15 2/5/19 1:21 PM

16 Food Safety Magazine

FSM2319pg8-31,55-56Final.indd 16 2/5/19 1:21 PM

Starting Organism Technique Intended Changes Unintended Changes EU Court Opinion

February n March 2019 17

FSM2319pg8-31,55-56Final.indd 17 2/5/19 1:21 PM

Recalls and Outbreaks: year in that regulators acknowledged

How WGS Will Change primarily targeted at those consum-

the Rules without WGS, this ground beef out-

18 Food Safety Magazine

FSM2319pg8-31,55-56Final.indd 18 2/5/19 1:21 PM

We are your lab, working with you to create the highest

Now Offering real-time PCR for

Same Day Allergen Analysis

Bia Diagnostics, LLC 802 540 0148

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

20 Food Safety Magazine