EMERGING PATHOGENS IN DRY AND LOW-MOISTURE FOODS - Which pose the most risk? - PLUS The Meaning of "Milk" Food Dust Control Nanoemulsions
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PLUS The Meaning of “Milk” ■ Food Dust Control ■ Nanoemulsions
Volume 28 Number 3
JUNE / JULY 2021
EMERGING
PATHOGENS
IN DRY AND
LOW-MOISTURE
FOODS
Which pose the most risk?
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Contents
JUNE/ JULY 2021 • VOLUME 28 NUMBER 3 • www.foodqualityandsafety.com
Features
16
COV E R STO R Y
Food Safety
in Dry, Low-Moisture,
and Low-Water-
Activity Foods
Part 1: Emerging pathogens
BY PURNENDU C. VASAVADA, PHD
AND ALVIN LEE, PHD
Safety & Sanitation Quality
24 26
How to Control Food Dusts Shelf Life and the
COVER: ©EZUME IMAGES - STOCK.ADOBE.COM / ©PATTADIS - STOCK.ADOBE.COM
in Your Processing Facility Clean Label Movement
Dusts can be combustible hazards As consumers demand more “natural” ingredients
and cause cross-contamination in their food and beverages, manufacturers take steps
BY ANDY THOMASON
to keep up with clean label preservative technology
BY ANDREA TOLU
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June / July 2021 3
Contents
(Continued from p. 3)
In The Lab Food Service & Retail
28 USING DIRECT MASS 37 INDUSTRY STANDARDS
SPECTROMETRY TO VERIFY AND THE “LAST MILE”
©IRINA - STOCK.ADOBE.COM
PRODUCT AUTHENTICITY How standards can help keep
The technology allows for rapid temperature-sensitive products
classification to quickly screen for safe during food delivery
food fraud
BY NEIL COOLE
BY SIMON HIRD, PHD
Manufacturing & Cannabis Corner
Distribution 14 NANOEMULSIONS IN FOODS
©F - STOCK.ADOBE.COM
AND BEVERAGES
30 VISION-BASED DETECTION Experts debate the safety of this
SYSTEMS FOR FOOD technology for use in cannabis-
PROCESSING infused products
Recent advances in computing
BY JESSE STANIFORTH
have made it possible for
hyperspectral systems to operate
on the line, in real time
BY OLGA PAWLUCZYK C0lumns Departments
Washington Report 6 FROM THE EDITORS
10 THE CHALLENGE 8 NEWS & NOTES
WITH LEAFY GREENS
40 NEW PRODUCTS
©ANUWAT - STOCK.ADOBE.COM
FDA issues a report on recurring
E. coli outbreaks and calls for more 41 ADVERTISER DIRECTORY
collaboration among growers,
government, and academia to 41 EVENTS
mitigate the problem 42 SCIENTIFIC FINDINGS
BY KAREN APPOLD
34 HOW REMOTE MONITORING
CAN IMPROVE WATER
TREATMENT MANAGEMENT
Legal Update Food Quality & Safety
These systems can help keep
12 IN SEARCH OF THE MEANING magazine welcomes letters
watch on water conditions at your
OF “MILK” to the editor on any relevant
food processing facility The courts and legislators debate industry topic.
whether the term can be applied Letters should be no longer
BY ROB FUSCO to plant-based products than 350 words.
BY JOEL S. CHAPPELLE, ESQ., AND Submit letters to:
SHAWN K. STEVENS, ESQ. Samara E. Kuehne
Professional Editor
Email: skuehne@wiley.com
(Letters may be edited for space
and style.)
Visit us online! Other articles available at www.FoodQualityandSafety.com include:
• U.S. Organic Food Sales Reach • CDC Report Warns about Pathogens
Record High in 2020 in Raw Flour
• FQ&S Blog: Smarter Food Safety • Large Producer Seeks Delay in
Begins with Situational Leadership Implementing Pork Processing Line
Speed Limit
facebook.com/FoodQualityandSafety @FQSmag
4 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
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CERTIFIED
From The Editors PUBLISHERLisa Dionne Lento, ldionne@wiley.com
SENIOR ACCOUNT MANAGER Bob Zander, bzander@wiley.com
PROFESSIONAL EDITOR Samara E. Kuehne, skuehne@wiley.com
DESIGN Maria Ender, mender@wiley.com
PRODUCTION Claudia Vogel, cvogel@wiley.com
Jörg Stenger, jstenger@wiley.com
Thank a Mentor Elli Palzer, palzer@wiley.com
I
CO-INDUSTRY EDITOR Purnendu C. Vasavada, PhD,
used to keep a sign on my purnendu.c.vasavada@uwrf.edu
CO-INDUSTRY EDITOR Richard Stier, rickstier4@aol.com
desk that read, “The sign of
a good boss is that he/she Advertising Director
Dan Nicholas
hires people smarter than 111 River Street, Hoboken, NJ 07030
they are.” One can look at this in (716) 587-2181, dnicholas@wiley.com
different ways, but I like to think of Sales Office
that boss as not being afraid to hire U.S./Canada/International
Bob Zander
bright, dedicated people who are in- (312) 925-7648
bzander@wiley.com
terested in growing. Having a bright
team makes life easier, as the boss Editorial Office
111 River Street, Hoboken, NJ 07030-5774, USA
should be able to delegate responsi- Reprints: E-mail dsurdel@wiley.com
bilities, which makes operations more efficient. This also has the
potential benefit of boosting staff confidence and putting them
in a position where they might think, “The boss has placed his
Editorial Advisory Panel
confidence in me, so I don’t want to let him/her down.”
Managers with this attitude also tend to be great mentors. Sit John N. Butts, PhD Hasmukh Patel, PhD
Founder and President, VP of Research and Development,
back and think about your life. I’ll wager that you can identify FoodSafetyByDesign, LLC; Whitehall Specialties
several people who helped your career path and/or helped you Advisor to CEO, Land O’Frost
Mary Ann Platt
grow as a person and as a professional. I can look back and pick Cliff Coles President,
President, Clifford M. Coles CNS/FoodSafe and RQA, Inc.
several persons who fit that bill, including two very supportive Food Safety Consulting, Inc.
parents. In fact, my mother, Dr. Elizabeth Stier, has a major award Manpreet Singh, PhD
Professor,
Virginia Deibel, PhD
offered through the IFT in her name—the only award named after Chief Scientific Officer,
Dept. of Poultry Science,
University of Georgia
a woman. I can pick people from Rutgers: Roy Morse and Mike Deibel Laboratories
Shawn K. Stevens
Solberg. They focused on teaching problem solving, as opposed James Dickson, PhD Food Industry Attorney,
Professor,
to regurgitating every little fact related to an issue. When I was a Department of Animal Science,
Food Industry Counsel, LLC
graduate student at UC Davis, my advisor, Dr. George York, actu- Iowa State University Patricia A. Wester
CEO,
ally sent me out into the field to help processors in need of help. Steven Gendel, PhD The Association for Food Safety
It was sink or swim, and I managed to swim. Senior Director, Auditing Professionals,
Food Science, AFSAP
But the greatest mentors for me were those from the National Food Chemicals Codex at USP
Steven Wilson
Canners Association, later the National Food Processors Associ- Vijay K. Juneja, PhD Director of Seafood Commerce
Lead Scientist, and Certification,
ation, a trade association that represented the food canning and Predictive Microbiology for Food Safety, Office of International Affairs
processing industry. I joined the microbiology section, headed USDA-Agricultural Research Service and Seafood Inspection
up by Keith Ito, whom I am proud to claim as a friend and men-
tor. Keith allowed his people to work up to their abilities. It was
a real pleasure to watch Keith work with, listen to, and advise Printed in the United States by Dartmouth Printing, Hanover, NH.
people. He had a unique ability to lead the discussion so that Copyright 2021 Wiley Periodicals, Inc., a Wiley Company. All rights reserved. No part
of this publication may be reproduced in any form or by any means, except as permitted
by the end of a meeting, the client felt that they themselves had under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior
figured things out. Keith would smile and say, “Let me know if written permission of the publisher, or authorization through the Copyright Clearance
Center, 222 Rosewood Drive, Danvers, MA 01923: (978) 750-8400: fax (978) 750-4470.
you have questions.” All materials published, including but not limited to original research, clinical notes,
If you have people in your lives who are mentors, consider editorials, reviews, reports, letters, and book reviews represent the opinions and views of
the authors and do not reflect any official policy or medical opinion of the institutions with
yourselves fortunate. We at Food Quality & Safety hope that you which the authors are affiliated or of the publisher unless this is clearly specified. Materials
may find one or two pieces in each issue that are added to your published herein are intended to further general scientific research, understanding, and
discussion only and are not intended and should not be relied upon as recommending or
reference files. We may not be mentors, but we hope we are a promoting a specific method, diagnosis or treatment by physicians for any particular patient.
good source. While the editors and publisher believe that the specifications and usage of equipment
and devices as set forth herein are in accord with current recommendations and practice
at the time of publication, they accept no legal responsibility for any errors or omissions,
and make no warranty, express or implied, with respect to material contained herein.
Richard F. Stier Publication of an advertisement or other discussions of products in this publication should
Co-Industry Editor not be construed as an endorsement of the products or the manufacturers’ claims. Readers
are encouraged to contact the manufacturers with any questions about the features or
limitations of the products mentioned.
6 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
NEWS & NOTES
Researchers Discover Listeriosis has a mortality rate of 20% to dress the unique attributes of controlled,
Five New Species of Listeria 30%, even for patients taking antibiotics, indoor environments,” says Marni Karlin,
While examining the prevalence of Liste- according to FDA. The Centers for Disease executive director of the coalition. “This new
ria in agricultural soil throughout the U.S., Control and Prevention estimate that 1,600 certification process and the accompanying
scientists at Cornell University in New York people in the U.S. acquire listeriosis annu- on-pack seal help to unify CEA growers while
City have stumbled upon five previously un- ally, and nearly 260 die. also differentiating them from traditional
known relatives of the bacteria. The discov- “This paper describes some unique field agriculture.”
ery, researchers say, will help food facilities characteristics of Listeria species that are CEA takes a technology-based ap-
identify potential growth niches that, until closely related to L. monocytogenes, which proach to produce optimal growing condi-
now, may have been overlooked, which will be important from an evolutionary per- tions inside controlled environments such
could improve food safety. spective and from a practical standpoint for as greenhouses and indoor vertical farms.
The research was published May 17, 2021 the food industry,” says co-author Martin Plants are typically grown year-round using
in the International Journal of Systematic Wiedmann, PhD, a professor in food safety hydroponic, aeroponic, or aquaponic meth-
and Evolutionary Microbiology. and food science. “Likely, some tests will ods, without the need for pesticides and un-
“This research increases the set of Liste- need to be re-evaluated.” affected by climate or weather.
ria species monitored in food production Understanding the different Listeria “The CEA industry is rapidly expanding
environments,” says lead author Catharine species is key to comprehending their simi- and predicted to support more than 10%
R. Carlin, a doctoral student in food science. larities. “This will help us to get better about of U.S. vegetable and herb production by
“Expanding the knowledge base to under- identifying L. monocytogenes,” Dr. Wied- 2025,” says Rebecca Anderson, technical
stand the diversity of Listeria will save the mann says, “and not misidentifying it as key account manager for GLOBALG.A.P.
commercial food world confusion and er- something else.” North America. “The CEA FSC Leafy Green
rors, as well as prevent contamination, ex- Since 2010, Dr. Wiedmann’s research Module will set a new industry standard for
plain false positives, and thwart foodborne group has discovered 13 of the 26 species CEA-grown produce while driving consumer
outbreaks.” classified in the genus Listeria. “When you’re awareness of the innovations happening in
inspecting the environments of food process- indoor agriculture today.”
ing plants or restaurants, you need to know The certification program is available to
the pathogenic Listeria from the non-patho- all coalition members for a nominal cost and
©KATERYNA_KON - STOCK.ADOBE.COM
genic species,” he says. “You need to tell the must be completed on an annual basis. CEA
good guys from the bad guys.” growers can be assessed at multiple sites
across four key areas:
• Hazard analysis: use of water, nu-
Group Launches Food Safety Standard trients, growing media, seeds, inputs, site
for Indoor-Grown Leafy Greens control and other relevant factors.
The CEA Food Safety Coalition (FSC), a group • Water: all contact with the plant and
One of the novel species, L. immobi- composed of leaders in the controlled en- with food contact surfaces. The use of recir-
lis, lacked motility. Motility has previously vironment agriculture (CEA) industry, has culating water will require a continuing haz-
been thought to be common among Listeria announced the first-ever food safety certi- ard analysis. Will also require zone-based
closely related to L. monocytogenes and fication program specifically for CEA-grown environmental monitoring based on com-
used as a key test in detection methods. This leafy greens. pany-specific risk assessment.
discovery effectively calls for a rewrite of the Members of the coalition can now choose
standard identification protocols issued by to be assessed for the CEA Leafy Greens Mod-
food safety regulators, Carlin says. ule and, upon successful completion, will be
As Listeria species are often found allowed to use the CEA food-safe seal on
co-existing in environments that support the certified product packaging. The module is
©PRESSMASTER - STOCK.ADOBE.COM
growth of L. monocytogenes, food facilities measured against science-based criteria and
will monitor for all Listeria species to verify is an add-on to existing compliance with an
their sanitation practices. underlying Global Food Safety Initiative (GF-
L. monocytogenes can have profound SI)-recognized food safety standard.
pathogenic influence on food processing “Current food safety standards were
plants and those plants must be kept clean. written for the field, and many do not ad-
8 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
• Site control/infrastructure system were able to describe what the “Use By”
design: all food contact surfaces and adja- label meant. It’s easy to understand why
©NATIKA - STOCK.ADOBE.COM
cent food contact surfaces, including plant these labels are confusing. The “Use By”
containers; will also assess associated farm date indicates when a food item may no lon-
physical hazards, including lighting, robot- ger be safe to consume. According to USDA,
ics, sensors, equipment, and utensils. you shouldn’t eat, cook or freeze any items
• Pesticide use/testing: the use of if this date has passed. The “Best If Used By”
pesticides or herbicides during the plant life date is when the food will be at its optimum
cycle. gation, seepage, and drainage) subsamples flavor and/or quality. USDA notes that this
The coalition was founded in 2019 to and in one sediment subsample; however, isn’t a “must purchase by” date, but merely
represent the interests of CEA leafy greens the whole genome sequencing of these sam- a suggestion of when you should eat it. If a
growers in developing credible and appro- ples did not match the outbreak strain. food looks and smells fresh a few days after
priate food safety standards while educating Although a conclusive root cause could this date, it’s still safe to consume.
consumers and regulators alike on the value not be identified, one leading hypothesis is “Educational messages are needed to
of controlled environment agriculture. that contaminated irrigation water used in improve understanding of the food indus-
a growing field in Holtville may have led to try’s date labeling system,” Turvey adds.
contamination of the onions. “The messages we tested significantly
Irrigation Water Likely Cause of 2020 Thomson International, Inc. cooperated improved understanding, but even after
Salmonella Outbreak in Red Onions with FDA throughout the investigation and reading an educational message, misunder-
In May 2021, FDA released a report on its in- is continuing to engage with the agency re-
vestigation of the Salmonella Newport out- garding its findings and recommendations.
break that caused more than 1,600 reported
illnesses in the U.S. and Canada between
June and October 2020. The agency worked Study: Many Consumers Confused
©TIJANA - STOCK.ADOBE.COM
with the U.S. Centers for Disease Control and about Food Date Labels
Prevention, state partners, and Canadian of-
BY KEITH LORIA
ficials (the Public Health Agency of Canada
and the Canadian Food Inspection Agency) Although most consumers rely on “Best If
to investigate the outbreak, which was Used By” and “Use By” notations on date la-
linked through epidemiology and traceback bels to make decisions about food, beliving standing was still common. The familiarity of
to whole red onions supplied by Thomson they know what these phrases mean, new food date labels and consumers’ overconfi-
International, Inc., headquartered in Ba- research shows that consumers commonly dence in their own understanding of the la-
kersfield, Calif., with an additional location misunderstand this system. A new study bels may be a barrier to reaching consumers
in Holtville, Calif. published in the Journal of Nutrition Edu- with educational messaging about what the
The outbreak is the largest Salmonella cation and Behavior, examined consumer labels mean.”
foodborne illness outbreak in more than a understanding of the U.S. food industry’s la- Once the researchers provided a brief
decade. The FDA report includes an overview beling system and the relative effectiveness explanation on what the two food label terms
of the traceback investigation, subsequent of messages in increasing understanding. meant, the level of understanding increased,
on-site interviews, visual observations of the “The majority of people use date labels with 82% of participants describing “Best If
growing fields, environmental sampling, and to make decisions about food,” says Cather- Used By” correctly and 82.4% explaining the
various factors that potentially contributed ine Turvey, MPH, a public health specialist in “Use By” label correctly.
to the contamination. the department of exercise and nutrition sci- The researchers believe that standardiz-
The report identified several potential ences at the Milken Institute School of Public ing labels and reducing the variety of labels
contributing factors to the outbreak in red Health at The George Washington University on products could help lower confusion.
onions: in Washington, D.C., and lead author of the “The food industry took an important step
• Potentially contaminated sources of study. “Misunderstanding food date labels by creating a voluntary standardized sys-
irrigation water; is a problem because it can lead people to tem with just two labels,” Turvey says. “As
• Sheep grazing on adjacent land; eat food that is no longer safe or waste food this system becomes more widely adopted,
• Signs of animal intrusion, including that is still good to eat. Reducing confusion engaging educational messaging is needed
scat (fecal droppings), and large flocks of around food date labeling is an important to help people realize they may misunder-
birds that may spread contamination; and strategy for reducing waste of food.” stand date labels and teach them the label
• Food contact surfaces that had not Americans throw out about a third of all meanings.”
been inspected, maintained, or cleaned as food purchased, representing more than $161 FDA has recently championed the con-
frequently as necessary to protect against billion in wasted food each year, she says. version to just the “Best If Used By” label in
the contamination of produce. The study polled 2,607 U.S. adults, and an effort to standardize labeling and help to
In sampling conducted in Holtville, FDA 64% correctly explained what the “Best If reduce food waste, but the agency hasn’t
found Salmonella Newport in 10 water (irri- Used By” label meant, while just 44.8% yet mandated any specific language.
June / July 2021 9
Washington Report
lettuce contamination with the strains of
STEC. Furthermore, FDA encouraged pro-
ducers in the Central Coast of California
growing region to participate in the Cal-
ifornia Longitudinal Study, an initiative
launched in November 2020 to improve
food safety after continued E. coli out-
breaks, and in a locally led, locally con-
vened workgroup organized by the Cali-
fornia Department of Food and Agriculture
and the Monterey County Farm Bureau to
identify what actions can be taken to re-
duce contamination.
When pathogens are identified
through microbiological surveys or
pre-harvest or post-harvest testing, FDA
recommends that growers implement
industry-led root cause analyses to de-
termine how the contamination likely oc-
curred and then implement appropriate
prevention and verification measures, Dr.
The Challenge
Gorny says.
Another Step: Updating the Leafy
with Leafy Greens Greens Action Plan
In addition to its investigation, FDA has
FDA issues a report on recurring E. coli outbreaks updated its Leafy Greens STEC Action
Plan (LGAP), originally released in 2020,
and calls for more collaboration among growers, for 2021. The new plan includes steps the
government, and academia to mitigate the problem agency will take in collaboration with
BY KAREN APPOLD leafy green stakeholders to advance let-
tuce safety.
E
The update is informed by work and
. coli outbreaks linked to leafy years: a reoccurring strain, a reoccurring knowledge gained over the past year.
greens grown in the California region, and reoccurring concerns with the “New actions have been added based on
Central Coastal region have potential impacts of adjacent lands. information collected and lessons learned,
plagued the area since 2017, de- According to Jim Gorny, PhD, senior including those from the 2020 investigative
spite efforts to stop them. The most recent science advisor for produce safety at FDA’s report,” Dr. Gorny says. “The updated plan
outbreak, in the fall of 2020, prompted an Center for Food Safety and Applied Nutri- includes a renewed emphasis on actions to
FDA investigation; the agency published tion in College Park, Md., the reoccurring prevent contamination stemming from ac-
its findings in April 2021. pathogenic E. coli strain appears to be a tivities on adjacent land, announces new
The investigation found that samples reasonably foreseeable hazard, specifi- actions that build on the accomplishments
collected in response to leafy greens out- cally in the South Monterey County area of and learnings from the 2020 plan, and re-
©IAKOV FILIMONOV - STOCK.ADOBE.COM
breaks in 2019 and 2020 contained the the Salinas Valley and Santa Maria Valley news FDA’s commitment to complete cer-
same strain of Shiga toxin-producing E. coli growing regions. tain actions that were difficult to accom-
(STEC) O157:H7. In light of this finding, FDA FDA’s report recommended that agri- plish in 2020 due to challenges presented
analyzed trends across outbreaks that had cultural communities in the affected areas by the COVID-19 pandemic.”
occurred each fall since 2017 and found work to identify where the reoccurring In commenting on the updated LGAP,
three key trends in the contamination of strain of pathogenic E. coli is persisting in Ben Miller, MPH, PhD, senior director of
leafy greens by E. coli O157:H7 in recent the environment and the likely routes of scientific and regulatory affairs at The
10 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comAcheson Group, a global food safety con- leafy greens safety, knowledge gaps still says it’s important to understand how
sulting group based in Bigfork, Mont., says, exist, which can be explored in new ways STEC from the environment makes its
“These approaches have been updated for through the use of emerging technologies, way onto leafy greens. “Monitoring and
2021 to better understand how STEC can Dr. Gorny says. Addressing these knowl- treating irrigation water is common
move from the surrounding environment edge gaps is critical to advancing future sense and an achievable control com-
and contaminate produce grown in Califor- prevention activities. pared to controlling by windborne con-
nia and Arizona. Based on investigations It’s also important to recognize that tamination,” he says. “Seasonal climate
in 2019 and 2020, addressing risks from these are not siloed areas of focus, but patterns may contribute to windborne
nearby cattle operations form the basis of rather numerous points of intersection contamination in the Salinas Valley;
many updates in the 2021 plan.” and mutual reinforcement, Dr. Gorny more research is needed in this area to
The updated LGAP includes 33 specific adds. understand the role that weather, cli-
action items. Each of these three approaches ac- mate, and cattle proximity play in field-
knowledges a current lack of data or con- level contamination.”
A Closer Look at LGAP sensus in a particular area. “By collecting A root cause analysis will seek to elim-
The updated LGAP emphasizes three more data, FDA hopes to create a more inate the hazard at its source, as cattle are
components: objective assessment of contributing risk a known and well-documented reservoir
• Enhancing prevention strategies; factors and preventive measures for leafy for STEC, Dr. Miller says. Cattle vaccines
• Improving response activities by FDA greens grown in the Yuma and Salinas re- against E. coli O157:H7 are commercially
and other entities; and gions,” Dr. Miller says. available, although their uptake has
• Identifying and addressing knowledge been limited. Cattle may not be the only
gaps that exist around STEC contami- Outlook source of environmental STEC where
nation of leafy greens. FDA and the leafy greens industry have lettuce is grown, although FDA investi-
Regarding prevention strategies, Dr. been working to reduce E. coli contam- gations in 2019 and 2020 identified the
Miller says the new approaches are largely ination in leafy greens since 2006. “A lot outbreak strain in cattle feces surround-
focused on irrigation water and adjacent of progress has been made and, while the ing growing fields identified in traceback
land use; however, the close proximity of risk is less today than it was in 2006, the investigations.
cattle to these growing areas and unknown ongoing outbreaks show that risks still While more research is needed to un-
routes of contamination from the environ- exist,” says David Acheson, MD, CEO, and derstand how STEC moves from cattle to
ment to leafy greens makes developing president of The Acheson Group. leafy greens, testing technology can also
and validating effective mitigation and Obviously, the problem has not been play a role in detecting contamination
control measures difficult. resolved despite the California Leafy events. “With COVID-19, we’ve seen that
Ensuring that outbreak response ac- Greens Marketing Agreement, a program rapid testing platforms can be quickly de-
tivities are conducted as quickly and thor- implemented in 2007 to ensure safe leafy veloped and in-line harvesting sampling
oughly as possible is essential for prevent- greens and a much greater use of testing with rapid turnaround times could allow
ing illnesses, Dr. Gorny says. In addition, it than in the past, Dr. Acheson says. “Part the industry to more quickly detect field-
is critical that FDA and stakeholders share of the problem links back to gaining a bet- level contamination at harvest time,” Dr.
lessons learned to inform future preven- ter understanding of the root cause, for Miller says.
tion efforts. example, the movement of E. coli in dust “If we continue to see outbreaks as-
“Much of the 2021 focus is on improv- and driven by the wind—which is hard to sociated with animal agricultural oper-
ing information sharing between FDA and control,” he says. ations, policy makers may decide that
the industry and improving the rapidity Dr. Acheson says situations still exist additional regulations on this industry
and accuracy of traceback investigations,” in which growers are not fully leveraging are needed to help manage these risks
Dr. Miller says. “Sharing learnings from what is known around risk: Some still grow through prioritizing land use or other
past outbreaks can help the FDA and in- lettuce at the bottom of a hill on which regulatory changes,” Dr. Miller adds.
dustry better understand potential sources cattle are grazing. While there are many “Produce growers are growing a ready-
of contamination. Traceback investiga- more controls in place today, along with to-eat food product outdoors, and there
tions have demonstrated their usefulness regulatory requirements in the form of the are probably limits on what they can in-
in helping determine the cause of out- FSMA Final Rule on Produce Safety, the dependently do to detect and prevent spo-
breaks and point investigators to suspect risks remain and the ultimate controls are radic contamination events that may still
growing fields to narrow the scope of field elusive. “As long as both live animals and lead to an outbreak. Success in reducing
investigations and sampling. Improving leafy greens are raised in the same broader these risks will require multiple stakehold-
traceability can also limit the impact and environment, this problem is not likely to ers to come together and identify how they
scope of consumer advisories when the totally go away,” he says. can minimize the risk of STEC in the envi-
next outbreak occurs if the source of an ronment in these growing regions.” ■
outbreak can be quickly identified.” Mitigating the Issue
While FDA and stakeholders have In order to resolve the issue of E. coli Appold is a writer in Lehigh Valley, Pa. Reach her at kappold@
greatly expanded what is known about contaminating leafy greens, Dr. Miller msn.com.
June / July 2021 11Legal Update
cerns about animal welfare, environmen-
tal impacts, and perceptions about the
nutritional value of plant-based products.
In response to the explosive growth
of plant-based dairy alternatives, i.e., al-
mond milk and oat milk, the dairy indus-
try has vociferously argued that using the
term “milk” in the names of these prod-
ucts should be prohibited. According to
the National Milk Producers Federation,
“Dairy farmers take great pride in their
high-quality, nutritious dairy products
and have spent many decades building
consumer confidence in them. Imitations
should not be allowed to unfairly capital-
ize on these associations, especially in
ways that encourage inadequate nutrition
and consumer confusion.” The organiza-
tion further advocates for efforts to end
the “continued proliferation and market-
ing of mislabeled non-dairy substitutes for
standardized dairy foods misrepresented
as ‘milk,’ ‘cheese,’ ‘butter,’ ‘yogurt,’ ‘ice
cream,’ or other dairy foods.”
Conversely, the Good Food Institute
(GFI), an organization that advocates on
In Search of
behalf of plant-based products, contends
that consumers are not fooled by plant-
based dairy alternatives. The GFI asserts
the Meaning of “Milk” itself as a proponent of protecting plant-
based companies’ first amendment rights
The courts and legislators debate whether to label their products using words that
consumers understand. Echoing recent
the term can be applied to plant-based products
court holdings, GFI argues that no rea-
BY JOEL S. CHAPPELLE, ESQ., AND SHAWN K. STEVENS, ESQ. sonable consumers are misled by the term
“almond milk,” which any consumer in-
A
stantly understands is not cow’s milk.
ttempts to legislatively con- by the complete milking of one or more
strain the English language healthy cows.” The FDA’s standard of iden- Legislation and Regulation
are rarely successful. There are tity of course excludes the milk from goats Politically, the campaign for and against
many reasons for this, both le- and other mammals. One final definition plant-based dairy alternatives has been
gal and practical. Yet, the appetite for such from Merriam Webster is “a liquid resem- bipartisan. In April 2021, U.S. Senator
efforts, especially in the food industry, bling milk in appearance, such as the latex Tammy Baldwin (D-Wisc.), who is the
seems to be all but insatiable. This article of a plant or the contents of an unripe ker- chair of the Senate Agriculture Appropria-
explores ongoing attempts to constrain nel of grain.” tions Subcommittee, and U.S. Senator Jim
the use of the term “milk,” and the legal In recent years, significant acrimony Risch (R-Idaho) reintroduced the Dairy
battles being waged in furtherance of that has arisen over which types of products Pride Act, a piece of federal legislation
pursuit. may be called “milk.” Throughout the that seeks to force FDA to take punitive
The online Merriam Webster dictio- country, laws are being enacted and bat- measures against food producers that use
nary offers several definitions of “milk.” tles are being waged—both in the court of dairy terms, such as “milk,” “cheese,” and
The first is “an opaque white fluid rich in public opinion and the actual courts—over “yogurt,” to describe plant-based dairy al-
fat and protein, secreted by female mam- what types of products may be called milk. ternatives. The act previously stalled in the
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mals for the nourishment of their young.” The increasing popularity of plant-based legislature, and it is unclear whether it will
Another is to exploit or defraud someone. milk alternatives is largely attributable to pass this time around.
FDA’s standard of identity for milk pro- shifting views about the health benefits From a regulatory standpoint, the
vides that “nilk is the lacteal secretion, of cow’s milk and the moral implications debate hinges on whether these products
practically free from colostrum, obtained of animal agriculture, which include con- are misleading or misbranded. The Food,
12 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comDrug, and Cosmetic Act (FDCA) prohibits On the one hand, it’s critically important to main-
the introduction or delivery into interstate
commerce of any misbranded foods. A
tain prohibitions against deliberately misleading or
food is misbranded if it violates any of the deceiving consumers. On the other hand, society
voluminous and arguably arcane labeling must take great care not to enact linguistic pre-
regulations intended to prevent manufac- scriptions, especially for the purpose of granting a
turers from misleading consumers about
the make-up or nutritional value of foods.
commercial advantage to one industry over another.
Under these regulations, a food is mis-
branded “if it purports to be or is repre-
sented as a food for which a definition and soy milk provided quality, taste, and nutri- The court went so far as to compare the
standard of identity has been prescribed tional benefits comparable to cow’s milk. plaintiffs’ claims in Ang to those in another
by regulations.” The court disagreed with the plain- case, Werbel ex rel. v. Pepsico, Inc. In Wer-
FDA has historically posited that the tiffs and held that the standard of identity bel, in which the plaintiff claimed to have
standard of identity for “milk” only ap- regulation “simply means that a company believed “Cap’n Crunch’s Crunch Berry”
plies to the use of the unqualified term. cannot pass off a product as ‘milk’ if it does cereal derived its nutrition from actual fruit
As such, if a producer of almond milk not meet the regulatory definition of milk.” because of its label’s reference to berries
simply labeled their product as “milk,” it The court assested that it was implausible and because the “crunch berries” resem-
would be mislabeled. Indeed, when the to believe that a reasonable consumer bled real berries. The court derided the
regulation establishing the identity stan- would believe soy milk is cow’s milk and allegations as “nonsense,” observing that
dard for “milk,” was promulgated, FDA has the same qualities as cow’s milk. In the word “berries” was always preceded by
stated the standard would not preclude granting the extraordinary relief of dis- the word “crunch” and that the crunch ber-
the use of the term “milk” for qualified missing the case, the court reasoned that ries depicted on the label did not remotely
products like chocolate milk. By way of Gitson was “one of those rare cases where resemble any naturally occurring fruit.
comparison, there are other similarly sit- the accused label itself makes it impossible These disputes highlight an import-
uated foods, such as corn bread and rice for the plaintiff to prove that a reasonable ant area of tension in the law. On the one
noodles, which are not bread or noodles consumer is likely to be deceived.” hand, it’s critically important to maintain
in the traditional sense. According to GFI, Ang v. Whitewave Food Co. resulted in prohibitions against deliberately mislead-
it’s equally clear that almond milk and a similar outcome. In this case, the plain- ing or deceiving consumers. On the other
other plant-based milks do not purport to tiffs alleged that the defendants had mis- hand, society must take great care not to
be “milk.” branded Silk products by using names enact linguistic prescriptions, especially
For several years, FDA has been re- like “soymilk,” “almond milk,” and “co- for the purpose of granting a commercial
viewing whether these terms are likely to conut milk,” since the Silk products are advantage to one industry over another.
mislead or confuse consumers. In a July plant-based, and FDA defines “milk” as Banning the use of descriptive terms, even
2018 statement, Scott Gottlieb, MD, then- a substance coming from lactating cows if they might conceivably be misconstrued
FDA Commissioner, stated that, “Because (the “milk claims”). The court forcefully by some consumers, is a very slippery
these dairy alternative products are often rejected the plaintiffs’ argument. In its de- slope and one that can have far-reaching
popularly referred to as ‘milk,’ we intend cision, the court asserted that the names and devastating implications. As for the
to look at whether parents may errone- “soymilk,” “almond milk,” and “coconut use of dairy terms to describe plant-based
ously assume that plant-based beverages’ milk” accurately describe Defendants’ products, it’s fair to say there are reason-
nutritional contents are similar to those products. able arguments on both sides. However,
of cow’s milk, despite the fact that some Further, the court noted that the name to the extent a manufacturer goes too far,
of these products contain only a fraction “almond milk” clearly conveyed the basic marketing a product that is in fact mislead-
of the protein or other nutrients found nature and content of the beverages, while ing, there are many remedies available to
in cow’s milk.” It is unclear at this point simultaneously distinguishing them from address that situation under the current
what that review has found or whether it cow’s milk. “Moreover, it is simply implau- civil and regulatory framework. As such,
remains ongoing. sible that a reasonable consumer would the courts will likely continue to reject fur-
mistake a product like soymilk or almond ther restraints. What state and federal leg-
Case Law milk with dairy milk from a cow. The first islators and regulators may do, however,
The cases that have been decided to date words in the products’ names should be is uncertain.
have been largely unfavorable to oppo- obvious enough to even the least discern- The only thing that is certain is that the
nents of plant-based dairy alternatives. ing of consumers,” the court concluded. Of lawyers will continue to milk this issue for
In Gitson v. Trader Joe’s Co., the plain- particular import, the court reasoned that all it’s worth. ■
tiffs sued to enjoin the sale of soy milk, adopting the plaintiffs’ position could in- Chappelle is a food industry lawyer and a consultant at Food
arguing they were misled to believe that crease confusion, “especially with respect Industry Counsel, LLC. Reach him at chappelle@foodindus-
organic soy milk complied with FDA’s stan- to other non-dairy alternatives such as goat trycounsel.com. Stevens, also a food industry attorney, is a
founding member of Food Industry Counsel, LLC. Reach him
dard of identity for milk and that organic milk or sheep milk.” at stevens@foodindustrycounsel.com.
June / July 2021 13Cannabis Corner
cannabinoid nanoemulsions in food and
beverages.
The Debate
“I have concerns about nanoemulsions in
general,” says Rebecca White, PhD, chief
technology officer for New Mexico–based
Trait Biosciences, which employs glyco-
sylation to offer a cannabinoid-infusion
technology that is an alternative to na-
noemulsions. Dr. White says there hasn’t
been enough study of nanoparticles in
food and beverages and, accordingly, food
nanoparticles are inadequately regulated.
“This suite of ingredients may have
unintended effects on cells and organs,
particularly the digestive tract,” says Dr.
White. “There are also indications that
nanoparticles may enter the bloodstream
and accumulate elsewhere in the body.
They have been linked to inflammation,
Nanoemulsions in Foods liver and kidney damage, and even heart
and brain damage.”
and Beverages Brad Douglass, PhD, is vice president
of intellectual property and regulatory af-
fairs for Monrovia, Calif.-based cannabis
Experts debate the safety of this technology for use biotechnology lab the Werc Shop. He offers
in cannabis-infused products | B Y J E S S E S T A N I F O R T H a largely opposing position, arguing that
if all ingredients used in the creation of a
V
nanoemulsion are classified as generally
isitors to cannabis trade shows In Canada in particular, where major recognized as safe (GRAS) for food use
in recent years may have no- beverage manufacturers own large stakes and are being used within acceptable con-
ticed the increasing number of among licensed cannabis producers, there centration limits, the nanoemulsion itself
companies touting some of the is a drive to deliver cannabis beverages as should be safe.
most advanced technology to be applied to a product that competes with alcoholic “If you’re using GRAS ingredients in
the consumption of cannabis: food-grade drinks. For such producers, nanoemul- the quantities and specifications that are
nanoemulsions. Such nanoemulsions en- sions are one of the most effective meth- permitted, that’s very unlikely to cause
capsulate a bioactive substance in a tiny ods not just to make cannabinoids water serious issues,” he tells Food Quality &
particle that can more easily be absorbed soluble, but also to make them metabolize Safety. “The term ‘nanoemulsion’ tends
by the body and combined with water or more quickly. While traditional edible to throw people off, particularly the ‘nano’
other ingredients. cannabis products normally have an on- prefix. When I see ‘nanoemulsion,’ I just
In the cannabis-infused food and bev- set time of more than one hour, products see ‘emulsion,’ and emulsions are emul-
erage industry, nanoemulsions are used to infused with cannabinoid nanoemulsions sions—you just have smaller vesicles and
make active cannabinoids, such as tetra- may take effect within as few as 15 min- a more stable emulsion that permeates.”
hydrocannabinol, cannabidiol, cannabig- utes—a huge gain for beverage producers David Julian McClements, PhD, dis-
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erol, and cannabinol, both water soluble hoping to make infused drinks as attrac- tinguished professor in the department
and bioavailable. These paired factors tive to consumers as hard seltzer and other of food science at the University of Massa-
make nanoemulsions a popular technol- market-leading alcohol products. chusetts Amherst, essentially concurs. Dr.
ogy in developing cannabis-infused bev- Yet, some in the cannabis industry McClements has published widely on the
erages, as well as other infused foods. have concerns about the safety of these subject of nanoemulsion safety and edited
14 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.coma book on the science of nanoemulsions. cern. “When it comes to food, there are Dr. Douglass, like Dr. White, stresses
He says, “We already consume nanoemul- fewer surfactants that have been judged to the gaps in understanding that sur-
sions in some foods (for example, homog- be GRAS for food use. There are so many round the emerging technology of
enized milk or soft drinks often contain types of surfactants—for example, poly- nanoemulsions.
nano-sized lipid droplets). If they are made sorbate, polysorbate 80 tween—these were “Lack of evidence isn’t evidence of
from digestible oils, which they typically developed for the pharmaceutical indus- lack,” Dr. Douglass says. “I tend to give
are, then they should be fully digested in try. Some have applicability for food use, some credence to anecdotal reports if they
the gastrointestinal tract, then behave like but some people have concerns. Are they happen over and over again. That window
normal fat.” [too effective as] surfactants, where they of uncertainty between what we know and
Likewise, Touseef Ahmed Wani, a se- start to bypass the intestinal barrier?” what we don’t know, there’s probably some
nior researcher at the University of Kash- At this point, Dr. Douglass’ position important effect.”
mir’s Department of Food Science and begins to align with that of Dr. White, who Wani notes that there are still ques-
Technology, was the lead author (along highlights the lack of understanding of tions surrounding how, for example,
with Dr. McClements) of a 2018 book chap- how nanoparticles are digested. nanoparticles are excreted. “Because
ter entitled “Safety of Nanoemulsions and “For organic nanoemulsions like those nanoemulsions are fabricated from food-
their Regulatory Status.” He tells Food that are used for delivering cannabinoids,” grade materials, the materials should nor-
Quality & Safety, “The analysis performed says Dr. White, “the concern is that little mally be excreted in urine,” he says. “How-
regarding the safety of nanoemulsions is known about the absorption or toxicity ever, because of their extremely small size,
reveals their use as safe at low concen- of the nanoparticles themselves. Canna- they could evade the xenobiotic pathways
trations. So, the use of nanoemulsions in binoids, including CBD, are pharmaco- and could be accumulated in various tis-
different foods is promising.” logically active ingredients. There is no sues or organs. Besides, they could find a
Yet, Wani is not categorical in his sup- way to know the health risks or effects of way across the blood–brain barrier and
port for nanoemulsions. He explains, “It is combining nanotechnology and cannabi- cause effects that are still a mystery.”
a matter of great concern to substantiate noids unless diligent toxicology study is All four scientists stress the impor-
the safety of nanoparticles before commer- conducted.” tance of continuing to develop new infor-
cializing them on the world food market.” The possibility remains that nanopar- mation to better understand nanoemul-
Wani lists four significant ques- ticles could be absorbed into different sion safety. Dr. McClements says, “It is
tions regarding the consumption of regions of the gastrointestinal tract, says important to carry out toxicity studies,” as
nanoemulsions: Dr. McClements, though he adds that he with any new food.
• Do nanoparticles have free access to doesn’t believe there is evidence to support As the most skeptical of the technol-
cells, or are they controlled in some this theory. ogy, Dr. White goes furthest, saying “I
way? “A particle that’s small enough can go think it is important to have rigorous stan-
• How long do nanoparticles remain in- around your cells—paracellular transport. dards for safety testing given how little we
side the body? That’s somewhat of a concern, at least a know about nanoemulsions in general,
• How are they excreted? conceptual concern, with nanoparticles,” and products using nanoemulsions should
• Do they have toxic effects? Dr. Douglass says. “With emulsions, the be subject to additional testing. It is not suf-
“These questions are yet to be an- idea is that you can disrupt that bilayer of ficient to test the nanoemulsion without
swered, [primarily] because the research the cells and make it more permeable to active ingredient and test the active ingre-
on the safety and toxicity of nanoparticles things it would normally keep out.” dient without the nanoemulsion; you have
is still in infancy,” Wani says. Yet, Dr. Douglass sees this concern as to test them separately and together.”
“mainly theoretical” in situations where Yet, she concludes on the note with
Where There’s Agreement all ingredients are designated GRAS for which Dr. Douglass most agrees, saying,
If it seems as though there are two camps of food use. Like Dr. McClements, he says “From a consumer transparency perspec-
diametrically opposed scientists debating there has been no “demonstrable concern tive, I think that products using nanopar-
the issue, there is much about nanoemul- from data sampling.” ticles should include that on the label
sions on which all parties essentially so that consumers may make informed
agree. The first factor everyone agrees on Lack of Evidence choices.”
is that nanoemulsions and nanoparticles This doesn’t mean that Dr. Douglass pre- “If I do have concerns about the use of
are an emerging technology we do not yet sumes the safety of GRAS nanoemulsions emulsions in cannabis beverages,” says
fully understand. This lack of a complete to be settled. He notes that GRAS designa- Dr. Douglass, “it’s the lack of transparency
understanding opens up serious questions tions change, and some ingredients des- in labelling. That’s a lot easier to enforce
about nanoemulsion safety, to which even ignated as GRAS have been removed from when you have an experienced regulator
an enthusiastic nanoemulsion supporter the list after they have become better un- like Health Canada overseeing things,
like Dr. Douglass yields. derstood. “But, generally there’s a pretty rather than [U.S.] state-based regulators.” ■
In particular, Dr. Douglass identifies good foundation to say there’s probably an
the issue of surfactant ingredients, which acceptable hazard or risk profile in using Staniforth is a freelance writer based in Montreal, Quebec,
lower surface tension, as a source of con- these ingredients,” he adds. Canada. Reach him at jbstaniforth@gmail.com.
June / July 2021 15FOOD SAFETY IN DRY,
LOW-MOISTURE, AND
LOW-WATER-ACTIVITY FOODS
Part 1: Emerging pathogens
BY PURNENDU C. VASAVADA, PHD,
AND ALVIN LEE, PHD
©JCHIZHE - STOCK.ADOBE.COM
16 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comCO V E R S T O R Y : F O O D S A F E T Y I N D R Y, LO W - M O I S T U R E , A N D LO W - W AT E R - A C T I V I T Y F O O D S
Despite the common
misconception that
bacteria aren’t able to
Editors’ note: This is part 1 of a two-part and during post-processing handling and survive and grow in dry,
series on emerging pathogens in dry, storage. Pathogens and spore-forming or-
low-moisture, and low-water-activity ganisms can survive during the extended low-moisture, and low-
foods. Part 1 looks at what pathogens pose storage of dried foods and ingredients, water-activity foods,
the most risk. Part 2, which will publish in and some pathogens are able to survive in
the August/September 2021 issue of Food a dehydrated state for long periods of time. managing the produc-
Quality & Safety, will focus on technologies Drying can inhibit the growth of microor- tion of dry foods and
and strategies for their control. ganisms, but vegetative cells and spores
D
can remain viable for months. Addition- controlling pathogenic
ried foods, low-moisture foods
(LMFs), and low-water-activity
ally, conditions during dehydration of dry
foods may increase the thermal resistance
bacteria poses a signifi-
foods (LawF) are those foods of the pathogens, protecting them from cant challenge.
and ingredients that have heat.
been dried to lower their mois- Many dried foods and ingredients are
ture content or/and reduce considered ready-to-eat (RTE) and are not
their water activity in order to preserve cooked prior to consumption. Thus, in inated with emerging pathogens such as
the food. The moisture content and water spite of a significant barrier to the growth Salmonella spp., Cronobacter sakazakii,
activity (aw) of dried foods are generally of pathogenic microorganisms provided B. cereus, Clostridium perfringens and C.
less than 25% (3% to 12%) and below 0.85, by low aw or low moisture content, dried, botulinum, E. coli O157:H7, and Staphylo-
respectively. Dried and LMFs are charac- LMFs and LawF are not inherently safe coccus aureus have been reported.
terized by low aw, ranging from 0.03 to 0.7. from pathogenic bacteria, as evidenced by Among these pathogens, Salmonella
Because moisture content is an import- the fact that dried foods and ingredients spp. are the most important, as they are
ant characteristic required for the growth have been increasingly involved in food- implicated in outbreaks associated with
and activity of microorganisms and en- borne illness outbreaks and recalls due a wide variety of food products and ingre-
zymes in food, lowering the moisture con- to contamination by emerging pathogens dients, including peanut butter, choco-
tent by drying and controlling the availabil- such as Salmonella spp., Bacillus cereus, late, powdered infant formula, almonds,
ity of water by reducing aw are among the Clostridium botulinum, E. coli O157:H7, and spices, and pet foods and treats. Some
most common ways of preserving food. Listeria monocytogenes. of these pathogens exhibit increased
Some common examples and cate- In this article, we will discuss the tolerance to heat, can survive for sev-
gories of dried foods and LMFs include emerging pathogens associated with dried eral months, and are found in dry foods
dried milk, egg powder, cocoa powder, foods, LMFs, and LawF. We’ll also give ex- and dry food ingredient processing and
flour, cereals, pasta, dried fruits and veg- amples of outbreaks and recalls, and dis- preparation environments. Major food-
etables, dried meats, meal, grits, herbs, cuss novel methods for dehydration and borne pathogens associated with dried,
condiments and spices, honey, hydrolyzed strategies and approaches for controlling LMF, and LawF and ingredients are listed
vegetable protein powder, peanut butter, these pathogens in the dry foods and pro- in Table 1 (see p. 20), along with their key
tree nuts and peanuts, powdered infant cessing environment. characteristics.
formula, and seeds and grains. The following is a brief description of
Drying is a very common and ancient Emerging Pathogens of Concern emerging pathogens associated with dried
method of food preservation. In LMFs, the The Centers for Disease Control defines foods:
moisture content and aw are reduced to a an emerging pathogen as an infectious Salmonella species: Salmonella en-
point at which spoilage and pathogenic agent whose incidence in humans has in- terica serovars have been the most com-
organisms are inhibited, resulting in an creased dramatically within the past two monly implicated bacteria in foodborne
increased shelf life for the foods. How- decades, or one that has the probability of illness outbreaks and recalls associated
ever, the drying process is not typically increasing in future. The agency includes with contaminated dried, LMF, and LawF
designed to inactivate microorganisms; new foodborne pathogens or those that and ingredients. Salmonella are Gram-neg-
therefore, dried foods and LMFs are not have been newly recognized as predom- ative, facultative anaerobic, non-spore
sterile foods. Dried foods may become con- inantly foodborne in the last 20 years. forming rods. There are more than 2,400
taminated with pathogens during harvest Many outbreaks of foodborne illnesses known strains of Salmonella. Foodborne
and storage, through processing equip- and widespread recalls caused by dried, illness outbreaks and recalls associated
ment and the processing environment, LMF, or low aw food /ingredients contam- (Continued on p. 18)
June / July 2021 17You can also read
