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PLUS Simplifying Allergen Control ■ Pathogen Detection in Low Moisture Foods ■ Traceability Using DNA
Volume 26 Number 1
FEBRUARY / MARCH 2019
Regulating
Food Safety
in 2019
Uncovering
new efforts to
improve food
quality standards
and prevent
future outbreaks
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Functional Foods Microbiology and Food Safety for the Handbook of
and Beverages: Technology of 21st Century: Vegetables and
In vitro Assessment of Fermented Foods, Managing HACCP and Food Vegetable Processing,
Nutritional, Sensory, 2nd Edition Safety Throughout the 2nd Edition
and Safety Properties Global Supply Chain,
2nd Edition
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Contents
FEBRUARY/MARCH 2019 • VOLUME 26 NUMBER 1 • www.foodqualityandsafety.com
Features
20
COVER STORY
Regulating
Food Safety
in 2019
Uncovering new efforts
to improve food quality standards and
prevent future outbreaks
BY TED AGRES
ORKIN LLC / ©PAKHNYUSHCHYY - STOCK.ADOBE.COM
Safety & Sanitation
24 27
Rodent Control with
Proactive Pest Management Remote Monitoring
Traceable policies help identify what Understanding how sensors
types of pests and how many are lurking allow pest management
behind the scenes to establish approaches professionals to actively
COVER: ©LENABSL / TALEX / DRAWKMAN - STOCK.ADOBE.COM
in preventing them from returning screen food facilities 24/7
BY MICHELLE HARTZER, BCE BY PATRICIA HOTTEL, BCE
Food Quality & Safety (ISSN 1092-7514) is published 6 times a year in Feb/Mar, Apr/May, Jun/July, Aug/Sept, Oct/Nov, Dec/Jan by Wiley Subscription Services, Inc.,
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February / March 2019 5
CO N T E N TS
(Continued
(Continued from
from p.
p. 5)
6)
NEW COLUMN
Quality Manufacturing & Food Defense
29 10 RESOLUTIONS TO Distribution 16 FOOD DEFENSE IS GOOD FOR
ENHANCE QUALITY AND BUSINESS
SAFETY PROGRAMS Addressing compliance
Ideas to start the New Year qualifications and responsibilities
right and improve upon food under the Intentional Adulteration
safety management systems rule reinforces honest and
BY RICHARD F. STIER effective communication between
all stakeholders
BY DAVID K. PARK
39 FITTING TRACEABILITY
INTO PRODUCE SAFETY:
Testing KEEPING IT REAL NEW COLUMN
32 TARGETING SHELLFISH
TOXINS
A traceability program is like
insurance coverage that is
Allergen Control
Stringent testing programs stop activated during recalls and 18 SIMPLIFYING COMPLEX
unique threats in seafood foodborne illness outbreaks WORLD OF ALLERGEN
BY TREVOR SUSLOW, PHD, ED TREACY, CONTROL
BY ALLISON HAMMERLY
JOHNNA HEPNER, AND VONNIE ESTES Practical tips on allergen
swabbing and choosing
a testing system
In The Lab Columns
BY STEVE L. TAYLOR, PHD, AND
JOE L. BAUMERT, PHD
34 AIM HIGH WHEN
DETECTING PATHOGENS IN
LOW MOISTURE FOODS Market Initiatives
From validated and verified
cleaning regimens to automated
12 GO FISH!
Seafood
Departments
pathogen testing practices, stakeholders are
©BAIBA OPULE / HVOSTIK16 - STOCK.ADOBE.COM / ©PRODUCE MARKETING ASSOCIATION
detailed workflows are helping 8 FROM THE EDITORS
continually casting
processors deliver safe products out advances in both 10 NEWS & NOTES
BY RAJ RAJAGOPAL, PHD safety and product development
BY LINDA L. LEAKE, MS 43 EVENTS
37 DNA AND FOOD TRACEABILITY 44 NEW PRODUCTS
Next-generation sequencing is
45 ADVERTISER INDEX
being used to assess the integrity
of food from a raw material to Legal Update 46 SCIENTIFIC FINDINGS
a final product 14 TO BE OR NOT TO BE
BY MÁRIO GADANHO, PHD, AND USDA releases final National Bio
FRANCK PANDIANI, PHD engineered Food Disclosure Rule
BY SHAWN K. STEVENS, ESQ. AND
JOEL S. CHAPPELLE, ESQ.
Food Quality & Safety magazine Other articles at www.FoodQualityandSafety.com/issue/february-march-2019:
welcomes letters to the editor on any
relevant industry topic. Letters should • Case Study: Meeting Strict Customer • Breastfeeding vs. Formula Feeding:
be no longer than 350 words. Standards in Potato Processing Debunking Myths
BY BOB SCHUMANN BY JAMIE WELLS, MD, FAAP
Submit letters to:
• Going Mobile for Internet of Things
Marian Zboraj, Professional Editor
and Traceability
Email: mzboraj@wiley.com
BY CORY HOVANETZ
(Letters may be edited for space or style.)
facebook.com/FoodQualityandSafety @FQSmag
6 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
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
From The Editors Lisa Dionne Lento, ldionne@wiley.com
PUBLISHER
SENIOR ACCOUNT MANAGER Ken Potuznik, kpotuzni@wiley.com
PROFESSIONAL EDITOR Marian Zboraj, mzboraj@wiley.com
DESIGN Maria Ender, mender@wiley.com
PRODUCTION Claudia Vogel, cvogel@wiley.com
T
Jörg Stenger, jstenger@wiley.com
his column was inspired Elli Palzer, palzer@wiley.com
by the late, great Made- CO-INDUSTRY EDITOR Purnendu C. Vasavada, PhD,
purnendu.c.vasavada@uwrf.edu
line Kahn and her role CO-INDUSTRY EDITOR Richard Stier, rickstier4@aol.com
as cabaret singer Lili Von
Advertising Director
Shtupp in Mel Brooks’ comedy Dan Nicholas
classic “Blazing Saddles.” Lili was 111 River Street, Hoboken, NJ 07030
(716) 587-2181, dnicholas@wiley.com
tired of men, whereas I am tired of
people trying to frighten me about Sales Office
U.S./CANADA/INTERNATIONAL
non-existent dangers in my food A | S | B | P| E
Fostering B2B editorial excellence Ken Potuznik
and in the environment. One surfs the internet and runs into American Society
of Business
29822 N 51st Place, Cave Creek, AZ 85331
Publication Editors (480) 419-1851 • fax (480) 718-7719
pieces about “Top 10 Most Dangerous Fruits,” or “15 Processed 2018 National kpotuzni@wiley.com
Foods to Avoid,” or “Chemicals that Cause Cancer.” Almost ev- PR INT Editorial Office
Award Winner
erything is based on bad or non-existent science, but people can Revenue of
$3 million or under
111 River Street, Hoboken, NJ 07030-5774, USA
Reprints: E-mail kpotuzni@wiley.com
write what they want thanks to freedom of speech.
As a resident of California, I am also constantly exposed to
Proposition 65 warnings. Signs at hardware stores read, “This
store sells products that contain chemicals deemed to be car- Editorial Advisory Panel
cinogenic under Proposition 65.” The same signs appear in the Ellen Bradley, CFS Vijay K. Juneja, PhD
Principal Food Scientist, Lead Scientist,
coffee shops, gas stations, car repair shops, and supermarkets. River City Food Group LLC Predictive Microbiology for Food Safety,
USDA-Agricultural Research Service
We are deluged by these warnings—so much so that I won- John N. Butts, PhD
der whether people are simply tuning things out. Founder and President, Hasmukh Patel, PhD
Technical Director and R&D Fellow–
FoodSafetyByDesign, LLC;
Is there an answer? Well, maybe. Websites could be more Advisor to CEO, Ingredient Solutions, Dairy Foods R&D,
Land O’Frost Land O’Lakes, Inc.
diligent when it comes to reviewing the “science” that they pub-
Mary Ann Platt
lish, but that is a stretch. Cliff Coles
President
President,
Our best answer might be federal legislation that makes food Clifford M. Coles CNS/FoodSafe and RQA, Inc.
Food Safety Consulting, Inc.
labeling and other product claims a federal Manpreet Singh, PhD
Professor, Dept. of Poultry Science,
I’m Tired prerogative. This could eliminate future Virginia Deibel, PhD
Director of Microbiology,
University of Georgia
Proposition 65s and prevent states from Eurofins Food Integrity
Shawn K. Stevens
& Innovation
enacting labeling laws that Food Industry Attorney,
Food Industry Counsel, LLC
would affect the whole coun- James Dickson, PhD
Professor, Patricia A. Wester
try; an example would be GMO Department of Animal Science, CEO, The Association for Food Safety
Iowa State University
labeling. But that is beyond me. Auditing Professionals, AFSAP
Unfortunately, food fad- Steven Gendel, PhD Steven Wilson
Senior Director, Director of Seafood Commerce and
dism and fearmongering are not new. Perhaps the solution is the Food Science, Certification, Office of International Affairs
Food Chemicals Codex at USP and Seafood Inspection
one proposed by San Francisco Chronicle columnist Art Hoppe
in his April 1989 piece entitled “Safe at Last.” In the column, he
tells the story of an overly cautious man named Harold who gave Printed in the United States by Dartmouth Printing, Hanover, NH.
up every food and product that was tested and deemed hazard- Copyright 2019 Wiley Periodicals, Inc., a Wiley Company. All rights reserved. No part
of this publication may be reproduced in any form or by any means, except as permitted
ous to his health. It wasn’t until Harold was reduced to a “safe” under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior
written permission of the publisher, or authorization through the Copyright Clearance
diet of organic rutabagas, alfalfa sprouts, and spring water that Center, 222 Rosewood Drive, Danvers, MA 01923: (978) 750-8400: fax (978) 750-4470.
his wife pointed out that every product that is tested seems to All materials published, including but not limited to original research, clinical notes,
editorials, reviews, reports, letters, and book reviews represent the opinions and views of
be hazardous—so it stands to reason that all products will turn the authors and do not reflect any official policy or medical opinion of the institutions with
out to be dangerous as soon as they are tested. Seeing no choice: which the authors are affiliated or of the publisher unless this is clearly specified. Materials
published herein are intended to further general scientific research, understanding, and
He [Harold] dug an organic hole in his backyard, placed discussion only and are not intended and should not be relied upon as recommending or
©REDBOXART - STOCK.ADOBE.COM
therein an organic pine box and climbed inside. “At last,” he said, promoting a specific method, diagnosis or treatment by physicians for any particular patient.
While the editors and publisher believe that the specifications and usage of equipment
as he pulled the lid down over him, “I shall be safe.” and devices as set forth herein are in accord with current recommendations and practice
(Read Art’s column in its entirety at https://bit.ly/2TExqEx.) at the time of publication, they accept no legal responsibility for any errors or omissions,
and make no warranty, express or implied, with respect to material contained herein.
Publication of an advertisement or other discussions of products in this publication should
Richard Stier not be construed as an endorsement of the products or the manufacturers’ claims. Readers
Co-Industry Editor are encouraged to contact the manufacturers with any questions about the features or
limitations of the products mentioned.
8 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
2019
Countdown to just desserts:
Last Call
for Entries
March 16, 2019
The 2019 Food Quality & Safety Award
If your company is a food processor, service or
retailer, and you uphold the highest food standards
supported by quantifiable results, you need to enter.
This prestigious award honors the dedication and
achievement of the food quality and safety assurance
team that has made exceptional contributions to their
company’s commitment in supplying safe
food products.
LEARN MORE AND APPLY AT:
https://www.foodqualityandsafety.com/award/
NEWS & NOTES
FDA Reports on Avocado and Hot Pepper Sampling
FDA releases two reports on its sampling of whole fresh avocados and hot peppers to determine the frequently
of harmful bacteria. For the hot pepper sampling, FDA analyzed domestic and imported hot pepper samples
for Salmonella, E. coli O157:H7, and other types of STEC. Of the 1,615 samples tested, 46 were positive for
Salmonella and one was positive for STEC, but further testing revealed that the STEC strain could not cause
severe illness. For the whole fresh avocado sampling, FDA analyzed 1,615 domestic and imported avo-
cado samples for Salmonella and Listeria monocytogenes. Of the 1,615 samples, 12 tested positive for
Salmonella. For the Listeria testing, the agency primarily tested the pulp of the avocado samples, and
some samples of the fruit’s skin. Of the 1,254 avocado pulp samples, three were positive for Listeria. Of
the 361 avocado skin samples, 64 were positive for Listeria. When FDA found positive samples in domestic
product, it worked with the responsible firms to conduct recalls and followed up with inspections of growers
and packinghouses to ensure they were following good agricultural and manufacturing practices. When FDA
found positive samples in imported product, the agency refused entry to all product in lots associated with the
positive(s), and placed the firms on import alert to stop additional product from entering the U.S.
Compliance Date for Food Labeling Rule
Business Briefs
FDA recently announced that Jan. 1, 2022, will be the uniform compliance date for final food ReposiTrak creates a Customer Advi-
labeling regulations that are issued in calendar years 2019 and 2020. All food products subject sory Board to provide the company with
to the Jan. 1, 2022, uniform compliance date must abide by the appropriate labeling regulations insights into challenges and opportu-
when initially introduced into interstate commerce on or after Jan. 1, 2022. This doesn’t change nities facing the retail industry and to
existing requirements for compliance dates contained in final rules published before Jan. 1, 2019. better align platform development with
customer needs.
Kerry signs a license agreement with
Global Food Safety Issues Increasing
Renaissance BioScience to supply
Through HorizonScan, FoodChain ID shares
Renaissance’s Acryleast, a non-GMO
its third quarter findings, noting an increase acrylamide-reducing yeast enzyme, to
in food integrity issues in key categories in- food and beverage manufacturers.
cluding poultry, seafood, vegetables, and
nuts. Poultry and poultry products saw an Bühler creates a Consumer Foods seg-
increase of issues by 14.3% over last quar- ment by combining the current choco-
ter, following a decline in Q1, which followed U.S. Farm Bill Opens Door on Hemp late, nuts, bakery, and coffee business
a record number of problems in 2017. These As reported by Reuters, FDA said on Dec. 20 with the Haas business.
issues stemmed primarily from Salmonella it will consider creating new policy regarding
Food Safety Net Services opens its
contamination in chicken meat from Brazil. the marketing and sale of cannabis after
latest analytical laboratory for the
Seafood issues continue to rise, up by 23.1% President Donald Trump signed the Farm
food and consumables industry in
due to issues such as mercury, altered or- Bill, which legalized commercial production Greeley, Colo.
ganolepsis or histamines in fish, and veter- of hemp in the U.S. The FDA said in a state-
inary drugs in crustaceans. There were also ment that it hopes to make more efficient Bright Light Agribusiness selects
issues with Listeria, E. coli, and Salmonella “pathways” for companies to introduce and TOMRA Food as its partner for an end-
in smoked/dried fish and clams. Other is- market cannabis and cannabis-derived prod- to-end almond sorting solution for
©KOVALEVA_KA / BASTIAANIMAGE - STOCK.ADOBE.COM
sues include pesticides found in peppers, ucts, including cannabidiol, into interstate its new processing facility in Hattah/
peas (with pods), strawberries, and goji ber- commerce. Hemp is a type of cannabis plant Victoria, Australia.
ries; and aflatoxins in almonds, pistachios, with no or extremely low concentrations of
Cloverleaf Cold Storage enters into an
hazelnuts, Brazil, and cashew nuts. On a the psychoactive compound known as THC,
agreement to merge with Zero Moun-
positive note, milk and dairy product haz- the ingredient in marijuana associated with
tain, a cold storage warehousing and
ard reports are down 4.7%, and meat and “high” feelings. The Farm Bill removes hemp transportation company serving cus-
meat product issues are down 14.1% after a from the Controlled Substances Act, allowing tomers in Arkansas.
Q2 increase of 9.9%. for its commercial production as long as the
plants contain no more than 0.3 percent THC.
10 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comMarket Initiatives SE A F O O D
“In cooperation with the Association
of Food and Drug Officials, the Seafood
HACCP Alliance has developed a uni-
form and cost-effective training pro-
gram for importers, processors, and
Go Fish! distributors of fish and fishery prod-
ucts,” Dr. Otwell notes.
Courses have been developed for
Seafood stakeholders are training in basic HACCP programs and
continually casting out the related Sanitation Control Proce-
advances in both safety dures. Train-the-trainer courses are
also offered. “The audience for these
and product development programs is the seafood processing and
BY LINDA L. LEAKE, MS importing industry, regulatory officials,
and extension agents based in the U.S.,”
Dr. Otwell relates.
W
Shrimp School
hen it comes to reeling in finfish aquaculture, with 35.7 million In 2000, Dr. Otwell initi-
seafood news, the catch of pounds produced. Atlantic salmon ated an annual Shrimp
the day is that the U.S. in- produced was valued at $67.7 million. School based at the Uni-
dustry is strong. Oysters had the highest volume for marine versity of Florida that has re-
It’s no fish tale that fishing and sea- shellfish production, 36.6 million pounds. cently been adopted under
food consumption in the U.S. increased the leadership of the National Fisheries
in 2017, with landings and value of domes- HACCP Training Institute (NFI). The first NFI edition was
tic fisheries continuing a strong, positive Hazard Analysis and Critical Control held in Manteo, N.C., in November 2018
trend, according to the National Oceanic Points (HACCP) training is strong in the and, based on the success of this event,
and Atmospheric Administration (NOAA). seafood industry, says Steve Otwell, PhD, a follow-up session is scheduled for April
Across the nation, fishermen landed 9.9 seafood specialist emeritus with the Uni- 2019 in the same location.
billion pounds of fish and shellfish in 2017, versity of Florida. Through the Florida Sea “Some 50,000 seafood professionals
while the U.S. imported 5.9 billion pounds Grant Seafood HACCP program, Dr. Ot- from every shrimp producing nation have
of seafood, NOAA notes in its annual Fish- well serves as coordinator of the National attended the schools to date,” Dr. Otwell
eries of the United States report released Seafood HACCP Alliance for Training and notes. “We cover how to monitor for bac-
Dec. 13, 2018. The estimated U.S. per capita Education. teria, sensory evaluation, temperature
consumption of fish and shellfish was 16.0 “The alliance provides science-based control, as well as product quality, safety,
pounds in 2017. information about aquatic food prod- and integrity.”
Overall, NOAA’s report says that the uct safety and quality through research,
highest-value U.S. commercial species in publications, and community outreach Public Health Training
2017 were salmon ($688 million), crabs programs,” Dr. Otwell explains. “Through Barry Nash, MS, North Carolina Sea
($610 million), lobsters ($594 million), its participation in the Seafood HACCP Al- Grant’s (NCSG) seafood technology and
shrimp ($531 million), scallops ($512 mil- liance, Florida Sea Grant provides curric- marketing specialist, and Jeff French, a
lion), and Alaska pollock ($413 million). ulum and essential training materials that regional environmental health specialist
By volume, the nation’s largest commercial enable seafood processors and importers with the North Carolina Division of Ma-
fishery remains Alaska pollock, which had to comply with federal food safety regula- rine Fisheries (NCDMF), focus on training
© HVOSTIK16 - STOCK.ADOBE.COM
near-record landings of 3.4 billion pounds. tions, including the Food Safety Modern- local health department inspectors and
NOAA notes that in 2016, estimated ization Act.” others regarding seafood safety.
freshwater plus marine U.S. aquaculture Since 1995, the Seafood HACCP Al- “The NCSG and NCDMF developed the
production was 633.5 million pounds, liance has trained over 90 percent of the North Carolina Seafood Quality and Safety
netting a value of $1.45 billion. Atlantic nation’s processors in food safety and com- Workshop to focus on seafood safety and
salmon was the leading species for marine pliance techniques. handling concerns in restaurants and re-
12 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comtail outlets, which the federal rule doesn’t ing to meet challenges in sion offers the major ben-
typically cover,” Nash says. aquaculture.” efits of labor efficiency,
This annual two-day training program As of the end of 2018, improved product recov-
is jointly organized by NCSG, NCDMF, and some 2,200 facilities in 35 ery, and precise control
the North Carolina Environmental Health countries on six continents of temperature, shape,
State of Practice Committee, French relates. are expected to be certified texture, moisture, and
“The target audiences are county-based against the BAP program, color.”
environmental health specialists who Hedlund reports. “Our stan- These extrusion
regulate restaurants and other retail food dards cover virtually 100 per- determinations came
establishments and seafood businesses, as cent of the finfish, crustacean, about in July 2016, when Sannito shipped
well as the general public,” he says. and mollusk species produced in aquacul- 500 pounds of frozen fish skins via FedEx
According to Nash and French, topics ture settings around the globe,” he elabo- to the Clextral pilot plant in Tampa, Fla.
presented include harvest methods, proper rates. “While there are other organizations “We ran the skins through an extruder
receiving and handling of seafood prod- that offer aquaculture auditing services, and it transformed them under high pres-
ucts, seafood-borne illnesses, economic BAP is the most comprehensive and is the sure and temperature, turning the colla-
fraud, and wholesale and retail HACCP is- only one that covers food safety.” gen in the skin into gummy bear texture,”
sues. Speakers are federal, state, and local Hedlund clarifies that BAP addresses Sannito says. “We added a few additional
experts in seafood safety and commerce. food safety for aquaculture facilities—the ingredients to achieve the desired consis-
“This training program is important process, not the food. “The ultimate goal tency and bind up the moisture.”
because new innovations in prepared with the BAP program is that the fish are Sannito opted for turning the pollock
seafood meals are starting to come from born in a BAP-certified hatchery, raised skins into a green rope (similar to licorice
restaurant chefs and community-sup- on a BAP-certified farm, fed feed from in appearance) and then cutting it into bite-
ported fisheries retailers who are not al- a BAP-certified mill, and processed in a sized pieces. While experimenting with
ways familiar with the safety rules that BAP-certified plant,” he relates. natural and artificial red and blue food col-
govern the production and distribution of ors during his day at the pilot plant, he de-
packaged-food products,” Nash empha- Resource Utilization: cided the natural Army green was the best.
sizes. “This course provides an overview Gone to the Dogs “The natural green color seemed
of the vulnerabilities and control measures There’s definitely something fishy about healthier and we wanted clean labels
that prevent, eliminate, or minimize safety the new product in development for four- showcasing a wholesome product,” San-
issues from dock to dish.” legged consumers at the Kodiak Seafood nito explains. “Our ultimate goal is to pro-
and Marine Science Center, a component duce a high-quality product that is safe for
Best Aquaculture Practices of the University of Alaska Fairbanks pets to eat, shelf stable, and enticing for
The Global Aquaculture Alliance (GAA), (UAF) College of Fisheries and Ocean humans to purchase.”
Portsmouth, N.H., offers Best Aquacul- Sciences. “We are making high-end dog In May 2017, Sannito and Quentin
ture Practices (BAP) certification to ensure treats from pollock skins,” says Chris Fong, PhD, Alaska Sea Grant’s seafood
that seafood products come from facilities Sannito, MS, an Alaska Sea Grant seafood marketing specialist, received the 2017
that are managed in an environmentally, technology specialist with this center, lo- Invent Alaska award for “innovation in re-
socially, and economically responsible cated on Kodiak Island. search leading to commercialization” from
manner, according to Steve Hedlund, “Currently, with pollock fillet pro- the UAF Fairbanks Office of Intellectual
GAA’s communications manager. duction, only about 25 percent of the fish Property and Commercialization.
“Established in 2002, BAP is the is recovered for consumption after har- “In 2018, a new funding opportunity
world’s most comprehensive third-party vest,” Sannito notes. “Millions of pounds came through with the UAF Center Ice
aquaculture certification program,” Hed- of product are either discharged as waste Seed Fund,” Sannito says. “This award is
lund relates. “It’s also the world’s only or processed for fish meal. But pollock is making a seed fund of $24,800 available to
third-party certification program encom- a valuable resource in our state, and pet move the pollock pet treats forward from
passing the entire aquaculture production treats can be a much higher-value com- the experimental stage to the commercial
chain. We oversee the standards develop- modity than fish meal, so our goal is to market.”
ment process and certification process for increase pollock’s utilization by adding To that end, Sannito and his longtime
hatcheries, farms, feed mills, and process- further value to this fish.” friend and business collaborator, Jerry Pu-
ing plants.” After some experimentation, San- pillo, MS, a marketing consultant based in
© ALTA OOSTHUIZEN - STOCK.ADOBE.COM
Hedlund explains that these standards nito determined that extrusion was the Hawaii, are currently pursuing industry
are audited for GAA by third-party certifi- most viable manufacturing method for partners to develop the pollock co-product
cation bodies, of which there are six cur- producing pollock pet treats. “At first, we for wholesale and retail sales.
rently. “We train their auditors regularly tried a forced air drying oven, but found According to Sannito, some pet food
to ensure every audit is fair, objective, this would be cost prohibitive due to the companies already make pet treats with
and traceable,” he says. “Our standards amount of labor required to prepare the fish components. “While some pet treat
are scientific, rigorous, and always evolv- material for drying,” he explains. “Extru- (Continued on p. 42)
February / March 2019 13LegalUpdate
“bioengineered” is misleading. AMS,
ostensibly in response to critics, wrote
that it had considered a variety of terms,
“but ultimately determined that bioen-
gineering and bioengineered food accu-
rately reflected the scope of disclosure
and the products and potential technol-
ogy at issue.” Moreover, AMS was con-
cerned that using terms such as “genetic
engineering” or “genetically modified
organisms” would conflict with preemp-
tion provisions.
Like almost any regulations that gov-
ern highly interpretive and controversial
subject matters, it is nearly impossible to
achieve consensus agreement. As for the
final BE Food Disclosure Rule, there are
compelling arguments on both sides. It re-
mains to be seen whether future changes
will be warranted, or what types of amend-
ments may eventually be enacted. For
now, and for better or worse, we have a
To BE or Not To BE Final Rule.
USDA releases final National Bioengineered What Is Bioengineered Food?
Predictably, given the controversy sur-
Food Disclosure Rule rounding bioengineering, much debate
BY SHAWN K. STEVENS, ESQ. AND JOEL S. CHAPPELLE, ESQ. has centered around how to define what is
(or is not) a BE food. The Final Rule adopts
I
the statutory definition of “bioengineered
n December 2018, the Agricultural advocates have responded favorably to it. food” as codified in the Amended Agri-
Marketing Service (AMS) published The Food Marketing Institute, for instance, cultural Marketing Act of 1946. Thus, BE
the final National Bioengineered lauded the Final Rule as a consistent and foods are those foods containing genetic
Food Disclosure Standard (Final transparent way to provide important in- material that has been modified through
Rule). Although mostly straightforward, formation to consumers regarding prod- in vitro recombinant DNA techniques, and
the rule does contain some nuance and ucts containing BE ingredients. for which the modification could not oth-
complexity, which regulated entities The Final Rule is not without crit- erwise be obtained naturally or through
should become familiar with before the ics, however. They charge that the rule is conventional breeding. It should be noted
Final Rule takes effect. deeply flawed, lacks transparency, and will that foods for which the presence of mod-
In short, the Final Rule requires food likely further confuse consumers. The Or- ified genetic material is due to incidental
manufacturers, importers, and retailers ganic Trade Association issued a statement additives are not considered BE.
who package and label food for retail expressing its deep disappointment with Even within the relatively technical
© SSSTOCKER / DEDMAZAY - STOCK.ADOBE.COM
sale or sell bulk food items (regulated the new rule. The Center for Science in the definition adopted in the Final Rule, sig-
entities) to disclose the presence of Public Interest expressed concern about nificant points of contention remain. For
bioengineered (BE) ingredients in their the potential for consumer confusion. instance, there are two countervailing
products. Importers and domestic entities More broadly, critics are especially viewpoints regarding whether highly re-
are subject to the same disclosure and com- unhappy with the lack of reference to fined foods and ingredients should be ex-
pliance requirements. genetically modified organisms (GMO) empted from BE disclosure requirements.
The Final Rule has been met with and genetic engineering in the disclosure One view, favored by many in the food in-
mixed reviews. By and large, industry requirements. They argue that the term dustry, holds that highly refined products
14 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comshould be exempt because the definition label, making it likely to be read and un- prescriptive requirements were deemed
expressly requires the presence of “genetic derstood by consumers under ordinary too difficult to implement.
material,” and genetic material is removed shopping conditions.
from highly refined foods in the course of The use of a USDA-approved Recordkeeping Require-
the refinement process. symbol is one form of BE food ments
Another view, counter to the first, is disclosure regulated enti- Every regulated entity subject
that the definition of “bioengineering” ties may use to designate BE to mandatory BE disclosure
ought to include highly refined products foods. AMS initially proposed must maintain customary or
because highly refined products that are three alternative symbols reasonable records that estab-
derived from genetically modified foods (with variations), all designed lish compliance. Records may
contain modified genetic material prior to to disclose a food’s BE status in a be kept in any format (hard copy
processing and may still contain modified non-disparaging manner. Ultimately, or electronic) and may be stored at any
genetic material—albeit at undetectable AMS adopted the two symbols located on business location. Examples of such re-
levels—after processing. this page. cords include invoices, bills of lading,
After thorough deliberation (the rule’s For regulated entities that do not wish supply chain records, country of origin
draft documents included significant to utilize the symbol, there are other per- records, process verifications, organic
written discussion on this topic), AMS has missible means of designating BE foods. certifications, and lab test results. Records
elected to adopt the first view. Though we One is on-package text. For foods (e.g., raw must be maintained for two years after the
understand and acknowledge both po- agricultural commodities or ingredients food is sold or shipped. USDA may request
sitions, we believe AMS made the right produced therefrom), the required text records, in which case records need to be
choice. Just from a practical standpoint, disclosure is “Bioengineered Food.” For produced within five business days.
it would be virtually impossible to deter- multi-ingredient foods that contain both AMS maintains a list of BE foods on its
mine whether a product containing no BE and non-BE ingredients, the required website. Foods on the list must be disclosed
detectable genetic material was derived text disclosure is “contains a bioengi- unless records are available to demonstrate
from modified genetic material. In any neered food ingredient.” they are not BE. Restaurants and similar
event, foods that do not contain detectable Disclosure of BE ingredients may be retail food establishments, as well as very
amounts of modified genetic material are also made through an electronic or digital small food manufacturers (< $2.5 million
exempt from BE disclosure requirements disclosure. Such disclosures must include in annual receipts) are exempted from
under the Final Rule. instructions to “scan here for more food the rule. The purpose of the BE foods list
Nevertheless, regulated entities must information” or similar language. Alter- is to provide a straightforward method
still be able to establish that their prod- natively, regulated entities can use a text of determining whether a food requires a
ucts do not contain detectable amounts of message disclosure, stating, “Text [com- BE disclosure. For products that contain a
modified genetic material. To do so, they mand word] to [number] for bioengineered food on the list, regulated entities would ei-
must maintain records that verify: 1) the food information.” ther make a disclosure consistent with the
food was made from a non-BE food; or, 2) In terms of placement, the disclosure National Bioengineered Food Disclosure
the food was refined using a process vali- may be placed anywhere on the principal Standard or not disclose if they believe the
dated to render the modified genetic ma- display panel or on the information panel food is not required to have a BE disclosure.
terial undetectable; or, 3) the absence of adjacent to the statement identifying the
detectable modified genetic material (i.e., name and location of the manufacturer/ Compliance Deadlines
test results). Acceptable types of records distributor. If there is insufficient space This Final Rule becomes effective on Feb.
may include, among others, supply chain on these panels, then on any other panel 19, 2019, and must be implemented by Jan.
records, organic certification, or documen- likely to be seen by a consumer under or- 1, 2020, except for small food manufactur-
tation that the ingredient is sourced from a dinary shopping conditions. ers, whose implementation date is Jan. 1,
country that does not allow production of Small food manufacturers have addi- 2021. The mandatory compliance date is
that specific ingredient in a BE form. tional options, such as directing consum- Jan. 1, 2022. Regulated entities may vol-
ers to call or visit a website for more untarily comply with the Final Rule until
Disclosure Requirements food information. This requires Dec. 31, 2021. All food manufacturers must
Generally, regulated entities an accompanying phone comply by Jan. 1, 2022.
have four options for disclos- number and/or website URL. The proposed compliance date of Jan.
ing the presence of BE ingre- Disclosure on small and very 1, 2020, is intended to align with FDA’s pro-
dients in their products: 1) a small packages may use an posed rule to extend the compliance dates
USDA-approved symbol; 2) on- abbreviated disclosure. for the changes to the Nutrition Facts and
package text; 3) electronic or AMS affirmatively decided Supplement Facts label final rule and the
digital disclosure; or, 4) a text mes- against prescribing specific type Serving Size final rule from July 26, 2018,
sage disclosure. The disclosure must be sizes for different disclosure options be- to Jan. 1, 2020, for manufacturers with $10
USDA AMS
of sufficient size and clarity to appear cause, given the enormous breadth and million or more in annual food sales.
prominently and conspicuously on the variety of available packaging options, (Continued on p. 42)
February / March 2019 15NEW COLUMN
Food Defense
pet food ingredients for economic gain
(i.e. they substituted inferior ingredi-
ents)—the company was ordered to
pay $7 million;
• A man from Belmont, Miss., plead
guilty in a U.S. District Court to di-
verting a possible 180 truckloads of
packaged food and beverage products
from 10 companies that were destined
for destruction or use in animal feed,
reselling these same goods for human
consumption on the open market and
also falsifying records on the pur-
ported “destruction” of these goods;
• A seafood business owner in New-
port News, Va., was charged with
committing Lacey Act (as amended)
and the Food, Drug, and Cosmetic
Act (FD&CA) (as amended) violations
for blending foreign-sourced crab
meat with Atlantic blue crab and mis-
labeling the crabmeat as “Product of
USA;” and
• In December 2018, after a long State
food fraud investigation, the New
York Attorney General reported the
“common practice” of seafood fraud
Food Defense as verified by “rampant” high levels
of species mislabeling found in ge-
Is Good for Business
nomically-tested seafood samples
taken from New York State supermar-
ket chains.
Addressing compliance qualifications and responsibilities These examples are what new FDA
under the Intentional Adulteration rule reinforces honest and Food Safety Modernization Act (FSMA)
intentional adulteration regulations, soon
effective communication between all stakeholders to be implemented, address. Regardless
BY DAVID K. PARK of the perpetrator’s motive (e.g., terrorism,
sabotage, extortion, counterfeiting, theft,
I
or economically motivated adulteration),
am grateful to Food Quality & Safety ples of recent intentional adulteration— intentional or unintentional food tamper-
magazine for the opportunity to economic and otherwise—include: ing can cause serious harm to humans
share my professional viewpoints • Australian-sourced fresh strawberries, and animals.
and personal experiences on the intentionally adulterated with sewing The arrival of FDA “Mitigation Strat-
subject of food defense and its critical im- needles, with subsequent copycat egies to Protect Food Against Intentional
portance to overall product security. As a metal contamination incidents, were Adulteration” (or as it’s perhaps better
new column, I hope Food Defense will pro- discovered in New Zealand and Sin- known, “Intentional Adulteration (IA)
vide subject matter knowledge, insight, gapore, causing consumer injury and Rule”), originally published as a Final
and thought-provoking conversation re- significantly disrupting global trade; Rule in the Federal Register on May 27,
garding experiences, challenges, and op- • The seizure of 45 tons of quality-ex- 2016 (81 FR 34166), will soon usher in new
portunities that confront us in managing pired, chemically-treated tuna from regulatory requirements for large food
food defense responsibilities. three seafood processing businesses businesses that must follow this rule. This
©WAVEBREAK3 - STOCK.ADOBE.COM
In case food defense-related news has in Spain that marketed and sold the requires certain businesses that manufac-
escaped your attention lately, a continuing seafood as “fresh;” ture, process/pack, or hold food must not
pattern of intentional adulteration and eco- • Two Missouri-based U.S. pet food in- only be already registered with FDA as a
nomic fraud incidents have been reported gredient companies and several in- Food Facility, but now must meet provi-
by both private and government media dividuals were convicted on a misde- sions of Section 415 of the FD&CA, conduct
sources around the globe in 2018. Exam- meanor count of selling misbranded a formal Vulnerability Assessment, and
16 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comdevelop and implement a Food Defense qualifications and responsibilities as con- 4. Does your facility pack, re-pack, la-
Plan. The IA Rule’s upcoming implemen- tained within the IA Rule. In regards to the bel, or re-label food where the container
tation and compliance date of July 26, 2019, qualifications: that directly contacts the food remains
is nearly upon us. If you must comply and 1. Are you the owner, operator, or agent intact? (21 CFR 121.5(c))
haven’t already addressed required facility in charge of a domestic or foreign facility 5. Is your facility a farm mixed-type
tasks that underpin the rule, the time to act that manufactures/processes, packs, facility that conducts activities that fall
is now! or holds food for consumption in the U.S within FDA’s “farm” definition? (21 CFR
and is required to register with FDA? (21 121.5(d))
IA Rule Basics CFR 121.1) 6. Does your facility produce alcoholic
Acts of intentional adulteration may take beverages? (21 CFR 121.5(e))
several forms: Acts intended to cause 7. Does your facility manufacture, pro-
wide-scale public health harm, such as As a food-related facility cess, pack, or hold food for animals? (21
acts of terrorism focused on safety of the covered under the require- CFR 121.5(f))
food supply, and acts of disgruntled em- ments of the IA Rule, 8. Is your facility a farm mixed-type
ployees, consumers, or competitors and facility whose only activities that would
their economically motivated adulteration trustworthiness must be be subject to section 418 of the FD&CA
for financial gain. Acts intended to cause earned by partnering with are on-farm manufacturing, processing,
wide-scale public health harm are asso- others occupying space in packing, or holding of eggs (in-shell,
ciated with intent to cause significant hu- other than raw agricultural commodities)
man morbidity and mortality. Other forms the global supply chain. and certain game meats? (Note that this
of adulteration are typically not intended is limited to small and very small busi-
to cause wide-scale harm, although public nesses. (21 CFR 121.5(g)) If applicable,
health harm results from unintended adul- 2. Does your business (including any your business is exempt from compliance
teration consequences that are unknown subsidiaries and affiliates) average less with the IA Rule.
to the perpetrator prior to the attack. At- than $10,000,000, adjusted for inflation, If you must comply with the IA Rule,
tacks intended to cause public health per year, during the three-year period the following are the principal tasks your
harm to both humans and animals are preceding the applicable calendar year in food-related business must formally
appropriately ranked as the highest risk. sales of human food plus the market value address:
Food defense experts Capt. Jon Woody, of human food manufactured, processed, 1. Develop and implement a written
Ryan Newkirk, and Colin Barthel of the packed, or held without sale (e.g., held for Food Defense Plan that includes (21 CFR
FDA Center for Food Safety and Applied a fee)? If so, your facility is exempt, except 121.126):
Nutrition Food Defense and Emergency that you are required to provide for official • A vulnerability assessment, including
Coordination Staff have made every effort review, upon request, documents suffi- required explanations, to identify sig-
to make all stakeholders aware and inform cient to show your status as a very small nificant vulnerabilities and actionable
and educate the global food industry and business. (21 CFR 121.5(a)) process steps (21 CFR 121.130(c));
regulating bodies, writ large, on agency ex- 3. Does your facility hold food, except • Mitigation strategies, including
pectations in how to comply with the new the holding of food in liquid storage tanks? required explanations (21 CFR
FSMA IA Rule. In addition, these agency (21 CFR 121.5(b)) 121.135(b));
“owners” have also been instrumental in (Continued on p. 42)
developing “Mitigation Strategies to Pro-
tect Food Against Intentional Adulteration:
Draft Guidance for Industry” (published in
June 2018 with the public comment period
closed in December 2018), on how to best
comply with agency IA Rule expectations
prior to the publication of its final guidance
document.
The IA Rule applies to the owner, op-
erator, or agent in charge of a domestic or
foreign food facility that manufactures/
processes, packs, or holds food for con-
©NORDRODEN - STOCK.ADOBE.COM
sumption in the U.S and is required to
register under section 415 of the FD&CA,
unless one of the exemptions provided in
21 CFR 121.5 applies. (21 CFR 121.1)
Let me briefly review the key FDA-di-
rected food defense facility compliance
February / March 2019 17NEW COLUMN
Allergen Control
also known as strip tests. Many aller-
gen-specific commercial companies offer
LFDs, including Neogen, r-Biopharm,
Romer Labs, and 3M. Commercial LFDs
exist to detect residues of peanut, milk,
egg, soy, gluten (wheat, rye, barley),
various tree nuts, crustacean shellfish,
and fish.
LFDs and swab tests are highly spe-
cific and based upon antibodies that bind
to protein(s) from the allergenic food.
These test methods are qualitative but
capable of detecting very low residual lev-
els of allergens on equipment surfaces.
Practical tips on allergen swabbing These methods can also be used for de-
tection of residues in clean-in-place (CIP)
and choosing a testing system final rinse water samples. Some compa-
BY STEVE L. TAYLOR, PHD AND JOE L. BAUMERT, PHD nies use these qualitative methods on in-
gredients or processed food samples, but
their use for such purposes is not recom-
F
mended unless careful evaluations have
DA has not mandated the use of develop an Allergen Control Plan, and ef- been done to ensure that the food matrix
allergen residue testing to assess fective and consistent procedures for the does not interfere with the detection of
the effectiveness of preventive al- cleaning of shared equipment. residues using LFDs.
lergen controls such as cleaning In the U.S., the major allergens are de- Because food allergens are proteins,
of shared equipment. However, the pru- fined as milk, eggs, fish, crustacean shell- allergen-specific swabs and LFDs are the
dent use of such methods is very useful fish (shrimp, crab, lobster), peanut, soy- most relevant approach to determine if
in determining whether allergen cleaning bean, tree nuts (walnut, cashew, etc.), and allergen residues remain on equipment
procedures (SSOPs) are effective and con- wheat. Ingredients derived from the major surfaces. However, other swab approaches
sistent. Increasingly, food companies do allergenic foods are also considered aller- are available, including general protein
use swab testing of equipment surfaces gens for labeling purposes, although the tests (e.g., 3M Clean-Trace) and ATP tests
for SSOP validation. comparative allergen loads (the amount (e.g., Charm AllerGiene). General protein
The Food Safety Modernization Act of protein from the allergenic source) tests detect protein residues from any
(FSMA) stipulates that allergens are a po- are highly variable from non-detectable source, allergen or not. ATP is a molecule
tential hazard. FSMA requires preventive (e.g., butter oil, cold-pressed soybean oil) found in all biological organisms, so ATP
allergen control implementation in man- to low (e.g., lactose) to high (e.g., wheat testing will detect soil residues on equip-
ufacturing facilities that handle allergens. flour, soybean flour, casein, whey protein ment surfaces from many sources. In our
The food industry makes extensive use concentrate). The effectiveness of allergen experience, general protein and ATP swab
of shared manufacturing equipment for SSOPs is typically focused on the major methods are slightly less sensitive than al-
multiple formulations, some containing allergenic foods and ingredients derived lergen-specific LFD methods. Due to their
allergenic foods or ingredients and others from them, especially ingredients with specificity, allergen-specific swabs with
not. The cleaning of shared equipment is high allergen loads. LFDs are more suitable for validation of
a critical preventive allergen control step. SSOP effectiveness.
While FDA has not yet released its antici- Allergen Swab Testing
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pated guidance on preventive allergen con- Allergen swabs can be effective in assess- Deciding on a Testing System
trol, it has already begun to conduct FSMA ing the cleanliness of equipment surfaces. Careful thought should be given to selec-
inspections, and some of those inspections The swabs can be tested directly using tion of the optimal commercial kit. The
have included assessment of preventive al- certain commercial kits such as Neogen following are some tips on choosing the
lergen controls. Thus, food companies us- Alert kits. More commonly, swab use is correct test to help ensure allergen SSOPs
ing allergenic foods or ingredients should coupled with lateral flow devices (LFD), are as effective as possible.
18 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comChoose the right swab. Swabs must levels of the allergen residue are present, Use the right technique. Swabbing of
remove protein residues that may adhere which overwhelms the detector antibodies hard-to-clean spots on the processing lines
to equipment surfaces, but must also be in the strip causing most (perhaps all) of (nooks and crannies) is important. Multi-
adsorbent. Swabs must also release the the allergen-antibody complexes to miss ple swabs should be taken, especially in
proteins back into an extraction solution. binding to the allergen-specific antibodies the initial stages of cleaning validation on
The swabs provided with commercial kits, bound at the test line in the strip—resulting a processing line to identify the spots that
such as the environmental swabs from in a false negative response. Some com- are hardest to clean. Those spots can then
Neogen, outperform regular cotton swabs. mercial LFDs have overload lines while become the focus of subsequent cleaning
Sponges should be avoided for al- others do not, and the level of allergen validations and verifications. Allergen
lergen testing, as they tend to hold on to needed to generate a false negative due cleaning protocol effectiveness should
proteins, failing to release them into ex- to overloading will be different for each be re-validated periodically or whenever
traction solutions. Furthermore, some commercial kit. With milk, overloading anything changes (product formulation,
sponges may contain microbial growth occurs at concentrations from 100 ppm up equipment matrix, processing condi-
media made from allergenic foods such as to >10,000 ppm (expressed as ppm NFDM), tions, etc.). The frequency of re-validation
milk and soy. is not fixed and is dependent upon the
Choose the most appropriate test frequency of changeovers. When using
method. The choice of an LFD that fits
your purpose is relatively straightforward:
Multiple swabs should the recommended environmental swabs,
the swabbing technique can vary without
It must be able to detect the allergen res- be taken, especially much effect on the observations. Swabs
idues in the product matrix of concern. in the initial stages of and surfaces can be either wet or dry.
Essentially, will the LFD detect residues cleaning validation Interpret the results. LFDs offer qual-
on the equipment surface before cleaning? itative results. Thus, results should be in-
Different commercial LFDs targeted on a processing line to terpreted primarily as negative or positive.
at residues of the same allergenic food are identify the spots that The goal for cleaning validation should be
not created equal. LFDs contain antibod- are hardest to clean. “negative by swab” after documenting that
ies raised against the allergenic food or the chosen LFD is fit for purpose.
specific proteins from the allergenic food. Commercial LFDs provide sensitiv-
Each commercial LFD kit has its own pro- ity limits in concentration terms, such as
prietary antibody/ies that may respond dif- depending upon the type of commercial ppm, and relate to the allergen concen-
ferently to the residues left on equipment kit. Serial dilutions of the swab or CIP rinse tration in the swab extraction solution.
surfaces. Food companies use a variety of water extraction solution can be used to This term has no bearing on the allergen
ingredients derived from a particular aller- avoid overloading. concentration that might be found on a fin-
genic food (e.g., milk-derived ingredients Set an achievable cleaning goal. LFD ished product that comes in contact with
can include non-fat dry milk, caseinates, swabs are used to validate the effectiveness the equipment surface. Swab test results
or whey derivatives). Don’t assume that of SSOPs for removal of detectable allergen should instead be provided in terms of µg/
a given LFD will detect all forms of milk residues from shared equipment surfaces cm2, but that presumes users will swab
equally well—some commercial milk LFDs (or CIP final rinse water). Each product uniform areas of the equipment surface.
do not detect whey or whey-based ingre- and processing line should be evaluated Since irregular surface areas are swabbed,
dients, for instance. The sensitivity levels separately. If formulations have similar the most appropriate expression of results
of different commercial kits for the same physical attributes (e.g., dry powders), would be µg/swab. And since the degree
analyte will also vary and be dependent on similar cleaning approaches can be used of hazard to the finished product cannot
the nature of the ingredient derived from on multiple formulations. When formu- be determined from a swab result, the goal
the allergenic source. lations contain multiple allergens, the should be “negative by swab” as noted
Processing conditions also affect a assessment can sometimes be limited to above unless you are brave enough to test
system’s ability to detect allergen residues the allergen that is present in the highest finished product (see below).
on equipment surfaces. Heat processing allergen load. Know when to test finished product.
causes protein aggregation, resulting in A corporate target level for effective The results of equipment surface swabs
difficulty with removal of residues from the allergen cleaning should be set, such cannot easily be translated to finished
surface and challenges with solubilization. as no detection of allergen residues on food products. Swabs with LFDs offer
Fermentation can alter proteins through swabs using a specific LFD with a partic- qualitative results while finished product
proteolysis, again affecting antibody rec- ular sensitivity level (e.g., no detection of testing is usually quantitative. LFDs tend
ognition on the LFD. milk protein residues with an LFD having to be extremely sensitive; they can detect
False negative results due to overload- a detection limit of 5 ppm). The LFD sen- extremely small amounts of allergen on
ing LFDs is a particularly important con- sitivity level will vary to some degree with equipment surfaces. When the subsequent
cern. Due to the “hook effect,” high levels the nature of the food matrix, but a general product is manufactured on the shared
of allergen residues can cause false neg- statement such as “no detection by swab equipment, allergen residues will likely
atives. The hook effect occurs when high with LFD” is usually sufficient. (Continued on p. 43)
February / March 2019 19You can also read
